Примери за използване на Tivozanib на Английски и техните преводи на Български
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The active substance is tivozanib.
Tivozanib is not recommended in patients with severe hepatic impairment.
There is no specific treatment or antidote for tivozanib overdose.
In vitro studies suggest that tivozanib is an inhibitor of intestinal BCRP.
Carcinogenesis Carcinogenicity studies have not been performed with tivozanib.
The active substance in Fotivda is tivozanib, which is a protein kinase inhibitor.
In vitro metabolism studies have shown that CYP3A4 andCYP1A1 are capable of metabolising tivozanib.
Direct N-glucoronidation of tivozanib was a minor pathway of metabolism in vitro.
Tivozanib should not be used in patients with severe hepatic impairment(see section 4.2 and section 4.4).
Reproduction, mutagenesis, impairment of fertility Tivozanib may impair human fertility.
Each capsule contains tivozanib hydrochloride monohydrate equivalent to 890 microgram of tivozanib.
In vitro protein binding studies have shown that tivozanib is> 99% bound to plasma proteins.
Tivozanib has not been studied in patients who had an ATE within the preceding 6 months of clinical study initiation.
Moderate CYP3A4 inducers are not expected to have a clinically relevant effect on tivozanib exposure.
By blocking this protein, tivozanib stops the formation of new blood vessels that the tumour needs.
No concentration dependence of plasma protein binding was observed over the range of 0.1 to 5 µmol/L tivozanib.
The efficacy of tivozanib in the treatment of advanced RCC was studied in the following randomised clinical study.
Animal studies indicate that male andfemale fertility may be affected by treatment with tivozanib(see section 5.3).
Each hard capsule contains tivozanib hydrochloride monohydrate equivalent to 890 microgram tivozanib. .
The occurrence of undesirable effects may require temporary interruption and/or dose reduction of tivozanib therapy(see section 4.4).
Tivozanib must be used with caution in patients who are at risk for, or who have a history of bleeding.
For precautionary reasons, temporary interruption of tivozanib therapy is recommended in patients undergoing major surgical procedures.
In clinical studies, one case of posterior reversible encephalopathy syndrome(PRES)was confirmed after treatment with tivozanib(see section 4.8).
E a Hazard ratio for tivozanib arm vs. sorafenib arm, based on stratified Cox proportional hazards model.
Pulmonary oedema was reported in two patients(0.3%) receiving tivozanib as initial therapy in the five core RCC monotherapy studies.
Tivozanib exposure was increased in patients with severe hepatic impairment(mean AUC0-∞ by 4.0-fold) and in patients with moderate hepatic impairment(mean AUC0-∞ by 2.6-fold).
According to the population pharmacokinetic analysis of tivozanib exposure, no dose adjustment is required in patients with mild or moderate renal impairment.
Tivozanib was shown to be teratogenic, embryotoxic and foetotoxic in pregnant rats at dose levels 5 times lower than the recommended clinical dose(based on a 60 kg human).
In vitro studies have shown that tivozanib is neither a substrate nor an inhibitor of the multidrug efflux pump, P-glycoprotein.
The decision to resume tivozanib therapy after surgery should be based on clinical judgment of adequate wound healing.