Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PROGESTERONE
MERCK SDN. BHD.
PROGESTERONE
2.6gm1Pieces Pieces; 2.6 gm 15 Pieces Pieces
Dendron Brands Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 CRINONE ® PROGESTERONE VAGINAL GEL Progesterone (8% w/w) WHAT IS IN THIS LEAFLET 1. What Crinone is used for 2. How Crinone works 3. Before you use Crinone 4. How to use Crinone 5. While you are using Crinone 6. Side Effects 7. Storage and Disposal of Crinone 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CRINONE IS USED FOR Crinone is used to supplement progesterone in women who have luteal phase defect. Crinone is also used to supplement or replace your own natural progesterone in Assisted Reproductive Technology procedures (eg IVF). Your doctor may have prescribed Crinone for another purpose. Ask your doctor if you have any questions why Crinone has been prescribed for you. HOW CRINONE WORKS Crinone is a vaginal gel that contains natural progesterone. Progesterone is a hormone that is produced by the ovaries during the second half of the menstrual cycle. It is an essential hormone for preparing the uterus (womb) for pregnancy and on-going support of pregnancy. The lack of normal progesterone production by the ovaries in the second half of the menstrual cycle is called luteal phase defect. Women who have this defect may have difficulties in becoming pregnant and may have a higher risk of miscarriage. BEFORE YOU USE CRINONE _- When you must not use it _ Do not use Crinone if: You have ever had an allergic reaction to progesterone or to any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • rash (itching or hives) on the skin • swelling of the face, lips, tongue or other parts of the body • shortness of breath, wheezing or • troubled breathing or a tight feeling in your chest Do not use Crinone if you have, or have had any of the following conditions: • porphyria (rare genetic disease which affects mainly the skin or nervous system) • abnormal vaginal bleeding that has not been diagnosed, or is due to a recent or current missed abortion o Przeczytaj cały dokument
1. NAME OF THE MEDICINAL PRODUCT Crinone 8% Progesterone Vaginal Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g vaginal gel contains 80 mg of progesterone. Each applicator delivers 1.125 g of vaginal gel containing 90 mg of progesterone. Excipient with known effect: Sorbic acid 0.9 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FROM Vaginal gel A smooth white to off-white gel 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Progesterone supplementation of the luteal phase in adults as part of an ART (assisted reproductive technology) procedure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology From the day of embryo transfer, 1.125 g Crinone vaginal gel (90 mg progesterone) should be inserted into the vagina once daily. Once the laboratory findings confirm pregnancy, this therapy should be continued for a total treatment duration of 30 days. Small white globules may appear as vaginal discharge possibly due to gel accumulation, up to several days after usage. _Paediatric population _ There is no relevant use of Crinone in the paediatric population. Method of Administration Patients should be instructed on how to administer Crinone, see section 6.6. 4.3 CONTRAINDICATIONS 1. Known hypersensitivity to progesterone or any of the excipients listed in section 6.1. 2. Undiagnosed vaginal bleeding 3. Known or suspected malignancy of the breast or genital organs. 4. Porphyria 5. Thrombophlebitis, thromboembolic disorder, cerebral apoplexy, or patients with a history of these conditions. 6. Missed abortion. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Crinone includes sorbic acid as an excipient. Sorbic acid may cause local skin reactions (e.g. contact dermatitis). Local skin reactions might also occur on the penis of the partner when having intercourse following vaginal application of Crinone. This may be prevented by the use of condoms. Gynaecological check-ups are required before and regularly under therapy with the drug; endometrial hyperplasia in particular should be ruled out Przeczytaj cały dokument