Diclofenac (Tablets, Solution, Ointment, Cream, Gel, Drops, Suppositories, Transdermal patch) Instructions for Use
ATC Code
M01AB05 (Diclofenac)
Active Substance
Diclofenac (Rec.INN registered by WHO)
Clinical-Pharmacological Group
NSAID
Pharmacotherapeutic Group
Anti-inflammatory and antirheumatic agents; non-steroidal anti-inflammatory and antirheumatic agents; acetic acid derivatives and related substances
Pharmacological Action
NSAID, a phenylacetic acid derivative. It has a pronounced anti-inflammatory, analgesic, and moderate antipyretic effect. The mechanism of action is associated with the inhibition of COX activity, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins that play an important role in the pathogenesis of inflammation, pain, and fever.
The analgesic effect is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system).
In vitro, at concentrations equivalent to those achieved in the treatment of patients, it does not inhibit the biosynthesis of proteoglycans in cartilage tissue.
In rheumatic diseases, it reduces joint pain at rest and during movement, as well as morning stiffness and joint swelling, and helps to increase the range of motion. It reduces post-traumatic and postoperative pain, as well as inflammatory edema.
In post-traumatic and postoperative inflammatory conditions, it quickly relieves pain (occurring both at rest and during movement), reduces inflammatory edema and postoperative wound edema.
It inhibits platelet aggregation. With long-term use, it has a desensitizing effect.
Pharmacokinetics
After intramuscular injection of diclofenac at a dose of 75 mg, its absorption begins immediately. The Cmax in plasma is on average about 2.5 µg/ml (8 µmol/l) and is reached in approximately 20 minutes. The amount of the absorbed active substance is linearly dependent on the administered dose. The AUC after intramuscular injection of diclofenac is approximately 2 times greater than after its oral or rectal administration, since in the latter cases about half of the amount of diclofenac is metabolized during the “first pass” through the liver. With subsequent administrations, the pharmacokinetic parameters do not change. Provided that the recommended intervals between diclofenac injections are observed, no accumulation is noted. Plasma protein binding is 99.7%, mainly with albumin (99.4%). The apparent Vd is 0.12-0.17 l/kg.
Diclofenac penetrates into the synovial fluid, where its Cmax is reached 2-4 hours later than in the blood plasma. The apparent T1/2 from the synovial fluid is 3-6 hours. Two hours after reaching Cmax in the blood plasma, the concentration of diclofenac in the synovial fluid is higher than in the blood plasma, and its values remain higher for a period of up to 12 hours.
Diclofenac was detected in low concentrations (100 ng/ml) in the breast milk of one of the nursing mothers. The estimated amount of the drug entering the child’s body through breast milk is equivalent to 0.03 mg/kg/day.
The metabolism of diclofenac is carried out partially by glucuronidation of the unchanged molecule, but predominantly by single and multiple hydroxylation and methoxylation, leading to the formation of several phenolic metabolites, most of which are converted into glucuronic conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than Diclofenac.
The total systemic plasma clearance of diclofenac is 263±56 ml/min. The terminal T1/2 is 1-2 hours. The T1/2 of 4 metabolites, including two pharmacologically active ones, is also short and amounts to 1-3 hours.
About 60% of the drug dose is excreted by the kidneys in the form of glucuronic conjugates of the unchanged substance, as well as in the form of metabolites, most of which are also glucuronic conjugates. Less than 1% of diclofenac is excreted unchanged. The remaining part of the dose is excreted in the form of metabolites with bile.
The concentration of diclofenac in the blood plasma linearly depends on the applied dose.
Indications
Inflammatory and degenerative diseases of the musculoskeletal system, including rheumatoid, juvenile, chronic arthritis; ankylosing spondylitis and other spondyloarthropathies; osteoarthritis; gouty arthritis; bursitis, tenosynovitis; pain syndrome from the spine (lumbago, sciatica, ossalgia, neuralgia, myalgia, arthralgia, radiculitis); post-traumatic postoperative pain syndrome accompanied by inflammation (for example, in dentistry and orthopedics). Renal colic, biliary colic. Post-traumatic and postoperative pain syndrome accompanied by inflammation. Severe migraine attacks.
ICD codes
| ICD-10 code | Indication |
| G43 | Migraine |
| K80 | Cholelithiasis [cholelithiasis] (including biliary colic) |
| M05 | Seropositive rheumatoid arthritis |
| M08 | Juvenile arthritis |
| M10 | Gout |
| M13.9 | Arthritis, unspecified |
| M15 | Polyosteoarthritis |
| M19.9 | Unspecified arthrosis |
| M25.5 | Pain in joint |
| M42 | Spinal osteochondrosis |
| M45 | Ankylosing spondylitis |
| M47 | Spondylosis |
| M54 | Dorsalgia |
| M54.1 | Radiculopathy |
| M54.3 | Sciatica |
| M54.4 | Lumbago with sciatica |
| M65 | Synovitis and tenosynovitis |
| M70 | Soft tissue disorders related to use, overuse, and pressure |
| M71 | Other bursopathies |
| M79.1 | Myalgia |
| M79.2 | Neuralgia and neuritis, unspecified |
| N23 | Unspecified renal colic |
| R52.0 | Acute pain |
| R52.2 | Other chronic pain |
| T14.3 | Dislocation, sprain and strain of joint and ligament of unspecified body region |
| T14.9 | Injury, unspecified |
| ICD-11 code | Indication |
| 8A80.Z | Migraine, unspecified |
| 8A8Z | Headache disorders, unspecified |
| 8B93.Z | Radiculopathy, unspecified |
| 8E4A.1 | Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system |
| DC11.Z | Cholelithiasis, unspecified |
| FA05 | Polyosteoarthritis |
| FA0Z | Osteoarthritis, unspecified |
| FA20.0 | Seropositive rheumatoid arthritis |
| FA24.Z | Juvenile idiopathic arthritis, unspecified |
| FA25 | Gout |
| FA2Z | Inflammatory arthropathies, unspecified |
| FA85.Z | Defects of vertebral end-plates, unspecified |
| FA8Z | Degenerative disease of spine, unspecified |
| FA92.0Z | Ankylosing spondylitis, unspecified |
| FB40.Z | Tenosynovitis, unspecified |
| FB50.1 | Bursitis associated with use, overuse or pressure |
| FB50.Z | Bursitis, unspecified |
| FB56 | Specified soft tissue diseases, not elsewhere classified |
| FB56.2 | Myalgia |
| ME82 | Pain in joint |
| ME84.20 | Lumbago with sciatica |
| ME84.3 | Sciatica |
| ME84.Z | Back pain, unspecified |
| MF56 | Renal colic |
| MG30.Z | Chronic pain syndrome, unspecified |
| MG31.Z | Acute pain, unspecified |
| ND56.3 | Dislocation, sprain or strain of unspecified body region |
| ND56.Z | Unspecified injury of unspecified part of trunk, limb or body region |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution
It is administered deep intramuscularly. A single dose is 75 mg. If necessary, repeated administration is possible, but not earlier than after 12 hours.
The duration of use is no more than 2 days; if necessary, further switch to oral or rectal administration of diclofenac.
In severe cases (for example, with colic), as an exception, 2 injections of 75 mg each can be given, with an interval of several hours (the second injection should be given in the opposite gluteal region). Alternatively, intramuscular injection once a day (75 mg) can be combined with the intake of diclofenac in other dosage forms (tablets, rectal suppositories), while the total daily dose should not exceed 150 mg.
For migraine attacks, Diclofenac is recommended to be administered as early as possible after the onset of the attack, intramuscularly at a dose of 75 mg, followed by the use of suppositories at a dose of up to 100 mg on the same day, if required. The total daily dose should not exceed 175 mg on the first day.
Tablets
The dose is selected individually, it is recommended to use the minimum effective dose, if possible, with the shortest treatment period.
Ointment, Cream, Gel
For external use, the amount of the drug depends on the size of the painful area. A single dose depends on the dosage form used and the age of the patient.
Gel, ointment, spray for external use
For adults and children over 12 years of age, the drug should be applied to the skin over the area of inflammation 3-4 times a day, For children aged 6 to 12 years – up to 2 times a day.
The duration of use depends on the indications and the effectiveness of the treatment. After 2 weeks of using the drug, the patient should consult a doctor.
Transdermal patch
It is used in the form of applications on the skin.
For adults, elderly patients and adolescents over 15 years of age, the patch is applied to the skin over the painful area for 24 hours. Only 1 patch is allowed per day.
When treating soft tissue injuries, the patch is used for no more than 14 days, and when treating diseases of muscles and joints – for no more than 21 days, unless there are special doctor’s recommendations.
If there is no improvement in the condition after 7 days and if you feel worse, you should consult a doctor.
Suppositories
The dose is selected individually; it is recommended to use the drug at the minimum effective dose, if possible, with the shortest treatment period.
For adults, the recommended initial dose is 100-150 mg/day. In relatively mild cases of the disease, as well as for long-term therapy, 75-100 mg/day may be sufficient.
With the combined use orally in the form of tablets and rectally in the form of suppositories, the daily dose should not exceed 150 mg.
In debilitated patients, patients with low body weight, it is recommended to adhere to the minimum dose.
The drug should be used with particular caution in patients with cardiovascular diseases (including uncontrolled arterial hypertension) or a high risk of developing cardiovascular diseases. If long-term therapy (more than 4 weeks) is necessary in such patients, the drug should be used at a daily dose not exceeding 100 mg.
Children aged 1 year and older
The drug is prescribed at a dose of 0.5-2 mg/kg of body weight per day (in 2-3 doses, depending on the severity of the disease). For the treatment of rheumatoid arthritis, the daily dose can be increased to a maximum of 3 mg/kg (in several doses). The maximum daily dose is 150 mg.
Drops
The frequency and duration of use are determined individually.
For inhibition of intraoperative miosis, the drug is instilled into the conjunctival sac for 2 hours at 30-minute intervals (4 times in total) before surgery.
For the prevention of cystoid macular edema, the drug is instilled 1 drop 3-4 times a day for 2 weeks after surgery.
For other indications – 1 drop 3-4 times a day depending on the severity of the condition. The course of treatment can last from 1 to 2 weeks.
Transdermal patch
It is used in the form of applications on the skin.
For adults, elderly patients and adolescents over 15 years of age, the patch is applied to the skin over the painful area for 24 hours. Only 1 patch is allowed per day.
When treating soft tissue injuries, the patch is used for no more than 14 days, and when treating diseases of muscles and joints – for no more than 21 days, unless there are special doctor’s recommendations.
If there is no improvement in the condition after 7 days and if you feel worse, you should consult a doctor.
Adverse Reactions
From the digestive system: frequently – abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, decreased appetite, anorexia, increased activity of aminotransferases in the blood serum; rarely – gastritis, gastrointestinal bleeding, vomiting blood, melena, diarrhea with blood, stomach and intestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, impaired liver function; very rarely – stomatitis, glossitis, damage to the esophagus, the occurrence of diaphragm-like strictures in the intestine, colitis (non-specific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn’s disease), constipation, pancreatitis, fulminant hepatitis, liver necrosis, liver failure.
From the nervous system: frequently – headache, dizziness; rarely – drowsiness; very rarely – sensitivity disorders, including paresthesia, memory disorders, tremor, convulsions, anxiety, acute cerebrovascular accidents, aseptic meningitis; very rarely – disorientation, depression, insomnia, nightmares, irritability, mental disorders.
From the senses: frequently – vertigo; very rarely – visual disturbances (blurred vision), diplopia, hearing impairment, tinnitus, dysgeusia.
Dermatological reactions: frequently – skin rash; rarely – urticaria; very rarely – bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell’s syndrome (toxic epidermal necrolysis), exfoliative dermatitis, itching, hair loss, photosensitivity reactions; purpura, Henoch-Schönlein purpura.
From the genitourinary system: very rarely – acute renal failure, hematuria, proteinuria, tubulointerstitial nephritis, nephrotic syndrome, papillary necrosis.
From the hematopoietic system: very rarely – thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.
Allergic reactions: rarely – hypersensitivity, anaphylactic/anaphylactoid reactions, including decreased blood pressure and shock; very rarely – angioedema (including facial edema).
From the cardiovascular system: very rarely – palpitations, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction. There is evidence of a slight increase in the risk of cardiovascular thrombotic complications (for example, myocardial infarction), especially with long-term use of diclofenac in high doses (daily dose more than 150 mg).
From the respiratory system: rarely – asthma (including shortness of breath); very rarely – pneumonitis.
General reactions and disorders at the injection site frequently – pain, induration at the injection site; rarely – edema, necrosis at the injection site.
Contraindications
Hypersensitivity to diclofenac and excipients of the drug used; “aspirin triad” (attacks of bronchial asthma, urticaria and acute rhinitis when taking acetylsalicylic acid or other NSAIDs); erosive and ulcerative lesions of the gastrointestinal tract in the acute phase; severe renal failure (creatinine clearance <30 ml/min), progressive kidney disease; severe hepatic failure, active liver disease; clinically confirmed coronary artery disease, diseases of peripheral arteries and cerebral vessels, uncontrolled arterial hypertension, decompensated heart failure; cerebrovascular bleeding; hemostasis disorders; early postoperative period after coronary artery bypass surgery; confirmed hyperkalemia; third trimester of pregnancy; breastfeeding; childhood and adolescence under 18 years.
With caution
Suspected gastrointestinal disease; history of gastrointestinal bleeding and ulcer perforation (especially in elderly patients), Helicobacter pylori infections, ulcerative colitis, Crohn’s disease; mild and moderate liver dysfunction, hepatic porphyria (Diclofenac may provoke porphyria attacks); in patients with gastrointestinal anastomosis (risk of anastomosis integrity impairment), after gastrointestinal surgery (it is necessary to monitor the condition of patients); in patients with bronchial asthma, seasonal allergic rhinitis, edema of the nasal mucosa (including with polyps in the nasal cavity), COPD, chronic infectious diseases of the respiratory tract (especially those associated with allergic rhinitis-like symptoms); cardiovascular diseases (including coronary artery disease, cerebrovascular diseases, compensated heart failure, peripheral vascular diseases); renal dysfunction, including chronic renal failure (creatinine clearance 30-60 ml/min); dyslipidemia/hyperlipidemia; diabetes mellitus; arterial hypertension; significant decrease in circulating blood volume of any etiology (for example, in the periods before and after major surgical interventions); risk of thrombosis (including myocardial infarction and stroke); systemic connective tissue diseases; elderly patients, especially debilitated or with low body weight (Diclofenac should be used at the minimum effective dose); simultaneous use with drugs that increase the risk of gastrointestinal bleeding, including systemic corticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel, acetylsalicylic acid), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); simultaneous treatment with diuretics or other drugs that can impair renal function; when treating smoking patients or patients who abuse alcohol.
Use in Pregnancy and Lactation
There is insufficient data on the safety of diclofenac use in pregnant women. Therefore, prescription in the first and second trimesters of pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Diclofenac (like other prostaglandin synthesis inhibitors), is contraindicated in the third trimester of pregnancy (possible suppression of uterine contractility and premature closure of the arterial duct in the fetus).
Use is contraindicated during breastfeeding.
Use in Hepatic Impairment
Contraindications: severe hepatic insufficiency, active liver disease.
Use in Renal Impairment
Contraindications: severe renal insufficiency (CrCl<30 ml/min), progressive kidney disease.
Pediatric Use
Use is contraindicated in children and adolescents under 18 years of age.
Geriatric Use
Use with particular caution in elderly patients.
Special Precautions
During treatment, systematic monitoring of liver and kidney function, and peripheral blood picture is necessary.
The anti-inflammatory effect of diclofenac may mask the signs of infectious processes.
During treatment with systemic dosage forms, alcohol consumption is not recommended.
Effect on ability to drive vehicles and operate machinery
During treatment, a decrease in the speed of psychomotor reactions is possible. If visual acuity deteriorates after using eye drops, you should not drive a car or engage in other potentially hazardous activities.
Drug Interactions
Potent CYP2C9 inhibitors – when diclofenac and potent CYP2C9 inhibitors (such as voriconazole) are co-administered, an increase in serum diclofenac concentration and enhanced systemic effects may occur due to inhibition of diclofenac metabolism.
Lithium, digoxin – an increase in plasma concentrations of lithium and digoxin is possible. Monitoring of serum lithium and digoxin concentrations is recommended.
Diuretic and antihypertensive agents – when used concomitantly with diuretics and antihypertensive drugs (e.g., beta-blockers, ACE inhibitors), Diclofenac may reduce their antihypertensive effect.
Cyclosporine – the effect of diclofenac on prostaglandin activity in the kidneys may enhance the nephrotoxicity of cyclosporine.
Drugs that can cause hyperkalemia – concomitant use of diclofenac with potassium-sparing diuretics, cyclosporine, tacrolimus, and trimethoprim may lead to an increase in plasma potassium levels (if this combination is used, this parameter should be monitored frequently).
Quinolone-derived antibacterial agents – there are isolated reports of seizures in patients receiving both quinolone derivatives and Diclofenac.
NSAIDs and corticosteroids – concomitant systemic use of diclofenac and other systemic NSAIDs or corticosteroids may increase the frequency of adverse events (particularly from the gastrointestinal tract).
Anticoagulants and antiplatelet agents – an increased risk of bleeding cannot be excluded when diclofenac is used concomitantly with drugs of these groups.
Selective serotonin reuptake inhibitors – an increased risk of gastrointestinal bleeding is possible.
Hypoglycemic drugs – cases of both hypoglycemia and hyperglycemia cannot be excluded, which necessitated a change in the dose of hypoglycemic drugs during the use of diclofenac.
Methotrexate – if diclofenac is used within 24 hours before or within 24 hours after methotrexate administration, an increase in methotrexate blood concentration and enhancement of its toxic effects may occur.
Phenytoin – an enhancement of phenytoin’s effect is possible.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for intramuscular administration 25 mg/1 ml: amp. 3 ml 5 pcs.
Marketing Authorization Holder
Hemofarm, A.D. (Serbia)
Dosage Form
 |
Diclofenac | Solution for intramuscular administration 25 mg/1 ml: amp. 3 ml 5 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular administration transparent, from colorless to pale yellow, with a faint characteristic odor of benzyl alcohol.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients : benzyl alcohol, sodium metabisulfite, mannitol, sodium hydroxide, propylene glycol, water for injections.
3 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packages.
Extended-release tablets, film-coated, 100 mg: 20 pcs.
Marketing Authorization Holder
Hemofarm, A.D. (Serbia)
Dosage Form
|
Diclofenac | Extended-release tablets, film-coated, 100 mg: 20 pcs. |
Dosage Form, Packaging, and Composition
| Extended-release tablets, film-coated | 1 tab. |
| Diclofenac sodium | 100 mg |
10 pcs. – blisters (2) – cardboard packs.
Gel for external use 1%: tube 40 g
Marketing Authorization Holder
Hemofarm, A.D. (Serbia)
Manufactured By
Hemofarm A.D. Vrsac Branch Plant Sabac (Serbia)
Quality Control Release
HEMOFARM, A.D. (Serbia)
Dosage Form
 |
Diclofenac | Gel for external use 1%: tube 40 g |
Dosage Form, Packaging, and Composition
Gel for external use colorless, transparent, homogeneous.
| 1 g | |
| Diclofenac sodium (in the form of diclofenac diethylamine) | 10 mg (11.6 mg) |
Excipients : isopropanol, carbomer 940, polysorbate 80, benzyl alcohol, sodium disulfite, sorbitol, trolamine, purified water.
40 g – aluminum tubes (1) – cardboard packs.
Enteric-coated tablets, 25 mg: 30 pcs.
Marketing Authorization Holder
M.J. Biopharm Pvt. Ltd. (India)
Dosage Form
|
Diclofenac | Enteric-coated tablets, 25 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
| Enteric-coated tablets | 1 tab. |
| Diclofenac sodium | 25 mg |
Excipients : lactose, dried corn starch, disodium edetate, sodium metabisulfite, corn starch, magnesium stearate.
Enteric coating composition polymethacrylate, diethyl phthalate, titanium dioxide, yellow iron oxide, red iron oxide.
10 pcs. – blisters (3) – cardboard packs.
Enteric-coated tablets, 50 mg: 30 pcs.
Marketing Authorization Holder
M.J. Biopharm Pvt. Ltd. (India)
Dosage Form
|
Diclofenac | Enteric-coated tablets, 50 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
| Enteric-coated tablets | 1 tab. |
| Diclofenac sodium | 50 mg |
Excipients : lactose, dried corn starch, disodium edetate, sodium metabisulfite, corn starch, magnesium stearate.
Enteric coating composition polymethacrylate, diethyl phthalate, titanium dioxide, yellow iron oxide, red iron oxide.
10 pcs. – blisters (3) – cardboard packs.
Solution for intramuscular administration 75 mg/3 ml: amp. 5 pcs.
Marketing Authorization Holder
M.J. Biopharm Pvt. Ltd. (India)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 75 mg/3 ml: amp. 5 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intramuscular administration | 1 ml | 1 amp. |
| Diclofenac sodium | 25 mg | 75 mg |
Excipients : benzyl alcohol, sodium disulfite, propylene glycol, sodium hydroxide (to maintain pH level), water for injections.
3 ml – ampoules of dark glass (5) – contour plastic packs (1) – cardboard packs.
Rectal suppositories 50 mg: 6 or 10 pcs.
Marketing Authorization Holder
Magistra C&C (Romania)
Dosage Form
|
Diclofenac | Rectal suppositories 50 mg: 6 or 10 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Diclofenac sodium | 50 mg |
3 pcs. – non-cell contour packs (2) – cardboard packs.
5 pcs. – non-cell contour packs (2) – cardboard packs.
Eye drops 0.1%: 5 ml dropper bottle 1 pc.
Marketing Authorization Holder
S.C. Rompharm Company S.R.L. (Romania)
Dosage Form
|
Diclofenac | Eye drops 0.1%: 5 ml dropper bottle 1 pc. |
Dosage Form, Packaging, and Composition
Eye drops 0.1% as a clear or almost clear solution from colorless to light yellow.
| 1 ml | |
| Diclofenac sodium | 1 mg |
Excipients : macrogol glycerol hydroxystearate (polyoxyl castor oil), trometamol, disodium edetate dihydrate, mannitol, benzalkonium chloride, hydrochloric acid (1M solution), purified water.
5 ml – polymer dropper bottles (1) – cardboard packs.
Solution for intramuscular administration 75 mg/3 ml: amp. 5 pcs.
Marketing Authorization Holder
Shreya Life Sciences, Pvt.Ltd. (India)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 75 mg/3 ml: amp. 5 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular administration clear, colorless or light yellow.
| 1 ml | 1 amp. | |
| Diclofenac sodium | 25 mg | 75 mg |
Excipients : benzyl alcohol, sodium metabisulfite, propylene glycol, sodium hydroxide, sterile water for injections.
3 ml – ampoules (5) – polyethylene trays (1) – cardboard packs.
Extended-release tablets, film-coated, 100 mg: 20 pcs.
Marketing Authorization Holder
Shreya Life Sciences, Pvt.Ltd. (India)
Dosage Form
|
Diclofenac | Extended-release tablets, film-coated, 100 mg: 20 pcs. |
Dosage Form, Packaging, and Composition
Extended-release tablets, film-coated reddish-brown, round, biconvex.
| 1 tab. | |
| Diclofenac sodium | 100 mg |
Excipients : hypromellose, dibasic calcium phosphate, lactose, povidone K30, magnesium stearate, talc.
Coating composition: hypromellose, polyethylene glycol 6000, diethyl phthalate, titanium dioxide, red iron oxide.
10 pcs. – blisters (2) – cardboard packs.
Dental gel 30 mg+500 mcg/1 g: tube 20 g
Marketing Authorization Holder
Unique Pharmaceutical Laboratories (India)
Dosage Form
|
Diclofenac | Dental gel 30 mg+500 mcg/1 g: tube 20 g |
Dosage Form, Packaging, and Composition
| Dental gel | 1 g |
| Diclofenac sodium | 30 mg |
| Chlorhexidine (as 20% chlorhexidine gluconate solution) | 500 mcg |
20 g – aluminum tubes (1) – cardboard packs.
20 g – plastic tubes (1) – cardboard packs.
Rectal suppositories 50 mg: 10 pcs.
Marketing Authorization Holder
Altayvitamins, JSC (Russia)
Dosage Form
|
Diclofenac | Rectal suppositories 50 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories torpedo-shaped, from white to white with a creamy tint.
| 1 supp. | |
| Diclofenac sodium | 50 mg |
Excipients : macrogol 400 (polyethylene oxide 400) 0.1 g, solid fats sufficient to obtain a suppository weighing 2 g.
5 pcs. – contour cell packs (2) – cardboard packs.
Solution for intramuscular injection 25 mg/ml: amp. 5 pcs.
Marketing Authorization Holder
Armavir Biopharmaceutical Plant, FSE (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular injection 25 mg/ml: amp. 5 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular injection clear or slightly opalescent, slightly colored, with a faint odor of benzyl alcohol.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients : propylene glycol, mannitol, benzyl alcohol, sodium disulfite, sodium hydroxide solution 1M, water for injections.
3 ml – ampoules (5) – cardboard packs.
3 ml – ampoules (10) – cardboard packs.
3 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
3 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
Enteric-coated tablets, 25 mg: 10 or 20 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Dosage Form
|
Diclofenac | Enteric-coated tablets, 25 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
| Enteric-coated tablets | 1 tab. |
| Diclofenac sodium | 25 mg |
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
Tablets, enteric-coated, 50 mg: 10 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Dosage Form
|
Diclofenac | Tablets, enteric-coated, 50 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
| Tablets, enteric-coated | 1 tab. |
| Diclofenac sodium | 50 mg |
10 pcs. – blister packs (1) – cardboard packs.
Solution for intramuscular injection 25 mg/1 ml: amp. 5 or 10 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular injection 25 mg/1 ml: amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular injection colorless or slightly yellowish, transparent or slightly opalescent, with a faint odor of benzyl alcohol.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients: propylene glycol – 200 mg, benzyl alcohol – 40 mg, mannitol – 6 mg, sodium metabisulfite (sodium disulfite) – 3 mg, 1M sodium hydroxide solution – to pH 8.0-9.0, water for injections – to 1 ml.
3 ml – ampoules with a capacity of 5 ml (5) – blister packs (1) – cardboard packs.
3 ml – ampoules with a capacity of 5 ml (5) – blister packs (2) – cardboard packs.
3 ml – ampoules with a capacity of 5 ml (5) – cardboard trays (1) – cardboard packs.
3 ml – ampoules with a capacity of 5 ml (5) – cardboard trays (2) – cardboard packs.
Gel for external use 1 g/100 g: tube 25 g, 30 g, 40 g, 50 g, or 60 g or jars 5 g, 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, or 50 g
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Diclofenac | Gel for external use 1 g/100 g: tube 25 g, 30 g, 40 g, 50 g, or 60 g or jars 5 g, 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, or 50 g |
Dosage Form, Packaging, and Composition
Gel for external use 1% colorless or with a faint yellowish tint, transparent, odorless.
| 100 g | |
| Diclofenac sodium (calculated as 100% dry substance) | 1 g |
Excipients: isopropanol – 45 g, macrogol 7 glyceryl cocoate – 6 g, hypromellose 4000 (calculated as dry substance) – 3 g, Scots pine needle oil – 0.15 g, lavender oil – 0.05 g, purified water – to 100 g.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
5 g – dark glass jars (1) – cardboard packs.
10 g – dark glass jars (1) – cardboard packs.
15 g – dark glass jars (1) – cardboard packs.
20 g – dark glass jars (1) – cardboard packs.
25 g – dark glass jars (1) – cardboard packs.
30 g – dark glass jars (1) – cardboard packs.
35 g – dark glass jars (1) – cardboard packs.
40 g – dark glass jars (1) – cardboard packs.
50 g – dark glass jars (1) – cardboard packs.
Gel for external use 5%: tubes 25 g, 30 g, 40 g, 50 g, or 60 g
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Diclofenac | Gel for external use 5%: tubes 25 g, 30 g, 40 g, 50 g, or 60 g |
Dosage Form, Packaging, and Composition
Gel for external use 5% colorless or with a faint yellowish tint, transparent, with a characteristic odor.
| 100 g | |
| Diclofenac sodium | 5 mg |
Excipients: isopropanol – 45 g, macrogol glyceryl cocoate 7 – 6 g, hypromellose 4000 (calculated as dry substance) – 3 g, Scots pine needle oil – 0.15 g, lavender oil – 0.05 g, water – to 100 g.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
Ointment for external use 1%: tube 40, 50, or 100 g
Marketing Authorization Holder
Atoll LLC (Russia)
Dosage Form
|
Diclofenac | Ointment for external use 1%: tube 40, 50, or 100 g |
Dosage Form, Packaging, and Composition
Ointment for external use white or almost white, with a faint specific odor of dimethyl sulfoxide.
| 100 g | |
| Diclofenac sodium | 1 g |
Excipients: dimethyl sulfoxide 10 g, macrogol 1500 (polyethylene oxide-1500) 30 g, macrogol 400 (polyethylene oxide 400) 49 g, 1,2-propylene glycol 10 g.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
Enteric-coated tablets, 25 mg: 10, 20, or 30 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Diclofenac | Enteric-coated tablets, 25 mg: 10, 20, or 30 pcs. |
Dosage Form, Packaging, and Composition
| Tablets, enteric-coated | 1 tab. |
| Diclofenac sodium | 25 mg |
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
30 pcs. – dark glass jars (1) – cardboard packs.
Solution for intramuscular administration 75 mg/3 ml: amp. 10 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 75 mg/3 ml: amp. 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular administration transparent, slightly colored, with a faint odor of benzyl alcohol.
| 1 ml | 1 amp. | |
| Diclofenac sodium | 25 mg | 75 mg |
3 ml – ampoules (5) blister packs (2) – cardboard packs.
Rectal suppositories 50 mg: 10 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Diclofenac | Rectal suppositories 50 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Diclofenac sodium | 50 mg |
5 pcs. – blister packs (2) – cardboard packs.
Ointment for external use 10 mg/1 g: tube 30 g
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Diclofenac | Ointment for external use 10 mg/1 g: tube 30 g |
Dosage Form, Packaging, and Composition
Ointment for external use white or almost white, with a faint specific odor.
| 1 g | |
| Diclofenac sodium | 10 mg |
30 g – aluminum tubes (1) – cardboard packs.
Solution for intramuscular administration 75 mg/3 ml: amp. 10 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 75 mg/3 ml: amp. 10 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intramuscular administration | 1 ml | 1 amp. |
| Diclofenac sodium | 25 mg | 75 mg |
3 ml – ampoules (10) – cardboard packs.
Ointment for external use 10 mg/1 g: tube and jars 30 g
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
Diclofenac | Ointment for external use 10 mg/1 g: tube and jars 30 g |
Dosage Form, Packaging, and Composition
Ointment for external use white or almost white, with a faint specific odor.
| 1 g | |
| Diclofenac sodium | 10 mg |
30 g – aluminum tubes (1) – cardboard packs.
30 g – dark glass jars (1) – cardboard packs.
Solution for intramuscular injection 25 mg/ml: amp. 3 ml 3, 5, 6 or 10 pcs.
Marketing Authorization Holder
Bright Way, LLC (Russia)
Manufactured By
Velpharm, LLC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular injection 25 mg/ml: amp. 3 ml 3, 5, 6 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular injection transparent, colorless or slightly colored, with a faint characteristic odor.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients: benzyl alcohol, propylene glycol, mannitol, sodium disulfite, 1M sodium hydroxide solution, water for injections.
3 ml – ampoules (3) – cardboard pack.
3 ml – ampoules (5) – cardboard pack.
3 ml – ampoules (6) – cardboard pack.
3 ml – ampoules (10) – cardboard pack.
Gel for external use 1%: tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, 100 g, or 150 g
Marketing Authorization Holder
Vita Line, LLC (Russia)
Manufactured By
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Diclofenac | Gel for external use 1%: tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, 100 g, or 150 g |
Dosage Form, Packaging, and Composition
Gel for external use colorless or with a faint yellowish tint, transparent, with a characteristic odor.
| 100 g | |
| Diclofenac sodium | 1 g |
Excipients: isopropanol – 45 g, macrogol glyceryl cocoate – 6 g, hypromellose 4000 – 3 g, Scots pine needle oil – 0.15 g, lavender oil – 0.05 g, purified water – to 100 g.
20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
90 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.
150 g – tubes (1) – cardboard packs.
Solution for intramuscular administration 25 mg/1 ml: amp. 3 ml 5 or 10 pcs.
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 25 mg/1 ml: amp. 3 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular administration in the form of a transparent, colorless or slightly yellowish liquid with a light specific odor.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients: mannitol – 6 mg, propylene glycol – 200 mg, benzyl alcohol – 40 mg, sodium disulfite – 0.6 mg, 1M sodium hydroxide solution – to pH 7.8-8.8, water for injections – to 1 ml.
3 ml – low-density polyethylene ampoules (5) – cardboard packs.
3 ml – low-density polyethylene ampoules (10) – cardboard packs.
3 ml – polypropylene ampoules (5) – cardboard packs.
3 ml – polypropylene ampoules (10) – cardboard packs.
3 ml – glass ampoules (5) – blister packs (1) – cardboard packs.
3 ml – glass ampoules (5) – blister packs (2) – cardboard packs.
Solution for intramuscular injection 25 mg/ml: amp. 3 ml 5 or 10 pcs.
Marketing Authorization Holder
Dalkhimpharm, JSC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular injection 25 mg/ml: amp. 3 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular injection transparent slightly colored with a faint odor of benzyl alcohol.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients: propylene glycol 200 mg, mannitol (mannite) 6 mg, benzyl alcohol 40 mg, sodium disulfite (sodium metabisulfite) 3 mg, 1 M sodium hydroxide solution to pH 8.4, water for injections to 1 ml.
3 ml – ampoules (10) – cardboard boxes.
3 ml – ampoules (5) – blister packs (1) – cardboard packs.
3 ml – ampoules (5) – blister packs (2) – cardboard packs.
Rectal suppositories 50 mg: 10 pcs.
Marketing Authorization Holder
Dalkhimpharm, JSC (Russia)
Dosage Form
|
Diclofenac | Rectal suppositories 50 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Diclofenac sodium | 50 mg |
5 pcs. – blister packs (2) – cardboard packs.
Rectal suppositories 100 mg: 10 pcs.
Marketing Authorization Holder
Dalkhimpharm, JSC (Russia)
Dosage Form
|
Diclofenac | Rectal suppositories 100 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Diclofenac sodium | 100 mg |
5 pcs. – contour cell packs (2) – cardboard packs.
Ointment for external use 2%: tube 30 g
Marketing Authorization Holder
Zelenaya Dubrava, CJSC (Russia)
Dosage Form
|
Diclofenac | Ointment for external use 2%: tube 30 g |
Dosage Form, Packaging, and Composition
Ointment for external use white or white with a grayish tint.
| 100 g | |
| Diclofenac sodium | 2 g |
Excipients: carbomer (Arespol, polyacrylate lightly crosslinked) – 1 g, sodium hydroxide – 0.37 g, benzyl benzoate (medical benzyl benzoate) – 6 g, polysorbate 80 (Tween 80) – 1 g, methylparahydroxybenzoate (Nipagin) – 0.08 g, propylparahydroxybenzoate (Nipasol) – 0.02 g, purified water – up to 100 g.
30 g – aluminum tubes (1) – cardboard packs.
Extended-release tablets, film-coated, 100 mg: 20 pcs.
Marketing Authorization Holder
ZiO-Health CJSC (Russia)
Dosage Form
|
Diclofenac | Extended-release tablets, film-coated, 100 mg: 20 pcs. |
Dosage Form, Packaging, and Composition
| Extended-release tablets, film-coated | 1 tab. |
| Diclofenac sodium | 100 mg |
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (100) – cardboard boxes.
10 pcs. – contour cell packs (200) – cardboard boxes.
10 pcs. – contour cell packs (300) – cardboard boxes.
10 pcs. – contour cell packs (400) – cardboard boxes.
10 pcs. – contour cell packs (500) – cardboard boxes.
500 pcs. – jars (1) – cardboard boxes.
500 pcs. – jars (2) – cardboard boxes.
500 pcs. – jars (3) – cardboard boxes.
500 pcs. – jars (4) – cardboard boxes.
500 pcs. – jars (5) – cardboard boxes.
500 pcs. – jars (6) – cardboard boxes.
1000 pcs. – jars (1) – cardboard boxes.
1000 pcs. – jars (2) – cardboard boxes.
1000 pcs. – jars (3) – cardboard boxes.
1000 pcs. – jars (4) – cardboard boxes.
1000 pcs. – jars (5) – cardboard boxes.
1000 pcs. – jars (6) – cardboard boxes.
2000 pcs. – jars (1) – cardboard boxes.
2000 pcs. – jars (2) – cardboard boxes.
2000 pcs. – jars (3) – cardboard boxes.
2000 pcs. – jars (4) – cardboard boxes.
2000 pcs. – jars (5) – cardboard boxes.
2000 pcs. – jars (6) – cardboard boxes.
Ointment for external use 1%: jars or tubes
Marketing Authorization Holder
Ivanovo Pharmaceutical Factory PJSC (Russia)
Dosage Form
|
Diclofenac | Ointment for external use 1%: jars or tubes |
Dosage Form, Packaging, and Composition
Ointment for external use white or almost white, with a faint specific odor.
| 100 g | |
| Diclofenac sodium | 1 g |
Excipients: dimethyl sulfoxide – 10 g, macrogol 1500 – 30 g, macrogol 400 – 49 g, propylene glycol – 10 g.
30 g – jars – cardboard packs.
30 g – jars 9-300 pcs. – cardboard boxes (for hospitals).
30 g – tubes – cardboard packs.
30 g – tubes 9-300 pcs. – cardboard boxes (for hospitals).
40 g – jars – cardboard packs.
40 g – jars 9-300 pcs. – cardboard boxes (for hospitals).
40 g – tubes – cardboard packs.
40 g – tubes 9-300 pcs. – cardboard boxes (for hospitals).
50 g – jars – cardboard packs.
50 g – jars 9-300 pcs. – cardboard boxes (for hospitals).
50 g – tubes – cardboard packs.
50 g – tubes 9-300 pcs. – cardboard boxes (for hospitals).
100 g – jars – cardboard packs.
100 g – jars 9-300 pcs. – cardboard boxes (for hospitals).
100 g – tubes – cardboard packs.
100 g – tubes 9-300 pcs. – cardboard boxes (for hospitals).
Eye drops 0.1%: 5 ml bottle with dropper cap included
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
|
Diclofenac | Eye drops 0.1%: 5 ml bottle with dropper cap included |
Dosage Form, Packaging, and Composition
| Eye drops 0.1% | 1 ml |
| Diclofenac sodium | 1 mg |
5 ml – bottles (1) complete with dropper cap – cardboard packs.
1.3 ml – dropper tubes (5) – cardboard packs.
Enteric film-coated tablets, 25 mg: 20, 30, 40, or 50 pcs.
Marketing Authorization Holder
N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)
Dosage Form
|
Diclofenac | Enteric film-coated tablets, 25 mg: 20, 30, 40, or 50 pcs. |
Dosage Form, Packaging, and Composition
| Enteric film-coated tablets | 1 tab. |
| Diclofenac sodium | 25 mg |
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
Solution for intramuscular administration 75 mg/3 ml: amp. 5 pcs.
Marketing Authorization Holder
N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 75 mg/3 ml: amp. 5 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intramuscular administration | 1 ml | 1 amp. |
| Diclofenac sodium | 25 mg | 75 mg |
3 ml – ampoules (5) – contour packs (1) – cardboard packs.
3 ml – ampoules (5) – contour packs (2) – cardboard packs.
Cream for external use 2%: 30 g tube
Marketing Authorization Holder
Murom Instrument-Making Plant, JSC (Russia)
Dosage Form
|
Diclofenac | Cream for external use 2%: 30 g tube |
Dosage Form, Packaging, and Composition
Cream for external use homogeneous, from white to white with a grayish-cream tint.
| 100 g | |
| Diclofenac sodium | 2 g |
Excipients: carbomer (Arespol) – 2 g, benzyl benzoate – 6 g, polysorbate 80 (Tween 80) – 1 g, methylparahydroxybenzoate (Nipagin) – 0.08 g, propylparahydroxybenzoate (Nipasol) – 0.02 g, purified water – up to 100 g.
30 g – aluminum tubes (1) – cardboard packs.
Gel for external use 1%: tube 15, 20, or 30 g
Marketing Authorization Holder
Murom Instrument-Making Plant, FSUE (Russia)
Dosage Form
|
Diclofenac | Gel for external use 1%: tube 15, 20, or 30 g |
Dosage Form, Packaging, and Composition
Gel for external use transparent or opalescent, colorless or yellowish, with a specific odor.
| 100 g | |
| Diclofenac sodium | 1 g |
Excipients: sodium benzoate 0.25 g, carbomer 1.5 g, trolamine 1.8 g, disodium edetate 0.02 g, dimethyl sulfoxide 5 g, propylene glycol 20 g, macrogol 400 20 g, purified water up to 100 g.
15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
Enteric-coated tablets, 50 mg: 20 pcs.
Marketing Authorization Holder
Nizhpharm JSC (Russia)
Manufactured By
Chemopharm, LLC (Russia)
Dosage Form
|
Diclofenac | Enteric-coated tablets, 50 mg: 20 pcs. |
Dosage Form, Packaging, and Composition
| Enteric-coated tablets | 1 tab. |
| Diclofenac sodium | 50 mg |
10 pcs. – blisters (2) – cardboard packs.
Extended-release film-coated tablets, 100 mg: 20 pcs.
Marketing Authorization Holder
Nizhpharm JSC (Russia)
Manufactured By
Chemopharm, LLC (Russia)
Dosage Form
|
Diclofenac | Extended-release film-coated tablets, 100 mg: 20 pcs. |
Dosage Form, Packaging, and Composition
Extended-release film-coated tablets pink, round, biconvex; on cross-section, the core is white to almost white.
| 1 tab. | |
| Diclofenac sodium | 100 mg |
Excipients: sucrose, cetyl alcohol, colloidal silicon dioxide, talc, povidone K25, magnesium stearate; coating: hypromellose, titanium dioxide (E171, CI 77891), talc, polysorbate 80, macrogol 6000, Ponceau 4R dye (E124), brown dye [Sunset Yellow FCF dye (E110), Azorubine dye (E122), Brilliant Black BN dye (E151), aluminum hydroxide, water], aluminum lake based on Sunset Yellow FCF dye (E110).
10 pcs. – contour cell packs (2) – cardboard packs.
Enteric-coated tablets, 50 mg: 20 pcs.
Marketing Authorization Holder
Nizhpharm JSC (Russia)
Labeled By
CHEMOPHARM, LLC (Russia)
Dosage Form
|
Diclofenac | Enteric-coated tablets, 50 mg: 20 pcs. |
Dosage Form, Packaging, and Composition
| Enteric-coated tablets | 1 tab. |
| Diclofenac sodium | 50 mg |
10 pcs. – blisters (2) – cardboard packs.
Enteric-coated tablets, 25 mg: 30 pcs.
Marketing Authorization Holder
Novosibkhimpharm, JSC (Russia)
Manufactured By
Valenta Pharm, JSC (Russia)
Dosage Form
|
Diclofenac | Enteric-coated tablets, 25 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Enteric-coated tablets white, round, biconvex.
| 1 tab. | |
| Diclofenac sodium | 25 mg |
Excipients: lactose (milk sugar), calcium hydrogen phosphate dihydrate, potato starch, copovidone (Kollidon VA-64), calcium stearate, Acryl-EZE (copolymer of methacrylic acid and ethyl acrylate 1:1, titanium dioxide, talc, triethyl citrate, colloidal anhydrous silicon dioxide, sodium bicarbonate, sodium lauryl sulfate).
10 pcs. – contour cell packs (3) – cardboard packs.
Solution for intramuscular administration 25 mg/1 ml: amp. 3 ml 5 or 10 pcs.
Marketing Authorization Holder
Novosibkhimpharm, JSC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 25 mg/1 ml: amp. 3 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular administration transparent or slightly opalescent, slightly colored, with a faint odor of benzyl alcohol.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients: propylene glycol – 200 mg, mannitol (mannite) – 6 mg, benzyl alcohol – 40 mg, sodium disulfite (sodium pyrosulfite) – 3 mg, 1M sodium hydroxide solution – to pH 8.4 mg, water for injections – up to 1 ml.
3 ml – glass ampoules (5) – contour cell packs (1) – cardboard packs.
3 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
3 ml – glass ampoules (10) – contour cell packs (1) – cardboard packs.
3 ml – glass ampoules (10) – contour cell packs (2) – cardboard packs.
3 ml – glass ampoules (10) – cardboard boxes.
Solution for intramuscular administration 75 mg/3 ml: amp. 10 pcs.
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
Manufactured By
Microgen NPO, JSC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 75 mg/3 ml: amp. 10 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intramuscular administration | 1 ml | 1 amp. |
| Diclofenac sodium | 25 mg | 75 mg |
3 ml – ampoules (10) – cardboard packs.
Gel for external use 1%: tube 30 g
Marketing Authorization Holder
Elfa SPC, JSC (Russia)
Manufactured By
Indus Pharma Pvt. Ltd. (India)
Dosage Form
|
Diclofenac | Gel for external use 1%: tube 30 g |
Dosage Form, Packaging, and Composition
Gel for external use transparent, from whitish to yellowish, with a characteristic odor.
| 1 g | |
| Diclofenac diethylamine | 11.6 mg, |
| Equivalent to diclofenac content | 10 mg |
Excipients: isopropanol, propylene glycol, bronopol, sodium metabisulfite, carbomer 934, citric acid monohydrate, triethanolamine, purified water.
30 g – aluminum tubes (1) – cardboard packs.
Solution for intramuscular administration 25 mg/1 ml: amp. 3 ml 5 or 10 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 25 mg/1 ml: amp. 3 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular administration as a transparent, slightly yellowish liquid with a faint odor.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients: propylene glycol – 200 mg, mannitol – 6 mg, benzyl alcohol – 40 mg, sodium disulfite (sodium metabisulfite) – 3 mg, 1M sodium hydroxide solution – to pH 8.4, water for injections – to 1 ml.
3 ml – glass ampoules capacity. 5 ml (5) – plastic contour packages (1) – cardboard packs.
3 ml – glass ampoules capacity. 5 ml (5) – plastic contour packages (2) – cardboard packs.
3 ml – glass ampoules capacity. 5 ml (5) – cardboard packs.
3 ml – glass ampoules capacity. 5 ml (10) – cardboard packs.
3 ml – glass ampoules capacity. 5 ml (10) – cardboard boxes.
Rectal suppositories 50 mg: 5 or 10 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Diclofenac | Rectal suppositories 50 mg: 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories white or white with a creamy tint, torpedo-shaped.
| 1 supp. | |
| Diclofenac sodium | 50 mg |
Excipients: hard fat (Witepsol W35) – 1150 mg. Suppository mass – 1200 mg.
5 pcs. – contour cell packages (1) – cardboard packs.
5 pcs. – contour cell packages (2) – cardboard packs.
Rectal suppositories 100 mg: 5 or 10 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Diclofenac | Rectal suppositories 100 mg: 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories white or white with a creamy tint, torpedo-shaped.
| 1 supp. | |
| Diclofenac sodium | 100 mg |
Excipients: hard fat (Witepsol W35) – 2200 mg. Suppository mass – 2300 mg.
5 pcs. – contour cell packages (1) – cardboard packs.
5 pcs. – contour cell packages (2) – cardboard packs.
Gel for external use 1%: tubes 15 g or 25 g
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Dosage Form
|
Diclofenac | Gel for external use 1%: tubes 15 g or 25 g |
Dosage Form, Packaging, and Composition
| Gel for external use 1% | 1 g |
| Diclofenac sodium | 10 mg |
15 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
25 g – dark glass jars (1) – cardboard packs.
Gel for external use 5%: tubes 25 g, 50 g, or 100 g
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Diclofenac | Gel for external use 5%: tubes 25 g, 50 g, or 100 g |
Dosage Form, Packaging, and Composition
Gel for external use homogeneous, white or white with a yellowish or pinkish tint, with a characteristic odor.
| 100 g | |
| Diclofenac sodium | 5 g |
Excipients: carbomer – 1.7 mg, tromethamine – 1.65 g, propylene glycol – 25 g, ethanol 95% – 5 g, methylparaben – 0.14 g, lavender oil – 0.1 g, purified water – to 100 g.
25 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
25 g – jars (1) – cardboard packs.
25 g – jars (20) – cardboard boxes (for hospitals).
Gel for external use 1%: tubes 30 g or 50 g
Gel for external use 5%: tubes 30 g or 50 g
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Forms
|
Diclofenac | Gel for external use 1%: tubes 30 g or 50 g |
| Gel for external use 5%: tubes 30 g or 50 g |
Dosage Form, Packaging, and Composition
Gel for external use 1% white or white with a yellowish or creamy tint, homogeneous, with a specific odor.
| 1 g | |
| Diclofenac sodium | 10 mg |
Excipients: rectified ethanol, propylene glycol, carbomer (Carbopol), methylparaben (Nipagin), triethanolamine (trolamine), lavender oil, purified water.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
Gel for external use 5% white or white with a yellowish or creamy tint, homogeneous, with a specific odor.
| 1 g | |
| Diclofenac sodium | 50 mg |
Excipients: ethanol, propylene glycol, carbomer (Carbopol), methylparaben, triethanolamine (trolamine), lavender oil, purified water.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
Ophthalmic drops 0.1%: bottle or dropper bottle 5 ml
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Form
|
Diclofenac | Ophthalmic drops 0.1%: bottle or dropper bottle 5 ml |
Dosage Form, Packaging, and Composition
Ophthalmic drops 0.1% as a transparent colorless or light yellow solution.
| 1 ml | |
| Diclofenac sodium | 1 mg |
Excipients: sodium chloride, propylene glycol, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, disodium edetate, 1 M sodium hydroxide solution (to pH 6.5-7.5), water for injections.
5 ml – polymer dropper bottles (1) – cardboard packs.
Solution for intramuscular injection 75 mg/3 ml: amp. 5 or 10 pcs.
Marketing Authorization Holder
Slavic Pharmacy, LLC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular injection 75 mg/3 ml: amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular administration clear, from colorless to light yellow, with a faint characteristic odor of benzyl alcohol.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients: propylene glycol – 200 mg, benzyl alcohol – 40 mg, mannitol – 6 mg, sodium disulfite – 3 mg, 1M sodium hydroxide solution – to pH 8.0-9.0, water for injections – to 1 ml.
3 ml – polymer ampoules (5) – cardboard packs.
3 ml – polymer ampoules (10) – cardboard packs.
Transdermal patch 15 mg/24 h: packages 2, 5 or 7 pcs.
Marketing Authorization Holder
Selvim, LLC (Russia)
Manufactured By
Sinil Pharmaceutical, Co. Ltd. (Republic Of Korea)
Packaging and Quality Control Release
SINIL PHARMACEUTICAL, Co. Ltd. (Republic Of Korea)
Or
SELVIM, LLC (Russia)
Dosage Form
|
Diclofenac | Transdermal patch 15 mg/24 h: packages 2, 5 or 7 pcs. |
Dosage Form, Packaging, and Composition
Transdermal patch on a non-woven base, light brown in color, rectangular in shape with rounded edges 70 mm × 101 mm, with a transparent adhesive layer of patch mass, without traces of the adhesive layer sticking to the white protective paper.
| 1 patch | |
| Diclofenac sodium | 15 mg |
Excipients: sorbitan monooleate – 16.966 mg, ethanol – 40.704 mg, L-menthol flavor – sufficient quantity, acrylic adhesive solution – 873.932 mg, rubber adhesive solution – 400 mg, non-woven backing, white protective paper.
2 pcs. – bags (1) – cardboard packs.
5 pcs. – bags (1) – cardboard packs.
7 pcs. – bags (1) – cardboard packs.
Gel for external use 1%: tubes 30 g or 50 g
Marketing Authorization Holder
Tatkhimpharmpreparaty, JSC (Russia)
Dosage Form
|
Diclofenac | Gel for external use 1%: tubes 30 g or 50 g |
Dosage Form, Packaging, and Composition
Gel for external use colorless or yellowish, semi-transparent, opalescent, with a characteristic odor.
| 100 g | |
| Diclofenac sodium | 1 g |
Excipients: carbomer 940 (Carbopol 980), methylparaben (Nipagin), macrogol 400, polyester PE 240, ethanol 95%, purified water.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
Rectal suppositories 50 mg: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 21, 24, 25, 27, 28 or 30 pcs.
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Diclofenac | Rectal suppositories 50 mg: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 21, 24, 25, 27, 28 or 30 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories from white to white with a yellowish tint, torpedo-shaped.
| 1 supp. | |
| Diclofenac sodium | 50 mg |
Excipients: macrogol 400 (polyethylene oxide 400) – 0.1 g, hard fat (Witepsol (grades H15, W35), Suppocire (grades NA15, NAS50)) – to obtain a suppository weighing 2 g.
1 pc. – contour cell packages (1) – cardboard packs.
1 pc. – contour cell packages (2) – cardboard packs.
1 pc. – contour cell packages (3) – cardboard packs.
1 pc. – contour cell packages (4) – cardboard packs.
1 pc. – contour cell packages (5) – cardboard packs.
1 pc. – contour cell packages (6) – cardboard packs.
1 pc. – contour cell packages (7) – cardboard packs.
1 pc. – contour cell packages (8) – cardboard packs.
1 pc. – contour cell packages (9) – cardboard packs.
1 pc. – contour cell packages (10) – cardboard packs.
2 pcs. – contour cell packages (1) – cardboard packs.
2 pcs. – contour cell packages (2) – cardboard packs.
2 pcs. – contour cell packages (3) – cardboard packs.
2 pcs. – contour cell packages (4) – cardboard packs.
2 pcs. – contour cell packages (5) – cardboard packs.
2 pcs. – contour cell packages (6) – cardboard packs.
2 pcs. – contour cell packages (7) – cardboard packs.
2 pcs. – contour cell packages (8) – cardboard packs.
2 pcs. – contour cell packages (9) – cardboard packs.
2 pcs. – contour cell packages (10) – cardboard packs.
3 pcs. – contour cell packages (1) – cardboard packs.
3 pcs. – contour cell packages (2) – cardboard packs.
3 pcs. – contour cell packages (3) – cardboard packs.
3 pcs. – contour cell packages (4) – cardboard packs.
3 pcs. – contour cell packages (5) – cardboard packs.
3 pcs. – contour cell packages (6) – cardboard packs.
3 pcs. – contour cell packages (7) – cardboard packs.
3 pcs. – contour cell packages (8) – cardboard packs.
3 pcs. – contour cell packages (9) – cardboard packs.
3 pcs. – contour cell packages (10) – cardboard packs.
4 pcs. – contour cell packages (1) – cardboard packs.
4 pcs. – contour cell packages (2) – cardboard packs.
4 pcs. – contour cell packages (3) – cardboard packs.
4 pcs. – contour cell packages (4) – cardboard packs.
4 pcs. – contour cell packages (5) – cardboard packs.
4 pcs. – contour cell packages (6) – cardboard packs.
4 pcs. – contour cell packages (7) – cardboard packs.
5 pcs. – contour cell packages (1) – cardboard packs.
5 pcs. – contour cell packages (2) – cardboard packs.
5 pcs. – contour cell packages (3) – cardboard packs.
5 pcs. – contour cell packages (4) – cardboard packs.
5 pcs. – contour cell packages (5) – cardboard packs.
5 pcs. – contour cell packages (6) – cardboard packs.
6 pcs. – contour cell packages (1) – cardboard packs.
6 pcs. – contour cell packages (2) – cardboard packs.
6 pcs. – contour cell packages (3) – cardboard packs.
6 pcs. – contour cell packages (4) – cardboard packs.
6 pcs. – contour cell packages (5) – cardboard packs.
7 pcs. – contour cell packages (1) – cardboard packs.
7 pcs. – contour cell packages (2) – cardboard packs.
7 pcs. – contour cell packages (3) – cardboard packs.
7 pcs. – contour cell packages (4) – cardboard packs.
8 pcs. – contour cell packages (1) – cardboard packs.
8 pcs. – contour cell packages (2) – cardboard packs.
8 pcs. – contour cell packages (3) – cardboard packs.
9 pcs. – contour cell packages (1) – cardboard packs.
9 pcs. – contour cell packages (2) – cardboard packs.
9 pcs. – contour cell packages (3) – cardboard packs.
10 pcs. – contour cell packages (1) – cardboard packs.
10 pcs. – contour cell packages (2) – cardboard packs.
10 pcs. – contour cell packages (3) – cardboard packs.
Rectal suppositories 100 mg: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 21, 24, 25, 27, 28 or 30 pcs.
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Diclofenac | Rectal suppositories 100 mg: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 21, 24, 25, 27, 28 or 30 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories from white to white with a yellowish tint, torpedo-shaped.
| 1 supp. | |
| Diclofenac sodium | 100 mg |
Excipients: macrogol 400 (polyethylene oxide 400) – 0.1 g, hard fat (Witepsol (grades H15, W35), Suppocire (grades NA15, NAS50)) – to obtain a suppository weighing 2 g.
1 pc. – contour cell packaging (1) – cardboard packs.
1 pc. – contour cell packaging (2) – cardboard packs.
1 pc. – contour cell packaging (3) – cardboard packs.
1 pc. – contour cell packaging (4) – cardboard packs.
1 pc. – contour cell packaging (5) – cardboard packs.
1 pc. – contour cell packaging (6) – cardboard packs.
1 pc. – contour cell packaging (7) – cardboard packs.
1 pc. – contour cell packaging (8) – cardboard packs.
1 pc. – contour cell packaging (9) – cardboard packs.
1 pc. – contour cell packaging (10) – cardboard packs.
2 pcs. – contour cell packaging (1) – cardboard packs.
2 pcs. – contour cell packaging (2) – cardboard packs.
2 pcs. – contour cell packaging (3) – cardboard packs.
2 pcs. – contour cell packaging (4) – cardboard packs.
2 pcs. – contour cell packaging (5) – cardboard packs.
2 pcs. – contour cell packaging (6) – cardboard packs.
2 pcs. – contour cell packaging (7) – cardboard packs.
2 pcs. – contour cell packaging (8) – cardboard packs.
2 pcs. – contour cell packaging (9) – cardboard packs.
2 pcs. – contour cell packaging (10) – cardboard packs.
3 pcs. – contour cell packaging (1) – cardboard packs.
3 pcs. – contour cell packaging (2) – cardboard packs.
3 pcs. – contour cell packaging (3) – cardboard packs.
3 pcs. – contour cell packaging (4) – cardboard packs.
3 pcs. – contour cell packaging (5) – cardboard packs.
3 pcs. – contour cell packaging (6) – cardboard packs.
3 pcs. – contour cell packaging (7) – cardboard packs.
3 pcs. – contour cell packaging (8) – cardboard packs.
3 pcs. – contour cell packaging (9) – cardboard packs.
3 pcs. – contour cell packaging (10) – cardboard packs.
4 pcs. – contour cell packaging (1) – cardboard packs.
4 pcs. – contour cell packaging (2) – cardboard packs.
4 pcs. – contour cell packaging (3) – cardboard packs.
4 pcs. – contour cell packaging (4) – cardboard packs.
4 pcs. – contour cell packaging (5) – cardboard packs.
4 pcs. – contour cell packaging (6) – cardboard packs.
4 pcs. – contour cell packaging (7) – cardboard packs.
5 pcs. – contour cell packaging (1) – cardboard packs.
5 pcs. – contour cell packaging (2) – cardboard packs.
5 pcs. – contour cell packaging (3) – cardboard packs.
5 pcs. – contour cell packaging (4) – cardboard packs.
5 pcs. – contour cell packaging (5) – cardboard packs.
5 pcs. – contour cell packaging (6) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (3) – cardboard packs.
6 pcs. – contour cell packaging (4) – cardboard packs.
6 pcs. – contour cell packaging (5) – cardboard packs.
7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
8 pcs. – contour cell packaging (1) – cardboard packs.
8 pcs. – contour cell packaging (2) – cardboard packs.
8 pcs. – contour cell packaging (3) – cardboard packs.
9 pcs. – contour cell packaging (1) – cardboard packs.
9 pcs. – contour cell packaging (2) – cardboard packs.
9 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
Gel for external use 1%: jars 5 g, 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, or 100 g, tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, or 100 g
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Diclofenac | Gel for external use 1%: jars 5 g, 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, or 100 g, tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, or 100 g |
Dosage Form, Packaging, and Composition
Gel for external use colorless or with a faint yellowish tint, transparent, with a characteristic odor.
| 100 g | |
| Diclofenac sodium | 1 g |
Excipients: 2-propanol – 45 g, macrogol 7 glyceryl cocoate – 6 g, hypromellose 4000 – 3 g, Scots pine needle oil – 0.15 g, lavender oil – 0.05 g, purified water – up to 100 g.
5 g – jars (1) – cardboard packs.
10 g – jars (1) – cardboard packs.
15 g – jars (1) – cardboard packs.
20 g – jars (1) – cardboard packs.
25 g – jars (1) – cardboard packs.
30 g – jars (1) – cardboard packs.
35 g – jars (1) – cardboard packs.
40 g – jars (1) – cardboard packs.
50 g – jars (1) – cardboard packs.
60 g – jars (1) – cardboard packs.
70 g – jars (1) – cardboard packs.
80 g – jars (1) – cardboard packs.
90 g – jars (1) – cardboard packs.
100 g – jars (1) – cardboard packs.
20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.
Gel for external use 5%: tubes 20 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 100 g, 150 g, or 200 g
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Diclofenac | Gel for external use 5%: tubes 20 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 100 g, 150 g, or 200 g |
Dosage Form, Packaging, and Composition
Gel for external use transparent, homogeneous, colorless or with a yellowish tint, with a characteristic odor.
| 1 g | |
| Diclofenac sodium | 0.05 g |
Excipients: isopropanol – 0.451 g, macrogol glyceryl cocoate – 0.06 g, hypromellose 4000 – 0.03 g, purified water – up to 1 g.
20 g – tubes – cardboard packs.
25 g – tubes – cardboard packs.
30 g – tubes – cardboard packs.
35 g – tubes – cardboard packs.
40 g – tubes – cardboard packs.
50 g – tubes – cardboard packs.
60 g – tubes – cardboard packs.
70 g – tubes – cardboard packs.
80 g – tubes – cardboard packs.
100 g – tubes – cardboard packs.
150 g – tubes – cardboard packs.
200 g – tubes – cardboard packs.
Ointment for external use 1%: jars 25 g or 30 g; tubes 25 g, 30 g, 40 g, 50 g, or 60 g
Marketing Authorization Holder
Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)
Manufactured By
Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)
Dosage Form
|
Diclofenac | Ointment for external use 1%: jars 25 g or 30 g; tubes 25 g, 30 g, 40 g, 50 g, or 60 g |
Dosage Form, Packaging, and Composition
Ointment for external use homogeneous, white or almost white in color with a faint characteristic odor.
| 100 g | |
| Diclofenac sodium | 1 g |
Excipients: dimethyl sulfoxide – 10 g, polyethylene oxide 400 (Macrogol 400) – 49 g, polyethylene oxide 1500 (Macrogol 1500) – 30 g, propylene glycol – 10 g.
25 g – dark glass jars (1) – cardboard packs.
30 g – dark glass jars (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
Gel for external use 5%: jars 25 g or 30 g; tubes 25 g, 30 g, 40 g, 50 g, or 60 g
Marketing Authorization Holder
Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)
Dosage Form
|
Diclofenac | Gel for external use 5%: jars 25 g or 30 g; tubes 25 g, 30 g, 40 g, 50 g, or 60 g |
Dosage Form, Packaging, and Composition
Gel for external use colorless or with a faint yellowish tint, transparent, homogeneous gel with a characteristic odor.
| 100 g | |
| Diclofenac sodium | 5 g |
Excipients: isopropanol – 45 g, macrogol 7 glyceryl cocoate – 6 g, hypromellose-4 thousand (calculated on dry substance) – 3 g, Scots pine needle oil – 0.15 g, lavender oil – 0.05 g, purified water – 40.8 g.
25 g – dark glass jars (1) – cardboard packs.
30 g – dark glass jars (1) – cardboard packs.
25 g – aluminum tubes (1) with a cap – cardboard packs.
30 g – aluminum tubes (1) with a cap – cardboard packs.
40 g – aluminum tubes (1) with a cap – cardboard packs.
50 g – aluminum tubes (1) with a cap – cardboard packs.
60 g – aluminum tubes (1) with a cap – cardboard packs.
Rectal suppositories 100 mg: 6 pcs.
Marketing Authorization Holder
Pharmaprim, LLC (Republic of Moldova)
Dosage Form
|
Diclofenac | Rectal suppositories 100 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Diclofenac sodium | 100 mg |
3 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
Solution for intramuscular administration 75 mg/3 ml: amp. 10 pcs.
Marketing Authorization Holder
Pharmstandard-Ufimsky Vitaminny Zavod OJSC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 75 mg/3 ml: amp. 10 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intramuscular administration | 1 ml | 1 amp. |
| Diclofenac sodium | 25 mg | 75 mg |
3 ml – ampoules (10) – cardboard packs.
Rectal suppositories 50 mg: 10 pcs.
Marketing Authorization Holder
Ferment Firm, LLC (Russia)
Dosage Form
|
Diclofenac | Rectal suppositories 50 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Diclofenac sodium | 50 mg |
5 pcs. – contour cell packaging (2) – cardboard packs.
Rectal suppositories 100 mg: 10 pcs.
Marketing Authorization Holder
Ferment Firm, LLC (Russia)
Dosage Form
|
Diclofenac | Rectal suppositories 100 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Diclofenac sodium | 100 mg |
5 pcs. – contour cell packaging (2) – cardboard packs.
Gel for external use 1%: tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, 100 g, or 150 g
Gel for external use 5%: tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, 100 g, or 150 g
Marketing Authorization Holder
Formula-FR, LLC (Russia)
Manufactured By
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Forms
|
Diclofenac | Gel for external use 1%: tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, 100 g, or 150 g |
| Gel for external use 5%: tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, 100 g, or 150 g |
Dosage Form, Packaging, and Composition
Gel for external use colorless or with a faint yellowish tint, transparent, with a characteristic odor.
| 100 g | |
| Diclofenac sodium | 1 g |
Excipients: isopropanol – 45 g, macrogol glyceryl cocoate – 6 g, hypromellose 4000 – 3 g, Scots pine needle oil – 0.15 g, lavender oil – 0.05 g, purified water – up to 100 g.
20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
90 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.
150 g – tubes (1) – cardboard packs.
Gel for external use colorless or with a yellowish tint, transparent, homogeneous, with a characteristic odor.
| 100 g | |
| Diclofenac sodium | 5 g |
Excipients: isopropanol – 45.1 g, macrogol glyceryl cocoate – 6 g, hypromellose 4000 – 3 g, purified water – up to 100 g.
20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
90 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.
150 g – tubes (1) – cardboard packs.
Solution for intramuscular administration 25 mg/1 ml: amp. 3 ml 5 or 10 pcs.
Marketing Authorization Holder
Ellara, LLC (Russia)
Dosage Form
|
Diclofenac | Solution for intramuscular administration 25 mg/1 ml: amp. 3 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular administration transparent or slightly opalescent, slightly colored solution with a characteristic odor.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients: propylene glycol – 200 mg, mannitol – 6 mg, benzyl alcohol – 40 mg, sodium disulfite – 3 mg, sodium hydroxide solution 1M – to pH 8.0-9.0, water for injection – up to 1 ml.
3 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
3 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
3 ml – ampoules (5) – cardboard packs with a corrugated insert.
3 ml – ampoules (10) – cardboard packs with a corrugated insert.
Solution for intramuscular injection 25 mg/1 ml: amp. 3 ml 5, 10 or 20 pcs.
Marketing Authorization Holder
Elfa SPC, JSC (Russia)
Manufactured By
Indus Pharma Pvt. Ltd. (India)
Dosage Form
|
Diclofenac Elfa | Solution for intramuscular injection 25 mg/1 ml: amp. 3 ml 5, 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular administration transparent, from colorless to yellowish in color.
| 1 ml | 1 amp. | |
| Diclofenac sodium | 25 mg | 75 mg |
Excipients: benzyl alcohol, mannitol, propylene glycol, sodium disulfite, sodium hydroxide, hydrochloric acid, water for injection.
3 ml – ampoules of colorless glass (5) – plastic trays (1) – cardboard boxes.
3 ml – ampoules of colorless glass (5) – plastic trays (2) – cardboard boxes.
3 ml – ampoules of colorless glass (10) – plastic trays (1) – cardboard boxes.
3 ml – ampoules of colorless glass (10) – plastic trays (2) – cardboard boxes.
Prolonged-release film-coated tablets, 100 mg: 20, 30, 40, or 50 pcs.
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Form
|
Diclofenac Renewal | Prolonged-release film-coated tablets, 100 mg: 20, 30, 40, or 50 pcs. |
Dosage Form, Packaging, and Composition
Prolonged-release film-coated tablets pink, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Diclofenac sodium | 100 mg |
Excipients: sucrose (sugar), cetyl alcohol, magnesium stearate, talc, povidone K30, colloidal silicon dioxide (aerosil).
Shell composition Opadry® 13F240000 pink [hypromellose, talc, titanium dioxide, polysorbate 80 (tween 80), macrogol 6000, ponceau 4R aluminum lake (E-124), quinoline yellow aluminum lake].
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
Enteric film-coated tablets, 25 mg: 20, 30, 40, 50, or 60 pcs.
Enteric film-coated tablets, 50 mg: 20, 30, 40, 50, or 60 pcs.
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Forms
|
Diclofenac Renewal | Enteric film-coated tablets, 25 mg: 20, 30, 40, 50, or 60 pcs. |
| Enteric film-coated tablets, 50 mg: 20, 30, 40, 50, or 60 pcs. |
Dosage Form, Packaging, and Composition
Enteric film-coated tablets from yellow to light brown, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Diclofenac sodium | 25 mg |
Excipients: corn starch, sodium carboxymethyl starch, lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide (aerosil), povidone K30, magnesium stearate.
Shell composition
Shell 1: OPADRY® COMPLETE FILM COATING SYSTEM 03F220133 YELLOW [hypromellose (hydroxypropyl methylcellulose), talc, iron oxide yellow (E172), titanium dioxide, macrogol (polyethylene glycol)].
Shell 2: ACRYL-EZE® AQUEOUS ACRYLIC ENTERIC SYSTEM 93F19255 CLEAR [methacrylic acid and ethyl acrylate copolymer [1:1], talc, macrogol (polyethylene glycol), colloidal silicon dioxide (aerosil), sodium bicarbonate, sodium lauryl sulfate], simethicone emulsion 30%.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
Enteric film-coated tablets from light brown to brown, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Diclofenac sodium | 50 mg |
Excipients: corn starch, sodium carboxymethyl starch, lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide (aerosil), povidone K30, magnesium stearate.
Shell composition
Shell 1: OPADRY® COMPLETE FILM COATING SYSTEM 03F230051 ORANGE [hypromellose (hydroxypropyl methylcellulose), talc, iron oxide yellow (E172), titanium dioxide, macrogol (polyethylene glycol), iron oxide red (E172)].
Shell 2: ACRYL-EZE® AQUEOUS ACRYLIC ENTERIC SYSTEM 93F19255 CLEAR [methacrylic acid and ethyl acrylate copolymer [1:1], talc, macrogol (polyethylene glycol), colloidal silicon dioxide (aerosil), sodium bicarbonate, sodium lauryl sulfate], simethicone emulsion 30%.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
Prolonged-release enteric film-coated tablets, 100 mg: 10, 20, 30, 40, 50, 60, 80, 100, 120, 160, or 200 pcs.
Marketing Authorization Holder
Ozon, LLC (Russia)
Dosage Form
|
Diclofenac Retard | Prolonged-release enteric film-coated tablets, 100 mg: 10, 20, 30, 40, 50, 60, 80, 100, 120, 160, or 200 pcs. |
Dosage Form, Packaging, and Composition
Prolonged-release enteric film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white; surface roughness is allowed.
| 1 tab. | |
| Diclofenac | 100 mg |
Excipients: hypromellose – 95 mg, microcrystalline cellulose (MCC-101) – 53 mg, lactose monohydrate (milk sugar) – 50 mg, povidone K25 – 7 mg, magnesium stearate – 3 mg, talc – 2 mg.
Shell composition: mixture “Acryl-EZE WHITE 93 A” – 13.5 mg (methacrylic acid and ethyl acrylate copolymer [1:1], talc, titanium dioxide, colloidal silicon dioxide, sodium bicarbonate, sodium lauryl sulfate), triethyl citrate – 1.5 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (8) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
Prolonged-release enteric tablets 100 mg: 10, 20, 30, 50, or 100 pcs.
Marketing Authorization Holder
Aliym, JSC (Russia)
Dosage Form
|
Diclofenac retard Obolenskoje | Prolonged-release enteric tablets 100 mg: 10, 20, 30, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Prolonged-release enteric tablets red-brown, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Diclofenac sodium | 100 mg |
Excipients: hypromellose (hydroxypropyl methylcellulose), hydroxyethyl cellulose, Kollidon SR [polyvinyl acetate, povidone, sodium lauryl sulfate, silicon dioxide], sodium alginate, microcrystalline cellulose type 101, magnesium stearate.
Shell composition methacrylic acid and ethyl acrylate copolymer (Kollicoat MAE 100 P), propylene glycol, talc, povidone K30, titanium dioxide, iron oxide red, iron oxide yellow.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
Film-coated tablets, 25 mg: 10, 20, 30, 50, or 100 pcs.
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
Salutas Pharma, GmbH (Germany)
Dosage Form
|
Diclofenac Sandoz | Film-coated tablets, 25 mg: 10, 20, 30, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellowish-brown, rounded, with a uniform surface; white on the break.
| 1 tab. | |
| Diclofenac sodium | 25 mg |
Excipients: lactose, calcium hydrogen phosphate, microcrystalline cellulose, corn starch, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, eudragit L 30, triethyl citrate, talc, titanium dioxide, iron oxide yellow.
10 pcs. – blisters (1) – cardboard boxes.
10 pcs. – blisters (2) – cardboard boxes.
10 pcs. – blisters (3) – cardboard boxes.
10 pcs. – blisters (5) – cardboard boxes.
10 pcs. – blisters (10) – cardboard boxes.
Film-coated tablets, 50 mg: 10, 20, 30, 50, or 100 pcs.
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
Salutas Pharma, GmbH (Germany)
Dosage Form
|
Diclofenac Sandoz | Film-coated tablets, 50 mg: 10, 20, 30, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets brown-yellow, rounded, with a double-sided rim and uniform surface, white on the break.
| 1 tab. | |
| Diclofenac sodium | 50 mg |
Excipients: lactose, calcium hydrogen phosphate, microcrystalline cellulose, corn starch, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, eudragit L 30, triethyl citrate, talc, titanium dioxide, iron oxide yellow.
10 pcs. – blisters (1) – cardboard boxes.
10 pcs. – blisters (2) – cardboard boxes.
10 pcs. – blisters (3) – cardboard boxes.
10 pcs. – blisters (5) – cardboard boxes.
10 pcs. – blisters (10) – cardboard boxes.
Extended-release tablets 100 mg: 10, 20, 30, 50, or 100 pcs.
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
Salutas Pharma, GmbH (Germany)
Dosage Form
|
Diclofenac Sandoz | Extended-release tablets 100 mg: 10, 20, 30, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Extended-release tablets white or almost white, round, biconvex, with a score on one side.
| 1 tab. | |
| Diclofenac sodium | 100 mg |
Excipients: lactose, methylhydroxypropylcellulose, magnesium stearate.
10 pcs. – blisters (1) – cardboard boxes.
10 pcs. – blisters (2) – cardboard boxes.
10 pcs. – blisters (3) – cardboard boxes.
10 pcs. – blisters (5) – cardboard boxes.
10 pcs. – blisters (10) – cardboard boxes.
Solution for intramuscular injection 25 mg/1 ml: amp. 3 ml 3, 5, 6 or 10 pcs.
Marketing Authorization Holder
Velpharm, LLC (Russia)
Dosage Form
|
Diclofenac Velpharm | Solution for intramuscular injection 25 mg/1 ml: amp. 3 ml 3, 5, 6 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular administration in the form of a transparent, slightly colored liquid with a weak characteristic odor.
| 1 ml | |
| Diclofenac sodium | 25 mg |
Excipients: benzyl alcohol, propylene glycol, mannitol (mannite), sodium disulfite (sodium metabisulfite), sodium hydroxide solution 1M, water for injection.
3 ml – glass ampoules (3) – contour cell packs (1) – cardboard packs.
3 ml – glass ampoules (3) – contour cell packs (2) – cardboard packs.
3 ml – glass ampoules (5) – contour cell packs (1) – cardboard packs.
3 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
Rectal suppositories 25 mg: 10 pcs.
Rectal suppositories 50 mg: 10 pcs.
Rectal suppositories 100 mg: 10 pcs.
Marketing Authorization Holder
Altpharm LLC (Russia)
Dosage Forms
|
Diclofenac-Altfarm | Rectal suppositories 25 mg: 10 pcs. |
| Rectal suppositories 50 mg: 10 pcs. | ||
| Rectal suppositories 100 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories from white to white with a yellowish tint, torpedo-shaped, without visible inclusions on the longitudinal section.
| 1 supp. | |
| Diclofenac sodium | 25 mg |
Excipients: solid fat (glycerides of fatty acids) – 0.975 g.
5 pcs. – contour cell packs (2) – cardboard packs.
Rectal suppositories from white to white with a yellowish tint, torpedo-shaped, without visible inclusions on the longitudinal section.
| 1 supp. | |
| Diclofenac sodium | 50 mg |
Excipients: solid fat (glycerides of fatty acids) – 1.95 g.
5 pcs. – contour cell packs (2) – cardboard packs.
Rectal suppositories from white to white with a yellowish tint, torpedo-shaped, without visible inclusions on the longitudinal section.
| 1 supp. | |
| Diclofenac sodium | 100 mg |
Excipients: solid fat (glycerides of fatty acids) – 1.9 g.
5 pcs. – contour cell packs (2) – cardboard packs.
Solution for intramuscular injection 75 mg/3 ml: amp. 5, 10 or 20 pcs.
Marketing Authorization Holder
Mir Chemical and Pharmaceutical Concern, LLC (Russia)
Dosage Form
|
Diclofenac-Eskom | Solution for intramuscular injection 75 mg/3 ml: amp. 5, 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intramuscular administration | 1 ml | 1 amp. |
| Diclofenac sodium | 25 mg | 75 mg |
3 ml – ampoules (5) – plastic contour packs (1) – cardboard packs.
3 ml – ampoules (5) – plastic contour packs (2) – cardboard packs.
3 ml – ampoules (10) – plastic contour packs (1) – cardboard packs.
3 ml – ampoules (10) – plastic contour packs (2) – cardboard packs.
Enteric film-coated tablets, 25 mg: 10, 20, 30, 40, 60, 100, or 200 pcs.
Enteric film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, 100, or 200 pcs.
Marketing Authorization Holder
Aliym, JSC (Russia)
Dosage Forms
|
Diclofenac-FPO® | Enteric film-coated tablets, 25 mg: 10, 20, 30, 40, 60, 100, or 200 pcs. |
| Enteric film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, 100, or 200 pcs. |
Dosage Form, Packaging, and Composition
Enteric film-coated tablets brown, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Diclofenac sodium | 25 mg |
Excipients: microcrystalline cellulose, potato starch, crospovidone, colloidal silicon dioxide (aerosil), calcium stearate.
Shell composition: methacrylic acid and ethyl acrylate copolymer (Kollicoat MAE P100), hypromellose (hydroxypropyl methylcellulose), povidone K30, talc, propylene glycol, titanium dioxide, iron oxide brown dye.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
Enteric film-coated tablets brown, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Diclofenac sodium | 50 mg |
Excipients: microcrystalline cellulose, potato starch, crospovidone, colloidal silicon dioxide (aerosil), calcium stearate.
Shell composition: methacrylic acid and ethyl acrylate copolymer (Kollicoat MAE P100), hypromellose (hydroxypropyl methylcellulose), povidone K30, talc, propylene glycol, titanium dioxide, iron oxide brown dye.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
Rectal suppositories 50 mg: 10 pcs.
Marketing Authorization Holder
Moscow Pharmaceutical Factory CJS (Russia)
Dosage Form
|
Diclofenac-MFF | Rectal suppositories 50 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories white or white with a slightly yellowish tint, torpedo-shaped, odorless; the presence of an air rod or a funnel-shaped depression on the cut is allowed.
| 1 supp. | |
| Diclofenac sodium | 50 mg |
Excipients: hard fat type A grade Hardfat (suppository base) – 1.45 g.
5 pcs. – contour cell packs (2) – cardboard packs.
Solution for injection 75 mg/2 ml: amp. 1 pc.
Marketing Authorization Holder
Ratiopharm Arzneimittel Vertriebs, GmbH (Germany)
Manufactured By
Merckle, GmbH (Germany)
Dosage Form
|
Diclofenac-Ratiopharm | Solution for injection 75 mg/2 ml: amp. 1 pc. |
Dosage Form, Packaging, and Composition
| Solution for injection | 1 ml | 1 amp. |
| Diclofenac sodium | 37.5 mg | 75 mg |
2 ml – dark glass ampoules (1) – cardboard packs.
Enteric-coated tablets, 25 mg: 20, 50, or 100 pcs.
Marketing Authorization Holder
Ratiopharm, GmbH (Germany)
Manufactured By
Merckle, GmbH (Germany)
Dosage Form
|
Diclofenac-Ratiopharm | Enteric-coated tablets, 25 mg: 20, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Enteric-coated tablets | 1 tab. |
| Diclofenac sodium | 25 mg |
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
Enteric-coated tablets, 50 mg: 20, 50 or 100 pcs.
Marketing Authorization Holder
Ratiopharm, GmbH (Germany)
Manufactured By
Merckle, GmbH (Germany)
Dosage Form
|
Diclofenac-Ratiopharm | Enteric-coated tablets, 50 mg: 20, 50 or 100 pcs. |
Dosage Form, Packaging, and Composition
| Enteric-coated tablets | 1 tab. |
| Diclofenac sodium | 50 mg |
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
Enteric-coated tablets, 25 mg: 10, 20, 30, or 50 pcs.
Marketing Authorization Holder
Uralbiopharm, JSC (Russia)
Dosage Form
|
Diclofenac-UBF | Enteric-coated tablets, 25 mg: 10, 20, 30, or 50 pcs. |
Dosage Form, Packaging, and Composition
| Enteric-coated tablets | 1 tab. |
| Diclofenac sodium | 25 mg |
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
![Diclofenac [Tablets, Solution, Ointment, Cream, Gel, Drops, Suppositories, Transdermal patch] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Diclofenac [Tablets, Solution, Ointment, Cream, Gel, Drops, Suppositories, Transdermal patch] 2")