Примери за използване на Embryo-fetal на Английски и техните преводи на Български
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Animal studies showed slight embryo-fetal toxicity(see section 5.3).
Two embryo-fetal development(EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day.
There was no treatment-related effect on embryo-fetal development.
The NOAEL for maternal-, embryo-fetal-, and offspring toxicity in rats was 49 times human exposure.
Therefore, preclinical results do not suggest a risk to fertility or embryo-fetal development.
In rabbits reproductive studies, embryo-fetal toxicity was observed at maternally toxic dosages.
Preclinical fertility studies were conducted andshowed no evidence of effect on fertility and embryo-fetal development.
A second study on embryo-fetal development in Lister-Hooded rats did not achieve sufficient exposure.
Enzalutamide treatment of pregnant mice resulted in an increased incidence of embryo-fetal deaths and external and skeletal changes.
The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has been assessed in rats.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity,carcinogenic potential, and embryo-fetal development.
An embryo-fetal study in rabbits reported no effects at intravenous doses up to 80 mg/kg colistimethate sodium(32 mg colistin base/kg).
A NOAEL of 78 times human exposure was derived for embryo-fetal toxicity in rabbits, and for maternal toxicity the NOAEL was 2.1 times human exposure.
In pregnant rats, daily intramuscular injections of 0.5, 1, or 4 Units/kg during the period of organogenesis(from gestation days 6 to 16),did not induce significant test article-related toxicological effects on the dams and on embryo-fetal development.
The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials.
Non-clinical data obtained with the mock-up vaccine using a H5N1 vaccine strain reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance,female fertility, embryo-fetal and postnatal toxicity(up to the end of the lactation period).
Repeated-dose toxicity testing and embryo-fetal toxicity studies are impractical due to induction of, and interference with antibodies.
In a study on embryo-fetal development in rats, metformin alone(300 mg/kg/day) caused absent/incomplete ossification, while canagliflozin alone(60 mg/kg/day) had no effects.
Developmental toxicity studies in the rat andrabbit have shown embryo-fetal lethality at maternally toxic dosages, but no direct embryo-foetal toxicity below maternally toxic dosages.
The adverse effects on embryo-fetal development at 350 mg/kg/day were associated with maternal toxicity(body weight loss/decreased body weight gain and decreased food consumption during gestation day(GD) 6 to 8).
In reproductive toxicity studies in mice, rats, hamsters, rabbits and dogs,dexamethasone has led to embryo-fetal malformations such as increase in cleft palate and skeletal defects; decreases in thymus, spleen and adrenal weight; lung, liver, and kidney abnormalities; and inhibition of growth.
In animal studies, embryo-fetal toxicities including congenital malformations were observed at brentuximab doses that resulted in maternal exposures that were similar to human exposures at the recommended dose.
Animal studies donot indicate direct or indirect harmful effects with respect to maintenance of pregnancy or embryo-fetal development; maternal toxicity was noted in rats, but not in monkeys at doses in excess of the human dose, and a weaker secondary immune response to antigen challenge was observed in the offspring of monkeys(see section 5.3).
The no observed adverse effect level for embryo-fetal toxicity in this study was 10 µg/kg/day, which corresponded to a systemic exposure of approximately 3-5 times the exposures observed in patients treated with the clinical dose.
Studies carried out in rats did not reveal significant findings on fertility, embryo-fetal development or pre- and post-natal development at any of the tested doses(corresponding to a systemic exposure in rats similar or lower than that observed in humans at the recommended dose of 150 mg once daily).