natgillin/translations-raw huggingface dataset:
No clinical or non-clinical fertility studies have been conducted with TRISENOX.
Nisu provedene klinička ili neklinička ispitivanja utjecaja TRISENOXA na plodnost.
No clinical signs of a hepatitis B re-infection were observed and no patient was tested HBsAg positive or HBV-DNA positive during the study which confirms that effective protection against Hepatitis B virus re-infection was provided by subcutaneous administration of Zutectra as part of the combination treatment with HBV virostatic therapy 8 – 18 days after orthotopic liver transplantation.
Nisu utvrđeni klinički znakovi ponovne infekcije hepatitisom B i nijedan bolesnik tijekom ispitivanja nije bio pozitivan na HBsAg ili na HBV-DNA, što potvrđuje da je supkutanom primjenom lijeka Zutectra u kombinaciji s liječenjem HBV-a virostaticima 8 – 18 dana od ortotopne transplantacije jetre pružena učinkovita zaštita od ponovne infekcije virusom hepatitisa B.
No clinical studies are available to date.
Do sada nisu bile dostupne kliničke studije o tome.
No clinical studies have been conducted in patients >75 years of age.
Nisu provedena klinička ispitivanja u bolesnika starijih od 75 godina.
No clinical studies have been conducted in patients >75 years of age.
Nisu provedena klinička ispitivanja u bolesnika u dobi >75 godina.
No clinical studies have been conducted in patients with severe hepatic impairment or children and adolescents.
Nisu provođena klinička ispitivanja u bolesnika s teškim oštećenjem jetre ili u djece i adolescenata.
No clinical studies have been performed in children 0-7 years old and therefore no dose can be recommended for this age group.
U djece u dobi od 0 do 7 godina nisu provedena klinička ispitivanja pa se za tu dobnu skupinu ne može preporučiti doza.
No clinical studies have been performed to evaluate the effects of talimogene laherparepvec on fertility see section 5.3).
Nisu provedena klinička ispitivanja za procjenu učinka virusa talimogene laherparepvec na plodnost (vidjeti dio 5.3).
No clinical studies have been performed with Hizentra in pregnant women.
Klinička ispitivanja o primjeni Hizentre u trudnica nisu provedene.
No clinical studies with Toujeo have been conducted in the paediatric population.
Nisu provedena klinička ispitivanja lijeka Toujeo u pedijatrijskoj populaciji.
No clinical study has been conducted to evaluate the effect of pH on dabrafenib pharmacokinetics.
Nisu se provodila klinička ispitivanja za procjenu djelovanja pH na farmakokinetiku dabrafeniba.
No clinical trials have been made with KIOVIG in pregnant or breast-feeding women.
Nisu provedena klinička ispitivanja s lijekom KIOVIG u trudnica ili dojilja.
No clinical trials in subjects with a creatinine clearance <10 mL/min or in patients undergoing dialysis have been conducted.
Nisu provedena klinička ispitivanja na ispitanicima s klirensom kreatinina <10 ml/min ili na bolesnicima koji su na dijalizi.
No clinically important differences in exposure to daratumumab were observed between patients with renal impairment and those with normal renal function.
Nisu primijećene klinički važne razlike u izloženosti daratumumabu između bolesnika s oštećenjem bubrežne funkcije i onih s normalnom bubrežnom funkcijom.
No clinically important differences in the clearance of Empliciti were found between patients with mild hepatic impairment and patients with normal hepatic function.
Nisu primijećene klinički značajne razlike u klirensu lijeka Empliciti između bolesnika s blagim oštećenjem funkcije jetre i onih s normalnomfunkcijom jetre.
No clinically important differences in the exposure to daratumumab were observed between patients with mild hepatic impairment (TB 1.0 x to
Nisu primijećene klinički važne razlike u izloženosti daratumumabu između bolesnika s blagim oštećenjem jetrene funkcije (ukupni bilirubin od 1,0
No clinically important pharmacokinetic difference due to ethnicity has been identified.
Nisu ustanovljene klinički važne razlike u farmakokinetici vezane uz etničku pripadnost.
No clinically important pharmacokinetic differences due to ethnicity have been identified.
Nisu utvrđene klinički važne farmakokinetičke razlike zbog etničke pripadnosti.
No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority of elderly patients.
S povećanjem doze na 300 mg u većine starijih bolesnika nije opaženo klinički značajno dodatno sniženje krvnog tlaka.
No clinically meaningful differences in ospemifene pharmacokinetics have been observed over the age range studied (40-80) years of age.
Nisu primijećene bitne razlike u farmakokinetici ospemifena u ispitivanom dobnom rasponu (40- 80 godina).
No clinically meaningful differences in safety were observed between these patients and younger patients.
Nisu primijećene klinički značajne razlike u sigurnosti između tih bolesnika i mlađih bolesnika.
no clinically meaningful increase in lomitapide exposure was observed.
povećanje u izloženosti lomitapidu.
No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that daclatasvir, which inhibits a HCV-specific target, is highly selective for HCV.
Nije primijećena klinički značajna antivirusna aktivnost protiv niza različitih RNK i DNK virusa, uključujući HIV, što potvrđuje da je daklatazvir, koji inhibira ciljno mjesto specifično za HCV, visoko selektivan za HCV.
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose, ketoconazole and erythromycin interaction trials.
Nisu uočene klinički značajne promjene u koncentraciji desloratadina u plazmi tijekom ispitivanja interakcija višestrukih doza desloratadina s ketokonazolom i eritromicinom.
No clinically relevant changes were observed in the total Cmax and AUC of isavuconazole in subjects with mild, moderate or severe renal impairment compared to subjects with normal renal function.
Nisu zabiljeţene klinički značajne promjene ukupnog Cmax i AUC izavukonazola kod ispitanika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega u usporedbi s ispitanicima čija je funkcija bubrega normalna.
No clinically relevant differences in aprepitant pharmacokinetics is expected due to age and gender.
Ne očekuju se nikakve klinički značajne razlike u farmakokinetici aprepitanta između dobnih skupina i spolova.
No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between patients with moderate impairment and healthy subjects.
Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira i kobicistata između bolesnika s umjerenim oštećenjem funkcije jetre i zdravih ispitanika.
No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects.
Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira i kobicistata između ispitanika s teškim oštećenjem funkcije bubrega i zdravih ispitanika.
No clinically relevant differences in elvitegravir, cobicistat, tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl > 15 but < 30 mL/min) in studies of cobicistat-boosted elvitegravir or of tenofovir alafenamide, respectively.
Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira, kobicistata, tenofoviralafenamida ili tenofovira između zdravih ispitanika i bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl > 15, ali < 30 ml/min) u ispitivanjima elvitegravira pojačanog kobicistatom ili tenofoviralafenamida.
No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl > 15 but
Nisu zapaţene klinički značajne razlike u farmakokinetici tenofoviralafenamida ili tenofovira izmeĎu zdravih ispitanika i bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl > 15, ali
No clinically relevant differences in the pharmacokinetics of rilpivirine have been observed between men and women.
Nisu primijećene klinički značajne razlike u farmakokinetici rilpivirina između muškaraca i žena.
No clinically relevant drug interactions between SANCUSO and emetogenic cancer chemotherapies have been seen.
Nisu uočene klinički značajne interakcije između lijeka SANCUSO i emetogenih kemoterapijskih lijekova.
No clinically relevant drug-drug interaction is expected.
Ne očekuje se klinički važna interakcija lijekova
No clinically relevant drug-drug interaction is expected.
Ne očekuju se klinički značajne interakcije između lijekova.
No clinically relevant drug-drug interaction was observed when simvastatin and Entresto were co- administered.
Nije primjećena klinički značajna interakcija među lijekovima prilikom istodobne primjene simvastatina i Entresta.
No clinically relevant drug-drug interaction was observed when simvastatin and Neparvis were co- administered.
Nije primjećena klinički značajna interakcija među lijekovima prilikom istodobne primjene simvastatina i Neparvisa.
No clinically relevant ECG morphological changes following administration of amifampridine phosphate were observed in a study of healthy volunteers (see section 5.1).
Nakon primjene amifampridin fosfata nisu opažene nikakve klinički značajne EKG morfološke promjene u ispitivanju na zdravim dobrovoljcima (vidjeti dio 5.1).
No clinically relevant effect of age on enzalutamide pharmacokinetics was seen in the population pharmacokinetic analysis.
Nije opažen klinički važan učinak dobi na farmakokinetiku enzalutamida u analizi populacijske farmakokinetike.
No clinically relevant effect was observed during steady-state lithium exposure following co- administration with multiple doses of vortioxetine in healthy subjects.
Nije opažen klinički relevantan učinak tijekom izloženosti litiju u stanju dinamičke ravnoteže nakon istodobne primjene s višekratnim dozama vortioksetina u zdravih ispitanika.
No clinically relevant effect was observed during steady-state lithium exposure following co- administration with multiple doses of vortioxetine in healthy subjects.
Nije opažen klinički relevantan učinak tijekom izloženosti litiju u stanju dinamičke ravnoteže nakon istodobne primjene s višestrukim dozama vortioksetina u zdravih ispitanika.
No clinically relevant effects of age, gender, race, renal function (calculated GFR), diabetes, or concomitant dialysis on clearance of belatacept was identified.
Nisu bili utvrđeni nikakvi klinički važni učinci dobi, spola, rase, funkcije bubrega (izračunati GFR), šećerne bolesti ili istovremene dijalize na klirens belatacepta.
No clinically relevant effects of Brimica Genuair on ECG parameters (including QT-interval) compared with aclidinium, formoterol and placebo were seen in Phase III studies of 6 to 12 months duration conducted in approximately 4,000 patients with COPD.
Nisu zabilježeni klinički značajni učinci Brimica Genuaira na EKG parametre (uključujući QT interval) u usporedbi s aklidinijem, formoterolom i placebom u ispitivanjima faze III u trajanju od 6 do 12 mjeseci provedenim na otprilike 4000 bolesnika koji su imali KOPB.
No clinically relevant effects of Duaklir Genuair on ECG parameters (including QT-interval) compared with aclidinium, formoterol and placebo were seen in Phase III studies of 6 to 12 months duration conducted in approximately 4,000 patients with COPD.
Nisu zabilježeni klinički značajni učinci Duaklir Genuaira na EKG parametre (uključujući QT interval) u usporedbi s aklidinijem, formoterolom i placebom u ispitivanjima faze III u trajanju od 6 do 12 mjeseci provedenim na otprilike 4000 bolesnika koji su imali KOPB.
No clinically relevant effects on the pharmacokinetics of either medicinal product are expected when daclatasvir is coadministered with any of the following: PDE-5 inhibitors, medicinal products in the ACE inhibitor class (e.g. enalapril), medicinal products in the angiotensin II receptor antagonist class (e.g. losartan, irbesartan, olmesartan, candesartan, valsartan), disopyramide, propafenone, flecainide, mexilitine, quinidine or antacids.
Ne očekuju se klinički značajni učinci na farmakokinetiku niti jednog lijeka kada se daklatazvir primjenjuje istodobno s nekim od sljedećih lijekova: inhibitorima PDE-5, lijekovima iz razreda ACE inhibitora (npr. enalaprilom), lijekovima iz razreda antagonista receptora angiotenzina II (npr. losartanom, irbesartanom, olmesartanom, kandesartanom, valsartanom), dizopiramidom, propafenonom, flekainidom, meksilitinom, kinidinom ili antacidima.
No clinically relevant effects on the pharmacokinetics of R-and S- enantiomers of warfarin were observed when a single dose of racemic warfarin (25 mg) was administered with steady-state albiglutide (50 mg weekly).
Nisu primijećeni klinički relevantni učinci na farmakokinetiku R- i S-enantiomera varfarina kada je jedna doza racemičnog varfarina (25 mg) primijenjena uz albiglutid u stanju dinamičke ravnoteže (50 mg tjedno).
No clinically relevant effects were observed when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Nisu opaženi klinički važni učinci kad su se posakonazol tablete istodobno primjenjivale s antacidima, antagonistima H2-receptora i inhibitorima protonske pumpe.
No clinically relevant ethnic differences among Caucasians, Afrian-American, Hispanic, Japanese or Chinese patients were observed.
Nisu primijećene klinički značajne etničke razlike među bolesnicima pripadnicima bjelačkog, afro-američkog, hispanskog, japanskog ili kineskog porijekla.
No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
Nisu primijećene klinički relevantne etničke razlike u populaciji bolesnika bijelaca, Afro- Amerikanaca, Hispanaca, Japanaca, ili Kineza.
No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
Nisu primijećene klinički značajne etničke razlike među bolesnicima pripadnicima bjelačkog, afro-američkog, hispanskog, japanskog ili kineskog porijekla.
No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
Nisu primijećene klinički značajne etničke razlike među bolesnicima pripadnicima bjelačkog, afro-američkog, hispanskog, japanskog, ili kineskog porijekla.
No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
Nisu primijećene klinički značajne razlike među bijelcima, Afro-Amerikancima, osobama hispanskog porijekla, Japancima, ili Kinezima.
No clinically relevant gender differences were observed in clinical studies.
U kliničkim ispitivanjima nisu opažene klinički značajne razlike između spolova.
No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding dabigatran pharmacokinetics and pharmacodynamics.
Nisu primijećene klinički relevantne međuetničke razlike u skupinama bolesnika bijelaca, Afro- Amerikanaca, osoba hispanskog porijekla, Japanaca, ili Kineza, s obzirom na farmakokinetiku i farmakodinamiku dabigatrana.
No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of co- administered interferon alpha 2a, erlotinib (and its active metabolite OSI-420), or the chemotherapies irinotecan (and its active metabolite SN38), capecitabine, oxaliplatin (as determined by measurement of free and total platinum), and cisplatin.
Nije primijećena klinički značajna interakcija bevacizumaba na farmakokinetiku istodobno primijenjenog interferona alfa-2a, erlotiniba (i njegova aktivnog metabolita OSI-420) ni kemoterapeutika irinotekana (i njegova aktivnog metabolita SN38), kapecitabina, oksaliplatina (što je utvrđeno određivanjem slobodne platine i ukupne platine) i cisplatina.
No clinically relevant interaction with food was observed (see section 4.2).
Nisu uočene klinički značajne interakcije s hranom (vidjeti dio 4.2).
No clinically relevant interactions have been observed when mirabegron was co-administered with therapeutic doses of solifenacin, tamsulosin, warfarin, metformin or a combined oral contraceptive medicinal product containing ethinylestradiol and levonorgestrel.
Nisu zabilježene klinički relevantne interakcije kada se mirabegron primjenjivao istodobno s terapijskim dozama solifenacina, tamsulozina, varfarina, metformina ili s kombiniranim oralnim kontracepcijskim lijekovima koji su sadržavali etinilestradiol i levonogestrel.
No clinically relevant pharmacokinetic differences due to ethnicity have been identified for boosted elvitegravir.
Klinički značajne farmakokinetičke razlike vezane uz etničku pripadnost nisu ustanovljene za pojačani elvitegravir.
No clinically relevant pharmacokinetic differences due to ethnicity have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil fumarate.
Klinički značajne farmakokinetičke razlike vezane uz etničku pripadnost nisu ustanovljene za kobicistatom pojačani elvitegravir, emtricitabin i tenofovirdizoproksilfumarat.
No clinically relevant pharmacokinetic differences due to gender have been identified for boosted elvitegravir.
Klinički značajne farmakokinetičke razlike vezane uz spol nisu ustanovljene za pojačani elvitegravir.
No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil fumarate.
Klinički značajne farmakokinetičke razlike vezane uz spol nisu ustanovljene za kobicistatom pojačani elvitegravir, emtricitabin i tenofovirdizoproksilfumarat.
No clinically relevant pharmacokinetic drug-drug interaction was observed between ipilimumab and paclitaxel/carboplatin, dacarbazine or its metabolite, 5-aminoimidazole-4- carboxamide (AIC).
Nisu primijećene klinički značajne farmakokinetičke interakcije između ipilimumaba i paklitaksela/karboplatina, dakarbazina ili njegova metabolita, 5-aminoimidazol-4-karboksamida (AIC).
No clinically relevant prolongation of bleeding time was observed after concomitant administration of rivaroxaban (15 mg) and 500 mg naproxen.
Nakon istodobne primjene rivaroksabana (15 mg) s naproksenom u dozi od 500 mg nije uočeno klinički značajno produženje vremena krvarenja.
No clinically significant
DMPA ostale niske, sukladno supresiji
No clinically significant
Nema klinički značajne
No clinically significant
Nema klinički značajnih
No clinically significant
Nema klinički značajnih farmakokinetičkih interakcija.
No clinically significant alterations of either saquinavir or efavirenz concentration were noted in studies in healthy volunteers or in HIV- infected patients (see section 4.5).
U ispitivanjima sa zdravim dobrovoljcima i bolesnicima zaraženima HIV-om nisu opažene klinički značajne promjene koncentracija sakvinavira ni efavirenza (vidjeti dio 4.5).
No clinically significant changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarisation.
Nisu se pokazale klinički značajne promjene na brzinu srčanih otkucaja, atrioventrikularnu (AV) provodljivost i srčanu repolarizaciju.
No clinically significant changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarization.
Nisu se pokazale klinički značajne promjene na brzinu srčanih otkucaja, atrioventrikularnu (AV) provodljivost i srčanu repolarizaciju.
No clinically significant differences in exposure to capecitabine or its metabolites, free platinum or total platinum occurred when capecitabine was administered in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab.
Kod primjene kapecitabina u kombinaciji s oksaliplatinom ili u kombinaciji s oksaliplatinom i bevacizumabom nisu uočene klinički značajne razlike u izloženosti kapecitabinu ili njegovim metabolitima, slobodnoj platini ili ukupnoj platini.
No clinically significant differences in LVMi were observed during the initial 6-month placebo-controlled period.
Nisu zabilježene klinički značajne razlike u pogledu LVMi tijekom početnog 6-mjesečnog, placebom kontroliranog razdoblja.
No clinically significant differences were observed during the initial 6-month placebo-controlled period.
Nisu zabilježene klinički značajne razlike tijekom početnog 6-mjesečnog, placebom kontroliranog razdoblja.
No clinically significant differences were seen when the safety data were analysed by gender or race.
Nisu opažene klinički značajne razlike kad su se podaci o sigurnosti analizirali prema spolu ili rasi.
No clinically significant effect is anticipated when temsirolimus is co-administered with agents that are metabolised by CYP2D6.
Ne očekuje se klinički značajan učinak kada se temsirolimus primijenjuje istovremeno s lijekovima koji se metaboliziraju putem CYP2D6.
No clinically significant effect on efavirenz pharmacokinetics.
Nema klinički značajnih farmakokinetičkih interakcija.
No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed.
Nisu uočene klinički značajne razlike u farmakokinetici daptomicina s obzirom na spol.
No clinically significant interaction is expected.
Ne očekuje se klinički značajna
No clinically significant interaction is observed.
Nije uočena klinički značajna interakcija.
No clinically significant interaction observed.
Nije bilo ispitivanja interakcija
No clinically significant pharmacodynamic interactions were observed when clopidogrel was co- administered with atenolol, nifedipine, or both atenolol and nifedipine.
Nisu primijećene klinički značajne farmakodinamičke interakcije pri istodobnoj primjeni klopidogrela i atenolola, odnosno nifedipina, ili klopidogrela i ta dva lijeka zajedno.
No clinically significant pharmacokinetic change.
Nema klinički značajnih
No clinically significant pharmacokinetic interaction
Interakcija nije ispitivana.
No clinically significant pharmacokinetic interaction
Nema klinički značajnih farmakokinetičkih interakcija.
No clinically significant pharmacokinetic interaction The geometric mean Cmin for
Nema klinički značajnih farmakokinetičkih interakcija.
No clinically significant pharmacokinetic interaction was seen when fenofibrate was coadministered with pravastatin.
Nisu opažene značajne farmakokinetičke interakcije kada se fenofibrat primjenjivao istodobno s pravastatinom.
No clinically significant pharmacokinetic interaction.
Interakcija nije ispitana.
No clinically significant pharmacokinetic interaction.
Interakcija nije ispitivana.
No clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with entecavir.
Ne postoje klinički značajne farmakokinetičke interakcije kod istovremene primjene tenofovirdizoproksilfumarata i entekavira.
No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin (substrate of P-gp), atorvastatin (substrate of CYP3A4 and P-gp) or omeprazole (proton pump inhibitor).
Pri istodobnoj primjeni rivaroksabana s midazolamom (supstrat CYP3A4), digoksinom (supstrat P-gp- a), atorvastatinom (supstrat CYP3A4 i P-gp-a) ili omeprazolom (inhibitor protonske pumpe) nisu uočene klinički značajne farmakokinetičke ili farmakodinamičke interakcije.
No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin (substrate of P-gp), atorvastatin (substrate of CYP3A4 and P-gp) or omeprazole (proton pump inhibitor).
Pri istodobnoj primjeni rivaroksabana s midazolamom (supstrat CYP3A4), digoksinom (supstrat P-gp- a), atorvastatinom (supstrat CYP3A4 i P-gp-a) ili omeprazolom (inhibitor protonske pumpe) nisu uočene klinički značajne farmakokinetičke ni farmakodinamičke interakcije.
NO Clumps, uniformly cloudy
NEMA grudica, jednoliko mutna otopina