PRIORIX VACCINE [SIN10822P]
Active ingredients: PRIORIX VACCINE
Product Info
PRIORIX VACCINE
[SIN10822P]
Product information
Active Ingredient and Strength | MEASLES VIRUS (SCHWARZ STRAIN) (LIVE ATTENUATED) - MIN 1,000 TCID50 |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Manufacturer and Country | FIDIA FARMACEUTICI S.P.A - ITALY |
Registration Number | SIN10822P |
Licence Holder | GLAXOSMITHKLINE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J07BD52 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
Indications
Priorix is indicated for the active immunisation against measles, mumps and rubella.
Dosing
Dosage and Administration
Posology
A single dose of the reconstituted vaccine is 0.5 ml.
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 Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Contraindications
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 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Priorix 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 is contraindicated in pregnant women. Pregnancy should be avoided for one month after vaccination (see Pregnancy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
