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IMOVAX D.T., SUSPENSION FOR INJECTION IN 0.5 ML PRE-FILLED SYRINGE [SIN16995P]
Active ingredients: IMOVAX D.T., SUSPENSION FOR INJECTION IN 0.5 ML PRE-FILLED SYRINGE
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Product Info
IMOVAX D.T., SUSPENSION FOR INJECTION IN 0.5 ML PRE-FILLED SYRINGE
[SIN16995P]
Product information
Active Ingredient and Strength | PURIFIED DIPHTHERIA TOXOID - ≥ 2 INTERNATIONAL UNITS/0.5 ML |
Dosage Form | INJECTION, SUSPENSION |
Manufacturer and Country | SANOFI PASTEUR (VDR) - FRANCE |
Registration Number | SIN16995P |
Licence Holder | SANOFI-AVENTIS SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J07AM51 |
Therapeutic indications
Imovax d.T. is indicated for booster vaccination against tetanus and diphtheria in individuals from 6 years of age.
The use of this vaccine should be in accordance with the official recommendations.
Posology and method of administration
Posology
For adults, adolescents and children from 6 years of age, the dose is 0.5 mL.
Booster vaccination of previously immunized individuals
Booster vaccination against tetanus and diphtheria should be based on official recommendations regarding the type of tetanus-diphtheria containing vaccine to be used and interval since previous vaccination.
Booster vaccination with Imovax d.T. consists of one dose (0.5 mL) of Imovax d.T. (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
In adults previously vaccinated and with important delay since last tetanus-diphtheria vaccination (range 11 to 60 years) a second booster dose (0.5 mL) may be required at least one month after the first booster dose for some individuals (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The decision to administer a second booster dose should be based on the assessment of antibodies level (serological test) achieved after the first booster dose.
Post-exposure prophylaxis of tetanus
In subjects previously immunized against tetanus, Imovax d.T. could be used for post-exposure prophylaxis of tetanus if in accordance with official recommendations.
Other pediatric population
The safety and efficacy of Imovax d.T. in children less than 6 years of age have not been established.
Method of administration
Imovax d.T. should be given by intramuscular injection. The preferred injection site is the deltoid muscle.
Imovax d.T. must not be administered by intradermal or intravascular routes.
For instructions on handling, see section Special precautions for disposal and other handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Contraindications
Hypersensitivity to the active substances or any of the excipients listed in section List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information or any of the possible production residues of formaldehyde
Allergic reactions or neurological dysfunction after previous administration of a vaccine with the same antigen components.
As a rule, there are no contraindications for vaccination in the event of injury, except in the case of a severe allergy.
