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

מדינה: הולנד

שפה: הולנדית

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

מרכיב פעיל:

AZACITIDINE 100 mg/flacon

זמין מ:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

INN (שם בינלאומי):

AZACITIDINE 100 mg/flacon

טופס פרצבטיות:

Poeder voor suspensie voor injectie

הרכב:

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

מסלול נתינה (של תרופות):

Subcutaan gebruik

תאריך אישור:

1900-01-01

עלון מידע

Sandoz B.V.
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Azacitidine Sandoz 25 mg/ml, poeder voor suspensie voor injectie
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V4
1.3.1.3 Bijsluiter
December 2023
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
Azacitidine Sandoz 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 [Nationally completed name] is and what it is used for
2. What you need to know before you use [Nationally completed name]
3. How to use [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
_ _
WHAT [NATIONALLY COMPLETED NAME] IS
[Nationally completed name] is an anti-cancer agent which belongs to a
group of medicines called
‘anti-metabolites’. [Nationally completed name] contains the
active substance ‘azacitidine’.
WHAT [NATIONALLY COMPLETED NAME] IS USED FOR
[Nationally completed name]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 [NATIONALLY COMPLETED NAME] WORKS
[Nationally completed name] 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

מאפייני מוצר

Sandoz B.V.
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Azacitidine Sandoz 25 mg/ml, poeder voor suspensie voor injectie
RVG 124391
V4
1.3.1.1 Samenvatting van de Productkenmerken
December
2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Azacitidine Sandoz 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
[Nationally completed name] 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
[Nationally completed name] 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.
Sandoz B.V.
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Azacitidine Sandoz 25 mg/ml, poeder voor suspensie voor injectie
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1.3.1.1 Samenvatting van de Productkenmerken
December
2023
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