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
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 |
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 |
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.
Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, Bad Homburg v.d.H 61352, Germany
PA2059/017/004
Date of First Authorisation: 18th April 2013
Date of Last Renewal: 12th March 2018
| Drug | Countries | |
|---|---|---|
| PROPOVEN | Estonia, Ireland, Lithuania, United Kingdom |
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