- Approval Id
- bbdb9cd262814458
- Drug Name
- PRIORIX-TETRA
- Product Name
- PRIORIX-TETRA
- Approval Number
- SIN13627P
- Approval Date
- 2009-04-03
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><strong>Posology</strong><br>
Primary immunisation consists of one dose of vaccine.<br>
A second dose of measles-containing vaccine should be administered according to the Singapore’s national immunization program.</p>
<p>It is preferable to respect an interval of at least 6 weeks between doses. In no circumstances should this interval be less than 4 weeks.</p>
<p><strong>Method of administration</strong><br>
The vaccine is to be injected subcutaneously (SC) or intramuscularly (IM) in the deltoid region or in the anterolateral area of the thigh.</p>
<p>The vaccine should be administered subcutaneously in subjects with bleeding disorders (e.g. thrombocytopenia or any coagulation disorder).</p>
<p>For instructions on reconstitution of the medicinal product before administration, see<em> Use and Handling</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- SUBCUTANEOUS, INTRAMUSCULAR
- Indication Info
- <p><strong>Indications</strong></p>
<p><em>Priorix-Tetra</em> is indicated for active immunisation of subjects from the age of 12 months against measles, mumps, rubella and varicella. (see <em>Warnings and Precautions, Pharmacodynamics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>The use of <em>Priorix-Tetra</em> should be based on official recommendations.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p><em>Priorix-Tetra</em> is contraindicated in subjects with known hypersensitivity to neomycin or to any other component of the vaccine (for egg allergy, see <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). A history of contact dermatitis to neomycin is not a contraindication.</p>
<p><em>Priorix-Tetra</em> is contraindicated in subjects having shown signs of hypersensitivity after previous administration of measles, mumps, rubella and/or varicella vaccines.</p>
<p><em>Priorix-Tetra</em> is contraindicated in subjects with severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ < 25%; children between 12–35 months: CD4+ < 20%; children between 36–59 months: CD4+ < 15% (see <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Priorix-Tetra is contraindicated in patients on current or recent immunosuppressive therapy (includes high doses of corticosteroids but not topical or low-dose parenteral corticosteroids) (see <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em>.</p>
<p><em>Priorix-Tetra</em> is contraindicated in pregnant women. Pregnancy should be avoided for one month after vaccination (see <em>Pregnancy and Lactation</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- J07BD54
- Atc Item Name
- measles, combinations with mumps, rubella and varicella, live attenuated
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
