Bendamustine hyrochloride Accord Pdr/Conc/Soln for Infus 2.5mg/ml (100mg)

国家: 马耳他

语言: 英文

来源: Medicines Authority

现在购买

资料单张 资料单张 (PIL)
29-06-2018
产品特点 产品特点 (SPC)
29-06-2018

有效成分:

bendamustine hydrochloride

可用日期:

Accord Healthcare Limited

ATC代码:

L01AA09

INN(国际名称):

bendamustine hydrochloride

药物剂型:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

组成:

bendamustine hydrochloride 2.5 mg/ml

处方类型:

POM

治疗领域:

ANTINEOPLASTIC AGENTS

授权状态:

Authorised

资料单张

                                Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE HYDROCHLORIDE 2.5 MG/ ML POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Bendamustine hydrochloride
The name of your medicine is Bendamustine hydrochloride 2.5 mg/ml
powder for concentrate for solution
for infusion’ but in the rest of the leaflet it will be called
“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 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 HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Bendamustine hydrochloride 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 lymphomas, which had not, or only shortly, responded to
prior rituximab treatment,
-
multiple myeloma in cases where high-dose 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 BENDAMUSTINE HYDROCHLORIDE
Do not use Benda
                                
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产品特点

                                Page 1 of 13
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bendamustine hydrochloride Accord 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 (as
bendamustine
hydrochloride monohydrate) 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, microcrystalline 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
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).
Monotherapy for chronic lymphocytic leukaemia
100 mg/m² body surface area bendamustine hydrochloride on days 1 and
2;
                                
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