DOSAGE AND ADMINISTRATION
HIBTITER 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 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.
HibTITER 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. 32,33 Preterm infants should be vaccinated with HibTITER 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 may be interchanged with other Haemophilus influenzae type b conjugate vaccines for the primary immunization series55,56
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.
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