Bupivacaine Hydrochloride Infusion Solution BP 0.1% w/v Ref.[2579] Active ingredients: Bupivacaine

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Antigen International Limited Roscrea Co. Tipperary Ireland

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

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 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

Antigen International Limited
Roscrea
Co. Tipperary
Ireland

Marketing authorization dates and numbers

PL 02848/0197

09/03/2000 / 29/09/2005

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