natgillin/translations-raw huggingface dataset:
An objective response was observed for four of six evaluable adolescent in an interim analysis of Study 5.
Objektivni odziv so ugotovili pri štirih od šestih ocenljivih mladostnikov na vmesni analizi študije 5.
An observation period of 30 to 60 minutes is recommended after each Perjeta infusion and before commencement of any subsequent infusion of trastuzumab or docetaxel (see section 4.4).
Po vsaki infuziji zdravila Perjeta in pred začetkom katere koli nadaljnje infuzije trastuzumaba ali docetaksela je priporočljivo 30- do 60-minutno opazovalno obdobje (glejte poglavje 4.4).
An observational non-interventional Registry in patients with PNH (M07-001) was also initiated to characterize the natural history of PNH in untreated patients and the clinical outcomes during Soliris treatment.
Zasnovali so tudi opazovalni, neintervencijski register bolnikov s PNH (M07-001) za opredelitev naravnega poteka PNH pri nezdravljenih bolnikih in kliničnih izidov med zdravljenjem z zdravilom Soliris.
An observational retrospective cohort study of ospemifene to assess the incidence of venous thromboembolism and other safety concerns as agreed in the risk management plan, in VVA patients treated with ospemifene compared to 1) patients newly prescribed SERMs for oestrogen-deficiency conditions or breast cancer prevention, and 2) the incidence in untreated VVA patients.
Opazovalna retrospektivna kohortna študija ospemifena za ocenitev incidence venske trombembolije in drugih skrbi glede varnosti, kot je bilo dogovorjeno v načrtu za obvladovanje tveganja, pri bolnicah z atrofijo vulve in vagine, ki so se zdravile z ospemifenom, v primerjavi z 1) bolnicami, ki jim je bil selektivni modulatorji receptorjev estrogenov zaradi pomanjkanja estrogena ali preprečevanja raka na dojki predpisan prvič in 2) incidenco nezdravljenih bolnic z atrofijo vulve in vagine.
an observed 9% increase in risk for progress of disease (PD) or death in the epoetin alfa plus SOC group from a primary analysis and a 15% increased risk that cannot be statistically ruled out in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 10 to 12 g/dl (6.2 to 7.5 mmol/l).
opaženo 9-odstotno povečanje tveganja za napredovanje bolezni ali smrt v skupini z epoetinom alfa in standardno nego iz primarne analize in 15-odstotno povečanje tveganja, ki ga ni mogoče statistično izključiti pri bolnikih z metastatskim rakom dojke, ki so prejemali kemoterapijo, kadar so prejemali odmerke za doseganje razpona koncentracije hemoglobina od 10 do 12 g/dl (6,2 do 7,5 mmol/l).
An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Občasno jemanje acetilsalicilne kisline (ne več kot 1000 mg v kateremkoli 24-urnem obdobju) ne bi smelo povzročati težav, o daljšem jemanju v drugih okoliščinah pa se morate posvetovati s svojim zdravnikom.
An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period), should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Občasno jemanje acetilsalicilne kisline (ne več kot 1000 mg v kateremkoli 24-urnem obdobju), ne bi smelo povzročati težav, o daljšem jemanju v drugih okoliščinah pa se morate posvetovati s svojim zdravnikom.
An occasional use of acetylsalicylic acid (not more than 1000 mg in 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Priložnostna uporaba acetilsalicilne kisline (ne več kot 1.000 mg v kateremkoli 24 urnem obdobju) na splošno ne bi smela povzročati težav, vendar pa se morate o daljši uporabi v drugih okoliščinah posvetovati s svojim zdravnikom.
An occasional use of acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever (no more than 1,000 mg in any 24 hour period), should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Občasno jemanje acetilsalicilne kisline, učinkovina, ki je v številnih zdravilih za lajšanje bolečine in zniževanje zvišane telesne temperature (ne več kot 1000 mg v kateremkoli 24-urnem obdobju), ne bi smelo povzročati težav, o daljšem jemanju v drugih okoliščinah pa se morate posvetovati s svojim zdravnikom.
An odds ratio (OR) > 1 indicates an advantage for BR-CAP.
Razmerje obetov (odds ratio-OR) > 1 predstavlja prednost za skupino BzR-CAP.
An odds ratio (OR) > 1 indicates an advantage for BzmbR-CAP.
Razmerje obetov (odds ratio-OR) > 1 predstavlja prednost za skupino BzmbR-CAP.
An odds ratio (OR) > 1 indicates an advantage for BzR-CAP.
Razmerje obetov (odds ratio-OR) > 1 predstavlja prednost za skupino BzR-CAP.
An on-line video to further elaborate on the required calculation and administration of the drug
Spletni videoposnetek za nadaljnjo pojasnilo glede predpisanega izračuna in dajanja zdravila.
An ongoing randomised, double-blinded study (MERIT), is exploring maraviroc versus efavirenz, both in combination with zidovudine/lamivudine (n=721, 1:1).
V dvojno slepi randomizirani študiji (MERIT), ki še poteka, raziskujejo maravirok v primerjavi z efavirenzom, oba v kominaciji z zidovudinom/lamivudinom (n=721, 1:1).
An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis.
V odprti, ne-randomizirani študiji faze I/II so ugotavljali varnost in učinkovitost bortezomiba pri bolnikih, s predhodno zdravljeno AL amiloidozo.
An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis.
V odprti, nerandomizirani študiji faze I/II so ugotavljali varnost in učinkovitost bortezomiba pri bolnikih s predhodno zdravljeno AL-amiloidozo.
An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of VELCADE in patients with previously treated light-chain (AL) Amyloidosis.
V odprti, ne-randomizirani študiji faze I/II so ugotavljali varnost in učinkovitost zdravila VELCADE pri bolnikih, s predhodno zdravljeno AL amiloidozo.
An open label trial based on a CHMP approved protocol, comparing RET negative and RET positive patients with sporadic medullary thyroid cancer treated with vandetanib.
Odprta študija primerjave bolnikov z negativnim statusom mutacije RET in bolnikov s pozitivnim statusom mutacije RET ter sporadičnim medularnim rakom ščitnice, zdravljenih z vandetanibom, na podlagi protokola, odobrenega s strani CHMP.
An open label, repeat dose study (3 cycles of 6 weeks of treatment, followed by 4 weeks off treatment) showed that episodic use with multiple courses of eltrombopag has demonstrated no loss of response.
Odprta študija s ponavljajočimi se odmerki (3 cikli 6 tedenskega zdravljenja, ki so jim sledili 4 tedni brez zdravljenja) je pokazala, da se pri epizodni uporabi eltrombopaga z multiplimi cikli zdravljenja odziv ne izgubi.
an open sore or hole in the lining of the stomach or small intestine (the signs may include abdominal pain, feeling bloated, black tarry stools or blood in your stools (faeces) or blood in your vomit),
odprta rana ali luknja v sluznici želodca ali tankega črevesa (znaki so lahko bolečina v trebuhu, občutek napihnjenosti, črna stolica ali kri v stolici ali kri v bruhanju),
An open-label extension study (PATENT-2) included 363 patients who had completed PATENT-1 at the cut-off-date.
V odprto podaljšanje študije (PATENT-2) je bilo vključenih 363 bolnikov, ki so zaključili študijo PATENT-1 na presečni dan zbiranja podatkov.
An open-label phase II study investigated the safety, efficacy and pharmacokinetics of fulvestrant in 30 girls aged 1 to 8 years with Progressive Precocious Puberty associated with McCune Albright Syndrome (MAS).
V odprti študiji II. faze so raziskovali varnost, učinkovitost in farmakokinetiko fulvestranta pri 30 deklicah, starih od 1 do 8 let, s progresivno prezgodnjo puberteto, povezano z MacCune-Albrightovim sindromom (MAS).
An open-label study evaluated the pharmacokinetics of elotuzumab in combination with lenalidomide and dexamethasone in patients with multiple myeloma with varying degrees of renal impairment (classified using the CrCl values).
Pri bolnikih z multiplim mielomom z različnimi stopnjami okvare ledvic (razvrstitev na osnovi vrednosti CrCl) so farmakokinetiko elotuzumaba v kombinaciji z lenalidomidom in deksametazonom ovrednotili v odprti študiji.
An open-label, multicenter, randomized phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Narejena je bila odprta multicentrična randomizirana študija III. faze za primerjavo monoterapije z docetakselom in paklitaksela pri zdravljenju napredovalega raka na dojki pri bolnicah, katerih predhodno zdravljenje je moralo vključevati nek antraciklin.
An open-label, multicentre, international, randomised phase III study supports the use of vemurafenib in previously untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma.
Odprta, multicentrična, randomizirana mednarodna študija faze III podpira uporabo vemurafeniba pri predhodno nezdravljenih bolnikih z neresektabilnim ali metastatskim melanomom s pozitivno mutacijo BRAF V600E.
An open-label, multicentre, randomised Phase III study was conducted to determine the efficacy of nilotinib versus imatinib in 846 adult patients with cytogenetically confirmed newly diagnosed Philadelphia chromosome positive CML in the chronic phase.
Izvedli so odprto, multicentrično, randomizirano študijo faze III, da bi določili učinkovitost nilotiniba v primerjavi z učinkovitostjo imatiniba pri 846 odraslih bolnikih s citogenetsko potrjeno novo odkrito KML s prisotnim kromosomom Philadelphia v kronični fazi.
An open-label, non-comparative study (AC-052-362[BREATHE-4]) was performed in 16 patients with WHO functional class III PAH associated with HIV infection.
V odprti, neprimerjalni študiji (AC-052-362 [BREATHE-4]) je sodelovalo šestnajst bolnikov s PAH razreda III po klasifikaciji SZO, povezanim z okužbo HIV.
An open-label, parallel-group trial in non-iron deficient adult subjects with a pre-treatment haemoglobin of ≥ 10 to ≤ 13 g/dl who were scheduled for major orthopaedic hip or knee surgery compared epoetin alfa 300 IU/kg subcutaneously daily for 10 days prior to surgery, on the day of surgery and for four days after surgery to epoetin alfa 600 IU/kg subcutaneously once weekly for 3 weeks prior to surgery and on the day of surgery.
V odprtem preskušanju z vzporednimi skupinami pri odraslih osebah brez pomanjkanja železa, predhodno zdravljenih s hemoglobinom ≥ 10 do ≤ 13 g/dl, ki so imeli načrtovan večji ortopedski kirurški poseg na kolku ali kolenu, so primerjali epoetin alfa 300 i.e./kg, subkutano, vsak dan, 10 dni pred kirurškim posegom, na dan kirurškega posega in štiri dni po kirurškem posegu, z epoetinom alfa 600 i.e./kg, subkutano, enkrat na teden, 3 tedne pred kirurškim posegom in na dan kirurškega posega.
An open-label, randomized, multicenter, Phase III study (ECOG E4A03) was conducted in 445 patients with newly diagnosed multiple myeloma; 222 patients were randomized to the lenalidomide/low dose dexamethasone arm, and 223 were randomized to the lenalidomide/standard dose dexamethasone arm.
Odprto, randomizirano, multicentrično študijo faze III (ECOG E4A03) so opravili pri 445 bolnikih z novo diagnosticiranim diseminiranim plazmocitomom; 222 bolnikov so randomizirali na skupino lenalidomida/deksametazona v majhnem odmerku, 223 pa so jih randomizirali na skupino lenalidomida/deksametazona v standardnem odmerku.
An open-label, two arm, randomised study (OMB114242) was conducted in patients with bulky fludarabine refractory CLL who had failed at least 2 prior therapies (n=122) comparing Arzerra monotherapy (n=79) to physicians’ choice (PC) of therapy (n=43).
Pri bolnikih z masivno, proti fludarabinu odporno KLL in vsaj 2 neuspešnima predhodnima zdravljenjema (n = 122) so opravili odprto, randomizirano študijo z dvema skupinama (OMB114242), v kateri so monoterapijo z zdravilom Arzerra (n = 79) primerjali z zdravljenjem po zdravnikovi izbiri (n = 43).
An open-label, uncontrolled, multicentre Phase II study was conducted to determine the efficacy of Tasigna in patients with imatinib resistant or intolerant CML with separate treatment arms for chronic and accelerated phase disease.
Izvedli so odprto nekontrolirano multicentrično študijo faze II, da bi določili učinkovitost zdravila Tasigna pri bolnikih s KML, ki so rezistentni na imatinib ali pa ga ne prenašajo, pri tem so bolnike v kronični fazi bolezni in tiste v pospešeni fazi razdelili v dva ločena kraka.
An oral anti-herpes agent should be administered to all patients during and for 1 month following treatment.
Med zdravljenjem in še en mesec po njem je treba vsem bolnikom dajati peroralna zdravila proti herpesu.
An oral dosing syringe and a plastic adapter for the bottle is included in the pack.
Škatlici je priložena peroralna odmerna brizga in nastavek za brizgo.
An oral polypropylene syringe graduated in mg of propranolol, is provided with each bottle.
Peroralna polipropilenska brizga, umerjena v mg propranolola je priložena vsaki steklenici.
An oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50kg and when tablets don’t allow accurate dosage.
Za dojenčke in otroke, mlajše od 6 let, za otroke in mladostnike (od 6 do 17 let), lažjih od 50 kg in kadar s tabletami ne moremo zagotoviti natančnega odmerjanja je zdravilo Levetiracetam Accord 100 mg/ml peroralna raztopina primernejša farmacevtska oblika.
An oral solution is also available for the treatment of children over 3 months of age, or for people who need a lower dose than usual, or who cannot take tablets.
Zdravilo Epivir je na voljo tudi v obliki peroralne raztopine za zdravljenje otrok, starejših od treh mesecev in bolnikov, ki potrebujejo nižji odmerek, kot je običajno ali ki tablet ne morejo jemati.
An oral solution is available to patients who have difficulty swallowing.
Za bolnike, ki imajo težave s požiranjem, je na voljo peroralna raztopina.
An oral solution is the formulation to use in infants.
Farmacevtska oblika, ki je prilagojena za uporabo pri tej skupini, je peroralna raztopina.
An oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Pri dojenčkih in otrocih, mlajših od 6 let je najprimernejša farmacevtska oblika za uporabo zdravilo peroralna raztopina.
An oral solution is the preferred formulation for use in this population.
Pri tej populaciji je najprimernejša farmacevtska oblika za uporabo zdravilo Matever peroralna raztopina.
An oral solution of Lamivudine is available for people who need a lower than usual dose, or who can’t take tablets.
Za osebe, ki potrebujejo manjši odmerek od običajnega ali ne morejo jemati tablet, je na voljo peroralna raztopina lamivudina.
An oral solution of Zeffix is available for people who need a lower than usual dose, or who can’t take tablets.
Za osebe, ki potrebujejo manjši odmerek od običajnega ali ne morejo jemati tablet, je na voljo peroralna raztopina zdravila Zeffix.
An oral suspension dosage form, which can be dosed according to body weight or body surface area, is available for children in this age group weighing less than 50 kg or whose body surface area is below 1.25 m2 (please refer to the Summary of Product Characteristics of Viramune oral suspension).
Za otroke iz te starostne skupine, ki tehtajo manj kot 50 kg ali katerih telesna površina ne dosega 1,25 m2, je na voljo peroralna suspenzija, katere odmerek lahko prilagajamo telesni masi ali površini (poglejte v Povzetek glavnih značilnosti Viramune peroralna suspenzija).
an oral suspension in a prefilled oral applicator;
kot peroralna suspenzija v predhodno napolnjenem peroralnem aplikatorju;
an oral suspension in a squeezable tube.
kot peroralna suspenzija v iztisljivi tubi.
An OS analysis of the study, carried out as planned at 72% (N = 574) of events, demonstrated a clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.68; 95% confidence interval [CI] [0.58 to 0.81]; p < 0.0001) and a median OS of 7.1 months vs 5.3 months, respectively; with 1-year survival rates of 26.6% and 17.6%, respectively.
Vnaprej načrtovana analiza OS, izvedena pri 72 % dogodkov (N = 574), je pokazala klinično pomembno ter statistično značilno podaljšanje preživetja pri zdravilu Lonsurf in BSC v primerjavi s placebom in BSC (razmerje ogroženosti 0,68; 95-% interval zaupanja [CI – Confidence Interval] [od 0,58 do 0,81]; p < 0,0001) z mediano OS 7,1 meseca v primerjavi s 5,3 meseca ter stopnjo preživetja po 1 letu 26,6 % v primerjavi s 17,6 %.
An osteosarcoma patient in a phase II study who had high creatinine level at enrolment showed an increase in blood urea and blood creatinine which was associated with mifamurtide use.
V študiji II. faze so pri bolniku z osteosarkomom, ki je imel ob vključitvi visoko vrednost kreatinina, poročali o zvišanih vrednostih sečnine v krvi in kreatinina v krvi, ki so bile povezane z uporabo mifamurtida.
An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control have not been demonstrated.
Študij izida z rosiglitazonom ni bilo, zato dolgoročne koristi, povezane z boljšo urejenostjo glikemije, niso ugotovljene.
An ovarian hyperstimulation syndrome should be treated symptomatically, e.g. with rest, intravenous electrolytes/colloids and heparin therapy.
Sindrom ovarijske hiperstimulacije moramo zdraviti simptomatsko, npr. s počitkom, intravenskimi elektroliti/koloidi in heparinsko terapijo.
An overall favourable response required meeting each of 5 criteria: (1) successful treatment of any baseline fungal infection (caspofungin 51.9 % [14/27], liposomal amphotericin B 25.9 % [7/27]), (2) no breakthrough fungal infections during administration of study drug or within 7 days after completion of treatment (caspofungin 94.8 % [527/556], liposomal amphotericin B 95.5 % [515/539]), (3) survival for 7 days after completion of study therapy (caspofungin 92.6 % [515/556], liposomal amphotericin B 89.2 % [481/539]), (4) no discontinuation from the study drug because of drug-related toxicity or lack of efficacy (caspofungin 89.7 % [499/556], liposomal amphotericin B 85.5 % [461/539]), and (5) resolution of fever during the period of neutropaenia (caspofungin 41.2 % [229/556], liposomal amphotericin B 41.4 % [223/539]).
Celotni odziv je bil ocenjen kot ugoden, če je bilo izpolnjenih vseh 5 naslednjih meril: (1) uspešno zdravljenje katere koli osnovne glivne okužbe (kaspofungin 51,9 % [14/27], liposomski amfotericin B 25,9 % [7/27]), (2) brez izbruha glivnih okužb med uporabo študijskega zdravila in 7 dni po zaključku zdravljenja (kaspofungin 94,8 % [527/556], liposomski amfotericin B 95,5 % [515/539]), (3) preživetje 7 dni po zaključku raziskovane terapije (kaspofungin 92,6 % [515/556], liposomski amfotericin B 89,2 % [481/539]), (4) brez prekinitve raziskovanega zdravila zaradi z njim povezane toksičnosti ali nezadostne učinkovitosti (kaspofungin 89,7 % [499/556], liposomski amfotericin B 85,5 % [461/539]), (5) izginotje zvišane telesne temperature med obdobjem nevtropenije (kaspofungin 41,2 % [229/556], liposomski amfotericin B 41,4 % [223/539]).
An overall survival analysis was confounded by the fact that placebo-treated subjects with confirmed disease progression had the option to cross over to open-label lenvatinib.
Analizo celotnega preživetja je otežilo dejstvo, da so preiskovanci s potrjenim napredovanjem bolezni, ki so prejemali placebo, imeli možnost izbire prehoda na odprti lenvatinib.
An overdose can induce drowsiness in horses
Preveliko odmerjanje lahko pri konjih povzroči zaspanost.
An overdose can induce drowsiness in horses.
Preveliko odmerjanje lahko pri konjih povzroči zaspanost.
An overdose is unlikely because injection is prepared as a single dose by the hospital personnel, under strictly controlled conditions.
Ker injekcijo pripravi bolnišnično osebje kot en odmerek v strogo nadzorovanih pogojih, ni verjetno, da bi prejeli prevelik odmerek.
An overdose is unlikely because you will get a specially measured amount of Lymphoseek precisely controlled by the doctor supervising the procedure.
Preveliko odmerjanje ni verjetno, saj boste prejeli posebej izmerjeno količino zdravila Lymphoseek, zdravnik pa bo nadzoroval postopek.
An overdose is unlikely because you will only receive a single dose of Amyvid precisely controlled by the nuclear medicine doctor supervising the procedure.
Ker boste prejeli samo en odmerek zdravila Amyvid pod strogim nadzorom zdravnika nuklearne medicine, ki nadzira postopek, ni verjetno, da bi dobili prevelik odmerek.
An overdose is unlikely since you will only receive a single dose of VIZAMYL from the nuclear medicine doctor under controlled conditions.
Prevelik odmerek je malo verjeten, saj boste prejeli le en odmerek zdravila VIZAMYL, ki vam ga bo dal zdravnik nuklearne medicine v kontroliranih pogojih.
An overdose is unlikely.
Prekomerno odmerjanje je malo verjetno.
An overdose may result in symptoms resulting from an exaggeration of prucalopride’s known pharmacodynamic effects and include headache, nausea and diarrhoea.
Pri prevelikem odmerjanju se lahko pojavijo simptomi, ki so posledica povečanja znanih farmakodinamskih učinkov prukaloprida ter vključujejo glavobol, navzeo in diarejo.
An overdose of 10,000 mg (total dose in a single cycle, over5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multiorgan failure and death.
Po prevelikem odmerku 10.000 mg (skupni odmerek v posameznem ciklu, v petih dneh), ki ga je vzel en bolnik, so poročali o pancitopeniji, pireksiji, odpovedi več organov in smrti.
An overdose of fluticasone furoate/vilanterol may produce signs and symptoms due to the individual component’s actions, including those seen with overdose of other beta2-agonists and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Preveliko odmerjanje flutikazonfuroata/vilanterola lahko povzroči znake in simptome, ki so posledica delovanja vsake od obeh sestavin, vključno z znaki in simptomi prevelikega odmerjanja drugih agonistov adrenergičnih receptorjev beta2 in skladnih z znanimi učinki inhaliranih kortikosteroidov (glejte poglavje 4.4).
An overdose of insulin can result in hypoglycaemia in which case immediate administration of a glucose solution and/or food is required.
Prevelik odmerek insulina lahko povzroči hipoglikemijo; v tem primeru je treba takoj dati raztopino glukoze in/ali hrano.
An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your immune system for longer.
Ni verjetno, da bi prevelik odmerek Simulecta takoj imel stranske učinke, vendar lahko oslabi vaš imunski sistem za dalj časa.
An overdose of the veterinary medicinal product may cause a sticky and tangled appearance of hair at the treatment spot for up to 24 hours.
Uporaba čezmernega odmerka zdravila lahko povzroči lepljenje in vozlanje dlak na mestu nanosa, kar lahko traja do 24 ur po uporabi zdravila.