Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ELTROMBOPAG OLAMINE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
ELTROMBOPAG OLAMINE
28Tablet Tablets; 14Tablet Tablets; 84Tablet Tablets
LEK PHARMACEUTICALS D.D.
_ _ _ _ _Consumer Medication Information Leaflet (RiMUP) _ _ _ REVOLADE ® FILM-COATED TABLET _ _ _ _ Eltrombopag olamine (25 mg, 50mg) 1 WHAT IS IN THIS LEAFLET 1. WHAT REVOLADE IS USED FOR 2. HOW REVOLADE WORKS 3. BEFORE YOU USE REVOLADE 4. HOW TO USE REVOLADE 5. WHILE YOU ARE USING IT 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF REVOLADE 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT REVOLADE IS USED FOR Revolade may be used to treat a bleeding disorder called immune (primary) thrombocytopenia (ITP) in patients (aged 6 years and over) 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 adult with chronic hepatitis C virus (HCV) infections, if they have any problems with side effects while on interferon treatment. Many people with hepatitis C have low platelet counts, not only as a result of the disease, but also due to some of the antiviral medicines that are used to treat it. Taking Revolade may make it easier for you to complete a full course of antiviral medicine (peginterferon and ribavirin). Revolade may be used to treat severe aplastic anaemia (SAA): • in combination with standard immunosuppressive therapy as first treatment for adults and adolescent from 12 years of age. • in adults when other medicines to treat SAA have not worked well enough. SAA is a disease in which the bone marrow is damaged causing a deficiency of the red blood cells (anaemia), white blood cells (leukopenia), and platelets (thrombocytopenia). HOW REVOLADE WORKS Eltrombopag the active substance in Revolade belongs to a group of medicine Belgenin tamamını okuyun
2 REVOLADE ® 1. NAME OF THE MEDICINAL PRODUCT Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Revolade 25mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag. Revolade 50mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 25mg: Round , biconvex , white film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS NX3’ and ‘25’ on one side. 50mg: Round , biconvex , brown film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS UFU’ and ‘50’ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Revolade is indicated for the treatment of patients aged 6 years 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 ). 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 combination with standard immunosuppressive therapy for the first-line treatment of adult and adolescent patients 12 years and older with severe aplastic anemia. 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Revolade treatment should be initiated by and remain under the supervision of a physician who is 3 experienced in the treatment of haematological diseases or the management of chronic hepatitis Belgenin tamamını okuyun