PROPOVEN Emulsion for injection/infusion Ref.[28011] Active ingredients: Propofol

Source: Health Products Regulatory Authority (IE)  Revision Year: 2018  Publisher: Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, Bad Homburg v.d.H 61352, Germany

Product name and form

Propoven 1% emulsion for injection/infusion in pre-filled syringe.

Pharmaceutical Form

Emulsion for injection/infusion in pre-filled syringe.

White oil-in-water emulsion.

pH of emulsion: 7.5-8.5
Osmolality of emulsion: 300 mosmol/kg

Qualitative and quantitative composition

Each ml emulsion contains 10 mg propofol.

Each 10 ml pre-filled syringe contains 100 mg propofol.
Each 20 ml pre-filled syringe contains 200 mg propofol.
Each 50 ml pre-filled syringe contains 500 mg propofol.

Excipients with known effect:

Each ml emulsion contains:

soya-bean oil, refined 50 mg
sodium max. 0.06 mg

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

Soya-bean oil, refined
Medium-chain triglycerides
Purified egg phosphatides
Glycerol
Oleic acid
Sodium hydroxide
Water for injections

Pack sizes and marketing

10 ml pre-filled syringe (cyclo-olefine-copolymer) with bromobutyl tip cap, bromobutyl plunger and PP piston rod.

20 ml pre-filled syringe (cyclo-olefine-copolymer) with bromobutyl tip cap, bromobutyl plunger and PP piston rod.

50ml pre-filled syringe (cyclo-olefine-copolymer) with bromobutyl tip cap, bromobutyl plunger and PP piston rod.

Packs containing 6 plastic syringes with 10 ml emulsion

Packs containing 6 plastic syringes with 20 ml emulsion.

Packs containing 1 plastic syringe with 50 ml emulsion.

Marketing authorization holder

Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, Bad Homburg v.d.H 61352, Germany

Marketing authorization dates and numbers

PA2059/017/004

Date of First Authorisation: 18th April 2013
Date of Last Renewal: 12th March 2018

Drugs

Drug Countries
PROPOVEN Estonia, Ireland, Lithuania, United Kingdom

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