البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
DINOPROSTONE
PFIZER CANADA ULC
G02AD02
DINOPROSTONE
0.5MG
GEL
DINOPROSTONE 0.5MG
INTRACERVICAL
2.5ML
Prescription
OXYTOCICS
Active ingredient group (AIG) number: 0111999005; AHFS:
APPROVED
1997-08-01
_PREPIDIL Gel (dinoprostone) Product Monograph _ _Page 1 of 28_ PRODUCT MONOGRAPH PREPIDIL ® (DINOPROSTONE GEL) 0.5 MG/2.5 ML SYRINGE (3 GM) PROSTAGLANDIN Pfizer Canada Inc 17,300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Date of revision: 05 September 2012 CONTROL NO. 156067 ® TM Pharmacia & Upjohn Company LLC Pfizer Canada Inc., Licensee © Pfizer Canada Inc. 2012 Distribution : Paladin Labs Inc. Montréal (Québec) _PREPIDIL Gel (dinoprostone) Product Monograph _ _Page 2 of 28_ NAME OF DRUG PREPIDIL® (Dinoprostone Gel) Gel - 0.5 mg / 2.5 ml Syringe (3 gm) THERAPEUTIC CLASSIFICATION Prostaglandin ACTION PREPIDIL (dinoprostone gel), which contains a prostaglandin E 2 analogue as the active ingredient, causes cervical ripening preparatory to the onset of labour when it is administered endocervically. Although the local effects of prostaglandin E 2 on cervical maturation is not specifically known, experimental data indicates the drug enhances cervical hemodynamics which in turn promotes ripening of the cervix. INDICATIONS AND CLINICAL USES PREPIDIL (dinoprostone gel), administered into the cervical canal, is indicated for inducing cervical softening and dilatation of the cervix in pregnant women at or near term, where cervical features are not conducive to induction. The use of PREPIDIL in this manner, in patients with unfavourable induction features prior to labour induction by conventional methods, has been shown to improve the overall outcome of labour induction attempt. _PREPIDIL Gel (dinoprostone) Product Monograph _ _Page 3 of 28_ CONTRAINDICATIONS Endocervically administered PREPIDIL (dinoprostone gel) is not recommended for use in the following: l. Patients in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate. These include the following situations: (a) Patients with a history of cesarean section or major uterine surgery; (b) Patients with a major degree of cephalopelvic disproportion; (c) Patients with a history of difficult اقرأ الوثيقة كاملة