AZACITIDINE JUNO azacitidine 100 mg powder for injection vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

azacitidine, Quantity: 100 mg

Saadav alates:

Dr Reddys Laboratories Australia Pty Ltd

INN (Rahvusvaheline Nimetus):

Azacitidine

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients: mannitol

Manustamisviis:

Intravenous Infusion, Subcutaneous

Ühikuid pakis:

100 mg

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

AZACITIDINE JUNO 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.

Toote kokkuvõte:

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

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2016-02-10

Infovoldik

AZACITIDINE JUNO
_Azacitidine Powder for Injection 100 mg/vial_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Azacitidine Juno.
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 Azacitidine Juno against the
benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
ACCORD WORKS OR WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
Azacitidine Juno will only be
prescribed
to you by a doctor who has
experience
in medicines to treat cancers
of the
blood.
BEFORE YOU ARE GIVEN
AZACITIDINE JUNO
_WHEN YOU MUST NOT BE GIVEN _
_AZACITIDINE JUNO_
TELL YOUR DOCTOR:
•
IF YOU ARE ALLERGIC TO AZACITIDINE OR
ANY OF THE OTHER INGREDIENTS OF
AZACITIDINE JUNO LISTED AT THE
END
OF THIS LEAFLET.
USE AN EFFECTIVE METHOD OF
CONTRACEPTION DURING TREATMENT WITH
AZACITIDINE JUNO AND FOR UP TO THREE
(3) MONTHS AFTER DISCONTINUATION OF
AZACITIDINE JUNO.
DO NOT BREAST-FEED WHILE YOU ARE
RECEIVING AZACITIDINE JUNO BUT IF
YOU
DO, TELL YOUR DOCTOR IMMEDIATELY.
It is not known if Azacitidine Juno is
excreted in human milk.
2. USE BY MEN
DO NOT FATHER A CHILD WHILE RECEIVING
TREATMENT WITH AZACITIDINE JUNO.
USE BARRIER METHODS OF CONTRACEPTION
(E.G. CONDOMS) DURING TREATMENT AND
FOR UP TO THREE (3) MONTHS AFTER
DISCONTINUATION OF AZACITIDINE JUNO,
IF
YOUR PARTNER IS OF CHILDBEARING
POTENTIAL.
Some of the symptoms of an allergic
Talk to your doctor if you wish to
WHAT IS AZACITIDINE
ACCORD USED FOR
Azacitidine Juno is an anti-cancer
agent.
Azacitidine Juno contains a
medicine
called azacitidine which
prevents the
growth of cancer cells.
Azacitidine Juno
has been prescribed
by your doctor for
the treatment of
myelodysplastic
syndrome (MDS).

Toote omadused

AUSTRALIAN PRODUCT INFORMATION – AZACITIDINE JUNO
(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 Azacitidine Juno 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
Azacitidine Juno 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 b