Usual Pediatric Dose for Haemophilus influenzae Prophylaxis

3 dose series: 0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• First dose may be given as early as 6 weeks of age.
• Three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis.
• The 3-dose series does not constitute a primary immunization against pertussis; an additional dose of a pertussis-containing vaccine is needed to complete the primary series. Pentacel(R), Quadracel(R) and Daptacel(R) contain the same pertussis antigens manufactured by the same process and should be used to complete the pertussis vaccination series.
• This vaccine may be used to complete the hepatitis B immunization series.
• This vaccine may be given to infants/children who have received 1 or 2 doses of inactivated polio vaccine (IPV) and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.
• This vaccine may be given to infants/children who have received 1 or 2 doses of H. influenzae type b Conjugate vaccine and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.

Use: Prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type B.

Usual Pediatric Dose for Poliomyelitis Prophylaxis

3 dose series: 0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• First dose may be given as early as 6 weeks of age.
• Three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis.
• The 3-dose series does not constitute a primary immunization against pertussis; an additional dose of a pertussis-containing vaccine is needed to complete the primary series. Pentacel(R), Quadracel(R) and Daptacel(R) contain the same pertussis antigens manufactured by the same process and should be used to complete the pertussis vaccination series.
• This vaccine may be used to complete the hepatitis B immunization series.
• This vaccine may be given to infants/children who have received 1 or 2 doses of inactivated polio vaccine (IPV) and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.
• This vaccine may be given to infants/children who have received 1 or 2 doses of H. influenzae type b Conjugate vaccine and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.

Use: Prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type B.

Usual Pediatric Dose for Diphtheria Prophylaxis

3 dose series: 0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• First dose may be given as early as 6 weeks of age.
• Three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis.
• The 3-dose series does not constitute a primary immunization against pertussis; an additional dose of a pertussis-containing vaccine is needed to complete the primary series. Pentacel(R), Quadracel(R) and Daptacel(R) contain the same pertussis antigens manufactured by the same process and should be used to complete the pertussis vaccination series.
• This vaccine may be used to complete the hepatitis B immunization series.
• This vaccine may be given to infants/children who have received 1 or 2 doses of inactivated polio vaccine (IPV) and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.
• This vaccine may be given to infants/children who have received 1 or 2 doses of H. influenzae type b Conjugate vaccine and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.

Use: Prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type B.

Usual Pediatric Dose for Pertussis Prophylaxis

3 dose series: 0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• First dose may be given as early as 6 weeks of age.
• Three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis.
• The 3-dose series does not constitute a primary immunization against pertussis; an additional dose of a pertussis-containing vaccine is needed to complete the primary series. Pentacel(R), Quadracel(R) and Daptacel(R) contain the same pertussis antigens manufactured by the same process and should be used to complete the pertussis vaccination series.
• This vaccine may be used to complete the hepatitis B immunization series.
• This vaccine may be given to infants/children who have received 1 or 2 doses of inactivated polio vaccine (IPV) and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.
• This vaccine may be given to infants/children who have received 1 or 2 doses of H. influenzae type b Conjugate vaccine and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.

Use: Prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type B.

Usual Pediatric Dose for Tetanus Prophylaxis

3 dose series: 0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• First dose may be given as early as 6 weeks of age.
• Three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis.
• The 3-dose series does not constitute a primary immunization against pertussis; an additional dose of a pertussis-containing vaccine is needed to complete the primary series. Pentacel(R), Quadracel(R) and Daptacel(R) contain the same pertussis antigens manufactured by the same process and should be used to complete the pertussis vaccination series.
• This vaccine may be used to complete the hepatitis B immunization series.
• This vaccine may be given to infants/children who have received 1 or 2 doses of inactivated polio vaccine (IPV) and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.
• This vaccine may be given to infants/children who have received 1 or 2 doses of H. influenzae type b Conjugate vaccine and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.

Use: Prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type B.

Usual Pediatric Dose for Hepatitis B Prophylaxis

3 dose series: 0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• First dose may be given as early as 6 weeks of age.
• Three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis.
• The 3-dose series does not constitute a primary immunization against pertussis; an additional dose of a pertussis-containing vaccine is needed to complete the primary series. Pentacel(R), Quadracel(R) and Daptacel(R) contain the same pertussis antigens manufactured by the same process and should be used to complete the pertussis vaccination series.
• This vaccine may be used to complete the hepatitis B immunization series.
• This vaccine may be given to infants/children who have received 1 or 2 doses of inactivated polio vaccine (IPV) and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.
• This vaccine may be given to infants/children who have received 1 or 2 doses of H. influenzae type b Conjugate vaccine and are scheduled to receive the other antigens in this vaccine, however no safety or efficacy data are available in such patients.

Use: Prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type B.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity: Do not administer to anyone with a history of severe hypersensitivity (e.g. anaphylaxis) to a previous dose of this vaccine, any of its ingredients, or any other diphtheria or tetanus toxoid, or pertussis containing-, inactivated polio-, hepatitis B-, or H. influenzae type b-vaccine.
• Encephalopathy: Do not administer to anyone with a history of encephalopathy (e.g. coma, decreased consciousness, prolonged seizures) within 7 days of a previous pertussis-containing vaccine that is not attributable to another identifiable cause.
• Progressive neurological disorder: Do not administer to anyone with a history of progressive neurological disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy until a treatment regiment has been established and the condition stabilized.

Safety and efficacy have not been established in patients younger than 6 weeks or older than 4 years (before 5th birthday); this drug is not recommended for use in these patients.

To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS) at: https://vaers.hhs.gov

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For intramuscular use only.
• The anterolateral aspect of the thigh is the preferred site for infants under 1 year; do not administer into the gluteal area.

Storage requirements:

• Refrigerate; do not freeze.
• Discard if exposed to freezing.
• Protect from light

Reconstitution/preparation techniques:

• Shake vial/syringe just before use until a uniform white, cloudy suspension results.
• Discard if particulate matter or discoloration are seen.
• Do not combine with any other vaccine.