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PRIORIX VACCINE

Prescription Only
Drug type: Therapeutic
ATC code: J07BD52
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route of administration: SUBCUTANEOUS, INTRAMUSCULAR
Active ingredient: RUBELLA VIRUS (RA27/3 STRAIN) (LIVE ATTENUATED); MEASLES VIRUS (SCHWARZ STRAIN) (LIVE ATTENUATED); MUMPS VIRUS (RIT 4385 STRAIN) (LIVE ATTENUATED); MEASLES VIRUS (SCHWARZ STRAIN) (LIVE ATTENUATED); MUMPS VIRUS (RIT 4385 STRAIN) (LIVE ATTENUATED); RUBELLA VIRUS (RA27/3 STRAIN) (LIVE ATTENUATED)

Indications

Priorix is indicated for the active immunisation against measles, mumps and rubella.

Contraindications

Priorix is contraindicated in subjects with known systemic 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 is contraindicated in subjects having shown signs of hypersensitivity after previous administration of measles, mumps and/or rubella vaccines.

Priorix is contraindicated in subjects with severe humoral or cellular (primary or acquired) immunodeficiency e.g. symptomatic HIV infection (see also “ Warnings and Precautions” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Priorix 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).

Dosage and Administration

Posology

A single 0.5 ml dose of the reconstituted vaccine is recommended.

As vaccination schemes vary from country to country, the advised schedule for each country must be in accordance with the national recommendations.

Method of administration

Priorix 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 “ Warnings and Precautions” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 “ Instructions for Use/Handling” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Registrant
GLAXOSMITHKLINE PTE LTD
Approval Date
1999-03-22
Approval Number
SIN10822P
Manufacturer
Fidia Farmaceutici S.P.A GlaxoSmithKline Biologicals - Diluent in ampoules Delpharm Tours - Diluent in ampoules Corixa Corporation d/b/a GlaxoSmithKline Vaccines Aspen Notre Dame De Bondeville - Diluent in syringes Catalent Belgium SA - Diluent in syringes Fidia Farmaceutici S.P.A (Diluent in ampoules)
Licence Holder
GLAXOSMITHKLINE PTE LTD