Azacitidine Sandoz 25 mg/ml powder for suspension for injection

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Tilgængelig fra:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC-kode:

L01BC07

INN (International Name):

AZACITIDINE 25 mg/ml

Lægemiddelform:

POWDER FOR SUSPENSION FOR INJECTION

Sammensætning:

AZACITIDINE 25 mg/ml

Recept type:

POM

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

Licence number in the source country: NOT APPLICAPABLE

Autorisation status:

Authorised

Autorisation dato:

2023-01-30

Indlægsseddel

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZACITIDINE SANDOZ 25 MG/ML POWDER FOR SUSPENSION FOR INJECTION_ _
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 Sandoz is and what it is used for
2. What you need to know before you use Azacitidine Sandoz
3. How to use Azacitidine Sandoz
4. Possible side effects
5. How to store Azacitidine Sandoz
6. Contents of the pack and other information
1. WHAT AZACITIDINE SANDOZ IS AND WHAT IT IS USED FOR
_ _
WHAT AZACITIDINE SANDOZ IS
Azacitidine Sandoz is an anti-cancer agent which belongs to a group of
medicines called ‘anti-
metabolites’. Azacitidine Sandoz contains the active substance
‘azacitidine’.
WHAT AZACITIDINE SANDOZ IS USED FOR
Azacitidine Sandoz 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 SANDOZ WORKS
Azacitidine
Sandoz
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

Produktets egenskaber

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1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Azacitidine Sandoz 25 mg/ml powder for suspension for injection
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 Sandoz 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
Sandoz
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 as long as the patient continues to benefit or until disease
progression.
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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.
Azacitidine Sandoz should n