- Approval Id
- 0361f7a129d29582
- Drug Name
- IMOVAX d.T., SUSPENSION FOR INJECTION IN 0.5 mL PRE-FILLED SYRINGE
- Product Name
- IMOVAX d.T., SUSPENSION FOR INJECTION IN 0.5 mL PRE-FILLED SYRINGE
- Approval Number
- SIN16995P
- Approval Date
- 2024-04-30
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- <p><strong>Posology and method of administration</strong></p>
<p><u>Posology</u><br>
For adults, adolescents and children from 6 years of age, the dose is 0.5 mL.</p>
<p><em>Booster vaccination of previously immunized individuals</em></p>
<p>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.</p>
<p>Booster vaccination with Imovax d.T. consists of one dose (0.5 mL) of Imovax d.T. (see section <strong>Pharmacodynamic properties</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>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 <strong>Pharmacodynamic properties</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). 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.</p>
<p><em>Post-exposure prophylaxis of tetanus</em><br>
In subjects previously immunized against tetanus, Imovax d.T. could be used for post-exposure prophylaxis of tetanus if in accordance with official recommendations.</p>
<p><em>Other pediatric population</em></p>
<p>The safety and efficacy of Imovax d.T. in children less than 6 years of age have not been established.</p>
<p><u>Method of administration</u></p>
<p>Imovax d.T. should be given by intramuscular injection. The preferred injection site is the deltoid muscle.<br>
<strong>Imovax d.T. must not be administered by intradermal or intravascular routes.</strong></p>
<p>For instructions on handling, see section <strong>Special precautions for disposal and other handling</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>Therapeutic indications</strong></p>
<p>Imovax d.T. is indicated for booster vaccination against tetanus and diphtheria in individuals from 6 years of age.</p>
<p>The use of this vaccine should be in accordance with the official recommendations.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Hypersensitivity to the active substances or any of the excipients listed in section <strong>List of excipients</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em> or any of the possible production residues of formaldehyde</p>
<p>Allergic reactions or neurological dysfunction after previous administration of a vaccine with the same antigen components.</p>
<p>As a rule, there are no contraindications for vaccination in the event of injury, except in the case of a severe allergy.</p>
- Atc Code
- J07AM51
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
