Azacitidine Seacross 25mg/ml powder for suspension for injection

देश: आर्मेनिया

भाषा: अंग्रेज़ी

स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

सक्रिय संघटक:

azacitidine

थमां उपलब्ध:

SEACROSS PHARMACEUTICALS LIMITED

ए.टी.सी कोड:

L01BC07

INN (इंटरनेशनल नाम):

azacitidine

डोज़:

100mg

फार्मास्यूटिकल फॉर्म:

powder for suspension for injection

पैकेज में यूनिट:

glass vial

प्रिस्क्रिप्शन प्रकार:

Prescription

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2022-06-22

उत्पाद विशेषताएं

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL
PRODUCT
Azacitidine Seacross 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 Seacross 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 Seacross 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.
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.
2
_Laboratory _
_tests _
Liver function tests, serum creatinine