Bupivacaine (Solution) Instructions for Use
ATC Code
N01BB01 (Bupivacaine)
Active Substance
Bupivacaine (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Local anesthetic for spinal anesthesia
Pharmacotherapeutic Group
Anesthetics; local anesthetics; amides
Pharmacological Action
A long-acting amide-type local anesthetic, four times more potent than lidocaine. It reversibly blocks impulse conduction along the nerve fiber by affecting sodium channels. It may have a similar effect in the brain and myocardium.
It has a hypotensive effect and slows the heart rate. Postoperative analgesia is maintained for 7-14 hours with intercostal block. After a single epidural injection, the duration of effect when using a concentration of 5 mg/ml is from 2 to 5 hours, and up to 12 hours with peripheral nerve block.
The use of solutions at a concentration of 2.5 mg/ml has a lesser effect on motor nerves.
Pharmacokinetics
The systemic absorption of bupivacaine depends on the dose, the method of its administration, and the vascularity of the injection site.
The anesthetic effect occurs rapidly; compared to other local anesthetics, the anesthetic effect of bupivacaine is significantly longer. It has been noted that after the return of sensation, the analgesic effect persists for some time, which makes it possible to reduce the doses of analgesics. Bupivacaine is completely absorbed from the epidural space; absorption is biphasic. TCmax in blood plasma during caudal epidural and conduction anesthesia is 30-45 minutes, followed by a decrease to a negligible level within 3-6 hours. The total plasma clearance of bupivacaine is 580 ml/min, Vd is 73 L. The terminal T1/2 is 2.7 hours.
Bupivacaine is metabolized in the liver, mainly by conjugation with glucuronic acid.
Bupivacaine is excreted mainly by the kidneys, with only 6% excreted unchanged in the urine.
Bupivacaine crosses the placenta by passive diffusion. Binding to plasma proteins in the fetal body is lower than in the maternal body, the concentration of the unbound fraction in the fetal and maternal body is the same. It is secreted into breast milk.
Pharmacokinetic parameters can be significantly altered by factors affecting urine pH and renal blood flow, depending on the route of administration of bupivacaine and the patient’s age, as well as in patients with liver and kidney diseases.
Indications
Surgical anesthesia in adults and children over 12 years of age; infiltration anesthesia when a long-lasting anesthetic effect is required, for example, for postoperative pain; conduction anesthesia with a prolonged effect or epidural anesthesia in cases where the addition of epinephrine is contraindicated and significant muscle relaxation is not required; anesthesia in obstetrics.
ICD codes
| ICD-10 code | Indication |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| QB9A | Preparatory procedures for subsequent treatment |
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. |
Administer the minimum effective dose to achieve adequate anesthesia. Adjust dosage individually based on the patient’s physical status, type of block, and vascularity of the area.
For lumbar epidural anesthesia in adults, use 10-20 mL of a 5 mg/mL (0.5%) solution. For caudal epidural block, administer 15-30 mL of a 5 mg/mL solution. For peripheral nerve block, doses range from 5 mL to 30 mL of a 5 mg/mL solution.
For infiltration anesthesia, the maximum single dose is 150 mg (30 mL of a 5 mg/mL solution). Use a 2.5 mg/mL (0.25%) solution when a lesser degree of motor block is desired.
For obstetric analgesia via lumbar epidural, an initial dose of 10-20 mL of a 2.5 mg/mL solution is typical. Do not repeat doses more frequently than every three hours.
The maximum recommended single dose for healthy adults is 150 mg. Do not exceed a dose of 2 mg per kg of body weight. Reduce the total dose by 25-50% for elderly, debilitated, or acutely ill patients.
Use only by physicians experienced in regional anesthesia techniques. Aspirate frequently during injection to avoid intravascular administration.
Adverse Reactions
From the CNS and peripheral nervous system numbness of the tongue, dizziness, blurred vision, muscle tremor, drowsiness, convulsions, loss of consciousness, neuropathy, peripheral nerve damage, arachnoiditis, paresis, paraplegia. In the area of anesthesia, paresthesia, weakening of sphincter tone are possible.
From the cardiovascular system decreased cardiac output, heart block, arterial hypotension, bradycardia, ventricular arrhythmias, cardiac arrest, arrhythmia.
From the digestive system nausea, vomiting.
From the urinary system: urinary retention.
From the respiratory system apnea.
From the organ of vision: diplopia.
Allergic reactions skin manifestations, in severe cases – anaphylactic shock.
Contraindications
Hypersensitivity to bupivacaine or other amide-type local anesthetics; conditions in which epidural anesthesia is contraindicated: current diseases of the CNS, such as meningitis, poliomyelitis, intracranial hemorrhage, as well as CNS neoplasms; spinal tuberculosis; pernicious anemia with subacute combined degeneration of the spinal cord; pustular skin lesion at the intended puncture site or adjacent to the puncture site; cardiogenic or hypovolemic shock; blood coagulation disorders or concomitant anticoagulant therapy; children under 12 years of age.
Bupivacaine is not used for intravenous regional anesthesia (Bier’s block).
With caution elderly age; debilitated patients; AV block II and III degree; severe impairment of liver and kidney function; pregnancy; concomitant use with class III antiarrhythmic drugs (e.g., amiodarone); concomitant use with other local anesthetics or drugs structurally similar to amide-type local anesthetics, such as class IB antiarrhythmic drugs (e.g., lidocaine, mexiletine); paracervical block.
Use in Pregnancy and Lactation
Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Paracervical block is contraindicated.
If it is necessary to use bupivacaine during lactation, breastfeeding should be discontinued.
Use in Hepatic Impairment
Should be used with caution in patients with severe hepatic impairment.
Use in Renal Impairment
Should be used with caution in patients with severe renal impairment.
Pediatric Use
Contraindicated for use in children under 12 years of age.
Geriatric Use
Should be used with caution in elderly patients.
Special Precautions
Certain types of blocks may be associated with serious adverse reactions.
Epidural anesthesia may be accompanied by depression of the cardiovascular system, especially against the background of hypovolemia. Therefore, caution should be exercised in patients with impaired cardiovascular function.
In rare cases, with retrobulbar administration, bupivacaine may penetrate into the cranial subarachnoid space, resulting in temporary blindness, cardiovascular collapse, apnea, and convulsions. These symptoms require immediate treatment.
With retrobulbar and peribulbar administration of local anesthetics, there is a small risk of persistent impairment of ocular muscle function. The main causes are trauma and/or local toxic effect of the administered bupivacaine on the muscles and/or nerves.
Accidental intravascular injection of local anesthetics in the head and neck area, even in low doses, can cause symptoms of CNS toxicity.
Paracervical block sometimes leads to fetal bradycardia/tachycardia, so the fetal heart rate should be carefully monitored.
Caution should be exercised in patients with atrioventricular block of stage II or III, since local anesthetics may reduce myocardial conductivity. Caution should be exercised in patients with severe impairment of liver or kidney function, elderly or debilitated patients.
Patients receiving class III antiarrhythmic drugs (e.g., amiodarone) should be under close supervision with ECG monitoring due to the risk of cardiovascular complications due to a possible additive effect.
Drug Interactions
With simultaneous use with antiarrhythmic drugs that have local anesthetic activity, the risk of additive toxic effects increases.
With simultaneous use with barbiturates, a decrease in the concentration of bupivacaine in the blood 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
Injection solution 5 mg/1 ml: 20 ml vial 1 pc.
Marketing Authorization Holder
Corgem Pharmaceuticals Pvt. Ltd. (India)
Manufactured By
Claris Lifesciences, Ltd. (India)
Dosage Form
 |
Bupivacaine | Injection solution 5 mg/1 ml: 20 ml vial 1 pc. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, colorless.
| 1 ml | |
| Bupivacaine hydrochloride (in the form of bupivacaine hydrochloride monohydrate) | 5 mg |
Excipients : methylparahydroxybenzoate – 1 mg, sodium chloride – 8 mg, 0.1 M sodium hydroxide solution and/or 0.1 M hydrochloric acid solution – to adjust pH, water for injections – up to 1 ml.
20 ml – vials of colorless glass (1) – cardboard packs.
Solution for injection 5 mg/1 ml: 4 ml amp. 5 or 10 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Dosage Form
|
Bupivacaine | Solution for injection 5 mg/1 ml: 4 ml amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, colorless.
| 1 ml | |
| Bupivacaine hydrochloride | 5 mg |
Excipients : sodium chloride – 8 mg, sodium hydroxide solution 0.1M or hydrochloric acid solution 0.1M – to pH 4.0-6.5, water for injections – up to 1 ml.
4 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules of colorless glass (5) – cardboard trays (1) – cardboard packs.
4 ml – ampoules of colorless glass (5) – cardboard trays (2) – cardboard packs.
Solution for injection 5 mg/1 ml: amp. 4 ml or 10 ml 5 or 10 pcs. and vial 4 ml or 10 ml 1, 5 or 10 pcs.
Marketing Authorization Holder
B-PHARM, LLC (Russia)
Dosage Form
|
Bupivacaine | Solution for injection 5 mg/1 ml: amp. 4 ml or 10 ml 5 or 10 pcs. and vial 4 ml or 10 ml 1, 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection in the form of a transparent, colorless liquid.
| 1 ml | |
| Bupivacaine hydrochloride monohydrate | 5.28 mg, |
| Equivalent to bupivacaine hydrochloride content | 5 mg |
Excipients : sodium chloride – 8 mg, hydrochloric acid – to pH from 4.5 to 6.5, sodium hydroxide – to pH from 4.5 to 6.5, water for injections – up to 1 ml.
4 ml – ampoules of neutral glass (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (2) – cardboard packs.
4 ml – vials (5) – contour cell packs (1) – cardboard packs.
4 ml – vials (5) – contour cell packs (2) – cardboard packs.
4 ml – vials (1) – cardboard packs.
10 ml – ampoules of neutral glass (5) – contour cell packs (1) – cardboard packs.
10 ml – ampoules of neutral glass (5) – contour cell packs (2) – cardboard packs.
10 ml – vials (5) – contour cell packs (1) – cardboard packs.
10 ml – vials (5) – contour cell packs (2) – cardboard packs.
10 ml – vials (1) – cardboard packs.
Solution for injection 5 mg/1 ml: 4 ml, 10 ml or 20 ml amp. 5 or 10 pcs., 20 ml fl. 5 pcs.
Marketing Authorization Holder
Velpharm, LLC (Russia)
Dosage Form
|
Bupivacaine | Solution for injection 5 mg/1 ml: 4 ml, 10 ml or 20 ml amp. 5 or 10 pcs., 20 ml fl. 5 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, colorless.
| 1 ml | |
| Bupivacaine hydrochloride | 5 mg |
Excipients : sodium chloride – 8 mg, disodium edetate dihydrate (disodium salt of ethylenediamine-N,N,N’,N’-tetraacetic acid dihydrate (Trilon B)) – 0.1 mg, sodium hydroxide solution 1M – to pH 4.0-6.5, water for injections – up to 1 ml.
4 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.
10 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
10 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.
20 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
20 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.
Solution for injection 5 mg/ml: 4 ml or 10 ml amp. 5, 10, 20, 50, or 100 pcs.
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Form
|
Bupivacaine | Solution for injection 5 mg/ml: 4 ml or 10 ml amp. 5, 10, 20, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection in the form of a transparent, colorless liquid.
| 1 ml | |
| Bupivacaine hydrochloride | 5 mg, |
| Equivalent to bupivacaine hydrochloride monohydrate content | 5.28 mg |
Excipients : sodium chloride – 8 mg, sodium hydroxide solution 0.01 M or hydrochloric acid solution 0.01 M – to pH 4-6.5, water for injections – up to 1 ml.
4 ml – ampoules (5) – cardboard packs.
4 ml – ampoules (10) – cardboard packs.
4 ml – ampoules (20) – cardboard packs.
4 ml – ampoules (50) – cardboard packs.
4 ml – ampoules (100) – cardboard packs.
10 ml – ampoules (5) – cardboard packs.
10 ml – ampoules (10) – cardboard packs.
10 ml – ampoules (20) – cardboard packs.
10 ml – ampoules (50) – cardboard packs.
10 ml – ampoules (100) – cardboard packs.
Injection solution 5 mg/1 ml: 4 ml vial 1 or 5 pcs, 10 ml vial 1, 5, 10 or 20 pcs.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
|
Bupivacaine | Injection solution 5 mg/1 ml: 4 ml vial 1 or 5 pcs, 10 ml vial 1, 5, 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, colorless.
| 1 vial | |
| Bupivacaine hydrochloride monohydrate | 5.28 mg, |
| Equivalent to bupivacaine hydrochloride content | 5 mg |
Excipients : sodium chloride – 8 mg, sodium hydroxide solution 1M or hydrochloric acid solution 1M – to pH 4.0-6.5.
4 ml – vials (1) – cardboard packs.
4 ml – vials (5) – contour cell packs (1) – cardboard packs.
10 ml – vials (5) – contour cell packs (1) – cardboard packs.
10 ml – vials (5) – contour cell packs (2) – cardboard packs.
10 ml – vials (5) – contour cell packs (4) – cardboard packs.
Solution for injection 5 mg/1 ml: 2 ml or 4 ml amp. 3, 5, or 10 pcs.
Marketing Authorization Holder
Mir Chemical and Pharmaceutical Concern, LLC (Russia)
Manufactured By
NPC Eskom, PJSC (Russia)
Dosage Form
|
Bupivacaine | Solution for injection 5 mg/1 ml: 2 ml or 4 ml amp. 3, 5, or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection in the form of a transparent, colorless liquid.
| 1 ml | |
| Bupivacaine hydrochloride (in the form of bupivacaine hydrochloride monohydrate) | 5 mg |
Excipients: sodium chloride – 8 mg, 1M sodium hydroxide solution or 1M hydrochloric acid solution – to pH 4.0-6.5, water for injection – up to 1 ml.
2 ml – ampoules (3) – carton packs.
2 ml – ampoules (5) – carton packs.
2 ml – ampoules (10) – carton packs.
4 ml – ampoules (3) – carton packs.
4 ml – ampoules (5) – carton packs.
4 ml – ampoules (10) – carton packs.
Solution for injection 5 mg/ml: 4 ml or 10 ml amp. 5 or 10 pcs.
Marketing Authorization Holder
Ecofarmplus, JSC (Russia)
Dosage Form
|
Bupivacaine | Solution for injection 5 mg/ml: 4 ml or 10 ml amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, colorless.
| 1 amp. | |
| Bupivacaine hydrochloride monohydrate | 5.28 mg, |
| Equivalent to bupivacaine hydrochloride content | 5 mg |
Excipients: sodium chloride – 8 mg, 1M hydrochloric acid solution – to pH 4.5 to 6.5, 1M sodium hydroxide solution – to pH from 4.5 to 6.5, water for injection – up to 1 ml.
4 ml – ampoules (5) – contour packs (1) – carton packs.
4 ml – ampoules (5) – contour packs (2) – carton packs.
10 ml – ampoules (5) – contour packs (1) – carton packs.
10 ml – ampoules (5) – contour packs (2) – carton packs.
Solution for injection 5 mg/1 ml: amp. 10 ml 5 pcs.
Marketing Authorization Holder
Grindeks, JSC (Latvia)
Manufactured By
Santonika, UAB (Lithuania)
Or
HBM Pharma, s.r.o. (Slovakia)
Contact Information
GRINDEX JSC (Latvia)
Dosage Form
|
Bupivacaine Grindex | Solution for injection 5 mg/1 ml: amp. 10 ml 5 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, colorless.
| 1 ml | |
| Bupivacaine hydrochloride (in the form of monohydrate) | 5 mg |
Excipients: sodium chloride – 8 mg, 0.1M sodium hydroxide solution or 0.1M hydrochloric acid solution – to pH 4.0-4.5, water for injection – up to 1 ml.
10 ml – ampoules of colorless glass (5) – PVC film blister packs (trays) (1) – carton packs.
Solution for intrathecal administration 5 mg/1 ml: amp. 4 ml 5 pcs.
Marketing Authorization Holder
Grindeks, JSC (Latvia)
Manufactured By
Santonika, UAB (Lithuania)
Or
HBM Pharma, s.r.o. (Slovakia)
Contact Information
GRINDEX JSC (Latvia)
Dosage Form
|
Bupivacaine Grindex Spinal | Solution for intrathecal administration 5 mg/1 ml: amp. 4 ml 5 pcs. |
Dosage Form, Packaging, and Composition
Solution for intrathecal administration transparent, colorless.
| 1 ml | |
| Bupivacaine hydrochloride (in the form of monohydrate) | 5 mg |
Excipients: sodium chloride – 8 mg, 0.1M sodium hydroxide solution or 0.1M hydrochloric acid solution – to pH 4.0-4.5, water for injection – up to 1 ml.
4 ml – ampoules of colorless glass (5) – PVC film blister packs (trays) (1) – carton packs.
Solution for injection 5 mg/1 ml: amp. 4 ml 5 or 10 pcs.
Marketing Authorization Holder
Binergia JSC (Russia)
Manufactured By
Kursk Biopharmaceutical Plant – Firm "Biok", FKP (Russia)
Dosage Form
|
Bupivacaine Spinal Heavy | Solution for injection 5 mg/1 ml: amp. 4 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, colorless.
| 1 ml | |
| Bupivacaine hydrochloride monohydrate | 5.28 mg, |
| Equivalent to bupivacaine hydrochloride content | 5 mg |
Excipients: dextrose monohydrate – 80 mg, calculated as anhydrous dextrose – 72.7 mg, 2M sodium hydroxide solution and/or 2M hydrochloric acid solution – to pH 4.0-6.0, water for injection – up to 1 ml.
4 ml – ampoules of colorless glass (5) – contour packs (1) – carton packs.
4 ml – ampoules of colorless glass (5) – contour packs (2) – carton packs.
Solution for intrathecal administration 5 mg/1 ml: amp. 4 ml 5 or 10 pcs.
Marketing Authorization Holder
Velpharm, LLC (Russia)
Dosage Form
|
Bupivacaine Spinal Heavy | Solution for intrathecal administration 5 mg/1 ml: amp. 4 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intrathecal administration transparent, colorless.
| 1 ml | |
| Bupivacaine hydrochloride monohydrate | 5.28 mg, |
| Equivalent to bupivacaine hydrochloride content | 5 mg |
Excipients: glucose monohydrate (dextrose monohydrate), 0.1M sodium hydroxide solution or 0.1M hydrochloric acid solution, water for injection.
4 ml – glass ampoules (5) – contour blister packs (1) – carton packs.
4 ml – glass ampoules (5) – contour blister packs (2) – carton packs.
Solution for intrathecal administration 5 mg/1 ml: amp. 4 ml 5 or 10 pcs.
Marketing Authorization Holder
Velpharm, LLC (Russia)
Dosage Form
|
Bupivacaine Spinal Heavy Velpharm | Solution for intrathecal administration 5 mg/1 ml: amp. 4 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intrathecal administration transparent, colorless.
| 1 ml | |
| Bupivacaine hydrochloride monohydrate | 5.28 mg, |
| Equivalent to bupivacaine hydrochloride content | 5 mg |
Excipients: dextrose monohydrate (glucose monohydrate), 0.1M sodium hydroxide solution or 0.1M hydrochloric acid solution, water for injection.
4 ml – glass ampoules (5) – contour blister packs (1) – carton packs.
4 ml – glass ampoules (5) – contour blister packs (2) – carton packs.
Solution for injection 5 mg/ml
Marketing Authorization Holder
Velpharm, LLC (Russia)
Dosage Form
|
Bupivacaine Velpharm | Solution for injection 5 mg/ml |
Dosage Form, Packaging, and Composition
Solution for injection
| 1 ml | |
| Bupivacaine hydrochloride | 5 mg |
10 ml – ampoules (10 pcs.) – carton packs – Prescription only
10 ml – ampoules (5 pcs.) – carton packs – Prescription only
20 ml – ampoules (10 pcs.) – carton packs – Prescription only
20 ml – ampoules (5 pcs.) – carton packs – Prescription only
4 ml – ampoules (10 pcs.) – carton packs – Prescription only
4 ml – ampoules (5 pcs.) – carton packs – Prescription only
Solution for injection 5 mg/1 ml: amp. 4 ml, 10 ml or 20 ml 5 or 10 pcs.; vial 10 ml or 20 ml 5 or 10 pcs.
Marketing Authorization Holder
Binergia JSC (Russia)
Manufactured By
Armavir Biopharmaceutical Plant, FSE (Russia)
Dosage Form
|
Bupivacaine-Binergia | Solution for injection 5 mg/1 ml: amp. 4 ml, 10 ml or 20 ml 5 or 10 pcs.; vial 10 ml or 20 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, colorless.
| 1 ml | |
| Bupivacaine hydrochloride monohydrate | 5.28 mg, |
| Equivalent to bupivacaine hydrochloride content | 5 mg |
Excipients: sodium chloride – 8 mg, 0.1M sodium hydroxide solution and/or 0.1M hydrochloric acid solution – to pH 5.0-6.5, water for injection – up to 1 ml.
4 ml – ampoules of colorless glass (5) – plastic contour packs* (1) – carton packs.
4 ml – ampoules of colorless glass (5) – plastic contour packs* (2) – carton packs.
10 ml – ampoules of colorless glass (5) – plastic contour packs* (1) – carton packs.
10 ml – ampoules of colorless glass (5) – plastic contour packs* (2) – carton packs.
20 ml – ampoules of colorless glass (5) – plastic contour packs* (1) – carton packs.
20 ml – ampoules of colorless glass (5) – plastic contour packs* (2) – carton packs.
10 ml – vials of colorless glass (5) – plastic contour packs* (1) – carton packs.
10 ml – vials of colorless glass (5) – plastic contour packs* (2) – carton packs.
20 ml – vials of colorless glass (5) – plastic contour packs* (1) – carton packs.
20 ml – vials of colorless glass (5) – plastic contour packs* (2) – carton packs.
* or contour blister packs.
Solution for intrathecal administration 5 mg/ml: 4 ml amp. 5 or 10 pcs.
Marketing Authorization Holder
Lekpharm, SOOO (Republic of Belarus)
Dosage Form
|
Bupivacaine-Lekpharm Spinal heavy | Solution for intrathecal administration 5 mg/ml: 4 ml amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intrathecal administration in the form of a transparent, colorless liquid.
| 1 ml | |
| Bupivacaine hydrochloride monohydrate | 5 mg |
Excipients: glucose monohydrate, sodium hydroxide and/or hydrochloric acid (0.1M solutions) – to pH 4.0-4.5, water for injection.
4 ml – ampoules of colorless glass (5) – PVC film contour blister packs (1) – carton packs.
4 ml – ampoules of colorless glass (5) – PVC film contour blister packs (2) – carton packs.
![Bupivacaine [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Bupivacaine [Solution] 2")