PRIORIX-TETRA [SIN13627P]
Active ingredients: PRIORIX-TETRA
Product Info
PRIORIX-TETRA
[SIN13627P]
Product information
Active Ingredient and Strength | LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN) - ≥ 103 CCID50/DOSE |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Manufacturer and Country | GLAXOSMITHKLINE BIOLOGICALS S.A. - BELGIUM |
Registration Number | SIN13627P |
Licence Holder | GLAXOSMITHKLINE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J07BD54 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
Indications
Priorix-Tetra is indicated for active immunisation of subjects from the age of 12 months against measles, mumps, rubella and varicella. (see Warnings and Precautions, Pharmacodynamics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
The use of Priorix-Tetra should be based on official recommendations.
Dosing
Dosage and Administration
Posology
Primary immunisation consists of one dose of vaccine.
A second dose of measles-containing vaccine should be administered according to the Singapore’s national immunization program.
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.
Method of administration
The vaccine is to be injected subcutaneously (SC) or intramuscularly (IM) in the deltoid region or in the anterolateral area of the thigh.
The vaccine should be administered subcutaneously in subjects with bleeding disorders (e.g. thrombocytopenia or any coagulation disorder).
For instructions on reconstitution of the medicinal product before administration, see Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Contraindications
Contraindications
Priorix-Tetra is contraindicated in subjects with known hypersensitivity to neomycin or to any other component of the vaccine (for egg allergy, see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). A history of contact dermatitis to neomycin is not a contraindication.
Priorix-Tetra is contraindicated in subjects having shown signs of hypersensitivity after previous administration of measles, mumps, rubella and/or varicella vaccines.
Priorix-Tetra 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 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
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 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Priorix-Tetra is contraindicated in pregnant women. Pregnancy should be avoided for one month after vaccination (see Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
