- Approval Id
- 93aae48425dedef4
- Drug Name
- DENGVAXIA, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
- Product Name
- DENGVAXIA, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
- Approval Number
- SIN15096P
- Approval Date
- 2016-10-11
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, FOR SUSPENSION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Screening</u></p>
<p>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.</p>
<p>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.</p>
<p><u>Posology</u></p>
<p>The vaccination schedule consists of 3 injections of 0.5 mL to be administered at 6 month intervals.</p>
<p>If flexibility in the vaccination schedule is necessary, a time window of +/- 20 days is acceptable (see Section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>For each injection, the dose is the same for adults and for the paediatric population.</p>
<p>Dengvaxia should not be administered in Singapore in individuals less than 12 years of age.</p>
<p><em>For individuals who have not been previously infected by dengue virus or with unknown history of prior dengue exposure</em></p>
<p>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.</p>
<p>Please refer to Section 4.4 <strong>Special warnings and precautions for use</strong> for individuals who have not been previously infected by dengue virus and Section 5.1, <em>Singaporean population (data from CYD28 study)</em> subsection – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><em>Booster dose</em></p>
<p>Current data suggest that a booster after primary vaccination with Dengvaxia does not provide any additional benefit.</p>
<p><u>Method of administration</u></p>
<p>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.</p>
<p><em>Precautions to be taken before handling or administering the medicinal product</em></p>
<p>Do not administer by intravascular injection.<br>
Dengvaxia must not be mixed with any other injectable vaccine(s) or medicinal product(s).</p>
<p>For instructions on reconstitution of Dengvaxia before administration, see Section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 12 through 45 years of age with test-confirmed previous dengue infection (see Section 4.2 and Section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Dengvaxia must not be administered to individuals with a history of severe allergic reaction to any component of Dengvaxia or after prior administration of Dengvaxia or a vaccine containing the same components.</p>
<p>Administration of Dengvaxia must be postponed in individuals suffering from moderate to severe febrile or acute disease.</p>
<p>Dengvaxia must not be administered to individuals with congenital or acquired immune deficiency that impairs cell-mediated immunity, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids generally given for 2 weeks or more.</p>
<p>Dengvaxia must not be administered to individuals with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function.</p>
<p>Dengvaxia must not be administered to pregnant women.</p>
<p>Dengvaxia must not be administered to breastfeeding women.</p>
- Atc Code
- J07BX
- Atc Item Name
- 其它病毒疫苗
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
