Azacitidine Vivanta 25 mg/ml, poeder voor suspensie voor injectie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

AZACITIDINE 100 mg/flacon

Beschikbaar vanaf:

Vivanta Generics s.r.o. Trtinova 260/1, Cakovice 196 00 PRAHA 9 (TSJECHIË)

INN (Algemene Internationale Benaming):

AZACITIDINE 100 mg/flacon

farmaceutische vorm:

Poeder voor suspensie voor injectie

Samenstelling:

MANNITOL (D-) (E 421) ; STIKSTOF (HEAD SPACE) (E 941)

Toedieningsweg:

Subcutaan gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
AZACITIDINE VIVANTA 25 MG/ML, POEDER VOOR SUSPENSIE VOOR INJECTIE
Azacitidine
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, pharmacist or
nurse.
-
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
WHAT IS
is an anti-cancer agent which belongs to a group of
medicines called ‘anti-metabolites’.
contains the active substance ‘azacitidine’.
WHAT IS USED FOR
is used in adults who are not able to have a stem cell
transplantation to treat:
•
higher-risk myelodysplastic syndromes (MDS).
•
chronic myelomonocytic leukaemia (CMML).
•
acute myeloid leukaemia (AML).
These are diseases which affect the bone marrow and can cause problems
with normal blood cell
production.
HOW WORKS
works by preventing cancer cells from growing.
Azacitidine becomes incorporated into
the genetic material of cells (ribonucleic acid (RNA) and
deoxyribonucleic acid (DNA)). It is thought to
work by altering the way the cell turns genes on and off and also by
interfering with the production of
new RNA and DNA. These actions are thought to correct problems with
the maturation and growth of
young blood cells in the bone marrow that cause myelodysplastic
disorders, and to kill cancerous cells in
leukaemia.
Talk to your doctor or nurse if you have any questions about how
works or why

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Azacitidine Vivanta 25 mg/ml, poeder voor suspensie voor injectie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg azacitidine. After reconstitution, each mL
of suspension contains 25 mg
azacitidine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for suspension for injection.
White lyophilised cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

is
indicated
for
the
treatment
of
adult
patients
who
are
not
eligible
for
haematopoietic stem cell transplantation (HSCT) with:
•
intermediate-2
and
high-risk
myelodysplastic
syndromes
(MDS)
according
to
the
International
Prognostic Scoring System (IPSS),
•
chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts
without myeloproliferative
disorder,
•
acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage
dysplasia, according to World
Health Organisation (WHO) classification,
•
AML with >30% marrow blasts according to the WHO classification.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
treatment should be initiated and monitored under the
supervision of a physician
experienced in the use of chemotherapeutic agents. Patients should be
premedicated with anti-emetics
for nausea and vomiting.
Posology
The recommended starting dose for the first treatment cycle, for all
patients regardless of baseline
haematology laboratory values, is 75 mg/m
2
of body surface area, injected subcutaneously, daily for 7
days, followed by a rest period of 21 days (28-day treatment cycle).
It is recommended that patients be treated for a minimum of 6 cycles.
Treatment should be continued
for as long as the patient continues to benefit or until disease
progression.
Patients should be monitored for haematologic response/toxicity and
renal toxicities (see section 4.4);
a delay in starting the next cycle or a dose reduction as described
below may be necessary.
should not be used interchangea