Enflonsia

7 mL intramuscular (IM) injection. For neonates and infants born during the RSV season, Enflonsia should be administered starting from birth. 1). 1 kg is based on extrapolation; no clinical data are available. 1 kg is anticipated to yield higher exposures than in those weighing more.

1 kg should be carefully considered. 3 There are limited clinical data available in extremely preterm infants (gestational age (GA) < 29 weeks) who are of chronological age less than 8 weeks. 1). Infants undergoing cardiac surgery with cardiopulmonary bypass For infants undergoing cardiac surgery with cardiopulmonary bypass during the RSV season, an additional 105 mg dose is recommended as soon as the infant is stable after surgery to ensure adequate clesrovimab serum levels.

Children from 1 to 18 years of age The safety and efficacy of clesrovimab in children aged 1 to 18 years have not yet been established. No data are available. Method of administration Enflonsia is for intramuscular use only. The medicinal product should be administered intramuscularly by a healthcare professional, in the anterolateral aspect of the thigh.

It should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel. 6.

3%). Most (> 96%) of the adverse reactions were mild or moderate. 1). Table 1 presents the adverse reactions reported in 2 409 preterm and full-term infants (GA ≥ 29 weeks) who received clesrovimab. Adverse reactions reported with clesrovimab are listed by MedDRA system organ class and in decreasing order of frequency.

Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), and very rare (< 1/10 000) and not known (cannot be estimated from available data). 1) was similar to palivizumab (450 infants) and consistent with the safety profile of clesrovimab in infants in Study 004.

Serious adverse events reported in early preterm infants GA < 29 weeks were similar in number and pattern between recipients of clesrovimab (21/97 participants) and palivizumab (31/108 participants). 1) across the age-groups in each study.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity including anaphylaxis If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, appropriate treatment and/or supportive therapy should be initiated.

Individuals with thrombocytopenia and coagulation disorders As with any other intramuscular injections, clesrovimab should be given with caution to infants with thrombocytopenia or any coagulation disorder, because bleeding or bruising may occur following an intramuscular administration in these individuals.

14 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions.

1.