Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
Treatment of post-partum haemorrhage due to uterine atony and refractory to conventional methods of treatment with oxytocic agents and ergometrine used either alone or in combination.
Conventional therapy should usually consist of 0.5-1 mg ergometrine with up to 50 units of oxytocin infused intravenously over periods of time from 20 minutes to 12 hours. The dosage and duration of administration should reflect the seriousness of the clinical situation.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
An initial dose of 250 micrograms (1.0 ml) of Hemabate should be administered as a deep intramuscular injection.
If necessary, further doses of 250 micrograms may be administered at intervals of approximately 1.5 hours. In severe cases the interval between doses may be reduced at the discretion of the attending physician, but it should not be less than 15 minutes. The total dose of Hemabate should not exceed 2 mg (8 doses).
Not applicable.
Not applicable.
Treatment of overdosage must be symptomatic and supportive as clinical studies with prostaglandin antagonists have not progressed to the point where recommendations may be made.
If evidence of excessive side-effects appears, the frequency of administration should be decreased or administration discontinued.
Ampoules: 4 years.
Vial: 2 years.
The ampoules must be stored in a refrigerator at 2-8°C.
The vial must be stored in a refrigerator at 0-6°C.
Ampoule: Type 1 glass ampoule containing 1 ml solution, packed in cartons of two or ten ampoules.
Vial: Type 1 glass with butyl rubber closure, containing 10 ml solution, packed individually in a carton.
Not all pack sizes may be marketed.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Any unused product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
