INFORMATION AND SERVICES EXCLUSIVELY FOR US HEALTHCARE PROFESSIONALS

A severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of HIBERIX is a contraindication to administration of HIBERIX

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HIBERIX is a primary series and booster Hib vaccine to help protect against Haemophilus influenzae type b.

HIBERIX is administered as a 4-dose series (0.5-mL each dose) given by intramuscular injection
The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age, followed by a booster dose administered at 15 through 18 months of age
The first dose may be given as early as 6 weeks of age

INDICATION

HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday).

No clinical data are available from controlled studies comparing booster immunization with HIBERIX and a US-licensed Haemophilus b Conjugate Vaccine.

HOW HIBERIX IS SUPPLIED

  • Single-dose vials of lyophilized vaccine accompanied by vials containing saline diluent
  • Use only the accompanying saline diluent for reconstitution
  • Packages of 10 doses
  • Packaged without syringes or needles
  • Not made with natural rubber latex
  • No preservatives

HOW TO STORE HIBERIX

Storage Before Reconstitution
  • Lyophilized vaccine vials:
  • Store refrigerated between 2° and 8°C (36° and 46°F)
  • Protect vials from light
  • Diluent:
  • Store refrigerated or at controlled room temperature between 2° and 25°C (36° and 77°F)
  • Do not freeze. Discard if the diluent has been frozen
Storage After Reconstitution
  • Administer immediately or store refrigerated between 2° and 8°C (36° and 46°F) and administer within 24 hours
  • Discard the reconstituted vaccine if not used within 24 hours
  • Do not freeze. Discard if the vaccine has been frozen

Please see full Prescribing Information for HIBERIX.

Prescribing Information for HIBERIX.

724601R0 July 2016