Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
Vadadustat
Akebia Europe Limited
vadadustat
Antianemic preparations
Renal Insufficiency, Chronic; Anemia
Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
Authorised
2023-04-24
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VAFSEO 150 MG FILM-COATED TABLETS VAFSEO 300 MG FILM-COATED TABLETS VAFSEO 450 MG FILM-COATED TABLETS vadadustat This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Vafseo is and what it is used for 2. What you need to know before you take Vafseo 3. How to take Vafseo 4. Possible side effects 5. How to store Vafseo 6. Contents of the pack and other information 1. WHAT VAFSEO IS AND WHAT IT IS USED FOR Vafseo is a medicine that increases the amount of haemoglobin (the protein in your red blood cells that carries oxygen around the body) and the number of red blood cells in your blood. It contains the active substance vadadustat. Vafseo is used to treat symptomatic anaemia (low levels of red blood cells or haemoglobin in your blood) that is associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. When the amount of haemoglobin or the number of red blood cells is low, the cells in your body might not receive enough oxygen. Anaemia can cause symptoms such as tiredness, weakness, or shortness of breath. HOW VAFSEO WORKS Vafseo increases the level of a substance called “Hypoxia-Inducible Factor” (HIF), which increases the production of red blood cells when oxygen levels are low. Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Vafseo 150 mg film-coated tablets Vafseo 300 mg film-coated tablets Vafseo 450 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vafseo 150 mg film-coated tablets Each 150 mg film-coated tablet contains 150 mg of vadadustat Vafseo 300 mg film-coated tablets Each 300 mg film-coated tablet contains 300 mg of vadadustat Vafseo 450 mg film-coated tablets Each 450 mg film-coated tablet contains 450 mg of vadadustat For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Vafseo 150 mg film-coated tablets Round, white tablets 8 mm in diameter, debossed with “VDT” on one side and “150” on the other side. Vafseo 300 mg film-coated tablets Oval, yellow tablets 8 mm in width, 13 mm in length, debossed with “VDT” on one side and “300” on the other side. Vafseo 450 mg film-coated tablets Oval, pink tablets 9 mm in width, 15 mm in length debossed with “VDT” on one side and “450” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 3 Vadadustat should be initiated by a physician experienced in the management of anaemia. All other causes of anaemia should be evaluated prior to initiating therapy with Vafseo, and when deciding to increase the dose. Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary. In addition to the presence of symptoms of anaemia, criteria such as rate of fall of hae Прочитать полный документ