natgillin/translations-raw huggingface dataset:
During the course of treatment, appropriate determination of factor VIII levels (by one-stage clotting or chromogenic assays) is advised to guide the dose to be administered and the frequency of repeated injections.
Tekom zdravljenja se priporoča ustrezno določanje ravni faktorja VIII (s pomočjo enostopenjskih strjevalnih ali kromogenih preskusov), kar je vodilo za odmerjanje zdravila in pogostnost ponovljenih injiciranj.
During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Med zdravljenjem je priporočljivo določanje vrednosti faktorja VIII kot vodilo pri odmerjanju in določanju pogostosti ponavljanja infuzij.
During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated injections.
Med zdravljenjem je priporočljivo določanje koncentracije faktorja VIII kot vodila za določitev potrebnega odmerka in določanje pogostosti ponavljanja injekcij.
During the course of treatment, appropriate determination of FVIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Tekom zdravljenja priporočamo ustrezno določanje ravni FVIII, kar je vodilo za odmerjanje zdravila in pogostost ponovljenih infundiranj.
During the darunavir/ritonavir clinical development program (N=3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
V kliničnem preskušanju darunavirja/ritonavirja (n=3.063) se je pri 0,4% bolnikov pojavil hud kožni izpuščaj, ki ga je lahko spremljala zvišana telesna temperatura in/ali zvvišane koncentracije transaminaz.
During the day
tekom dneva
During the dialysis sessions the mean half-life of plasma concentration decline was in the range
Med postopkom dialize je bila srednja vrednost razpolovnega časa zmanjšanja koncentracije v plazmi 5
During the Double- blind, Placebo-controlled Phase of the 52-week long-term trial, the incidence of weight gain of  7 % from baseline to last visit was 6.4 % for Abilify Maintena and 5.2 % for placebo.
Med dvojno slepo, s placebom nadzorovano fazo 52-tedenskega dolgotrajnega preskušanja je incidenca povečanja telesne mase  7 % od izhodiščne vrednosti do zadnjega obiska znašala 6,4 % prizdravilu Abilify Maintena in 5,2 % pri placebu.
During the double-blind controlled period, the incidence of indirect bilirubin greater than the upper limit of normal, collected as a routine laboratory parameter, is 6.2% in patients treated with 8 mg/kg tocilizumab + DMARD.
V obdobju dvojno slepe kontrole je incidenca zvišanja indirektnega bilirubina (parameter rutinskih laboratorijskih preiskav) nad ZMN pri bolnikih, zdravljenih z 8 mg/kg tocilizumaba in DMARD, znašala 6,2 %.
During the double-blind treatment a significant positive effect on quality of life was seen with Kentera based on the Incontinence Impact Questionnaire (IIQ).
Na podlagi vprašalnika o vplivu inkontinence (Incontinence Impact Questionnaire – IIQ) so med dvojno slepim delom študije ugotovili pomemben pozitiven učinek na kakovost življenja.
During the Double-blind, Active-controlled Phase of the 38-week long-term trial, the incidence of weight gain of  7 % from baseline to last visit was 9.5 % for Abilify Maintena and 11.7 % for the oral aripiprazole tablets 10-30 mg.
Med dvojno slepo aktivno nadzorovano fazo 38-tedenskega dolgotrajnega preskušanja je incidenca povečanja telesne mase  7 % od izhodiščne vrednosti do zadnjega obiska znašala 9,5 % pri zdravilu Abilify Maintena in 11,7 % pri aripiprazolu v 10–30 mg peroralnih tabletah.
During the evaluation phase of 12 weeks, 47% (30 out of 64) of Pexion treated dogs were free from generalised seizures, whilst 58% (51 out of 88) of phenobarbital treated dogs had no seizures.
Med 12-tedensko fazo ocenjevanja se generalizirani epileptični napadi niso pojavili pri 47 % (30 od 64) psov, zdravljenih z zdravilom Pexion, in pri 58 % (51 od 88) psov, zdravljenih s fenobarbitalom.
During the extension phase, 74 patients continued receiving pasireotide intramuscular use and
V fazi podaljšanja je 74 bolnikov še naprej prejemalo pasireotid za intramuskularno uporabo,
During the fertility studies, a reduction in the number of corpora lutea and prolonged oestrous cycle were observed at dose levels that were associated with decreased food intake and body weight gain in maternal animals; however, no effects on indices of fertility and conception or embryonic development were observed.
Med raziskavami plodnosti so opazili zmanjšano število rumenih telesc in podaljšan estrusni cikel pri ravneh odmerka, povezanih z zmanjšanim vnosom hrane in zmanjšanim pridobivanjem telesne mase pri materi; kljub temu pa niso opazili nobenih učinkov na kazalce plodnosti in spočetja ali embrionalni razvoj.
During the first 18 weeks of treatment with Nevirapine Teva it is very important that you and your doctor watch out for signs of liver or skin reactions.
Prvih 18 tednov zdravljenja z zdravilom Nevirapin Teva je zelo pomembno, da ste vi in vaš zdravnik pozorni na znake jetrnih ali kožnih reakcij.
During the first 21-day chemotherapy cycle, patients treated with either Ratiograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Med prvim 21–dnevnim ciklom kemoterapije so imeli bolniki, zdravljeni bodisi z zdravilom Ratiograstim ali Neupogen, hudo nevtropenijo v povprečju 1,1 dan, v primerjavi s 3,8 dneva pri tistih, ki so prejemali placebo.
During the first 3 months of your treatment with GRANUPAS, you must be attentive to any sign of allergic reaction or hepatitis, like skin eruption and/or fever.
V prvih 3 mesecih zdravljenja z zdravilom GRANUPAS morate biti pozorni na kakršne koli znake alergijske reakcije ali hepatitisa, kot sta na primer kožni izpuščaj in/ali zvišana telesna temperatura.
During the first 4 weeks of double-blind treatment, patients received triple combination aliskiren/amlodipine/hydrochlorothiazide (HCTZ) 150/5/12.5 mg (N=308), or dual combinations of aliskiren/HCTZ 150/12.5 mg (N=295), aliskiren/amlodipine
V prvih 4 tednih dvojno slepega zdravljenja so bolniki prejemali trojno kombinacijo aliskirena/amlodipina/hidroklorotiazida 150/5/12,5 mg (N=308) ali pa kombinacije samo dveh učinkovin: aliskirena/hidroklorotiazida 150/12,5 mg (N=295), aliskirena/amlodipina 150/5 mg (N=282) ali amlodipina/hidroklorotiazida 5/12,5 mg (N=295).
During the first procedure a sample of healthy cartilage cells (a biopsy) will be taken from the affected joint by an arthrotomy or arthroscopy.
Med prvim postopkom se odvzame vzorec zdravega hrustančnega tkiva (biopsija) iz prizadetega sklepa v postopku artrotomije ali artroskopije.
During the first procedure, a sample of healthy cartilage cells (a biopsy) will be taken from your joint by arthrotomy or arthroscopy.
Med prvim postopkom se odvzame vzorec zdravega hrustančnega tkiva (biopsija) s prizadetega sklepa v postopku artrotomije ali artroskopije.
During the first procedure, a sample of healthy cartilage tissue (a biopsy) will be taken from the affected joint by an arthrotomy or arthroscopy.
Med prvim postopkom se v postopku artrotomije ali artroskopije odvzame vzorec zdravega hrustančnega tkiva (biopsija) iz prizadetega sklepa.
During the first week, the usual dose is 1 tablet Pramipexole Teva 0.088 mg three times a day (equivalent to 0.264 mg daily):
Običajni odmerek za prvi teden zdravljenja je 1 tableta zdravila Pramipeksol Teva po 0,088 mg 3-krat na dan (0,264 mg na dan):
During the first year of treatment, the patient should be assessed at least every 3 months for:
V prvem letu zdravljenja morate bolnika vsaj vsake 3 mesece ocenjevati glede:
During the first year, patients treated with Plegridy every two or four weeks experienced fewer relapses on average than patients on placebo: 0.26 and 0.29 relapses versus 0.40, respectively.
V prvem letu so imeli bolniki, zdravljeni z zdravilom Plegridy vsaka dva do štiri tedne, povprečno manj relapsov kot bolniki, ki so prejemali placebo: 0,26 in 0,29 relapsa v primerjavi z 0,40 relapsa.
During the first year, patients were given Plegridy every two or four weeks, or placebo (a dummy treatment); during the second year, all patients were given Plegridy every two or four weeks.
V prvem letu so bolniki zdravilo Plegridy prejemali vsaka dva do štiri tedne ali placebo (zdravljenje brez zdravilne učinkovine); v drugem letu so vsi bolniki prejemali zdravilo Plegridy vsaka dva do štiri tedne.
During the first year, significantly fewer subjects in the Rotarix group reported severe rotavirus gastro- enteritis caused by the circulating wild-type RV compared to the placebo group from 2 weeks after Dose 2 up to one year of age (0.0% versus 0.3%), with a vaccine efficacy of 100% (95% CI: 72.2; 100).
V prvem letu so pri prejemnikih cepiva Rotarix zabeležili značilno manj primerov hudega rotavirusnega gastroenteritisa, ki ga je povzročil krožeči divji tip RV, kot pri prejemnikih placeba, in sicer od 2. tedna po 2. odmerku do enega leta starosti (0,0 % v primerjavi z 0,3 %), pri čemer je bila učinkovitost cepiva 100 % (95 % IZ: 72,2; 100).
During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 3 in the INCIVO group (incidence ≥ 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea.
V fazi zdravljenja z zdravilom INCIVO oz. placebom so najpogosteje poročali o naslednjih neželenih učinkih jakosti najmanj 3.stopnje, ki je prejemala zdravilo INCIVO (pogostnost ≥ 1,0%): anemija, izpuščaj, trombocitopenija, limfopenija, pruritus innavzea.
During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people) may occur:
Med infundiranjem v bolnišnici se lahko pojavijo naslednje alergijske reakcije (pojavijo se lahko pri več kot 1 od 10 bolnikov):
During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people):
Med infundiranjem v bolnišnici se lahko pojavijo naslednje alergijske reakcije (pojavijo se pri več kot 1 od 10 bolnikov):
During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people): flushing, skin reactions, itching
Med infundiranjem v bolnišnici se lahko pojavijo naslednje alergijske reakcije (prizadenejo lahko več kot 1 od 10 bolnikov):
During the infusion at the hospital the following allergic reactions (may affectmore than 1 in 10 people):
Med infundiranjem v bolnišnici se lahko pojavijo naslednje alergijske reakcije (pojavijo se lahko pri več kot 1 od 10 bolnikov):
During the infusion at the hospital the following very common allergic reactions may occur (may affect more than 1 in 10 people):
Med infundiranjem v bolnišnici se lahko zelo pogosto pojavijo naslednje alergijske reakcije (pojavijo se lahko pri več kot 1 od 10 bolnikov):
During the infusion with SYLVANT, you will be monitored for side effects.
Med infundiranjem zdravila SYLVANT vas bodo opazovali zaradi morebitnih neželenih učinkov.
During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels <100 mg/dl [5.5 mmol/l], and post-prandial glucose levels
V prvih 18 tednih in zadnjih 12 tednih je bil odmerek insulina stabilen, a je bil med 19. in 40. tednom prilagojen za doseganje preprandialnih ravni glukoze
During the initial double blind 6 months period (short- term period), the overall immunogenicity frequency to abatacept was 1.1% (8/725) and 2.3% (16/710) for the subcutaneous and intravenous groups, respectively.
Med začetnim dvojno slepim 6-mesečnim obdobjem (kratkoročno obdobje) je bila celokupna pogostnost imunogenosti v skupini, ki je prejemala abatacept subkutano 1,1% (8/725), v skupini, ki je abatacept prejemala intravensko pa 2,3% (16/710).
During the initial three months of treatment with ZYPADHERA, accumulation of olanzapine was observed but there was no additional accumulation during long-term use (12 months) in patients who were injected with up to 300 mg every two weeks.
V začetnih treh mesecih zdravljenja z zdravilom ZYPADHERA so opazili kopičenje olanzapina, vendar ni bilo dodatnega kopičenja med dolgoročno uporabo (12 mesecev) pri bolnikih, katerim so injicirali do 300 mg vsaka dva tedna.
During the initiation of therapy and dose adjustment, serum and urine bile acid levels should be monitored intensively using gas chromatography-mass spectrometry (GC-MS) or equivalent technology coupled to mass spectrometry.
Med uvajanjem zdravljenja in prilagajanjem odmerka je treba intenzivno spremljati ravni žolčnih kislin v serumu in urinu s plinsko kromatografijo z masno spektrometrijo (GC-MS) ali enakovredno tehnologijo, ki je povezana z masno spektrometrijo.
During the initiation of therapy and dose adjustment, serum and/or urine bile acid levels should be monitored intensively (at least every three months during the first year of treatment, every six months during the second year) using gas chromatography-mass spectrometry (GC-MS) or equivalent technology coupled to mass spectrometry.
Med uvajanjem zdravljenja in prilagajanjem odmerka je treba intenzivno spremljati (vsaj vsake tri mesece v prvem letu, vsakih 6 mesecev v drugem letu) ravni žolčnih kislin v serumu in/ali urinu s plinsko kromatografijo z masno spektrometrijo (GC-MS) ali enakovredno tehnologijo, ki je povezana z masno spektrometrijo.
During the injection process (Figure J):
Med postopkom injiciranja (slika J):
During the injection: The status light alternately flashes green and orange.
Med injiciranjem: Kontrolna lučka izmenoma utripa zeleno in oranžno.
During the last years there has been an increase of the exposure of Zoely in women above 35 years.
V obdobju zadnjih let se je povečala izpostavitev zdravilu Zoely pri ženskah, starejših od 35 let.
During the maintenance of anaesthesia, increasing the concentration of sevoflurane produces a dose dependent decrease in blood pressure.
Med vzdrževanjem anestezije povzroči zviševanje koncentracije sevoflurana od odmerka odvisno znižanje krvnega tlaka.
During the maintenance period in study GAO4753g, the most common adverse reactions were cough (15%), upper respiratory infections (12%), neutropenia (11%), sinusitis (10%), diarrhea (8%), infusion related reactions (8%), nausea (8%), fatigue (8%), bronchitis (7%), arthralgia (7%), pyrexia (6%), nasopharyngitis (6%), and urinary tract infections (6%).
V obdobju vzdrževalnega zdravljenja v študiji GAO4753g so bili najbolj pogosti neželeni učinki kašelj (15 %), okužba zgornjih dihal (12 %), nevtropenija (11 %), sinuzitis (10 %), diareja (8 %),reakcije, povezane z infuzijo (8 %), navzea (8 %), utrujenost (8 %), bronhitis (7 %), artralgija (7 %), zvišana telesna temperatura (6 %), nazofaringitis (6 %) in okužbe sečil (6 %).
During the maintenance phase, 19 patients were evaluated, with 17 patients achieving complete remission (89%), and 1 patient with therapeutic efficacy (5%).
V vzdrževalni fazi so ovrednotili 19 bolnikov, pri čemer je 17 bolnikov doseglo popolno remisijo (89 %), 1 bolnik pa je dosegel terapevtsko učinkovitost (5 %).
During the marketing of Desloratadine ratiopharm, the following side effects were reported as:
Med trženjem zdravila Desloratadin ratiopharm so poročali o naslednjih neželenih učinkih:
During the marketing of Desloratadine Teva, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Med trženjem zdravila Desloratadin Teva so zelo redko poročali o primerih hudih alergijskih reakcij (težave z dihanjem, piskanje, srbenje, koprivnica in otekanje).
During the marketing of Desloratadine Teva, the following side effects were reported as:
Med trženjem zdravila Desloratadin Teva so poročali o naslednjih neželenih učinkih:
During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Med obdobjem tržne uporabe desloratadina so zelo redko poročali o hudih alergijskih reakcijah (težave z dihanjem, piskajoče dihanje, srbenje, koprivnica in otekanje).
During the marketing of desloratadine, the following side effects were reported as: Very rare: the following may affect up to 1 in 10,000 people
Med trženjem desloratadina so poročali o naslednjih neželenih učinkih: Zelo redki: naslednji se lahko pojavijo pri največ 1 od 10.000 bolnikov
During the marketing of desloratadine-containing products, the following side effects were reported as:
Med trženjem zdravil, ki vsebujejo desloratadin, so poročali o naslednjih neželenih učinkih:
During the menopause, the amount of the oestrogen produced by a woman’s body drops.
Med menopavzo se količina estrogena, ki ga proizvaja telo, zmanjša.
During the monotherapy phase, the dose and way you receive Temodal in this phase will be different.
Med fazo zdravljenja z enim zdravilom bosta odmerek in način odmerjanja zdravila Temodal drugačna.
During the monotherapy phase, the dose and way you take Temomedac will be different.
Med fazo zdravljenja z enim zdravilom bosta odmerek in način odmerjanja zdravila Temomedac drugačna.
During the one year of treatment with ribavirin in combination with interferon alfa-2b, some children and adolescents did not grow or gain weight as much as expected.
V času enoletnega zdravljenja z ribavirinom v kombinaciji z interferonom alfa-2b nekateri otroci in mladostniki niso zrasli in niso pridobili na telesni masi toliko, kot bi pričakovali.
During the open-label periods of Studies I, II, III, and VI the improvement in physical function has been maintained through 7 years, 5 years, 5 years, and 2 years, respectively.
Izboljšanje fizične funkcije med odprtim obdobjem študije I se je ohranilo 7 let, med odprtim obdobjem študije II 5 let, med odprtim obdobjem študije III 5 let in med odprtim obdobjem študije VI 2 leti.
During the overall study period in the ITT population (analysis set to show superiority), adjudicated stroke or SEE occurred in 296 subjects in the edoxaban 60 mg group (1.57% per year), and 337 subjects in the warfarin group (1.80% per year).
Med celotnim obdobjem študije se je v populaciji ITT (analiza z namenom prikaza superiornosti) možganska kap ali SEE po strokovni presoji pojavila pri 296 preiskovancih v skupini z edoksabanom 60 mg (1,57 % na leto) in pri 337 preiskovancih v skupini z varfarinom (1,80 % na leto).
During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Med pandemijo bo vlagatelj zbiral podatke o klinični varnosti in učinkovitosti pandemskega cepiva in te podatke posredoval v vrednotenje Odboru za zdravila za uporabo v
During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan
kohortno študijo, kot je opredeljeno v načrtu
During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Med pandemijo bo vlagatelj izvajal perspektivno kohortno
During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Med pandemijo bo vlagatelj izvajal prospektivno kohortno študijo, kot je navedeno v načrtu farmakovigilance.
During the pandemic, the applicant will conduct a surveillance on the safety of the vaccine during pregnancy using dedicated registry.
Med pandemijo bo vlagatelj z uporabo ustreznega registra izvajal nadzor nad varnostjo cepiva med nosečnostjo.
During the period covered by this PSUR, 4 cases of incorrect administration of Carbaglu by intravenous infusion have been identified, one of which had a fatal outcome.
V obdobju poročanja, zajetem v tem poročilu PSUR, so ugotovili 4 primere nepravilne uporabe zdravila Carbaglu z intravenskim infundiranjem, pri čemer je en primer imel smrtni izid.
During the placebo controlled period through week 12, the efficacy of both the recommended and half of the recommended dose groups were generally comparable at the primary endpoint (69.4% and 67.6% respectively) although there was evidence of a dose response for higher level efficacy criteria (e.g.
Do 12. tedna zdravljenja, nadzorovanega s placebom je bila učinkovitost primarnih ciljev pri skupini, ki je prejemala priporočeni odmerek in pri skupini, ki je prejemala polovico priporočenega odmerka v splošnem primerljiva (69,4% oziroma 67,6%).
During the placebo-controlled period of the phase III clinical trials PSOR, 1.2% (14/1184) of patients treated with apremilast reported depression compared to 0.5% (2/418) treated with placebo.
Med s placebom kontroliranim obdobjem kliničnih preskušanj faze III pri bolnikih s PSOR je 1,2 % (14/1184) bolnikov, zdravljenih z apremilastom, poročalo o depresivnosti, v primerjavi z 0,5 % (2/418) tistih, ki so jemali placebo.
During the post-marketing period, reports of hypersensitivity reactions included rash, pruritus, urticaria, and isolated cases of severe anaphylactic/anaphylactoid reactions.
V obdobju trženja so poročali o preobčutljivostnih reakcijah vključno z osipom, pruritusom, urtikarijo, in posameznih primerih anafilaktičnih/anafilaktoidnih reakcij.
During the randomised period of the study, subjects were randomised by 3 age cohort strata (2:1) to eltrombopag (n=45) or placebo (n=22).
Za obdobje randomiziranega zdravljenja v študiji so bolnike v treh starostnih skupinah randomizirali (v razmerju 2:1) na jemanje eltrombopaga (n = 45) ali na jemanje placeba (n = 22).
During the randomised period, platelet transfusions were administered to 4.7% of patients receiving Jakavi and to 4.0% of patients receiving control regimens.
V randomiziranem obdobju je infuzijo trombocitov dobilo 4,7 % bolnikov, ki so prejemali zdravilo Jakavi, in 4,0 % tistih bolnikov, ki so prejemali kontrolne sheme zdravljenja.
During the reporting a number of serious and non-serious adverse drug reactions (ADRs) from post- marketing data sources regarding “hyponatraemia” raised a concern that led to the submission of a cumulative review from the Marketing Authorisation Holder (MAH).
V času poročanja iz podatkov po prihodu zdravila na trg, o številnih resnih neželenih učinkih in tistih, ki niso opredeljeni kot resni, so skrb vzbujali podatki o "hiponatriemiji", zaradi česar je imetnik dovoljenja za promet z zdravilom predložil kumulativni pregled zbranih podatkov.
During the reporting period concomitant use of ACE inhibitors and vildagliptin resulted in a slightly higher incidence of angioedema in the vildagliptin group versus the comparator group.
V obdobju poročanja je sočasna uporaba zaviralcev angiotenzinske konvertaze (zaviralcev ACE) in vildagliptina povzročila rahlo povečanje pogostnosti angioedema v skupini z vildagliptinom v primerjavi s pogostnostjo angioedema v skupini s primerjalnim zdravilom.
During the reporting period of this PSUR, a certain number of cases from routine pharmacovigilance activities were reported and indicated a causal relationship with the use of bimatoprost containing medicinal products.
Med obdobjem poročanja tega poročila PSUR je bilo izpostavljeno določeno število primerov iz rutinskih dejavnosti na področju farmakovigilance, ki so kazali na povezavo z uporabo zdravil, ki vsebujejo bimatoprost.
During the reporting period, 2 cases of torsade de pointe have been reported.
Med obdobjem poročanja so poročali o dveh primerih torsade de pointes.
During the reporting period, a total of 8 new cases of serious gastrointestinal disorders associated with the presence of sevelamer crystals were reported.
Med obdobjem poročanja so skupno poročali o 8 novih primerih resnih bolezni prebavil, povezanih s prisotnostjo kristalov sevelamerja.