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Pentacel

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Pentacel

Indications
Dosage
How Supplied

INDICATIONS

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

DOSAGE AND ADMINISTRATION

Immunization Series

Pentacel vaccine is to be administered as a 4 dose series at 2, 4, 6 and 15-18 months of age. The first dose may be given as early as 6 weeks of age. Four doses of Pentacel vaccine constitute a primary immunization course against pertussis. Three doses of Pentacel vaccine constitute a primary immunization course against diphtheria, tetanus, H influenzae type b invasive disease, and poliomyelitis; the fourth dose is a booster for diphtheria, tetanus, H influenzae type b invasive disease, and poliomyelitis immunizations. [See Clinical Studies]

Mixed Sequences of Pentacel Vaccine and DTaP Vaccine

While Pentacel and DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [DTaP], Sanofi Pasteur Limited) vaccines contain the same pertussis antigens, manufactured by the same process, Pentacel vaccine contains twice the amount of detoxified pertussis toxin (PT) and four times the amount of filamentous hemagglutinin (FHA) as DAPTACEL vaccine. Pentacel vaccine may be used to complete the first 4 doses of the 5-dose 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 vaccine. However, data are not available on the safety and immunogenicity of such mixed sequences of Pentacel vaccine and DAPTACEL vaccine for successive doses of the primary DTaP series. Children who have completed a 4-dose series with Pentacel vaccine should receive a fifth dose of DTaP vaccine using DAPTACEL at 4-6 years of age.1

Data are not available on the safety and effectiveness of using mixed sequences of Pentacel vaccine and DTaP vaccine from different manufacturers.

Mixed Sequences of Pentacel Vaccine and IPV Vaccine

Pentacel vaccine may be used in infants and children who have received 1 or more doses of another licensed IPV vaccine and are scheduled to receive the antigens of Pentacel vaccine. However, data are not available on the safety and immunogenicity of Pentacel vaccine in such infants and children.

The Advisory Committee on Immunization Practices (ACIP) recommends that the final dose in the 4-dose IPV series be administered at age ≥ 4 years.2 When Pentacel vaccine is administered at ages 2, 4, 6, and 15-18 months, an additional booster dose of IPV vaccine should be administered at age 4-6 years, resulting in a 5-dose IPV series.2

Mixed Sequences of Pentacel Vaccine and Haemophilus b Conjugate Vaccine

Pentacel vaccine may be used to complete the vaccination series in infants and children previously vaccinated with one or more doses of 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 vaccine. However, data are not available on the safety and immunogenicity of Pentacel vaccine in such infants and children. 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

The package contains a vial of the DTaP-IPV component and a vial of lyophilized ActHIB vaccine component.

After removing the “flip-off” caps, cleanse the DTaP-IPV and ActHIB vial stoppers with a suitable germicide. Do not remove the vial stoppers or metal seals holding them in place. Just before use, 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. Gently swirl the vial now containing Pentacel vaccine until a cloudy, uniform, white to off-white (yellow tinge) suspension results.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, Pentacel vaccine should not be administered.

Using a sterile needle and syringe and aseptic technique, withdraw and administer a single 0.5 mL dose of Pentacel vaccine intramuscularly. Use a separate sterile needle and syringe for each injection. Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Pentacel vaccine should be used immediately after reconstitution. Refer to Figures 1, 2, 3, 4 and 5.

Pentacel Vaccine: Instructions for Reconstitution of ActHIB Vaccine Component with DTaP-IPV Component

Figure 1

Gently shake the vial - Illustration

Gently shake the vial of DTaP-IPV component.

Figure 2

Withdraw the entire liquid - Illustration

Withdraw the entire liquid content.

Figure 3

Insert the syringe needle through the stopper - Illustration

Insert the syringe needle through the stopper of the vial of lyophilized ActHIB vaccine component and inject the liquid into the vial.

Figure 4

Swirl vial gently - Illustration

Swirl vial gently.

Figure 5

Withdraw 0.5 mL of Pentacel vaccine - Illustration

After reconstitution, immediately withdraw 0.5 mL of Pentacel vaccine and administer intramuscularly. Pentacel vaccine should be used immediately 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.

Pentacel vaccine should not be mixed in the same syringe with other parenteral products.

HOW SUPPLIED

Dosage Forms And Strengths

Pentacel vaccine is a suspension for injection (0.5-mL dose) supplied as a liquid vaccine component that is combined through reconstitution with a lyophilized vaccine component, both in single dose vials. [See DOSAGE AND ADMINISTRATION and Storage and Handling]

Storage And Handling

The vial stoppers for the DTaP-IPV and ActHIB vaccine components of Pentacel are not made with natural rubber latex.

5 Dose Package (NDC No. 49281-510-05) containing 5 vials of DTaP-IPV component (NDC No. 49281-560-05) to be used to reconstitute 5 single dose vials of lyophilized ActHIB vaccine component (NDC No. 49281-545-15).

Pentacel vaccine should be stored at 2° to 8°C (35° to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

Pentacel vaccine should be used immediately after reconstitution.

REFERENCES

1 DAPTACEL® [full prescribing information]. Toronto, ON: Sanofi Pasteur; 2011.

2 CDC. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding routine poliovirus vaccination. MMWR 2009;58:829-30.

Manufactured by: Sanofi Pasteur Limited, Toronto Ontario Canada and Sanofi Pasteur SA, Lyon France. Distributed by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA

Last reviewed on RxList: 8/18/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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