Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Bendamustine Hydrochloride Monohydrate
MEDISPEC (M) SDN.BHD
Bendamustine Hydrochloride Monohydrate
1 Vials
SICHUAN HUIYU PHARMACEUTICAL COMPANY LIMITED
BENDAMUSTINE HYDROCHLORIDE SEACROSS 25MG/VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION BENDAMUSTINE HYDROCHLORIDE SEACROSS 100MG/VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2 QUALITATIVE AND QUANTITATIVE COMPOSITION • One vial contains 25 mg of bendamustine hydrochloride (as bendamustine hydrochloride monohydrate). • One vial contains 100 mg of bendamustine hydrochloride (as bendamustine hydrochloride monohydrate). 1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate) when reconstituted according to section 6.6. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion Before reconstitution: White to off-white cake or powder. After reconstitution: Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bendamustine Hydrochloride Seacross is indicated for monotherapy in patients with chronic lymphocytic leukaemia. Efficacy relative to first line therapies other than chlorambucil has not been established. Bendamustine Hydrochloride Seacross is indicated for monotherapy in patients with indolent B-cell non-Hodgkin’s lymphomas that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous infusion over 30 - 60 minutes. (see Instructions for Use and Handling and Disposal). Infusion must be administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents. Poor bone marrow function is related to increased chemotherapy-induced haematological toxicity. Treatment should not be started if leukocyte and/or platelet values have dropped to < 3,000/μl or < 75,000/μl, respectively (see Contraindications). _MONOTHERAPY FOR CHRONIC LYMPHOCYTIC LEUKAEMIA _ 100 mg/m2 body surface area bendamustine hydrochloride on days 1 and 2; every 4 weeks. _MONOTHERAPY FOR INDOLENT NON-HODGKIN'S LYMPHOMAS REFRACTORY TO RITUXIMAB _ 120 mg/m2 body surface area bendamustine hydroch Baca dokumen lengkapnya