Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Rituximab 10 mg/mL (murine/human monoclonal antibody); ; ;
Roche Products (NZ) Ltd
Rituximab 10 mg/mL (murine/human monoclonal antibody)
10 mg/mL
Concentrate for infusion
Active: Rituximab 10 mg/mL (murine/human monoclonal antibody) Excipient: Citric acid Hydrochloric acid Polysorbate 80 Sodium chloride Sodium citrate dihydrate Water for injection
Vial, glass, 50 mL, 1 dose unit
Prescription
Prescription
Genentech Inc
Mabthera is indicated for the treatment of patients with: · CD20 positive, previously untreated low-grade or follicular, B-cell non-Hodgkin's lymphoma in combination with chemotherapy. · CD20 positive, relapsed or chemoresistant low-grade or follicular, B-cell non-Hodgkin's lymphoma. · CD20 positive diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. Mabthera is indicated for maintenance treatment of patients with CD20 positive, low grade or follicular, B-cell non-Hodgkin's lymphoma.
Package - Contents - Shelf Life: Vial, glass, 50 mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Prepared with 0.9% aqueous saline solution 24 hours diluted stored at or below 30°C. Prepared with 0.9% aqueous saline solution 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze). Prepared with 5% aqueous dextrose solution 12 hours diluted stored at or below 30°C. Prepared with 5% aqueous dextrose solution - Vial, glass, 10 mL - 2 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Prepared with 0.9% aqueous saline solution 24 hours diluted stored at or below 30°C. Prepared with 0.9% aqueous saline solution 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze). Prepared with 5% aqueous dextrose solution 12 hours diluted stored at or below 30°C. Prepared with 5% aqueous dextrose solution
1997-06-03
Mabthera CMI (NHL & CLL)20230201 1 _ _ NEW ZEALAND CONSUMER MEDICINE INFORMATION MABTHERA ® _NON-HODGKIN’S LYMPHOMA AND _ _ _ _ _ _ _ _ CHRONIC LYMPHOCYTIC LEUKAEMIA_ _ _ RITUXIMAB 100 MG IN 10 ML AND 500 MG IN 50 ML CONCENTRATE FOR SOLUTION FOR INFUSION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MABTHERA infusion. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given MABTHERA against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT MABTHERA IS USED FOR MABTHERA contains the active ingredient rituximab. MABTHERA is used to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia (both are types of blood cancer). MABTHERA belongs to a group of medicines known as monoclonal antibodies. Monoclonal antibodies are proteins which specifically recognise and bind to another unique protein called an antigen. MABTHERA works by binding to an antigen on the surface of certain white blood cells known as B lymphocytes. It is the abnormally growing B lymphocytes that are responsible for certain types of non- Hodgkin’s lymphoma and chronic lymphocytic leukaemia. During the process of binding to the antigen, the abnormal growth of the B lymphocytes is stopped. MABTHERA may be used on its own or together with other chemotherapy. Your doctor, however, may have prescribed MABTHERA for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY MABTHERA HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. Mabthera CMI (NHL & CLL)20230201 2 _ _ BEFORE YOU ARE GIVEN MABTHERA _WHEN YOU MUST NOT BE GIVEN MABTHERA _ YOU SHOULD NOT BE GIVEN MABTHERA IF: • YOU HAVE HAD AN ALLERGIC REACTION TO MABTHERA OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET • YOU Soma hati kamili
MabThera 20230201 1 NEW ZEALAND DATA SHEET MABTHERA ® (RITUXIMAB) 1. PRODUCT NAME MabThera (rituximab) concentrate for intravenous infusion 100mg MabThera (rituximab) concentrate for intravenous infusion 500mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 10 mg of rituximab. Each 10 mL vial of MabThera 100mg concentrate for intravenous (IV) infusion contains 100 mg of rituximab. Each 50 mL vial of MabThera 500mg concentrate for intravenous (IV) infusion contains 500 mg of rituximab. Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light chain and heavy chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures. Excipients with known effect MabThera 100mg contains 2.3 mmol (52.6 mg) sodium per 10mL vial. MabThera 500mg contains 11.5 mmol (263.2 mg) sodium per 50mL vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM MabThera concentrate for solution for intravenous (IV) infusion is a clear, colourless liquid supplied in sterile, preservative-free, non-pyrogenic single-dose vials. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NON-HODGKIN’S LYMPHOMA MabThera is indicated for the treatment of patients with: - CD20 positive, previously untreated low-grade or follicular, B-cell non-Hodgkin’s lymphoma in combination with chemotherapy, - CD20 positive, relapsed or chemoresistant low-grade or follicular, B-cell non-Hodgkin’s lymphoma, - CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. MabThera is indicated for maintenance treatment of patients with CD20 positive, low grade or follicular, B-cell non-Hodgkin’s lymphoma. CHRONIC LYMPHOCYTIC LEUKAEMIA MabThera in combinati Soma hati kamili