natgillin/translations-raw huggingface dataset:
As serious and life threatening hepatotoxicity has been observed in controlled and uncontrolled studies predominantly in patients with a plasma HIV-1 viral load of 50 copies/ml or higher, nevirapine should not be initiated in adult females with CD4 cell counts greater than 250 cells/mm3 or in adult males with CD4 cell counts greater than 400 cells/mm3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
Ker so v nadzorovanih in nenadzorovanih raziskavah poročali o resni in življenjsko nevarni hepatotoksičnosti pretežno pri bolnikih z virusnim bremenom s HIV-1 50 kopiij/ml ali večjim, ne smemo uvesti nevirapina pri odraslih ženskah s številom celic CD4 nad 250 celic/mm3 in odraslih moških s številom celic CD4 nad 400 celic mm3, in izmerljivo ravnijo HIV-1 RNA v plazmi razen, če je korist zdravljenja večja od njegovega tveganja.
As serious and life threatening hepatotoxicity has been observed in controlled and uncontrolled studies predominantly in patients with a plasma HIV-1 viral load of 50 copies/ml or higher, nevirapine should not be initiated in adult females with CD4 cell counts greater than 250 cells/mm3 or in adult males with CD4 cell counts greater than 400 cells/mm3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
ne smemo uvesti nevirapin pri odraslih ženskah s številom celic CD4 nad 250 celic/mm3 in odraslih moških s številom celic CD4 nad 400 celic mm3, in izmerljivo ravnijo HIV-1 RNA v plazmi razen, če je korist zdravljenja večja od njegovega tveganja.
As shown in Table 1, oral Aloxi capsules 500 micrograms demonstrated non-inferiority to the active comparator during the 0 to 24 hour and 0 to 120 hour time intervals; however, for the 24 to 120 hour time period, non-inferiority was not shown.
Kot kaže preglednica 1, so bile 500-mikrogramske peroralne kapsule zdravila Aloxi ne-manjvredne aktivnemu primerjanemu zdravilu v časovnem obdobju od 0 do 24 ur in od 0 do 120 ur; za obdobje 24 do 120 ur pa ne-manjvrednosti niso dokazali.
As shown in table 4 below, the absolute bioavailability of isavuconazole following oral administration of a single dose of CRESEMBA is 98%.
Kot je prikazano v Preglednici 4 spodaj, absolutna biološka uporabnost izavukonazola po zauţitju enkratnega odmerka zdravila CRESEMBA znaša 98 %.
As shown in the above table, there were only 16 patients harbouring baseline virus with resistance to FPV/RTV according to the ANRS score.
Kot prikazuje zgornja preglednica, je imelo izhodiščno samo 16 bolnikov po rezultatu ANRS virus odporen proti FPV/RTV.
As side effects were less frequent than with phenobarbital, Pexion is a suitable treatment option for some dogs, considering in particular its safety profile.
Ker so bili neželeni učinki manj pogosti kot pri fenobarbitalu, je Pexion zlasti zaradi svojega varnostnega profila primerna možnost zdravljenja za nekatere pse.
as smooth as possible (no major creases or skin folds)
čim bolj gladka (brez večjih pregibov ali kožnih gub);
As solvent Sterilised Water for Injections is used.
Kot vehikel je uporabljena sterilna voda za injekcije.
As some other tyrosine kinase inhibitors are known to exert an effect on QT, caution should be exercised when administered nintedanib in patients who may develop QTc prolongation.
Ker je znano, da nekateri drugi zaviralci tirozin-kinaze učinkujejo na interval QT, je potrebna previdnost pri dajanju nintedaniba bolnikom, pri katerih se lahko razvije podaljšanje intervala QTc.
As soon as data becomes available
Takoj, ko so podatki na voljo.
As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide ratiopharm and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately.
Čim se na koži in/ali sluznici pojavijo reakcije, ki zbujajo sum na takšne hude reakcije, je treba prekiniti uporabo zdravila Leflunomid ratiopharm in drugih zdravil, ki bi jih lahko povzročila, in takoj začeti postopek izpiranja.
As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide Winthrop and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately.
Čim se na koži in/ali sluznici pojavijo reakcije, ki zbujajo sum na takšne hude reakcije, je treba prekiniti uporabo zdravila Leflunomid Winthrop in drugih zdravil, ki bi jih lahko povzročila, in takoj začeti postopek izpiranja.
As soon as the first liquid stool occurs, start drinking large volumes ofrehydration fluids (е.g. water, soda water, fizzy drinks, soup) to avoid losing too much liquid and salts from your body.
Ob prvem pojavu tekočega blata začnite piti večje količine rehidracijske tekočine (npr. vode, gazirane vode, gazirane pijače, juhe), da preprečite preveliko izgubo tekočine in soli iz telesa.
As soon as the tablet is disintegrated, swallow the content of the teaspoon.
Ko ste tableta razpusti, zaužijte celotno vsebijo čajne žličke.
As soon as you have done the injection, take the needle off the pen using the outer needle cap.
Ko končate injiciranje, snemite iglo z injekcijskega peresnika s pomočjo zunanjega pokrovčka igle.
As soon as you have done the injection, take the needle off the pen using the outer needle cap.
Ko končate z injiciranjem, snemite iglo z injekcijskega peresnika s pomočjo zunanjega pokrovčka igle.
As soon as you have done the injection, unscrew the needle from the KwikPen using the outer needle cap.
Ko končate injiciranje, snemite iglo s KwikPena s pomočjo zunanjega pokrovčka igle.
As soon as you have done the injection, unscrew the needle from the KwikPen using the outer needle cap.
Ko končate z injiciranjem, snemite iglo s KwikPena s pomočjo zunanjega pokrovčka igle.
As spironolactone has an antiandrogenic effect (acts against male hormones), it is not recommended to administer the veterinary medicinal product to growing dogs.
Ker ima spironolakton antiandrogen učinek, ni priporočljiva uporaba zdravila za uporabo v veterinarski medicini pri rastočih psih.
As spironolactone undergoes extensive hepatic (liver) biotransformation, care should be taken when using the veterinary medicinal product in dogs with liver dysfunction.
Ker je spironolakton podvržen intenzivni jetrni je potebna previdnost, kadar se z zdravilom za uporabo v veterinarski medicini zdravi pse z jetrno disfunkcijo.
As splenic enlargement is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to filgrastim treatment is unclear (see section 4.4)..
Ker je povečanje vranice pogost pojav pri bolnikih z okužbo HIV in je pri večini bolnikov z aidsom prisotno v različnih stopnjah, povezava z zdravljenjem s filgrastimom ni znana (glejte poglavje 4.4).
As splenomegaly is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to filgrastim treatment is unclear (see section 4.4).
Ker je splenomegalija pogost pojav pri bolnikih z okužbo HIV in je pri večini bolnikov z AIDS-om prisotna v različnih stopnjah, povezava z zdravljenjem s filgrastimom ni znana (glejte poglavje 4.4).
As splenomegaly is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to filgrastim treatment is unclear (see section 4.4).
Ker je splenomegalija pogost pojav pri bolnikih z okužbo HIV in je pri večini bolnikov z aidsom prisotno v različnih stopnjah, povezava z zdravljenjem s filgrastimom ni jasna (glejte poglavje 4.4).
As splenomegaly is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to filgrastim treatment is unclear (see section 4.4).
Ker je splenomegalija pri bolnikih, ki so okuženi z virusom HIV, pogosta in v različni meri prisotna pri večini bolnikov, okuženih z virusom HIV, povezava s filgrastimom ni jasna (glejte poglavje 4.4).
As stated in section 4.2, the safety and efficacy of Bronchitol in children and adolescents aged less than 18 years has not been established.
Kot je navedeno v poglavju 4.2, varnost in učinkovitost zdravila Bronchitol pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
As Stribild contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, any interactions that have been identified with these active substances individually may occur with Stribild.
Zdravilo Stribild vsebuje elvitegravir, kobicistat, emtricitabin in dizoproksiltenofovirijev fumarat, zato se pri uporabi zdravila Stribild lahko pojavijo katere koli interakcije, ki so jih opazili pri uporabi teh zdravilnih učinkovin.
As Strimvelis will be administered following busulfan conditioning, patients of childbearing potential must use reliable barrier contraception during administration of Strimvelis and for at least 6 months afterwards.
Ker se zdravilo Strimvelis uporablja po predpripravi z busulfanom, morajo bolnice v rodni dobi uporabljati zanesljivo pregradno kontracepcijsko zaščito med uporabo zdravila Strimvelis in vsaj še 6 mesecev potem.
AS Study 1 (MEASURE 1) evaluated 371 patients, of whom 14.8% and 33.4% used concomitant MTX or sulfasalazine, respectively.
V 1. študiji ankilozirajočega spondilitisa (študiji MEASURE 1) so ocenjevali 371 bolnikov, med katerimi jih je 14,8% sočasno prejemalo metotreksat, 33,4% pa jih je sočasno prejemalo sulfasalazin.
AS Study 2 (MEASURE 2) evaluated 219 patients, of whom 11.9% and 14.2% used concomitant MTX or sulfasalazine, respectively.
V 2. študiji ankilozira jočega spondilitisa (študiji MEASURE 2) so ocenjevali 219 bolnikov, med katerimi jih je 11,9% sočasno prejemalo metotreksat, 14,2% pa jih je sočasno prejemalo sulfasalazin.
As such, half-life was 8 hours (range: 2-32 hours) after the first 30 mg dose and was 6 days (range: 1-14 days) after the last 30 mg dose.
V teh okoliščinah je bil razpolovni čas 8 ur (razpon od 2 do 32 ur) po prvem 30-mg odmerku in 6 dni (razpon od 1 do14 dni) po zadnjem 30-mg odmerku.
As such, tenofovir alafenamide exposures following administration of Genvoya are not expected to be further increased when used in combination with another P-gp inhibitor (e.g., ketoconazole).
Ne pričakuje se, da bi se izpostavljenosti alafenamidtenofovirata kot take po dajanju zdravila Genvoya še povečale, če se uporablja v kombinaciji z drugim zaviralcem P-gp (npr. ketokonazolom).
As such, the following section outlines the adverse reactions of the individual components of Incresync (alogliptin/pioglitazone) as reported in their respective Summary of Product Characteristics.
Zato so v nadaljevanju opisani neželeni učinki posameznih učinkovin zdravila Incresync (alogliptin/pioglitazon), kot so navedeni v njunih povzetkih glavnih značilnosti zdravila.
As such, the following section outlines the adverse reactions of the individual components of Vipdomet (alogliptin/metformin) as reported in their respective Summary of Product Characteristics.
Zato so v nadaljevanju opisani neželeni učinki posameznih učinkovin zdravila Vipdomet (alogliptin/metformin), kot so navedeni v njunih povzetkih glavnih značilnosti zdravila.
As such, the oral dexamethasone dose should be reduced by approximately 50% when co-administered with Akynzeo (see section 4.2).
Zato je treba ob sočasnem dajanju z zdravilom Akynzeo peroralni odmerek deksametazona zmanjšati za približno 50 % (glejte poglavje 4.2).
as support to stitching during surgery on the blood vessels;
kot pomoč pri šivanju pri kirurških posegih na ožilju;
As systemic exposure to linaclotide is minimal, excretion in breast milk is not likely, although it has not been evaluated.
Ker je sistemska izpostavitev linaklotidu minimalna, izločanje v materino mleko ni verjetno, čeprav ni bilo ocenjeno.
As tacrolimus is a substance with low clearance, adjustments to the Advagraf dose regimen may take several days before steady state is achieved.
Ker je očistek takrolimusa majhen, lahko prilagajanje odmerka zdravila Advagraf za vzpostavitev ravnovesnega stanja traja več dni.
As tacrolimus is a substance with low clearance, adjustments to the Envarsus dose regimen may take several days before steady state is achieved.
Ker je očistek takrolimusa majhen, lahko prilagajanje odmerka zdravila Envarsus za vzpostavitev stanja dinamičnega ravnovesja traja več dni.
As tacrolimus is a substance with low clearance, following adjustments to the Advagraf dose regimen it may take several days before the targeted steady state is achieved.
Takrolimus je učinkovina z majhnim očistkom, zato lahko po prilagoditvi odmerka zdravila Advagraf vzpostavitev ciljnega ravnovesnega stanja traja več dni.
As tacrolimus is a substance with low clearance, following adjustments to the Envarsus dose regimen it may take several days before the targeted steady state is achieved.
Ker je takrolimus učinkovina z majhnim očistkom, lahko prilagajanje odmerka zdravila Envarsus za vzpostavitev ravnovesnega stanja traja več dni.
As tacrolimus is a substance with low clearance, it may take several days after adjustments to the Modigraf dose regimen before steady state is achieved (see below under “Therapeutic drug monitoring” and section 5.2).
Ker je očistek takrolimusa majhen, lahko prilagajanje odmerka zdravila Modigraf za vzpostavitev ravnovesnega stanja traja več dni (glejte spodaj “Spremljanje koncentracije zdravila” in poglavje 5.2).
As talimogene laherparepvec is injected and replicates intratumourally, bioavailability and systemic concentration of talimogene laherparepvec are not predictive of drug substance activity and therefore have not been evaluated.
Ker se talimogen laherparepvek injicira in razmnožuje v tumorju, biološka uporabnost in sistemska koncentracija talimogena laherparepveka ne napovedujeta aktivnosti zdravilne učinkovine in ju zato niso ovrednotili.
As Tarceva seems to be more effective in patients with pancreatic cancer who develop a rash, treatment should be re-assessed after four to eight weeks if no rash has developed.
Ker se zdravilo Tarceva zdi učinkovitejše pri zdravljenju bolnikov z rakom trebušne slinavke, pri katerih se pojavi izpuščaj, je treba zdravljenje ponovno pretehtati po štirih do osmih tednih, če se izpuščaj ne pojavi.
As Tasmar decreases the breakdown of levodopa in the body, side effects due to increased levodopa concentrations may occur when beginning Tasmar treatment.
Ker zdravilo Tasmar zmanjša razgradnjo levodope v telesu, se lahko ob začetku zdravljenja z zdravilom Tasmar zaradi zvišanih koncentracij levodope pojavijo neželeni učinki.
As Tecfidera gastro-resistant hard capsules contain microtablets, which are protected by an enteric coating, absorption does not commence until they leave the stomach (generally less than 1 hour).
Zdravilo Tecfidera gastrorezistentne trde kapsule vsebujejo mikrotablete, ki so zaščitene z enterično oblogo, zato se absorpcija začne šele, ko zapustijo želodec (na splošno manj kot čez 1 uro).
As telbivudine is a nucleoside analogue, this risk cannot be excluded.
Ker je telbivudin nukleozidni analog, tveganja ni mogoče izključiti.
As thalidomide is found in semen, male patients must use condoms during treatment and for 1 week after dose interruption and/or cessation of treatment if their partner is pregnant or is of childbearing potential not using effective contraception.
Ker je talidomid prisoten v spermi, morajo moški bolniki uporabljati kondome med zdravljenjem, 1 teden po prekinitvi odmerjanja in/ali po koncu zdravljenja, če je partnerica noseča ali v rodni dobi in ne uporablja zanesljive kontracepcije.
As thalidomide is found in semen, male patients taking thalidomide must meet the following conditions:
Ker je talidomid prisoten v spermi, morajo moški bolniki, ki jemljejo talidomid, izpolnjevati naslednje pogoje:
As the
Ker
As the administration system contains electromechanical parts and a used needle, the administration system must not be disposed of in household waste.
Ker vsebuje aplikacijski sistem elektromehanične dele in uporabljeno iglo, ga ne smemo zavreči med gospodinjske odpadke.
As the amount given depends on the individual’s bodyweight, the doctor will need to adjust the dose as patient’s weight changes, particularly in growing children.
Ker je uporabljena količina odvisna od telesne mase posameznika, bo zdravnik moral odmerek prilagajati, ko se bolnikova telesna masa spreminja, predvsem pri rastočih otrocih.
As the animal swallows, the administration tool will move easily over the base of the tongue.
Ko žival požira, se orodje za dajanje z lahkoto premika po korenu jezika.
As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis (see section 5.1).
Za preţivetje brez bolezni (DFS – disease-free survival) in celokupno preţivetje (OS – overall survival) ugotovljena korist pri bolnicah z bezgavkami 4+ ni bila statistično značilna, zato končna analiza ni v celoti potrdila pozitivnega razmerja med koristjo in tveganjem TAC pri bolnicah z bezgavkami 4+ (glejte poglavje 5.1).
As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis (see section 5.1).
Za preživetje brez bolezni (DFS – disease-free survival) in celokupno preživetje (OS – overall survival) ugotovljena korist pri bolnicah z bezgavkami 4+ ni bila statistično značilna, zato končna analiza ni v celoti potrdila pozitivnega razmerja med koristjo in tveganjem TAC pri bolnicah z bezgavkami 4+ (glejte poglavje 5.1).
As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demontrated at the final analysis (see section 5.1).
Za preživetje brez bolezni (DFS – disease-free survival) in celokupno preživetje (OS – overall survival) ugotovljena korist pri bolnicah z bezgavkami 4+ ni bila statistično značilna, zato končna analiza ni v celoti potrdila pozitivnega razmerja med koristjo in tveganjem TAC pri bolnicah z bezgavkami 4+ (glejte poglavje 5.1).
As the benefit observed in patients with 4+ nodes was not statistically significant on DFS and OS, the positive benefit/risk ratio for TAC patients with 4+ nodes was not fully demonstrated at the final analysis.
Korist za preživetje brez bolezni in celokupno preživetje pri bolnicah z bezgavkami 4+ ni bila statistično značilna, zato končna analiza ni v celoti potrdila pozitivnega razmerja med koristjo in tveganjem TAC pri bolnicah z bezgavkami 4+.
As the body breaks down protein after eating waste nitrogen, in the form of ammonia, accumulates because the body cannot eliminate it.
Ker telo razgradi zaužite beljakovine, se odpadni dušik v obliki amoniaka kopiči, saj ga telo ne zmore odstraniti.
As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see section 4.4 and 5.2).
Ker klinična pomembnost tega povečanja pri izpostavljenosti ni znana, se sočasno dajanje močnih zaviralcev P-gp, kot so ciklosporin, ketokonazol, eritromicin, klaritromicin, verapamil, dronedaron in amiodaron ne priporoča (glejte poglavji 4.4 in 5.2).
As the company had submitted the additional information requested, the ‘exceptional circumstances’ ended on 21 September 2009.
Ker je družba predložila dodatne zahtevane podatke, so 21. septembra 2009 izjemne okoliščine prenehale veljati.
As the company had supplied the additional information requested at the time of authorisation, the ‘exceptional circumstances’ ended on 26 August 2013.
Ker je družba predložila dodatne informacije, zahtevane ob odobritvi, so izjemne okoliščine prenehale veljati 26. avgusta 2013.
As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 10 August 2010.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 10. avgusta 2010.
As the company had supplied the additional information requested, the ‘Exceptional Circumstances’ ended on 10 March 2004.
Ko je družba predložila dodatne zahtevane podatke, je odobritev „v izjemnih okoliščinah“ prenehala veljati dne 10. marca 2004.
As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 11 July 2002.
Ker je družba predložila dodatne zahtevane podatke, so „izjemne okoliščine“ prenehale veljati 11. julija 2002.
As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 12 August 2010.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 12. avgusta 2010.
As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 16 December 2015.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 16. decembra 2015.
As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 17 January 2014.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 17. januarja 2014.
As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 19 March 2012.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 19. marca 2012.
As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 20 July 2015.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati dne 20. julija 2015.
As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 22 May 2008.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 22. maja 2008.
As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 27 May 2015.
Ker je družba zagotovila dodatne zahtevane informacije so izjemne okoliščine prenehale 27. maja 2015.
As the company had supplied the additional information requested, the ‘Exceptional Circumstances’ ended on 6 July 2004.
Ker je družba predložila dodatne zahtevane podatke, so bile „izjemne okoliščine“ razveljavljene 6. julija 2004.
As the company had supplied the additional information requested, the ‘Exceptional Circumstances’ ended on 8 July 2008.
Ker je družba predložila dodatne zahtevane informacije so „izjemne okoliščine“ prenehale veljati 8. julija 2008.
As the company had supplied the additional information requested, the ’Exceptional Circumstances’ ended on 28 July 2006.
Ker je podjetje posredovalo zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 28. julija 2006.
As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Ker pa je družba predložila dodatne zahtevane podatke, je bilo dovoljenje za promet spremenjeno iz pogojnega v običajno.
As the disease is very severe and there are no other effective treatments approved, the Committee for Medicinal Products for Human Use (CHMP) decided that Refludan’s benefits are greater than its risks for the treatment of patients with HIT and thromboembolic disease.
Ker je bolezen zelo huda in zanjo ne obstajajo nobena druga odobrena učinkovita zdravila, je Odbor za zdravila za uporabo v humani medicini (CHMP) zaključil, da so koristi zdravila Refludan pri zdravljenju bolnikov s HIT in tromboembolijo večje od z njim povezanih tveganj.