AZACITIDINE-TEVA azacitidine 100 mg powder for injection vial

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

azacitidine, Quantity: 100 mg

Tilgængelig fra:

Teva Pharma Australia Pty Ltd

Lægemiddelform:

Injection, powder for

Sammensætning:

Excipient Ingredients: monobasic sodium phosphate monohydrate; dibasic sodium phosphate dihydrate; sucrose

Indgivelsesvej:

Intravenous, Subcutaneous

Enheder i pakken:

1

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Azacitidine-Teva 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 percent-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

Produkt oversigt:

Visual Identification: The drug product is a white to almost white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

2019-07-23

Indlægsseddel

AZACITIDINE-TEVA
®
_POWDER FOR INJECTION_
_(azacitidine 100 mg)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Azacitidine-Teva.
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-
Teva against the benefits they expect
it will 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.
WHAT AZACITIDINE-TEVA
IS USED FOR
Azacitidine-Teva is an anti-cancer
agent.
Azacitidine-Teva contains a
medicine called azacitidine which
prevents the growth of cancer cells.
Azacitidine-Teva 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 AZACITIDINE-
TEVA WORKS OR WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Azacitidine-Teva 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-TEVA
_WHEN YOU MUST NOT BE GIVEN_
_AZACITIDINE-TEVA_
TELL YOUR DOCTOR
•
IF YOU ARE ALLERGIC TO AZACITIDINE
OR ANY OF THE OTHER INGREDIENTS
OF AZACITIDINE-TEVA LISTED AT THE
END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include:
-
shortness of breath
-
wheezing or difficulty breathing
-
swelling of the face, lips, tongue
or other parts of the body
-
rash, itching or hives on the skin.
•
IF YOU HAVE ADVANCED LIVER
CANCER
•
IF YOU ARE PREGNANT
•
IF YOU HAVE SEVERE PROBLEMS
WITH YOUR KIDNEY FUNCTION
_BEFORE YOU ARE GIVEN_
_AZACITIDINE-TEVA_
1.
USE BY WOME

Produktets egenskaber

Azacitidine-Teva 08072019 v1.0
1
AUSTRALIAN PI – AZACITIDINE-TEVA
® (AZACITIDINE) POWDER FOR
INJECTION
1
NAME OF THE MEDICINE
Azacitidine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vials of Azacitidine-Teva contain 100 mg of azacitidine.
The azacitidine solution is adjusted to pH 7.0±0.5
List of excipients with known effect:
Sucrose
For the full list of excipients, see Section 6.1 List of excipients.
3
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.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Azacitidine-Teva 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-Teva treatment should only be administered under the
supervision of a
Azacitidine-Teva 08072019 v1.0
2
physician experienced in the use of cancer chemotherapeutic agents.
Patients should be
premedicated for nausea and vomiting.
R
ECOMMENDED
D
OSAGE IN
A
DULTS
:
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 peri