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

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 other potent oxytocic agents, should be used only with strict adherence to recommended dosages.

This preparation should not be used for induction of labour.

Hemabate must not be given intravenously.

Special caution is necessary in patients with history of asthma, hypo- or hypertension, cardiovascular, renal, or hepatic disease, glaucoma or raised intra-ocular pressure, anaemia, jaundice, diabetes, or epilepsy.

Benefit/risk ratio should be assessed in patients with cardiovascular disease (risk of decreased blood pressure up to cardiovascular collapse, bradycardia), and in patients with a history of asthma (risk of bronchoconstriction) and pulmonary disease (possibility of decreased pulmonary blood flow and increased arterial pulmonary pressure).

Very rare cases of cardiovascular collapse have been reported following the use of prostaglandins. This should always be considered when using Hemabate.

Decreases in maternal arterial oxygen content have been observed in patients treated with carboprost tromethamine. A causal relationship to carboprost tromethamine has not been established, however, it is recommended that patients with pre-existing cardio-pulmonary problems receiving Hemabate are monitored during treatment and given additional oxygen if necessary.

As with any oxytocic agent, Hemabate should be used with caution in patients with previously compromised (scarred) uteri.

Prior treatment with, or concomitant administration of anti-emetics and antidiarrhoeal drugs significantly reduces the very high incidence of the gastrointestinal side effects common to all prostaglandins. Their use should be considered an integral part of the management of patients.

Transient pyrexia that may be due to hypothalamic thermoregulation has been observed after intramuscular Hemabate. Temperature elevations exceeding 1.1°C were observed in approximately one-eighth of patients who received the recommended dosage regimen but if not complicated by endometritis, the temperature elevation will usually return to normal within several hours of the last injection.

Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who have received prostaglandin E1 during prolonged treatment. There is no evidence that short-term administration of Hemabate can cause similar bone effects.

Benzyl alcohol

This medicine contains 9.45 mg benzyl alcohol in each ampoule which is equivalent to 9.45 mg/ml. Benzyl alcohol may cause allergic reactions.

The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome”, and death in paediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per ml of solution, that is to say essentially ‘sodium-free’.

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

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 the embryo or foetus at risk.

Benzyl alcohol can cross the placenta.

Breast-feeding

There are no data on the excretion into breast milk for carboprost tromethamine.

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 to drive or use machines.

Therefore patients should refrain from driving until they know that Hemabate does not affect their ability to drive or use machines.

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 presented in order of decreasing seriousness. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (frequency cannot be estimated from the available data).

The adverse effects of Hemabate are generally transient and reversible on discontinuation of therapy. The most frequent adverse reactions observed are related to its contractile effect on smooth muscles.

In patients studied, approximately two-thirds (66%) experienced vomiting and diarrhoea, approximately one-third (33%) had nausea, one-eighth (12%) had a temperature increase greater than 1.1°C, and one-fourteenth (7%) experienced flushing.

^* Events reported for both intramuscular and intra-amniotic routes of administration are marked with an asterisk. All other events were reported only for the intramuscular route.
^† Identified from post-marketing experience

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.