Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
omalizumab
Novartis Europharm Limited
R03DX05
omalizumab
Drugs for obstructive airway diseases,
Asthma; Urticaria
Allergic asthmaXolair is indicated in adults, adolescents and children (6 to
Revision: 48
Authorised
2005-10-25
156 B. PACKAGE LEAFLET 157 PACKAGE LEAFLET: INFORMATION FOR THE USER XOLAIR 75 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE (pre-filled syringe with 26-gauge staked needle, blue syringe guard) omalizumab 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 Xolair is and what it is used for 2. What you need to know before you use Xolair 3. How to use Xolair 4. Possible side effects 5. How to store Xolair 6. Contents of the pack and other information 1. WHAT XOLAIR IS AND WHAT IT IS USED FOR Xolair contains the active substance omalizumab. Omalizumab is a man-made protein that is similar to natural proteins produced by the body. It belongs to a class of medicines called monoclonal antibodies. Xolair is used for the treatment of: - allergic asthma - chronic rhinosinusitis (inflammation of the nose and sinuses) with nasal polyps Allergic asthma This medicine is used to prevent asthma from getting worse by controlling symptoms of severe allergic asthma in adults, adolescents and children (6 years of age and older) who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high-dose steroid inhalers and beta-agonist inhalers. Chronic rhinosinusitis with nasal polyps This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (18 years of age and older) who are already receiving intranasal corticosteroids (corticosteroid nasal spray), but whose symptoms are not well controlled by these medicines. Nasal polyps are sm Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xolair 75 mg solution for injection in pre-filled syringe Xolair 75 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xolair 75 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 75 mg of omalizumab* in 0.5 ml solution. Xolair 75 mg solution for injection in pre-filled pen Each pre-filled pen contains 75 mg of omalizumab* in 0.5 ml solution. *Omalizumab is a humanised monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Clear to slightly opalescent, colourless to pale brownish-yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Allergic asthma Xolair is indicated in adults, adolescents and children (6 to <12 years of age). Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2). _Adults and adolescents (12 years of age and older) _ Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or _in vitro_ reactivity to a perennial aeroallergen and who have reduced lung function (FEV 1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high- dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. _Children (6 to <12 years of age) _ Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or _in vitro_ reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2 Aqra d-dokument sħiħ