PABAL Solution for injection

Active ingredients: Carbetocin

Therapeutic indications

PABAL is indicated for the prevention of postpartum haemorrhage due to uterine atony.

Posology and method of administration

Posology

Caesarean section under epidural or spinal anaesthesia

Withdraw 1 ml of PABAL containing 100 micrograms carbetocin and administer only by intravenous injection, under adequate medical supervision in a hospital.

Vaginal delivery

Withdraw 1 ml of PABAL containing 100 micrograms carbetocin and administer by intravenous injection or intramuscular injection, under adequate medical supervision in a hospital.

Method of administration

For intravenous or intramuscular administration.

Carbetocin must only be administered after delivery of the infant, and as soon as possible after delivery, preferably before the delivery of the placenta.

For intravenous administration carbetocin must be administered slowly, over 1 minute.

PABAL is intended for single use only. No further doses of carbetocin should be administered.

Paediatric population

There is no relevant use of carbetocin in children below 12 years of age.

The safety and efficacy of carbetocin in adolescents has not yet been established.

Currently available data are described in section 5.1 but no recommendation on a posology can be made.

Overdose

Overdosage of carbetocin may produce uterine hyperactivity whether or not due to hypersensitivity to this agent.

Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions resulting from oxytocin overdose can lead to uterine rupture or postpartum haemorrhage.

Overdosage of oxytocin may lead to hyponatraemia and water intoxication in severe cases, especially when associated with excessive concomitant fluid intake. As carbetocin is an analogue of oxytocin, the possibility of a similar event cannot be excluded.

Treatment of overdosage of carbetocin consists of symptomatic and supportive therapy. When signs or symptoms of overdosage occur oxygen should be given to the mother. In cases of water intoxication, it is essential to restrict fluid intake, promote diuresis, correct electrolyte imbalance, and control convulsions that may eventually occur.

Shelf life

Shelf life: 3 years.

Shelf life after first opening the vial: the solution should be used immediately.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of the user.

Special precautions for storage

Keep vials in the outer carton, in order to protect from light. Store below 30°C. Do not freeze.

Nature and contents of container

Type I glass vials (2R) with type 1 bromobutyle stoppers with aluminium crimp cap containing 1 ml of solution for injection.

Packs of 5 vials.

Special precautions for disposal and other handling

PABAL is for intravenous and intramuscular use only.

Only clear solutions practically free from particles should be used.

Any unused product or waste material should be disposed of in accordance with local requirements.