Finished product reference
Palivizumab
Injection, Solution · Parenteral · 100 mg/1mL
- List code
- 53259
- Pharmacologic class
- Antiviral monoclonal antibody (anti-RSV F protein); passive immunisation
What it is and how it works
Palivizumab is a humanised IgG1 monoclonal antibody directed against the fusion (F) protein of respiratory syncytial virus, neutralising the virus and inhibiting its fusion with host cells, thereby providing passive protection.
Indications
Prevention of serious lower respiratory tract disease caused by RSV in children at high risk, such as infants born at 35 weeks’ gestation or less, children with bronchopulmonary dysplasia, and those with haemodynamically significant congenital heart disease.
Dosage and administration (summary)
Intramuscular injection, preferably into the anterolateral thigh, 15 mg/kg once a month during the RSV season (usually up to 5 doses).
Contraindications
Hypersensitivity to palivizumab or other humanised monoclonal antibodies.
Warnings and precautions
Anaphylaxis and severe hypersensitivity reactions are rare; facilities for resuscitation should be available. Use with caution in thrombocytopenia or coagulation disorders because of intramuscular administration. It is not indicated for treatment of established RSV disease and may interfere with some RSV antigen-based diagnostic tests.
Pregnancy
Not indicated for adults; not relevant to use in pregnancy.
Storage and supply
Store at 2–8 °C in a refrigerator; do not freeze; keep in the original carton.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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