PROVIVE Emulsion for injection Ref.[50449] Active ingredients: Propofol

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2021  Publisher: Provive 1% is distributed in New Zealand by: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, Auckland 1060 Baxter Healthcare Ltd, PO Box 14 062, Panmure, Auckland 1741 Phone (09) 574 2400

Product name and form

Provive 1% 10mg/mL emulsion for injection.

Pharmaceutical Form

Emulsion for injection.

A white, oilโ€inโ€water emulsion for injection.

Qualitative and quantitative composition

Propofol 10mg/mL.

Excipients with known effect: Soya oil.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Propofol

Propofol (2, 6-diisopropylphenol) is a short-acting general anaesthetic agent with a rapid onset of action of approximately 30 seconds.

List of Excipients

Egg lecithin
Glycerol
Sodium hydroxide (for pH adjustment)
Sodium oleate
Soya oil
Water for injections

Pack sizes and marketing

Provive 1% is supplied in 20mL, 50mL or 100mL clear glass vials in pack sizes of 5 vials.

Marketing authorization holder

Provive 1% is distributed in New Zealand by:

Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, Auckland 1060

Baxter Healthcare Ltd, PO Box 14 062, Panmure, Auckland 1741

Phone (09) 574 2400

Marketing authorization dates and numbers

Date of first approval: 11 December 2008

Drugs

Drug Countries
PROVIVE Brazil, Ecuador, Hong Kong, Lithuania, Nigeria, New Zealand, Poland, South Africa

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