Riik: Holland
keel: hollandi
Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BORTEZOMIB ANHYDRIDE 3,336 mg/flacon SAMENSTELLING overeenkomend met ; BORTEZOMIB 3,5 mg/flacon
Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)
L01XX32
BORTEZOMIB ANHYDRIDE 3,336 mg/flacon SAMENSTELLING overeenkomend met ; BORTEZOMIB 3,5 mg/flacon
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);
1900-01-01
Common Technical Document Bortezomib Powder for solution for infusion Page 1 of 15 1.3.1 Package leaflet - Core PACKAGE LEAFLET: INFORMATION FOR THE USER BORTEZOMIB POLPHARMA 1 MG, POEDER VOOR OPLOSSING VOOR INJECTIE BORTEZOMIB POLPHARMA 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 [product name] is and what it is used for 2. What you need to know before you use [product name] 3. How to use [product name] 4. Possible side effects 5. How to store [product name] 6. Contents of the pack and other information 1 WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [product 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. [product 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. • in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy w Lugege kogu dokumenti
Common Technical Document Bortezomib Powder for solution for injection Page 1 of 38 1.3.1 Summary of Product Characteristics - Core 1 NAME OF THE MEDICINAL PRODUCT Bortezomib Polpharma 1 mg, poeder voor oplossing voor injectie Bortezomib Polpharma 3,5 mg, poeder voor oplossing voor injectie 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg bortezomib (as a mannitol boronic ester). 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. After reconstitution, 1 ml of solution for intravenous injection contains 1 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. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [product 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. [product 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. [product name] 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. [product name] in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation. Common Technical Document Bortezomib Powder for solution for injection Page 2 of 38 4.2 POSOLOGY Lugege kogu dokumenti