Pazopanib Pharmacare 200 mg film-coated tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

थमां उपलब्ध:

Pharmacare Premium Limited HHF 003 Halfar Industrial Estate Birzebbugia BBG 3000, Malta

ए.टी.सी कोड:

L01EX03

INN (इंटरनेशनल नाम):

PAZOPANIB 200 mg

फार्मास्यूटिकल फॉर्म:

FILM-COATED TABLET

रचना:

PAZOPANIB 200 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

ANTINEOPLASTIC AGENTS

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2023-12-05

सूचना पत्रक

Page
1
of
10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PAZOPANIB PHARMACARE 200 MG
FILM-COATED TABLETS
PAZOPANIB PHARMACARE 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 Pharmacare is and what it is used for
2.
What you need to know before you take Pazopanib Pharmacare
3.
How to take Pazopanib Pharmacare
4.
Possible side effects
5.
How to store Pazopanib Pharmacare
6.
Contents of the pack and other information
1.
WHAT PAZOPANIB PHARMACARE IS AND WHAT IT IS USED FOR
Pazopanib Pharmacare 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 Pharmacare 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 PHARMACARE
DO NOT TAKE PAZOPANIB PHARMACARE
-
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.
Page
2
of
10
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Pazopanib Pharmacare:
-
if you have
HEART DISEASE.
-
if you have
LIVER DISEASE.
-
if you have had
HEART FAILURE OR A HEART ATTACK.
-
if

उत्पाद विशेषताएं

Page
1
of
32
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pazopanib Pharmacare 200 mg film-coated tablets
Pazopanib Pharmacare 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pazopanib Pharmacare 200 mg film-coated tablets
Each film-coated tablet contains 200 mg pazopanib (as hydrochloride).
Pazopanib Pharmacare 400 mg film-coated tablets
Each film-coated tablet contains 400 mg pazopanib (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pazopanib Pharmacare 200 mg film-coated tablets
Pink, oblong shaped, biconvex, film-coated tablet debossed with
‘200’ one side and
plain on the other side.
Pazopanib Pharmacare 400 mg film-coated tablets
Pink, oblong shaped, biconvex, film-coated tablet debossed with
‘400’ one side and
plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renal cell carcinoma (RCC)
Pazopanib Pharmacare 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 Pharmacare 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Page
2
of
32
Pazopanib Pharmacare 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 manage adverse
reactions. The dos