Examples of using Repeat dose in English and their translations into Hungarian
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Repeat dose.
They may also be given a repeat dose after one hour.
The repeat dose is not recommended in these populations.
Cataracts and lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies.
Single dose and repeat dose studies in a range of animal models(rats, dogs and primates) were performed.
The non clinical programme was based on 7 repeat dose toxicology studies in rats and dogs.
Other long-term repeat dose and carcinogenicity studies revealed no clinically relevant changes.
No evidence of an associated risk was identified in the rat and monkey repeat dose toxicity studies.
A single dose study in rabbits and a 13-week repeat dose toxicity study in Cynomolgus monkeys were conducted.
If a repeat dose is required to control the bleed, the prolonged half-life of ALPROLIX should be taken into account(see section 5.2).
The second vaccination should beadministered one month after the first vaccination, and a repeat dose should be administered after 12 months.
Adverse reactions seen in repeat dose studies in animals include hyperpigmentation of the thyroid and tubular degeneration in the kidney.
The recommended daily dose of 12.5 mg/ kg body weight corresponds to the Maximum Tolerated Dose(MTD)that was derived from repeat dose toxicity studies in healthy Beagle dogs.
A second or repeat dose when seizures re-occur after an initial response should not be given without prior medical advice(see section 5.2).
Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but not in monkeys.
In a repeat dose study with 12 patients receiving Abraxane administered intravenously at 260 mg/m2, intrapatient variability in AUC was 19%(range= 3.21%-37.70%).
Cataracts and lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were.
Administration of rifampin(a CYP3A4/CYP2C8 inducer) 600 mgonce daily with dabrafenib 150 mg twice daily resulted in a decrease in repeat dose dabrafenib Cmax(27%) and AUC(34%).
Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 1.4-fold greater than that achieved therapeutically.
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.
No effects were seen on male orfemale reproductive organs in repeat dose toxicology studies in mice, rats or monkeys with levodopa alone, or in combination with carbidopa.
One out of two 26-week rat repeat dose studies, initiated in 4-5 weeks old rats, showed a dose related increase of the incidence of malignant hibernoma, a rare tumour in rats.
There were no notable effects in the male andfemale reproductive organs in mice based on repeat dose toxicity studies and no binding to reproductive tissues was observed in tissue cross-reactivity studies.
The main findings observed in repeat dose toxicity studies in rats and dogs comprised atrophic, inflammatory and/or degenerative changes affecting the epithelia of the cornea(accompanied by corneal translucencies and opacities in dogs at ophthalmology examination), GI tract(including tongue), skin, and male and female reproductive tracts with secondary changes in spleen.
No effects on electrocardiograms, including QT and QTc intervals,were seen in a repeat dose safety pharmacology study in monkeys at systemic exposures 4.6-fold greater than the concentrations obtained at therapeutic doses in humans.
Knowledge of the mechanism of action or from repeat dose studies that the active substance may have neurotoxic or developmental neurotoxic properties then additional information or specific studies will be required.
No effects on electrocardiograms, including QT and QTc intervals,were seen in a repeat dose safety pharmacology study in monkeys at maximal plasma concentrations 8.5-fold greater than the concentrations obtained at therapeutic doses in humans.
Cataracts and lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
In addition to the above mentioned effects,several other less adverse effects were found in the repeat dose studies; in particular decreased body weight gain, food intake and increased liver weight without a histological correlate and of unclear clinical significance.
No effects on electrocardiograms, including QT and QTc intervals,were seen in a repeat dose safety pharmacology study in monkeys at maximal plasma concentrations 8.9-fold greater than the concentrations obtained at therapeutic doses in humans with 300 mg intravenous infusion administration.