Bendamustine 25mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bendamustine hydrochloride

Available from:

Dr Reddy's Laboratories (UK) Ltd

ATC code:

L01AA09

INN (International Name):

Bendamustine hydrochloride

Dosage:

25mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010100; GTIN: 5036072006386 5036072006423

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE HYDROCHLORIDE 2.5 MG/ML 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 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’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 HYDROCHLORIDE
DO NOT USE BENDAMUSTINE HYDROCHLORIDE
•
if you are allergic to bendamustine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6)
•
while breastfeeding, if treatment with Bendamustine hydrochloride is
necessary during lactation you
must discontinue breastfeeding (see section warnings and precautions
on breastfeeding)
•
if you have severe liver dy

Summary of Product characteristics

OBJECT 1
BENDAMUSTINE HYDROCHLORIDE 2.5 MG/ML POWDER
FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 15-Feb-2018 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Bendamustine hydrochloride 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
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/m
2
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/m
2
body surface area bendamustine hydrochloride on days 1 and 2; every 3
weeks.
_Multiple myeloma_
120 - 150 mg/m
2
body surface area bendamustine hydrochloride on days 1 and 2, 60 mg/m
2
body surface
area prednisone i.v. or per os on days 1 to 4; ever