Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
DINOPROSTONE
Pharmacia Ireland
3 Milligram
Vaginal Tablets
2000-05-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prostin® E2 3mg Vaginal Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 3 mg dinoprostone. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal Tablet White, biconvex, special shaped tablet, embossed with ‘Upjohn 715’ one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The induction of labour when there are no gynaecological, obstetrical or medical conditions, either maternal or foetal, that preclude vaginal delivery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _One tablet to be inserted high into the posterior fornix. After insertion of the tablet, the patient should be under observation using external cardiotocography to monitor foetal heart rate and uterine activity. If no contractions have occurred by 6 hours, a further tablet is inserted and monitoring continued as above. Maximum dose 6 mg. Once labour has started, the membranes may be ruptured and the foetal heart monitored using a scalp electrode. Uterine contractions should be monitored using external tocography. If evidence of hypertonus develops, any remains of the tablet should be removed and an intravenous injection of a tocolytic agent given. Delivery by the appropriate route should be considered. _Elderly: _Not applicable. _Children: _Not applicable. 4.3 CONTRAINDICATIONS Prostin E2 Vaginal Tablets should not be used where the patient is sensitive to prostaglandins or other constituents of the tablet. Prostin E2 Vaginal Tablets are not recommended in the following circumstances: 1. For patients in whom oxytocic drugs are generally contra-indicated or where prolonged contractions of the uterus are considered inappropriate such as: Cases with a history of Caesarean section or ma Baca dokumen lengkapnya