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

Interactions
PK
Renal impairment
References

Tocophersolan (vitamin E-TPG)

Generic name
Tocophersolan (vitamin E-TPG)
Brand name
ATC Code
A11HA08

Pharmacokinetics in children

Absorption: As α-tocopherol, variable. Stored in fatty tissues. Metabolization: Tocophersolan is hydrolysed in the intestine. α-tocopherol is glucuronidated in the liver. Elimination: largely via the bile (75%), with the faeces.

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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

Chronic cholestasis
  • Oral
    • Term neonate
      • 17 mg/kg/day in 1 dose

      • The dose must be adjusted depending on the vitamin E plasma concentration.
        17 mg/kg/day is equivalent to 0.34 ml/kg/day.

    • 1 month up to 18 years
      • 17 mg/kg/day in 1 dose

      • The dose must be adjusted depending on the vitamin E plasma concentration.
        17 mg/kg/day is equivalent to 0.34 ml/kg/day.
Supplementation in cystic fibrosis
  • Oral
    • 0 years up to 18 years
      • For persistent deficiencies 20 - 30 mg/kg/day in 1 dose

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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

No information is present at this moment.

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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

Vedrop must not be used in premature infants.

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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Other plain vitamin preparations
A11HA05
A11HA01
A11HA06
A11HA02
A11HA04
A11HA03

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References

  1. Orphan Europe S.A.R.L, SPC Vedrop, www.emea.europa.eu, http://www.ema.europa.eu/humandocs/PDFs/EPAR/vedrop/emea-combined-h920nl.pdf (geraadpleegd 07 april 2010)
  2. Kneepkens CMF et al, Werkboek Kindergastro-Enterologie, VU Uitgeverij, 2002, 2e druk

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Changes

Changes