국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CETRORELIX
MERCK SDN. BHD.
CETRORELIX
1vial Vials; 7vial Vials
FAREVA PAU 2
_Consumer Medication Information Leaflet (RiMUP) _ 1 CETROTIDE INJECTION Cetrorelix Acetate (0.25mg) WHAT IS IN THIS LEAFLET 1. What Cetrotide is used for 2. How Cetrotide works 3. Before you use Cetrotide 4. How to use Cetrotide 5. While you are using Cetrotide 6. Side Effects 7. Storage and Disposal of Cetrotide 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CETROTIDE IS USED FOR Cetrotide is used to prevent premature ovulation (the release of an egg from the ovary) in women undergoing an assisted reproduction cycle, such as in vitro fertilization (IVF). Ovulation that is too early, before the egg has fully matured, is undesirable during hormone treatment for ovarian stimulation, because only mature egg cells are suitable for fertilization. HOW CETROTIDE WORKS The active substance in Cetrotide, cetrorelix, blocks the effects of a natural hormone called luteinising- hormone-releasing hormone (LHRH). LHRH controls the production and release of another hormone called luteinising hormone (LH), which causes ovulation during the menstrual cycle. During fertility treatment, ovarian stimulation is normally used to make the ovaries produce more eggs. By blocking the effect of LHRH, Cetrotide stops the production of LH, and therefore prevents premature ovulation, which can result in the release of eggs that are immature and unsuitable for use in techniques such as in vitro fertilisation (IVF). BEFORE YOU USE CETROTIDE - _When you must not take it _ Do not use Cetrotide if you have an allergy to: • Cetrorelix acetate • Mannitol • Exogenous peptide hormones (medicines similar to Cetrotide). Symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. Do not use Cetrotide if you are or have any of the following conditions: • severe kidney disease • you are pregnant or suspect that you might be pregnant • breastfee 전체 문서 읽기
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 0.25 mg cetrorelix (as acetate). After reconstitution with the solvent provided, each ml of the solution contains 0.25 mg cetrorelix. For a full list of excipients, see List of Excipients. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Appearance of the powder: white lyophilisate. Appearance of the solvent: clear and colourless solution. The pH of the reconstituted solution is 4.0 – 6.0. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques. In clinical trials Cetrotide® 0.25 mg was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle-stimulating hormone (FSH) suggested similar efficacy. POSOLOGY AND METHOD OF ADMINISTRATION Cetrotide® 0.25 mg should only be prescribed by a specialist experienced in this field. Posology The first administration of Cetrotide® should be performed under the supervision of a physician and under conditions where treatment of possible allergic/pseudo-allergic reactions (including life-threatening anaphylaxis) is immediately available. The following injections may be self- administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention. The contents of 1 vial (0.25 mg cetrorelix) are to be administered once daily, at 24 h intervals, either in the morning or in the evening. Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo- allergic reaction to the injection. Facilities for the treatment of such reactions should be immediately available. _Elderly _ There is no relevant use of Cetrotide in the geriatric population. _Paediatric population _ There is no relevant use of Cetrotide in the 전체 문서 읽기