Bupivacaine Hydrochloride Infusion Solution BP 0.1% w/v

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

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