A clear to opalescent, colorless to yellow liquid injection filled in a pre-filled syringe, practically free of visible particles.

Nirsevimab 50 mg in one pre-filled syringe (0.5mL)

Nirsevimab 100 mg in one pre-filled syringe (1mL)

Prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:

• 1. Neonates and infants born during or entering their first RSV season.
• 2. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

1) Neonates and infants entering or born during their first RSV season:

The recommended dose is a single fixed dose of 50 mg for infants weighing less than 5 kg, and a single fixed dose of 100 mg for infants weighing 5 kg or more.

For infants born during the RSV season, this medicinal product should be administered from birth. For infants not born during the RSV season, administration is preferably given immediately prior to the start of the RSV season.

2) Children entering their second RSV season who remain vulnerable to severe RSV disease:

The recommended dose is a single dose of 200 mg administered as two intramuscular injections (2 × 100 mg).

Children undergoing cardiac surgery with cardiopulmonary bypass

For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose is recommended as soon as the patient is stable after surgery in order to maintain adequate serum concentrations of this medicinal product.

First RSV season

If surgery occurs within 90 days after administration of this medicinal product, an additional dose should be administered according to body weight (50 mg for children weighing less than 5 kg and 100 mg for children weighing 5 kg or more).

If 90 days or more have elapsed since administration of this medicinal product, a single additional dose of 50 mg should be administered, regardless of body weight.

Second RSV season

If surgery occurs within 90 days after administration of this medicinal product, an additional dose of 200 mg should be administered, regardless of body weight.

If 90 days or more have elapsed since administration of this medicinal product, an additional dose of 100 mg may be administered, regardless of body weight, to provide coverage for the remainder of the RSV season.

Method of Administration

This medicinal product is administered intramuscularly, preferably into the anterolateral aspect of the thigh.

The gluteal muscle should not be routinely used as an injection site because of the risk of sciatic nerve injury.

If two injections are required, they should be administered at different injection sites.

For instructions on use, handling, and disposal, refer to Section 8, “Precautions for Storage and Handling,” under “Precautions for Use.”

1 pre-filled syringe/box [Pre-filled syringe (0.5 mL)]

1 pre-filled syringe/box [Pre-filled syringe (1.0 mL)]

Needle for each syringe is packed in box

Store in a tightly closed container at 2~8℃, protected from light.