Bendamustine Moosmann 2,5mg/ml powder for concentrate for solution for infusion

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

bendamustine (bendamustine hydrochloride)

Disponível em:

Thymoorgan Pharmazie GmbH

Código ATC:

L01AA09

DCI (Denominação Comum Internacional):

bendamustine (bendamustine hydrochloride)

Dosagem:

100mg

Forma farmacêutica:

powder for concentrate for solution for infusion

Unidades em pacote:

(1) glass vial

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2017-06-22

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDAMUSTINE MOOSMANN 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
or nurse.
–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, or pharmacist
_ _
or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Bendamustine Moosmann is and what it is used for
2. What you need to know before you use Bendamustine Moosmann
3. How to use Bendamustine Moosmann
4. Possible side effects
5. How to store Bendamustine Moosmann
6. Contents of the pack and other information
1. WHAT BENDAMUSTINE MOOSMANN IS AND WHAT IT IS USED FOR
Bendamustine Moosmann is a medicine which is used for the treatment of
certain types of
cancer (cytotoxic medicine).
Bendamustine Moosmann is used alone (monotherapy) or in combination
with other
medicines for the treatment of the following forms of cancer:
– chronic lymphocytic leukaemia (a type of cancer of the white blood
cells) in cases where
fludarabine combination chemotherapy is not appropriate for you,
– non-Hodgkin’s lymphomas (cancer that begins in a type of white
blood cell that normally
fights infection), which had not, or only shortly, responded to prior
rituximab treatment,
– multiple myeloma (a cancer of the plasma cells, a type of white
blood cell present in the
bone marrow ) 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 MOOSMANN
DO NOT USE BENDAMUSTINE MOOSMANN
– if you are alle

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bendamustine Moosmann 2.5 mg/ml powder for concentrate for solution
for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
vial
contains
25
mg
or
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 to off-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
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).
Posology
_Monotherapy for chronic lymphocytic leukaemia _
100 mg/m² body surface area bendamustine hydrochloride on days 1 and
2; every 4 weeks.
1
_Monotherapy for indolent non-Hodgkin's lymphomas refractory to
rituximab _
120 mg/m² body surface area bendamustine hydrochloride on days