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HibTITER

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HibTITER

Indications
Dosage
How Supplied

INDICATIONS

Haemophilus b Conjugate Vaccine (Diphtheria CRM197Protein Conjugate) HibTITER (diphtheria crm197 protein conjugate) is indicated for the immunization of children 2 months to 71 months of age against invasive diseases caused by H. influenzae type b.

As with any vaccine, HibTITER (diphtheria crm197 protein conjugate) may not protect 100% of individuals receiving the vaccine.

The American Academy of Pediatrics (AAP), the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP) encourage the routine simultaneous administration of Haemophilus influenzae type b vaccines with other currently recommended vaccines, but at different sites (see DRUG INTERACTIONS).32,33,34,35

DOSAGE AND ADMINISTRATION

HibTITER (diphtheria crm197 protein conjugate) is for intramuscular use only.

Any parenteral drug product should be inspected visually for particulate matter and/or discoloration prior to administration whenever solution and container permit. If these conditions exist, or if cloudy, HibTITER (diphtheria crm197 protein conjugate) should not be administered.

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to help avoid inadvertent injection into a blood vessel.

The vaccine should be injected intramuscularly, preferably into the midlateral muscles of the thigh or deltoid, with care to avoid major peripheral nerve trunks. Do not inject in the gluteal area.

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 vaccine is not to be mixed with other vaccines/products in the same syringe.

HibTITER (diphtheria crm197 protein conjugate) is indicated for children 2 months to 71 months of age for the prevention of invasive Haemophilus b disease. For infants 2 to 6 months of age, the immunizing dose is three separate injections of 0.5 mL given at approximately 2-month intervals. Previously unvaccinated infants from 7 through 11 months of age should receive two separate injections approximately 2 months apart. Children from 12 through 14 months of age who have not been vaccinated previously receive one injection. All vaccinated children receive a single booster dose at 15 months of age or older, but not less than 2 months after the previous dose. Previously unvaccinated children 15 to 71 months of age receive a single injection of HibTITER (diphtheria crm197 protein conjugate) .32,33 Preterm infants should be vaccinated with HibTITER (diphtheria crm197 protein conjugate) according to their chronological age, from birth.32

Recommended Immunization Schedule

Age at First Immunization (Mo) No. of Doses Booster
2 -6 3 Yes
7 - 11 2 Yes
12 - 14 1 Yes
15 and over 1 No

Interruption of the recommended schedules with a delay between doses does not interfere with the final immunity achieved nor does it necessitate starting the series over again, regardless of the length of time elapsed between doses.32,33

Data support that HibTITER (diphtheria crm197 protein conjugate) may be interchanged with other Haemophilus influenzae type b conjugate vaccines for the primary immunization series and booster dose.55,56,57

Each dose of 0.5 mL is formulated to contain 10 µg of purified Haemophilus b saccharide and approximately 25 µg of CRM197 protein.

Storage

DO NOT FREEZE. Store refrigerated away from freezer compartments at 2°C-8°C (36°F-46°F). Discard if the vaccine has been frozen.

HOW SUPPLIED

Vial, 1 Dose (5 per package) – Product No. 0005-0104-32

REFERENCES

32. Recommendations of the AAP: Haemophilus influenzae type b conjugate vaccines: recommendations for immunization of infants and children 2 months of age and older: update. Pediatrics. 1991;88:169-172.

33. Recommendation of the ACIP: Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older. MMWR. 1991;40:1-7.

34. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR. 2002;51(No. RR-2);1-36.

35. 2000 Red Book: Report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000: 26, 266-72.

55. Greenberg DP, Lieberman JM, Marcy SM, et al. Enhanced antibody responses in infants given different sequences of heterogenous Haemophilus influenzae type b conjugate vaccines. J Pediatr. 1995;126:206-11.

56. Anderson EL, Decker MD, Englund JA, et al. Interchangeability of conjugated Haemophilus influenzae type b vaccines in infants. JAMA. 1995;273:849-53.

57. Scheifele D, Law B, Mitchell L, Ochnio J. Study of booster doses of two Haemophilus influenzae type b conjugate vaccines including their interchangeability. Vaccine. 1996;14(15):1399-1406.

This product's label may have been revised after this insert was used in production. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll free at 1-800-934-5556. Manufactured by: Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101.

Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.

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