DURATOCIN RTS SOLUTION FOR INJECTION 100 MCG/ML

INJECTION, SOLUTION

**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_.