Haemophilus b conjugate vaccine warnings and precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Warnings And Precautions
Guillain-Barré Syndrome
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including HIBERIX, should be based on careful consideration of the potential benefits and possible risks.
Latex
The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals [see How Supplied/Storage and Handling ].
Syncope
Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
Preventing and Managing Allergic Vaccine Reactions
Prior to administration, the healthcare provider should review the patient's immunization history for possible vaccine hypersensitivity. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
Altered Immunocompetence
Safety and effectiveness of HIBERIX in immunosuppressed children have not been evaluated. If HIBERIX is administered to immunosuppressed children, including children receiving immunosuppressive therapy, the expected immune response may not be obtained.
Interference With Laboratory Tests
Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receipt of a H. influenzae type b-containing vaccine, including HIBERIX [see Drug Interactions ].
Tetanus Immunization
Immunization with HIBERIX does not substitute for routine tetanus immunization.[1]
References
Adapted from the FDA Package Insert.