Pays: Israël
Langue: anglais
Source: Ministry of Health
CETRORELIX AS ACETATE
MERCK SERONO LTD
H01CC02
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
CETRORELIX AS ACETATE 0.25 MG/VIAL
S.C
Required
MERCK HEALTHCARE KGAA, GERMANY
CETRORELIX
Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
2018-10-24
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1 PRESCRIBING INFORMATION CETROTIDE ® 0.25 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 follicule-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. 2 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 pop Lire le document complet