AZADINE azacitidine 100 mg powder for injection vial

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

azacitidine, Quantity: 100 mg

Предлага се от:

Dr Reddys Laboratories Australia Pty Ltd

INN (Международно Name):

Azacitidine

Лекарствена форма:

Injection, powder for

Композиция:

Excipient Ingredients: mannitol

Начин на приложение:

Intravenous Infusion, Subcutaneous

Броя в опаковка:

100 mg

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

AZADINE is indicated for the treatment of patients with intermediate-2 and high-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS), Chronic Myelomonocytic Leukemia (CMMoL (10-29 percent marrow blasts without Myeloproliferative Disorder)), Acute Myeloid Leukemia (AML) with 20-30 percent blasts and multi-lineage dysplasia, according to World Health Organisation Classification (WHO), in whom allogenic stem cell transplantation is not indicated.

Каталог на резюме:

Visual Identification: White to off white lyophilized powder in a sealed vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Оторизация:

Licence status A

Дата Оторизация:

2016-02-10

Листовка

AZADINE CMI V1
1
AZADINE
®
_POWDER FOR INJECTION_
_(azacitidine 100 mg)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Azadine.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Azadine against
OR WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Azadine will only be prescribed to
you by a doctor who has experience
in medicines to treat cancers of the
blood.
BEFORE YOU ARE
GIVEN AZADINE
USE AN EFFECTIVE METHOD OF
CONTRACEPTION DURING TREATMENT
WITH AZADINE AND FOR UP TO THREE
(3) MONTHS AFTER DISCONTINUATION OF
AZADINE.
DO NOT BREAST-FEED WHILE YOU ARE
RECEIVING AZADINE BUT IF YOU DO,
TELL YOUR DOCTOR IMMEDIATELY.
It is not known if Azadine is
excreted in human milk.
2. USE BY MEN
DO NOT FATHER A CHILD WHILE
the benefits this medicine is expected
to have for you.
_WHEN YOU MUST NOT BE GIVEN_
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING TREATMENT WITH AZADINE.
USE BARRIER METHODS OF
CONTRACEPTION (E.G. CONDOMS)
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS
AZADINE USED
FOR
Azadine is an anti-cancer agent.
Azadine contains a medicine called
azacitidine which prevents the
growth of cancer cells. Azadine has
been prescribed by your doctor for
the treatment of myelodysplastic
syndrome (MDS). Myelodysplastic
syndrome is a blood disorder in
which the bone marrow is not
working normally and does not
produce enough mature blood cells.
This causes a lack of healthy blood
cells that can function properly in the
body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT HOW AZADINE
WORKS,
_AZADINE_
TELL YOUR DOCTOR:
•
IF YOU ARE ALLERGIC TO AZACITIDINE
OR ANY OF THE OTHER INGREDIENTS
OF AZADINE LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include:
-
s

Данни за продукта

AUSTRALIAN PRODUCT INFORMATION – AZADINE (AZACITIDINE)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Azacitidine
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Azacitidine is a white to off-white solid. It is insoluble in acetone,
ethanol, and methyl ethyl
ketone. Azacitidine is slightly soluble in ethanol/water (50/50) and
propylene glycol; it is
sparingly soluble in water (13.8 mg/mL), 5% glucose in water and in
normal saline.
The finished product is supplied in a sterile form for reconstitution
as a suspension for
subcutaneous injection or reconstitution as a solution with further
dilution for intravenous
infusion. Vials of Azadine contain 100 mg of azacitidine and 100 mg
mannitol as a white to off-
white, sterile lyophilised powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Azadine is indicated for the treatment of patients with:
•
Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS) according
to the
International Prognostic Scoring System (IPSS),
•
Chronic Myelomonocytic Leukemia (CMMoL (10%-29% marrow blasts without
Myeloproliferative Disorder)),
•
Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage
dysplasia,
according to World Health Organisation Classification (WHO),
in whom allogenic stem cell transplantation is not indicated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Azacitidine treatment should only be administered under the
supervision of a physician
experienced in the use of cancer chemotherapeutic agents. Patients
should be premedicated
for nausea and vomiting.
RECOMMENDED DOSAGE IN ADULTS:
_First Treatment Cycle_
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 given subcutaneously
or by intravenous infusion, daily for seven days, followed by a rest
period of 21 days (28-day
treatment cycle).
1
_Subsequent Treatment Cycles_
Cycles should be repeated every 28 days. It is recommended that
patients be treated for a
minimum of