Bendamustine Hydrochloride 2.5mg/ml Powder for concentrate for solution for Infusion (25mg vial)

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Tilgængelig fra:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATC-kode:

L01AA09

INN (International Name):

bendamustine hydrochloride 2.5 mg/ml

Lægemiddelform:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sammensætning:

bendamustine hydrochloride 2.5 mg/ml

Recept type:

POM

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Autorisation status:

Authorised

Autorisation dato:

2016-07-19

Indlægsseddel

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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, 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
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 KABI IS AND WHAT IT IS USED FOR
Bendamustine Hydrochloride Kabi 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 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 breast-feeding; if treatment with bendamustine hydrochloride is
necessary during lactation
you must discontinue breast-feeding (see s

Produktets egenskaber

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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
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.
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_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