Land: Indonesië
Taal: Indonesisch
Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
RITUXIMAB
BOEHRINGER INGELHEIM INDONESIA - Indonesia
RITUXIMAB
1400 MG/ 11,7 ML
CAIRAN INJEKSI
DUS, 1 VIAL @ 11,7 ML
F HOFFMANN LA ROCHE - Switzerland
2019-12-10
Page 1 of 50 MABTHERA ® Rituximab 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Antineoplastic agent. ATC Code: L01XC02 1.2 TYPE OF DOSAGE FORM Intravenous (IV) formulation: concentrate for solution for infusion. Subcutaneous (SC) formulation: solution for subcutaneous injection. 1.3 ROUTE OF ADMINISTRATION Intravenous formulation: intravenous infusion Subcutaneous formulation: subcutaneous injection 1.4 STERILE/RADIOACTIVE STATEMENT Sterile 1.5 QUALITATIVE AND QUANTATIVE COMPOSITION Active ingredient: rituximab _INTRAVENOUS FORMULATION _ MabThera IV is a clear, colorless 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, water for injection. _SUBCUTANEOUS FORMULATION _ MabThera SC is a colorless to yellowish, clear to opalescent solution supplied in sterile, preservative-free, non-pyrogenic single-dose vials. MabThera SC contains recombinant human hyaluronidase (rHuPH20), an enzyme used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously (see section _ 2.5 Use in Special Populations, Pregnancy_ ). Excipients: rHuPH20, L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dehydrate, L-methionine, polysorbate 80, water for injection. Subcutaneous formulation for non-Hodgkin’s lymphoma: Single dose vials contain 1400 mg/11.7 mL (in 15 mL vial). 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) NON-HODGKIN’S LYMPHOMA MabThera IV/SC is indicated for the treatment of patients with relapsed or chemoresistant low- grade or follicular, CD 20-positive, B-cell non-Hodgkin’s lymphomas. Page 2 of 50 MabThera IV/SC is indicated for the treatment of patients with stage III-IV follicular lymphoma in combination with CVP chemotherapy. MabThera IV/SC is indicated for patients with follicular lymphoma as maintenance treatment, after response to induction therapy. MabThera IV/S Lees het volledige document