Pharmacokinetics in children

No information is present at this moment.

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%): local reactions such as pain, redness and swelling at the injection site. Reduced appetite, fever, drowsiness, irritability, abnormal crying, nervousness. Vomiting. Common (1-10%): diarrhoea. Bleeding or exsanguination at the injection site. Lymphadenopathy. Uncommon (0.1-1%): extensive swelling of the limb. Convulsions. Upper respiratory tract infection. Coughing, rhinorrhoea. Rare (0.1-0.01%): itching, dermatitis. Also noted: allergic reactions including anaphylaxis. Sleepiness. Hypotonic hyporesponsive episode. Paleness. Apnoea. Rash. Induration at the injection site. Oedematous response in the limb (cyanosis, redness, transient purpura and a lot of crying). Thrombocytopenia.

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

Consider the administration of vaccines containing whooping cough carefully if any of the following symptoms have occurred when previously given: high fever (> 40°C) within 48 hours of vaccination that is not attributable to any other cause; collapse or a shock-like condition within 48 hours of vaccination; continuous (≥ 3 hours) and inconsolable crying within 48 hours of vaccination; convulsions with or without fever within 3 days of vaccination. Be cautious in children with progressive neurological conditions. Excretion of capsular polysaccharide antigen in the urine has been described within 1-2 weeks after vaccination after being given Hib vaccines. This should be considered in cases of primary immunization. In very premature children (born after ≤ 28 weeks of pregnancy), particularly with immature respiratory systems, assess the risk of apnoea and the need to monitor respiratory function for 48-72 hours. Do not postpone vaccination, because there are major benefits to vaccination for this group of children. The immunogenicity of the vaccine can be reduced by immunosuppressive treatment or immunodeficiency. If the DaPTP vaccine is administered at the same time as hepatitis B or meningococcus type C vaccine, inject the vaccines into different limbs. The safety and efficacy in children aged > 3 years (Infanrix-IPV + HiB) and < 6 weeks (primary vaccination) and > 4 years (revaccination) (Pediacel) have not been studied.

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. RIVM, Vaccinatieschema , Geraadpleegd 19 okt 2014
2. Sanofi Pasteur MSD, SPC Pediacel RVG 32118, www.cbg-meb.nl, http://db.cbg-meb.nl/IB-teksten/h32118.pdf (geraadpleegd 28 okt 2009)
3. GlaxoSmithKline BV, SPC Infanrix-IPV+Hib RVG 34567, www.cbg-meb.nl, http://db.cbg-meb.nl/IB-teksten/h22123.pdf (geraadpleegd 28 okt 2009)

Changes

Therapeutic Drug Monitoring

Overdose