Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Mepolizumab
GlaxoSmithKline Trading Services
R03DX09
mepolizumab
Drugs for obstructive airway diseases,
Asthma
Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older .Chronic rhinosinusitis with nasal polyps (CRSwNP)Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.Eosinophilic granulomatosis with polyangiitis (EGPA)Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA).Hypereosinophilic syndrome (HES)Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.
Revision: 18
Authorised
2015-12-01
94 B. PACKAGE LEAFLET 95 PACKAGE LEAFLET: INFORMATION FOR THE USER NUCALA 100 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN mepolizumab 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. - 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 Nucala is and what it is used for 2. What you need to know before you use Nucala 3. How to use Nucala 4. Possible side effects 5. How to store Nucala 6. Contents of the pack and other information 7. Step-by-step instructions for use 1. WHAT NUCALA IS AND WHAT IT IS USED FOR Nucala contains the active substance MEPOLIZUMAB, a _monoclonal antibody_ , a type of protein designed to recognise a specific target substance in the body. It is used to treat SEVERE ASTHMA and EGPA (Eosinophilic Granulomatosis with Polyangiitis) in adults, adolescents and children aged 6 years and older. It is also used to treat CRSWNP (Chronic Rhinosinusitis with Nasal Polyps) and HES (Hypereosinophilic syndrome) in adults. Mepolizumab, the active substance in Nucala, blocks a protein called _interleukin-5_ . By blocking the action of this protein _, _ it limits the production of eosinophils from the bone marrow and lowers the number of eosinophils in the bloodstream and the lungs. SEVERE EOSINOPHILIC ASTHMA Some people with severe asthma have too many _eosinophils_ (a type of white blood cell) in the blood and lungs. This condition is called _eosinophilic asthma – _ the type of asthma Nucala can treat. Nucala can reduce your number of asthma attacks, if you or your child are already using medicines such as high dose inhalers, but your asthma is not well controlled by these medicines. If you are taking medicines called _oral corticosteroids,_ Nucala can also help reduce the dai Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nucala 100 mg solution for injection in pre-filled pen Nucala 100 mg solution for injection in pre-filled syringe Nucala 40 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nucala 100 mg solution for injection in pre-filled pen Each 1 ml pre-filled pen contains 100 mg of mepolizumab. Nucala 100 mg solution for injection in pre-filled syringe Each 1 ml pre-filled syringe contains 100 mg of mepolizumab. Nucala 40 mg solution for injection in pre-filled syringe Each 0.4 mL pre-filled syringe contains 40 mg of mepolizumab. Mepolizumab is a humanised monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) A clear to opalescent, colourless to pale yellow to pale brown solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe eosinophilic asthma Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older (see section 5.1). Chronic rhinosinusitis with nasal polyps (CRSwNP) Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Eosinophilic granulomatosis with polyangiitis (EGPA) Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA). 3 Hypereosinophilic syndrome (HES) Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nucala should be prescribed by physicians experienced in the diagnosis and treatmen Lue koko asiakirja