Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Eltrombopag
Novartis Europharm Limited
B02BX05
eltrombopag
Other systemic hemostatics, Antihemorrhagics
Purpura, Thrombocytopenic, Idiopathic
Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1).Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).
Revision: 34
Authorised
2010-03-11
108 B. PACKAGE LEAFLET 109 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT REVOLADE 12.5 MG FILM-COATED TABLETS REVOLADE 25 MG FILM-COATED TABLETS REVOLADE 50 MG FILM-COATED TABLETS REVOLADE 75 MG FILM-COATED TABLETS eltrombopag 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 of the 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 Revolade is and what it is used for 2. What you need to know before you take Revolade 3. How to take Revolade 4. Possible side effects 5. How to store Revolade 6. Contents of the pack and other information 1. WHAT REVOLADE IS AND WHAT IT IS USED FOR Revolade contains eltrombopag, which belongs to a group of medicines called thrombopoietin-receptor agonists _. _ It is used to help increase the number of platelets in your blood. Platelets are blood cells that help to reduce or prevent bleeding. • Revolade is used to treat a bleeding disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and above who have already taken other medicines (corticosteroids or immunoglobulins), which have not worked. ITP is caused by a low blood platelet count (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms patients with ITP may notice include petechiae (pinpoint- sized flat round red spots under the skin), bruising, nosebleeds, bleeding gums and not being able to control bleeding if they are cut or injured. • Revolade can also be used to treat low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infections, if they have had problems with side effects while on Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Revolade 12.5 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag. Revolade 25 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag. Revolade 50 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag. Revolade 75 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Revolade 12.5 mg film-coated tablets White, round, biconvex film-coated tablet (approximately 7.9 mm in diameter) debossed with ‘GS MZ1’ and ‘12.5’ on one side. Revolade 25 mg film-coated tablets White, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS NX3’ and ‘25’ on one side. Revolade 50 mg film-coated tablets Brown, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS UFU’ and ‘50’ on one side. Revolade 75 mg film-coated tablets Pink, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS FFS’ and ‘75’ on one side. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 an Lesen Sie das vollständige Dokument