MARCAIN POLYAMP STERIPACK Solution for injection Ref.[9275] Active ingredients: Bupivacaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Marcain Polyamp Steripack 0.5%.

Pharmaceutical Form

Injection.

Qualitative and quantitative composition

Bupivacaine Hydrochloride BP 5.28 mg/ml equivalent to bupivacaine hydrochloride anhydrous 5.0 mg/ml.

Excipient(s) with known effect: Each millilitre (ml) of Marcain Polyamp Steripack contains 3.15 mg of sodium, equivalent to 31.4 mg per 10 ml ampoule.

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 (tonicity contributor)
Sodium hydroxide/hydrochloric acid (pH adjustment to 4.0-6.5)
Water for injections

Pack sizes and marketing

10 ml and 20 ml polypropylene ampoules PolyampR. Cartons contain 5 or 10 ampoules. Not all pack sizes may be marketed.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PL 39699/0079

4th June 2002

Drugs

Drug Countries
MARCAIN Hong Kong, Ireland, Japan, Lithuania, Malta, New Zealand, United Kingdom

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