Indication and Important Safety Information
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PRIVID220003 November 2022
Produced in USA.
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©2022 GSK or licensor.
PRIVID220003 November 2022
Produced in USA.
©2022 GSK or licensor.
PRIVID220003 November 2022
Produced in USA.
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Indication for PRIORIXPRIORIX is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.Important Safety Information for PRIORIXContraindications 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 vaccinationAppropriate medical treatment used to manage immediate allergic reactions must be available in the event an acute anaphylactic reaction occurs following administration of PRIORIXThere is a risk of febrile seizures following immunization with PRIORIXThrombocytopenia and thrombocytopenic purpura have been reported following vaccination with PRIORIXSyncope (fainting) can occur in association with administration of injectable vaccines, including PRIORIX. Procedures should be in place to avoid injury from faintingThe tip caps of the prefilled syringes of diluent contain natural rubber latex, which may cause allergic reactionsVaccination with PRIORIX may not result in protection in all vaccine recipientsIn 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 vaccineIf 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 resultsPlease see full Prescribing Information for PRIORIX.
Indication for PRIORIXPRIORIX is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.Important Safety Information for PRIORIXContraindications 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 vaccinationAppropriate medical treatment used to manage immediate allergic reactions must be available in the event an acute anaphylactic reaction occurs following administration of PRIORIXThere is a risk of febrile seizures following immunization with PRIORIXThrombocytopenia and thrombocytopenic purpura have been reported following vaccination with PRIORIXSyncope (fainting) can occur in association with administration of injectable vaccines, including PRIORIX. Procedures should be in place to avoid injury from faintingThe tip caps of the prefilled syringes of diluent contain natural rubber latex, which may cause allergic reactionsVaccination with PRIORIX may not result in protection in all vaccine recipientsIn 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 vaccineIf 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 resultsPlease see full Prescribing Information for PRIORIX.