Leaflet SYNAGIS 100mg / ml solution for injection

Indicated for: prevention of respiratory syncytial virus disease

Route of administration: injectable

Substance: palivizumab (monoclonal antibody)

ATC: J06BB16 (Antiinfectives for systemic use | Immunoglobulins | Specific immunoglobulins)

Precautions:
Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Palivizumab is a monoclonal antibody used for the prevention of severe respiratory syncytial virus (RSV) infections in infants and children at high risk. It works by binding to the F protein of the virus, preventing its replication.

The medication is administered via intramuscular injection, usually once a month during the RSV season, as directed by your doctor. It is important to follow the administration schedule to ensure optimal protection.

Side effects may include injection site reactions, fever, rash, or, in rare cases, severe allergic reactions.

Patients should inform their doctor about any known allergies or other conditions to ensure the safe use of palivizumab.

General data about SYNAGIS 100mg / ml

  • Substance: palivizumab
  • Date of latest medicines list: 01-06-2021
  • Product code: W67585001
  • Concentration: 100mg / ml
  • Pharmaceutical form: solution for injection
  • Quantity: 1
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: ABBVIE S.R.L. - ITALIA
  • Holder: ASTRAZENECA AB - SUEDIA
  • Number: 117/1999/04
  • Shelf life: 3 years

Pharmaceutical forms available for palivizumab

Concentrations available for palivizumab

  • 100mg
  • 100mg/ml
  • 50mg
PDF icon EMA leaflet
Published: 04/12/2009
Updated: 11/10/2023