Bendamustine hydrochloride Accord 2.5mg/ml Pdr/Conc/Soln for Infusion (100mg)

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

L01AA09

INN (International Name):

bendamustine hydrochloride 2.5 mg/ml

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

bendamustine hydrochloride 2.5 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2016-01-28

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE HYDROCHLORIDE 2.5 MG/ ML POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
bendamustine hydrochloride
The name of your medicine is Bendamustine hydrochloride 2.5 mg/ml
powder for concentrate for
solution for infusion’ but in the rest of the leaflet it will be
called “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.
•
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 hydrochloride is and what it is used for
2.
What you need to know before you use Bendamustine hydrochloride
3.
How to use Bendamustine hydrochloride
4.
Possible side effects
5.
How to store Bendamustine hydrochloride 6. Contents of the pack and
other information
1.
WHAT BENDAMUSTINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Bendamustine hydrochloride is a medicine which is used for the
treatment of certain types of cancer
(cytotoxic medicine).
Bendamustine hydrochloride 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 thalidomide or bortezomib containing
therapy is not appropriate
for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BENDAMUSTINE HYDROCHLORIDE
Do not use Bendamustine hydrochloride :
-
if you are allergic to bendamustine hyd

Summary of Product characteristics

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SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bendamustine hydrochloride Accord 2.5 mg/ ml Powder for concentrate
for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 25 mg bendamustine hydrochloride (as bendamustine
hydrochloride
monohydrate).
One vial contains 100 mg bendamustine hydrochloride (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
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.
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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.
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 at least 3 times.