מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BENRALIZUMAB
ASTRAZENECA SDN. BHD.
BENRALIZUMAB
1 ml
AstraZeneca Pharmaceuticals LP
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ FASENRA ® 30mg Solution for Injection in Pre-filled Pen _ _ 1 WHAT IS IN THIS LEAFLET 1. What FASENRA is used for 2. How FASENRA works 3. Before you use FASENRA 4. How to use FASENRA 5. While you are using it 6. Side effects 7. Storage & Disposal of FASENRA 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number WHAT FASENRA IS USED FOR FASENRA is used to treat severe eosinophilic asthma in adults from 18 years. 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 (inhaled corticosteroids plus other asthma medicines). HOW FASENRA WORKS FASENRA helps prevent severe asthma attacks (exacerbations) and may improve your breathing. Medicines such as FASENRA reduce blood eosinophils. Eosinophils are a type of white blood cell that may contribute to your asthma by causing inflammation in the lungs. BEFORE YOU USE FASENRA _- When you must not use it: _ Do not use FASENRA • If you are allergic to benralizumab or any of the other ingredients of this medicine (listed in ingredients). Check with your doctor, nurse or pharmacist if you think this applies to you. _- Before you start to use it _ Before you use FASENRA, tell your doctor, nurse or pharmacist: • If you have had any symptoms of an allergic reaction (see section ‘side effects’). Allergic reactions have occurred in patients receiving this medicine. • If you have a parasitic infection or if you live in an area where parasitic infections are common or if you are travelling to such region, as this medicine may weaken your ability to fight certain types of parasitic infections. _- Taking other medicines _ Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Do not suddenly stop taking or change the dose of your preventer medicines for your asthma once you have started FASENRA. These medicine קרא את המסמך השלם
1 (18) FASENRA ® 30MG SOLUTION FOR INJECTION IN PRE-FILLED PEN benralizumab 1. NAME OF THE MEDICINAL PRODUCT FASENRA 30mg Solution for Injection in Pre-filled Pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each autoinjector/pen contains 30 mg benralizumab in 1 mL Benralizumab is a humanised, afucosylated, monoclonal antibody selective for interleukin-5Rα. Benralizumab is of the IgG1/κ-class produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Benralizumab has a molecular weight of approximately 150 kDa. 3. PHARMACEUTICAL FORM Solution for Injection in an autoinjector (injection) (FASENRA PEN) The solution is a clear to opalescent, colourless to yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION FASENRA is indicated as an add-on maintenance treatment in adult patients from 18 years with severe eosinophilic asthma characterised by the following criteria: • At least two exacerbations in the past 12 months on the current standard therapy (high-dose inhaled corticosteroids plus long-acting bronchodilators) and/or need for treatment with systemic corticosteroids. • Eosinophil count in the blood of ≥0.3 G/L (corresponding to ≥300 cells/μL). For detailed information about the patient populations investigated in trials, please see “Clinical Efficacy”. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma. Posology The recommended dose is 30 mg of FASENRA by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. Fasenra is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on disease severity, level of exacerbation control and blood eosinophil counts. 2 (18) _Paediatric population _ The safety and efficacy of FASENRA in children aged 6 to 18 years have not been established. No data are available for children aged 6 to 11 years old. Currently available data in children 12 קרא את המסמך השלם