ONUREG 300 MG

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

AZACITIDINE

Доступно од:

BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL

АТЦ код:

L01BC07

Фармацеутски облик:

FILM COATED TABLETS

Састав:

AZACITIDINE 300 MG

Пут администрације:

PER OS

Тип рецептора:

Required

Произведен од:

CELGENE CORPORATION, USA

Терапеутска област:

AZACITIDINE

Терапеутске индикације:

ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy

Датум одобрења:

2022-06-27

Информативни летак

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
ONUREG 200 MG
ONUREG 300 MG
FILM-COATED TABLETS
Active ingredient and its quantity:
Onureg 200 mg: Each film-coated tablet contains 200 mg azacitidine
Onureg 300 mg: Each film-coated tablet contains 300 mg azacitidine
Inactive ingredients – See section 6 “Additional information”
and section 2 under
“Important information about some of this medicine’s
ingredients”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Onureg is indicated for continued treatment of adult patients with
acute myeloid
leukaemia )AML( who achieved first complete remission or complete
remission with
incomplete blood count recovery following intensive induction
chemotherapy and are
not able to complete intensive curative therapy.
THERAPEUTIC GROUP: Antineoplastic agent, antimetabolite, pyrimidine
analogue
HOW ONUREG WORKS
AML is a type of cancer which affects the bone marrow and can cause
problems
in producing normal blood cells. Onureg prevents cancer cells from
growing.
Azacitidine, the active substance in Onureg, alters the way by which
the cell turns
genes on and off. It also reduces the production of new genetic
material (DNA or
RNA). These effects are thought to block the growth of cancer cells in
leukaemia.
Talk to your doctor or nurse if you have any further questions about
how Onureg
works or why this medicine has been prescribed for you.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to azacitidine or to any of the other
ingredients of this
medicine (listed in section 6)
Yo

Карактеристике производа

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Onureg_API_June2022_clean
1.
NAME OF THE MEDICINAL PRODUCT
Onureg 200 mg
Onureg 300 mg
Film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Onureg 200 mg film-coated tablets
Each film-coated tablet contains 200 mg azacitidine.
_Excipient with known effect _
Each film-coated tablet contains 3.61 mg of lactose (as lactose
monohydrate).
Onureg 300 mg film-coated tablets
Each film-coated tablet contains 300 mg azacitidine.
_Excipient with known effect _
Each film-coated tablet contains 5.42 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Onureg 200 mg film-coated tablets
Pink, oval, film-coated tablet, debossed with “200” on one side
and “ONU” on the other side.
Onureg 300 mg film-coated tablets
Brown, oval, film-coated tablet, debossed with “300” on one side
and “ONU” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Onureg is indicated for continued treatment of adult patients with
acute myeloid leukemia who
achieved first complete remission (CR) or complete remission with
incomplete blood count recovery
(CRi) following intensive induction chemotherapy and are not able to
complete intensive curative
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Onureg treatment should be initiated and monitored under the
supervision of a physician experienced
in the use of chemotherapeutic medicinal products.
Patients are to be treated with an anti-emetic 30 minutes prior to
each dose of Onureg for the first
2 treatment cycles. Anti-emetic prophylaxis may be omitted after 2
cycles, if there has been no nausea
and vomiting (see section 4.4).
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Posology
The recommended dose is 300 mg azacitidine orally once daily. Each
repeated cycle consists of a
treatment period of 14 days followed by a treatment free period of 14
days (28-day treatment cycle).
Onureg treatment should be continued until no more than 15% blasts are
observed in peripheral blood
or bone marrow or until un