Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Prostin E2 Sterile Solution 1 mg/ml.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colourless, alcoholic solution free from particulate matter, which after appropriate dilution is intended for intravenous administration to human beings. |
Each ml contains 1 mg dinoprostone (750 micrograms per ampoule).
Following dilution in accordance with instructions, each ml of the resultant solution for infusion contains 1.5 micrograms dinoprostone.
Excipient(s) with known effect: Each 0.75 ml ampoule contains 515 mg dehydrated alcohol (ethanol).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dinoprostone |
|
| List of Excipients |
|---|
|
Dehydrated alcohol (ethanol) |
Ph. Eur. Type I glass ampoule, containing 0.75 ml sterile solution, packed in a carton.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
PL 00057/1028
Date of first authorisation: 27 June 1986
Date of latest renewal: 28 October 2004
| Drug | Countries | |
|---|---|---|
| PROSTIN E2 | Austria, Canada, Cyprus, Hong Kong, Croatia, Ireland, Israel, Malta, Netherlands, New Zealand, Singapore, United Kingdom, United States |
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