País: Israel
Idioma: inglés
Fuente: Ministry of Health
TRIPTORELIN ACETATE
FERRING PHARMACEUTICALS LTD
L02AE04
SOLUTION FOR INJECTION
TRIPTORELIN ACETATE 0.1 MG/ML
S.C
Required
FERRING GmbH ,GERMANY
TRIPTORELIN
TRIPTORELIN
IVF
2022-05-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only DECAPEPTYL 0.1 SOLUTION FOR SUBCUTANEOUS INJECTION COMPOSITION: Each syringe of Decapeptyl 0.1 contains 0.1 mg of triptorelin (as acetate). INACTIVE INGREDIENTS AND ALLERGENS: see section 2 ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? This medicine is intended for infertility treatments. THERAPEUTIC GROUP: synthetic analogue of the gonadotropin-releasing hormone (GnRH). 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to triptorelin acetate or to any of the other ingredients in this medicine (see section 6). You are sensitive (allergic) to the gonadotropin-releasing hormone (GnRH) or its analogues. You are pregnant or breastfeeding (see section ‘Pregnancy and breastfeeding’). SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE USING THIS MEDICINE, TELL YOUR DOCTOR IF: There have been reports on depression that may be severe among patients taking Decapeptyl. If you are taking this medicine and develop a depressed mood, tell your doctor. There have been reports on mood changes during the course of treatment with this medicine. Your doctor will monitor your condition if you have depression. In rare cases, treatment with this medicine can cause brain hemorrhage (pituitary apoplexia). If you experience a sudden headache, vomiting or vision disturbances – contact your doctor immediately. Treatment with this medicine may lead to thinning of bones and an in Leer el documento completo
1 1. NAME OF THE MEDICINAL PRODUCT. DECAPEPTYL ® 0.1 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 disposable syringe with 1 ml solution for injection contains 100 ug triptorelin acetate, corresponding to 95.6 ug triptorelin free base. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM. Solution for injection Clear colourless solution 4. CLINICAL PARTICULARS. 4.1 THERAPEUTIC INDICATIONS IVF. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment can be started in the early follicular phase (day 2 or 3 of the menstrual cycle) or in the mid-luteal phase (day 21-23 of the menstrual cycle or 5-7 days before expected start of menses). Controlled ovarian hyperstimulation with gonadotrophins should be started after approximately 2-4 weeks of Decapeptyl 0.1 treatment. Ovarian response should be monitored clinically (including ovarian ultrasound alone or preferably in combination with measurement of oestradiol levels) and the dose of gonadotrophins adjusted accordingly. When a suitable number of follicles have reached an appropriate size, treatment with Decapeptyl 0.1 and gonadotrophin is stopped and a single injection of hCG is administered to induce the final follicular maturation. If downregulation is not confirmed after 4 weeks (determined by ultrasound documentation of a shedded endometrium alone or preferably in combination with measurement of oestradiol levels), discontinuation of Decapeptyl 0.1 should be considered. The total duration of treatment is usually 4-7 weeks. When using Decapeptyl 0.1, luteal phase support should be provided according to the reproductive medical center's practice. _Special population _ No specific dose recommendations are given for subjects with renal or hepatic impairment. A clinical study indicated that the risk of accumulation of triptorelin in patients with severe liver and renal impairment is small (see section 5.2). Method of administration Treatment with Decapeptyl 0.1 should be initiated under the supervision of a physician experienced in the treatment Leer el documento completo