VOTRIENT pazopanib 200 mg tablet bottle

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

pazopanib hydrochloride, Quantity: 216.7 mg

Հասանելի է:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Միջազգային անվանումը):

pazopanib hydrochloride

Դեղագործական ձեւ:

Tablet, film coated

Կազմը:

Excipient Ingredients: povidone; magnesium stearate; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

90, 30

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

VOTRIENT is indicated for the treatment of advanced and/or metastatic renal cell carcinoma (RCC). VOTRIENT is indicated for the treatment of patients with advanced (unresectable and/or metastatic) Soft Tissue Sarcoma (STS) in patients who, unless otherwise contraindicated, have received prior chemotherapy including an anthracycline treatment. The Phase III trial population excluded patients with gastrointestinal stromal tumour (GIST) or adipocytic soft tissue sarcoma.

Ապրանքի ամփոփագիր:

Visual Identification: Modified capsule-shaped, pink, film-coated tablets, one side plain and the other side debossed with an identifying code of 'GS JT'.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Լիազորման կարգավիճակը:

Licence status A

Հաստատման ամսաթիվը:

2010-06-30

Տեղեկատվական թերթիկ

VOTRIENT
®
_FILM-COATED TABLETS_
_Pazopanib hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU TAKE VOTRIENT.
This leaflet answers some common
questions about VOTRIENT
(pazopanib hydrochloride). It does
not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you taking
VOTRIENT against the risks this
medicine could 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 VOTRIENT IS
USED FOR
VOTRIENT contains the active
substance pazopanib, which belongs
to an anti-cancer group of medicines
called protein kinase inhibitors.
VOTRIENT is used as a single agent
to treat kidney cancer that is
advanced or that has spread to other
organs (metastatic). VOTRIENT is
also used as a single agent to treat
advanced Soft Tissue Sarcoma,
which is a type of cancer that affects
the supportive tissue of the body. It
can occur in muscles, blood vessels,
fat tissue or in other tissues that
support, surround and protect organs.
VOTRIENT works by preventing the
activity of proteins that are involved
in the growth and spread of cancer
cells.
Your doctor may have prescribed
VOTRIENT for another reason.
This medicine is available only with
a doctor's prescription.
VOTRIENT is not addictive.
BEFORE YOU TAKE
VOTRIENT
_WHEN YOU MUST NOT TAKE IT_
YOU MUST NOT TAKE VOTRIENT IF:
•
You have ever had a severe
allergic (hypersensitive) reaction
to VOTRIENT (pazopanib
hydrochloride). CHECK WITH YOUR DOCTOR IF YOU
THINK THIS MAY

Ապրանքի հատկությունները

VOTRIENT Product Information
Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION -VOTRIENT
®
(PAZOPANIB)
TABLETS
SEVERE AND FATAL HEPATOTOXICITY HAVE BEEN OBSERVED IN CLINICAL
STUDIES.
MONITOR
HEPATIC
FUNCTION
AND
INTERRUPT,
REDUCE,
OR
DISCONTINUE
DOSING
AS
RECOMMENDED. [SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE.]
1.
NAME OF THE MEDICINE
pazopanib hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Each 200 mg film coated tablet contains 217 mg pazopanib hydrochloride
equivalent to 200
mg pazopanib free base.
Each 400 mg film coated tablet contains 433 mg pazopanib hydrochloride
equivalent to 400
mg pazopanib free base.
EXCIPIENTS
See section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
200 MG TABLET
Pink, modified capsule-shaped film coated tablet. One face is plain
and the opposite face is
debossed with the identifying code 'GS JT'.
400 MG TABLET
White, modified capsule-shaped film coated tablet. One face is plain
and the opposite face is
debossed with the identifying code 'GS UHL'.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VOTRIENT is indicated for the treatment of:
•
Advanced and/or metastatic renal cell carcinoma (RCC).
•
Advanced (unresectable and/or metastatic) soft tissue sarcoma (STS) in
patients who,
unless otherwise contraindicated, have received prior chemotherapy
including an
anthracycline treatment.
The Phase III trial population excluded patients with gastrointestinal
stromal tumour
(GIST) or adipocytic soft tissue sarcoma.
VOTRIENT Product Information
Page 2 of 29
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended dose of VOTRIENT for the treatment of RCC or STS is
800 mg orally once
daily.
Dose Modifications
Dose modification, either an increase or decrease in dose, should be
in 200 mg increments, in
a stepwise fashion, based on individual tolerability, in order to
manage adverse reactions. The
daily dose of VOTRIENT should not exceed 800 mg per day.
Special populations
_Paediatric use _
VOTRIENT is not recommended for use in children and ado