Imatinib (Tablets, Capsules) Instructions for Use
ATC Code
L01EA01 (Imatinib)
Active Substance
Imatinib (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antitumor drug. Protein kinase inhibitor
Pharmacotherapeutic Group
Antineoplastic agents; protein kinase inhibitors; BCR-ABL tyrosine kinase inhibitors
Pharmacological Action
Protein tyrosine kinase inhibitor. It inhibits the Bcr-Abl tyrosine kinase enzyme at the cellular level, in vitro and in vivo. It selectively suppresses proliferation and induces apoptosis of Bcr-Abl-positive cell lines, as well as young leukemic cells in chronic myeloid leukemia with positive Philadelphia chromosome and in acute lymphoblastic leukemia.
In colony transformation studies conducted on samples of peripheral blood and bone marrow, it was shown that Imatinib selectively inhibits Bcr-Abl-positive colonies obtained from patients with chronic myeloid leukemia.
In in vivo studies on animal models using Bcr-Abl-positive tumor cells, it was shown that Imatinib has antitumor activity in monotherapy.
In addition, Imatinib is an inhibitor of tyrosine kinase receptors for platelet-derived growth factor and stem cell factor, and also suppresses cellular responses mediated by the aforementioned factors.
In vitro, Imatinib inhibits proliferation and induces apoptosis of gastrointestinal stromal tumor cells expressing kit mutations.
Pharmacokinetics
After oral administration, the bioavailability averages 98%. The coefficient of variation for AUC is 40-60%. When taken with high-fat food, compared to taking on an empty stomach, a slight decrease in the degree of absorption (decrease in Cmax by 11%, AUC by 7.4%) and a slowdown in the rate of absorption (prolongation of Tmax by 1.5 hours) are noted.
At clinically significant concentrations of imatinib, its binding to plasma proteins is about 95% (mainly with albumin and acid alpha-glycoprotein, to a lesser extent with lipoprotein).
The main metabolite of imatinib circulating in the bloodstream is the N-demethylated piperazine derivative, which in vitro has pharmacological activity similar to that of the unchanged active substance. The AUC value for the metabolite is 16% of the imatinib AUC.
After oral administration of 14C-labeled imatinib, 68% of the administered dose was excreted in feces and 13% of the dose in urine over 7 days. About 25% of the dose is excreted unchanged (20% in feces and 5% in urine). The remaining amount of imatinib is excreted as metabolites.
The T1/2 of imatinib in healthy volunteers was about 18 hours.
In case of impaired liver function, an increase in the concentration of imatinib in blood plasma is possible.
Indications
Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in children and adults; Ph+ CML in the chronic phase after failure of prior interferon alpha therapy or in the accelerated phase, or blast crisis in children and adults; newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in children and adult patients in combination with chemotherapy; recurrent or refractory Ph+ ALL in adult patients as monotherapy; myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor gene rearrangements in adult patients; systemic mastocytosis in adult patients without the D816V c-Kit mutation or with unknown c-Kit mutation status; hypereosinophilic syndrome and/or chronic eosinophilic leukemia in adult patients with positive or negative abnormal FIP1L1-PDGRF alpha tyrosine kinase; inoperable and/or metastatic malignant gastrointestinal stromal tumors (GIST), positive for c-Kit (CD117) in adult patients; adjuvant therapy in adult patients with GIST, positive for c-Kit (CD117); inoperable, recurrent and/or metastatic dermatofibrosarcoma protuberans in adult patients.
ICD codes
| ICD-10 code | Indication |
| C15 | Malignant neoplasm of esophagus |
| C16 | Malignant neoplasm of stomach |
| C17 | Malignant neoplasm of small intestine |
| C18 | Malignant neoplasm of colon |
| C19 | Malignant neoplasm of rectosigmoid junction |
| C20 | Malignant neoplasm of rectum |
| C44 | Other malignant neoplasms of skin |
| C48 | Malignant neoplasm of retroperitoneum and peritoneum |
| C91.0 | Acute lymphoblastic leukemia [ALL] |
| C92.1 | Chronic myeloid leukemia [CML], BCR/ABL-positive |
| C96.2 | Malignant mast cell tumor |
| D46 | Myelodysplastic syndromes |
| D47.5 | Chronic eosinophilic leukemia [hypereosinophilic syndrome] |
| ICD-11 code | Indication |
| 2A20.0Z | Chronic myelogenous leukemia, BCR-ABL1-positive, unspecified |
| 2A20.3 | Chronic eosinophilic leukemia, not elsewhere classified |
| 2A21.Z | Mastocytosis, unspecified |
| 2A3Z | Myelodysplastic syndromes, unspecified |
| 2B33.3 | Lymphoid leukemia, not elsewhere classified |
| 2B70.Z | Malignant neoplasm of esophagus, unspecified |
| 2B72.Z | Malignant neoplasms of stomach, unspecified |
| 2B80.0Z | Malignant tumors of duodenum, unspecified |
| 2B80.Z | Malignant neoplasm of small intestine, unspecified |
| 2B90.Z | Malignant neoplasm of colon, unspecified |
| 2B91.Z | Malignant neoplasm of rectosigmoid junction, unspecified |
| 2B92.Z | Malignant neoplasm of rectum, unspecified |
| 2C31.Z | Squamous cell carcinoma of skin |
| 2C32.Z | Basal cell carcinoma of skin, unspecified |
| 2C33 | Skin adnexal carcinoma |
| 2C34 | Cutaneous neuroendocrine carcinoma |
| 2C35 | Sarcoma of skin |
| 2C3Z | Malignant neoplasms of skin of unknown or unspecified type |
| 2C50.Z | Malignant neoplasms of the retroperitoneum and peritoneum, unspecified |
| 2C51.Z | Malignant neoplasms of the peritoneum, unspecified |
| 2C5Z | Malignant neoplasms of retroperitoneal space, peritoneum or omentum, unspecified |
| XH4XG8 | Chronic myelogenous leukemia, NOS |
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. |
Take orally with a meal and a large glass of water to minimize gastrointestinal irritation.
Swallow tablets or capsules whole; do not crush or chew.
The prescribed dose is taken once daily, unless otherwise directed by a physician.
For adults with newly diagnosed Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) in chronic phase, the recommended dose is 400 mg once daily.
For adults with Ph+ CML in accelerated phase or blast crisis, the recommended dose is 600 mg once daily.
For adults with Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL), the recommended dose is 600 mg once daily.
For adults with Gastrointestinal Stromal Tumors (GIST), the recommended dose is 400 mg once daily.
Dose escalation from 400 mg to 600 mg, or from 600 mg to 800 mg (given as 400 mg twice daily), may be considered in the absence of severe adverse drug reactions and severe non-leukemia related neutropenia or thrombocytopenia in the following circumstances: disease progression, failure to achieve a satisfactory hematological response after at least 3 months of treatment, or loss of a previously achieved hematological response.
For pediatric patients with Ph+ CML in chronic phase, the recommended daily dose is 340 mg/m² (not to exceed 600 mg).
For pediatric patients with Ph+ ALL, the recommended daily dose is 340 mg/m² (not to exceed 600 mg).
Treatment is intended to be continuous, as long as the patient derives clinical benefit.
Regularly monitor complete blood counts and liver function tests.
Manage adverse reactions, such as severe neutropenia and thrombocytopenia, through temporary interruption of therapy or dose reduction.
In cases of fluid retention, manage with diuretics, dose reduction, or therapy interruption.
For patients with severe hepatic impairment, reduce the dose by 25%.
For patients with severe renal impairment (CrCl < 30 mL/min), consider a dose reduction of 50%.
Do not take a double dose to make up for a forgotten one. If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose.
Adverse Reactions
Infectious and parasitic diseases: infrequently – herpes zoster, herpes simplex, nasopharyngitis, pneumonia, sinusitis, subcutaneous tissue inflammation, upper respiratory tract infections, influenza, urinary tract infections, gastroenteritis, sepsis; rarely – mycosis.
From the hematopoietic system: very often – neutropenia, thrombocytopenia, anemia; often – pancytopenia, febrile neutropenia; infrequently – thrombocythemia, lymphopenia, bone marrow suppression, eosinophilia, lymphadenopathy; rarely – hemolytic anemia.
From metabolism: very often – weight gain; often – anorexia, weight loss; infrequently – hypokalemia, increased appetite, hypophosphatemia, decreased appetite, dehydration, hyperuricemia, gout, hypercalcemia, hyperglycemia, hyponatremia; rarely – hyperkalemia, hypomagnesemia.
From the psyche: often – insomnia; infrequently – depression, decreased libido, anxiety; rarely – confusion.
From the nervous system: very often – headache; often – dizziness, paresthesia, taste disturbance, hypoesthesia; infrequently – migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless legs syndrome, tremor, hemorrhagic stroke; rarely – increased intracranial pressure, convulsions, optic neuritis.
From the organ of vision: often – eyelid edema, increased lacrimation, conjunctival hemorrhages, conjunctivitis, dry eye syndrome, blurred vision; infrequently – eye irritation, eye pain, orbital edema, scleral hemorrhage, retinal hemorrhage, blepharitis, macular edema; rarely – cataract, optic disc edema, glaucoma.
Hearing and vestibular disorders: infrequently – vertigo, tinnitus, hearing loss.
From the cardiovascular system: often – hot flashes, hemorrhages; infrequently – palpitations, tachycardia, chronic heart failure, pulmonary edema, increase or decrease in blood pressure, hematoma, subdural hematoma, cold extremities, Raynaud’s syndrome; rarely – arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion.
From the respiratory system: often – nosebleed, dyspnea, cough; infrequently – pleural effusion, pain in the pharynx or larynx, pharyngitis; rarely – pleural pain, pulmonary fibrosis, pulmonary hypertension, pulmonary hemorrhage.
From the digestive system: very often – nausea, vomiting, diarrhea, dyspepsia, abdominal pain; often – abdominal distension, flatulence, constipation, gastroesophageal reflux, dry mouth, gastritis; infrequently – stomatitis, oral mucosa ulceration, gastrointestinal bleeding, belching, melena, esophagitis, ascites, gastric ulcer, vomiting blood, cheilitis, dysphagia, pancreatitis; rarely – colitis, paralytic/obstructive intestinal obstruction, colon inflammation.
From the liver and biliary tract: often – increased activity of hepatic transaminases; infrequently – jaundice, hepatitis, hyperbilirubinemia; rarely – hepatic failure, liver necrosis.
From the skin and subcutaneous tissues: very often – periorbital edema, dermatitis, eczema, skin rash; often – skin itching, facial swelling, dry skin, erythema, alopecia, night sweats, photosensitivity reactions; infrequently – pustular rash, petechiae, increased sweating, urticaria, ecchymosis, predisposition to hematoma formation, hypotrichosis, skin hyperpigmentation/hypopigmentation, exfoliative dermatitis, nail damage, folliculitis, petechiae, psoriasis, purpura, bullous rash; rarely – acute febrile neutrophilic dermatosis (Sweet’s syndrome), nail discoloration, angioedema, vesicular rash, erythema multiforme, leukocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalized pustular exanthema.
From the musculoskeletal system: very often – muscle cramps and spasms, musculoskeletal pain, including myalgia and arthralgia, bone pain; often – joint swelling; infrequently – muscle and joint stiffness; rarely – muscle weakness, arthritis.
From the urinary system: infrequently – kidney pain, hematuria, acute renal failure, frequent urination.
From the reproductive system: infrequently – gynecomastia, erectile dysfunction, menorrhagia, menstrual cycle disorders, sexual dysfunction, nipple pain, breast enlargement, scrotal edema.
General disorders: very often – fluid retention, edema, increased fatigue; often – weakness, increased body temperature, anasarca, chills, tremor; infrequently – chest pain, general malaise.
From laboratory parameters: infrequently – increased blood creatinine concentration, increased blood CPK activity, increased ALP, LDH activity; rarely – increased plasma amylase activity.
Contraindications
Hypersensitivity to imatinib; pregnancy, breastfeeding period; childhood (efficacy and safety not established) under 1 year in patients with Ph+ acute lymphoblastic leukemia, under 2 years in patients with Ph+ chronic myeloid leukemia, under 18 years for other indications.
With caution in patients with severe hepatic insufficiency; patients with severe renal impairment; patients with cardiovascular diseases or with risk factors for heart failure; during regular hemodialysis procedure; with simultaneous use with drugs that inhibit the CYP3A4 isoenzyme, strong inducers of the CYP3A4 isoenzyme, drugs that are substrates of the CYP3A4 isoenzyme; with simultaneous use with paracetamol, warfarin.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and during lactation (breastfeeding).
Use in Hepatic Impairment
Use with caution in patients with severe hepatic insufficiency.
Use in Renal Impairment
Use with caution in patients with severe renal impairment.
Pediatric Use
Imatinib is contraindicated for use under the age of 1 year in patients with Ph+ acute lymphoblastic leukemia; under 2 years in patients with Ph+ chronic myeloid leukemia; under 18 years for other indications.
Geriatric Use
Should be used with caution in elderly patients.
The highest frequency of fluid retention is noted in elderly patients with concomitant cardiovascular diseases.
Special Precautions
Treatment with imatinib should be carried out only under the supervision of a physician with experience in working with antitumor drugs.
Cases of severe fluid retention have been noted with the use of imatinib; it is recommended to regularly monitor body weight. In case of unexpected rapid weight gain, an examination should be carried out and, if necessary, imatinib therapy should be temporarily discontinued, and/or the use of diuretics should be started.
The development of neutropenia or thrombocytopenia was noted with the use of imatinib; these phenomena had a clear relationship with the stage of the disease, the frequency of their occurrence was higher in patients with CML in the blast crisis phase or accelerated phase compared to patients with CML in the chronic phase. It may be necessary to temporarily suspend therapy or reduce the dose of imatinib.
When using imatinib, it is recommended to regularly conduct clinical blood tests and monitor liver function (transaminases, bilirubin, ALP). When used in patients with liver diseases, a clinical blood test and determination of liver enzyme activity should be regularly performed.
Imatinib and its metabolites are excreted by the kidneys to a small extent. Creatinine clearance decreases with age, while age does not have a significant effect on the pharmacokinetic parameters of imatinib. No correlation was found between imatinib exposure and the degree of renal impairment in patients with renal impairment from mild (creatinine clearance 40-59 ml/min) to severe (creatinine clearance <20 ml/min). Nevertheless, in case of intolerance in patients of this category, the initial dose of imatinib should be reduced.
There are reports of the development of hypothyroidism during the use of imatinib in patients who have undergone thyroidectomy and are receiving replacement therapy with levothyroxine sodium. The concentration of thyroid-stimulating hormone should be regularly determined in this category of patients.
Careful monitoring should be provided for patients with cardiovascular diseases, risk factors for heart failure, as well as patients with a history of renal failure. If signs or symptoms indicating these conditions are detected, the patient’s condition should be assessed and appropriate treatment should be initiated.
In patients with myelodysplastic/myeloproliferative diseases and a high eosinophil count, an ECG should be performed and the concentration of cardiospecific troponin in the blood serum should be determined. If abnormalities are detected at the beginning of therapy, the possibility of prophylactic use of systemic corticosteroids for 1-2 weeks simultaneously with imatinib should be considered.
There are isolated reports of cases of gastric antral vascular ectasia (GAVE syndrome), a rare cause of gastrointestinal bleeding, registered in patients with CML and ALL and other diseases.
It is necessary to monitor the condition of the gastrointestinal tract in patients with metastatic malignant GIST (abdominal pain, gastrointestinal bleeding, constipation and others) at the beginning and throughout the course of imatinib therapy. If necessary, the possibility of discontinuing imatinib therapy should be considered.
Due to the risk of developing tumor lysis syndrome, clinically significant dehydration and increased uric acid concentration should be corrected before using imatinib, if necessary.
In patients who are carriers of the hepatitis B virus, reactivation of this virus is possible after therapy with BCR-ABL tyrosine kinase inhibitor drugs, such as Imatinib. In some cases, when using drugs of this class, the development of acute liver failure or fulminant hepatitis, leading to liver transplantation or death, has been noted.
Before starting imatinib therapy, all patients should be examined for the presence of the hepatitis B virus. The condition of a patient who is a carrier of the hepatitis B virus, if treatment with imatinib is necessary, should be carefully monitored for the development of signs and symptoms of an active infectious process both during imatinib therapy and for several months after its completion.
Effect on the ability to drive vehicles and mechanisms
Some side effects, such as dizziness and blurred vision, may adversely affect the ability to drive vehicles and perform other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. In this regard, patients with the described adverse events should refrain from performing these types of activities.
Drug Interactions
With simultaneous use of imatinib with drugs that inhibit the cytochrome P450 CYP3A4 isoenzyme, for example, viral protease inhibitors (indinavir, lopinavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir), antifungal drugs of the azole group (including ketoconazole, itraconazole, posaconazole, voriconazole), some macrolide antibiotics (erythromycin, clarithromycin, telithromycin), it is possible to slow down the metabolism of imatinib and increase its concentration in blood plasma. Caution is required when using imatinib simultaneously with drugs that inhibit CYP3A4 isoenzymes.
Simultaneous use of drugs that are inducers of the CYP3A4 isoenzyme (for example, rifampicin, dexamethasone, St. John’s wort preparations, antiepileptic drugs: carbamazepine, oxcarbazepine, phenytoin, primidone) may lead to increased metabolism of imatinib and, as a result, a decrease in its plasma concentration and ineffectiveness of therapy. Simultaneous use of imatinib and strong inducers of the CYP3A4 isoenzyme should be avoided.
When imatinib and simvastatin are used concomitantly, an increase in the Cmax and AUC of simvastatin by 2 and 3.5 times, respectively, is noted, which is a consequence of the inhibition of CYP3A4 by imatinib.
Caution is recommended when using imatinib concomitantly with drugs that are substrates of CYP3A4 and have a narrow therapeutic range (e.g., cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, fentanyl, terfenadine, bortezomib, docetaxel, quinidine).
Imatinib may increase serum concentrations of other drugs metabolized by the CYP3A4 isoenzyme (triazolobenzodiazepines, dihydropyridine, “slow” calcium channel blockers, most HMG-CoA reductase inhibitors, including statins).
Imatinib also inhibits the CYP2C9 and CYP2C19 isoenzymes in vitro.
Prolongation of prothrombin time was observed with concomitant use with warfarin.
When used concomitantly with coumarin derivatives, short-term monitoring of prothrombin time is necessary at the beginning and end of therapy, as well as when changing the dosage regimen.
The use of low molecular weight heparins should be considered as an alternative to warfarin.
The issue of drug interaction between imatinib and chemotherapy drugs in patients with Ph+ ALL has not been sufficiently studied.
Caution should be exercised when using imatinib concomitantly with chemotherapeutic drugs due to a possible increased risk of drug complications, such as hepatotoxicity, myelosuppression, and others.
When imatinib is combined with chemotherapeutic drugs in high doses, transient hepatic toxicity may develop, manifested as increased activity of liver transaminases and hyperbilirubinemia.
When combining imatinib with chemotherapy regimens that may potentially cause liver dysfunction, liver function monitoring should be provided.
In vitro, Imatinib inhibits the CYP2D6 isoenzyme of cytochrome P450 at the same concentrations at which it inhibits the CYP3A4 isoenzyme.
In patients after thyroidectomy receiving replacement hormone therapy with levothyroxine sodium, a decrease in its concentration is possible when used concomitantly with imatinib.
Reports of liver damage have been noted with the concomitant use of imatinib and asparaginase.
Cases of fatal liver failure have been reported when imatinib was taken concomitantly with paracetamol.
Storage Conditions
Store at 2°C (36°F) to 30°C (86°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
Coated tablets, 100 mg: 30, 50, 100, or 120 pcs.
Marketing Authorization Holder
Jodas Expoim, LLC (Russia)
Manufactured By
NOVALEK PHARMACEITICALS, Pvt. Ltd. (India)
Dosage Form
 |
Imatinib | Coated tablets, 100 mg: 30, 50, 100, or 120 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from yellow to orange with a brownish tint, oblong, biconvex; on the cross-section, the tablet core is from white to light yellow in color.
| 1 tab. | |
| Imatinib mesylate | 120 mg, |
| Equivalent to imatinib content | 100 mg |
Excipients: colloidal silicon dioxide – 2 mg, hypromellose – 2 mg, microcrystalline cellulose – 25 mg, crospovidone – 19 mg, croscarmellose sodium – 19 mg, magnesium stearate – 2 mg.
Shell composition film coating Opadry yellow 04F52022, consisting of: hypromellose, macrogol 6000, talc, titanium dioxide, yellow iron oxide, red iron oxide.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.
Coated tablets, 400 mg: 30, 50, 100, or 120 pcs.
Marketing Authorization Holder
Jodas Expoim, LLC (Russia)
Manufactured By
NOVALEK PHARMACEITICALS, Pvt. Ltd. (India)
Dosage Form
|
Imatinib | Coated tablets, 400 mg: 30, 50, 100, or 120 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from yellow to orange with a brownish tint, oblong, biconvex; on the cross-section, the tablet core is from white to light yellow in color.
| 1 tab. | |
| Imatinib mesylate | 478 mg, |
| Equivalent to imatinib content | 400 mg |
Excipients: colloidal silicon dioxide – 5 mg, hypromellose – 10 mg, microcrystalline cellulose – 100 mg, crospovidone – 75 mg, croscarmellose sodium – 75 mg, magnesium stearate – 7 mg.
Shell composition film coating Opadry yellow 04F52022, consisting of: hypromellose, macrogol 6000, talc, titanium dioxide, yellow iron oxide, red iron oxide.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.
Capsules 50 mg: 20, 24, 30, 36, 40, 48, 80, 96, 100, 120 or 180 pcs.
Marketing Authorization Holder
Nanopharma Development, LLC (Russia)
Manufactured By
Izvarino Pharma LLC (Russia)
Or
Nanopharma Development, LLC (Russia)
Dosage Form
|
Imatinib | Capsules 50 mg: 20, 24, 30, 36, 40, 48, 80, 96, 100, 120 or 180 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin size #3, with opaque white or almost white capsule body and cap; capsule contents – powder or compacted powder mass from white with a slight yellowish tint to light yellow with a brownish tint.
| 1 caps. | |
| Imatinib mesylate | 59.75 mg |
| Equivalent to imatinib content | 50 mg |
Excipients: microcrystalline cellulose 87.25 mg, colloidal silicon dioxide 1.5 mg, magnesium stearate 1.5 mg.
Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition titanium dioxide – 2%, gelatin – up to 100%.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (8) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.
10 pcs. – blisters (15) – cardboard packs.
24 pcs. – polymer jars (1) – cardboard packs.
36 pcs. – polymer jars (1) – cardboard packs.
48 pcs. – polymer jars (1) – cardboard packs.
96 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.
180 pcs. – polymer jars (1) – cardboard packs.
Capsules 100 mg: 20, 24, 30, 36, 40, 48, 80, 96, 100, 120 or 180 pcs.
Marketing Authorization Holder
Nanopharma Development, LLC (Russia)
Manufactured By
Izvarino Pharma LLC (Russia)
Or
Nanopharma Development, LLC (Russia)
Dosage Form
|
Imatinib | Capsules 100 mg: 20, 24, 30, 36, 40, 48, 80, 96, 100, 120 or 180 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin size #1, with capsule body and cap opaque from yellowish-brownish to yellowish-orangeish tint; capsule contents – powder or compacted powder mass from white with a slight yellowish tint to light yellow with a brownish tint.
| 1 caps. | |
| Imatinib mesylate | 119.5 mg |
| Equivalent to imatinib content | 100 mg |
Excipients: microcrystalline cellulose 174.5 mg, colloidal silicon dioxide 3 mg, magnesium stearate 3 mg.
Capsule body composition: titanium dioxide – 2%, yellow iron oxide dye – 0.6286%, gelatin – up to 100%.
Capsule cap composition titanium dioxide – 2%, yellow iron oxide dye – 0.6286%, gelatin – up to 100%.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (8) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.
10 pcs. – blisters (15) – cardboard packs.
24 pcs. – polymer jars (1) – cardboard packs.
36 pcs. – polymer jars (1) – cardboard packs.
48 pcs. – polymer jars (1) – cardboard packs.
96 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.
180 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 100 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 90, 100, 120, 125 or 150 pcs.
Film-coated tablets, 400 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 90, 100, 120, 125 or 150 pcs.
Marketing Authorization Holder
Ozon Medica, LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Forms
|
Imatinib | Film-coated tablets, 100 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 90, 100, 120, 125 or 150 pcs. |
| Film-coated tablets, 400 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 90, 100, 120, 125 or 150 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellow or yellow with a brownish tint, round, biconvex, with a score; slight surface roughness is allowed; on the cross-section: a core of almost white or white with a yellowish or brownish tint and a film coating.
| 1 tab. | |
| Imatinib mesylate | 119.5 mg, |
| Equivalent to imatinib content | 100 mg |
Excipients: low-substituted hyprolose – 37.35 mg, crospovidone – 28 mg, povidone K25 – 2.5 mg, magnesium stearate – 1.4 mg, colloidal silicon dioxide – 1.25 mg.
Film coating composition: hypromellose – 3 mg, titanium dioxide – 1.05 mg, macrogol 4000 – 0.7 mg, talc – 0.15 mg, yellow iron oxide dye – 0.1 mg.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
20 pcs. – contour cell blisters (1) – cardboard packs.
20 pcs. – contour cell blisters (2) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
20 pcs. – contour cell blisters (4) – cardboard packs.
20 pcs. – contour cell blisters (5) – cardboard packs.
25 pcs. – contour cell blisters (1) – cardboard packs.
25 pcs. – contour cell blisters (2) – cardboard packs.
25 pcs. – contour cell blisters (3) – cardboard packs.
25 pcs. – contour cell blisters (4) – cardboard packs.
25 pcs. – contour cell blisters (5) – cardboard packs.
30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.
30 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – contour cell blisters (4) – cardboard packs.
30 pcs. – contour cell blisters (5) – cardboard packs.
Film-coated tablets yellow or yellow with a brownish tint, capsule-shaped, biconvex, with a score; slight surface roughness is allowed; on the cross-section: a core of almost white or white with a yellowish or brownish tint and a film coating.
| 1 tab. | |
| Imatinib mesylate | 478 mg, |
| Equivalent to imatinib content | 400 mg |
Excipients: low-substituted hyprolose – 149.4 mg, crospovidone – 112 mg, povidone K25 – 10 mg, magnesium stearate – 5.6 mg, colloidal silicon dioxide – 5 mg.
Film coating composition: hypromellose – 12 mg, titanium dioxide – 4.2 mg, macrogol 4000 – 2.8 mg, talc – 0.6 mg, yellow iron oxide dye – 0.4 mg.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
20 pcs. – contour cell blisters (1) – cardboard packs.
20 pcs. – contour cell blisters (2) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
20 pcs. – contour cell blisters (4) – cardboard packs.
20 pcs. – contour cell blisters (5) – cardboard packs.
25 pcs. – contour cell blisters (1) – cardboard packs.
25 pcs. – contour cell blisters (2) – cardboard packs.
25 pcs. – contour cell blisters (3) – cardboard packs.
25 pcs. – contour cell blisters (4) – cardboard packs.
25 pcs. – contour cell blisters (5) – cardboard packs.
30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.
30 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – contour cell blisters (4) – cardboard packs.
30 pcs. – contour cell blisters (5) – cardboard packs.
Capsules 100 mg: 6, 10, 12, 18, 20, 24, 30, 36, 40, 42, 48, 50, 54, 60, 70, 72, 80, 84, 90, 96, 100, 108, 120, 144, 180 or 216 pcs.
Marketing Authorization Holder
Ozon Medica, LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Imatinib | Capsules 100 mg: 6, 10, 12, 18, 20, 24, 30, 36, 40, 42, 48, 50, 54, 60, 70, 72, 80, 84, 90, 96, 100, 108, 120, 144, 180 or 216 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #2, body and cap opaque, white; capsule contents – a mixture of granules and powder from white to white with a brown or yellow tint; compaction of the capsule contents into lumps shaped like the capsule is allowed, which disintegrates when pressed.
| 1 caps. | |
| Imatinib mesylate | 119.5 mg, |
| Equivalent to imatinib content | 100 mg |
Excipients: microcrystalline cellulose (MCC-102) – 48.5 mg, crospovidone – 5 mg, povidone K-25 – 3.7 mg, magnesium stearate – 1.8 mg, colloidal silicon dioxide – 1.5 mg.
Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: titanium dioxide – 2%, gelatin – up to 100%.
6 pcs. – contour cell blisters (1) – cardboard packs.
6 pcs. – contour cell blisters (2) – cardboard packs.
6 pcs. – contour cell blisters (3) – cardboard packs.
6 pcs. – contour cell blisters (4) – cardboard packs.
6 pcs. – contour cell blisters (5) – cardboard packs.
6 pcs. – contour cell blisters (6) – cardboard packs.
6 pcs. – contour cell blisters (7) – cardboard packs.
6 pcs. – contour cell blisters (8) – cardboard packs.
6 pcs. – contour cell blisters (9) – cardboard packs.
6 pcs. – contour cell blisters (10) – cardboard packs.
6 pcs. – contour cell blisters (12) – cardboard packs.
6 pcs. – contour cell blisters (18) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (7) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (12) – cardboard packs.
10 pcs. – contour cell blisters (18) – cardboard packs.
12 pcs. – contour cell blisters (1) – cardboard packs.
12 pcs. – contour cell blisters (2) – cardboard packs.
12 pcs. – contour cell blisters (3) – cardboard packs.
12 pcs. – contour cell blisters (4) – cardboard packs.
12 pcs. – contour cell blisters (5) – cardboard packs.
12 pcs. – contour cell blisters (6) – cardboard packs.
12 pcs. – contour cell blisters (7) – cardboard packs.
12 pcs. – contour cell blisters (8) – cardboard packs.
12 pcs. – contour cell blisters (9) – cardboard packs.
12 pcs. – contour cell blisters (10) – cardboard packs.
12 pcs. – contour cell blisters (12) – cardboard packs.
12 pcs. – contour cell blisters (18) – cardboard packs.
Coated tablets, 100 mg: 10, 20, 24, 30, 36, 48, 50, 60, 98, 100, 120, or 180 pcs.
Marketing Authorization Holder
Pharmasintez-Nord, JSC (Russia)
Dosage Form
|
Imatinib | Coated tablets, 100 mg: 10, 20, 24, 30, 36, 48, 50, 60, 98, 100, 120, or 180 pcs. |
Dosage Form, Packaging, and Composition
Coated tablets of a brownish-pink color, round, biconvex; the tablet core on a cross-section is light yellow.
| 1 tab. | |
| Imatinib mesylate | 128.56 mg, |
| Equivalent to imatinib content | 100 mg |
Excipients: anhydrous lactose – 350.94 mg, croscarmellose sodium – 10 mg, povidone K30 – 7.5 mg, talc – 3 mg, magnesium stearate – 5 mg, crospovidone – 15 mg.
Shell composition: Insta-Coat film coating – 6 mg (polyethylene glycol – 1.2 mg, hypromellose – 2.4 mg, talc – 1.2 mg, titanium dioxide (E171) – 1.2 mg), iron (III) oxide red (E172) – 4 mg.
10 pcs. – Al/PVC blisters (1) – cardboard packs.
10 pcs. – Al/PVC blisters (2) – cardboard packs.
10 pcs. – Al/PVC blisters (3) – cardboard packs.
10 pcs. – Al/PVC blisters (5) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
20 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
24 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
30 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
36 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
48 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
50 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
60 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
96 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
100 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
120 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
180 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
Coated tablets, 400 mg: 10, 20, 24, 30, 36, 48, 50, 60, 98, 100, 120, or 180 pcs.
Marketing Authorization Holder
Pharmasintez-Nord, JSC (Russia)
Dosage Form
|
Imatinib | Coated tablets, 400 mg: 10, 20, 24, 30, 36, 48, 50, 60, 98, 100, 120, or 180 pcs. |
Dosage Form, Packaging, and Composition
Coated tablets of a brownish-pink color, oblong, biconvex; the tablet core on a cross-section is light yellow.
| 1 tab. | |
| Imatinib mesylate | 514.25 mg, |
| Equivalent to imatinib content | 400 mg |
Excipients: anhydrous lactose – 80.174 mg, croscarmellose sodium – 10 mg, povidone K30 – 12.545 mg, talc – 7.527 mg, magnesium stearate – 10 mg, crospovidone – 15.5 mg.
Shell composition: Insta-Coat film coating – 19.5 mg (polyethylene glycol – 3.9 mg, hypromellose – 7.8 mg, talc – 3.9 mg, titanium dioxide (E171) – 3.9 mg), iron (III) oxide red (E172) – 0.5 mg.
10 pcs. – Al/PVC blisters (1) – cardboard packs.
10 pcs. – Al/PVC blisters (2) – cardboard packs.
10 pcs. – Al/PVC blisters (3) – cardboard packs.
10 pcs. – Al/PVC blisters (5) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
20 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
24 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
30 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
36 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
48 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
50 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
60 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
96 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
100 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
120 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
180 pcs. – polymer jars (1) – cardboard boxes (for hospitals).
Capsules 100 mg: 30, 60 or 120 pcs.
Marketing Authorization Holder
Dr. Reddy's Laboratories Ltd. (India)
Dosage Form
|
Imatinib D-r Reddy`s | Capsules 100 mg: 30, 60 or 120 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #1, opaque, from orange to greyish-orange with red inscriptions “RDY” on the cap and “100” on the capsule body; capsule contents – a granulated powder from almost white to brownish-yellow.
| 1 caps. | |
| Imatinib mesylate | 119.5 mg, |
| Equivalent to imatinib content | 100 mg |
Excipients: crospovidone, sodium stearyl fumarate.
Composition of the hard gelatin capsule: sodium lauryl sulfate, water, titanium dioxide (E171), iron oxide red dye (E172), iron oxide yellow dye (E172), gelatin.
Composition of the red ink used for printing on the capsule: shellac, ethanol, 2-propanol, butanol, propylene glycol, concentrated ammonia solution, iron oxide red dye (E172).
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.
Capsules 400 mg: 30, 60, or 120 pcs.
Marketing Authorization Holder
Dr. Reddy's Laboratories Ltd. (India)
Dosage Form
|
Imatinib D-r Reddy`s | Capsules 400 mg: 30, 60, or 120 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #00, opaque, from dark yellow to brownish-orange with red inscriptions “RDY” on the cap and “400” on the capsule body; capsule contents – a granulated powder from almost white to brownish-yellow.
| 1 caps. | |
| Imatinib mesylate | 477.88 mg, |
| Equivalent to imatinib content | 400 mg |
Excipients: crospovidone, sodium stearyl fumarate.
Composition of the hard gelatin capsules: sodium lauryl sulfate, water, titanium dioxide (E171), iron oxide black dye (E172), iron oxide red dye (E172), iron oxide yellow dye (E172), gelatin.
Composition of the red ink used for printing on the capsule: shellac, ethanol, 2-propanol, butanol, propylene glycol, concentrated ammonia solution, iron oxide red dye (E172).
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.
Capsules 100 mg: 24, 36, 48, 96, 120 or 180 pcs.
Marketing Authorization Holder
Forsight, LLC (Russia)
Manufactured By
Vivimed Labs, Ltd. (India)
Dosage Form
|
Imatinib Forsite | Capsules 100 mg: 24, 36, 48, 96, 120 or 180 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #2, body and cap are blue; capsule contents – white or almost white powder.
| 1 caps. | |
| Imatinib mesylate | 119.5 mg, |
| Equivalent to imatinib content | 100 mg |
Excipients: anhydrous lactose – 112.5 mg, crospovidone – 3.0 mg, colloidal silicon dioxide – 2.0 mg, magnesium stearate – 3.0 mg.
Composition of the capsule body: gelatin 36.6%, methylparaben 0.176%, propylparaben 0.044%, colloidal silicon dioxide 0.183%, bronopol 0.018%, sodium lauryl sulfate 0.055%, glycerol 0.037%, titanium dioxide 0.549%, brilliant blue dye 0.091%, water qs to 100%.
Composition of the capsule cap: gelatin 24.6%, methylparaben 0.118%, propylparaben 0.030%, colloidal silicon dioxide 0.123%, bronopol 0.012%, sodium lauryl sulfate 0.037%, glycerol 0.025%, titanium dioxide 0.369%, brilliant blue dye 0.061%, water qs to 100%.
10 pcs. – blisters (3) – cardboard packs.
Capsules 100 mg: 60 or 120 pcs.
Marketing Authorization Holder
Grindeks, JSC (Latvia)
Dosage Form
|
Imatinib Grindex | Capsules 100 mg: 60 or 120 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #1, body and cap are brown-orange; capsule contents – powder from white to light yellow or brownish-yellow.
| 1 caps. | |
| Imatinib mesylate | 119.5 mg, |
| Equivalent to imatinib content | 100 mg |
Excipients: prosolv (microcrystalline cellulose – 92.46 mg, anhydrous colloidal silicon dioxide – 1.89 mg) – 94.35 mg, crospovidone – 11.75 mg, talc – 7.05 mg, magnesium stearate – 2.35 mg.
Composition of the capsule body and cap: titanium dioxide (E171) – 1%, iron oxide red dye (E172) – 0.13%, iron oxide yellow dye (E172) – 0.7%, gelatin – up to 100%.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (12) – cardboard packs.
Capsules 100 mg: 60 pcs.
Capsules 400 mg: 30 pcs.
Marketing Authorization Holder
Medac, GmbH (Germany)
Manufactured By
Pabianice Pharmaceutical Works Polfa S.A. (Poland)
Dosage Forms
|
Imatinib medac | Capsules 100 mg: 60 pcs. |
| Capsules 400 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #3, with orange body and cap; capsule contents – powder or a mixture of powder and granules, white or almost white.
| 1 caps. | |
| Imatinib mesylate | 119.47 mg, |
| Equivalent to imatinib content | 100 mg |
Excipients: lactose monohydrate – 12.518 mg, crospovidone (type A) – 10.241 mg, magnesium stearate – 0.738 mg.
Composition of the capsule shell: gelatin – 47.0192 mg, titanium dioxide (E171) – 0.64 mg, iron oxide yellow (E172) – 0.312 mg, iron oxide red (E172) – 0.0288 mg).
15 pcs. – blisters (4) – cardboard packs.
Capsules hard gelatin, size #00, with brownish-orange body and cap; capsule contents – powder or a mixture of powder and granules, white or almost white.
| 1 caps. | |
| Imatinib mesylate | 477.88 mg, |
| Equivalent to imatinib content | 400 mg |
Excipients: lactose monohydrate – 50.072 mg, crospovidone (type A) – 40.964 mg, magnesium stearate – 2.952 mg.
Composition of the capsule shell: gelatin – 115.4512 mg, titanium dioxide (E171) – 1.18 mg, iron oxide yellow (E172) – 1.18 mg, iron oxide red (E172) – 0.1416 mg, iron oxide black (E172) – 0.0472 mg).
10 pcs. – blisters (3) – cardboard packs.
Film-coated tablets, 100 mg: 30 or 120 pcs.
Marketing Authorization Holder
Alvogen Ipco S.a.r.l. (Luxembourg)
Manufactured By
Remedica, Ltd. (Cyprus)
Primary Packaging
REMEDICA, Ltd. (Cyprus)
Secondary Packaging
S.C. LABORMED-PHARMA, S.A. (Romania)
Dosage Form
|
Imatinib-Alvogen | Film-coated tablets, 100 mg: 30 or 120 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from dark yellow to orange-brown, round, biconvex, with a score on one side and engraving “100” on the other side; on a cross-section – the core is white to almost white.
| 1 tab. | |
| Imatinib mesylate | 119.5 mg, |
| Equivalent to imatinib content | 100 mg |
Excipients: microcrystalline cellulose – 141.4 mg, low-substituted hypromellose – 41.5 mg, povidone K-30 – 8.5 mg, crospovidone – 24 mg, colloidal silicon dioxide – 1.7 mg, magnesium stearate – 3.4 mg.
Coating composition: hypromellose – 6.9 mg, macrogol – 0.7 mg, talc – 2.2 mg, iron oxide red dye – 0.1 mg, iron oxide yellow dye – 1.1 mg.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.
Film-coated tablets, 400 mg: 30 or 120 pcs.
Marketing Authorization Holder
Alvogen Ipco S.a.r.l. (Luxembourg)
Manufactured By
Remedica, Ltd. (Cyprus)
Primary Packaging
REMEDICA, Ltd. (Cyprus)
Secondary Packaging
S.C. LABORMED-PHARMA, S.A. (Romania)
Dosage Form
|
Imatinib-Alvogen | Film-coated tablets, 400 mg: 30 or 120 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from dark yellow to orange-brown, oval, biconvex, with a score on one side and engraving “400” on the other side; on a cross-section – the core is white to almost white.
| 1 tab. | |
| Imatinib mesylate | 478 mg, |
| Equivalent to imatinib content | 400 mg |
Excipients: microcrystalline cellulose – 565.6 mg, low-substituted hypromellose – 166 mg, povidone K-30 – 34 mg, crospovidone – 96 mg, colloidal silicon dioxide – 6.8 mg, magnesium stearate – 13.6 mg.
Coating composition: hypromellose – 27.5 mg, macrogol – 2.9 mg, talc – 8.9 mg, iron oxide red dye – 0.3 mg, iron oxide yellow dye – 4.4 mg.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.
Capsules 100 mg: 30, 60 or 120 pcs.
Capsules 200 mg: 30, 60, 90 or 120 pcs.
Capsules 400 mg: 10, 30, 60, 90, or 120 pcs.
Marketing Authorization Holder
Siegardis Rus LLC (Russia)
Manufactured By
Adipharm, EAD (Bulgaria)
Labeled By
ADIPHARM, EAD (Bulgaria)
Dosage Forms
|
Imatinib-Sigardis | Capsules 100 mg: 30, 60 or 120 pcs. |
| Capsules 200 mg: 30, 60, 90 or 120 pcs. | ||
| Capsules 400 mg: 10, 30, 60, 90, or 120 pcs. |
Dosage Form, Packaging, and Composition
Capsules yellow, hard gelatin #1; capsule contents – white or almost white powder.
| 1 caps. | |
| Imatinib mesylate | 119.50 mg |
| Equivalent to imatinib content | 100 mg |
Excipients: lactose monohydrate – 12.5 mg, crospovidone – 7.5 mg, microcrystalline cellulose – 2.5 mg, colloidal silicon dioxide – 0.68 mg, magnesium stearate – 2.5 mg.
Composition of capsule #1: titanium dioxide (E171) – 2%, iron oxide yellow dye (E172) – 0.6286%, gelatin – up to 100%.
10 pcs. – aluminum blisters (3) – cardboard packs.
10 pcs. – aluminum blisters (6) – cardboard packs.
10 pcs. – aluminum blisters (12) – cardboard packs.
Capsules from white to light yellow, hard gelatin #0; capsule contents – white or almost white powder.
| 1 caps. | |
| Imatinib mesylate | 239 mg |
| Equivalent to imatinib content | 200 mg |
Excipients: lactose monohydrate – 25 mg, crospovidone – 15 mg, microcrystalline cellulose – 5 mg, colloidal silicon dioxide – 1.35 mg, magnesium stearate – 5 mg.
Composition of capsule size No. 0: titanium dioxide (E171) – 1%, iron oxide yellow dye (E172) – 0.0733%, gelatin – up to 100%.
10 pcs. – aluminum blisters (3) – cardboard packs.
10 pcs. – aluminum blisters (6) – cardboard packs.
10 pcs. – aluminum blisters (9) – cardboard packs.
10 pcs. – aluminum blisters (12) – cardboard packs.
Capsules orange, hard gelatin size No. 00; capsule contents – white or almost white powder.
| 1 caps. | |
| Imatinib mesylate | 478 mg |
| Equivalent to imatinib content | 400 mg |
Excipients: lactose monohydrate – 50 mg, crospovidone – 30 mg, microcrystalline cellulose – 10 mg, colloidal silicon dioxide – 2.7 mg, magnesium stearate – 10 mg.
Composition of capsule size No. 00: iron oxide red dye (E171) – 0.09%, titanium dioxide (E171) – 1.3333%, iron oxide yellow dye (E172) – 0.7%, gelatin – up to 100%.
10 pcs. – aluminum blisters (1) – cardboard packs.
10 pcs. – aluminum blisters (3) – cardboard packs.
10 pcs. – aluminum blisters (6) – cardboard packs.
10 pcs. – aluminum blisters (9) – cardboard packs.
10 pcs. – aluminum blisters (12) – cardboard packs.
Capsules 100 mg: 24, 48, 60, 96, 120 or 180 pcs.
Marketing Authorization Holder
Actavis Group PTC ehf. (Iceland)
Manufactured By
S.C. Sindan-Pharma S.R.L. (Romania)
Dosage Form
|
Imatinib-Teva | Capsules 100 mg: 24, 48, 60, 96, 120 or 180 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard size No. 1, light orange in color with marking “100 mg” in black ink on the body; capsule contents light yellow powder.
| 1 caps. | |
| Imatinib mesylate | 119.5 mg, |
| Equivalent to imatinib content | 100 mg |
Excipients: microcrystalline cellulose – 79.72 mg, copovidone – 22.44 mg, crospovidone – 26.92 mg, sodium stearyl fumarate – 3.92 mg, colloidal hydrophobic silicon dioxide – 0.75 mg, anhydrous colloidal silicon dioxide – 0.75 mg.
Capsule shell hypromellose – 74.1836 mg, titanium dioxide – 1.2925 mg, iron oxide yellow dye (E 172) – 0.4747 mg, iron oxide red dye (E 172) – 0.0486 mg.
Ink composition shellac 24-27%, ethanol 23-26%, isopropanol 1-3%, butanol 1-3%, propylene glycol 3-7%, concentrated ammonia solution 1-2%, iron oxide black dye (E172) 24-28%, potassium hydroxide 0.05-0.1%, purified water 15-18%.
8 pcs. – blisters (3) – cardboard packs.
8 pcs. – blisters (6) – cardboard packs.
8 pcs. – blisters (12) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.
10 pcs. – blisters (18) – cardboard packs.
Capsules 50 mg: 60, 100 or 120 pcs.
Capsules 100 mg: 60, 100 or 120 pcs.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Manufactured By
Ortat, JSC (Russia)
Dosage Forms
|
Imatinib-TL | Capsules 50 mg: 60, 100 or 120 pcs. |
| Capsules 100 mg: 60, 100 or 120 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size No. 3, with a white body and an orange cap; capsule contents – powder from white to yellow in color; a brownish tint is allowed.
| 1 caps. | |
| Imatinib mesylate | 59.75 mg, |
| Equivalent to imatinib base content | 50 mg |
Excipients: microcrystalline cellulose, crospovidone, colloidal silicon dioxide (aerosil), magnesium stearate.
Composition of capsule body: titanium dioxide, gelatin.
Composition of capsule cap azorubine dye (E122), sunset yellow FCF dye (E110), titanium dioxide, gelatin.
60 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.
Capsules hard gelatin, size No. 1, with a yellow body and cap; capsule contents – powder from white to yellow in color; a brownish tint is allowed.
| 1 caps. | |
| Imatinib mesylate | 119.5 mg, |
| Equivalent to imatinib base content | 100 mg |
Excipients: microcrystalline cellulose, crospovidone, colloidal silicon dioxide (aerosil), magnesium stearate.
Composition of capsule body: titanium dioxide, iron oxide yellow, gelatin.
Composition of capsule cap titanium dioxide, iron oxide yellow, gelatin.
60 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.
![Imatinib [Tablets, Capsules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Imatinib [Tablets, Capsules] 2")