BENDAMUSTINE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENDAMUSTINE HYDROCHLORIDE

Available from:

Accord Healthcare Limited

ATC code:

L01AA09

INN (International Name):

BENDAMUSTINE HYDROCHLORIDE

Dosage:

100 Milligram

Pharmaceutical form:

Pdr/Conc/Soln for Infus

Prescription type:

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

Therapeutic area:

bendamustine

Authorization status:

Marketed

Authorization date:

2014-10-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE 25 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BENDAMUSTINE 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Bendamustine hydrochloride
The name of your medicine is
BENDAMUSTINE 25 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION,
BENDAMUSTINE 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
but in the rest of the leaflet it will be
called “Bendamustine for Infusion”.
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.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or
healthcare professional. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bendamustine for Infusion is and what it is used for
2.
What you need to know before you use Bendamustine for Infusion
3.
How to use Bendamustine for Infusion
4.
Possible side effects
5.
How to store Bendamustine for Infusion
6.
Contents of the pack and other information
1.
WHAT BENDAMUSTINE FOR INFUSION IS AND WHAT IT IS USED FOR
Bendamustine for Infusion is a medicine which is used for the
treatment of certain types of cancer (cytotoxic
medicine).
Bendamustine for Infusion 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 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.
W

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bendamustine 100mg Powder for Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 100 mg bendamustine hydrochlorid (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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
White, microcrystalline 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
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 section
4.3).
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 hydrochloride on days 1 and
2; every 3 weeks.
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