Synagis

Synagis

palivizumab

Manufacturer:

AstraZeneca

Distributor:

Zuellig
Concise Prescribing Info
Contents
Palivizumab
Indications/Uses
Prevention of serious lower resp tract disease caused by resp syncytial virus (RSV) in childn at high risk of RSV disease. Childn born at 35 wk of gestation or less & <6 mth of age at the onset of the RSV season. Childn <2 yr requiring treatment of bronchopulmonary dysplasia w/in the last 6 mth & w/ haemodynamically significant congenital heart disease.
Dosage/Direction for Use
IM 15 mg/kg once a mth during anticipated periods of RSV risk in the community. Childn undergoing cardiac bypass 15 mg/kg administered as soon as stable after surgery to ensure adequate serum levels. Subsequent doses should resume mthly through the remainder of the RSV season for childn that continue to be at high risk of RSV disease.
Contraindications
Hypersensitivity to palivizumab, any of the excipients or other humanized monoclonal antibodies.
Special Precautions
Allergic reactions; moderate to severe acute infection or febrile illness may warrant delay of use; thrombocytopenia or any coagulation disorders. As a 2nd course of treatment during an ensuing RSV season has not been formally investigated. Possible risk of enhanced RSV infection in the season following the season in which the patients were treated w/ palivizumab has not been conclusively ruled out.
Adverse Reactions
Very common Rash, pyrexia. Common Apnoea, inj site reaction.
Drug Interactions
May interfere w/ immune-based RSV diagnostic tests eg, someantigen detection based assays. Inhibits virus replication in cell culture &, therefore, may also interfere w/ viral culture assays. False-negative RSV diagnostic test results.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BB16 - palivizumab ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Additional Information
The commercial rights to Synagis will be transferred from AbbVie to AstraZeneca with effect from 1 July 2021.
Presentation/Packing
Form
Synagis soln for inj 50 mg/0.5 mL
Packing/Price
(Single-use) 1's
Form
Synagis soln for inj 100 mg/mL
Packing/Price
(Single-use) 1's
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