1. NAME OF THE MEDICINAL PRODUCT Abrysvo powder and solvent for solution for injection Abrysvo powder and solvent for solution for injection in multidose container 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. Powder and solvent for solution for injection in multidose container. The powder is white. The solvent is a clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Abrysvo is indicated for: active immunisation of pregnant individuals for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age (see sections 4.2 and 5.1). active immunisation of individuals 18 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 in the third trimester of pregnancy (28-36 weeks) (see sections 4.4 and 5.1). Individuals 18 years of age and older A single dose of 0.5 mL should be administered. The need for revaccination has not been established. 2