DURATOCIN RTS SOLUTION FOR INJECTION 100 MCG/ML [SIN15173P]

Product Info

DURATOCIN RTS SOLUTION FOR INJECTION 100 MCG/ML

[SIN15173P]

4.1 Therapeutic indications

DURATOCIN® RTS is indicated for the prevention of postpartum haemorrhage due to uterine atony.

4.2 Posology and method of administration

Posology
Caesarean section under epidural or spinal anaesthesia:
Withdraw 1 ml of DURATOCIN® RTS containing 100 micrograms carbetocin and administer only by intravenous injection, under adequate medical supervision in a hospital.

Vaginal delivery:
Withdraw 1 ml of DURATOCIN® RTS 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.

DURATOCIN® RTS 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Pregnancy and labour before delivery of the infant.
Induction of labour.
Serious cardiovascular disorders.
Hypersensitivity to carbetocin or oxytocin or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.