MABTHERA

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

RITUXIMAB

제공처:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (International Name):

RITUXIMAB

복용량:

10 MG/ML

약제 형태:

CAIRAN INJEKSI

패키지 단위:

DUS, 1 VIAL @ 50 ML

Manufactured by:

ROCHE DIAGNOSTIC - Germany

승인 날짜:

2018-03-28

제품 특성 요약

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