Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein
Pfizer Europe MA EEIG
J07BX05
Respiratory syncytial virus vaccine (bivalent, recombinant)
Vaccines
Respiratory Syncytial Virus Infections
Abrysvo is indicated for:Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. See sections 4.2 and 5.1.Active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV.The use of this vaccine should be in accordance with official recommendations.
Authorised
2023-08-23
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE USER ABRYSVO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Respiratory syncytial virus vaccine (bivalent, recombinant) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE 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 Abrysvo is and what it is used for 2. What you need to know before you receive Abrysvo 3. How Abrysvo is given 4. Possible side effects 5. How to store Abrysvo 6. Contents of the pack and other information 1. WHAT ABRYSVO IS AND WHAT IT IS USED FOR Abrysvo is a vaccine to prevent lung (respiratory tract) disease caused by a virus called respiratory syncytial virus (RSV). Abrysvo is given to: • pregnant individuals to protect their infants from birth through 6 months of age or • individuals 60 years of age and older. RSV is a common virus which, in most cases, causes mild, cold-like symptoms such as a sore throat, cough or a blocked nose. However, in young infants RSV can cause serious lung problems. In older adults and people with chronic medical conditions, RSV can worsen illnesses such as chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). RSV can lead to hospitalisation in severe cases and in some cases it can be fatal. HOW ABRYSVO WORKS This vaccine helps the immune system (the body’s natural defences) to make antibodies (substances in the blood that help the body fight infections) which protect against lung disease caused by RSV. In pregnant indivi Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Abrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent, recombinant) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 mL) contains: RSV subgroup A stabilised prefusion F antigen 1,2 60 micrograms RSV subgroup B stabilised prefusion F antigen 1,2 60 micrograms (RSV antigens) 1 glycoprotein F stabilised in the prefusion conformation 2 produced in Chinese Hamster Ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white. The solvent is a clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abrysvo is indicated for: • Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. See sections 4.2 and 5.1. • Active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV. The use of this vaccine should be in accordance with official recommendations. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Pregnant individuals _ A single dose of 0.5 mL should be administered between weeks 24 and 36 of gestation (see sections 4.4 and 5.1). 3 _Individuals 60 years of age and older _ A single dose of 0.5 mL should be administered. _Paediatric population _ The safety and efficacy of Abrysvo in children (from birth to less than 18 years of age) have not yet been established. Limited data are available in pregnant adolescents and their infants (see section 5.1). Method o Đọc toàn bộ tài liệu