Vidaza
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
07-12-2023
Produktets egenskaber
(SPC)
07-12-2023
Offentlige vurderingsrapport
(PAR)
17-08-2016
Aktiv bestanddel:
azacitidine
Tilgængelig fra:
Bristol-Myers Squibb Pharma EEIG
ATC-kode:
L01BC07
INN (International Name):
azacitidine
Terapeutisk gruppe:
Antineoplastic agents
Terapeutisk område:
Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Terapeutiske indikationer:
Vidaza 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.Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.
Produkt oversigt:
Revision: 26
Autorisation status:
Authorised
Autorisation dato:
2008-12-17
Indlægsseddel
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIDAZA 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 Vidaza is and what it is used for
2.
What you need to know before you use Vidaza
3.
How to use Vidaza
4.
Possible side effects
5.
How to store Vidaza
6.
Contents of the pack and other information
1.
WHAT VIDAZA IS AND WHAT IT IS USED FOR
WHAT VIDAZA IS
Vidaza is an anti-cancer agent which belongs to a group of medicines
called ‘anti-metabolites’. Vidaza
contains the active substance ‘azacitidine’.
WHAT VIDAZA IS USED FOR
Vidaza 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 VIDAZA WORKS
Vidaza 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
Vidaza works or why this medicine
has been prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VIDAZA
DO NOT USE VIDAZ
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vidaza 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
Vidaza 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
Vidaza 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.
U
Posology
The recommended starting dose for the first treatment cycle, for all
patients regardless of baseline
haematology laboratory values, is 75 mg/m
P
2
P
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.
Vidaza should not be used interchangeably with oral azacitidine. D
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