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There are limited data on the use of entocort cr capsules in children see sections 5.

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Budesonide pharmacokinetics were dose-proportional following repeated administration in the dose range of 3 to 15 mgNo accumulation of budesonide was observed following repeated dosing.

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individualsChicken pox and measlesfor examplecan have a more serious or even fatal course in susceptible patients or patients on immunosuppressant doses of corticosteroidsIn patients who have not had these diseasesparticular care should be taken to avoid exposure.

In patients with mildChild-Pugh Class An=4or moderateChild-Pugh Class Bn=4hepatic impairmentbudesonide 4 mg was administered orally as a single doseThe patients with moderate hepatic impairment had a 3.5-fold higher AUC compared to the healthy subjects with normal hepatic function while the patients with mild hepatic impairment had an approximately 1.4-fold higher AUCThe Cmax values demonstrated similar increasessee DOSAGE AND ADMINISTRATIONWARNINGS AND PRECAUTIONSThe increased systemic exposure in patients with mild hepatic impairment was not considered to be clinically relevantPatients with severe liver impairmentChild-Pugh Class Cwere not studied.

Use of ENTOCORT EC in this age group is supported by evidence from adequate and well-controlled studies of ENTOCORT EC in adultsand by safety and pharmacokinetic studies performed in pediatric patients.

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reduced liver function affects the elimination of glucocorticosteroids, and increased systemic availability of oral entocort ec has been demonstrated in patients with liver cirrhosis.

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