VOTRIENT 400 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

PAZOPANIB AS HYDROCHLORIDE

Dostupné z:

NOVARTIS ISRAEL LTD

ATC kód:

L01XE11

Forma lieku:

FILM COATED TABLETS

Zloženie:

PAZOPANIB AS HYDROCHLORIDE 400 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

GLAXO WELLCOME SA, SPAIN

Terapeutické skupiny:

PAZOPANIB

Terapeutické oblasti:

PAZOPANIB

Terapeutické indikácie:

Renal cell carcinoma (RCC)Votrient 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)Votrient 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.

Dátum Autorizácia:

2015-12-31

Príbalový leták

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
Votrient
®
200 mg
Each film-coated tablet contains:
Pazopanib (as hydrochloride) 200 mg
Votrient
®
400 mg
Each film-coated tablet contains:
Pazopanib (as hydrochloride) 400 mg
The list of inactive ingredients is detailed in Section 6 “Further
Information”.
See also in Section 2 “Important information about some of the
ingredients of
the medicine”.
Read this leaflet carefully in its entirety before using the medicine.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not
pass it on to others.
It may harm them even if it seems to you that their ailment is
similar.
1. WHAT IS THE MEDICINE INTENDED fOR?
Votrient is used in adults to treat:
-
kidney cancer that is advanced or has spread to other organs.
-
certain forms of advanced 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 in other tissues that support, surround and protect the
organs.
Therapeutic group:
Protein kinase inhibitor.
Votrient works by inhibiting the activity of proteins that are
involved in the growth
and spread of cancer cells.
2. BEfORE USING THE MEDICINE
Do not use the medicine if:
- you are sensitive (allergic) to pazopanib or to any of the
additional
ingredients contained in the medicine (detailed in Section 6
“Further
Information”).
Check with your doctor if you think this applies to you.
Special warnings regarding use of the medicine
Before treatment with Votrient, tell your doctor if:
-
you have heart disease.
-
you have liver disease.
-
you have had heart failure or a heart attack.
-
you have had prior collapse of a lung (loss of lung volume).
- you have had problems with bleeding, blood clots or narrowing of the
arteries.
- y

Súhrn charakteristických

VOT SPI Jan22 V3 EU SmPC 12-Nov-2021
Page 1 of 29
1.
NAME OF THE MEDICINAL PRODUCT
Votrient® 200 mg
Votrient® 400 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Votrient 200 mg
Each film-coated tablet contains 200 mg pazopanib (as hydrochloride).
Votrient 400 mg
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.
Votrient 200 mg
Capsule-shaped, pink, film-coated tablet. One side plain and the
opposite side debossed with an identifying
code, GS JT.
_ _
Votrient 400 mg
Capsule-shaped, white, film-coated tablet. One side plain and the
opposite side debossed with an identifying
code, GS UHL.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renal cell carcinoma (RCC)
Votrient 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)
_ _
Votrient 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Votrient 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.
VOT SPI Jan22 V3 EU SmPC 12-Nov-2021
Page 2 of 29
_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 dose of pazopanib should
not exceed 800 mg.
_Paediatric population _
_ _
Pazopanib is not indicated for children under 18 years old.
_ _
_Elderly _
There are limited data on the use of pazopanib in patients aged 65
years and older. In the RCC studies of
pazopanib,