natgillin/translations-raw huggingface dataset:
In each Member State where Aripiprazole Accord for the treatment up to 12 weeks of moderate to severe manic episode in Bipolar I Disorder in adolescents aged 13 years and older is launched the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
U svakoj državi članici u kojoj će se Aripiprazol Accord koristiti za liječenje umjerenih do teških maničnih epizoda u bipolarnom poremećaju tipa I u adolescenata u dobi od 13 godina i starijih u trajanju od najviše 12 tjedana, nositelj odobrenja će s nacionalnim nadležnim tijelom dogovoriti edukacijski program.
In each Member State where Aripiprazole Mylan Pharma for the treatment up to 12 weeks of moderate to severe manic episode in Bipolar I Disorder in adolescents aged 13 years and older is launched the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
U svakoj državi članici u kojoj će se Aripiprazole Mylan Pharma koristiti za novu indikaciju, liječenje umjerenih do teških maničnih epizoda u bipolarnom poremećaju tipa I u adolescenata u dobi od 13 godina i starijih u trajanju od najviše 12 tjedana, nositelj odobrenja će s nacionalnim nadležnim tijelom dogovoriti edukacijski program.
In each Member State where Aripiprazole Sandoz for the treatment up to 12 weeks of moderate to severe manic episode in Bipolar I Disorder in adolescents aged 13 years and older is launched the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
U svakoj državi članici u kojoj će se Aripiprazol Sandoz koristiti za novu indikaciju, liječenje umjerenih do teških maničnih epizoda u bipolarnom poremećaju tipa I u adolescenata u dobi od 13 godina i starijih u trajanju od najviše 12 tjedana, nositelj odobrenja će s nacionalnim nadležnim tijelom dogovoriti edukacijski program.
In each Member State where EFFENTORA is marketed the Marketing Authorisation Holder (MAH) shall agree an updated educational programme with the National Competent Authority.
U svakoj zemlji članici u kojoj je EFFENTORA stavljena u promet, nositelj odobrenja dogovorit će nadopunjenni edukacijski program s nacionalnim nadležnim tijelom.
In each of the clinical studies performed in the treatment of VOD, over 50% of patients were under the age of 18 years.
U svakom od kliničkih ispitivanja provedenih u svrhu liječenja veno-okluzivne bolesti, više od 50% bolesnika bilo je mlađe od 18 godina.
In each of the RA studies by study design, patients in the long-term extension may have switched between the 50 mg and 100 mg Simponi doses at the discretion of the study physician.
Prema ustroju ispitivanja, bolesnici u dugotrajnom produžetku ispitivanja mogli su prelaziti s doze lijeka Simponi od 50 mg na 100 mg i obrnuto prema procjeni liječnika ispitivača.
In each of the studies, the primary endpoint (proportion of patients with an iPTH ≤ 250 pg/ml (≤ 26.5 pmol/l)) was achieved by 41%, 46%, and 35% of patients receiving cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo.
U svakoj od studija primarni ishod (postotak bolesnika s iPTH ≤ 250 pg/ml (≤ 26,5 pmol/l)) postignut je u 41 %, 46 % i 35 % bolesnika liječenih sinakalcetom, u usporedbi sa 4 %, 7 % i 6 % bolesnika koji su primili placebo.
In each pack
U svakom pakiranju
In each study 350 pigs were vaccinated with Coliprotec F4 and 350 pigs remained unvaccinated.
U svakom ispitivanju 350 svinja cijepljeno je VMP- om Coliprotec F4, a 350 svinja je ostalo necijepljeno.
In each study around 300 suckling piglets were vaccinated with Porcilis PCV M Hyo and a second group of around 300 suckling piglets received a dummy injection.
U svakom je ispitivanju približno 300 praščića koji sisaju bilo cijepljeno lijekom Porcilis PCV M Hyo, a druga skupina od približno 300 praščića koji sisaju primila je injekciju placeba.
In each treatment cycle, two injections of Xiapex 0.58 mg or two injections of placebo were administered 1 to 3 days apart.
U svakom ciklusu liječenja primijenjene su dvije injekcije s 0,58 mg Xiapexa ili placeba u razmaku od 1 do 3 dana.
In each treatment cycle, you will receive one injection of Xiapex, followed by a second injection on a separate day (1 to 3 days later).
U svakom ciklusu liječenja primit ćete jednu injekciju Xiapexa, a zatim još jednu neki drugi dan (1-3 dana kasnije).
In each treatment group, there was a slightly greater percentage of subjects in the 2+ lines of prior systemic therapy for advanced disease (58 % and 55 % respectively for placebo and pazopanib treatment arms) compared with 0 or 1 lines of prior systemic therapy (42 % and 45 % respectively for placebo and pazopanib treatment arms).
U svakoj terapijskoj skupini, bio je malo veći postotak ispitanika s 2+ linije prethodne sistemske terapije za uznapredovalu bolest (58% i 55% za placebo i pazopanib krakove) u usporedbi s 0 ili 1 linijom prethodne sistemske terapije (42% odnosno 45% za placebo odnosno pazopanib krakove).
In each trial, the daily dose was divided into two equal doses.
U svakom ispitivanju dnevna doza bila je podijeljena u dvije jednake doze.
In early and advanced Parkinson’s disease, efficacy of pramipexole in controlled clinical trials was maintained for approximately six months.
U ranoj i uznapredovaloj Parkinsonovoj bolesti djelotvornost pramipeksola u kontroliranim kliničkim ispitivanjima održavana je tijekom 6 mjeseci.
In early and advanced Parkinson’s disease, efficacy of pramipexole in controlled clinical trials was maintained for approximately six months.
U ranoj i uznapredovaloj Parkinsonovoj bolesti, djelotvornost pramipeksola u kontroliranim kliničkim ispitivanjima održavana je tijekom 6 mjeseci.
In early and advanced Parkinson’s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
U ranoj i uznapredovaloj Parkinsonovoj bolesti, djelotvornost pramipeksola u kontroliranim kliničkim ispitivanjima održavana je tijekom 6 mjeseci.
In EGFR mutation-positive patients, significantly more IRESSA-treated patients experienced an improvement in quality of life and lung cancer symptoms vs carboplatin/paclitaxel (see Table 4).
Među bolesnicima pozitivnima na mutaciju EGFR-a, poboljšanje kvalitete života i simptoma raka pluća zabilježeno je u značajno većem broju onih liječenih lijekom IRESSA u odnosu na one liječene karboplatinom/paklitakselom (vidjeti Tablicu 4).
In eight clinical studies, the overall rates of adverse reactions after a second dose of ProQuad were generally similar to, or lower than, those seen with the first dose.
U osam kliničkih ispitivanja, ukupne stope nuspojava nakon druge doze cjepiva ProQuad bile su općenito slične onima opaženim nakon prve doze ili manje.
In eight patients receiving 40 mg twice daily in the fasted state, steady-state AUC0-12h was 1284±227 ngh/ml (18%) (mean ± SD [% CV]), Cmax was 536±146 ng/ml (27%), and Cmin was 9±8 ng/ml (89%).
U osam bolesnika koji su dobivali 40 mg dva puta dnevno natašte, AUC0-12h za stanje dinamičke ravnoteže je iznosio 1284±227 ng·h/ml (18%) (srednja vrijednost ± SD [% CV]), Cmax je bio 536±146 ng/ml (27%), a Cmin 9±8 ng/ml (89%).
In Einstein DVT 3,449 patients with acute DVT were studied for the treatment of DVT and the prevention of recurrent DVT and PE (patients who presented with symptomatic PE were excluded from this study).
U ispitivanju Einstein DVT proučavano je liječenje DVT-a i prevencija ponavljajućeg DVT-a i plućne embolije (bolesnici sa simptomatskom plućnom embolijom nisu uključeni u ovo ispitivanje) na 3449 bolesnika s akutnim DVT-om.
In Einstein Extension 1,197 patients with DVT or PE were studied for the prevention of recurrent DVT and PE.
U ispitivanju Einstein Extension proučavana je prevencija ponavljajućeg DVT-a i plućne embolije kod 1197 bolesnika s DVT-om ili plućnom embolijom.
In Einstein PE, 4,832 patients with acute PE were studied for the treatment of PE and the prevention of recurrent DVT and PE.
U Einstein PE ispitivano je liječenje plućne embolije i prevencija ponavljajućeg DVT-a i plućne embolije na 4832 bolesnika s akutnom plućnom embolijom.
In either case it should be confirmed by a blood test that AUBAGIO has been sufficiently removed from your body and you need confirmation from your treating physician that the blood level of AUBAGIO is low enough to allow you to become pregnant.
U oba slučaja treba krvnim pretragama potvrditi da je AUBAGIO u dovoljnoj mjeri uklonjen iz tijela, a nadležni liječnik mora potvrditi da su razine lijeka AUBAGIO u krvi dovoljno niske da biste zatrudnjeli.
In either case the A771726 plasmaconcentration is then measured for thefirst time.
U oba se slučaja tek tada prvi put mjeri koncentracija A771726 u plazmi.
In elderly healthy subjects (aged ≥65 years; n=20), the exposure to vortioxetine increased up to 27% (Cmax and AUC) compared to young healthy control subjects (aged ≤45 years) after multiple doses of 10 mg/day.
U starijih zdravih ispitanika (u dobi ≥ 65 godina; n=20), izloženost vortioksetinu povećala se do 27% (Cmax i AUC) u usporedbi s mladim zdravim kontrolnim ispitanicima (u dobi ≤45 godina) nakon višekratnih doza od 10 mg/dan.
In elderly healthy subjects (aged ≥65 years; n=20), the exposure to vortioxetine increased up to 27% (Cmax and AUC) compared to young healthy control subjects (aged ≤45 years) after multiple doses of 10 mg/day.
U starijih zdravih ispitanika (u dobi ≥65 godina; n=20), izloženost vortioksetinu povećala se do 27% (Cmax i AUC) u usporedbi s mladim zdravim kontrolnim ispitanicima (u dobi ≤45 godina) nakon višekratnih doza od 10 mg/dan.
In elderly healthy subjects, pharmacokinetics of fondaparinux are linear in the range of 2 to 8 mg by subcutaneous route.
U zdravih starijih osoba farmakokinetika fondaparinuksa primijenjenog supkutano je linearna u rasponu 2 to 8 mg.
In elderly patients (> 75 years) there is limited clinical experience.
Kod starijih osoba (> 75 godina) kliničko iskustvo je ograničeno.
In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking medicines for schizophrenia compared with those not receiving these medicines.
U starijih osoba s demencijom, zabilježen je mali porast u broju smrti kod bolesnika koji su uzimali lijekove za shizofreniju u usporedbi s onima koji nisu primali te lijekove.
In eleven patients PDGFR gene rearrangements was detected, 9 of them achieved a CHR and 1 PHR.
U 11 bolesnika otkrivene su preraspodjele PDGFR gena, od kojih je 9 postiglo KHO, a 1 PHO.
In eltrombopag clinical trials in ITP thromboembolic events were observed at low and normal platelet counts.
U kliničkim ispitivanjima eltrombopaga u bolesnika s ITP-om, tromboembolijski događaji (TED) su primijećeni i pri niskom i normalnom broju trombocita.
In embryo- and foetotoxicity studies in rats continuous intravenous administration of iloprost led to anomalies of single phalanges of the forepaws in a few foetuses/pups without dose dependence.
U ispitivanjima toksičnosti za embrije i fetuse štakora kontinuirana intravenska primjena iloprosta dovela je do anomalije članka prsta na prednjim šapama u nekoliko fetusa/mladunčadi neovisno o dozi.
In embryo-fetal and developmental toxicity studies (rats and rabbits) with dextromethorphan hydrobromide/quinidine sulfate, abnormalities were observed at mid and high dose with reduced ossification from the lowest dose in rats which is approximately 1 and 50 times the human dose of 30/18 mg/day on a mg/m2 basis, respectively.
U ispitivanjima embriofetalne i razvojne toksičnosti (štakori i kunići) s dekstrometorfan hidrobromidom / kinidin sulfatom, abnormalnosti su opažene pri srednjoj i visokoj dozi uz smanjenu osifikaciju pri najnižoj dozi u štakora, što je približno 1 i 50 puta više od doze u ljudi od 30/18 mg na dan izraženo na bazi mg/m2.
In embryo-foetal development studies, malformations, growth retardation, ossification retardation and skeletal effects were observed in rats at all doses (5-fold exposure ratio compared to human exposure) and in rabbits at high doses (32-fold exposure ratio compared to human exposure) of lixisenatide.
U istraživanjima embriofetalnog razvoja opažene su malformacije, zastoj u rastu, zakašnjelo okoštavanje i učinci na skeletu pri svim dozama u štakora omjer izloženosti 5 puta veći od onog u ljudi) te pri visokim dozama u kunića (omjer izloženosti 32 puta veći od onog u ljudi).
In embryo/foetal developmental studies abortion, but no developmental effects were seen in mice and rats at doses that were at least 860-times or 1700-times higher than the dose in humans, respectively.
U ispitivanjima embrionalnog/fetalnog razvoja kod miševa i štakora zapaženi su pobačaji, ali ne i poremećaji razvoja ploda, pri dozama koje su bile barem 860 odnosno 1700 puta veće od doze u ljudi.
In endemic areas regular monthly application will prevent angiostrongylosis and patent infection with
U enzootskim područjima redovito mjesečno spriječiti će angiostrongilozu i patentnu invaziju s
In endemic areas regular monthly applications will prevent angiostrongylosis and patent infection with
U enzootskim područjima redovito tretiranje mjesečno spriječiti će angiostrongilozu i patentnu invaziju s Angiostrongylus vasorum.
in endoscopic procedures (procedures that use an endoscope for viewing internal organs) or keyhole surgery
u endoskopskim postupcima (postupci koji koriste endoskop za gledanje unutarnjih organa) ili laparoskopskoj kirurgiji
In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs.
Simptomi eozinofilne astme povezani su s prevelikim brojem bijelih krvnih stanica zvanih eozinofili u krvi, te flegmom u plućima.
In ESPRIT, bleeding events were reported at 48 hours, and non-bleeding events were reported at 30 days.
U ESPRIT ispitivanju krvarenja su procjenjivana nakon 48 sati, a nuspojave nevezane uz krvarenja 30. dana.
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
U ispitivanjima pomoću euglikemijske spone (engl. euglycaemic clamp studies) u zdravih osoba odnosno u bolesnika sa šećernom bolešću tipa 1 početak djelovanja supkutano primijenjenog inzulina glargina bio je sporiji u odnosu na ljudski NPH inzulin, dok mu je profil učinka bio ravnomjeran, bez vršnih koncentracija, a trajanje produljeno.
In Europe, irinotecan has been authorised for a number of years for the treatment of colorectal cancer.
U Europi je irinotekan odobren već niz godina za liječenje raka debelog crijeva.
In Europe, it is estimated that these are responsible for about 56 to 90% of the cases of invasive disease caused by S. pneumoniae in children under the age of five years.
Procjenjuje se da su u Europi ti serotipovi odgovorni za otprilike 56% do 90% slučajeva invazivne bolesti uzrokovane bakterijom S. pneumoniae u djece mlađe od pet godina.
In Europe, it is estimated that these are responsible for between 73 and 100% of the cases of invasive disease in children under the age of five years, and at least 50 – 76% of the cases of invasive disease in adults, depending on the country.
Procjenjuje se da su ovi serotipovi u Europi odgovorni za između 73 i 100% slučajeva invazivne bolesti u djece mlađe od pet godina, i najmanje 50 - 76% slučajeva invanzivne bolesti u odraslih osoba, ovisno o državi.
In evaluating patients for infections, the patient’s risk for relevant opportunistic infections (e.g., exposure to endemic mycoses) should be considered.
Pri ocjeni podložnosti bolesnika infekcijama treba razmotriti rizik za razvoj oportunističke infekcije (npr. izlaganje endemskim mikozama).
In every 4-week cycle a dose of dexamethasone should be taken on the first day of each week only.
U svakom ciklusu od 4 tjedna, dozu deksametazona treba uzeti samo prvog dana svakog tjedna.
In every 4-week cycle, Imnovid should be taken once a day for 3 weeks, followed by a week off.
U svakom ciklusu od 4 tjedna, Imnovid treba uzimati jedanput na dan tijekom 3 tjedna, a zatim slijedi tjedan dana stanke.
In ex vivo plasma samples from colorectal cancer patients at steady state exposure after 300 mg once daily, the mean percentage protein binding was 93.7% (range 92.2 to 95.7%).
U ex vivo ispitivanju uzoraka plazme bolesnika s kolorektalnim karcinomom, pri izloženosti u stanju dinamičke ravnoteže nakon primjene doze od 300 mg jedanput na dan, prosječno vezanje za proteine iznosilo je 93,7% (u rasponu od 92,2 do 95,7%).
In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
U izuzetnim okolnostima može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući odgovarajuće simptomatsko liječenje.
In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
U izuzetnim okolnostima može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući simptomatsku terapiju.
In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
U izuzetnim okolnostima može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajuću simptomatsku terapiju.
In exceptional circumstances in adults, when travel is anticipated within one month or more after initiating the vaccination course, but where insufficient time is available to allow the standard 0, 1, 6 month schedule to be completed, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used.
U iznimnim okolnostima u odraslih, kad se predviđa putovanje za mjesec ili više dana nakon započinjanja cijepljenja, ali nema dovoljno vremena da se primarni ciklus završi po standardnoj shemi od 0, 1 i 6 mjeseci, može se primijeniti shema od tri intramuskularne injekcije po rasporedu 0, 7 i 21 dan.
In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
U izuzetnim okolnostima, dan nakon cijepljena može se uočiti apatija i smanjeni tek.
In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
U izuzetnim okolnostima, može se uočiti apatija i smanjeni tek, dan nakon cijepljenja.
In exceptional circumstances, where prolonged systemic fusidic acid is needed e.g for the treatment of severe infections, the need for co-administration of pravastatin and fusidic acid should only be considered on a case by case basis and under close medical supervision.
U iznimnim okolnostima, kada je potrebna produžena primjena sistemske fusidatne kiseline, npr. za liječenje teških infekcija, potrebu za istodobnom primjenom pravastatina i fusidatne kiseline treba razmotriti od slučaja do slučaja i pod strogim liječničkim nadzorom.
In excess, VEGF-A causes abnormal blood vessel growth and swelling in the eye which can lead to impairment of vision in diseases like AMD, PM, DME or RVO.
Ako ga ima previše, VEGF-A uzrokuje abnormalan rast krvnih žila i oticanje u oku koje može dovesti do oštećenja vida u bolestima kao što su AMD, PM, DME ili RVO.
In experimental studies Zinforo was shown to have activity against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work (methicillin resistant Staphylococcus aureus (MRSA) and penicillin non-susceptible Streptococcus pneumoniae (PNSP)).
Eksperimentalna ispitivanja lijeka Zinforo pokazala su da djeluje protiv određenih bakterija protiv kojih drugi antibiotici koji pripadaju klasi beta-laktamaza ne djeluju (meticilin-rezistentni sojevi bakterije Staphylococcus aureus (MRSA) te u penicilin neosjetljivih sojeva bakterije Streptococcus pneumoniae (PNSP)).
In exploratory pharmacokinetic adverse event analyses, higher exposure to nintedanib tended to be associated with liver enzyme elevations, but not with gastrointestinal adverse events.
U istraživačkim farmakokinetičkim analizama štetnih događaja, veća izloženost nintedanibu bila je povezana s porastom vrijednosti jetrenih enzima, ali nije bila povezana s gastrointestinalnim štetnim događajima.
In extensive field testing no interactions between Stronghold and routinely used veterinary medicinal products or medical or surgical procedures were observed.
U opsežnom terenskom ispitivanju nisu uočene interakcije između Strongholdai veterinarsko- medicinskih proizvoda koji se uobičajeno koriste te medicinskih ili kirurških postupaka.
In extensive field testing no interactions between the veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures were observed.
U opsežnom terenskom ispitivanju nisu uočene interakcije između Strongholda i veterinarsko- medicinskih proizvoda koji se uobičajeno koriste te medicinskih ili kirurških postupaka.
In external gamma imaging analysis, bound technetium Tc 99m tilmanocept has been shown to be retained in the same draining lymph nodes for up 30 hours.
Vanjskim oslikavanjem pomoću gama kamere utvrđeno je da se vezani tilmanocept obilježen radioaktivnim tehnecijem Tc 99m zadržava u istim drenažnim limfnim čvorovima do 30 sati.
In extremely rare cases the following side effects have been reported with hepatitis B vaccine.
U iznimno rijetkim slučajevima su kod primjene cjepiva protiv hepatitisa B prijavljene sljedeće nuspojave:
In extremely rare cases, allergic reactions mimicking serum sickness, paralysis, neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis, muscular weakness, Guillain- Barré syndrome, encephalopathy, encephalitis and meningitis have been reported.
U izuzetno rijetkim slučajevima zabilježeni su alergijske reakcije koje oponašaju serumsku bolest, paraliza, neuropatija, neuritis, hipotenzija, vaskulitis, lichen planus, multiformni eritem, artritis, mišićna slabost, sindrom Guillain-Barré, encefalopatija, encefalitis i meningitis.
In fact, the use of gloves is recommended in preparing the solution for infusion.
Stoga se preporučuje nositi rukavice prilikom pripreme otopine za infuziju.
In fact, the use of gloves is recommended in preparing the solution for infusion.
Stoga se preporučuje uporaba rukavica prilikom pripreme otopine za infuziju.
In factor VII deficiency, the dose is 15 to 30 micrograms/kg every four to six hours until the bleeding is controlled.
U slučaju nedostatka faktora VII doza iznosi od 15 do 30 mikrograma po kilogramu tjelesne težine svaka četiri do šest sati do uspostave kontrole krvarenja.
In families with one flu patient, 7% of the family members in the household developed flu when receiving Tamiflu, compared with 20% of those receiving no preventative treatment.
U obiteljima s jednim oboljelim od gripe, 7% članova obitelji u kućanstvu razvilo je gripu nakon terapije lijekom Tamiflu, u usporedbi s 20% onih koji su primali preventivnu terapiju.
In feces, approximately 15% of the dose was excreted as parent drug.
U fecesu je otprilike 15% doze izlučeno u obliku osnovnog spoja.
In feces, approximately 15% of the dose was excreted as parent drug.
U fecesu je približno 15% doze izlučeno u obliku ishodišnog spoja.
In feed inclusion rate
Omjer dodavanja u hranu za životinje
In feed use
Uporaba u hrani
In feed use for rabbits:
Primjena u hrani za kuniće:
In female adult patients with metastatic breast cancer, subcutaneous co-administration of 40,000 IU/ml epoetin alfa with trastuzumab 6 mg/kg had no effect on the pharmacokinetics of trastuzumab.
U odraslih bolesnica s metastatskim rakom dojke, istovremena supkutana primjena 40 000 IU/ml epoetina alfa sa 6 mg/kg trastuzumaba nije utjecala na farmakokinetiku trastuzumaba.
In female mice an increased incidence, dose-dependent, of bronchiolo-alveolaradenomas and carcinomas of the lung was noted.
U ženki miševa zabilježena je povećana incidencija (ovisna o dozi) bronhioloalveolarnih adenoma i karcinoma pluća.
In female rats, there were no compound-related effects on ovaries or oestrus cycles at exposures up to 4.7 times the human daily dose based on AUC.
U ženki štakora nije bilo s lijekom povezanih učinaka na jajnike niti spolne cikluse, pri izloženosti dozama do 4,7 puta većima od dnevne doze za ljude na temelju AUC-a.