Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
CARBETOCIN
FERRING PHARMACEUTICALS LTD
H01BB03
SOLUTION FOR INJECTION
CARBETOCIN 100 MCG/ML
I.V, I.M
Required
FERRING GmbH ,GERMANY
CARBETOCIN
PABAL is indicated for the prevention of postpartum haemorrhage due to uterine atony
2023-02-28
1 NAME OF THE MEDICINAL PRODUCT PABAL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Carbetocin 100 micrograms/ml. Oxytocic activity: approximately 50 IU of oxytocin/vial For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PABAL 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 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, preferably before removal 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. 4.3 CONTRAINDICATIONS • During pregnancy and labour before delivery of the infant. • Carbetocin must not be used for the induction of labour. • Hypersensitivity to carbetocin, oxytocin or to any of the excipients listed in section 6.1. • Hepatic or renal disease. • Serious cardiovascular disorders. • Epilepsy. 2 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Carbetocin is intended for use only at well equipped specialist obstetrics units with experienced and qualified staff available at Прочитайте повний документ