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liečivo je vismodegib.
the active substance is vismodegib.
Last Update: 2017-04-26
Usage Frequency: 1
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vismodegib je prítomný v semene.
vismodegib is present in semen.
Last Update: 2017-04-26
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erivedge 150 mg tvrdé kapsuly vismodegib
erivedge 150 mg hard capsules vismodegib
Last Update: 2017-04-26
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in vitro je vismodegib inhibítorom oatp1b1.
in vitro, vismodegib is an inhibitor of oatp1b1.
Last Update: 2017-04-26
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Účinky súbežne podávaných liekov na vismodegib
effects of concomitant medicinal products on vismodegib
Last Update: 2017-04-26
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je to liek na rakovinu a obsahuje liečivo vismodegib.
erivedge is an anti-cancer medicine and contains the active substance vismodegib.
Last Update: 2017-04-26
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perorálne podaný vismodegib sa obličkami vylučuje v malej miere.
renal excretion of orally administered vismodegib is low.
Last Update: 2017-04-26
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erivedge je protirakovinový liek, ktorý obsahuje účinnú látku vismodegib.
erivedge is a cancer medicine that contains the active substance vismodegib.
Last Update: 2017-04-26
Usage Frequency: 1
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vismodegib sa pomaly eliminuje kombináciou metabolizmu a exkrécie východiskového liečiva.
vismodegib is slowly eliminated by a combination of metabolism and excretion of parent drug substance.
Last Update: 2017-04-26
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nie je známe, do akej miery sa vismodegib vylučuje do materského mlieka.
the extent to which vismodegib is excreted in breast milk is not known.
Last Update: 2017-04-26
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vismodegib a s ním spojené metabolické produkty sa eliminujú predovšetkým prostredníctvom pečene.
vismodegib and associated metabolic products are eliminated primarily by the hepatic route.
Last Update: 2017-04-26
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nevyhnutná je opatrnosť najmä, ak je vismodegib podávaný v kombinácii s akýmkoľvek statínom.
in particular, caution should be exercised if vismodegib is administered in combination with any statin.
Last Update: 2017-04-26
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naviazaním na bielkovinu smo vismodegib blokuje túto dráhu, a tak spomaľuje rast a šírenie rakovinových buniek bazocelulárneho karcinómu.
by attaching to smo, vismodegib blocks this pathway, thereby slowing down the growth and spread of the cancer cells in basal cell carcinoma.
Last Update: 2017-04-26
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avšak interakčná štúdia trvala len 7 dní a nie je možné vylúčiť, že vismodegib po dlhšej liečbe je induktor enzýmov, ktoré metabolizujú kontraceptívne steroidy.
however, the interaction study was of only 7 days duration and it cannot be excluded that vismodegib upon longer treatment is an inducer of enzymes which metabolise contraceptive steroids.
Last Update: 2017-04-26
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preto so zreteľom na údaje posúdené v psure, prac zvážil, že zmeny týkajúce sa informácii o lieku a podmienok registrácie liekov obsahujúcich vismodegib sú opodstatnené.
therefore, in view of the data presented in the reviewed psur, the prac considered that changes to the product information and conditions of the marketing authorisation of medicinal products containing vismodegib were warranted.
Last Update: 2017-04-26
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na základe vedeckých záverov pre vismodegib je chmp toho názoru, že pomer prínosu a rizika lieku obsahujúceho vismodegib je nezmenený za predpokladu, že budú prijaté navrhované zmeny v informáciách o lieku.
on the basis of the scientific conclusions for vismodegib, the chmp is of the opinion that the benefit- risk balance of the medicinal product containing vismodegib is unchanged subject to the proposed changes to the product information.
Last Update: 2017-04-26
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nie je možné vylúčiť, že vismodegib môže zvýšiť expozíciu substrátov oatp1b1, napr. bosentanu, ezetimibu, glibenklamidu, repaglinidu, valsartanu a statínov.
it cannot be excluded that vismodegib may increase the exposure to substrates of oatp1b1, e.g. bosentan, ezetimibe, glibenclamide, repaglinide, valsartan and statins.
Last Update: 2017-04-26
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in vitro štúdie naznačujú, že vismodegib má potenciál pôsobiť ako inhibítor proteínu rezistencie rakoviny prsníka (breast cancer resistance protein - bcrp).
in vitro studies indicate that vismodegib has the potential to act as an inhibitor of breast cancer resistance protein (bcrp).
Last Update: 2017-04-26
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po perorálnom podaní rádioaktívne označenej dávky sa vismodegib absorboval a pomaly eliminoval kombináciou metabolizmu a exkrécie východiskového liečiva, z ktorého väčšina sa vylúči stolicou (82 % podanej dávky), pričom 4,4 % podanej dávky sa vylúči močom.
after oral administration of a radiolabelled dose, vismodegib is absorbed and slowly eliminated by a combination of metabolism and excretion of parent drug substance, the majority of which is recovered in the faeces (82 % of the administered dose), with 4.4 % of the administered dose recovered in urine.
Last Update: 2017-04-26
Usage Frequency: 1
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