Description
One dose (0.5 ml) contains: Tetanus toxoid ≥40 I.U.; adsorbed on hydrated aluminium hydroxide 0.6 mg Al.
Excipients/Inactive Ingredients: Acetic acid (for pH adjustment), Sodium hydroxide (for pH adjustment), Buffer solution containing sodium chloride, disodium dihydrate phosphate, monopotassium phosphate and water for injections.
Action
Pharmacotherapeutic Group: Tetanus toxoid. ATC Code: J07 AM01.
Pharmacology: Pharmacodynamics: This vaccine is prepared from tetanus toxin detoxified with formaldehyde and purified.
The immune response is activated as from the second injection: it is enhanced after the third one and persists for 5 to 10 years after the fourth one.
Pharmacokinetics: Not applicable.
Toxicology: Preclinical Safety Data: Not applicable.
Pharmacology: Pharmacodynamics: This vaccine is prepared from tetanus toxin detoxified with formaldehyde and purified.
The immune response is activated as from the second injection: it is enhanced after the third one and persists for 5 to 10 years after the fourth one.
Pharmacokinetics: Not applicable.
Toxicology: Preclinical Safety Data: Not applicable.
Indications/Uses
Tetanus prevention and, in particular: Post-exposure tetanus prophylaxis for recent wounds that may have been contaminated with tetanus spores in subjects who have not had any primary vaccination or for whom primary vaccination is incomplete or uncertain; Neonatal tetanus prophylaxis in non-immunised women either of childbearing age or pregnant in countries where neonatal tetanus is frequent; Primary vaccination; Booster injections.
Dosage/Direction for Use
Posology: Post-tetanus exposure prophylactic vaccination: When dealing with minor wounds, the doctor must evaluate the risks of Clostridium tetani infection at the injured site.
Disinfecting, debriding the wound and administering the vaccine excepted, the subject must, in some cases, be passively immunized with a human tetanus immunoglobulin injected at a different site
