Leaflet FSME-IMMUN 0.5ml suspension for injection in pre-filled syringe

Indicated for: prevention of tick-borne encephalitis

Route of administration: injectable

Substance: tick-borne encephalitis vaccine (vaccine)

ATC: J07BA01 (Antiinfectives for systemic use | Viral vaccines | Encephalitis vaccines)

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.

Refrigerated storage
Refrigerated storage

Store in the refrigerator as instructed in the leaflet.

Protect from light
Protect from light

Store protected from light.

The tick-borne encephalitis (TBE) vaccine is used to prevent encephalitis caused by the virus transmitted through the bite of infected ticks. This viral disease can cause severe inflammation of the brain and spinal cord, with risks of long-term neurological complications or even death. The TBE virus is endemic in many regions of Europe and Asia.

The vaccine is administered intramuscularly, usually in three doses for primary immunization, followed by booster doses at regular intervals to maintain immunity. It is recommended for individuals living in or traveling to endemic areas, as well as those engaging in outdoor activities in high-risk regions.

Common side effects include pain at the injection site, mild fever, fatigue, and headache. In rare cases, severe allergic reactions may occur.

The TBE vaccine is an essential preventive measure for reducing the risk of infection and protecting public health in affected regions.

General data about FSME-IMMUN 0.5ml

  • Substance: tick-borne encephalitis vaccine
  • Date of latest medicines list: 01-06-2026
  • Product code: W64744005
  • Concentration: 0.5ml
  • Pharmaceutical form: suspension for injection in pre-filled syringe
  • Quantity: 1
  • Product type: Original
  • Price: 191.59 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: PFIZER MANUFACTURING AUSTRIA GMBH - AUSTRIA
  • Holder: PFIZER EUROPE MA EEIG - BELGIA
  • Number: 11508/2019/05
  • Shelf life: 30 months

Concentrations available for tick-borne encephalitis vaccine

  • 0.25ml
  • 0.5ml
  • 0.75mcg/0.25ml
  • 1.5mcg/0.5ml