DOSAGE AND ADMINISTRATION
The vaccine should be inspected visually for extraneous particulate matter and/or discoloration prior to administration. If these conditions exist, the vaccine should not be used.
Shake vial well to obtain a homogeneous suspension before withdrawing each dose. Inject 0.5 ml of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM intramuscularly only. The preferred injection sites are the anterolateral aspect of the thigh and the deltoid muscle of the upper arm. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Before injection, the skin over the injection site should be cleansed with suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel. Fractional doses (doses
A 0.5 ml intramuscular injection of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM is recommended for administration at 2, 4, and 6 months of age, at intervals of six to eight weeks, with a fourth dose given at 15-20 months of age (see CLINICAL PHARMACOLOGY). The interval between the third and fourth doses should be at least 6 months. The customary age for the first dose is two months of age, but the vaccine may be given starting at six weeks of age. It is recommended that Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM be given for all doses in the series because no interchangeability data on DTaP vaccines exist.
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM may be used to complete the immunization series in infants who have received one or two doses of whole-cell DTP vaccine. However, the safety and efficacy of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM in such infants have not been evaluated.
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM as a fourth dose is recommended at 15-20 months of age in children who have received three doses of whole-cell DTP vaccine. The interval between the third and fourth dose should be at least 6 months.
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM as a fifth dose is recommended at 4-6 years of age (prior to the seventh birthday) in children who have received 4 doses of a whole-cell DTP vaccine or 3 doses of a whole-cell DTP vaccine followed by one dose of a DTaP vaccine. A fifth dose is not needed if the fourth dose was given on or after the fourth birthday. At this time, there are no data to establish the frequency of adverse events following a fifth dose of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM in children who previously received 4 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM.
ADDITIONAL DOSING INFORMATION
If any recommended dose of pertussis vaccine cannot be given, DT (For Pediatric Use) should be given as needed to complete the series.
Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM. There is no need to start the series over again regardless of the time elapsed between doses.
A reduced or fractional dose (dose
Pre-term infants should be vaccinated according to their chronological age from birth.19
Persons 7 years of age or older should not be immunized with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM. They should receive Tetanus and Diphtheria Toxoids (Td) for adult use for routine booster immunization against tetanus and diphtheria.
SIMULTANEOUS VACCINE ADMINISTRATION
In clinical trials, Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM was routinely administered, at separate sites, concomitantly with one or more of the following vaccines: polio vaccine live oral (OPV), hepatitis B vaccine, Haemophilus influenzae type b conjugate vaccine (Hib), and measles, mumps and rubella vaccine (MMR) (see CLINICAL PHARMACOLOGY).
No data are available on the simultaneous administration of inactivated polio vaccine (IPV) as a primary series or varicella vaccine with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM.
When concomitant administration of other vaccines is required, they should be given with different syringes and at different injection sites.
The ACIP encourages routine simultaneous administration of acellular DTaP, Hib, IPV or OPV, hepatitis B, MMR and varicella vaccines for children who are at the recommended age to receive these vaccines and for whom no specific contraindications exist at the time of the visit, unless, in the judgment of the provider, complete vaccination of the child will not be compromised by administering vaccines at different visits. 19, 22 Simultaneous administration is particularly important if the child might not return for subsequent vaccinations.
Vial, 15 Dose (7.5 ml) -- Product No. 40121
Store between 2-8o C (35-46 o F). DO NOT FREEZE.
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