BENDAMUSTINE MEDAC 25 Milligram Pdr/Conc/Soln for Infus

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENDAMUSTINE HYDROCHLORIDE

Available from:

Medac Gesellschaft fur Klinische Spezialpraparate mbH

ATC code:

L01A

INN (International Name):

BENDAMUSTINE HYDROCHLORIDE

Dosage:

25 Milligram

Pharmaceutical form:

Pdr/Conc/Soln for Infus

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

ALKYLATING AGENTS

Authorization status:

Authorised

Authorization date:

2015-08-21

Patient Information leaflet

pal (IE) Bendamustine medac 25 mg, 100 mg powder for concentrate for
solution for infusion
National version: 04/2018
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE MEDAC 25 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
BENDAMUSTINE MEDAC 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
bendamustine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bendamustine medac is and what it is used for
2.
What you need to know before you use Bendamustine medac
3.
How to use Bendamustine medac
4.
Possible side effects
5.
How to store Bendamustine medac
6.
Contents of the pack and other information
1.
WHAT BENDAMUSTINE MEDAC IS AND WHAT IT IS USED FOR
Bendamustine medac is a medicine containing an active substance called
bendamustine hydrochloride
(hereafter called bendamustine).
Bendamustine is a medicine which is used for the treatment of certain
types of cancer (cytotoxic
medicine).
Bendamustine is used alone (monotherapy) or in combination with other
medicines for the treatment
of the following forms of cancer:

chronic lymphocytic leukaemia in cases where fludarabine combination
chemotherapy is not
appropriate for you,

non-Hodgkin’s lymphomas, which had not, or only shortly, responded
to prior rituximab
treatment,

multiple myeloma in cases where high-dose chemotherapy with autologous
stem cell
transplantation, thalidomide or bortezomib containing therapy is not
appropriate for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BENDAMUSTINE MEDAC
DO NOT USE BENDAMUSTINE MEDAC:_ _

if you are allergic to bendamustine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6).


Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bendamustine Medac 25mg Powder for concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 25 mg bendamustine hydrochloride (as bendamustine
hydrochloride monohydrate).
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.
Front line treatment of multiple myeloma (Durie-Salmon stage II with
progress or stage III) in combination with
prednisone for patients older than 65 years who are not eligible for
autologous stem cell transplantation and who have
clinical neuropathy at time of diagnosis precluding the use of
thalidomide or bortezomib containing treatment.
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 cycles (see also
sec. 5.1).
_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, depending on response for
at least 6 cycles (see also sec. 5.1).
_Multiple myeloma_
120 – 150 mg/m² body surface area bendamustine hydrochloride on
days 1 and 2, 60 mg/m² body surface area
prednisone i.v. or per os on days 1 to 4; every 4 weeks, for a minimum
of 3 cycles (for median numbers of cycles see
sec. 5.1).
_Hepatic impairment_
On the basis of pharmacokinetic data, no dose adjustment