البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PAZOPANIB AS HYDROCHLORIDE
NOVARTIS ISRAEL LTD
L01XE11
FILM COATED TABLETS
PAZOPANIB AS HYDROCHLORIDE 200 MG
PER OS
Required
GLAXO WELLCOME SA, SPAIN
PAZOPANIB
PAZOPANIB
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.
2015-12-31
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 اقرأ الوثيقة كاملة
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, اقرأ الوثيقة كاملة