Azacitidine AqVida 25 mg/ml powder for suspension for injection (100 mg vial)

Држава: Малта

Језик: Енглески

Извор: Malta Medicines Authority

Активни састојак:

AZACITIDINE

Доступно од:

AqVida GmbH Kaiser-Wilhelm-Str 89, 20355 Hamburg, Germany

АТЦ код:

L01BC07

INN (Међународно име):

AZACITIDINE 25 mg/ml

Фармацеутски облик:

POWDER FOR SUSPENSION FOR INJECTION

Састав:

AZACITIDINE 25 mg/ml

Тип рецептора:

POM

Терапеутска област:

ANTINEOPLASTIC AGENTS

Резиме производа:

Licence number in the source country: NOT APPLICAPABLE

Статус ауторизације:

Withdrawn

Датум одобрења:

2021-01-12

Информативни летак

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

Карактеристике производа

smpc-mt-en-azacitidine-aqvida-de-h-6264-001-dc-2021-04-16
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1.
NAME OF THE MEDICINAL PRODUCT
Azacitidine AqVida 25 mg/ml powder for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 MG VIAL:
One vial contains 100 mg azacitidine. After reconstitution, 1 ml of
suspension contains 25 mg azacitidine.
150 MG VIAL:
One vial contains 150 mg azacitidine. After reconstitution, 1 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 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 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.
smpc-mt-en-azacitidine-aqvida-de-h-6264-001-dc-2021-04-16
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Patients should be monitored for haematol