Country: Olanda
Lingwa: Olandiż
Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BORTEZOMIB 1-WATER 3,7 mg/flacon SAMENSTELLING overeenkomend met ; BORTEZOMIB 3,5 mg/flacon
Aurobindo Pharma B.V. Baarnsche Dijk 1 3741 LN BAARN
BORTEZOMIB 1-WATER 3,7 mg/flacon SAMENSTELLING overeenkomend met ; BORTEZOMIB 3,5 mg/flacon
Poeder voor oplossing voor injectie
MANNITOL (D-) (E 421)
Intraveneus gebruik, Subcutaan gebruik
2020-12-30
BORTEZOMIB EUGIA 3,5 MG, POEDER VOOR OPLOSSING VOOR INJECTIE RVG 125205 MODULE 1 Administrative information and prescribing information 1.3.1 BIJSLUITER Rev.nr. 2205 Pag. 1 van 14 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER BORTEZOMIB EUGIA 3,5 MG, POEDER VOOR OPLOSSING VOOR INJECTIE _bortezomib _ 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 or pharmacist. - 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 or pharmacist. This includes any side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Bortezomib Eugia 3,5 mg is and what it is used for 2. What you need to know before you use bortezomib 3. How to use bortezomib 4. Possible side effects 5. How to store bortezomib 6. Contents of the pack and other information 1. WHAT BORTEZOMIB EUGIA 3,5 MG IS AND WHAT IT IS USED FOR Bortezomib contains the active substance bortezomib, a so-called ‘proteasome inhibitor’. Proteasomes play an important role in controlling cell function and growth. By interfering with their function, bortezomib can kill cancer cells. Bortezomib is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years: - Alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (progressive) after receiving at least one prior treatment and for whom blood stem cell transplantation was not successful or is unsuitable. - In combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation. - In combination with the medicines dexamethasone or dexamethasone t Aqra d-dokument sħiħ
BORTEZOMIB EUGIA 3,5 MG, POEDER VOOR OPLOSSING VOOR INJECTIE RVG 125205 MODULE 1 Administrative information and prescribing information 1.3.1 SAMENVATTING VAN DE PRODUCTKENMERKEN Rev.nr. 2204 Pag. 1 van 40 1 SAMENVATTING VAN DE PRODUCTKENMERKEN 1. NAAM VAN HET GENEESMIDDEL Bortezomib Eugia 3,5 mg, poeder voor oplossing voor injectie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester). After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib (as a mannitol boronic ester). After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib (as a mannitol boronic ester). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. White to off-white lyophilized cake or powder. pH reconstitution solution INTRAVENOUS ADMINISTRATION : Reconstitution with 3.5 mL 0.9% sodium chloride solution - 5.345 SUBCUTANEOUS ADMINISTRATION: Reconstitution with 1.4 mL 0.9% sodium chloride solution - 5.137 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. BORTEZOMIB EUGIA 3,5 MG, POEDER VOOR OPLOSSING VOOR INJECTIE RVG 125205 MODULE 1 Administrativ Aqra d-dokument sħiħ