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• Contraindications for PRIORIX are: a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of any measles, mumps, and rubella virus-containing vaccine; severe humoral or cellular (primary or acquired) immunodeficiency; and pregnancy. Pregnancy should be avoided for 1 month after vaccination
• Appropriate medical treatment used to manage immediate allergic reactions must be available in the event an acute anaphylactic reaction occurs following administration of PRIORIX
• There is a risk of febrile seizures following immunization with PRIORIX
• Thrombocytopenia and thrombocytopenic purpura have been reported following vaccination with PRIORIX
• Syncope (fainting) can occur in association with administration of injectable vaccines, including PRIORIX. Procedures should be in place to avoid injury from fainting
• The tip caps of the prefilled syringes of diluent contain natural rubber latex, which may cause allergic reactions
• Vaccination with PRIORIX may not result in protection in all vaccine recipients
• In clinical trials, the most commonly reported (≥10%) solicited adverse reactions were:

– Age 12 through 15 months–local: pain (26%) and redness (25%); systemic: irritability (63%), loss of appetite (45%), drowsiness (45%), and fever (35%)

– Age 4 through 6 years–local: pain (41%), redness (22%) and swelling (11%); systemic: loss of appetite (21%), drowsiness (27%), and fever (24%)

– Age 7 years and older–local: pain (12%) and redness (12%)

• Administration of immune globulins and other blood products concurrently with PRIORIX may interfere with the expected immune response to the vaccine
• If a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or at least 4 weeks after PRIORIX to avoid false-negative results

Please see full Prescribing Information for PRIORIX.