BENDARED (Bendamustine Hydrochloride concentrate for solution for infusion 180mg4mL)

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

BENDAMUSTINE HYDROCHLORIDE

Prieinama:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Tarptautinis Pavadinimas):

BENDAMUSTINE HYDROCHLORIDE

Vienetai pakuotėje:

1 Vials

Pagaminta:

DR. REDDY'S LABORATORIES LIMITED

Prekės savybės

COMPOSITION
Each vial contains Bendamustine Hydrochloride 180.0 mg/4mL
CLINICAL INFORMATION
THERAPEUTIC INDICATIONS
Bendared is indicated for monotherapy in patients with chronic
lymphocytic leukaemia. Efficacy relative to first line therapies other
than chlorambucil has not been established.
Bendared 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
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_
2
100 mg/m body surface area bendamustine hydrochloride on days 1 and 2;
every 4 weeks.
_Monotherapy for indolent non-Hodgkin's lymphomas refractory to
rituximab_
2
120 mg/m body surface area bendamustine hydrochloride on days 1 and 2;
every 3 weeks.
Treatment should be terminated or delayed if leukocyte and/or platelet
values drop to < 3000/µL or < 75000/µL, respectively. Treatment can
be continued after leukocyte values
have increased to > 4000/µL and platelet values to > 100000/µL.
The leukocyte and platelet nadir is reached after 14-20 days with
regeneration after 3-5 weeks. During therapy free intervals strict
monitoring of the blood count is recommended (see
Warnings and Precautions).
In case of non-hematological toxicity, dose reductions have to be
based on the worst common toxicity criteria (CTC) grades in the
preceding cycle. A 50% dose reduction is
recommended in case of CTC grade 3 toxicity. An interruption of
treatment is recommended in case of CTC grad