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

Interactions
PK
Renal impairment
References

Insuline Glargine

Generic name
Insuline Glargine
Brand name
ATC Code
A10AE04

Pharmacokinetics in children

Geen informatie

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

On-label

Licensed use Licensed use

Registration Status Title

Lantus is geregistreerd voor de behandeling van kinderen vanaf 2 jaar met diabetes mellitus, waarbij behandeling met insuline vereist is.

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Available formulations

Inj.vlst. 100 E/ml

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Dosages

Diabetes mellitus, insulin-dependent
  • Subcutaneous
    • 2 years up to 18 years
      • Dosering op geleide van bloedsuikers.

      • Behandeling door of na overleg met een kinderarts-specialist (kinder-endocrinoloog) die ervaring heeft met gebruik van insulines.

         

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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

Bij kinderen jonger dan 18 jaar traden relatief vaker huidreacties (uitslag, urticaria) op de injectieplaats op dan bij volwassenen

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

Adult Side Effects

Zeer vaak (> 10%): hypoglykemie. Vaak (1–10%): reacties op de injectieplaats, zoals roodheid, pijn, jeuk, zwelling, huiduitslag, ontsteking (meestal voorbijgaand na enkele dagen tot weken). Lokaal lipodystrofie, vooral bij herhaalde injectie op dezelfde plaats. Zelden (0,01–0,1%): allergische reacties. Oedeem, verslechterde visus en (verergering van) diabetische retinopathie, met name tijdelijk bij een snelle verbetering van de glucoseregulatie. Zeer zelden (< 0,01%): dysgeusie. Myalgie.

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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. Sanofi-Aventis Deutschland GmbH, SPC Lantus (EU/1/00/134/001-004 en 012) (12-03-2015), www.ema.europa.eu
  2. CHMP, Pending EC decision on Lantus, 19 mei 2012, http://www.emea.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000284/smops/Positive/human_smop_000370.jsp&mid=WC0b01ac058001d127

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Changes

Changes