Bendistin 2.5mg/ml (100mg vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

bendamustine hydrochloride

Available from:

Actavis Group PTC ehf   

ATC code:

L01AA09

INN (International Name):

bendamustine hydrochloride

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

bendamustine hydrochloride 2.5 milligram(s)/millilitre

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2015-04-07

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDISTIN 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bendistin is and what it is used for
2.
What you need to know before you use Bendistin
3.
How to use Bendistin
4.
Possible side effects
5.
How to store Bendistin
6.
Contents of the pack and other information
1.
WHAT BENDISTIN IS AND WHAT IT IS USED FOR
Bendistin is a medicine which is used for the treatment of certain
types of cancer (cytotoxic medicine).
Bendistin 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 highdose 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 BENDISTIN
DO NOT USE BENDISTIN:
-
if you are allergic to bendamustine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6)
-
while breastfeeding
-
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 and platelets in the blood
(white blood cells and/or
thrombocyte values

Summary of Product characteristics

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bendistin 2.5 mg/ml 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 25 mg bendamustine hydrochloride.
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
Administration precautions
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).
2
Posology
_Monotherapy for chronic lymphocytic leukaemia _
100 mg/m² 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/m² body surfac