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10 gange den anbefalede humandosis på 20 mg/ kg/ dag baseret på kropsoverfladeareal.
mannitol (e421) calcium hydrogen phosphate, anhydrous crospovidone type a ascorbic acid (e300) sodium stearyl fumarate riboflavin (e101)
Last Update: 2011-10-23
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1, 5 gange den daglige humandosis [90 mg] baseret på systemisk optagelse).
etoricoxib was not teratogenic in reproductive toxicity studies conducted in rats at 15 mg/ kg/ day (this represents approximately 1.5 times the daily human dose [90 mg] based on systemic exposure).
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disse effekter blev observeret ved eksponeringer, som lå 14 og 3 gange højere end den daglige humandosis, baseret på auc hos henholdsvis rotter og hunde.
these effects were observed at exposures of 14 and 3 times the human daily dose based on the auc in rats and dogs respectively.
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der er i toksikologiske studier med gentagne doser til gnavere og hunde med doser 26 gange humandosis set testikelforandringer (seminiferøs tubulær degeneration) .
testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures 26 times those in humans.
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rotter udviklede hepatocellulære og thyroide follikulære celleadenomer ved doser 2 gange den daglige humandosis [ 90 mg ] baseret på systemisk optagelse ved daglig dosering i ca.
rats developed hepatocellular and thyroid follicular cell adenomas at 2-times the daily human dose [ 90 mg ] based on systemic exposure when dosed daily for approximately two years.
Last Update: 2012-04-12
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hos rotter og kaniner sås ingen embryo/ føtal påvirkning ved systemisk optagelse der svarer til, eller er lavere, end den daglige humandosis [90 mg].
in rats and rabbits, no embryo/ foetal effects were seen at systemic exposures equal to or less than those at the daily human dose [90 mg].
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9 i gentagne dosis- toksicitetsstudier med tigecyklin på rotter og hunde sås lymfoid depletion/ atrofi af lymfekirtler, milt og thymus, nedsat antal erytrocytter, retikulocytter, leucocytter og trombocytter i forbindelse med knoglemarvshypocellularitet og uønskede nyre - og gastrointestinale virkninger ved eksponeringer med tigecyklin på 8 og 10 gange højere end den daglige humandosis, baseret på auc hos henholdsvis rotter og hunde.
in repeated dose toxicity studies in rats and dogs, lymphoid depletion/ atrophy of lymph nodes, spleen and thymus, decreased erythrocytes, reticulocytes, leukocytes, and platelets, in association with bone marrow hypocellularity, and adverse renal and gastrointestinal effects have been seen with tigecycline at exposures of 8 and 10 times the human daily dose based on auc in rats and dogs, respectively.
Last Update: 2012-04-12
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