Bendamustine 25mg powder for concentrate for solution for infusion vials

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Bendamustine hydrochloride

Disponível em:

Accord-UK Ltd

Código ATC:

L01AA09

DCI (Denominação Comum Internacional):

Bendamustine hydrochloride

Dosagem:

25mg

Forma farmacêutica:

Powder for solution for infusion

Via de administração:

Intravenous

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 08010100; GTIN: 5055565723722

Folheto informativo - Bula

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 Bendamustine hydr

Características técnicas

OBJECT 1
BENDAMUSTINE HYDROCHLORIDE ACCORD 2.5 MG/ ML
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 07-Mar-2017 | Accord
Healthcare Limited
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