DENGVAXIA, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

INJECTION, POWDER, FOR SUSPENSION

**4.2 Posology and method of administration** Screening Dengvaxia should only be administered to individuals with a previous dengue infection. Previous dengue infection must be confirmed by a test, either documented in the medical history or performed prior to vaccination. In non-endemic areas or low transmission settings, the lower the proportion of true seropositive individuals, the higher the risk of false seropositives with any test used to determine dengue serostatus. Thus, testing performed prior to vaccination should be limited to individuals who have been in potential contact with dengue virus (e.g. individuals who lived before or had recurrent stay in endemic areas) and who are likely to be exposed to dengue in the future. The objective is to minimize the risk of a false positive test, as in non-endemic areas, the proportion of individuals truly infected by dengue is considered generally very low. Posology The vaccination schedule consists of 3 injections of 0.5 mL to be administered at 6 month intervals. If flexibility in the vaccination schedule is necessary, a time window of +/- 20 days is acceptable (see Section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For each injection, the dose is the same for adults and for the paediatric population. Dengvaxia should not be administered in Singapore in individuals less than 12 years of age. _For individuals who have not been previously infected by dengue virus or with unknown history of prior dengue exposure_ For individuals with unknown history of prior dengue exposure, previous infection can be substantiated through serotesting. Vaccination is not recommended for individuals who have not been previously infected by dengue virus. Please refer to Section 4.4 **Special warnings and precautions for use** for individuals who have not been previously infected by dengue virus and Section 5.1, _Singaporean population (data from CYD28 study)_ subsection – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. _Booster dose_ Current data suggest that a booster after primary vaccination with Dengvaxia does not provide any additional benefit. Method of administration Once the freeze-dried vaccine has been completely reconstituted using the solvent provided, it is administered by subcutaneous (SC) injection. The recommended injection site is the deltoid region. _Precautions to be taken before handling or administering the medicinal product_ Do not administer by intravascular injection. Dengvaxia must not be mixed with any other injectable vaccine(s) or medicinal product(s). For instructions on reconstitution of Dengvaxia before administration, see Section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.