PRIORIX®

Product Information

• Name: PRIORIX®
• Type: Combined measles, mumps, and rubella vaccine, live, attenuated
• Form: Lyophilized powder for injection
• Manufacturer: GlaxoSmithKline Inc.

Indications and Clinical Use

• Indication: Active immunization against infection by measles, mumps, and rubella.
• Recommended for:
• Children: A single dose on or after their first birthday.
• Older children: If no documented evidence of vaccination.
• High-risk groups: Post-secondary students, health care workers, military personnel, and international travellers.

Contraindications

• Known hypersensitivity to neomycin or any other component of the vaccine.
• Severe humoral or cellular immunodeficiency (e.g., symptomatic HIV infection).
• Pregnancy: Women should avoid pregnancy for one month following vaccination.

Warnings and Precautions

• General: Postpone vaccination in case of acute severe febrile illness.
• Administration: Do not administer intravascularly; administer subcutaneously or intramuscularly.
• Anaphylaxis: Appropriate medical treatment should be available in case of a rare anaphylactic event.
• Special Populations:
• Pregnant Women: Must not be vaccinated; avoid pregnancy for one month post-vaccination.
• Nursing Women: Can be vaccinated if benefits outweigh risks.
• Immunocompromised: Limited data; vaccinate only if benefits outweigh risks.

Adverse Reactions

• Very Common (≥10%): Injection site redness, fever ≥38°C (rectal) or ≥37.5°C (axillary/oral).
• Common (≥1% and <10%): Upper respiratory tract infection, rash, injection site pain and swelling, fever >39.5°C (rectal) or >39°C (axillary/oral).
• Uncommon (≥0.1% and <1%): Otitis media, lymphadenopathy, anorexia, nervousness, abnormal crying, insomnia, conjunctivitis, bronchitis, cough, parotid gland enlargement, diarrhea, vomiting.
• Rare (≥0.01% and <0.1%): Allergic reactions, febrile convulsions.
• Post-Market Surveillance: Rare reports of meningitis, thrombocytopenia, anaphylactic reactions, encephalitis, Guillain-Barré syndrome, vasculitis, erythema multiforme, arthralgia, and arthritis.

Drug Interactions

• Other Vaccines: Can be administered with other vaccines like DTPa, Hib, IPV, HBV, HAV, MenB, MenC, MenACWY, VZV, and PCV. Administer at different injection sites.
• Immune Globulins: Delay vaccination for at least three months after administration of immune globulins or blood transfusion.
• Tuberculin Testing: Perform before, simultaneously with, or 4-6 weeks after vaccination.

Dosage and Administration

• Dose: 0.5 mL subcutaneous injection; can also be given intramuscularly.
• Primary Vaccination: Routine immunization at 12 months of age or as soon as practicable thereafter. A second dose is recommended at least one month after the first dose.
• Reconstitution: Use sterile water for injection to reconstitute the lyophilized powder. Inspect for particulate matter and color variation. Administer promptly after reconstitution or within 8 hours if refrigerated.

Storage and Stability

• Store refrigerated at 2°C to 8°C. Do not freeze. Protect from light. Reconstituted vaccine should be used promptly or stored for up to 8 hours in the refrigerator.