Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
cetrorelix (as acetate)
Merck Europe B.V.
H01CC02
cetrorelix
Pituitary and hypothalamic hormones and analogues
Ovulation; Ovulation Induction
Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques.In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.
Revision: 27
Authorised
1999-04-12
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: INFORMATION FOR THE USER CETROTIDE 0.25 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Cetrorelix READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cetrotide is and what it is used for 2. What you need to know before you use Cetrotide 3. How to use Cetrotide 4. Possible side effects 5 How to store Cetrotide 6. Contents of the pack and other information How to mix and inject Cetrotide 1. WHAT CETROTIDE IS AND WHAT IT IS USED FOR WHAT CETROTIDE IS Cetrotide contains a medicine called ‘cetrorelix’. This medicine stops your body from releasing an egg from your ovary (ovulation) during your menstrual cycle. Cetrotide belongs to a group of medicines called ‘anti-gonadotropin-releasing hormones’. WHAT CETROTIDE IS USED FOR Cetrotide is one of the medicines used during ‘assisted reproductive techniques’ to help you get pregnant. It stops eggs being released straight away. This is because if the eggs are released too early (premature ovulation) it may not be possible for your doctor to collect them. HOW CETROTIDE WORKS Cetrotide blocks a natural hormone in your body called LHRH (‘luteinising hormone releasing hormone’). • LHRH controls another hormone, called LH (‘luteinising hormone’). • LH stimulates ovulation during your menstrual cycle. This means that Cetrotide stops the chain of events that leads to an egg being released from your ovary. When your eggs are ready to be collected, another medicine will be given to you that will release Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cetrotide 0.25 mg powder and solvent for solution for injection 2. 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 the full list of excipients, see section 6.1. 3. 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. 4. CLINICAL PARTICULARS 4.1 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 was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle-stimulating hormone (FSH) suggested similar efficacy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cetrotide 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. _ _ _Elderly _ There is no relevant use of Cetrotide in the geriatric population. _Paediatric populat Lestu allt skjalið