MARCAIN HEAVY Solution for injection Ref.[28023] Active ingredients: Bupivacaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Marcain Heavy, 0.5% solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless solution.

Qualitative and quantitative composition

Bupivacaine Hydrochloride BP 5.28 mg/ml equivalent to 5 mg/ml bupivacaine hydrochloride anhydrous.

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

Glucose anhydrous and/or glucose monohydrate
Sodium hydroxide
Water for injections

Pack sizes and marketing

4 ml sterile wrapped glass ampoules or One Point Cut 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 39699/0077

20/09/2004

Drugs

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

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