Pharmacokinetics in children

No information

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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%): pain, fatigue, redness, swelling at the injection site. Fever ≥ 38 ° C. Loss of appetite, abnormal crying, restlessness, irritability. Vomiting. Drowsiness.

Common (1-10%): Hematoma, induration, injection site nodules, Nervousness. Fever> 39.5 ° C. Diarrhea.

Uncommon (0.1-1%): Heat at injection site, diffuse swelling of the injected limb, sometimes involving the nearby joint. Lymphadenopathy. Increased appetite. Stomach ache. Rash, excessive sweating. Sleep disorders including insomnia. Whiteness. Hypotonia. Fatigue. Cough, upper respiratory tract infections, rhinitis.

Rare (0.01-0.1%): skin rash. Bronchitis. Apnea (especially in very premature children). Angioedema. Thrombocytopenia.

Very rare (<0.01%): convulsions (with or without fever). Dermatitis.

In addition, collapse or shock-like state (hypotonic-hyporesponsive episode (HHE) within 48 hours of vaccination, anaphylactic reactions, anaphylactoid reactions (including urticaria), allergic reactions (including pruritus) have been reported. rare allergic reactions resembling serum sickness, paralysis, neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis, muscle weakness, Guillain-Barré syndrome, encephalopathy, encephalitis and meningitis have been reported and these side effects may also occur with this medicine.

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

Carefully consider administration of pertussis containing vaccines if any of the following have occurred with previous administration:

• high fever (≥ 40 ° C) with no other cause within 48 hours of vaccination;
• collapse or shock-like state within 48 hours of vaccination (hypotonic-hyporesponsive episode [HHE]);
• persistent (> 3 hours) and inconsolable crying within 48 hours of vaccination;
• convulsions with or without fever within 3 days of vaccination.

Use caution if Guillain-Barré syndrome develops within 6 weeks of previous administration of a tetanus toxoid vaccine. Weigh potential benefits and potential risks.

Monitor vaccinees with a history of febrile seizures carefully as such adverse events may occur within 2 to 3 days of vaccination. A greater number of convulsions, with or without fever, and hypotonic hyporesponsive episodes have been observed with the combination of Infanrix with Prevenar. The rate of febrile reactions is higher when combined with pneumococcal or measles, mumps, rubella, chicken pox (MMRV) vaccine. In children with a history of convulsive illness or febrile seizures, an antipyretic such as paracetamol is recommended.

Caution in children with a new neurological condition or a progressive neurological condition.

Due to the risk of hematoma formation, be careful with thrombocytopenia or blood clotting disorders.

For primary immunization in very preterm infants (≤ 28 weeks gestation), take into account the risk of apnea and the need to monitor respiratory functions for 48–72 hours, especially in children with an underdeveloped respiratory system. However, given the importance of vaccination, do not delay or withhold vaccination from these children. There may be a lower immune response in premature children.

Immunological response may be lacking after vaccination of immunocompromised patients.

Urinary excretion of Haemophilus influenza b capsular polysaccharide antigen has been reported following vaccination with a Hib vaccine; if sensitive tests are used within at least 30 days of vaccination, the test may be positive; Always confirm a Hib infection with another test during this time.

Interactions

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

• ANTIINFECTIVES FOR SYSTEMIC USE
• VACCINES

BACTERIAL AND VIRAL VACCINES, COMBINED

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

1. GlaxoSmithKline BV, Infanrix hexa EU/1/00/152, 29-05-2018, www.emea.europa.eu
2. RIVM, Rijksvaccinatieprogramma: vaccinatieschema versie 1.0 , 18 dec 2020

Changes

Therapeutic Drug Monitoring

Overdose