দেশ: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
TRIPTORELIN AS EMBONATE
FERRING PHARMACEUTICALS LTD
L02AE04
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
TRIPTORELIN AS EMBONATE 22.5 MG
I.M
Required
DEBIOPHARM RESEARCH & MANUFACTURING S.A, SWITZERLAND
TRIPTORELIN
Symptomatic treatment of advanced hormone-dependent prostate cancer. As an alternative treatment, if orchiectomy or the administration of oestrogens are not indicated or are unacceptable to the patient. Treatment of central precocious puberty (CPP) in children 2 years and older with an onset of CPP before 8 years in girls and 10 years in boys.
2020-09-30
Patient leaflet in accordance with the Pharmacists’ Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only Decapeptyl Depot 22.5 mg Powder and solvent for reconstituting a suspension for intramuscular injection Composition: Each vial of Decapeptyl Depot 22.5 mg contains 22.5 mg triptorelin (as embonate). Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional Information’. Read the entire leaflet carefully before 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 treating advanced hormone-dependent prostate cancer as an alternative treatment, if surgical testicle resection or administration of estrogens is not indicated or not suitable for the patient. for treating early puberty in children over two years old who have started puberty before 8 years old in girls and before 10 years old in boys. Therapeutic group: long-term analogue of GnRH (gonadotropin releasing hormone) 2. Before using this medicine Do not use this medicine if: you are sensitive (allergic) to triptorelin embonate, gonadotropin releasing hormone (GnRH), other analogues of the gonadotropin releasing hormone (GnRH is also called LHRH), or to any of the other ingredients that this medicine contains (see Section 6). you are pregnant or breastfeeding. Special warnings about using this medicine _Before using this medicine, tell your doctor if:_ you are depressed. There have been reports of depression, which may be serious, among patients taking Decapeptyl Depot. you are using anticoagulants, because you may get a bruise at the injection site. you are a heavy drinker, a smoke সম্পূর্ণ নথি পড়ুন
_ _ _Page 1 of 13 _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Decapeptyl depot 22.5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains triptorelin embonate equivalent to 22.5 mg triptorelin. After reconstitution in 2 ml solvent, 1 ml of reconstituted suspension contains 11.25 mg of triptorelin. For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for prolonged-release suspension for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DECAPEPTYL DEPOT 22.5 MG is indicated for symptomatic treatment of advanced hormone- dependent prostate cancer. As an alternative treatment, if orchiectomy or the administration of oestrogens are not indicated or are unacceptable to the patient. Decapeptyl 22.5 mg is also indicated for the treatment of central precocious puberty (CPP) in children 2 years and older with an onset of CPP before 8 years in girls and 10 years in boys. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ The usual dosage is one intramuscular injection of Decapeptyl depot 22.5mg every 24 weeks under medical supervision. _Paediatric population _ PRECOCIOUS PUBERTY (BEFORE 8 YEARS IN GIRLS AND 10 YEARS IN BOYS) The treatment of children with Decapeptyl 22.5 mg should be under the overall supervision of a paediatric endocrinologist or of a paediatrician or an endocrinologist with expertise in the treatment of central precocious puberty. Treatment should be stopped around the physiological age of puberty in boys and girls and should not be continued in girls with a bone maturation of more than 12-13 years. There are limited data available in boys relating to the optimum time to stop treatment based on bone age, however it is advised that treatment is stopped in boys with a bone maturation age of 13-14 years. TREATMENT MONITORING _Prostate cancer _ The efficacy of treatment can be monitored by measuring serum levels of testosterone and prostate specific agent (PSA) and by subjective evaluation (symptomatic improvement e.g. ur সম্পূর্ণ নথি পড়ুন