ANTITOXINA BOTULINICA ABE 500UI / 500UI / 100UI / ml injectible solution medication leaflet

J06AA04 botulinum antitoxin • 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 ANTITOXINA BOTULINICA ABE 500UI / 500UI / 100UI / ml

Substance: botulinum antitoxin

Date of last drug list: 01-09-2023

Commercial code: W68007001

Concentration: 500UI / 500UI / 100UI / ml

Pharmaceutical form: injectible solution

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: ALLIANCE HEALTHCARE ROMANIA SRL - ROMANIA

Number: 639/2021/01

Shelf life: 3 years