Leaflet TETANEA 1500UI / ml solution for injection in pre-filled syringe


Indicated for: prevention of tetanus

Route of administration: injectable

Substance: tetanus immunoglobulin (immunoglobulin)

ATC: J06BB02 (Antiinfectives for systemic use | Immunoglobulins | Specific immunoglobulins)

Tetanus immunoglobulin is a product derived from human plasma, used for the prevention and treatment of tetanus, a serious infection caused by the bacterium Clostridium tetani. It contains specific antibodies against the tetanus toxin, neutralizing its effects and providing immediate protection.

It is used for post-exposure prophylaxis in individuals with contaminated wounds who are unvaccinated or have an incomplete vaccination history. It is also used to treat active tetanus by neutralizing the toxin.

It is administered via intramuscular injection, with the dose determined by the doctor based on the wound's severity or the patient's condition. Side effects are rare but may include pain at the injection site, mild fever, or allergic reactions.

Tetanus immunoglobulin provides temporary protection, and vaccination with tetanus toxoid is required for long-term immunity.

General data about TETANEA 1500UI / ml

  • Substance: tetanus immunoglobulin
  • Date of last drug list: 01-03-2021
  • Commercial code: W61098001
  • Concentration: 1500UI / ml
  • Pharmaceutical form: solution for injection in pre-filled syringe
  • Quantity: 1
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: SANOFI PASTEUR SA - FRANTA
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 460/2019/01
  • Shelf life: 3 years