PRIORIX supplied as two components in box

HOW SUPPLIED AND STORAGE

PRIORIX is supplied as 2 different components in a box1

 

  • 10 single-dose vials of Lyophilized Antigen Component, Live
  • 10 single-dose prefilled ungraduated syringes of Sterile Water Diluent Component (packaged without needles)
  • After reconstitution, each vial contains one dose (approximately 0.5 mL) of PRIORIX

For your convenience for reconstitution: an MMR vaccine with a syringe prefilled with Sterile Water Diluent Component1

MMR=measles, mumps, and rubella.

  • Storing PRIORIX in the refrigerator in its original packaging keeps both components together until it’s time to reconstitute
  • Store the Lyophilized Antigen Component, Live vials in a refrigerator between 36°F and 46°F (2°C and 8°C). Protect vials from light
  • Store the prefilled ungraduated syringes of Sterile Water Diluent Component in a refrigerator between 36°F and 46°F (2°C and 8°C) or at controlled room temperature up to 77°F (25°C)
  • Do not freeze Lyophilized Antigen Component, Live or Sterile Water Diluent Component
  • Administer PRIORIX immediately after reconstitution. If not used immediately, store refrigerated between 36°F and 46°F (2°C and 8°C) for up to 8 hours
  • Discard reconstituted vaccine if not used within 8 hours
  • Do not freeze. Discard if the reconstituted vaccine has been frozen

INDICATION & IMPORTANT SAFETY INFO

INDICATION FOR PRIORIX

IMPORTANT SAFETY INFORMATION FOR PRIORIX

INDICATION FOR PRIORIX

PRIORIX 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 PRIORIX

  • Contraindications for PRIORIX: Do not administer PRIORIX to individuals with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine or after a previous dose of any measles, mumps, and rubella virus-containing vaccine. Do not administer PRIORIX to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. These individuals are at risk of disseminated vaccine virus infection. Do not administer PRIORIX to individuals who are pregnant. 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.

References

  1. Prescribing Information for PRIORIX.