Bendamustine 25mg powder for concentrate for solution for infusion vials

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Bendamustine hydrochloride

थमां उपलब्ध:

Zentiva Pharma UK Ltd

ए.टी.सी कोड:

L01AA09

INN (इंटरनेशनल नाम):

Bendamustine hydrochloride

डोज़:

25mg

फार्मास्यूटिकल फॉर्म:

Powder for solution for infusion

प्रशासन का मार्ग:

Intravenous

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 08010100; GTIN: 5000283658191

सूचना पत्रक

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 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 hydrochloride 2.5mg/ml Powder for concentrate for
solution for infusion is a
medicine containing an active substance called bendamustine
hydrochloride (hereafter
called bendamustine).
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 breastfeeding, 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 t

उत्पाद विशेषताएं

OBJECT 1
BENDAMUSTINE HYDROCHLORIDE 2.5MG/ML POWDER
Summary of Product Characteristics Updated 05-Jun-2018 | Zentiva
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 (as bendamustine
hydrochloride monohydrate).
One vial contains 100 mg bendamustine hydrochloride (as bendamustine
hydrochloride monohydrate).
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 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/m
2
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/m
2
body surface area bendamustine hydrochloride on days 1 and 2; every 3
weeks.
_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.
Poor bone marrow function is related to increased chem