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

Interactions
PK
Renal impairment
References

Influenza vaccine

Generic name
Influenza vaccine
Brand name
ATC Code
J07BB02

Pharmacokinetics in children

No information

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

No information is present at this moment.

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Available formulations

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Dosages

Annual influenza vaccination
  • Intramuscular
    • 6 months up to 18 years
      [1] [6] [8]
      • 0.5 ml/dose, once only. Repeat the vaccination after at least 4 weeks in children aged less than 9 years unless the child has been fully vaccinated previously..
Prophylaxis for influenza (in an officially declared non-medical healthcare situation)
  • Intramuscular
    • ≥ 6 months
      [2] [3] [5]
      • PANDEMRIX:
        6 months-9 years: 0.25 ml/dose. Repeat after at least 3 weeks
        > 10 years: 0.5 ml/dose. Repeat after at least 3 weeks if necessary

        FOCETRIA:
        6 months - 17 years: 0.5 ml/dose. Repeat after at least 3 weeks

         

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

Children 6 to 36 months of age:
Very common (> 10%): pain, tenderness, erythema at injection site. Headache. Vomiting, diarrhea. Myalgia. Irritability, irritability, loss of appetite, abnormal crying, malaise, fever, drowsiness.

Common (1-10%): induration, swelling, ecchymosis of the injection site. Chills.

Uncommon (0.1-1%): hypersensitivity.

Rare (< 0.1%): Local: rash, itching at the injection site. Systemic allergic reactions such as itching, papular rash.

Also reported: anaphylactic reaction.

Children aged 3 to 18 years:
Very common (> 10%): pain, redness, swelling, hardening at the injection site. Headache, drowsiness. Loss of appetite. Abdominal pain, nausea. Irritability, irritability. Myalgia. Fatigue, malaise.


Common (1-10%): ecchymosis at injection site. Sweating. Diarrhea, vomiting. Arthralgia. Fever, chills.


Uncommon (0.1-1%): heat, itching at injection site. Thrombocytopenia. Restlessness. Dizziness. Abdominal pain.


Furthermore, allergic reactions (in rare cases leading to shock) have been reported. Transient lymphadenopathy. Neuralgia, paresthesia, febrile convulsions, other neurological disorders such as encephalomyelitis, neuritis and Guillain-Barré syndrome. Vasculitis (such as Henoch-Schönlein purpura) with transient kidney problems in very rare cases. Itching, rash.

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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

No information available on specific contra indications in children.

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

Warnings & precautions

No information available on specific warnings and precautions in children.

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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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References

  1. Solvay Biologicals BV, SPC Influvac (RVG 22289), www.cbg-meb.nl, Geraadpleegd 12 aug 2010, http://db.cbg-meb.nl/IB-teksten/h22289.pdf
  2. Gezondheidsraad. . 2009;3-5: (geraadpleegd 11 nov 2009), Vaccinatie tegen pandemische influenza A/H1N1 2009: doelgroepen en prioritering (3), www.gezondheidsraad.nl, 2009, 3-5, (geraadpleegd 11 nov 2009)
  3. GlaxoSmithKline Biologicals BV. , SPC Pandemrix, (EU/1/08/452/001), Geraadpleegd 24-08-2015
  4. LAREB, Kwartaalbericht 1, 2014
  5. Novartis Vaccines and Diagnostics. , SPC Focetria, EU/1/07/385/001-002, Geraadpleegd 11 nov 2009
  6. Vrieze HA et al, NHG/SNPG Handleiding Griepvaccinatie herziening 2016, https://www.nhg.org/sites/default/files/content/nhg_org/uploads/final_nhg_snpg_praktijkhandleiding_griepvaccinatie_2019.pdf
  7. Abbott Biologicals B.V. , SmPC Influvac Tetra (RVG 119816) 07-08-2019, www.geneesmiddeleninformatiebank.nl
  8. Sanofi Pasteur Europe, SmPC Vaxigrip Tetra (RVG 117963) 31-07-2019, www.geneesmiddeleninformatiebank.nl

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Changes

Changes