Bendamustine HCl 25 mg Powder for Concentrate for Solution for Infusion

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Bendamustine hydrochloride

Tersedia dari:

Fresenius Kabi Deutschland GmbH

Kode ATC:

L01AA; L01AA09

INN (Nama Internasional):

Bendamustine hydrochloride

Dosis:

25 milligram(s)

Bentuk farmasi:

Powder for concentrate for solution for infusion

Area terapi:

Nitrogen mustard analogues; bendamustine

Status otorisasi:

Marketed

Tanggal Otorisasi:

2016-10-28

Selebaran informasi

Black
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE HCL 25 MG OR 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 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 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).
Bendamustineis 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 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 hydrochloride is
necessary
during lactation you must discontinue breast-feeding (see section
Pregnancy,
breast-feeding and fertility);
-
if you have severe liver dysfunction (damage to the functional cells
of the liver);
-
if

Karakteristik produk

Health Products Regulatory Authority
22 July 2022
CRN009YKX
Page 1 of 10
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
_Posology_
_Monotherapy for chronic lymphocytic leukaemia _
100 mg/m
2
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/m
2
body surface area bendamustine hydrochloride on days 1 and 2; every 3
weeks for at least 6 times.
_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; every 4 weeks for at least 3 times.
_Hepatic impairment_
On the basis of pharmacokinetic data, no dose adjustment is necessary
in patient