Land: Niederlande
Sprache: Niederländisch
Quelle: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BORTEZOMIB
Sandoz B.V.
L01XX32
BORTEZOMIB
Poeder voor oplossing voor injectie
MANNITOL (D-) (E 421) ; STIKSTOF (HEAD SPACE) (E 941),
Intraveneus gebruik, Subcutaan gebruik
Bortezomib
Hulpstoffen: MANNITOL (D-) (E 421); STIKSTOF (HEAD SPACE) (E 941);
2017-02-06
Sandoz B.V. Page 1/19 Bortezomib Sandoz 3,5 mg, poeder voor oplossing voor injectie RVG 118804 1313-v4 1.3.1.1 Package leaflet Maart 2019 PACKAGE LEAFLET: INFORMATION FOR THE USER BORTEZOMIB SANDOZ 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. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Nationally completed name] is and what it is used for 2. What you need to know before you use [Nationally completed name] 3. How to use [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] 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. [Nationally completed name] 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. Sandoz B.V. Page 2/19 Bortezomib Sandoz 3,5 mg, poeder voor oplossing voor injectie RVG 118804 1313-v4 1.3.1.1 Package leaflet Maart 2019 - in combination with Lesen Sie das vollständige Dokument
Sandoz B.V. Page 1/50 Bortezomib Sandoz 3,5 mg, poeder voor oplossing voor injectie RVG 118804 1311-v3 1.3.1.1 Samenvatting van de Productkenmerken Maart 2019 1. NAME OF THE MEDICINAL PRODUCT Bortezomib Sandoz 3,5 mg, poeder voor oplossing voor injectie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 3.5 mg of bortezomib (as mannitol boronic ester). After reconstitution with 3.5 ml, 1 ml of solution for intravenous injection contains 1 mg bortezomib. After reconstitution with 1.4 ml, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder for solution for injection White to off-white cake or powder pH of the reconstituted solution: 4.0 -7.0 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS {[Nationally completed name]} 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. {[Nationally completed name]} 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. {[Nationally completed name]} in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously Sandoz B.V. Page 2/50 Bortezomib Sandoz 3,5 mg, poeder voor oplossing voor injectie RVG 118804 1311-v3 1.3.1.1 Samenvatting van de Productkenmerken Maart 2019 untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. {[Nationally completed name]} in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated m Lesen Sie das vollständige Dokument