Leaflet CASIRIVIMAB/IMDEVIMAB 120mg / ml+120mg / ml concentrate for solution for infusion

Indicated for: COVID-19

Route of administration: infusion

Substance: casirivimab + imdevimab (monoclonal antibodies)

ATC: J06BD07 (Antiinfectives for systemic use | Immunoglobulins | Antiviral monoclonal antibodies)

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.

Casirivimab and imdevimab are monoclonal antibodies used for the treatment and prevention of COVID-19 in patients at high risk of developing severe disease. These antibodies work by binding to the spike protein of the SARS-CoV-2 virus, preventing it from entering human cells.

This combination is administered either as an intravenous infusion or subcutaneous injections, depending on the doctor's instructions. The treatment is most effective when given in the early stages of infection or as post-exposure prophylaxis.

Patients should be closely monitored during and after administration to detect potential adverse reactions, such as allergic reactions or hypersensitivity symptoms. It is important that the treatment is administered under medical supervision.

Side effects may include injection site reactions, fever, fatigue, headache, or, in rare cases, severe allergic reactions. Patients should inform their doctor of any unusual symptoms.

General data about CASIRIVIMAB/IMDEVIMAB 120mg / ml+120mg / ml

  • Substance: casirivimab + imdevimab
  • Product code: W68130001
  • Concentration: 120mg / ml+120mg / ml
  • Pharmaceutical form: concentrate for solution for infusion
  • Quantity: 2
  • Product type: Generic medicine
  • Prescription status: S - Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Marketing authorisation

  • Manufacturer: ROCHE REGISTRATION GMBH - GERMANIA
  • Holder: ROCHE ROMANIA S.R.L. - ROMANIA
  • Number: 655/2021/01

Pharmaceutical forms available for casirivimab + imdevimab

Concentrations available for casirivimab + imdevimab

  • 120mg/ml+120mg/ml
  • 300mg+300mg