Bendamustine 25 mg/ml concentrate for solution for infusion

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Bendamustine hydrochloride

Prieinama:

Accord Healthcare Ireland Ltd.

ATC kodas:

L01AA09

INN (Tarptautinis Pavadinimas):

Bendamustine hydrochloride

Vaisto forma:

Concentrate for solution for infusion

Gydymo sritis:

bendamustine

Autorizacija statusas:

Marketed

Leidimo data:

2022-08-26

Pakuotės lapelis

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE 25 MG/ML 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
healthcare professional. 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

Prekės savybės

Health Products Regulatory Authority
29 November 2023
CRN00DJ2N
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bendamustine 25 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains bendamustine hydrochloride monohydrate equivalent to
25 mg bendamustine hydrochloride.
Each vial of 1 ml contains bendamustine hydrochloride monohydrate
equivalent to 25 mg bendamustine hydrochloride.
Each vial of 4 ml contains bendamustine hydrochloride monohydrate
equivalent to 100 mg bendamustine hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate)
Clear colourless to yellow solution.
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 leas