Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pazopanib
Glaxo Wellcome S.A.
L01XE11
pazopanib
400mg
tablets film-coated
(30) plastic container
Prescription
Registered
2015-03-10
VOTRIENT ® 200 MG FILM-COATED TABLETS VOTRIENT ® 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 VOTRIENT IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOTRIENT 3 HOW TO TAKE VOTRIENT 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE VOTRIENT 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 What Votrient is and what it is used for Votrient 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. Votrient is used in adults to treat: • kidney cancer that is advanced or has spread to other organs • certain forms of soft tissue sarcoma 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. 2 What you need to know before you take Votrient Do not take Votrient • 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. Don’t take Votrient. Warnings and precautions BEFORE YOU TAKE VOTRIENT your doctor needs to know: • 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 problems with BLEEDING, BLOOD CLOTS OR NARROWING OF THE ARTERIES • if you have had STOMACH OR BOWEL PROBLEMS su Read the complete document
VOTRIENT 200 MG AND 400 MG FILM COATED TABLETS Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Votrient® 200 mg and 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg or 400 mg pazopanib (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 200 mg: capsule-shaped, pink, film-coated tablet with GS JT debossed on one side. 400 mg: Capsule-shaped, white, film-coated tablet with GS UHL debossed on one side. 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. Efficacy and safety has only been established in certain STS histological tumour subtypes (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Votrient treatment should only be initiated by a physician experienced in the administration of anti-cancer agents. Posology _Adults_ The recommended dose of pazopanib for the treatment of RCC or STS is 800 mg once daily. _Dose modifications_ Dose modification should be in 200 mg 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 should not be used in children younger than 2 years of age because of safety concerns on organ growth and maturation (see section 4.4 and 5.3). The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established (see section 5.1). _Elderly_ There are limited data of the use of pazopanib in patients aged 65 Read the complete document