HibTITER WILL NOT PROTECT AGAINST H. INFLUENZA OTHER THAN TYPE b STRAINS, NOR WILL HibTITER PROTECT AGAINST OTHER MICROORGANISMS THAT CAUSE MENINGITIS OR SEPTIC DISEASE.

AS WITH ANY INTRAMUSCULAR INJECTION, HibTITER SHOULD BE GIVEN WITH CAUTION TO INFANTS OR CHILDREN WITH THROMBOCYTOPENIA OR ANY COAGULATION DISORDER THAT WOULD CONTRAINDICATE INTRAMUSCULAR INJECTION (SEE DRUG INTERACTIONS).

ANTIGENURIA HAS BEEN DETECTED FOLLOWING RECEIPT OF HAEMOPHILUS b CONJUGATE VACCINE³⁴ AND THEREFORE ANTIGEN DETECTION IN URINE MAY NOT HAVE DIAGNOSTIC VALUE IN SUSPECTED HAEMOPHILUS b DISEASE WITHIN 2 WEEKS OF IMMUNIZATION.

Health care professionals should administer HibTITER with caution to patients with a possible history of latex sensitivity, since its packaging contains dry natural rubber.

GENERAL

1. CARE IS TO BE TAKEN BY THE HEALTH CARE PROVIDER FOR SAFE AND EFFECTIVE USE OF THIS PRODUCT.

2. PRIOR TO ADMINISTRATION OF ANY DOSE OF HibTITER, THE PARENT OR GUARDIAN SHOULD BE ASKED ABOUT THE PERSONAL HISTORY, FAMILY HISTORY, AND RECENT HEALTH STATUS OF THE VACCINE RECIPIENT. THE HEALTH CARE PROVIDER SHOULD ASCERTAIN PREVIOUS IMMUNIZATION HISTORY, CURRENT HEALTH STATUS, AND OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE EVENT AFTER PREVIOUS IMMUNIZATION IN THE CHILD TO BE IMMUNIZED, IN ORDER TO DETERMINE THE EXISTENCE OF ANY CONTRAINDICATION TO IMMUNIZATION WITH HibTITER AND TO ALLOW AN ASSESSMENT OF BENEFITS AND RISKS.

3. BEFORE THE INJECTION OF ANY BIOLOGICAL, THE HEALTH CARE PROVIDER SHOULD TAKE ALL PRECAUTIONS KNOWN FOR THE PREVENTION OF

ALLERGIC OR ANY OTHER SIDE REACTIONS. This should include: a review of the patient's history regarding possible sensitivity; the ready availability of epinephrine 1:1,000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use.

4. Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunization procedures.^35,36 Deferral of administration of vaccine may be considered in individuals receiving immunosuppressive therapy.³⁵ Other groups should receive this vaccine according to the usual recommended schedule.^35-37 (See DRUG INTERACTIONS.)

5. This product is not contraindicated based on the presence of human immunodeficiency virus infection.³⁸

6. Any acute infection or febrile illness is reason for delaying use of HibTITER except when in the opinion of the physician, withholding the vaccine entails a greater risk. A minor afebrile illness, such as a mild upper respiratory infection, is not usually reason to defer immunization.

7. As reported with Haemophilus b polysaccharide vaccine, cases of Haemophilus b disease may occur prior to the onset of the protective effects of the vaccine.^3,39

8. The vaccine should not be injected intradermally since the safety and immunogenicity of this route have not been evaluated. The vaccine should be given intramuscularly.

9. A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.

10. Special care should be taken to prevent injection into a blood vessel.

11. The vaccine is to be administered immediately after being drawn up into a syringe. Single dose 0.5 mL vial contains no preservative. Use one dose per vial; do not re-enter vial. Discard unused portions.

The US Department of Health and Human Services has established a new Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986.⁴⁰ The VAERS toll-free number for VAERS forms and information is 800-822-7967.

ALTHOUGH SOME ANTIBODY RESPONSE TO DIPHTHERIA TOXIN OCCURS, IMMUNIZATION WITH HibTITER DOES NOT SUBSTITUTE FOR ROUTINE DIPHTHERIA IMMUNIZATION.

Packaging for HibTITER contains dry natural rubber. Health care professionals should administer HibTITER with caution to patients with a possible history of latex sensitivity.

INFORMATION FOR PATIENT

PRIOR TO ADMINISTRATION OF HibTITER, HEALTH CARE PERSONNEL SHOULD INFORM THE PARENT, GUARDIAN OR OTHER RESPONSIBLE ADULT, OF THE RECOMMENDED IMMUNIZATION SCHEDULE FOR PROTECTION AGAINST HAEMOPHILUS b DISEASE AND THE BENEFITS AND RISKS TO THE CHILD RECEIVING THIS VACCINE. GUIDANCE SHOULD BE PROVIDED ON MEASURES TO BE TAKEN SHOULD ADVERSE EVENTS OCCUR, SUCH AS, ANTIPYRETIC

MEASURES FOR ELEVATED TEMPERATURES AND THE NEED TO REPORT

ADVERSE EVENTS TO THE HEALTH CARE PROVIDER. Parents should be provided with vaccine information pamphlets at the time of each vaccination, as stated in the National Childhood Vaccine Injury Act.⁴⁰

PATIENTS, PARENTS, OR GUARDIANS SHOULD BE INSTRUCTED TO REPORT ANY SERIOUS ADVERSE REACTIONS TO THEIR HEALTH CARE PROVIDER.

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