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

Država: Nizozemska

Jezik: nizozemščina

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

Aktivna sestavina:

AZACITIDINE 100 mg/flacon

INN (mednarodno ime):

AZACITIDINE 100 mg/flacon

Farmacevtska oblika:

Poeder voor suspensie voor injectie

Sestava:

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

Pot uporabe:

Subcutaan gebruik

Datum dovoljenje:

2021-11-29

Navodilo za uporabo

Azacitidine NL-H-5204_
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PACKAGE LEAFLET: INFORMATION FOR THE USER
AZACITIDINE ZENTIVA 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 Azacitidine Zentiva is and what it is used for
2.
What you need to know before you use Azacitidine Zentiva
3.
How to use Azacitidine Zentiva
4.
Possible side effects
5.
How to store Azacitidine Zentiva
6.
Contents of the pack and other information
1.
WHAT AZACITIDINE ZENTIVA IS AND WHAT IT IS USED FOR
WHAT AZACITIDINE ZENTIVA IS
Azacitidine Zentiva is an anticancer agent which belongs to a group of
medicines called “anti-
metabolites”. Azacitidine Zentiva contains the active substance
“azacitidine”.
WHAT AZACITIDINE ZENTIVA IS USED FOR
Azacitidine Zentiva 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 AZACITIDINE ZENTIVA WORKS
Azacitidine Zentiva 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

Lastnosti izdelka

Azacitidine NL-H-5204_
11/2023 PRAC recommendation
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Azacitidine Zentiva 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 powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azacitidine Zentiva 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
Azacitidine Zentiva 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).
Azacitidine NL-H-5204_
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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 c