Χώρα: Κύπρος
Γλώσσα: Ελληνικά
Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
DINOPROSTONE
PFIZER HELLAS AE (0000003442) 243 MESSOGHION AVENUE, NEO PSYCHIKO, ATHENS, 15451
G02AD02
DINOPROSTONE
2MG
VAGINAL GEL
DINOPROSTONE (0000363246) 0,666MG
VAGINAL USE
Ειδική άδεια άρθρο 126A
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 PRE-FILLED SYRINGE X 3G () 1 SYRINGE - Εγκεκριμένο - Με Ιατρική Συνταγή
Page 1 of 10 2021-0069533 PROSTIN ® E2 1 MG AND 2 MG VAGINAL GELS DINOPROSTONE PHYSICIAN LEAFLET PROSTIN® E2 1 MG AND 2 MG VAGINAL GELS (dinoprostone) PRESENTATION Translucent, thixotropic gel containing 1 or 2 mg dinoprostone per 3 g (2.5 ml). USES Oxytocic. Prostin E2 Vaginal Gel is indicated for induction of labour, when there are no foetal or maternal contraindications. DOSAGE AND ADMINISTRATION Usage is restricted to qualified health care professionals and to hospitals and clinics with specialised obstetric units with facilities for continuous monitoring. The recommended dose should not be exceeded, and the dosing interval should not be shortened as this increases the risk of uterine hyperstimulation, uterine rupture, uterine haemorrhage, foetal and neonatal death. In primigravida patients with unfavourable induction features (Bishop score of 4 or less), an initial dose of 2 mg should be administered vaginally. In other patients an initial dose of 1 mg should be administered vaginally. In both groups of patients, a second dose of 1 mg or 2 mg may be administered after 6 hours as follows: 1 mg should be used where uterine activity is insufficient for satisfactory progress of labour. 2 mg may be used where response to the initial dose has been minimal. Maximum dose 4 mg in unfavourable primigravida patients or 3 mg in other patients (see section 4.4 of SmPC). The gel should be inserted high into the posterior fornix avoiding administration into the cervical canal. The patient should be instructed to remain recumbent for at least 30 minutes. CONTRAINDICATIONS, WARNINGS, ETC. _Contraindications: _ Prostin E2 Vaginal Gel should not be used where the patient is sensitive to prostaglandins or other constituents of the gel. Prostin E2 Vaginal Gel is not recommended in the following circumstances: 1. For patients in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate such as: • Cases with a history of Caesarean section or major uterine surge Διαβάστε το πλήρες έγγραφο