Land: Armenien
Sprache: Englisch
Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
rituximab
F. Hoffmann-La Roche Ltd. Wurmisweg CH-4303 Kaiseraugst-batch releaser
rituximab
100mg/10ml
concentrate for solution for infusion
Prescription
MABTHERA ® Rituximab 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Anti-neoplastic agent ATC Code: L01XC02 1.2 TYPE OF DOSAGE FORM Concentrate for solution for infusion. 1.3 ROUTE OF ADMINISTRATION Intravenous (i.v.) infusion. 1.4 STERILE/RADIOACTIVE STATEMENT Sterile. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: rituximab MabThera/Rituxan is a clear, colourless liquid supplied in sterile, preservative-free, non-pyrogenic single-dose vials. Single-dose vials: Vials contain 100 mg/10 ml and 500 mg/50 ml. Excipients: Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) _NON-HODGKIN’S LYMPHOMA_ MabThera/Rituxan is indicated for the treatment of: – patients with relapsed or chemoresistant low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma; – previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy; – patients with follicular lymphoma as maintenance treatment, after response to induction therapy; – patients with CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. _CHRONIC LYMPHOCYTIC LEUKAEMIA_ MabThera/Rituxan in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL). _RHEUMATOID ARTHRITIS_ MabThera/Rituxan in combination with methotrexate is indicated in adult patients for: - the treatment of moderate to severe, active rheumatoid arthritis when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of moderate to severe, active rheumatoid arthritis in patients with an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies. MabThera/Rituxan has been shown to reduce the rate of progression of joi Lesen Sie das vollständige Dokument
Summary of Product Characteristics MabThera 1 MABTHERA ® Rituximab 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Anti-neoplastic agent ATC Code: L01XC02 1.2 TYPE OF DOSAGE FORM Concentrate for solution for infusion. 1.3 ROUTE OF ADMINISTRATION Intravenous (i.v.) infusion. 1.4 STERILE/RADIOACTIVE STATEMENT Sterile. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: rituximab MabThera/Rituxan is a clear, colourless liquid supplied in sterile, preservative-free, non- pyrogenic single-dose vials. Single-dose vials: Vials contain 100 mg/10 ml and 500 mg/50 ml. Excipients: Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) _NON-HODGKIN’S LYMPHOMA _ MabThera/Rituxan is indicated for the treatment of: – patients with relapsed or chemoresistant low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma; – previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy; – patients with follicular lymphoma as maintenance treatment, after response to induction therapy; Summary of Product Characteristics MabThera 2 – patients with CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. _CHRONIC LYMPHOCYTIC LEUKAEMIA _ MabThera/Rituxan in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL). _RHEUMATOID ARTHRITIS _ MabThera/Rituxan in combination with methotrexate is indicated in adult patients for: - the treatment of moderate to severe, active rheumatoid arthritis when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of moderate to severe, active rheumatoid arthritis in patients with an inadequate response or intolerance to one or more tumour necrosis factor (TN Lesen Sie das vollständige Dokument