VIDAZA azacitidine 100mg powder for injection

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

azacitidine, Quantity: 100 mg

Հասանելի է:

Celgene Pty Ltd

INN (Միջազգային անվանումը):

Azacitidine

Դեղագործական ձեւ:

Injection, powder for

Կազմը:

Excipient Ingredients: mannitol

Կառավարման երթուղին:

Subcutaneous, Intravenous Infusion

Միավորները փաթեթում:

1 vial

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

a)Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS), b)Chronic Myelomonocytic Leukemia (CMMoL 10%-29% marrow blasts without Myeloproliferative Disorder)), c) 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.

Ապրանքի ամփոփագիր:

Visual Identification: White to off-white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2009-11-30

Տեղեկատվական թերթիկ

VIDAZA
®
_POWDER FOR INJECTION_
_(azacitidine 100 mg)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Vidaza.
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 Vidaza 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.
WHAT IS VIDAZA
USED FOR
Vidaza is an anti-cancer agent.
Vidaza contains a medicine called
azacitidine which prevents the
growth of cancer cells. Vidaza 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 VIDAZA WORKS,
OR WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Vidaza will only be prescribed to you
by a doctor who has experience in
medicines to treat cancers of the
blood.
BEFORE YOU ARE
GIVEN VIDAZA
_WHEN YOU MUST NOT BE GIVEN_
_VIDAZA_
TELL YOUR DOCTOR:
•
IF YOU ARE ALLERGIC TO AZACITIDINE
OR ANY OF THE OTHER INGREDIENTS
OF VIDAZA 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 VIDAZA_
1.
USE BY WOMEN
AVOID BECOMING PREGNANT WHILE
RECEIVING VIDAZA BUT IF YOU DO, TELL
YOUR DOCTOR IMMEDIATELY.
USE AN EFFECTIVE METHOD OF

Ապրանքի հատկությունները

Vidaza® (azacitidine) 100 mg Powder for Injection – AU Product
Information
Celgene V3.0 – 5 April 2022 (CCDS V15.1)
1
AUSTRALIAN PRODUCT INFORMATION
VIDAZA
® (AZACITIDINE 100 MG) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Azacitidine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg azacitidine.
For the full list of excipients, see Section 6.1 [List of excipients].
3
PHARMACEUTICAL FORM
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 Vidaza
contain 100 mg of azacitidine and 100 mg mannitol as a white to
off-white, sterile lyophilised
powder.
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.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Vidaza 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.
4.2.1 DOSE
INJECTABLE AZACITIDINE SHOULD NOT BE USED INTERCHANGEABLY WITH ORAL
AZACITIDINE DUE TO DIFFERENCES
IN THE EXPOSURE, DOSE AND SCHEDULE OF TREATMENT (SEE SECTION 5.2
[PHARMACOKINETIC PROPERTIES]).
HEALTHCARE PROFESSIONALS ARE RECOMMENDED TO VERIFY DR