Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Haemophilus influenzae B vaccine (HiB)

Generic name
Haemophilus influenzae B vaccine (HiB)
Brand name
ATC Code
J07AG01

Pharmacokinetics in children

No information

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

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Available formulations

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Dosages

NATIONAL VACCINATION PROGRAMME for HiB (Haemophilus influenzae B)
  • Intramuscular
    • 2 months
      [1]
      • First vaccination 0.5 ml/dose, once only.

      • Can be at the same time as the DPTP injection; in that case, both injections should be given in different parts of the body. The national vaccination programme uses combined DPTP-HiB or DPTP-HiB-HepB vaccines (see the monographs in question)

         

    • 3 months
      [1]
      • Second vaccination 0.5 ml/dose, once only.

      • Can be at the same time as the DPTP injection; in that case, both injections should be given in different parts of the body. The national vaccination programme uses combined DPTP-HiB or DPTP-HiB-HepB vaccines (see the monographs in question)

    • 4 months
      [1]
      • Third vaccination 0.5 ml/dose, once only.

      • Can be at the same time as the DPTP injection; in that case, both injections should be given in different parts of the body. The national vaccination programme uses combined DPTP-HiB or DPTP-HiB-HepB vaccines (see the monographs in question)

    • 11 months
      [1]
      • Fourth vaccination 0.5 ml/dose, once only.

      • Can be at the same time as the DPTP injection; in that case, both injections should be given in different parts of the body. The national vaccination programme uses combined DPTP-HiB or DPTP-HiB-HepB vaccines (see the monographs in question)
Vaccination for Haemophilus influenzae B: alternative schedule
  • Intramuscular
    • 6 months up to 12 months

      • If the first vaccination is given at age 6-12 months, the following vaccination pattern should be used:
        first vaccination: at any time once the child has reached the age of 6-12 months: 0.5 ml/dose one-time
        Second vaccination: 1-2 months after the first vaccination: 0.5 ml/dose one-time
        Third vaccination: at the age of 14-18 months: 0.5 ml/dose one-time

        If the first vaccination is given after the age of 12 months, a single dose (0.5 ml/dose, one-time) is sufficient.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Very common (> 10%): reaction at the injection site (redness, pain, swelling). Irritability, restlessness. Lack of appetite. Common (1-10%): crying (inconsolable or abnormal), vomiting, diarrhoea, pyrexia (sometimes above 39°C). Uncommon (0.1-1%): (atypical) rash. Very rare (< 0.01%): hypersensitivity reactions such as rashes, itching, urticaria, angio-oedema, larynx oedema, anaphylactic and anaphylactoid responses. Convulsions (with or without fever), vasovagal reaction. Oedema of the lower limbs, reducing within 24 hours. In very premature children (≤ 28 weeks pregnancy): apnoea.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Acute infectious disease with high fever. Hypersensitivity to tetanus toxoid.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

The vaccine cannot entirely prevent the occurrence of the disease. The vaccine does not protect against other Haemophilus influenzae serotypes than serotype B, or against meningitis with other causes. In primary immunization of very premature children (≤ 28 weeks of pregnancy), there is a risk of apnoea: monitor respiratory function for 48–72 hours, particularly in children whose anamnesis includes a respiratory system that was not yet fully developed. Given the importance of vaccinating, the vaccination should not be stopped or withheld from these children. Immunodeficient patients (because of immunosuppressants, HIV, functional or anatomical asplenia or genetic defects) have a reduced immunological response. Because of the risk of haematoma, caution is needed in thrombocytopenia or clotting disorders. Immunization with this vaccine does not replace the standard immunization against tetanus.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Cholera vaccines
J07AE01
Meningococcal vaccines
J07AH09
J07AH07
J07AH08
Pertussis vaccines
J07AJ52
Pneumococcal vaccines
J07AL02
Tuberculosis vaccines
J07AN01
Typhoid vaccines
J07AP03
J07AP01

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References

  1. RIVM, Rijksvaccinatieprogramma, Geraadpleegd 25 okt 2014
  2. Sanofi Pasteur MSD, SPC Act-Hib RVG 17508, www.cbg-meb.nl, (geraadpleegd 30 okt 2009), http://db.cbg-meb.nl/IB-teksten/h17508.pdf
  3. GlaxoSmithKline BV, SPC Hiberix RVG 19510, www.cbg-meb.nl, (geraadpleegd 30 okt 2009), http://db.cbg-meb.nl/IB-teksten/h19510.pdf

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Changes

Changes