Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
TRIPTORELIN AS EMBONATE
FERRING PHARMACEUTICALS LTD
L02AE04
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
TRIPTORELIN AS EMBONATE 11.25 MG
I.M
Required
DEBIOPHARM RESEARCH & MANUFACTURING S.A, SWITZERLAND
TRIPTORELIN
TRIPTORELIN
- Lowering of sexual hormones and- treatment of advanced hormone-dependent prostate cancer.
2022-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only DECAPEPTYL DEPOT 11.25 MG POWDER AND SOLVENT FOR RECONSTITUTING A SUSPENSION FOR INTRAMUSCULAR INJECTION COMPOSITION: Each vial of Decapeptyl Depot 11.25 mg contains 11.25 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. This medicine is intended for use in adults only. 1. WHAT IS THIS MEDICINE INTENDED FOR? This medicine is intended for treating advanced hormone-dependent prostate cancer lowering sexual hormones level THERAPEUTIC GROUP: long-term analog 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 analogs of the gonadotropin releasing hormone )GnRH is also called LHRH(, or to any of the other ingredients that this medicine contains )see Section 6(. 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 smoker, have osteoporosis or have a family history of osteoporosis )a condition that weakens your bones(, have a poor diet or take medicines )for example anticonvulsants, steroids(. When Decapeptyl Depot is used for a long period of time the ris Citiți documentul complet
_ _ _Page 1 of 10 _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Decapeptyl Depot 11.25 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DECAPEPTYL DEPOT 11.25 MG . Each vial of _Decapeptyl Depot 11.25 mg_ contains triptorelin embonate equivalent to 11.25 mg triptorelin. After reconstitution in 2 ml solvent, 1 ml of reconstituted suspension contains 5.625 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 11.25 mg_ is indicated for lowering of sexual hormone; treatment of advanced hormone-dependent prostate cancer 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ The usual dosage is one intramuscular injection of _Decapeptyl Depot 11.25mg_ every 12 weeks as under medical supervision. DRUG 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. urinary symptoms, cancer pain etc). Testosterone levels can be measured immediately before or after injection. PATIENTS WITH IMPAIRED HEPATIC FUNCTION No dosage adjustment is necessary for patients suffering from limited hepatic function. PATIENTS WITH IMPAIRED RENAL FUNCTION No dosage adjustment is necessary for patients suffering from limited renal function. ELDERLY PATIENTS No dosage adjustment is necessary. CHILDREN AND ADOLESCENTS The safety and efficacy of Decapeptyl Depot 11.25 mg have not been established in children and adolescents, it is not indicated for use in these populations. MODE OF ADMINISTRATION Since Decapeptyl Depot 11.25 mg is a suspension of microgranules, inadvertent intravascular injection must be strictly avoided. Decapeptyl Depot 11.25mg may only be administered by doctors or medical personnel. _ _ _Page 2 of 10 _ The injection site should be changed periodically. For instructions on reconstitution Citiți documentul complet