BENDAMUSTINE

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

BENDAMUSTINE HYDROCHLORIDE

MAH:

Generics (UK) Limited

ATC_code:

L01AA09

INN:

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:

bendamustine

authorization_status:

Not Marketed

authorization_date:

2015-08-21

PIL

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BENDAMUSTINE 25 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BENDAMUSTINE 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bendamustine is and what it is used for
2.
What you need to know before you use Bendamustine
3.
How to use Bendamustine
4.
Possible side effects
5.
How to store Bendamustine
6.
Contents of the pack and other information
1. WHAT BENDAMUSTINE IS AND WHAT IT IS USED FOR
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 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
DO NOT USE BENDAMUSTINE
-
if you are allergic to bendamustine hydrochloride or any of the other
ingredients of this medicine (listed
in section 6);
-
while breast-feeding if treatment with Bendamustine is necessary
during lactation you must discontinue
breast-feeding (see section warnings and precautions on
breastfeeding);
-
if you have severe liver dysfunction (damage to the functional cells
of the liver);
-
if you have yellowing of the skin or whites of the eyes caused by
liver or blood problems (jaundice);
-
if you

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bendamustine 25 mg Powder for Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg:
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 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 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 necessary
in patients with mild hepatic impairment (serum
bilirub