Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Pegvisomant
Pfizer Europe MA EEIG
H01AX01
pegvisomant
Pituitary and hypothalamic hormones and analogues
Acromegaly
Treatment of adult patients 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 normalize IGF-I concentrations or was not tolerated.Treatment of adult patients 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 normalize IGF -I concentrations or was not tolerated.
Revision: 28
Authorised
2002-11-12
59 B. PACKAGE LEAFLET 60 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 pegvisomant READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What SOMAVERT is and what it is used for 2. What you need to know before you use SOMAVERT 3. How to use SOMAVERT 4. Possible side effects 5. How to store SOMAVERT 6. Contents of the pack and other information 1. WHAT SOMAVERT IS AND WHAT IT IS USED FOR SOMAVERT is used for the treatment of acromegaly, a hormonal disorder resulting from the increased secretion of growth hormone (GH) and IGF-I (Insulin-like growth factors), which is characterised by overgrowth of bone, soft tissue swelling, heart disease and related disorders. The active substance in SOMAVERT, pegvisomant is known as a growth hormone receptor antagonist. These substances decrease the action of GH and levels of IGF-I circulating in the blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOMAVERT DO NOT USE SOMAVERT If you are allergic to pegvisomant or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using SOMAVERT. - If you experience disturbed vision or headaches you must contact your doctor immediately. - Yo Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 section 6.1. 3 3. PHARMACEUTICAL FORM Powder and solvent for s Przeczytaj cały dokument