SYNAGIS Solution for injection Ref.[8976] Active ingredients: Palivizumab

Posology

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

The volume (expressed in ml) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15.

Where possible, the first dose should be administered prior to commencement of the RSV season. Subsequent doses should be administered monthly throughout the RSV season. The efficacy of palivizumab at doses other than 15 mg per kg or of dosing differently from monthly throughout the RSV season, has not been established.

The majority of experience including the pivotal phase III clinical trials with palivizumab has been gained with 5 injections during one season (see section 5.1). Data, although limited, are available on greater than 5 doses (see sections 4.8 and 5.1), therefore the benefit in terms of protection beyond 5 doses has not been established.

To reduce risk of rehospitalisation, it is recommended that children receiving palivizumab who are hospitalised with RSV continue to receive monthly doses of palivizumab for the duration of the RSV season.

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. Subsequent doses should resume monthly through the remainder of the RSV season for children that continue to be at high risk of RSV disease (see section 5.2).

Method of administration

Palivizumab is administered 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.

Injection volumes over 1 ml should be given as a divided dose.

Synagis solution for injection is a ready to use formulation. For instructions on special handling requirements, see section 6.6.

In clinical studies, three children received an overdose of more than 15 mg/kg. These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg. No medical consequences were identified in these instances.

From the post-marketing experience, overdoses with doses up to 85 mg/kg have been reported and in some cases, adverse reactions were reported which did not differ from those observed with 15 mg/kg dose (see section 4.8). In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately

Shelf-life: 3 years.

Store in a refrigerator (2ºC to 8ºC).

Do not freeze.

Keep the vial in the carton in order to protect from light.

Single-use vials: 3 ml capacity, clear, colourless type I glass vial with a chlorobutyl stopper and flipoff seal containing either 0.5 ml or 1 ml of solution for injection.

Pack size of 1.

Do not mix the palivizumab liquid and lyophilised formulations.

Do not dilute the product.

Do not shake the vial.

Both the 0.5 ml and 1 ml vials contain an overfill to allow the withdrawal of 50 mg or 100 mg, respectively.

To administer, remove the tab portion of the vial cap and clean the stopper with 70 % ethanol or equivalent. Insert the needle into the vial and withdraw into the syringe an appropriate volume of solution.

Palivizumab solution for injection does not contain a preservative, is for single use and should be administered immediately after drawing the dose into the syringe.

Any unused product or waste material should be disposed of in accordance with local requirements.