Abbreviated Prescribing Information
Synagis

Presentation: 50mg/0.5mL and 100 mg/1mL for solution for injection.
Indications: Treatment prevention of serious lower respiratory tract disease requiring hospitalization caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease including:

• Children born at ≤35 weeks of gestation and < 6 months of age at the onset of RSV season

• Children < 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months

• Children < 2 years of age and with haemodynamically significant congenital heart disease

Dosage: 15 mg/kg of body weight administrated as an intramuscularly, given once a month during anticipated periods of RSV risk in the community

Contraindications: Hypersensitivity to the active substance or to the excipients or to other humanized monoclonal antibodies
Precautions: Allergic reactions including very rare cases of anaphylaxis and anaphylactic shock have been reported following palivizumab administration. In some cases, fatalities have been reported. A moderate to severe acute infection or febrile illness may warrant delaying the use of palivizumab, unless, in the opinion of the physician, withholding palivizumab entails a greater risk. A mild febrile illness, such as mild upper respiratory infection, is not usually reason to defer administration of palivizumab. Palivizumab should be given with caution to patients with thrombocytopaenia or any coagulation disorder.
Undesirable effects: Rash, pyrexia, apnoea and injection site reaction
Full local prescribing information is available upon request.
API.HK.SYN.0615

HK-10000 19/02/2024