Примери за използване на Defibrotide на Английски и техните преводи на Български
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The active substance is defibrotide.
Non-defibrotide treated Defibrotide treated.
Each 2.5 mL vial contains 200 mg defibrotide.
Defibrotide does not inhibit or induce CYP450s.
One mL of concentrate contains 80 mg defibrotide.
Defibrotide is not removed by dialysis(see section 5.2).
There are no studies using defibrotide in pregnant women.
Defitelio 80 mg/mL concentrate for solution for infusion defibrotide.
Accumulation of defibrotide over 4 doses was not found.
Defitelio is a medicine that contains the active substance defibrotide.
In addition, defibrotide may protect the cells that line blood vessels.
All patients who experienced VOD received treatment with defibrotide and recovered.
The safety and efficacy of defibrotide in children aged less than 1 month has not yet been established.
Data analysis from CIBMTR for patients treated andnot treated with defibrotide.
However, the exact mechanism of action of defibrotide is not fully elucidated.
NAME OF THE MEDICINAL PRODUCT Defitelio 80 mg/mL concentrate for solution for infusion defibrotide.
The active substance in Defitelio, defibrotide, works by increasing the breakdown of clots in the blood.
In a sub-study it was shown that haemodialysis did not remove defibrotide(see section 4.2).
Each 2.5 mL vial contains 200 mg defibrotide and each mL solution contains 80 mg defibrotide.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Defitelio 80 mg/mL sterile concentrate defibrotide.
Potential interactions with other medicinal products Defibrotide does not inhibit or induce CYP450s(see section 5.2).
Defibrotide works by protecting the cells of the blood vessels and preventing or breaking down the blood clots.
There are no studies investigating the effects of defibrotide on human fertility.
Defibrotide is an oligonucleotide mixture with demonstrated antithrombotic, fibrinolytic, anti-adhesive and anti-inflammatory actions.
Due to this maternal toxicity, no conclusion can be drawn regarding the effects of defibrotide on embryo-foetal development.
The efficacy and safety of defibrotide in the treatment of severe VOD were studied in a pivotal Phase 3 historical-controlled study(2005-01).
In the Phase 3pivotal treatment study(2005-01 Study), the overall incidence of adverse events was similar in the defibrotide treatment group and in the control group(historical).
Administration of defibrotide to patients who have haemodynamic instability, defined as inability to maintain mean arterial pressure with single pressor support, is not recommended.
In HGB-207 and HGB-212 prophylaxis for VOD/hepatic sinusoidal obstruction syndrome was required per institutional practice with ursodeoxycholic acid or defibrotide.
Embryo-foetal developmental toxicology studies in pregnant rats and rabbits of defibrotide doses close to the recommended therapeutic human dose, revealed a high rate of haemorrhagic abortion(see section 5.3).