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Pentacel

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Pentacel

Pentacel

INDICATIONS

Pentacel (tetanus toxoid conjugate) vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel (tetanus toxoid conjugate) vaccineis approved for use in children 6 weeks through 4 years of age (prior to fifth birthday).

DOSAGE AND ADMINISTRATION

Vaccination Schedule

Pentacel (tetanus toxoid conjugate) vaccine is approved for administration as a 4 dose series at 2, 4 and 6, and 15-18 months of age. The first dose may be given as early as 6 weeks of age. Four doses of Pentacel (tetanus toxoid conjugate) vaccine constitute a primary immunization course against pertussis. Three doses of Pentacel (tetanus toxoid conjugate) vaccine constitute a primary immunization course against diphtheria, tetanus, H influenzae type b invasive disease, and poliomyelitis; the fourth dose constitutes a booster vaccination against diphtheria, tetanus, H influenzae type b invasive disease, and poliomyelitis (See CLINICAL PHARMACOLOGY.)

If a decision is made to withhold pertussis vaccine, (see CONTRAINDICATIONS and WARNINGS), vaccination against diphtheria, tetanus, poliomyelitis and invasive disease due to H influenzae type b should be provided.

Children who have completed a four-dose series with Pentacel (tetanus toxoid conjugate) vaccine should receive a fifth dose of DTaP vaccine at 4-6 years of age. Because the pertussis antigens in DAPTACEL vaccine are the same as those in Pentacel (tetanus toxoid conjugate) vaccine (although with different amounts of detoxified PT and FHA), these children should receive DAPTACEL vaccine as their fifth dose of DTaP. However, data are not available to evaluate the safety of DAPTACEL vaccine following four previous doses of Pentacel (tetanus toxoid conjugate) vaccine.

Children Previously Vaccinated With One or More Doses of DAPTACEL Vaccine: Pentacel (tetanus toxoid conjugate) vaccine may be used to complete the first 4 doses of the DTaP series in infants and children who have received 1 or more doses of DAPTACEL vaccine and are also scheduled to receive the other antigens of Pentacel (tetanus toxoid conjugate) vaccine. However, the safety and efficacy of Pentacel (tetanus toxoid conjugate) vaccine in such infants have not been evaluated.

Children Previously Vaccinated With One or More Doses of IPV: Pentacel (tetanus toxoid conjugate) vaccine may be used to complete the 4 dose IPV series in infants and children who have received 1 or more doses of another licensed IPV vaccine and are also scheduled to receive the other antigens of Pentacel (tetanus toxoid conjugate) vaccine. However, the safety and efficacy of Pentacel (tetanus toxoid conjugate) vaccine in such infants have not been evaluated.

Children Previously Vaccinated With One or More Doses of Haemophilus b Conjugate Vaccine: Pentacel (tetanus toxoid conjugate) vaccine may be used to complete the vaccination series in infants and children previously vaccinated with one or more doses of a Haemophilus b Conjugate Vaccine (either separately administered or as part of another combination vaccine), who are also scheduled to receive the other antigens of Pentacel (tetanus toxoid conjugate) vaccine. However, the safety and efficacy of Pentacel (tetanus toxoid conjugate) vaccine in such infants have not been evaluated. If different brands of Haemophilus b Conjugate Vaccines are administered to complete the series, three primary immunizing doses are needed, followed by a booster dose.

Administration

Pentacel (tetanus toxoid conjugate) vaccine should be inspected visually for extraneous particulate matter and/or discoloration before administration. (See DESCRIPTION.) If these conditions exist, Pentacel (tetanus toxoid conjugate) vaccine should not be administered.

Reconstitution of Freeze-Dried Product and Withdrawal from Stoppered Vial

Thoroughly but gently shake the vial of DTaP-IPV component, withdraw the entire liquid content and inject into the vial of the lyophilized ActHIB vaccine component. Shake the vial now containing Pentacel (tetanus toxoid conjugate) vaccine thoroughly until a cloudy, uniform suspension results. Withdraw and administer a 0.5 mL dose of Pentacel (tetanus toxoid conjugate) vaccine intramuscularly. Pentacel (tetanus toxoid conjugate) vaccine should be used immediately after reconstitution. Refer to Figures 1, 2, 3, 4 and 5.

Pentacel (tetanus toxoid conjugate) Vaccine: Instructions For Reconstitution of ActHIB Vaccine Component With DTaP-IPV Component

Gently shake the vial of DTap-IPV component.

Figure 1: Gently shake the vial of DTap-IPV component.

Withdraw the entire liquid content.

Figure 2: Withdraw the entire liquid content.

Insert the syringe neddle through the stopper of the vial

Figure 3: Insert the syringe neddle through the stopper of the vial of lyophilized ActHIB vaccine component and inject the liquid into the vial.

Shake vial thoroughly

Figure 4: Shake vial thoroughly

After reconstitution, immediately withdraw 0.5mL of pentacel vaccine and administer intramuscularly

Figure 5 : After reconstitution, immediately withdraw 0.5mL of pentacel (tetanus toxoid conjugate) vaccine and administer intramuscularly pentacel (tetanus toxoid conjugate) vaccine should be used after reconstitution

In infants younger than 1 year, the anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection. In older children, the deltoid muscle is usually large enough for injection. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product intravenously or subcutaneously.

Concomitant Administration with Other Vaccines

In clinical trials, Pentacel (tetanus toxoid conjugate) vaccine was routinely administered, at separate sites, concomitantly with one or more of the following vaccines: hepatitis B vaccine, 7-valent pneumococcal conjugate vaccine, MMR and varicella vaccines. (See CLINICAL PHARMACOLOGY and ADVERSE REACTIONS.) When Pentacel (tetanus toxoid conjugate) vaccine is given at the same time as another injectable vaccine(s), the vaccines should be given with different syringes.

HOW SUPPLIED

5 Dose Package containing 5 vials of DTaP-IPV Component to be used to reconstitute five single dose vials of lyophilized ActHIB vaccine component - Product No. 49281-510-05.

Storage

Store at 2° to 8°C (35° to 46°F). Do not freeze. Discard product if exposed to freezing.

Do not use after expiration date.

Pentacel (tetanus toxoid conjugate) vaccine should be used immediately after reconstitution.

Product information as of June 2008. Manufactured by: Sanofi Pasteur Limited, Toronto, Ontario, Canada and Sanofi Pasteur SA, Lyon, France. Distributed by:Sanofi Pasteur Inc. Swiftwater PA 18370, USA. FDA Rev date: 6/20/2008

Last reviewed on RxList: 7/25/2008
This monograph has been modified to include the generic and brand name in many instances.

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