HEMABATE Solution for injection (2021)

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Περιεχόμενα

1. Name of the medicinal product

Hemabate Sterile Solution.

2. 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 ...

3. Pharmaceutical form

Solution for injection. Colourless, sterile, aqueous solution for intramuscular injection.

4.1. Therapeutic indications

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 ...

4.2. Posology and method of administration

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) ...

4.3. Contraindications

Hemabate should not be used where the patient is sensitive to carboprost tromethamine or to any of the excipients listed in section 6.1. Acute pelvic inflammatory disease. Patients with known active cardiac, ...

4.4. Special warnings and precautions for use

Hemabate should be used by medically trained personnel and is available only to hospitals and clinics with specialised obstetric units where 24 hour resident medical cover is provided. Hemabate, as with ...

4.5. Interaction with other medicinal products and other forms of interaction

As Hemabate can potentiate the effect of other oxytocics, concomitant use is not recommended.

4.6. Fertility, pregnancy and lactation

Fertility There are no clinical data on the effects of carboprost on fertility. Pregnancy Studies in animals have shown reproductive toxicity and any dose which produces increased uterine tone could put ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. There have been reports of undesirable effects such as syncope, dizziness and somnolence which could impair the ability ...

4.8. Undesirable effects

The table below lists the adverse effects identified through clinical trials and post-marketing surveillance by System Organ Class (SOC) and frequency. Within each frequency grouping, adverse events are ...

4.9. Overdose

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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Prostaglandins ATC code: G02AD04 Carboprost is a synthetic 15-methyl analogue of dinoprost (prostaglandin F2 alpha). It is a uterine stimulant with a more prolonged ...

5.2. Pharmacokinetic properties

The presence of the methyl group delays inactivation by enzymic dehydrogenation. Peak plasma levels vary depending on the route of administration. In the Rhesus monkey after a single i.m. injection of ...

5.3. Preclinical safety data

Data not available.

6.1. List of excipients

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

6.2. Incompatibilities

None known.

6.3. Shelf life

Ampoules: 4 years. Vial: 2 years.

6.4. Special precautions for storage

The ampoules must be stored in a refrigerator at 2-8°C. The vial must be stored in a refrigerator at 0-6°C.

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

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 ...

7. Marketing authorization holder

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

8. Marketing authorization number(s)

PL 00057/1000

9. Date of first authorization / renewal of the authorization

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

10. Date of revision of the text

01/2021

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