Bendamustine Pdr/Conc/Soln for Infus 2.5mg/ml (25mg vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

bendamustine hydrochloride

Available from:

Fresenius Kabi Oncology PLC

ATC code:

L01AA09

INN (International Name):

bendamustine hydrochloride

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:

Authorised

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE2.5 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, 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 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’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
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 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 have severely disturbed bone marrow function (bone marrow
depression) and
serious changes in your number of white blood cells and platelets in
the blood (white
blood cel

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT
CHARACTERISTICS
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.
One vial contains 100 mg bendamustine hydrochloride.
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 lyophilized powder or cake
pH: 2.5- 3.5
Osmolality: 200- 320 mOsmol/Kg.
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
For intravenous infusion over 30 - 60 minutes (see section 6.6).
Infusion must be administered under the supervision of a physician
qualified and experienced in
the use of chemotherapeutic agents.
Poor bone marrow function is related to increased chemotherapy-induced
haematological
Page 2 of 13
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/m
2
body surface area bendamustine hydrochloride on days 1 and 2; every 4
weeks.
Monotherapy for indolent non-Hodgkin's lymphomas refract