If ProHIBiT ® is used in persons with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.

As with any vaccine, vaccination with ProHIBiT ® may not protect 100% of susceptible individuals.

General

As with the injection of any biological material, Epinephrine Injection (1: 1000) should be available for immediate use should an anaphylactic or other allergic reaction occur.

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient†s history with respect to possible hypersensitivity to the vaccine or similar vaccines.

Any febrile illness or infection likely to be accompanied by fever is reason to delay the use of ProHIBiT ® , since fever may result occasionally from administration of ProHIBiT ® alone.

As reported with Haemophilus b polysaccharide vaccine, 30 cases of Haemophilus b disease may occur in the week after vaccination, prior to the onset of protective effects of the vaccine.¹⁵

Antigenuria has been detected following receipt of Haemophilus b Conjugate Vaccine.³¹ Antigen detection may not have diagnostic value in suspected Haemophilus b disease within two weeks of immunization.

Special care should be taken to ensure that the injection does not enter a blood vessel. A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis or other infectious agents from person to person. Needles should not be recapped and should be disposed of properly.

Although some immune response to the diphtheria toxoid component may occur, immunization with ProHIBiT ® does not substitute for routine diphtheria immunization.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

ProHIBiT ® has not been evaluated for its carcinogenic, mutagenic potential or impairment of fertility.

Pregnancy Reproductive Studies † Pregnancy Category C

Animal reproduction studies have not been conducted with ProHIBiT ® . It is also not known whether ProHIBiT ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ProHIBiT ® is NOT recommended for use in a pregnant woman.

Pediatric Use

ProHIBiT ® is not recommended for use in children younger than 12 months of age.

Information For Patient

Parents should be fully informed of the benefits and risks of immunization with Haemophilus b Conjugate Vaccine (Diphtheria ToxoidConjugate). Information sheets are available from the Centers for Disease Control and Prevention (CDC) or the State Health Department.

Prior to administration of Haemophilus b Conjugate Vaccine (Diphtheria Toxoid- Conjugate), the parent or guardian should be asked about the recent health status of the infant or child to be injected.

The physician should inform the parents or guardian about the significant adverse reactions that have been temporally associated with Haemophilus b Conjugate Vaccine (Diphtheria Toxoid- Conjugate) administration, informed consent should be obtained and recorded, and the parent should inform the physician if any of these events occur.

As proof of the child†s immunization record, the date, lot number and manufacturer of the vaccine administered should be recorded.^32,33

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