Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Dinoprostone 10mg;
Pharmaco (NZ) Ltd
Dinoprostone 10 mg
10 mg
Pessary
Active: Dinoprostone 10mg Excipient: Hydrogel Texturised polyester yarn retrieval system
Sachet, laminate, Al/Polyethylene x 1 pessary, 1 pessary
Prescription
Prescription
Kyowa Pharma Chemical Co. Ltd.
Cervical ripening in patients, at or near term, who have favourable induction features and in whom there is a medical or obstetrical indication for induction of labour.
Package - Contents - Shelf Life: Sachet, laminate, Al/Polyethylene - 1 pessaries - 36 months from date of manufacture stored below -20°C (Deep freeze). (stability data to -15°C only) - Sachet, laminate, Al/Polyethylene - 5 pessaries - 36 months from date of manufacture stored below -20°C (Deep freeze). (stability data to -15°C only)
2000-10-11
CERVIDIL® 1 CERVIDIL® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or midwife. 1. WHY AM I BEING GIVEN CERVIDIL? CERVIDIL can be used to prepare the birth canal in women who require, and have favourable features for, induction of labour after 37 weeks of pregnancy have been completed. It helps the part of the birth canal, known as the cervix, to soften and open to allow the baby through. It contains the active ingredient dinoprostone. There can be several reasons why you might need treatment with CERVIDIL. Ask your doctor if you would like to know more. For more information, see Section 1. Why am I being given CERVIDIL? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE I AM GIVEN CERVIDIL? CERVIDIL SHOULD NOT BE USED IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO DINOPROSTONE, URETHANE, OR ANY OF THE INGREDIENTS LISTED AT THE END OF THE CMI. There are several circumstances in which CERVIDIL should not be used or when it should only be used with additional caution. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR TAKE ANY OTHER MEDICINES. For more information, see Section 2. What should I know before I am given CERVIDIL? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CERVIDIL and affect how it works. This includes aspirin and other NSAIDs. Refer to Section 3. What if I am taking other medicines? in the full CMI for more information. YOU MUST NOT BE GIVEN CERVIDIL IF YOU ARE BEING GIVEN, OR WILL BE GIVEN WITHIN THE NEXT 30 MINUTES, OTHER MEDICINES TO MAKE YOUR WOMB CONTRACT OR BRING ON (INDUCE) LABOUR, E.G. OXYTOCIN. 4. HOW WILL I BE GIVEN CERVIDIL? • CERVIDIL MUST ONLY BE USED IN A HOSPITAL SETTING BY HEALTHCARE PROFESSIONALS TRAINED IN THE CARE OF WOMEN AND BABIES DURING PREGNANCY AND CHILDBIRTH. Facilities for continuous monitoring of you and your baby must be available. • When you are lying down, your doctor or midwife will place one p Soma hati kamili
NEW ZEALAND DATA SHEET CERVIDIL – CERVIDIL004 October 2021 Page 1 of 12 CERVIDIL® 10MG PESSARY Dinoprostone (Prostaglandin E 2 ) 1 PRODUCT NAME CERVIDIL® 10mg PESSARY 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary (vaginal insert) contains 10 mg of dinoprostone (prostaglandin E 2 ) and releases a mean dose of approximately 0.3 mg dinoprostone per hour over 24 hours. The dinoprostone is dispersed throughout a matrix consisting of 241 mg of hexanetriol/macrogol 8000/isocyanate cross-linked hydrogel copolymer, which is a semi-transparent, beige coloured, flat rectangular pessary (vaginal insert) measuring 29 mm by 9.5 mm and 0.8 mm in thickness. The pessary (vaginal insert) and its retrieval system, made of polyester yarn, are non-toxic and, when placed in a moist environment, absorb water, swell, and release dinoprostone. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM CERVIDIL® is a thin, flat, polymeric pessary (vaginal insert) which is rectangular in shape with rounded corners. The pessary (vaginal insert) is contained within the pouch of an off-white knitted polyester retrieval system designed to aid retrieval at the end of the dosing interval. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cervical ripening in patients, at or near term, who have favourable induction features and in whom there is a medical or obstetrical indication for induction of labour. 4.2 DOSE AND METHOD OF ADMINISTRATION CERVIDIL® is used as a single dosage in a single application. Cervidil should only be administered by qualified healthcare personnel in hospitals and clinics with obstetric units with facilities for continuous fetal and uterine monitoring. After insertion, uterine activity and fetal condition must be carefully and regularly monitored. _ _ _PAEDIATRIC POPULATION _ The safety and efficacy of CERVIDIL® in pregnant woman aged less than 18 years has not been established. No data are available. _ _ _ADMINISTRATION _ CERVIDIL® should be removed from the freezer immediately prior to the ins Soma hati kamili