BENDAMUSTINE MEDAC 25 MG

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

BENDAMUSTINE HYDROCHLORIDE

Disponible des:

TZAMAL BIO-PHARMA LTD

Codi ATC:

L01AA09

formulario farmacéutico:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

BENDAMUSTINE HYDROCHLORIDE 25 MG

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY

Área terapéutica:

BENDAMUSTINE

indicaciones terapéuticas:

First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.Indolent non-Hodgkin’s lymphomas as monotherapy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen. Follicular non-Hodgkin’s lymphoma as first line treatment in combination with rituximab.

Data d'autorització:

2020-02-19

Fitxa tècnica

1.
NAME OF THE MEDICINAL PRODUCT
Bendamustine medac 25 mg
Bendamustine medac 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of Bendamustine medac 25 mg contains 25 mg bendamustine
hydrochloride
One vial of Bendamustine medac 100 mg contains 100 mg bendamustine
hydrochloride
1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride
when reconstituted according to
section 6.6.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
White to off-white powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
First-line treatment of chronic lymphocytic leukaemia (Binet stage B
or C) in patients for whom
fludarabine combination chemotherapy is not appropriate.
Indolent non-Hodgkin's lymphomas as monotherapy in patients who have
progressed during or within
6 months following treatment with rituximab or a rituximab containing
regimen.
Follicular non-
Hodgkin’s lymphoma as first line treatment in combination with
rituximab.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Monotherapy for chronic lymphocytic leukaemia _
100 mg/m² body surface area bendamustine hydrochloride on days 1 and
2; every 4 weeks up to 6
times.
_Monotherapy for indolent non-Hodgkin's lymphomas refractory to
rituximab _
120 mg/m² body surface area bendamustine hydrochloride on days 1 and
2; every 3 weeks for at least
6 times.
_Follicular non-_
_Hodgkin’s lymphoma: Combination with rituximab_
_ _
The dose is 90 mg/m² body surface area bendamustine hydrochloride on
days 1 and 2 plus 375 mg/m²
rituximab on day 1; repetition every 4 weeks.
_ _
_Hepatic impairment _
On the basis of pharmacokinetic data, no dose adjustment is necessary
in patients with mild hepatic
impairment (serum bilirubin < 1.2 mg/dl). A 30% dose reduction is
recommended in patients with
moderate hepatic impairment (serum bilirubin 1.2 - 3.0 mg/dl).
No data is available in patients with severe hepatic impairment (serum
bilirubin values of > 3.0 mg/dl)
(see section 4.3).
_Renal impairme