Diphtheria and Tetanus Toxoids, Acellular Pertussis, Poliovirus and Haemophilus b Conjugate Vaccine

(dif THEER ee a & TET a nus TOKS oyds ay CEL yoo lar per TUS sis POE lee oh VYE rus & hem OF fi lus bee KON joo gate vak SEEN)

Pentacel: Store at 2°C to 8°C (35°F to 46°F). Do not freeze; discard if product has been frozen. Use immediately after reconstitution.

Infanrix-IPV/Hib [Canadian product]: Store at 2°C to 8°C (35°F to 46°F). Do not freeze; discard if product has been frozen. Following reconstitution, the vaccine is stable for 8 hours at +21°C (70°F); however, the manufacturer recommends using the vaccine immediately.

Pediacel [Canadian product]: Manufacturer recommends storing at 2°C to 8°C (35°F to 46°F). Do not freeze; discard if product has been frozen. Product is stable at >8°C (46°F) to 25°C (77°F) for a maximum of 72 hours.

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

>10%:

Central nervous system: Irritability (≤54% to 77%; >3 hours: ≤4% to 5%), uncontrolled crying (36% to 60%; >3 hours: ≤2%), lethargy (≤24% to 46%; severe: ≤3%), hypoactivity (≤24% to 46%; severe: ≤3%)

Endocrine & metabolic: Increased arm circumference (>5 mm: 34%; >40 mm: <1%)

Local: Tenderness at injection site (39% to 56%; severe: 1% to 5%), erythema at injection site (>5 mm: 7% to 17%)

Miscellaneous: Fussiness (≤54% to 77%; >3 hours: ≤4% to 5%), fever (≥38°C: 6% to 16%)

1% to 10%: Local: Swelling at injection site (>5 mm: 5% to 10%)

<1% (Limited to important or life-threatening): Anaphylaxis, apnea, asthma, brain disease, bronchiolitis, cough, cyanosis, decreased appetite, dehydration, diarrhea, drowsiness, erythema, gastroenteritis, hypersensitivity reaction, hypotonia, hypotonic/hyporesponsive episode, impaired consciousness, injection site reaction (includes abscess at injection site, extensive swelling of injected limb, inflammation at injection site, residual mass at injection site), meningitis, pallor, pneumonia, screaming, seizure, skin discoloration, vomiting

Animal reproduction studies have not been conducted for this combination product. This product is not indicated for use in women of childbearing age.

Diphtheria/haemophilus/pertussis/tetanus/polio (Pentacel) 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 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 constitutes a booster vaccination against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis

Children who have completed a four dose series with Pentacel vaccine should receive a fifth dose of DTaP vaccine at 4 to 6 years of age. Because the pertussis antigens in DAPTACEL vaccine are the same as those in Pentacel 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 vaccine.

Children previously vaccinated with one or more doses of DAPTACEL vaccine: Pentacel 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 vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.

Children previously vaccinated with one or more doses of IPV: Pentacel 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 vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.

Children previously vaccinated with one or more doses of 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 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 vaccine. However, the safety and efficacy of Pentacel 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.

Diphtheria/haemophilus/pertussis/tetanus/polio (Pentacel) 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 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 constitutes a booster vaccination against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis

Children who have completed a four dose series with Pentacel vaccine should receive a fifth dose of DTaP vaccine at 4 to 6 years of age. Because the pertussis antigens in DAPTACEL vaccine are the same as those in Pentacel 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 vaccine.

Children previously vaccinated with one or more doses of DAPTACEL vaccine: Pentacel 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 vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.

Children previously vaccinated with one or more doses of IPV: Pentacel 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 vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.

Children previously vaccinated with one or more doses of 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 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 vaccine. However, the safety and efficacy of Pentacel 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.

Data not available

Data not available

Pentacel is supplied in two vials; be sure to administer the contents of both vials as directed in package labeling.