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Bupivacaine Hydrochloride Infusion Solution BP 0.1% w/v (2012)

Active ingredients: Bupivacaine

Product Name and Form

Bupivacaine Hydrochloride 0.1%w/v Solution for Infusion.

Pharmaceutical form

Solution for Infusion.

Qualitative and Quantitative Composition

Each 100ml contains anhydrous bupivacaine hydrochloride 0.10g equivalent to 0.1055g of bupivacaine hydrochloride.

For excipients, see 6.1

Chemical substance
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
Sodium Hydroxide
Water for Injections

Pack sizes and Marketing

100ml or 250ml polypropylene infusion bags in packs of 10, 20 or 50.

Marketing authorization holder
Authorization dates

Antigen International Limited
Roscrea
Co. Tipperary
Ireland

09/03/2000 / 29/09/2005

Marketing authorization number:

PL 02848/0197