国家: 以色列
语言: 英文
来源: Ministry of Health
PEGVISOMANT
PFIZER PHARMACEUTICALS ISRAEL LTD
H01AX01
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
PEGVISOMANT 20 MG
S.C
Required
PFIZER MANUFACTURING BELGIUM NV/SA
PEGVISOMANT
PEGVISOMANT
Treatment of adult patient with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not narmalize IGF-I concentrations or was not tolerated.
2021-08-31
Somavert 10 mg, 15 mg, 20 mg, 25 mg, 30 mg PIL CC technical change 24 June 2021 0069070 - 2021 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only SOMAVERT ® 10 MG SOMAVERT ® 15 MG SOMAVERT ® 20 MG SOMAVERT ® 25 MG SOMAVERT ® 30 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION COMPOSITION: Each vial contains: pegvisomant 10 mg Each vial contains: pegvisomant 15 mg Each vial contains: pegvisomant 20 mg Each vial contains: pegvisomant 25 mg Each vial contains: pegvisomant 30 mg Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions about using this medicine, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Treatment of adult patients with acromegaly (gigantism) who are responding inadequately to surgery and/or radiation therapy, and in whom medical treatment with synthetic somatostatin analogues did not normalize IGF-I growth factor levels or was not tolerated. Acromegaly (gigantism) is a hormonal disorder resulting from the increased secretion of growth hormone (GH) and insulin-like growth factor 1 (IGF-1), which is characterised by overgrowth of bone, soft tissue swelling, heart disease and other related disorders. THERAPEUTIC GROUP: growth hormone receptor antagonist. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (see section 6). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE CONSULT YOUR DOCTOR BEFORE STARTING TREATMENT WITH SOMAVERT ® . 阅读完整的文件
Somavert ® 10 mg, 15 mg, 20 mg, 25 mg, 30 mg LPD CC 021022 2021-0073283 1 1. NAME OF THE MEDICINAL PRODUCT SOMAVERT ® 10 mg powder and solvent for solution for injection SOMAVERT ® 15 mg powder and solvent for solution for injection SOMAVERT ® 20 mg powder and solvent for solution for injection SOMAVERT ® 25 mg powder and solvent for solution for injection SOMAVERT ® 30 mg powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SOMAVERT ® 10 mg powder and solvent for solution for injection One vial contains 10 mg of pegvisomant. After reconstitution, 1 ml of solution contains 10 mg of pegvisomant.* Excipient with known effect The 10 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder. SOMAVERT ® 15 mg powder and solvent for solution for injection One vial contains 15 mg of pegvisomant. After reconstitution, 1 ml of solution contains 15 mg of pegvisomant.* Excipient with known effect The 15 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder. SOMAVERT ® 20 mg powder and solvent for solution for injection One vial contains 20 mg of pegvisomant. After reconstitution, 1 ml of solution contains 20 mg of pegvisomant.* Excipient with known effect: The 20 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder. SOMAVERT ® 25 mg powder and solvent for solution for injection One vial contains 25 mg of pegvisomant. After reconstitution, 1 ml of solution contains 25 mg of pegvisomant.* Excipient with known effect The 25 mg strength of the medicinal product contains 0.5 mg of sodium per vial of powder. SOMAVERT ® 30 mg powder and solvent for solution for injection One vial contains 30 mg of pegvisomant. After reconstitution, 1 ml of solution contains 30 mg of pegvisomant.* Excipient with known effect The 30 mg strength of the medicinal product contains 0.6 mg of sodium per vial of powder. *produced in _ Escherichia coli _ cells by recombinant DNA technology. For the full list of excipients, see se 阅读完整的文件