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Beyfortus
Eintrag öffnenBeyfortus · 4.1 Therapeutic indications · 1
Eintrag öffnenBeyfortus · 4.3 Contraindications · 1
Eintrag öffnenBeyfortus · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenBeyfortus · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenBeyfortus · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenBeyfortus · 4.5 · Concomitant administration with vaccines
Eintrag öffnenBeyfortus · 4.5 · Nirsevimab does not interfere with reverse transcriptase polymerase chain reaction (RT-PCR) or rapid antigen d
Eintrag öffnenBeyfortus · 4.5 · Nirsevimab should not be mixed with any vaccine in the same syringe or vial (see section 6.2). When administer
Eintrag öffnenBeyfortus · 4.5 · No interaction studies have been performed. Monoclonal antibodies do not typically have significant interactio
Eintrag öffnenBeyfortus · 4.5 · Since nirsevimab is a monoclonal antibody, a passive immunisation specific for RSV, it is not expected to inte
Eintrag öffnenBeyfortus · 4.5 · There is limited experience of co-administration with vaccines. In clinical trials, when nirsevimab was given
Eintrag öffnenBeyfortus · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenBeyfortus · 4.8 Undesirable effects · 1
Eintrag öffnenBeyfortus · 4.8 · 5 second RSV season was consistent with the safety profile of nirsevimab in term and preterm infants GA ≥29 we
Eintrag öffnenBeyfortus · 4.8 · Adverse reactions reported from controlled clinical trials are classified by MedDRA System Organ Class (SOC).
Eintrag öffnenBeyfortus · 4.8 · Children who remain vulnerable to severe RSV disease in their second season
Eintrag öffnenBeyfortus · 4.8 · Infants at higher risk for severe RSV disease in their first season
Eintrag öffnenBeyfortus · 4.8 · MedDRA SOC MedDRA Preferred Term Frequency a Immune system disorders Hypersensitivity Not known b Skin and sub
Eintrag öffnenBeyfortus · 4.8 · Reporting of suspected adverse reactions
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