Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Benralizumab
AstraZeneca AB
R03DX10
benralizumab
Drugs for obstructive airway diseases,
Asthma
Fasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists.
Revision: 13
Authorised
2018-01-08
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FASENRA 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE benralizumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Fasenra is and what it is used for 2. What you need to know before you use Fasenra 3. How to use Fasenra 4. Possible side effects 5. How to store Fasenra 6. Contents of the pack and other information 1. WHAT FASENRA IS AND WHAT IT IS USED FOR WHAT FASENRA IS Fasenra contains the active substance benralizumab, which is a monoclonal antibody, a type of protein that recognises and attaches to a specific target substance in the body. The target of benralizumab is a protein called interleukin-5 receptor, which is found particularly on a type of white blood cell called an eosinophil. WHAT FASENRA IS USED FOR Fasenra is used to treat SEVERE EOSINOPHILIC ASTHMA in adults. Eosinophilic asthma is a type of asthma where patients have too many eosinophils in the blood or lungs. Fasenra is used together with other medicines to treat asthma (high doses of ‘corticosteroid inhalers’ plus other asthma medicines) when the disease is not well controlled by those other medicines alone. HOW FASENRA WORKS Eosinophils are white blood cells involved in asthma inflammation. By attaching to the eosinophils, Fasenra helps to reduce their numbers and inflammation. WHAT ARE THE BENEFITS OF USING FASENRA Fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and decrease your asthma Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fasenra 30 mg solution for injection in pre-filled syringe Fasenra 30 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe Each pre-filled syringe contains 30 mg benralizumab* in 1 mL. Pre-filled pen Each pre-filled pen contains 30 mg benralizumab* in 1 mL. *Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) in pre-filled syringe Solution for injection (injection) in pre-filled pen (Fasenra Pen) Clear to opalescent, colourless to yellow solution and may contain translucent or white to off-white particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma. After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary. Self-administration should only be considered in patients already experienced with Fasenra treatment. Posology The recommended dose of benralizumab is 30 mg by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. If an injection is missed on the planned date, dosing should resume as soon as possible on the indicated regimen; a double dose must not be administered. 3 Fasenra is intended for long-term treatment. A decis Прочетете целия документ