국가: 몰타
언어: 영어
출처: Medicines Authority
PAZOPANIB
Lotus Support Services S.R.L. 47 Theodor Pallady Blvd. 2nd Office, Entrance B, 1st Floor 3rd District Bucharest, Romania
L01EX03
PAZOPANIB 200 mg
FILM-COATED TABLET
PAZOPANIB 200 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2021-03-22
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PAZOPANIB LOTUS 200 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 Lotus is and what it is used for 2. What you need to know before you take Pazopanib Lotus 3. How to take Pazopanib Lotus 4. Possible side effects 5. How to store Pazopanib Lotus 6. Contents of the pack and other information 1. WHAT PAZOPANIB LOTUS IS AND WHAT IT IS USED FOR Pazopanib Lotus 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 Lotus 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 LOTUS DO NOT TAKE PAZOPANIB LOTUS - 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 Lotus: - 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 ar 전체 문서 읽기
Page 1 of 30 1. NAME OF THE MEDICINAL PRODUCT Pazopanib Lotus 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg pazopanib (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Capsule-shaped, pink, film-coated tablet (14.5 mm length and 5.6 mm width) with “173” debossed on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Renal cell carcinoma (RCC) Pazopanib Lotus 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 Lotus 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 Pazopanib Lotus 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 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 with regard to organ growth and maturation (see sections 4.4 and 5.3). Page 2 of 30 The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established. No data are available (see section 5.1). _Elderly _ There are limited data on the use of pazopanib in patients 전체 문서 읽기