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The following potentially clinically significant laboratory changes in clinical trialsirrespective of relationship to ENTOCORT ECwere reported in greater than or equal to 1of patientshypokalemialeukocytosisanemiahematuriapyuriaerythrocyte sedimentation rate increasedalkaline phosphatase increasedatypical neutrophilsc-reactive protein increased and adrenal insufficiency.
In a peri-and post-natal development studyrats dosed subcutaneously with budesonide during the period of Day 15 post coitum to Day 21 postpartumbudesonide had no effects on delivery but did have an effect on growth and development of offspringIn additionoffspring survival was reduced and surviving offspring had decreased mean body weights at birth and during lactation at exposures 0.02 times the MRHDon a mg/m2 basis at maternal subcutaneous doses of 20 mcg/kg/day and higherThese findings occurred in the presence of maternal toxicity.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leafletDo not use ENTOCORT EC for a condition for which it was not prescribedDo not give ENTOCORT EC to other peopleeven if they have the same symptoms you haveIt may harm themYou can ask your healthcare provider or pharmacist for information about ENTOCORT EC that is written for health professionals.
Signs/symptoms of hypercorticism reported by active questioning of patients in the long-term maintenance clinical trials are displayed in Table 3.
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