- Approval Id
- 9c03e25b58c5fcb2
- Drug Name
- PRIORIX VACCINE
- Product Name
- PRIORIX VACCINE
- Approval Number
- SIN10822P
- Approval Date
- 1999-03-22
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><em><strong>Posology</strong></em></p>
<p>A single dose of the reconstituted vaccine is 0.5 ml.</p>
<p>As vaccination schemes vary from country to country, the advised schedule for each country must be in accordance with the national recommendations.</p>
<p><em><strong>Method of administration</strong></em></p>
<p><strong>Priorix</strong> is for subcutaneous injection, although it can also be given by intramuscular injection, in the deltoid region or in the anterolateral area of the thigh (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>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><strong>Priorix</strong> is indicated for the active immunisation against measles, mumps and rubella.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p><strong>Priorix</strong> is contraindicated in subjects with known systemic 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><strong>Priorix</strong> is contraindicated in subjects having shown signs of hypersensitivity after previous administration of measles, mumps and/or rubella vaccines.</p>
<p><strong>Priorix</strong> is contraindicated in subjects with severe humoral or cellular (primary or acquired) immunodeficiency e.g. symptomatic HIV infection (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><strong>Priorix</strong> 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>).</p>
<p><strong>Priorix</strong> is contraindicated in pregnant women. Pregnancy should be avoided for one month after vaccination (see <em>Pregnancy</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- J07BD52
- Atc Item Name
- measles, combinations with mumps and rubella, live attenuated
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
