SYNAGIS SOLUTION FOR INJECTION 100MG/ML [SIN15112P]

Product Info

SYNAGIS SOLUTION FOR INJECTION 100MG/ML

[SIN15112P]

4.1 Therapeutic indications

SYNAGIS is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease.

Safety and efficacy were established in:

• Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season

• Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months

• Children less than 2 years of age and with haemodynamically significant congenital heart disease (CHD)

4.2 Posology and method of administration

Posology

The recommended dose of SYNAGIS is 15 mg/kg of body weight, given once a month during anticipated periods of RSV risk in the community.

The first dose should be administered prior to commencement of the RSV season and subsequent doses should be administered monthly throughout the RSV season.

To avoid risk of reinfection, it is recommended that children receiving SYNAGIS who become infected with RSV continue to receive monthly doses of SYNAGIS for the duration of the RSV season.

The efficacy of SYNAGIS at doses less than 15mg/kg, or of dosing less frequently than monthly throughout the RSV season has not been established.

For children undergoing cardiac bypass, it is recommended that a 15 mg/kg of body weight injection of palivizumab be administered as soon as stable after surgery to ensure adequate palivizumab serum levels.

Method of administration

Palivizumab is to be administered by intramuscular injection only.

SYNAGIS is administered in a dose of 15 mg/kg once a month intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The injection should be given using standard aseptic technique. The dose per month = patient weight (kg) x 15 mg/kg ÷ 100 mg/ml of SYNAGIS. Injection volumes over 1 mL should be given as a divided dose.

For instructions for use, handling, and disposal of the medicinal product, see Section 6.6 Instructions for use, handling, and disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

SYNAGIS is contraindicated in patients with known hypersensitivity to palivizumab or to any of its excipients. It is also contraindicated in patients with known hypersensitivity to other humanized monoclonal antibodies.