Examples of using Systemic exposures in English and their translations into Dutch
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Medicine
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Studies in animals have shown reproductive toxicity where systemic exposures were several times above the therapeutic exposure level see section 5.3.
However, systemic exposures achieved in animals were either in a similar range
Histamine dihydrochloride was not teratogenic in rats or rabbits at doses resulting in several hundred- fold greater systemic exposures than the clinical exposure. .
effects on embryofoetal survival in the rat at maternal systemic exposures lower than those in humans at therapeutic doses see section 5.3.
foetal malformations of the great vessels and skull at systemic exposures similar to human exposure at recommended dose.
Nephrotoxicity was observed in animals at systemic exposures at least 3-10 times higher than those achieved in humans at the recommended therapeutic dose of 10 mg/ day.
not in the rat even at very high systemic exposures.
Concomitant use of inhaled glucocorticoids metabolised with CYP3A can increase systemic exposures of the glucocorticoids, and cases of Cushing's syndrome and subsequent adrenal suppression
there were indications of an increase in early embryonic deaths in rabbits at relatively low systemic exposures, comparable to those achieved in humans.
Systemic exposures to lomitapide at these doses were estimated to be 4 times(females)
post-natal development in rats were seen at systemic exposures up to 2,300 times human exposures at the maximum recommended intrathecal dose.
Systemic exposures of atazanavir in mice(males),
were seen in rats and monkeys at systemic exposures 1.4-fold and 4.6-fold greater,
cardiomegaly) at systemic exposures 36-fold higher than observed at the MHRD.
female rats at systemic exposures approximately 14 times those observed in humans at the therapeutic dose.
rabbits provided systemic exposures of 1 to 4
In a repeat dose toxicity study in juvenile rats, cobimetinib systemic exposures were 2 to11 fold higher on post natal day 10 than on post natal day 38 when exposures were similar to those in adult rats.
In an embryo-foetal development study in rats, ossification delays of metatarsal bones were observed at systemic exposures 73 times and 19 times higher
In mice, increased incidences of combined bronchiolar/alveolar adenoma and/or carcinoma were observed at systemic exposures, 144- 213 times the expected plasma exposure in humans at 1 mg/day.
However, in a 9 month study in dogs, no organ weight changes nor gross or histomorphologic findings were present in male reproductive organs at systemic exposures 35-fold above the therapeutic exposure in humans at 40 mg.