BENDAMUSTINE HCL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENDAMUSTINE HYDROCHLORIDE

Available from:

Fresenius Kabi Oncology Plc

ATC code:

L01AA09

INN (International Name):

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:

Marketed

Authorization date:

2016-10-28

Patient Information leaflet

BENDAMUSTINE PACK INSERT-BORDON-IRE- 592X300
Black
Font Size: 9 Pt
Date: 19 June 2017 Version: 09
Final Packaging Site: Bordon
Mfg. Site: Baddi-2
Font: Times New Roman
Dimension: 592x300 mm
Folding Size: 60x33 mm
_(Outline of folding size for indication purpose only, _
_it should be removed before final printing.)_
\\fre-kp-fp01\PDD-Artworks\Europe\Bendamustine\IRE\Bendamustine Pack
Insert-Bordon-IRE- 592x300.indd
Form No.: SOP/PDD/014-02 Rev. 00
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE HCL 25MG OR 100MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BENDAMUSTINE HYDROCHOLORIDE
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 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’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 hydroch

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bendamustine HCl 25 mg Powder for Concentrate for Solution for
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 25 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 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 refractory to
rituximab
120 mg/m
2
body surface area bendamustine hydrochloride on days 1 and 2; every 3