Bendamustine Hydrochloride Seacross 100mgvial Powder For Concentrate For Solution For Infusion

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

Bendamustine Hydrochloride Monohydrate

제공처:

MEDISPEC (M) SDN.BHD

INN (국제 이름):

Bendamustine Hydrochloride Monohydrate

패키지 단위:

1 Vials

Manufactured by:

SICHUAN HUIYU PHARMACEUTICAL COMPANY LIMITED

제품 특성 요약

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