Bendamustine 25 mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bendamustine hydrochloride

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

L01AA; L01AA09

INN (International Name):

Bendamustine hydrochloride

Dosage:

25 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Therapeutic area:

Nitrogen mustard analogues; 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 thalidomide or bortezomib containing
therapy is not appropriate for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BENDAMUSTINE FOR INFUSION
Do n

Summary of Product characteristics

Health Products Regulatory Authority
25 March 2021
CRN00C5CY
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bendamustine 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 (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.
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.
Hepatic impairment
On the basis of pharmacokinetic data, no dose adjustment is necess