Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Biotech Laboratories (Pty) Ltd, Ground Floor, Block K West, Central Park, 400 16th Road, Randjespark, Midrand 1685, South Africa
BUPICAN 5 mg/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear and colourless or almost colourless solution, free from visible particles. The pH of the solution is between 4,0 and 6,5. The osmolality is between 250 and 320 mOsmol/kg. |
Each 1 mL contains 5,0 mg bupivacaine hydrochloride.
Each vial with 10 mL solution contains 50 mg of bupivacaine hydrochloride.
Sugar free.
Excipient with known effect: Contains sodium chloride.
For the full list of excipients, see section 6 .1.
| Active Ingredient | Description | |
|---|---|---|
| Bupivacaine |
Bupivacaine is an amide-type, long-acting local anesthetic. Bupivicaine reversibly binds to specific sodium ion channels in the neuronal membrane, resulting in a decrease in the voltage-dependent membrane permeability to sodium ions and membrane stabilization; inhibition of depolarization and nerve impulse conduction; and a reversible loss of sensation. |
| List of Excipients |
|---|
|
Sodium chloride |
10 mL tubular clear type I glass vials with a 20 mm grey bromobutyl rubber closure covered by an aluminium crimp with a plastic flip-off cap. 5 vials are packed in PVC/aluminium foil blisters and are placed in cardboard cartons.
Biotech Laboratories (Pty) Ltd, Ground Floor, Block K West, Central Park, 400 16th Road, Randjespark, Midrand 1685, South Africa
45/4/0127
30 September 2016
| Drug | Countries | |
|---|---|---|
| BUPICAN | Brazil, Estonia, South Africa |
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