natgillin/translations-raw huggingface dataset:
In the postmarketing experience there have been reports of restlessness, bleeding into the chest, excessive sweating, pain and redness at the injection site, increased body temperature, and increased need for catecholamines (medicine to elevate blood pressure) in the course of the treatment.
Nakon stavljanja lijeka u promet tijekom liječenja prijavljeni su nemir, krvarenje u prsište, prekomjerno znojenje, bol i crvenilo na mjestu injekcije, vrućica i povećana potreba za kateholaminima (lijek za povišenje krvnog tlaka).
In the postmarketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other central nervous system depressant medicinal products.
Nakon stavljanja lijeka u promet, u bolesnika koji su uzimali pregabalin i druge depresore središnjeg živčanog sustava (SŽS) prijavljeni su zatajenje disanja i koma.
In the postmarketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medicinal products.
Nakon stavljanja lijeka u promet, u bolesnika koji su uzimali pregabalin i druge depresore središnjeg živčanog sustava (SŽS) prijavljeni su zatajenje disanja i koma.
In the postmarketing setting five cases of MabThera overdose have been reported.
Nakon stavljanja lijeka u promet prijavljeno je pet slučajeva predoziranja lijekom MabThera.
in the powder: mannitol and human albumin, in the solvent (sodium chloride solution 5.4 mg/ml (0.54% w/v)): sodium chloride, water for injection.
u prašku: manitol i ljudski albumin, u otapalu (otopina natrijevog klorida od 5,4 mg/ml (0,54 % m/V)): natrijev klorid, voda za injekciju.
in the powder: mannitol and human albumin, in the solvent (sodium chloride solution 5.4 mg/ml (0.54% w/v)): sodium chloride, water for injection.
u prašku: manitol i ljudski albumin, u otapalu (otopina natrijevog klorida od 5,4 mg/ml (0,54 % m/V): natrijev klorid, voda za injekciju.
in the powder: mannitol and human albumin. in the solvent: sodium chloride, water for injection.
u prašku: manitol i ljudski albumin. u otapalu: natrijev klorid, voda za injekciju.
In the powder: poly (D,L-lactide-co-glycolide) and sucrose.
U prašku: poli(D,L-laktid-ko-glikolid) i saharoza.
In the powder: poly(D,L-lactide-co-glycolide) (50-60:40-50), poly(D,L-lactide-co-glycolide) (50:50).
U prašku: poli(D,L-laktid-ko-glikolid) (50-60:40-50), poli(D,L-laktid-ko-glikolid) (50:50).
In the powder: sucrose and trometamol
U prašku: saharoza i trometamol
In the PPE population of women vaccinated with Gardasil in the base study, no cases of HPV diseases (HPV types 6/11/16/18 related high grade CIN) were observed up to approximately 10 years.
U PPE populaciji nije bio opažen nijedan slučaj HPV bolesti (visoki stupanj CIN-a povezan s tipovima HPV-a 6/11/16/18) u razdoblju od približno 10 godina.
In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 8.4 years (median follow-up of 7.2 years).
U PPE populaciji, nije bio opažen nijedan slučaj HPV bolesti (bilo koji stupanj CIN-a povezan s HPV tipovima 6/11/16/18 i genitalne bradavice) tijekom 8,4 godine (medijan praćenja od 7,2 godine).
In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related External Genital Lesions) were observed through 10.6 years (median follow- up of 9.9 years).
U PPE populaciji nije bio opažen nijedan slučaj HPV bolesti (vanjske genitalne lezije povezane s HPV tipovima 6/11/16/18) tijekom 10,6 godina (medijan praćenja od 9,9 godina).
In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related high grade CIN) were observed up to approximately 10 years.
U PPE populaciji nije bio opažen nijedan slučaj HPV bolesti (visoki stupanj CIN-a povezan s tipovima HPV-a 6/11/16/18) u razdoblju od približno 10 godina.
In the PPE population, no cases of HPV types 6/11 related genital warts, HPV 6/11/16/18 external genital lesions or HPV 6/11/16/18 high grade AIN in MSM were observed through 9.6 years (median follow-up of 8.5 years).
U PPE populaciji nisu bili opaženi slučajevi genitalnih bradavica povezanih s HPV tipovima 6/11 , vanjskih genitalnih lezija povezanih s HPV tipovima 6/11/16/18 ili AIN-a visokog stupnja povezanog s HPV tipovima 6/11/16/18 u muškaraca koji imaju spolne odnose s muškarcima tijekom 9,6 godina (medijan praćenja od 8,5 godina).
In the PPE population, the efficacy of qHPV vaccine against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 88.7% (95% CI: 78.1, 94.8).
U PPE populaciji, djelotvornost cjepiva qHPV protiv kombinirane incidencije perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i raka cerviksa povezanih s tipovima 6, 11, 16 ili 18 HPV-a iznosila je 88,7% (95% CI: 78,1; 94,8).
In the pre- and post- natal study in rats, reduced viability of the offspring was observed at doses that were toxic to the dams.
U ispitivanjima prenatalnog i postnatalnog razvoja u štakora uočena je smanjena održivost potomstva pri dozama koje su bile toksične za gravidne ženke.
In the pre- and post- natal study in rats, reduced viability of the offspring was observed at doses that were toxic to the dams.
U prenatalnom i postnatalnom ispitivanju u štakora uočena je smanjena održivost potomstva pri dozama koje su bile toksične za gravidne ženke.
In the pre- and post-natal development study in rats, there were no undesirable effects on pregnancy, parturition or lactation of F0 female rats at maternally non-toxic doses (10 and 20 mg/kg/day) and no effects on the growth, development, neurobehavioral or reproductive function of the offspring (F1).
U studiji pre- i post-natalnog razvoja štakora, nije bilo nepoželjnih učinaka na trudnoću, porod ili laktaciju F0 ženki štakora, u dozama netoksičnim po majku (10 i 20 mg/kg/dan) i nije bilo učinka na rast, razvoj, neurobihevioralnu ili reproduktivnu funkciju potomstva (F1).
In the pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams (a dose corresponding to a plasma exposure level 4-fold higher than observed in patients).
U pre- i postnatalnom ispitivanju, primijećeno je povećanje fetalne smrtnosti pri dozama koje su bile toksične za ženke (doza koja odgovara 4 puta većoj izloženosti u plazmi u odnosu na opažene u bolesnika).
In the pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams (a dose corresponding to a plasma exposure level 4-fold higher than observed in patients).
U prenatalnom i postnatalnom ispitivanju, zabilježen je porast fetalnog mortaliteta pri dozama toksičnim za ženke (doza koja odgovara 4-struko višoj razini izloženosti od one zabilježene u bolesnika).
In the pre-antiviral treatment phase, subjects received open-label eltrombopag to increase the platelet count to ≥ 90,000/µl for ENABLE 1 and ≥ 100,000/µl for ENABLE 2.
U fazi prije antivirusnog liječenja, ispitanici su otvoreno primali eltrombopag kako bi povećali broj trombocita na ≥ 90 000/µl u ENABLE 1 i ≥ 100 000/µl u ENABLE 2 ispitivanju.
In the pre-specified ITT NIS-LL Responder analysis, patients who discontinued prior to the 18-month time point due to liver transplantation were categorized as non-responders.
U unaprijed određenoj analizi bolesnika planiranih za liječenje koji su prema ljestvici NIS-LL odgovorili na liječenje, bolesnici koji su prekinuli ispitivanje prije isteka 18 mjeseci zbog presađivanja jetre svrstani su u kategoriju bolesnika bez odgovora.
In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (≤34 mg/dl or 0.88 mmol/L) and highest tertile of TG (≥204 mg/dl or 2.3 mmol/L) at baseline, fenofibrate plus simvastatin therapy demonstrated a 31% relative reduction compared to simvastatin monotherapy for the composite primary outcome (hazard ratio [HR] 0.69, 95% CI 0.49-0.97, p = 0.03 ; absolute risk reduction: 4.95%).
U unaprijed određenoj podskupini oboljelih od dislipidemije, koji su definirani kao oni u najnižoj tercili HDL-C (≤34 mg/dl ili 0,88 mmol/L) i najvišoj tercili TG (≥204 mg/dl ili 2,3 mmol/L) na početku liječenja, terapija fenofibratom uz simvastatin pokazala je relativno smanjenje od 31% u odnosu na monoterapiju simvastatinom za kompozitni primarni ishod (omjer hazarda [HR] 0,69, 95% CI 0,49-0,97, p = 0,03; apsolutno smanjenje rizika: 4,95%).
In the pregnant rat, the transfer of 35S-enoxaparin across the maternal placenta to the foetus is minimal.
U skotnih ženki štakora transplacentarni prijenos 35S-enoksaparina na fetus je minimalan.
In the presence of 400/100 mg lopinavir/ritonavir twice daily, a strong OATP (OATP1B1 and OATP1B3) and P-gp inhibitor, exposure to selexipag increased approximately 2-fold, whereas the exposure to the active metabolite of selexipag did not change.
Pri primjeni 400/100 mg lopinavira/ritonavira, jakog inhibitora OATP (OATP1B1 i OATP1B3) i P-gp-a, dva puta dnevno, izloženost seleksipagu povećala se približno dvostruko, dok se izloženost aktivnom metabolitu seleksipaga nije mijenjala.
In the presence of clinical manifestations of CHF, discontinuation of sunitinib is recommended.
U slučaju kliničke manifestacije kongestivnog zatajivanja srca preporučuje se prekinuti primjenu sunitiniba.
In the presence of documented resistance that includes Q148 + 2 secondary mutations from G140A/C/S, E138A/K/T, L74I, modelling suggests that an increased dose may be considered for patients with limited treatment options (less than 2 active agents) due to advanced multi class resistance (see section 5.2).
U slučaju dokumentirane rezistencije koja uključuje Q148 + 2 sekundarne mutacije G140A/C/S, E138A/K/T, L74I, modeliranje upućuje da se može razmotriti povišenje doze u bolesnika s ograničenim mogućnostima liječenja (manje od 2 aktivna lijeka) zbog uznapredovale rezistencije na više skupina lijekova (vidjeti dio 5.2).
In the presence of gadoversetamide, the OCP technique produces an erroneous, low value for plasma calcium.
U prisutnosti gadoversetamida, OCP metoda, mjeri pogrešnu, sniženu vrijednost kalcija u plazmi.
In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture.
U slučaju hipertenzije, ili postojećih kardiovaskularnih i cerebrovaskularnih bolesti, ili bolesti perifernih krvnih žila, tjedni porast Hb te ciljnu vrijednost Hb treba određivati za svakog bolesnika posebno na temelju kliničke slike.
in the presence of immune deficiencies AFLUNOV may be administered but a protective immune response may not be elicited.
u prisutnosti imunodeficijencije AFLUNOV može se primijeniti, no možda neće doći do zaštitnog imunološkog odgovora;
in the presence of immune deficiencies Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics may be administered but a protective immune response may not be elicited.
u prisutnosti imunodeficijencije Prepandemijsko cjepivo protiv influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano) Novartis Vaccines and Diagnostics može se primijeniti, no možda neće doći do zaštitnog imunološkog odgovora.
In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for Tivicay in children and adolescents.
U slučaju rezistencije na inhibitore integraze, nema dovoljno podataka za preporuku doze lijeka Tivicay u djece i adolescenata.
In the presence of LVDr mutations, combination use of entecavir plus a second antiviral agent (which does not share cross-resistance with either lamivudine or entecavir) should be considered in preference to entecavir monotherapy (see section 4.4.).
Ako su prisutne LVDr mutacije, treba razmotriti i dati prednost kombiniranoj uporabi entekavira s drugim antivirusnim lijekom (koji ne dijeli križnu rezistenciju bilo s lamivudinom bilo s entekavirom) naspram monoterapije entekavirom (vidjeti dio 4.4.).
In the presence of myelosuppression or its complications, treatment with Dacogen may be interrupted and/or supportive measures instituted (see sections 4.2 and 4.8).
Pri pojavi mijelosupresije ili povezanih komplikacija, liječenje Dacogenom može se prekinuti i/ili se mogu uvesti potporne mjere (vidjeti dijelove 4.2 i 4.8).
In the presence of oxygen NO rapidly forms NO2, see section 4.5.
U prisutnosti kisika NO brzo stvara NO2, vidjeti dio 4.5.
In the presence of symptoms of hyperammonemia (e.g. nausea, vomiting, lethargy, irritation), ammonia levels should be monitored closely.
U prisutnosti simptoma hiperamonemije (npr. mučnine, povraćanja, letargije, iritacije) razine amonijaka treba pomno nadzirati.
In the presence of these infections, the balance of risks and benefits associated with Protopic use should be evaluated.
U prisutnosti ovih infekcija, potrebno je procijeniti ravnotežu rizika i koristi povezanih s primjenom Protopica.
In the presence of viral infections, corticosteroids may worsen or hasten the progress of the disease.
U slučaju virusnih infekcija, kortikosteroidi mogu pogoršati ili ubrzati napredak bolesti.
In the prevention of flu, Ebilfumin must be started within two days of contact with someone who has flu.
Za sprječavanje gripe terapiju lijekom Ebilfumin treba započeti unutar dva dana od kontakta s osobom koja ima gripu.
In the prevention of flu, Tamiflu was studied in patients who had been exposed to the disease when one of their family members contracted flu (962 cases) or during an epidemic (1,562 people aged between 16 and 65 years, and 548 elderly people in nursing homes).
U prevenciji gripe lijek Tamiflu je ispitan u bolesnika koji su izloženi bolesti kada je jedan od članova njihove obitelji zaražen gripom (962 slučajeva) ili tijekom epidemije (1 562 osobe u dobi između 16 i 65 godina, te 548 starije osobe u domovima umirovljenika).
In the prevention of porcine colonic spirochaetosis (colitis), Econor in feed at a dose of 1-1.5 mg valnemulin/kg bodyweight/day (i.e.
U prevenciji svinjske kolonske spirohetoze (kolitis), Econor u hrani pri dozi d 1-1,5 mg valnemulina/kg tjelesne težine/danu (tj.
In the prevention of skeletal events in patients with breast cancer and bone metastases, treatment is most frequently associated with asthenia followed by rise in body temperature and headache.
U sprječavanju koštanih događaja u bolesnika s rakom dojke i koštanim metastazama liječenje je najčešće povezano s astenijom praćenom porastom tjelesne temperature i glavoboljom.
In the prevention studies, Tamiflu reduced the incidence of flu among the people in contact with a flu patient.
U ispitivanjima prevencije, lijek Tamiflu smanjio je incidenciju gripe među osobama koje su bile u kontaktu s bolesnicima s gripom.
In the prevention study, 2.3% of patients taking Eliquis (2.5 mg twice a day) experienced a clotting event or died, compared with 9.3% of patients taking placebo.
U ispitivanju prevencije, u 2,3% bolesnika koji su uzimali Eliquis (2,5 mg dva puta na dan) zabilježen je ugrušak ili su preminuli u usporedbi s 9,3% bolesnika koji su uzimali placebo.
In the prevention trials, the percentage of subjects experiencing an increase or decrease in BMD during raloxifene therapy was: for the spine 37 % decreased and 63 % increased; and for the total hip 29 % decreased and 71 % increased.
U istraživanjima prevencije, postotak ispitanika u kojih se povećao ili smanjio BMD tijekom liječenja raloksifenom iznosio je: za kralježnicu smanjenje od 37 % i povećanje od 63 % te za kuk smanjenje od 29 % i povećanje d 71 %.
In the previously treated patients, Imbruvica was also shown to be effective when combined with bendamustine and rituximab.
U prethodno liječenih bolesnika lijek Imbruvica također se pokazao djelotvornim kada ga se kombiniralo s bendamustinom i rituksimabom.
In the primary 48 weeks analysis, the proportion of patients with virologic suppression in the dolutegravir + ABC/3TC arm , was superior to the EFV/TDF/FTC arm, p=0.003, the same treatment difference was observed in subjects defined by baseline HIV RNA level (< or > 100,000 copies/mL).
U primarnoj analizi 48 tjedana liječenja, udio bolesnika s virološkom supresijom u skupini liječenoj kombinacijom dolutegravir + ABC/3TC bio je superioran u odnosu na skupinu koja je primala EFV/TDF/FTC (p=0,003), a ista razlika između liječenja primijećena je i među ispitanicima grupiranima prema početnoj razini HIV RNK (< ili > 100 000 kopija/ml).
In the primary analysis for DFS in the ITT population, XELOX was shown to be significantly superior to 5-FU/LV (HR=0.80, 95% CI=[0.69; 0.93]; p=0.0045).
Primarnom analizom preživljenje bez znakova bolesti u populaciji bolesnika predviđenih za liječenje XELOX se pokazao značajno superiornijim u odnosu na 5-FU/LV (omjer hazarda=0,80; 95% CI=[0,69; 0,93]; p=0,0045).
In the primary efficacy analysis, global response in the MITT populations at the end of intravenous therapy, anidulafungin was compared to fluconazole in a pre-specified two- step statistical comparison (non-inferiority followed by superiority).
U primarnoj analizi djelotvornosti, opći odgovor u MITT populaciji na kraju intravenske terapije, anidulafungin je bio uspoređen s flukonazolom pomoću prethodno specificirane statističke usporedbe u dva stupnja (utvrđivanje neinferiornosti nakon koje je slijedilo utvrđivanje superiornosti).
In the primary efficacy studies of general populations, 81% of patients reported that tadalafil improved their erections as compared to 35% with placebo.
U primarnim ispitivanjima djelotvornosti u općoj populaciji, 81 % bolesnika prijavilo je poboljšanje erektilne funkcije kod primjene tadalafila, u usporedbi s 35 % bolesnika koji su primali placebo.
In the primary efficacy studies, 75% of intercourse attempts were successful in tadalafil treated patients as compared to 32% with placebo.
U primarnim ispitivanjima djelotvornosti u bolesnika liječenih lijekom tadalafil 75 % pokušaja spolnog odnosa bilo je uspješno, u usporedbi s 32 % kod primjene placeba.
In the primary endpoint analysis covering the referred period, the age-adjusted rate (number per subject year) of treatment-requiring bleeds during the rFXIII treatment period was 0.053/year (95% CI: 0.010 - 0.272; model-based estimate corresponding to the mean age of 26.4 years for the 41 patients).
Analizom primarne krajnje točke za navedeno razdoblje, stopa prilagođena dobi (broj ispitanika-godina) krvarenja za koje je potrebno liječenje tijekom terapije rFXIII bila je 0,053/godini (95% CI: 0,010 - 0,272; procjena na temelju modela odgovara srednjoj dobi od 26,4 godine za 41 bolesnika).
In the primary treatment phases of three phase III active-controlled clinical trials in patients with advanced malignancies involving bone, ONJ was confirmed in 1.8% of patients treated with XGEVA (median exposure of 12.0 months; range 0.1 – 40.5) and 1.3% of patients treated with zoledronic acid.
U primarnim fazama liječenja u tri aktivno kontrolirana klinička ispitivanja faze III u bolesnika s uznapredovanim malignim bolestima koje zahvaćaju kosti, ONČ je potvrđena u 1,8% bolesnika koji su primali lijek XGEVA (medijan izloženosti od 12 mjeseci, raspon 0,1 – 40,5) i u 1,3% bolesnika koji su primali zoledronatnu kiselinu.
In the printing ink: shellac glaze, black iron oxide (E172), propylene glycol and ammonium hydroxide.
U tinti za označavanje: šelak glazura, crni željezov oksid (E172), propilenglikol i amonijev hidroksid.
In the printing ink: shellac, povidone, titanium dioxide (E171).
U tinti za označavanje: šelak, povidon, titanijev dioksid (E171).
In the prior-NNRTI stratum, response rates were 98.9% vs 97.4% for Atripla and SBR patients respectively; a difference (95%CI) of 1.4% (-4.0%, 6.9%)].
U skupini pacijenata koji su prethodno liječeni NNRTI lijekovima stope odgovora bile su 98,9% u pacijenata koji su primali Atriplu u usporedbi s 97,4% u SBR pacijenata: razlika (95%CI) od 1,4% (-4,0%, 6,9%)].
In the prospective randomized controlled cardiovascular outcomes study, investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) in addition to standard of care.
U prospektivnom randomiziranom kontroliranom ispitivanju kardiovaskularnih ishoda, događaji hipoglikemije koje su prijavili ispitivači bili su slični u bolesnika koji su primali placebo (6,5%) i bolesnika koji su primali alogliptin (6,7%) kao dodatak standardnoj oj terapiji.
In the prospective randomized controlled cardiovascular outcomes study, investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) in addition to standard of care.
U prospektivnom randomiziranom kontroliranom ispitivanju kardiovaskularnih ishoda, događaji hipoglikemije koje su prijavili ispitivači bili su slični u bolesnika koji su primali placebo (6,5%) i bolesnika koji su primali alogliptin (6,7%) kao dodatak standardnoj terapiji.
In the prospectively defined primary analysis statistical significance was not reached at the primaryefficacy endpoint at week 24.
U prospektivno definiranoj primarnoj analizi nije postignuta statistička značajnost primarnih ishoda djelotvornosti u 24. tjednu.
In the psoriatic arthritis study, 58% of patients receiving Cimzia 200 mg every two weeks and 52% of patients receiving Cimzia 400 mg every four weeks achieved at least 20% reductions compared with 24% of patients receiving placebo.
U ispitivanju psorijatičnog artritisa, u 58 % bolesnika koji su primali lijek Cimzia od 200 mg svaka dva tjedna i u 52 % bolesnika koji su primali lijek Cimzia od 400 mg svaka četiri tjedna postignuto je najmanje 20%-tno smanjenje u usporedbi s 24 % bolesnika koji su primali placebo.
In the psychiatric cohort, the percentage of subjects with suicidal ideation and/or behaviour based on the Columbia-Suicide Severity Rating Scale (C-SSRS) was similar between the varenicline and placebo groups during treatment and in the non- treatment follow-up, as shown in the following table:
U psihijatrijskoj kohorti postotak ispitanika sa suicidalnim idejama i/ili ponašanjem na temelju Columbia ljestvice ocjenjivanja ozbiljnosti suicidalnosti (C-SSRS) bio je sličan između skupina s vareniklinom i placebom tijekom liječenja i praćenja bez liječenja kako je to prikazano u sljedećoj tablici.
In the psychiatric cohort, the percentage of subjects with suicidal ideation and/or behaviour based on the Columbia-Suicide Severity Rating Scale (C-SSRS) was similar between the varenicline and placebo groups during treatment and in the non- treatment follow-up, as shown in the following table:
U psihijatrijskoj kohorti postotak ispitanika sa suicidalnim idejamai/ili ponašanjem na temelju Columbia ljestvice ocjenjivanja ozbiljnosti suicidalnosti (C-SSRS) bio je sličan između skupina s vareniklinom i placebom tijekom liječenja i praćenja bez liječenja kako je to prikazano u sljedećoj tablici.
In the pump
U pumpi
In the pump, the medicine is stable for 45 days at 37°C.
Lijek je u pumpi stabilan tijekom 45 dana na temperaturi od 37°C.
In the PURSUIT trial, there were 9 patients who received bolus and/or infusion doses more than double the recommended dose, or who were identified by the investigator as having received an overdose.
U ispitivanju PURSUIT, 9 je bolesnika primilo doze bolusa i/ili infuzije koje su bile dvostruko veće od onih preporučenih ili za koje je ispitivač ustanovio da su primili preveliku dozu.
In the PURSUIT trial, there were 9 patients who received bolus and/or infusion doses more than double the recommended dose, or who were identified by the investigator as having received an overdose.
U ispitivanju PURSUIT, 9 je bolesnika primilo doze bolusa i/ili infuzije koje su bile više nego dvostruko veće od onih preporučenih ili za koje je ispitivač ustanovio da su primili preveliku dozu.
In the PV population, the CTCAE grade 3 and 4 events were reported in 1.8%, while in the MF patients the frequency was 42.56%.
U populaciji s PV-om, događaji stupnja 3 i 4 prema CTCAE-u bili su prijavljeni u 1,8%, dok je u bolesnika s MF-om učestalost bila 42,56%.