Xevudy

4). 1). 6). 2). 2). 2). Paediatric population The safety and efficacy of Xevudy in children under 12 years old or weighing less than 40 kg have not yet been established. 2 but no recommendation on posology can be made. Method of administration For intravenous use.

This medicinal product must be diluted prior to administration. 2-μm in-line filter. Xevudy must not be administered as an intravenous push or bolus injection. 6.

1). The most common adverse reactions were hypersensitivity reactions (2%) and infusion-related reactions (1%). 05%). Tabulated list of adverse reactions The adverse reactions in Table 1 are listed by system organ class and frequency.

Frequencies are defined as follows: 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), very rare (<1/10,000).

Table 1:

Tabulated list of adverse reactions System organ class Adverse reaction Frequency Immune system disorders Hypersensitivity reactions a Anaphylaxis Common Rare Respiratory, thoracic and mediastinal disorders Dyspnoea Uncommon Injury, poisoning and procedural complications Infusion-related reactions Common aSuch as rash and bronchospasm.

Pruritus may also be seen as a manifestation of hypersensitivity reactions. 4). g. atrial fibrillation), tachycardia, bradycardia, chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, fatigue and diaphoresis.

Paediatric population Based on limited data (n=7) from adolescents (aged 12 to less than 18 years and weighing at least 40 kg), there were no new adverse reactions identified beyond those observed in the adult population. Data (n=3) obtained in children (aged 6 to less than 12 years and weighing at least 15 kg), are too limited to establish safety in this group.

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. 8). If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, administration should be discontinued immediately and appropriate medications and/or supportive care should be given.

8). These reactions may be severe or life threatening. If an IRR occurs, the infusion may be interrupted, slowed or stopped. 1). When molecular testing or sequencing data are available, they should be considered to rule out SARS- CoV-2 variants that are shown to have reduced susceptibility to sotrovimab.

8 mg of polysorbate 80 in each 500 mg dose. Polysorbates may cause allergic reactions.

1.