natgillin/translations-raw huggingface dataset:
No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage and in vitro and in vivo chromosomal aberration studies.
U in vitro testovima mutageneze na mikroorganizmima (Amesov test), in vitro testovima alkalne elucije radi utvrđivanja oštećenja DNK te in vitro i in vivo istraživanjima kromosomskih aberacija nisu otkriveni znakovi mutagenosti ili genotoksičnosti.
No experience exists for the treatment of BCC and Bowen’s disease, which should therefore not be treated with the product.
Nema iskustava u liječenju karcinoma bazalnih stanica i Bowenove bolesti, te se stoga lijek ne smije primjenjivati za njihovo liječenje.
No experience exists for the use of Ameluz in patients with inherited or acquired coagulation defects or in immunosuppressed patients.
Nema iskustava s primjenom lijeka Ameluz u bolesnika s naslijeđenim ili stečenim defektima u koagulaciji ili u imunosuprimiranih bolesnika.
No experience exists in patients with hepatic impairment from causes other than
Nema iskustva u liječenju bolesnika s oštećenjem funkcije jetre koje je uzrokovano drugim uzrocima, a ne pomanjkanjem 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ili pomanjkanjem
No experience exists in patients with hepatic impairment from causes other than 3β-
Nema iskustva u liječenju bolesnika s oštećenjem funkcije jetre koje je uzrokovano drugim uzrocima, a ne pomanjkanjem 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ili pomanjkanjem
No experience in the treatment of patients with renal and/or hepatic impairment is available and therefore it is recommended that such patients be monitored more closely.
Nema iskustva u liječenju pacijenata s bubrežnim i/ili jetrenim oštećenjem, te se stoga preporučuje pažljivije praćenje tih pacijenata.
No explanation can be given to this higher number of PE.
Ne postoji objašnjenje za tako visok broj slučajeva plućne embolije.
No fatal case was observed during the study.
Tijekom ispitivanja nije došlo do smrtnog ishoda.
No fertility data are available.
Nema dostupnih podataka.
No fertility data are available.
Nema podataka o učinku na plodnost.
No fertility data are available.
Nisu dostupni podaci o utjecaju na plodnost.
No fertility studies have been performed with ingenol mebutate.
Nisu provedena ispitivanja plodnosti s ingenol mebutatom.
No fertility studies in humans have been conducted.
Nisu provedena ispitivanja učinaka na plodnost u ljudi.
No fibrosis or minimal fibrosis
Bez fibroze ili minimalna fibroza
No findings of toxicological significance were observed and the no observed adverse effect level (NOAEL) in both studies was ≥ 200 mg/kg, which is 19 times the exposure in humans at the highest clinically tested dose (10 mg/kg).
Nisu primijećeni nikakvi toksikološki značajni nalazi, a razina izloženosti pri kojoj nisu opaženi štetni učinci (engl. no observed adverse effect level, NOAEL) u oba je ispitivanja iznosila ≥200 mg/kg, što je 19 puta više od izloženosti koja se postiže u ljudi nakon primjene najveće klinički ispitivane doze (10 mg/kg).
No food should be eaten for at least two hours before and two hours after the dose is taken.
Ne smije se uzimati nikakva hrana barem dva sata prije i dva sata nakon uzimanja doze.
No food should be given until 4 hours after treatment.
Ne smije se davati nikakva hrana unutar 4 sata nakon tretiranja.
No food should be taken within 3 hours after each dose.
Hrana se ne smije uzimati 3 sata nakon doze.
No formal clinical drug interaction studies with decitabine have been conducted.
Nisu provedena službena klinička ispitivanja interakcije lijekova s decitabinom.
No formal clinical studies have been conducted in children or teenagers.
Kod djece i adolescenata nisu provedena formalna klinička ispitivanja.
No formal clinical trials have been conducted in these patient populations.
Klinička ispitivanja nisu provedena u bolesnika s oštećenjem funkcije bubrega.
No formal clinical trials have been conducted in these patient populations.
Klinička ispitivanja nisu provedena u bolesnika sa oštećenjem funkcije bubrega.
No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Nisu provedena službena klinička ispitivanja niti farmakokinetičke studije na djeci i adolescentima.
No formal drug-drug interaction studies have been conducted for Repatha.
Nisu provedena formalna ispitivanja interakcija lijekova za lijek Repatha.
No formal drug-drug interaction studies have been performed with cetrorelix.
Nisu provedna formalna ispitivanja interakcija lijekova s cetroreliksom.
No formal drug-drug interaction studies have been performed, although limited drug-drug interaction sub-studies have been undertaken for Gazyvaro with bendamustine, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone), FC (fludarabine, cyclophosphamide) and chlorambucil.
Nisu provedena formalna ispitivanja interakcija s drugim lijekovima, ali su provedena ograničena podispitivanja interakcija lijeka Gazyvaro s bendamustinom, protokolom CHOP (ciklofosfamid, doksorubicin, vinkristin, prednizolon) , FC (fludarabin, ciklofosfamid) te klorambucilom.
No formal drug-drug interaction studies have been performed.
Nisu provedena formalna ispitivanja interakcija.
No formal evaluation has been conducted to investigate the potential differences in ketoconazole pharmacokinetics between males and females and data evaluating the effect of weight on pharmacokinetics of ketoconazole are very limited.
Nisu provedena službena ispitivanja o potencijalnoj razlici u farmakokinetici ketokonazola u muškaraca i žena, a podaci o utjecaju težine na farmakokinetiku ketokonazola vrlo su ograničeni.
No formal evaluation of the effect of age on the pharmacokinetics of Ketoconazole HRA has been performed.
Nisu provedena službena ispitivanja utjecaja dobi na farmakokinetiku Ketoconazolea HRA.
No formal in vivo drug-drug interaction studies have been conducted.
Nisu provedena formalna ispitivanja interakcija između lijekova in vivo.
No formal interaction studies have been undertaken with vernakalant injection.
Nisu provedena formalna ispitivanja interakcija vernakalanta primjenjenog putem injekcije.
No formal interaction studies with Praxbind and other medicinal products have been performed.
Nisu provedena formalna ispitivanja interakcija Praxbinda i drugih lijekova.
No formal interaction study has been
Nije provedeno službeno ispitivanje interakcija.
No formal interactions studies with other medicinal products were conducted, .
Nisu provedena formalna ispitivanja interakcija s drugim lijekovima.
No formal pharmacokinetic studies have been performed in patients with hepatic impairment; however, the medicinal product has been used in clinical trials of patients developing hepatic impairment without dose adjustment with no safety issues identified.
Nisu provedena službena farmakokinetička ispitivanja u bolesnika s oštećenjem funkcije jetre, međutim, lijek je u kliničkim ispitivanjima primjenjivan u bolesnika koji su razvili oštećenje funkcije jetre bez prilagodbe doze, i nisu bile opažene teškoće s obzirom na sigurnost.
No formal PK study has been conducted in patients with renal impairment.
U bolesnika s oštećenjem bubrežne funkcije nisu provedena formalna ispitivanja farmakokinetike.
No formal preclinical safety studies have been conducted however data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Nisu provedena formalna pretklinička ispitivanja o sigurnosti primjene, no podaci u literaturi ne upućuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne toksičnosti.
No formal studies have been conducted to evaluate the effect of hepatic impairment on the PK of necitumumab.
Nisu provedena formalna ispitivanja kojima bi se ocijenio učinak oštećenja jetrene funkcije na farmakokinetiku necitumumaba.
No formal studies have been conducted to evaluate the effect of hepatic impairment on the PK of olaratumab.
Nisu provedena formalna ispitivanja kojima bi se ocijenio učinak oštećenja funkcije jetre na farmakokinetiku olaratumaba.
No formal studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of ramucirumab.
Nisu provedena službena ispitivanja kojima bi se ocijenio učinak oštećenja bubrežne funkcije na farmakokinetiku ramucirumaba.
No formal studies have been conducted to evaluate the effect of renal impairment on the PK of necitumumab.
Nisu provedena formalna ispitivanja kojima bi se ocijenio učinak oštećenja bubrežne funkcije na farmakokinetiku necitumumaba.
No formal studies have been conducted to evaluate the effect of renal impairment on the PK of olaratumab.
Nisu provedena formalna ispitivanja kojima bi se ocijenio učinak oštećenja funkcije bubrega na farmakokinetiku olaratumaba.
No formal studies have been conducted to investigate the effect of renal impairment on the pharmacokinetics of mepolizumab.
Nisu provedena službena ispitivanja učinka oštećenja bubrežne funkcije na farmakokinetiku mepolizumaba.
No formal studies have been conducted with JETREA in patients with hepatic impairment.
Formalna ispitivanja JETREE u bolesnika s oštećenjem funkcije jetre nisu provedena.
No formal studies have been conducted with JETREA in patients with renal impairment.
Formalna ispitivanja JETREE u bolesnika s oštećenjem bubrega nisu provedena.
No formal studies of Arzerra in patients with hepatic impairment have been performed.
Nisu provođena ispitivanja lijeka Arzerra u bolesnika s oštećenjima jetre.
No formal studies of Arzerra in patients with renal impairment have been performed.
Nisu provođena ispitivanja lijeka Arzerra u bolesnika s oštećenjem bubrega.
No formal studies of daratumumab in patients with hepatic impairment have been conducted.
Nisu provedena formalna ispitivanja daratumumaba u bolesnika s oštećenjem funkcije jetre.
No formal studies of daratumumab in patients with renal impairment have been conducted.
Nisu provedena formalna ispitivanja daratumumaba u bolesnika s oštećenjem funkcije bubrega.
No formal studies of the effect of axitinib on wound healing have been conducted.
Nisu provedena formalna ispitivanja utjecaja aksitiniba na cijeljenje rana.
No formal studies on the effect of pazopanib on wound healing have been conducted.
Službena ispitivanja djelovanja pazopaniba na cijeljenje rana nisu provođena.
No formal study of the effect of hepatic impairment on the pharmacokinetics of siltuximab has been conducted.
Formalna ispitivanja učinka oštećenja jetre na farmakokinetiku siltuksimaba nisu provedena.
No formal study of the effect of renal impairment on the pharmacokinetics of siltuximab has been conducted.
Nisu provedena formalna ispitivanja učinka oštećenja bubrega na farmakokinetiku siltuksimaba.
No FPV/RTV drug
interakcija lijeka
No gender differences were observed.
Nisu primijećene razlike između spolova.
No gender effect on the pharmacokinetics of peginterferon beta-1a was found in a population pharmacokinetic analysis.
U farmakokinetičkoj analizi populacije s peginterferonom beta-1a nije pronađen utjecaj spola na farmakokinetiku.
No gender-related pharmacokinetic differences in the phase III studies have been observed in adult patients.
U ispitivanjima faze III nisu opažene farmakokinetičke razlike s obzirom na spol u odraslih bolesnika.
No gender-specific pharmacokinetic studies have been done with NutropinAq.
Nisu provedena farmakokinetička ispitivanja specifična za spol s lijekom NutropinAq.
No genotoxicity studies have been performed with ONIVYDE.
Nisu provedena ispitivanja genotoksičnosti s lijekom ONIVYDE.
No Grade 4 denoted in CTCAE, Version 4.0
4. stupanj nije naznačen u CTCAE, verzija 4.0.
No Grade 4 or 5 cases were reported in these studies.
U tim ispitivanjima nije prijavljen nijedan slučaj 4. ili 5. stupnja.
No Grade 4 rash or diarrhoea was observed in either study.
Ni u jednom od ta dva ispitivanja nisu uočeni ni osip ni proljev stupnja 4.
No Grade 4 rash or diarrhoea was observed.
Nisu zabilježeni ni osip ni proljev stupnja 4.
No Grade 5 cases were reported in these studies.
U tim ispitivanjima nije prijavljen nijedan slučaj 5. stupnja.
No hemolysis was found with the commercial formulation up to a fosaprepitant concentration of 1 mg/ml in human whole blood and washed human erythrocytes.
S farmaceutskim oblicima fosaprepitanta namijenjenih tržištu u koncentraciji do najviše mg/ml nije utvrđena hemoliza u punoj ljudskoj krvi, odnosno ispranim ljudskim eritrocitima.
No histological changes were observed in organs involved in the excretion of radium-223 dichloride.
Nisu bile opažene histološke promjene u organima koji sudjeluju u izlučivanju radij-223 diklorida.
No human data on the effect of asparaginase on fertility are available.
Nisu dostupni podaci o učinku asparaginaze na plodnost u ljudi.
No human data on the effect of Enzepi on fertility are available.
Nisu dostupni podaci o utjecaju lijeka Enzepi na plodnost u ljudi.
No human data on the effect of Viekirax on fertility are available.
Nema dostupnih podataka o utjecaju lijeka Viekirax na plodnost u ljudi.
No human fertility data are available.
Nisu dostupni podaci o utjecaju na plodnost u ljudi.
No ICS (SABA alone)
Short Acting Beta Agonist)
No imbalance was observed in postmenopausal women or men with osteoporosis or in women undergoing aromatase inhibitor therapy for nonmetastatic breast cancer.
Neuravnoteženost nije zabilježena u žena u postmenopauzi i muškaraca s osteoporozom ni u žena koje primaju terapiju inhibitorima aromataze zbog nemetastazirajućeg raka dojke.
No immunogenic response was detected in a 12-week study in mice in which pegaspargase was weekly administered at the dose of 10.5 U/mouse intramuscular or intraperitoneally.
U 12-tjednom ispitivanju na miševima u kojih je pegaspargaza primjenjivana jednom tjedno u dozi od 10,5 U po mišu intramuskularno ili intraperitonealno, nije otkriven imunogeni odgovor.
No impact on fertility was detected in animal studies (see section 5.3).
Nije otkriven utjecaj na plodnost u ispitivanjima na životinjama ( vidjeti dio 5.3).
No impact on male or female fertility as assessed by fertility indices was detected in animal studies (see section 5.3).
Prema ocjeni indeksa plodnosti u ispitivanjima na životinjama nije pronađen učinak na mušku ili žensku plodnost (vidjeti dio 5.3).
No impact on the pharmacokinetics or the reversal effect of idarucizumab or hypersensitivity reactions were observed in these subjects.
U tih ispitanika utjecaj na farmakokinetiku ili poništenje učinka idarucizumaba ili reakcije preosjetljivosti nisu zapažene.
No impairment of fertility has been observed in nonclinical studies (see section 5.3).
U nekliničkim ispitivanjima nije opaženo oštećenje plodnosti (vidjeti dio 5.3).
No impairment of fertility has been observed in nonclinical studies (see section 5.3).
U nekliničkim istraživanjima nije opažen poremećaj plodnosti (vidjeti dio 5.3).
No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section 5.3).
U životinja koje su primale ciklosporin intravenski nije zabilježeno oštećenje plodnosti (vidjeti dio 5.3).
No impairment of fertility was observed in a fertility and general reproduction toxicity study in mice performed with an analogous antibody that inhibits IL-5 in mice.
Nije opažen poremećaj plodnosti u ispitivanju plodnosti i opće reproduktivne toksičnosti u miševa, provedenom s analognim protutijelom koje inhibira IL-5 u miševa.
No implications on the use of Zalmoxis in patients of 65 and older have been established.
Nisu utvrđene nikakve implikacije primjene Zalmoxisa u bolesnika u dobi od 65 godina i starijih.
No improvement
Bez poboljšanja
No improvement / worse
Nema poboljšanja/pogoršanje
No improvement was observed in very elderly patients (≥75 years, N= 69, of which 48 on agomelatine).
Poboljšanje nije primijećeno u vrlo starih bolesnika (≥ 75 godina, N = 69, od kojih je 48 liječenih agomelatinom).
No improvement was seen with the higher dose (80 mg/kg/day).
Poboljšanja nisu uočena s većim dozama (80 mg/kg/dan).
No incompatibilities between Perjeta and polyvinylchloride (PVC) or non-PVC polyolefin bags including polyethylene have been observed.
Nisu primijećene inkompatibilnosti između lijeka Perjeta i vrećica od polivinil klorida (PVC) ili vrećica od poliolefina koje ne sadrže PVC, uključujući vrećice od polietilena.
No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%) solution for injection in polyvinyl chloride bags or polyolefin bags.
Nisu primijećene inkompatibilnosti između lijeka Vectibix i 0,9% (9 mg/ml) otopine natrijeva klorida za injekciju u vrećicama od polivinilklorida ili poliolefina.
No incompatibilities have been observed between Yondelis and type I glass bottles, polyvinylchloride (PVC) and polyethylene (PE) bags and tubing, polyisoprene reservoirs and titanium implantable vascular access systems.
Nisu primijećene inkompatibilnosti između Yondelisa i bočica od stakla tipa I, vrećica i cijevi od polivinilklorida (PVC) i polietilena (PE), spremnika od poliizoprena i titanijevih ugradbenih sustava za pristup krvnim žilama.
No incompatibilities have been observed between Zevalin and infusion sets.
Između Zevalina i setova za infuziju nisu primijećene nikakve inkompatibilnosti.
No increase in adverse events related to exemestane was observed in patients with hormone receptor-positive advanced breast cancer receiving the combination.
U bolesnica s uznapredovalim rakom dojke pozitivnim na hormonske receptore koje su primale spomenutu kombinaciju nije uočen povećani broj štetnih događaja povezanih s eksemestanom.
No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Nije bilo opaženo povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,3%) naspram usporednog lijeka (1,5%).
No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Nije primijećeno povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,3%) u odnosu na usporedni lijek (1,5%).
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Nije bilo opaženo povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,7%) naspram onih liječenih usporednim lijekom (2,1%).
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Nije bilo primijećeno povećanje učestalosti prijeloma u muškaraca liječenih pioglitazonom (1,7%) u odnosu na one liječene usporednim lijekom (2,1%).
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Nije primijećeno povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,7%) u odnosu na one liječene usporednim lijekom (2,1%).
No increase in major hypoglycaemia was observed with empagliflozin compared to placebo as monotherapy, add-on to metformin, add-on to metformin and a sulfonylurea, add-on to pioglitazone with or without metformin, and for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components.
Nije opaženo povećanje epizoda teške hipoglikemije u skupinama koje su primale empagliflozin u odnosu na placebo u obliku monoterapije, kao dodatak uz metformin, kao dodatak uz metformin i sulfonilureju, kao dodatak uz pioglitazon sa ili bez metformina, te u prethodno neliječenih bolesnika koji su primali kombinaciju empagliflozina i metformina u usporedbi s bolesnicima liječenim empagliflozinom i metforminom kao pojedinačnim komponentama.
No increase in mean heart rate in patients with type 2 diabetes was seen in all placebo controlled phase III studies.
U placebom kontroliranim kliničkim ispitivanjima faze III u bolesnika sa šećernom bolešću tipa 2 nije primijećen porast srednje vrijednosti srčane frekvencije.
No increase in mean heart rate patients with type 2 diabetes was seen in all placebo controlled phase III studies.
U placebom kontroliranim kliničkim ispitivanjima faze III u bolesnika sa šećernom bolešću tipa 2 nije primijećen porast vrijednosti srednje srčane frekvencije.
No increase in reactions was reported when a booster dose is administered 6 months-18 months later after the initial dosing series.
Nije prijavljeno nikakvo povećanje reakcija kad je booster doza primijenjena 6-18 mjeseci nakon početne serije cijepljenja.
No increase in reactions was reported when a booster dose is administered 6 months-18 months later, after the initial dosing series.
Nije prijavljeno nikakvo povećanje reakcija primjenom booster doze 6-18 mjeseci nakon početne serije cijepljenja.
No increased bleeding tendency is observed in the elderly within the prophylactic dose ranges.
Nije primijećena povećana sklonost krvarenja u starijih bolesnika unutar raspona profilaktičkih doza.
No increased frequency of impaired wound healing was observed in the LUME-Lung 1 trial.
Nije opažena povećana učestalost usporenog cijeljenja rane u ispitivanju LUME-Lung 1.
No increased risk of Kawasaki disease was observed among infants receiving RotaTeq in a large post- marketing observational safety surveillance study (see section 5.1).
U velikom opservacijskom ispitivanju praćenja sigurnosti nakon stavljanja u promet nije primijećen povećan rizik od Kawasakijeve bolesti u dojenčadi koja su primila RotaTeq (vidjeti dio 5.1).
No influence
nema utjecaja
No influence on the monkey oestrous cycle has been observed.
Nije primjećen utjecaj na rasplodni ciklus u rezus-majmuna.
No influence on the monkey oestrous cycle has been observed.
Nije primjećen utjecaj na spolni ciklus u rezus-majmuna.
No information is available concerning treatment of patients on renal dialysis and therefore ticagrelor is not recommended in these patients.
Budući da ne postoje informacije koje se odnose na liječenje bolesnika na dijalizi, tikagrelor se ne preporučuje kod ovih bolesnika.
No information is available on overdose in humans; overdose is unlikely to occur after ocular administration.
Nema dostupnih podataka o predoziranju u ljudi; nije vjerojatno da predoziranje može nastupiti nakon okularne primjene.
No information is available on the compatibility of this vaccine with any other.
Ne postoje dostupni podaci o kompatibilnosti ovog cjepiva s bilo kojim drugim veterinarsko- medicinskim proizvodom.
No information is available on the possible effects of antithrombin alfa on male and female fertility.
Nema dostupnih informacija o mogućim učincima antitrombina alfa na plodnost muškaraca i žena.
No information is available on the safety and efficacy in other categories such as breeding or pet rabbits.
Ne postoje dostupni podaci o neškodljivosti i djelotvornosti u drugih kategorija kao što su kunići za uzgoj ili kućni ljubimci.
No information is available on the safety and efficacy in other categories such as breeds or pet rabbits.
Ne postoje dostupni podaci o neškodljivosti i djelotvornosti u drugih kategorija kao što kunići za uzgoj ili kućni ljubimci.
No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product.
Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog imunološkog veterinarsko- medicinskog proizvoda kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom.
No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product.
Ne postoje dostupni podatci o neškodljivosti i djelotvornosti ovog imunološkog veterinarsko- medicinskog proizvoda kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom.
No information is available on the safety and efficacy of this product when used with any other veterinary medicinal product.
Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog imunološkog veterinarsko- medicinskog proizvoda kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom.