Examples of using Macitentan in English and their translations into Dutch
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Colloquial
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Official
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Ecclesiastic
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Medicine
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Financial
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Computer
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Ecclesiastic
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Official/political
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Programming
Opsumit 10 mg tablets macitentan.
Macitentan is not a substrate for P- gp/MDR-1.
Each tablet contains 10 mg macitentan.
Macitentan is only excreted after extensive metabolism.
Each film-coated tablet contains 10 mg macitentan.
Treatment Comparison: Macitentan 10 mg vs Placebo.
Opsumit is a medicine that contains the active substance macitentan.
Macitentan was teratogenic in rabbits
Exposure to the active metabolite of macitentan was reduced by 26.
Macitentan was not genotoxic in a standard battery of in vitro and in vivo assays.
The active substance in Opsumit, macitentan, works by blocking‘endothelin receptors.
Macitentan 10 mg improved quality of life assessed by the SF-36 questionnaire.
Maximum plasma concentrations of macitentan are achieved about 8 hours after administration.
Macitentan has been administered as a single dose of up to 600 mg to healthy subjects.
In the presence of strong CYP3A4 inducers reduced efficacy of macitentan could occur.
The effect of macitentan on human male fertility is not known section 4.6.
Cases of anaemia requiring blood cell transfusion have been reported with macitentan and other ERAs.
The pharmacokinetics of macitentan and its active metabolite were not affected by warfarin.
was not affected by macitentan.
The increase in 6MWD achieved with macitentan was maintained for the duration of the study.
In rats, macitentan and its metabolites are excreted into milk during lactation see section 5.3.
Due to the high degree of protein binding of macitentan, dialysis is unlikely to be effective.
Exposure to macitentan in patients with PAH was approximately 1.2-fold greater than in healthy subjects.
After repeated administration, the pharmacokinetics of macitentan are dose-proportional up to and including 30 mg.
Macitentan was not phototoxic in vivo after single dose at exposures of up to 24-fold the human exposure.
There is no clinical experience with the use of macitentan in PAH patients with severe renal impairment.
In dogs, macitentan decreased blood pressure at exposures similar to the therapeutic human exposure.
Consequently, if signs of pulmonary oedema occur when macitentan is administered in patients with PAH, the possibility of pulmonary veno-occlusive disease should be considered.
Macitentan and its active metabolite do not have clinically relevant inhibitory or inducing effects on cytochrome P450 enzymes.
The pharmacokinetics of macitentan in PAH patients were not influenced by the severity of the disease.