Pazopanib PharOs 200mg film-coated tablets

Երկիր: Մալթա

Լեզու: անգլերեն

Աղբյուրը: Medicines Authority

Ակտիվ բաղադրիչ:

PAZOPANIB

Հասանելի է:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

ATC կոդը:

L01EX03

INN (Միջազգային անվանումը):

PAZOPANIB 200 mg

Դեղագործական ձեւ:

FILM-COATED TABLET

Կազմը:

PAZOPANIB 200 mg

Ռեկվիզորի տեսակը:

POM

Թերապեւտիկ տարածք:

ANTINEOPLASTIC AGENTS

Ապրանքի ամփոփագիր:

Licence number in the source country: NOT APPLICAPABLE

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2022-01-03

Տեղեկատվական թերթիկ

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PAZOPANIB PHAROS 200 MG FILM-COATED TABLETS
PAZOPANIB PHAROS 400 MG FILM-COATED TABLETS
pazopanib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pazopanib PharOS is and what it is used for
2.
What you need to know before you take Pazopanib PharOS
3.
How to take Pazopanib PharOS
4.
Possible side effects
5.
How to store Pazopanib PharOS
6.
Contents of the pack and other information
1.
WHAT PAZOPANIB PHAROS IS AND WHAT IT IS USED FOR
Pazopanib PharOS is a type of medicine called a
_protein kinase inhibitor. _
It works by preventing
the activity of proteins that are involved in the growth and spread of
cancer cells.
Pazopanib PharOS is used in adults to treat:
-
kidney cancer that is advanced or has spread to other organs.
-
certain forms of soft-tissue sarcoma, which is a type of cancer that
affects the supportive
tissues of the body. It can occur in muscles, blood vessels, fat
tissue or other tissues
that support, surround and protect the organs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PAZOPANIB PHAROS
DO NOT TAKE
PAZOPANIB PHAROS
-
IF YOU ARE ALLERGIC
to pazopanib or any of the other ingredients of this medicine (listed
in section 6).
CHECK WITH YOUR DOCTOR
if you think this applies to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Pazopanib PharOS:
-
if you have
HEART DISEASE.
-
if you have
LIVER DISEASE.
-
if you have had
HEART FAILURE OR A HEART ATTACK.
-
if you have had prior
COLLAPSE OF A LUNG.
-
if you have had pro

Ապրանքի հատկությունները

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_Pazopanib PharOS 400 mg film-coated tablets: _
Each tablet contains pazopanib hydrochloride equivalent to 400 mg
pazopanib
_Pazopanib PharOS 400 mg film-coated tablets: _
Capsule-shaped, white, film-coated tablet with “400” debossed on
one side, with dimensions 18.0 mm
x 7.1 mm approximately.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pazopanib PharOS 200 mg film-coated tablets
Pazopanib PharOS 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Pazopanib PharOS 200 mg film-coated tablets: _
Each tablet contains pazopanib hydrochloride equivalent to 200 mg
pazopanib
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_Pazopanib PharOS 200 mg film-coated tablets: _
Capsule-shaped, pink, film-coated tablet with “200” debossed on
one side, with dimensions 14.3 mm x
5.7 mm approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renal cell carcinoma (RCC)
Pazopanib PharOS is indicated in adults for the first-line treatment
of advanced renal cell carcinoma
(RCC) and for patients who have received prior cytokine therapy for
advanced disease.
Soft-tissue sarcoma (STS)
Pazopanib PharOS is indicated for the treatment of adult patients with
selective subtypes of advanced
soft-tissue sarcoma (STS) who have received prior chemotherapy for
metastatic disease or who have
progressed within 12 months after (neo) adjuvant therapy.
Efficacy and safety has only been established in certain STS
histological tumour subtypes (see section
5.1).
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Pazopanib PharOS treatment should only be initiated by a physician
experienced in the administration of
anti-cancer medicinal products.
Posology
_Adults _
The recommended dose of pazopanib for the treatment of RCC or STS is
800 mg once daily.
_Dose modifications _
Dose modification (decrease or increase) should be in 200 mg
decrements or increments in a stepwise
fashion based on individual tolerability in order to man