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PedvaxHIB

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Pedvax HIB

Indications
Dosage
How Supplied

INDICATIONS

Liquid PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age.

Liquid PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis. As with any vaccine, vaccination with Liquid PedvaxHIB may not result in a protective antibody response in all individuals given the vaccine.

BECAUSE OF THE POTENTIAL FOR IMMUNE TOLERANCE, Liquid PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE. (See PRECAUTIONS.)

Revaccination

Infants completing the primary two-dose regimen before 12 months of age should receive a booster dose (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

Liquid PedvaxHIB

FOR INTRAMUSCULAR ADMINISTRATION

DO NOT INJECT INTRAVENOUSLY

If there is an interruption or delay between doses in the primary series, there is no need to repeat the series, but dosing should be continued at the next clinic visit. (See CONTRAINDICATIONS and PRECAUTIONS.)

2 to 14 Months of Age

Infants 2 to 14 months of age should receive a 0.5 mL dose of vaccine ideally beginning at 2 months of age followed by a 0.5 mL dose 2 months later (or as soon as possible thereafter). When the primary two-dose regimen is completed before 12 months of age, a booster dose is required (see below and TABLE 6). Infants born prematurely, regardless of birth weight, should be vaccinated at the same chronological age and according to the same schedule and precautions as full-term infants and children.46

15 Months of Age and Older

Children 15 months of age and older previously unvaccinated against Hib disease should receive a single 0.5 mL dose of vaccine.

Booster Dose

In infants completing the primary two-dose regimen before 12 months of age, a booster dose (0.5 mL) should be administered at 12 to 15 months of age, but not earlier than 2 months after the second dose.

Vaccination regimens for Liquid PedvaxHIB by age group are outlined in TABLE 6.

TABLE 6
Vaccination Regimens for Liquid PedvaxHIB By Age Groups

Age (Months) at First Dose Primary Age (Months) at Booster Dose
2-10 2 doses, 2 mo. apart 12-15
11-14 2 doses, 2 mo. apart -
15-71 1 dose -

Interchangeability

PedvaxHIB may be interchanged with other licensed Haemophilus b Conjugate Vaccines for the primary and booster doses.52 (See CLINICAL PHARMACOLOGY.)

Use with Other Vaccines

Results from clinical studies indicate that Liquid PedvaxHIB can be administered concomitantly with DTP, OPV, eIPV (enhanced inactivated poliovirus vaccine), VARIVAX [Varicella Virus Vaccine Live (Oka/Merck)], M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) or RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)]. No impairment of immune response to these individually tested vaccine antigens was demonstrated.

The type, frequency and severity of adverse experiences observed in these studies with PedvaxHIB were similar to those seen with the other vaccines when given alone. (See CLINICAL PHARMACOLOGY.)

In addition, a PRP-OMPC-containing product, COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine], was given concomitantly with a booster dose of DTaP [diphtheria, tetanus, acellular pertussis] at approximately 15 months of age, using separate sites and syringes for injectable vaccines. No impairment of immune response to these individually tested vaccine antigens was demonstrated. COMVAX has also been administered concomitantly with the primary series of DTaP to a limited number of infants. PRP antibody responses are satisfactory for COMVAX, but immune responses are currently unavailable for DTaP (see Manufacturer's Product Circular for COMVAX). No serious vaccine-related adverse events were reported.33

Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit.

Liquid PedvaxHIB is a slightly opaque white suspension. (See DESCRIPTION.)

The vaccine should be used as supplied; no reconstitution is necessary.

Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.

Inject 0.5 mL intramuscularly, preferably into the anterolateral thigh or the outer aspect of the upper arm. The buttocks should not be used for active vaccination of infants and children, because of the potential risk of injury to the sciatic nerve.

HOW SUPPLIED

Liquid PedvaxHIB is supplied as follows:

No. 4897 - A box of 10 single-dose vials of liquid vaccine, NDC 0006-4897-00.

Storage

Store vaccine at 2-8°C (36-46°F).

DO NOT FREEZE.

REFERENCES

33. Data on file at Merck Research Laboratories.

52. American Academy of Pediatrics. Recommended Childhood Immunization Schedule - United States, January- December 1998. Pediatr 101(1): 154-157, 1998.

Manuf. and Dist. by: MERCK & CO., INC., West Point, PA 19486, USA. Issued January 2001. FDA Rev date: 1/1/2001

Last reviewed on RxList: 12/19/2007
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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