MABTHERA

国家: 印度尼西亚

语言: 印度尼西亚文

来源: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

有效成分:

RITUXIMAB

可用日期:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN（国际名称）:

RITUXIMAB

剂量:

10 MG/ML

药物剂型:

CAIRAN INJEKSI

每包单位数:

DUS, 2 VIAL @ 10 ML

厂商:

ROCHE DIAGNOSTIC - Germany

授权日期:

2018-03-28

产品特点

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