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končni razpolovni čas cisteaminijevega bitartrata je približno 4 ure.
the terminal half-life of cysteamine bitartrate is approximately 4 hours.
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ni ustreznih podatkov o uporabi cisteaminijevega bitartrata pri nosečnicah.
there are no adequate data from the use of cysteamine bitartrate in pregnant women.
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farmakokinetike cisteaminijevega bitartrata pri posebnih skupinah bolnikov niso proučevali.
the pharmacokinetics of cysteamine bitartrate has not been studied in special populations.
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Študij kancerogenosti z gastrorezistentnimi trdimi kapsulami cisteaminijevega bitartrata niso izvedli.
no carcinogenic studies have been conducted with cysteamine bitartrarte gastro-resistant hard capsules.
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pri farmacevtski obliki cisteaminijevega bitartrata s takojšnjim sproščanjem je neželene učinke mogoče pričakovati pri približno 35 % bolnikov.
for the immediate-release formulation of cysteamine bitartrate, approximately 35% of patients can be expected to experience adverse reactions.
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cisteaminijevega bitartrata se ne sme jemati skupaj s hrano, bogato z maščobami ali beljakovinami, ali z zamrznjeno hrano, kot je sladoled.
cysteamine bitartrate should not be administered with food rich in fat or proteins, or with frozen food like ice-cream.
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pri bolnikih, zdravljenih z velikimi odmerki cisteaminijevega bitartrata s takojšnjim sproščanjem ali drugimi cisteaminovimi solmi, so poročali o resnih kožnih lezijah, ki so se izboljšale po zmanjšanju odmerka cisteamina.
there have been reports of serious skin lesions in patients treated with high doses of immediate-release cysteamine bitartrate or other cysteamine salts that have responded to cysteamine dose reduction.
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bolniki s cistinozo, ki jemljejo cisteaminijev bitartrat s takojšnjim sproščanjem, lahko preidejo na skupni dnevni odmerek zdravila procysbi, ki ustreza predhodnemu skupnemu dnevnemu odmerku cisteaminijevega bitartrata s takojšnjim sproščanjem.
patients with cystinosis taking immediate-release cysteamine bitartrate may be transferred to a total daily dose of procysbi equal to their previous total daily dose of immediate-release cysteamine bitartrate.
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odmerek cisteaminijevega bitartrata s takojšnjim sproščanjem 1,95 grama/m2/dan je povezan z višjo stopnjo prekinitve zdravljenja zaradi nezmožnosti prenašanja zdravila in povečano pojavnostjo neželenih učinkov.
the dose of 1.95 grams/m2/day of immediate-release cysteamine bitartrate has been associated with an increased rate of withdrawal from treatment due to intolerance and an increased incidence of adverse events.
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po enkratnem peroralnem odmerku cisteaminijevega bitartrata, ki ustreza 1,05 g proste baze cisteamina, je pri zdravih prostovoljcih povprečen (± sd) čas do dosežene najvišje koncentracije 1,4 (± 0,5) h, najvišja plazemska koncentracija pa znaša 4,0 (± 1,0) µg/ml.
following a single oral dose of cysteamine bitartrate equivalent to 1.05 g of cysteamine free base in healthy volunteers, the mean ( sd) values for the time to peak and peak plasma concentration are 1.4 ( 0.5) hours and 4.0 ( 1.0) µg/ml, respectively.
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