natgillin/translations-raw huggingface dataset:
The MAH will continue to submit 6 monthly PSURs unless otherwise specified by CHMP.
Če Odbor za zdravila za uporabo v humani medicini (CHMP) ne določi drugače, bo imetnik dovoljenja za promet z zdravilom vsakih 6 mesecev predložil poročilo o varnosti zdravila (PSUR).
The MAH will continue to submit yearly PSURs unless otherwise specified by the CHMP.
Imetnik dovoljenja za promet z zdravilom bo nadaljeval s predajanjem letnih poročil o varnosti zdravila PSUR, razen če CHMP določi drugače.
The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Imetnik dovoljenja za promet z zdravilom bo predložil Posodobljeno poročilo o varnosti zdravila (PSUR) enkrat na leto, razen če Odbor za zdravila za uporabo v humani medicini (CHMP) ne določi drugače.
The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Imetnik dovoljenja za promet z zdravilom bo še naprej oddajal letna periodična poročila o varnosti, razen če CHMP ne določi drugače.
The MAH will ensure that material provided to physicians provides information on the post-marketing surveillance programme and the immunosurveillance programme.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bo material, ki ga bodo prejeli zdravniki, vseboval informacije o programu spremljanja zdravila po dajanju na trg in o programu imunskega
The MAH will submit a progress report for the CHIP trial, including an update on safety data, in the 8th annual reassessment and will submit a full study report for the completed study when available.
Imetnik dovoljenja za promet bo predložil poročilo o napredku preskušanja– CHIP, vključno s posodobljenimi podatki o varnosti v 8. vsakoletni ponovni oceni, ter celotno poročilo o zaključeni študiji, ko bo le-to na voljo.
The MAH will submit PSURs on a yearly basis until otherwise requested by the CHMP.
Imetnik dovoljenja za promet bo posodobljena periodična poročila o varnosti zdravila (PSURs) predložil vsako leto, če CHMP ne zahteva drugače.
The MAH will submit the results of a prospective cohort safety study in at least 9,000 patients in different age groups, including immunocompromised subjects, in accordance with the protocol submitted with the Risk Management Plan.
Imetnik dovoljenja za promet z zdravilom bo rezultate prospektivne kohortne študije varnosti na najmanj 9000 bolnikih iz različnih starostnih skupin, vključno z imunokomprimiranimi osebami, posredoval v skladu s protokolom, predloženim skupaj z načrtom o obvladovanju tveganja.
The MAH will submit the results of the GBS surveillance study.
Imetnik dovoljenja za promet z zdravilom bo predložil rezultate študije spremljanja GBS.
The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to ensure proper injection placement to minimize occurrence of injection-related adverse events and to inform on expected and potential risks associated with the treatment.
Imetnik dovoljenja za promet z zdravilom mora, po dogovoru s pristojnimi organi v državah članicah, zagotoviti izobraževalni program za zdravnike, ki bo namenjen zagotavljanju izbire primernega mesta za injiciranje zdravila za čimmanjšo pojavnost neželenih učinkov, ki so povezani z injiciranjem, ter informiranju o pričakovanih in možnih tveganjih, ki so povezani z zdravljenjem, preden da zdravilo v promet.
The MAH’s offer of testing or re-testing antibody (AB) status in a reference laboratory.
Ponudbo imetnika dovoljenja za promet za testiranje ali ponovno testiranje statusa protiteles v referenčnem laboratoriju.
The main active metabolite of pimobendan is eliminated with a plasma elimination half-life of 2.6 h.
Razpolovni čas izločanja glavnega aktivnega metabolita pimobendana iz plazme je 2,6 ure.
The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the ‘anti-metabolites’ group.
Zdravilna učinkovina zdravila Teysuno, tegafur, je citotoksik (zdravilo, ki uniči celice, ki se delijo, kot na primer rakave celice) iz skupine antimetabolitov.
The main adverse events reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactatemia, hyperlipasemia).
Glavni opisani neželeni učinki so hematološke motnje (anemija, nevtropenija) in presnovne motnje (hiperlaktatemija, hiperlipazemija).
The main adverse reaction of treatment with 6–mercaptopurine is bone marrow suppression leading to leucopenia and thrombocytopenia.
Glavni neželeni učinek pri zdravljenju s 6-merkaptopurinom je supresija kostnega mozga, ki vodi v levkopenijo in trombocitopenijo.
The main adverse reactions reported are haematological disorders (anaemia, neutropenia), metabolic disorders ( hyperlipasemia).
Glavni opisani neželeni učinki so hematološke motnje (anemija, nevtropenija) in presnovne motnje (hiperlipazemija).
The main clinical outcomes are venous thromboembolism events especially deep vein thrombosis of the lower extremities and pulmonary embolism.
Glavni klinični izidi so venski trombembolični dogodki, zlasti globoka venska tromboza spodnjih okončin in pljučna embolija.
The main disposition pathway of brivaracetam is by CYP-independent hydrolysis.
Glavna presnovna pot brivaracetama je najpomembnejša od CYP neodvisna hidroliza.
The main efficacy data for both studies are summarised in Table 3.
Najpomembnejši podatki o učinkovitosti iz obeh študij so prikazani v preglednici 3.
The main efficacy endpoint of the study was the number of days during which patients experienced severe oral mucositis (grade 3/4 on the World Health Organisation (WHO) scale).
Glavna končna točka glede učinkovitosti v študiji je bilo število dni, ko so bolniki imeli hud oralni mukozitis (3./4. stopnja po lestvici Svetovne zdravstvene organizacije [SZO]).
The main efficacy outcome measure was progression-free survival (PFS) as determined by blinded independent radiologic review using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. Secondary efficacy outcome measures included overall response rate and overall survival.
Glavno merilo izida učinkovitosti je bilo preživetje brez napredovanja bolezni (progression-free survival ali PFS), ugotovljeno s slepim neodvisnim radiološkim pregledom z uporabo meril za ocenjevanje odziva pri čvrstih tumorjih (Response Evaluation Criteria in Solid Tumours ali RECIST) 1.1. Sekundarna merila izida učinkovitosti so vključevala celotno odzivnost in celotno preživetje.
The main elimination half-life of telithromycin is 2-3 h and the terminal, less important, half-life is about 10 h at the dose 800 mg once daily.
Pri odmerku 800 mg enkrat na dan je glavni razpolovni čas izločanja telitromicina od 2 do 3 ure, terminalni, manj pomembni razpolovni čas, pa približno 10 ur.
The main EU study involved male and female cats of various ages infested with fleas, ticks, or both.
Glavna študija v EU je zajela mačje samce in samice različnih starosti, ki so imeli bolhe, klope ali oboje.
The main EU study showed effectiveness of 86 to 87% against adult fleas for Broadline throughout the 30 day post-treatment period compared with between 76 and 82% for the cats treated with just fipronil and (S)-methoprene.
Glavna študija v EU je pokazala od 86- do 87-odstotno učinkovitost zdravila Broadline proti odraslim bolham v celotnem 30-dnevnem obdobju po zdravljenju v primerjavi z od 76- do 82-odstotno učinkovitostjo pri mačkah, zdravljenih samo s fipronilom in (S)-metoprenom.
The main excretory route is via urine and faeces.
Izloča se pretežno z urinom in blatom.
The main excretory routes are via urine and faeces.
Zdravilo se pretežno izloča z urinom in blatom.
The main findings found in repeat-dose toxicity studies (rat, dog), in a 2-year rat carcinogenicity study, and in toxicity to reproduction studies (rat, rabbit) were limited to injection site reactions for which no NOAEL could be determined.
Poglavitne ugotovitve, ki so jih ugotovili v študijah toksičnosti po večkratnem odmerjanju (podgana, pes), v 2-letni študiji kancerogensti pri podganah ter v študijah vpliva na sposobnost razmnoževanja (podgana, zajec), so bile omejene na reakcije na mestu injiciranja, za katere ni bilo možno ugotoviti nobenega NOAEL.
The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions: depression, anxiety and urinary incontinence
Poglavitno sestavino zdravila ARICLAIM, duloksetin, uporabljamo tudi v drugih zdravilih za zdravljenje drugih bolezni: depresije, anksioznosti in urinske inkontinence
The main ingredient of Cymbalta, duloxetine, is used in other medicines for other conditions: diabetic neuropathic pain, depression, anxiety and urinary incontinence
Poglavitno sestavino zdravila Cymbalta, duloksetin, uporabljamo tudi v drugih zdravilih za zdravljenje drugih bolezni: bolečina diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
The main ingredient of DULOXETINE BOEHRINGER INGELHEIM, duloxetine, is used in other medicines for other conditions: depression, anxiety and urinary incontinence.
Poglavitno sestavino zdravila DULOKSETIN BOEHRINGER INGELHEIM, duloksetin, uporabljamo tudi v drugih zdravilih za zdravljenje drugih bolezni: depresije, anksioznosti in urinske inkontinence
The main ingredient of Duloxetine Lilly, duloxetine, is used in other medicines for other conditions: diabetic neuropathic pain, depression, anxiety and urinary incontinence
Poglavitno sestavino zdravila Duloxetine Lilly, duloksetin, uporabljamo tudi v drugih zdravilih za zdravljenje drugih bolezni: bolečina diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
The main ingredient of Duloxetine Mylan, duloxetine, is used in other medicines for other conditions: diabetic neuropathic pain, depression, anxiety and urinary incontinence
Poglavitno sestavino zdravila Duloksetin Mylan, duloksetin, uporabljamo tudi v drugih zdravilih za zdravljenje drugih bolezni: bolečina diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
The main ingredient of Xeristar, duloxetine, is used in other medicines for other conditions: diabetic neuropathic pain, depression, anxiety and urinary incontinence
Poglavitno sestavino zdravila Xeristar, duloksetin, uporabljamo tudi v drugih zdravilih za zdravljenje drugih bolezni: bolečina diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
The main ingredient of YENTREVE, duloxetine, is used in other medicines for other conditions: diabetic neuropathic pain, depression, anxiety and urinary incontinence
Duloksetin, glavna zdravilna učinkovina zdravila YENTEREVE se uporablja v drugih zdravilih za zdravljenje drugih bolezni: bolečine zaradi diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
The main measure of effectiveness for all the HIV studies was based on the levels of HIV in the blood (viral load).
Glavno merilo učinkovitosti v vseh študijah okužbe z virusom HIV je temeljilo na ravni virusa HIV v krvi (virusno breme).
The main measure of effectiveness for these four studies was based on the number of patients who had blood clots forming in the veins (DVT) or lungs (PE), or who died from cardiovascular causes during the treatment period.
V vseh štirih študijah je glavno merilo učinkovitosti temeljilo na številu bolnikov, pri katerih so nastali krvni strdki v venah (globoka venska tromboza) ali pljučih (pljučna embolija) ali ki so med zdravljenjem umrli zaradi srčno-žilnega zapleta.
The main measure of effectiveness in all the studies was the change in the levels of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Glavno merilo učinkovitosti v vseh študijah je bila sprememba ravni glikoziliranega hemoglobina (HbA1c), kar je odstotek hemoglobina v krvi, na katerega je vezana glukoza.
The main measure of effectiveness in all the studies was the number of patients with a level of HIV in the blood (viral load) that was below 50 copies/ml after 24 weeks of treatment.
Glavno merilo učinkovitosti v vseh študijah je bilo število bolnikov, pri katerih je bila raven virusa HIV v krvi (virusna obremenitev) po 24 tednih zdravljenja pod 50 kopij/ml.
The main measure of effectiveness in all three studies was the improvement of the patients’ international prostate symptom score (IPSS) after 12 weeks of treatment.
Glavno merilo učinkovitosti v vseh treh študijah je bilo izboljšanje ocene IPSS (International Prostate Symptom Score) pri bolnikih po 12 tednih zdravljenja.
The main measure of effectiveness in both studies was overall survival (how long the patients lived).
Glavno merilo učinkovitosti v obeh študijah je bilo celokupno preživetje (kako dolgo so bolniki živeli).
The main measure of effectiveness in both studies was the ability to trigger the production of antibodies against the flu virus (‘immunogenicity’) after six weeks.
Glavno merilo učinkovitosti v obeh študijah je bila sposobnost cepiva, da sproži nastajanje protiteles (imunogenost) proti virusu gripe po šestih tednih.
The main measure of effectiveness in both studies was the number of patients whose bowels opened within four hours of the first dose.
Glavno merilo učinkovitosti pri obeh študijah je bilo število bolnikov, ki so odvedli blato v štirih urah po prvem odmerku.
The main measure of effectiveness in both studies was the proportion of patients who ‘responded’ to treatment after 16 weeks.
Glavno merilo učinkovitosti v obeh študijah je bil delež bolnikov, ki so se odzvali na zdravljenje po 16 tednih.
The main measure of effectiveness in the four studies was how long the patients lived without the disease getting worse.
Glavno merilo učinkovitosti v teh štirih študijah je bil čas preživetja bolnikov brez poslabšanja bolezni.
The main measure of effectiveness in the studies was the change in the patients’ symptoms after nine or 13 weeks assessed using a standard scale for schizophrenia.
Glavno merilo učinkovitosti v študijah je bila sprememba bolnikovih simptomov po devetih ali 13 tednih zdravljenja, ocenjena z uporabo standardne ocenjevalne lestvice za shizofrenijo
The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
Glavno merilo učinkovitosti v študijah je bilo število terapij, ki so bile potrebne za zaustavitev vsake nove krvavitve.
The main measure of effectiveness in these studies was based on improvements in patients’ percent of predicted forced expiratory volume in one second (FEV1), adjusted for the patient’s age, height and sex.
Glavno merilo učinkovitosti v teh študijah je bilo izboljšanje odstotka forsiranega ekspiracijskega volumna bolnikov v eni sekund (FEV1), pri čemer so pri rezultatih upoštevali bolnikovo starost, višino in spol.
The main measure of effectiveness was a reduction in flea count of 90% or more on day 14 and 30 after treatment.
Glavno merilo učinkovitosti je bilo zmanjšanje števila bolh za 90 % ali več na 14. in 30. dan po uporabi zdravila.
The main measure of effectiveness was a reduction in the risk of death due to heart problems and non fatal heart attack.
Glavno merilo učinkovitosti je bilo zmanjšanje tveganja smrtnega izida zaradi težav s srcem in srčnih napadov brez smrtnega izida.
The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.
Glavno merilo učinkovitosti je bilo zmanjšanje tveganja smrti zaradi težav s srcem in srčne kapi brez smrtnega izida.
The main measure of effectiveness was a reduction of lameness.
Najpomembnejše merilo učinkovitosti je bilo zmanjšanje šepavosti.
The main measure of effectiveness was based on an assessment of the patients’ nerve damage and quality of life after 18 months of treatment.
Glavno merilo učinkovitosti je temeljilo na oceni poškodbe živcev pri bolniku in kakovosti življenja po 18 mesecih zdravljenja.
The main measure of effectiveness was based on an improvement in lameness and pain.
Glavno merilo učinkovitosti je bilo izboljšanje šepavosti in bolečine.
The main measure of effectiveness was based on changes in patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after six months.
Glavno merilo učinkovitosti je bila sprememba forsiranega ekspiracijskega volumna (FEV1, tj. največje količine zraka, ki jo oseba lahko izdihne v eni sekundi) pri bolnikih po šestih mesecih.
The main measure of effectiveness was based on changes in the patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Glavno merilo učinkovitosti je bila sprememba forsiranega ekspiracijskega volumna (FEV1 – največja količina zraka, ki jo oseba lahko izdihne v eni sekundi) pri bolnikih.
The main measure of effectiveness was based on clinical signs of diarrhoea and the animal’s behaviour, feed intake, body temperature, respiratory rate, heart rate and general condition.
Glavno merilo učinkovitosti so bili klinični znaki driske in vedenje živali, ješčnost, telesna temperatura, hitrost dihanja in bitje srca ter splošno stanje živali.
The main measure of effectiveness was based on how many patients had a ‘complete response’, which was defined as no vomiting, retching or dry heaves and no need for any other medication to control nausea and vomiting 25 to 120 hours after the start of chemotherapy (delayed phase).The study also looked at how many patients achieved a complete response in the first 24 hours after chemotherapy (acute phase).
Glavno merilo učinkovitosti je temeljilo na številu bolnikov s popolnim odzivom, kar pomeni, da niso bruhali, jih ni sililo na bruhanje oziroma se jim ni spahovalo in niso potrebovali drugega zdravila za obvladanje slabosti in bruhanja v 25 do 120 urah po začetku kemoterapije (zapoznela faza).V študiji so ugotavljali tudi, koliko bolnikov je doseglo popoln odziv v prvih 24 urah po kemoterapiji (akutna faza).
The main measure of effectiveness was based on how much the patient’s main brain tumour shrank after six months of treatment.
Glavno merilo učinkovitosti je temeljilo na zmanjšanju bolnikovega glavnega možganskega tumorja po šestih mesecih zdravljenja.
The main measure of effectiveness was based on improvement in patients’ percent of predicted FEV1 which is a measure of how well the lungs work.
Glavno merilo učinkovitosti je temeljilo na izboljšanju odstotka napovedane vrednosti FEV1, kar je merilo, kako dobro pljuča delujejo.
The main measure of effectiveness was based on improvements in mobility, local inflammation and pain.
Glavna merila učinkovitosti so bila izboljšana gibljivost, lokalna vnetja in bolečina.
The main measure of effectiveness was based on improvements in patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Glavno merilo za učinkovitost je temeljilo na izboljšanju forsiranega ekspiracijskega volumna (FEV1 – največja prostornina zraka, ki ga lahko bolnik izdihne v eni sekundi).
The main measure of effectiveness was based on improvements in walking speed along a path of 25 feet (about 7.5 metres).
Glavno merilo učinkovitosti je bilo izboljšanje hitrosti hoje na 25 čevljev (okrog 7,5 metra).
The main measure of effectiveness was based on patients’ assessment of how well treatment worked.
Glavno merilo učinkovitosti je temeljilo na oceni bolnikov o tem, kako uspešno je bilo zdravljenje.
The main measure of effectiveness was based on signs of colic.
Glavno merilo učinkovitosti so bili znaki kolike.
The main measure of effectiveness was based on signs of lameness.
Glavno merilo učinkovitosti so bili znaki šepavosti.
The main measure of effectiveness was based on the doctor’s and patient’s assessment of how well the treatment worked in preventing and treating bleeding episodes.
Glavno merilo učinkovitosti je temeljilo na zdravnikovi in bolnikovi oceni, kako učinkovito je bilo zdravljenje pri preprečevanju in zdravljenju epizod krvavitev.
The main measure of effectiveness was based on the number of new digital ulcers developing during the studies.
Glavno merilo učinkovitosti je temeljilo na številu novih razjed prstov, ki so nastale med potekom študij.
The main measure of effectiveness was based on the number of new digital ulcers developing during the studies.
Glavno merilo učinkovitosti je temeljilo na številu novih razjed prstov, ki so se pojavile med študijama.
The main measure of effectiveness was based on the number of patients having an ‘event’ such as a heart attack or clots in the heart blood vessels requiring intervention, or dying from any cause, in the 48 hours following PCI.
Glavno merilo učinkovitosti je temeljilo na številu bolnikov, pri katerih so v 48 urah po PKI zabeležili „dogodek“, kot je srčna kap ali krvni strdek v srčnih žilah, zaradi katerega je bilo treba ukrepati, ali smrt zaradi katerega koli razloga.
The main measure of effectiveness was based on the number of patients having an ‘event’ such as a heart attack or stroke, or dying from cardiovascular disease (problems affecting the heart and blood vessels).
Glavno merilo učinkovitosti je temeljilo na številu bolnikov, ki so doživeli „dogodek“, kot je srčni infarkt ali možganska kap, ali so umrli zaradi kardiovaskularne bolezni (težav, ki prizadenejo srce in ožilje).
The main measure of effectiveness was based on the number of patients who had 20% reductions in the number and severity of symptoms after 14 weeks.
Glavno merilo učinkovitosti je temeljilo na številu bolnikov, pri katerih sta se po 14 tednih za 20 % zmanjšala število in resnost simptomov.
The main measure of effectiveness was based on the number of patients who had 20% reductions in the number and severity of symptoms after 16 weeks.
Glavno merilo učinkovitosti je temeljilo na številu bolnikov, pri katerih sta se po 16 tednih za 20 % zmanjšala število in resnost simptomov.
The main measure of effectiveness was based on the patients’ FEV1 after 24 weeks of treatment.
Glavno merilo učinkovitosti je temeljilo na FEV1 pri bolnikih po 24 tednih zdravljenja.
The main measure of effectiveness was based on the percentage of patients who responded completely or partially to treatment.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so se popolnoma ali deloma odzvali na zdravljenje.
The main measure of effectiveness was based on the percentage of patients who, after two treatment cycles, responded to treatment, measured as resolution of signs of leukaemia and complete or partial normalisation of blood cell counts.
Glavno merilo učinkovitosti je temeljilo na deležu bolnikov, ki so se po dveh ciklusih zdravljenja odzvali na zdravljenje, kar se je merilo kot izginotje znakov levkemije in popolna oziroma delna normalizacija števila krvničk.
The main measure of effectiveness was based on the reduction in symptoms of arthritis 15 days after treatment, as assessed using standard criteria.
Glavno merilo učinkovitosti je temeljilo na zmanjšanju simptomov artritisa 15 dni po zdravljenju, pri čemer so bila za ocenjevanje uporabljena standardna merila.
The main measure of effectiveness was based on the reduction in the length of time that the patients had severe neutropenia.
Glavno merilo učinkovitosti je bilo skrajšanje trajanja hude nevtropenije pri bolnikih.
The main measure of effectiveness was based on the reduction in viral load (the amount of HIV-1 virus in the blood).
Glavno merilo učinkovitosti je temeljijo na zmanjšanju virusnega bremena (količine virusa HIV-1 v krvi).
The main measure of effectiveness was based on the time to disease flare.
Glavno merilo učinkovitosti je temeljilo na času do zagona bolezni.
The main measure of effectiveness was blood cortisol levels 30 minutes after surgery.
Glavno merilo učinkovitosti je bila raven kortizola v krvi 30 minut po kirurškem posegu.
The main measure of effectiveness was how Bretaris Genuair improved patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after six months.
Glavno merilo učinkovitosti je bilo izboljšanje forsiranega ekspiracijskega volumna (FEV1, največja količina zraka, ki jo oseba lahko izdihne v eni sekundi) po šestih mesecih uporabe zdravila Bretaris Genuair.