Bendamustine 100 mg Powder for Concentrate for Solution for Infusion

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Bendamustine hydrochloride

Prieinama:

Actavis Group PTC ehf

ATC kodas:

L01AA; L01AA09

INN (Tarptautinis Pavadinimas):

Bendamustine hydrochloride

Dozė:

100 milligram(s)

Vaisto forma:

Powder for concentrate for solution for infusion

Vartojimo būdas:

Intravenous infusion

Vienetai pakuotėje:

packs of 1 or 5 vials. Not all pack sizes may be marketed

Recepto tipas:

Product subject to prescription which may not be renewed (A)

Pagaminta:

S.C. SINDAN-PHARMA S.R.L

Farmakoterapinė grupė:

Antineoplastic agents, alkylating agents

Gydymo sritis:

Nitrogen mustard analogues; bendamustine

Terapinės indikacijos:

First-line treatment of chronic lymphocytic leukaemia. Indolent non-Hodgkin's lymphomas. Front line treatment of multiple myeloma.

Autorizacija statusas:

Marketed

Leidimo data:

2015-05-15

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE 25 MG AND 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.
-
If you get any side effects, talk to your doctor or pharmacist. 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 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
-
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 a

Prekės savybės

Health Products Regulatory Authority
04 May 2021
CRN00C4WD
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bendamustine 100 mg Powder for Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride
when reconstituted according to section 6.6.
One vial contains 100 mg bendamustine hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white lyophilisate powder.
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/m² 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/m² body surface area bendamustine hydrochloride on days 1 and
2; every 3 weeks for at least 6 times.
_Multiple myeloma _
120‑150 mg/m² body surface area bendamustine hydrochloride on days
1 and 2, 60 mg/m² 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 patients with mild hepatic impairment (serum
bilirubi