natgillin/translations-raw huggingface dataset:
There were no clinically relevant differences observed for the safety profile of pemetrexed plus cisplatin within the histology subgroups.
Za varnostni profil pemetrekseda s cisplatinom niso opazili nobenih klinično pomembnih razlik histoloških podskupin.
There were no clinically relevant differences observed for the safety profile of pemetrexed within the histology subgroups
Za varnostni profil pemetrekseda niso opazili nobenih klinično pomembnih razlik znotraj histoloških podskupin.
There were no clinically relevant differences observed for the safety profile of pemetrexed within the histology subgroups.
Za varnostni profil pemetreksedaniso opazili nobenih klinično pomembnih razlik znotraj histoloških podskupin.
There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ethinyl oestradiol.
Pri sočasni uporabi dizoproksiltenofovirijevega fumarata in emtricitabina, lamivudina, indinavirja, efavirenza, nelfinavirja, sakinavirja (okrepljenega z ritonavirjem), metadona, ribavirina, rifampicina, takrolimusa ali hormonskega kontracepcijskega sredstva norgestimata/etinilestradiola ni bilo klinično pomembnih farmakokinetičnih interakcij.
There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with emtricitabine, nelfinavir or ribavirin.
Klinično pomembnih farmakokinetičnih interakcij prav tako ni bilo pri sočasni uporabi dizoproksiltenofovirijevega fumarata in emtricitabina, nelfinavirja ali ribavirina.
There were no clinically-relevant alterations in trough serum concentration and pharmacodynamics of denosumab (creatinine adjusted urinary N- telopeptide, uNTx/Cr) by concomitant chemotherapy and/or hormone therapy or by previous intravenous bisphosphonate exposure.
Sočasna kemoterapija in/ali hormonsko zdravljenje ali predhodna intravenska izpostavljenost bisfosfonatom niso klinično pomembno spremenili najmanjše koncentracije denosumaba v serumu in farmakodinamike denosumaba (N-telopeptid v urinu, prilagojen na kreatinin, uNTx/Cr).
There were no concomitant or subsequent clinically meaningful elevations in serum bilirubin, INR, or alkaline phosphatase.
Sočasnega ali poznejšega klinično pomembnega povečanja koncentracije bilirubina, INR ali alkalne fosfataze v serumu ni bilo.
There were no deaths due to serious infections in RA or CAPS studies.
Zaradi resnih okužb ni bilo med študijami RA in CAPS nobenega smrtnega primera.
There were no deaths due to serious infections in RA studies.
Zaradi resnih okužb ni bilo med študijami RA in CAPS nobenega smrtnega primera.
There were no differences between insulin glargine and standard care for the two co- primary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Med insulinom glargin in standardnim zdravljenjem ni bilo razlik glede dveh primarnih izidov, glede katere koli komponente opazovanega dogodka, ki je vključevala te izide, glede celokupne smrtnosti in glede sestavljenega mikrovaskularnega izida.
There were no differences between insulin glargine and standard care for the two co-primary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Med insulinom glarginom in standardno oskrbo ni bilo razlik pri dveh soprimarnih izidih; pri katerem koli elementu, ki je vključeval ta izida, pri umrljivosti zaradi vseh vzrokov ali pri sestavljenem mikrovaskularnem izidu.
There were no differences between the two dose frequencies.
Tako manjša kot večja pogostost nanašanja sta pripeljali do enakih rezultatov.
There were no differences in Cmax.
Vrednosti Cmax. se niso razlikovale.
There were no differences in haemoglobin, neutrophils or platelets between both treatment groups.
Koncentracije hemoglobina, število nevtrofilcev oziroma trombocitov se med obema študijskima skupinama niso razlikovale.
There were no differences in the clearance of tigecycline based on race.
Očistek tigeciklina se med pripadniki različnih ras ni razlikoval.
There were no differences in the phase 3 clinical studies for efficacy and safety data between men and women.
V kliničnih raziskavah 3. faze se podatki o učinkovitosti in varnosti pri moških in ženskah niso razlikovali.
There were no effects of note on red cell mass or reticulocyte counts after dosing for up to 28 weeks in rats, 52 weeks in dogs and 2 years in mice or rats at maximally tolerated doses which were 2 to 4 times human clinical exposure in adult or paediatric ITP patients at 75 mg/day and ≤ 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Pomembnih učinkov na maso eritrocitov ali število retikulocitov niso opazili pri uporabi zdravila do 28 tednov pri podganah, 52 tednov pri psih in 2 leti pri miših ali podganah pri največjih odmerkih, ki so jih živali prenašale, to je izpostavljenosti, ki je ustrezala 2- do 4-kratni izpostavljenosti človeka pri klinični uporabi pri odraslih oziroma pediatričnih bolnikih z ITP pri odmerkih 75 mg/dan in ≤ 2-kratni izpostavljenosti človeka pri klinični uporabi pri bolnikih s HCV pri odmerkih 100 mg/dan na osnovi vrednosti AUC.
There were no fatal infusion reactions (see section 4.4).
Infuzijskih reakcij s smrtnim izidom ni bilo (glejte poglavje 4.4).
There were no fatal infusion reactions(see section 4.4).
Infuzijskih reakcij s smrtnim izidom ni bilo (glejte poglavje 4.4).
There were no findings on reproductive performance and no findings of concern on offspring viability when fluralaner was administered orally to Beagle dogs at overdoses of up to 3 times the maximum recommended dose (up to 168 mg/kg bodyweight of fluralaner).
Ko so fluralaner dajali biglom v odmerkih, ki so bili do 3krat večji od največjega priporočenega odmerka (do 168 mg fluralanerja na kg telesne teže), niso ugotovili vplivov na reprodukcijo in tudi ne zaskrbljujočih vplivov na življenjsko sposobnost potomcev.
There were no food restrictions in the studies that demonstrated the efficacy and safety of maraviroc (see section 5.1).
V študijah, ki so pokazale učinkovitost in varnost maraviroka, ni bilo prehranskih omejitev (glejte poglavje 5.1).
There were no indications of gross inflammatory reaction.
Znakov večje vnetne reakcije ni bilo.
There were no major differences in total systemic exposure (AUC) for both compounds between Japanese and Caucasian subjects.
Med Japonci in belci ni bilo večjih razlik v celotni sistemski izpostavljenosti (AUC) obema posameznima učinkovinama.
There were no major safety concerns.
Ni bilo večjih pomislekov glede varnosti.
There were no new cross resistance patterns at week 96 compared to week 48.
Novih vzorcev navzkrižne rezistence v 96. tednu v primerjavi z 48. tednom ni bilo.
There were no new toxicities or increased severity of the toxicities which were associated with either component.
Novih vrst toksičnega delovanja ali povečanega obsega toksičnega delovanja v primerjavi z uporabo posameznih učinkovin niso opažali.
There were no observed clinically significant adverse interactions in patients taking lamivudine concurrently with commonly used immunosuppressant medicinal products (e.g. cyclosporin A).
Pri bolnikih, ki so sočasno jemali lamivudin in pogosto uporabljana imunosupresivna zdravila (na primer ciklosporin A), niso opazili klinično pomembnih neželenih interakcij.
There were no other clinically relevant differences between two concurrent injections of Xiapex in the same hand and up to three single injections of Xiapex in the types of adverse events reported (ie, most adverse events were local to the treated extremity and of mild or moderate intensity).
Drugih klinično pomembnih razlik med dvema sočasnima injekcijama zdravila Xiapex v isto roko in do tremi enkratnimi injekcijami zdravila Xiapex med vrstami poročanih neželenih učinkov ni bilo (tj. večina neželenih učinkov je bilo lokalnih v zdravljeni okončini in blage do zmerne intenzivnosti).
There were no other subjects with more than infusion with adverse reactions in both groups.
V nobeni od teh dveh skupin ni bilo drugih bolnikov z več kot infuzijo z neželenimi učinki.
There were no patients 85 years or older in the RECOURSE study and the Japanese phase 2 study.
V kliničnem preskušanju III. faze (RECOURSE) in japonskem preskušanju II. faze ni bilo bolnikov, starejših od 85 let.
There were no relevant differences between Nivestim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Pri tem niso odkrili nobenih pomembnih razlik med zdravilom Nivestim in referenčnim zdravilom v trajanju hude nevtropenije in pojavnosti febrilne nevtropenije.
There were no relevant effects observed in the non-clinical studies.
V predkliničnih študijah niso opazili pomembnih učinkov.
There were no reported sequelae.
Opisanih ni bilo nobenih posledic.
There were no reports of anaphylaxis on belatacept.
O pojavu anafilaksije pri uporabi belatacepta niso poročali.
There were no reports of serious renal failure.
Poročil o resni ledvični odpovedi ni bilo.
There were no reports of syncope or other severe adverse events associated with lowering of blood pressure on either cohort of subjects.
V nobeni kohorti oseb niso zabeležili izgube zavesti ali drugih resnih neželenih dogodkov, povezanih z znižanjem krvnega tlaka.
There were no reports of TLS in study MCL-001 (see section 4.4).
V študiji MCL-001 ni bilo poročil o sindromu tumorske lize (glejte poglavje 4.4).
There were no safety differences in these subjects in terms of incidence and severity of adverse events, change in duration or volume of menses or incidence of intermenstrual bleeding.
Med temi ženskami niso bile opažene razlike v varnosti zdravila glede incidence in resnosti neželenih učinkov, sprememb v trajanju menstruacije ali količini menstrualne krvi ali glede incidence krvavitev v času med dvema menstruacijama.
There were no significant differences between active treatments and placebo for any of the other pre- specified event categories (renal dysfunction/failure, upper GI ulcer complications or surgical wound complications).
Aktivne terapije se niso pomembno razlikovale od placeba glede nobene vnaprej opredeljene kategorije pojavov (moteno delovanje ledvic/ledvična odpoved, zapleti z razjedami v zgornjih prebavilih ali zapleti kirurške rane).
There were no significant differences between the 0.5 mg and the 1.25 mg doses as regards study endpoints.
Pri nobenem od ciljev opazovanja ni bilo statistično značilnih razlik med odmerkoma 0,5 mg in 1,25 mg.
There were no significant differences in AUCs of 5-FU, tegafur, gimeracil, or oteracil after either single or multiple dose administration of Teysuno 30 mg/m2 twice daily in patients with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function.
Pri vrednostih AUC za 5-FU, tegafur, gimeracil ali oteracil po enkratnem odmerku ali večkratnem odmerjanju zdravila Teysuno 30 mg/m2 dvakrat dnevno pri bolnikih z blago, zmerno ali hudo jetrno okvaro v primerjavi z bolniki z normalno jetrno funkcijo niso opazili izrazitih razlik.
There were no significant differences in serum estradiol and estrone levels in patients treated with Intrinsa for up to 52 weeks compared to baseline.
Pri bolnicah, ki so prejemale zdravljenje z zdravilom Intrinsa, po 52 tednih ni bilo pomembnih razlik v koncentracijah estradiola in estrona, v primerjavi z izhodiščno vrednostjo.
There were no significant differences in serum estradiol and estrone levels in patients treated with Livensa for up to 52 weeks compared to baseline.
Pri bolnicah, ki so prejemale zdravljenje z zdravilom Livensa, po 52 tednih ni bilo pomembnih razlik v koncentracijah estradiola in estrona, v primerjavi z izhodiščno vrednostjo.
There were no significant differences in the overall safety profile, including the four pre-specified event categories described above for the second CABG surgery study, for parecoxib/valdecoxib compared to placebo treatment in these post-surgical patients.
Glede profila splošne varnosti niso pri bolnikih po prestani operaciji zaznali nobene pomembne razlike, tudi ne glede vnaprej določenih štirih kategorij, ki so opisane zgoraj v zvezi z drugo študijo operacije CABG, glede prejemanja parekoksiba/valdekoksiba v primerjavi s prejemanjem placeba.
There were no statistically significant differences between the arms in OS in the overall population or in the subgroups by prior therapy.
Kar se tiče celokupnega preživetja ni bilo nobenih statistično pomembnih razlik med skupinama, bodisi pri celokupni populaciji bodisi pri podskupinah, ki so se razlikovale glede na predhodno zdravljenje.
There were no statistically significant differences in any of these endpoints between the two treatment groups.
Med obema zdravljenima skupinama ni bilo statistično značilnih razlik v nobeni od omenjenih končnih ciljev.
There were no teratogenic effects observed in rabbits at doses up to 10 mg/kg/day (approximately 20-fold human exposure at 6 mg/m2 based on body surface area).
Pri kuncih po uporabi odmerkov do 10 mg/kg/dan (kar pomeni približno 20-krat večjo izpostavljenost kot pri ljudeh po odmerjanju 6 mg/m2 glede na telesno površino) niso opažali teratogenega delovanja.
There were no treatment- related effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Pri mladičih niso opazili učinkov cepiva na razvoj, obnašanje, sposobnost za razmnoževanje ali plodnost.
There were no treatment- related malformations in rats.
Pri podganah niso opazili malformacij, ki bi bile posledice uporabe zdravila.
There were no treatment-related effects of mirabegron on fertility in animals (see section 5.3).
Pri ţivalih niso ugotovili z zdravljenjem povezanih vplivov mirabegrona na plodnost (glejte poglavje 5.3).
There were other side effects that are seen commonly (i.e. in 1% – 10% of dogs ) which have severe effects, these are vomiting, diarrhoea, anorexia, lethargy, dehydration, skin necrosis, fever, blood in faeces/hemorrhagic diarrhoea/gastrointestinal bleeding and ulcers, nausea, septicaemia, weight loss, increased alanine aminotransferase and decreased haematocrit.
Pogosto opazni neželeni učinki (pri 1 – 10% psov), ki so imeli resne učinke so bruhanje, diareja, anoreksija, letargičnost, dehidracija, nekroza kože, vročina, kri v iztrebkih/hemoragična diareja, gastrointestinalne krvavitve in ulkusi, slabost, septikemija, izguba teže povišana alanin aminotransferaza, znižan hematokrit
There were six main studies of Multaq in adults who had had atrial fibrillation.
Izvedenih je bilo šest glavnih študij z zdravilom Multaq, v katerih so sodelovali odrasli z atrijsko fibrilacijo.
There were six overall discontinuations during this period, only one of which was due to an AE (the SAE of post- operative wound infection).
V celoti je bilo v tem obdobju iz študije izključenih 6 bolnikov, od tega le eden zaradi neželenega učinka (resen neželeni učinek pooperativne okužbe rane).
There were some cases of more severe neutropenia in patients treated with Ribavirin Teva Pharma B.V. in combination with peginterferon alfa-2b (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]); WHO grade 3 leukopenia was also reported in 7 % of this treatment group.
Bilo je tudi nekaj primerov hujše nevtropenije (3. stopnje po WHO: 39 od 186 [21 %] in 4. stopnje po WHO: 13 od 186 [7 %]) med bolniki, zdravljenimi z zdravilom Ribavirin Teva Pharma B.V. v kombinaciji s peginterferonom alfa-2b; pri 7 % bolnikov iz te terapevtske skupine so poročali tudi o levkopeniji 3. stopnje po WHO.
There were some concerns about the balance of benefit and risk in patients with reduced kidney function taking the fixed dose combination, and the CHMP recommended restricting its use in these patients.
Prisotnih je bilo nekaj pomislekov glede razmerja med tveganji in koristmi pri bolnikih z zmanjšanim delovanjem ledvic, ki jemljejo fiksno kombinacijo, zato je odbor CHMP priporočil omejitev njegove uporabe pri teh bolnikih.
There were too few patients also receiving interferon-gamma to determine whether this improved the patients’ outcome further.
Bolnikov, ki so prejemali tudi interferon gama, je bilo premalo, da bi lahko potrdili, ali je to pri bolnikih dodatno izboljšalo izid.
There were too few patients in this study aged below 6 years to demonstrate the safety and effectiveness of Exjade in this age group.
V študiji je sodelovalo premalo bolnikov, mlajših od šest let, da bi lahko potrdili varnost in učinkovitost zdravila Exjade v tej starostni skupini.
There were too few patients over 65 years of age, or black/African American patients enrolled in the controlled clinical trials to draw meaningful conclusions about the effects of age or race on clinical outcomes.
V kontrolirana klinična preskušanja je bilo vključenih premalo bolnikov, starejših od 65 let in premalo bolnikov črncev/Afroameričanov, da bi bilo mogoče smiselno sklepati o vplivu starosti in rase na klinične izide.
There were two deaths that were possibly treatment related.
Dve smrti sta bili verjetno povezani z zdravljenjem.
There were two further deaths; however, relation to treatment could not be established.
Pri dveh sledečih poginih povezave z zdravljenjem ni bilo mogoče dokazati.
There will also be an information pack for patients, including a booklet and an audio CD.
Pripravila bo tudi informativni paket za bolnike z brošuro in zvočno zgoščenko.
There will be a rubber stopper underneath – keep this in the vial.
Pod njim bo gumijasti zamašek - obdržite ga v viali.
There will still be some water in the solvent vial.
V viali z vehiklom še vedno ostane nekaj vode.
Thereafter a single booster dose of 2 ml should be administered every six months.
Po zaključenem osnovnem cepljenju je vsakih šest mesecev potreben spodbujevalen odmerek po 2 ml.
Thereafter it will be given as an infusion over a period of 60 minutes, every 2 weeks (single-agent phase).
Pri nadaljevanju zdravljenja (faza zdravljenja samo z enim zdravilom) boste infuzijo, ki bo trajala 60 minut, prejemali vsaka 2 tedna.
Thereafter the cup is rinsed once with the same quantity of water and the rinsings consumed by the patient.
Po tem je kozarec potrebno sprati z enako količino vode in zaužiti tudi vodo, uporabljeno za spiranje.
Thereafter the haemoglobin can be measured at longer intervals.
Potem lahko hemoglobin kontrolirate v daljših presledkih
Thereafter the haemoglobin can be measured at longer intervals.
Potem lahko hemoglobin kontrolirate v daljših presledkih..
Thereafter the recommended dose of OPDIVO is 3 mg of nivolumab per kilogram of your body weight (single- agent phase).
Pri nadaljevanju zdravljenja pa je priporočeni odmerek zdravila OPDIVO 3 mg nivolumaba na kilogram telesne mase (faza zdravljenja samo z enim zdravilom).
Thereafter your child will be switched to a twice daily dosing schedule and your child’s doctor will decide the right dose based either on your child’s weight or body surface area.
Nato bodo pri otroku prešli na shemo odmerjanja z dajanjem dvakrat na dan, otrokov zdravnik pa bo ustrezni odmerek določil na podlagi telesne mase ali površine vašega otroka.
Thereafter, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag for infusion or other suitable infusion container (e.g., glass bottle).
Takoj nato odvzemite 5 ml rekonstituirane raztopine iz viale in jo dodajte v 100-mililitrsko vrečko za intravensko infuzijo ali drug primeren vsebnik za infuzijo (na primer steklenico).
Thereafter, as cinacalcet levels begin to decline, PTH levels increase until 12 hours post-dose, and then PTH suppression remains approximately constant to the end of the once-daily dosing interval.
Ko začne koncentracija cinakalceta upadati, se koncentracija PTH zvišuje do 12 ur po odmerku zdravila, nato ostane supresija PTH približno stalna do konca odmernega intervala enkrat na dan.
Thereafter, asparagine serum levels increased again and returned to normal values within 1 – 3 weeks.
Nato se je raven serumskega asparagina spet zviševala in dosegla normalne vrednosti po 1-3 tednih.
Thereafter, injections should be scheduled every 3 months from the date of the last injection.
Nato moramo injekcije dajati vsake 3 mesece od dneva zadnje.
Thereafter, monitored at month 3 and at month 4, and as clinically indicated.
Potem je kontrola potrebna 3. mesec in 4. mesec, ter kadar je to klinično indicirano.
Thereafter, the clinical benefit of memantine and the patient’s tolerance of treatment should be reassessed on a regular basis according o current clinical guidelines.
Potem je treba ocenjevati klinično korist in prenašanje zdravljenja z memantinom v skladu s trenutno veljavnimi kliničnimi smernicami.
Thereafter, the clinical benefit of memantine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines.
Potem je treba klinično korist in prenašanje zdravljenja z memantinom ocenjevati v skladu s trenutno veljavnimi kliničnimi smernicami.
Thereafter, the clinical benefit of memantine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines.
Potem je treba ocenjevati klinično korist in prenašanje zdravljenja z memantinom skladno s trenutno veljavnimi kliničnimi smernicami.
Thereafter, the clinical benefit of memantine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines.
Potem je treba ocenjevati klinično korist in prenašanje zdravljenja z memantinom v skladu s trenutno veljavnimi kliničnimi smernicami.
Thereafter, the difference between the two groups was not significant.
Po tistem razlika med obema skupinama ni bila signifikantna.
Thereafter, the dose may be adjusted individually, based upon ovarian response.
Nato odmerke lahko prilagajate glede na odzivanje jajčnikov.
Thereafter, the recommended dose is 20 mg once daily.
Nato je priporočeni odmerek 20 mg enkrat na dan.
Thereafter, the recommended dose is 30 mg daily administered 3 times weekly on alternate days up to a maximum of 12 weeks.
Pozneje je priporočeni odmerek 30 mg na dan, apliciran trikrat na teden vsak drugi dan, največ 12 tednov.
Thereafter, the usual dose is 40 mg every other week.
Nato je običajni odmerek 40 mg vsak drugi teden.
Thereafter, the usual dose is 40mg every other week.
Zatem je običajni odmerek 40 mg vsak drugi teden.
Thereafter, you will receive an injection (ranging from 25 mg to 150 mg) in either the upper arm or buttocks once a month.
Potem vam bodo zdravilo (v odmerkih od 25 mg do 150 mg) injicirali v zgornji del roke ali v zadnjico enkrat na mesec.
thereafter:
potem:
Thereby this TNFα is blocked by Cimzia and this decreases inflammation in rheumatoid arthritis ,axial spondyloarthritis and psoriatic arthritis.
Na ta način zdravilo Cimzia to TNFα blokira, kar ima za posledico zmanjšanje vnetja pri revmatoidnem artritisu, aksialnem spondiloartritisu in psoriatičnem artritisu.
Thereby this TNFα is blocked by Cimzia and this decreases inflammation in rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis.
Na ta način zdravilo Cimzia to TNFα blokira, kar ima za posledico zmanjšanje vnetja pri revmatoidnem artritisu, aksialnem spondiloartritisu in psoriatičnem artritisu.
Thereby, increasing the potential for sildenafil- associated adverse events (which include hypotension and syncope).
Zaradi tega večja možnost neželenih učinkov sildenafila (vključno s hipotenzijo in sinkopo).
Thereby, increasing the potential for sildenafil- associated adverse events (which include hypotension and syncope).
Zaradi tega večja možnost neželenih učinkov, povezanih s sildenafilom (med takšnimi sta hipotenzija in sinkopa).
Thereby, increasing the risk of arrhythmias or other serious adverse reactions from these agents.
S tem se poveča tveganje za aritmije ali druge resne neželene učinke teh zdravil.
Thereby, increasing the risk of arrhythmias or other serious adverse reactions.
Zaradi tega večje tveganje za motnje srčnega ritma ali druge resne neželene učinke