BENDAMUSTINE MEDAC 100 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BENDAMUSTINE HYDROCHLORIDE

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

L01AA09

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

BENDAMUSTINE HYDROCHLORIDE 100 MG

Administration route:

I.V

Prescription type:

Required

Manufactured by:

MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY

Therapeutic area:

BENDAMUSTINE

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.

Authorization date:

2020-02-19

Summary of Product characteristics

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