HEMABATE Solution for injection Ref.[27723] Active ingredients: Carboprost

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK

Product name and form

Hemabate Sterile Solution.

Pharmaceutical Form

Solution for injection.

Colourless, sterile, aqueous solution for intramuscular injection.

Qualitative and quantitative composition

Each 1 ml contains carboprost tromethamine equivalent to carboprost 250 micrograms.

Excipient(s) with known effect:

This medicine contains 9.45 mg benzyl alcohol in each ampoule which is equivalent to 9.45 mg/ml.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Carboprost

Carboprost is a synthetic 15-methyl analogue of dinoprost (prostaglandin F2 alpha). Administered intramuscularly carboprost stimulates in the gravid uterus myometrial contractions similar to labor contractions at the end of a full term pregnancy. It is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and for the treatment of postpartum hemorrhage due to uterine atony, which has not responded to conventional methods of management. The most frequent adverse reactions observed are related to its contractile effect on smooth muscle: vomiting, diarrhea, nausea, fever and flushing. Carboprost may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.

List of Excipients

Benzyl alcohol
Sodium chloride
Tromethamine
Sodium hydroxide
Hydrochloric acid
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK

Marketing authorization dates and numbers

PL 00057/1000

Date of first authorisation: 16 August 1990
Date of latest renewal: 23 February 1996

Drugs

Drug Countries
HEMABATE Canada, Hong Kong, Singapore, United Kingdom, United States

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