Leaflet BOTULINUM ANTITOXIN ABE 500UI+500UI+100UI/ml 500UI / 500UI / 100UI / ml solution for injection


Indicated for: botulism

Route of administration: injectable

Substance: botulinum antitoxin (therapeutic serum)

ATC: J06AA04 (Antiinfectives for systemic use | Immune sera)

Botulinum antitoxin is a treatment used to neutralize botulinum toxin, produced by the bacterium Clostridium botulinum. It is indicated in cases of botulism, a serious condition that can cause muscle paralysis and respiratory failure.

The antitoxin works by binding to free botulinum toxin in the bloodstream, preventing its effects on the nervous system. It is effective only if administered early after symptom onset, as it cannot reverse already established paralysis but can stop the progression of the disease.

It is available as an injectable solution and is administered intravenously, usually in a hospital setting under strict medical supervision.

Side effects may include fever, skin rashes, pain at the injection site, or, rarely, severe allergic reactions. Prompt administration is crucial, as botulism is a medical emergency requiring immediate intervention.

General data about BOTULINUM ANTITOXIN ABE 500UI+500UI+100UI/ml 500UI / 500UI / 100UI / ml

  • Substance: botulinum antitoxin
  • Date of last drug list: 01-03-2024
  • Commercial code: W69404001
  • Concentration: 500UI / 500UI / 100UI / ml
  • Pharmaceutical form: solution for injection
  • Quantity: 1
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: BIOMED SP. Z O.O. - POLONIA
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 774/2023/01
  • Shelf life: 3 years