البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
palivizumab
AstraZeneca AB
J06BD01
palivizumab
Immune sera and immunoglobulins,
Respiratory Syncytial Virus Infections
Synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease:children born at 35 weeks of gestation or less and less than six months of age at the onset of the RSV season;children less than two years of age and requiring treatment for bronchopulmonary dysplasia within the last six months;children less than two years of age and with haemodynamically significant congenital heart disease.
Revision: 46
Authorised
1999-08-13
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER SYNAGIS 50 MG/0.5 ML SOLUTION FOR INJECTION SYNAGIS 100 MG/1 ML SOLUTION FOR INJECTION Active substance: palivizumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU AND YOUR CHILD. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. If any of the side effects get serious, or if you notice that your child has any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. WHAT IS IN THIS LEAFLET 1. What Synagis is and what it is used for 2. What you need to know before Synagis is given to your child 3. How will my child receive Synagis 4. Possible side effects 5. How to store Synagis 6. Contents of the pack and other information 1. WHAT SYNAGIS IS AND WHAT IT IS USED FOR Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV. Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV). Children who are more likely to get severe RSV disease (high-risk children) include babies born prematurely (35 weeks or less) or babies born with certain heart or lung problems. Synagis is a medicine to help protect your child from getting severe RSV illness. 2. WHAT YOU NEED TO KNOW BEFORE SYNAGIS IS GIVEN TO YOUR CHILD YOUR CHILD SHOULD NOT BE GIVEN SYNAGIS If he/she is allergic to palivizumab or any of the other ingredients of this medicine (listed in section 6). Signs and symptoms of a severe allergic reaction include: severe rash, hives, or itching skin swelling of the lips, tongue, or face closing of the throat, difficulty swallowing difficult, rapid, or irregular breathing bluish colour of skin, lips, or under fingernails muscle weakness or floppiness a drop in blood pressure unresponsiven اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Synagis 50 mg/0.5 ml solution for injection Synagis 100 mg/1 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of Synagis solution contains 100 mg of palivizumab*. Each 0.5 ml vial contains 50 mg of palivizumab. Each 1 ml vial contains 100 mg of palivizumab. *Palivizumab is a recombinant humanised monoclonal antibody produced by DNA technology in mouse myeloma host cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear or slightly opalescent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Synagis is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season. Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months. Children less than 2 years of age and with haemodynamically significant congenital heart disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of palivizumab is 15 mg/kg of body weight, given once a month during anticipated periods of RSV risk in the community. The volume (expressed in ml) of // Palivizumab // to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15. Where possible, the first dose should be administered prior to commencement of the RSV season. Subsequent doses should be administered monthly throughout the RSV season. The efficacy of palivizumab at doses other than 15 mg per kg or of dosing differently from monthly throughout the RSV season, has not been established. The majority of experience including the pivotal phase III clinical trials with palivizumab has been gained with 5 injections during one season (see section 5.1). Data, although limited, are a اقرأ الوثيقة كاملة