natgillin/translations-raw huggingface dataset:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost veterinarsko medicinskog proizvoda nije ispitana tijekom graviditeta i laktacije.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost veterinarsko medicinskog proizvoda nije utvrđena tijekom graviditeta ili laktacije.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost veterinarsko – medicinskog proizvoda nije utvrđena tijekom graviditeta i laktacije.
The safety of the veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena u mačaka koje teže manje od 2,5 kg ili u onih mlađih od četiri mjeseca.
The safety of the veterinary medicinal product has not been established in horses during pregnancy, and the product should not be used during pregnancy.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena u konja za vrijeme graviditeta, te se proizvod ne smije koristiti tijekom graviditeta.
The safety of the veterinary medicinal product has not been established in pregnant and lactating bitches; therefore, the product should not be used during pregnancy and lactation.
Neškodljivost veterinarsko- medicinskog proizvoda nije bila utvrđena kod gravidnih i kuja u laktaciji; stoga se proizvod ne smije koristiti tijekom graviditeta i laktacije.
The safety of the veterinary medicinal product has not been investigated in pregnant dogs and lactating dogs.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije.
The safety of the veterinary medicinal product has not been investigated in pregnant dogs and lactating dogs.
Neškodljivost VMP nije utvrđena za vrijeme graviditeta i laktacije.
The safety of the veterinary medicinal product has not been tested at intervals of less than 2 weeks or in kittens weighing less than 0.6 kg and/or under 7 weeks of age.
Neškodljivost veterinarsko medicinskog proizvoda nije ispitana u intervalu kraćem od 2 tjedna ili u mačića lakših od 0,6 kg i/ili mlađih od 7 tjedana.
The safety of the veterinary medicinal product has not been tested in dogs weighing less than 5 kg or in dogs with safety concerns such as renal, liver, cardiac, gastrointestinal or other disease.
Neškodljivost veterinarsko-medicinskog proizvoda nije testirana u pasa koji teže manje od 5 kg ili u pasa u kojih je neškodljivost primjene proizvoda upitna zbog bolesti bubrega, jetre, srca, probavnog sustava ili neke druge bolesti.
The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has been demonstrated.
Neškodljivost ovog veterinarsko medicinskog proizvoda demonstrirana je u vrijeme plodnosti, gravidnosti i laktacije u pasa.
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Sigurnost primjene ovog lijeka u trudnoći nije ustanovljena kontroliranim kliničkim ispitivanjima i prema tome može se primijeniti samo uz oprez trudnicama i dojiljama.
The safety of this medicinal product for use in human pregnancy has not been established.
Sigurnost primjene ovog lijeka u ljudi za vrijeme trudnoće još nije ustanovljena.
The safety of this medicinal product has not been evaluated in clinical trials of duration longer than 2 years (see section 4.2).
Sigurnost ovog lijeka nije ocijenjena u kliničkim ispitivanjima trajanja duljeg od 2 godine (vidjeti dio 4.2.).
The safety of this veterinary medicinal product has not been established during pregnancy and lactation in the target species.
Neškodljivost ovog veterinarsko-medicinskog proizvoda nije utvrđena tijekom graviditeta i laktacije u ciljnim vrstama životinja.
The safety of this veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.
Neškodljivost ovog veterinarsko-medicinskog proizvoda nije utvrđena u mačaka koje teže manje od 2,5 kg ili u onih mlađih od četiri mjeseca.
The safety of this veterinary medicine has not been established in cat younger than 7 weeks of age or weighing less than 0.6 kg.
Neškodljivost ovog veterinarskog lijeka nije utvrđena u mačaka mlađih od 7 tjedana ili težine manje od 0,6 kg.
The safety of this veterinary medicine in bitches has not been established during pregnancy and lactation.
Neškodljivost veterinarsko-medicinskog proizvoda u kuja tijekom graviditeta i laktacije nije utvrđena.
The safety of TMZ in children under the age of 3 years has not been established.
Sigurnost primjene TMZ–a u djece mlađe od 3 godine nije ustanovljena.
The safety of TMZ in children under the age of 3 years has not been established.
Sigurnost primjene TMZ–a u djece u dobi do 3 godine nije ustanovljena.
The safety of tocilizumab has been studied in 4 placebo-controlled studies (studies II, III, IV and V), 1 MTX-controlled study (study I) and their extension periods (see section 5.1).
Sigurnost primjene tocilizumaba ispitivana je u 4 placebom kontrolirana ispitivanja (ispitivanja II, III, IV i V), jednom MTX-om kontroliranom ispitivanju (ispitivanje I) i njihovim produžecima (vidjeti dio 5.1).
The safety of tocilizumab in pJIA has been studied in 188 patients from 2 to 17 years of age.
Sigurnost primjene tocilizumaba u pJIA ispitana je kod 188 bolesnika u dobi od 2 do 17 godina.
The safety of tocilizumab in sJIA has been studied in 112 patients from 2 to 17 years of age.
Sigurnost tocilizumaba ispitana je na 112 bolesnika sa sJIA u dobi od 2 do 17 godina.
The safety of toclizumab in the pediatric population in the sections on pJIA and sJIA below.
Sigurnost tocilizumaba u pedijatrijskoj populaciji opisuje se u dijelovima o pJIA i sJIA u nastavku.
The safety of trametinib in combination with dabrafenib has been evaluated in 2 Phase III studies, MEK115306 and MEK116513, where an analysis of the safety of trametinib in combination with dabrafenib has been conducted in 209 and 350 patients, respectively, with BRAF V600 mutation positive unresectable or metastatic melanoma receiving trametinib (2 mg once daily) and dabrafenib (150 mg twice daily) combination therapy (see section 5.1 combination therapy).
Sigurnost trametiniba u kombinaciji s dabrafenibom ocijenjena je u 2 ispitivanja faze III, MEK115306 i MEK116513, gdje je analiza sigurnosti primjene trametiniba u kombinaciji s dabrafenibom provedena na 209 odnosno 350 bolesnika, s neoperabilnim ili metastatskim melanomom s pozitivnom BRAF V600 mutacijom koji su primali kombiniranu terapiju trametinibom (2 mg jedanput na dan) i dabrafenibom (150 mg dvaput na dan) (vidjeti dio 5.1 Kombinirana terapija).
The safety of trastuzumab emtansine has been evaluated in1871 breast cancer patients in clinical studies.
Sigurnost trastuzumab emtanzina ocijenjena je u 1871 bolesnika s rakom dojke u kliničkim ispitivanjima.
The safety of tulathromycin during pregnancy and lactation has not been established in cattle and pigs.
Neškodljivost veterinarsko – medicinskog proizvoda nije utvrđena tijekom graviditeta i laktacije.
The safety of Tybost in 73 HIV-1 infected treatment-experienced patients with mild to moderate renal impairment (eGFR by Cockcroft-Gault method 50-89 ml/min) who switched pharmacokinetic enhancer from ritonavir to cobicistat was evaluated in an open-label clinical study (GS-US-236-0118) of cobicistat-boosted atazanavir or darunavir plus two NRTIs.
U otvorenom kliničkom ispitivanju (GS-US-236-0118) kobicistatom pojačanog atazanavira ili darunavira zajedno s dva NRTI-ja, procjenjivana je sigurnost primjene lijeka Tybost u 73 već liječena HIV-1 zaražena pacijenta s blagim do umjerenim oštećenjem funkcije bubrega (eGFR izračunat metodom Cockcroft-Gault 50-89 ml/min) kojima je farmakokinetički pojačivač ritonavir zamijenjen kobicistatom.
The safety of using Protopic for a long time is not known.
Sigurnost primjene Protopica tijekom dugog razdoblja nije poznata.
The safety of using Senshio concomitantly with oestrogens or other SERMS, such as tamoxifen, toremifene, bazedoxifene and raloxifene, has not been studied and its concurrent use is not recommended.
Sigurnost istodobnog uzimanja lijeka Senshio s estrogenima ili drugim selektivnim modulatorima estrogenskih receptora, poput tamoksifena, toremifena, bazedoksifena i raloksifena, nije ispitana te se istodobna primjena ne preporučuje.
The safety of ustekinumab has been studied in a phase 3 study of 110 patients from 12 to 17 years of age for up to 60 weeks.
Sigurnost ustekinumaba ispitana je u ispitivanju faze 3 u 110 bolesnika u dobi od 12 do 17 godina starosti tijekom 60 tjedana.
The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: severe hepatic impairment (Child-Pugh C),
Sigurnost primjene vardenafila nije ispitana u sljedećim podskupinama bolesnika i stoga je njegova primjena kontraindicirana dok se ne prikupe dodatne informacije: teško oštećena funkcija jetre (Child-Pugh C),
The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: severe hepatic impairment (Child-Pugh C),
Sigurnost primjene vardenafila nije ispitana u sljedećim podskupinama bolesnika i stoga je njegova primjena kontraindicirana dok se ne prikupe dodatne informacije: teško oštećena jetrena funkcija (Child-Pugh C),
The safety of Vaxelis in children over 15 months of age has not been studied in clinical trials.
Sigurnost cjepiva Vaxelis u djece starije od 15 mjeseci nije ispitivana u kliničkim studijama.
The safety of Veraflox has not been established during pregnancy and lactation in cats and dogs.
Neškodljivost Verafloxa nije dokazana tijekom gravidnosti i laktacije kod pasa i mačaka.
The safety of Veraflox has not been established during pregnancy and lactation in dogs.
Neškodljivost Verafloxa nije dokazana tijekom gravidnosti i laktacije kod pasa i mačaka.
The safety of Veraflox has not been established in queens during pregnancy and lactation.
Neškodljivost Verafloxa nije dokazana tijekom gravidnosti i laktacije.
The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to
Sigurnost vorikonazola ispitana je u 288 pedijatrijskih bolesnika u dobi od 2 do < 12 godina (169) i 12 do
The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to<18 years (119) who received voriconazole for prophylaxis (183 ) and therapeutic use (105 ) in clinical trials.
Sigurnost vorikonazola ispitana je u 288 pedijatrijskih bolesnika u dobi od 2 do < 12 godina (169) i 12 do <18 godina (119) koji su primili vorikonazol kao profilaksu (183) ili terapiju (105) u kliničkim ispitivanjima.
The safety of XGEVA was evaluated in:
Sigurnost lijeka XGEVA procijenjena je u:
The safety of ZALTRAP in combination with FOLFIRI was evaluated in 1216 patients previously treated for metastatic colorectal cancer, of which 611 patients were treated with ZALTRAP 4 mg/kg every two weeks (one cycle) and 605 patients were treated with placebo/FOLFIRI in a phase III study.
Sigurnost primjene lijeka ZALTRAP u kombinaciji s protokolom FOLFIRI ocijenjena je u ispitivanju faze III u kojem je sudjelovalo 1216 bolesnika prethodno liječenih zbog metastatskog kolorektalnog karcinoma, od kojih je njih 611 primalo ZALTRAP u dozi od 4 mg/kg svaka dva tjedna (jedan ciklus), a 605 protokol placebo/FOLFIRI.
The safety parameters of the mixed vaccines are not different from those described for the vaccines administered separately.
Parametri sigurnosti mješovitih cjepiva nisu drugačiji od onih opisanih za cjepiva koja se primjenjuju zasebno.
The safety population of Gilenya is derived from two Phase III placebo-controlled clinical studies and one Phase III active-controlled clinical study in patients with relapsing remitting multiple sclerosis.
Populacija za za ocjenu sigurnosti primjene lijeka Gilenya izvedena je iz dva placebom kontrolirana klinička ispitivanja faze III i jednog aktivno kontroliranog kliničkog ispitivanja faze III u bolesnika s relapsno remitirajućom multiplom sklerozom.
The safety profile for axial spondyloarthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Sigurnosni profil za bolesnike s aksijalnim spondiloartritisom liječenih Cimzijom bio je u skladu sa sigurnosnim profilom za reumatoidni artritis i prethodnim iskustvom s Cimzijom.
The safety profile in 50 adolescent patients who received treatment with Genvoya was similar to that in adults (see section 5.1).
Sigurnosni profil u 50 adolescentnih bolesnika liječenih lijekom Genvoya bio je sličan onome u odraslih (vidjeti dio 5.1).
The safety profile in a 26-week open-label extension trial was similar to that observed in the short- term, placebo-controlled trial.
Sigurnosni profil u 26-tjednom otvorenom produžetku ispitivanja bio je sličan onome opaženom u kratkotrajnom, placebom kontroliranom ispitivanju.
The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older people subjects.
Sigurnosni profil u imunokompromitiranih ispitanika i pacijenata s kroničnim bolestima sličan je sigurnosnom profilu u zdravih odraslih i starijih ispitanika.
The safety profile in the first paediatric uncontrolled study performed with the film-coated tablet (BREATHE-3: n = 19, median age 10 years [range 3–15 years], open-label bosentan 2 mg/kg twice daily; treatment duration 12 weeks) was similar to that observed in the pivotal trials in adult patients with PAH.
Sigurnosni profil u prvoj nekontroliranoj pedijatrijskoj studiji provedenoj s filmom obloženom tabletom (BREATHE-3: n = 19, medijan dobi 10 godina [raspon 3–15 godina], otvoreno davanje bosentana 2 mg/kg dvaput dnevno; trajanje liječenja 12 tjedana) bio je sličan kao kod pivotalnih studija odraslih bolesnika s PAH-om.
The safety profile in these paediatric patients is consistent with that in adult patients.
Sigurnosni profil u tih pedijatrijskih bolesnika podudara se s onim u odraslih bolesnika.
The safety profile in these studies was overall comparable to that seen in previous paediatric and adult studies.
Sigurnosni profil u tim ispitivanjima općenito je bio je usporediv s onime u prijašnjim pedijatriskim ispitivanjima i ispitivanjima na odraslima.
The safety profile in this study is consistent with adverse reactions observed with patients on FIRDAPSE.
Sigurnosni profil u ovom ispitivanju dosljedan je nuspojavama uočenim u bolesnika koji primaju lijek FIRDAPSE.
The safety profile is based on pooled data from 2,672 patients treated with Afinitor in ten clinical studies, consisting of five randomised, double-blind, placebo controlled phase III studies and five open-label phase I and phase II studies, related to the approved indications.
Sigurnosni profil temelji se na objedinjenim podacima od 2672 bolesnika liječenih Afinitorom u deset kliničkih ispitivanja, od kojih su pet bila randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III, a pet su bila otvorena ispitivanja faze I i faze II, vezana uz odobrene indikacije.
The safety profile is based on pooled data from 981 patients treated with IMBRUVICA in three phase 2 clinical studies and four randomised phase 3 studies and from post-marketing experience.
Sigurnosni profil temelji se na objedinjenim podacima 981 bolesnika liječenih lijekom IMBRUVICA u tri klinička ispitivanja faze 2 i četiri randomizirana ispitivanja faze 3 te iz razdoblja nakon stavljanja lijeka u promet.
The safety profile is based on pooled data from Phase IIb and Phase III clinical studies in 1222 previously untreated patients, 357 previously treated patients unexposed to integrase inhibitors and 264 patients with prior treatment failure that included an integrase inhibitor (including integrase class resistance).
Sigurnosni profil temelji se na objedinjenim podacima iz kliničkih ispitivanja faze IIb i faze III, u kojima je sudjelovalo 1222 prethodno neliječenih bolesnika, 357 prethodno liječenih bolesnika koji nisu bili izloženi inhibitorima integraze te 264 bolesnika koji nisu odgovorili na prethodno liječenje koje je uključivalo inhibitor integraze (uključujući rezistenciju na skupinu inhibitora integraze).
The safety profile is generally consistent among children and adolescents and is also consistent with adult patients.
Sigurnosni profil uglavnom je sličan između djece i adolescenata te je također sukladan onome u odraslih bolesnika.
The safety profile observed in patients with ankylosing spondylitis treated with Cosentyx is consistent with the safety profile in psoriasis.
Sigurnosni profil opažen u bolesnika s ankilozantnim spondilitisom liječenih Cosentyxom u skladu je sa sigurnosnim profilom kod psorijaze.
The safety profile observed in patients with psoriatic arthritis treated with Cosentyx is consistent with the safety profile in psoriasis.
Sigurnosni profil opažen u bolesnika s psorijatičnim artritisom liječenih Cosentyxom u skladu je sa sigurnosnim profilom kod psorijaze.
The safety profile of anidulafungin is based on 840 patients with candidaemia/invasive candidiasis receiving the recommended daily dose of 100 mg in 9 studies.
Sigurnosni profil anidulafungina temelji se na 840 bolesnika s kandidemijom/invazivnom kandidijazom koji su primali preporučenu dnevnu dozu od 100 mg u 9 ispitivanja.
The safety profile of ANORO is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Sigurnosni profil lijeka ANORO temelji se na iskustvu povezanom sa sigurnošću primjene umeklidinija/vilanterola i njegovih pojedinačnih sastavnica u kliničkom razvojnom programu kojim je obuhvaćeno 6855 bolesnika s KOPB-om i iz spontanih prijava.
The safety profile of aprepitant was evaluated in approximately 6,500 adults.
Sigurnost primjene aprepitanta ispitana je u približno 6500 odraslih osoba.
The safety profile of aprepitant was evaluated in approximately 6,500 adults.
Sigurnost primjene aprepitanta ispitana je u približno 6500 odraslih.
The safety profile of aprepitant was evaluated in approximately 6,500 individuals.
Sigurnosni profil aprepitanta procijenjen je u oko 6500 osoba.
The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Sigurnosni profil bortezomiba u 240 bolesnika s MCLom liječenih s 1,3 mg/m2 bortezomiba u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BR-CAP), naspram 242 bolesnika liječena rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom i prednizonom [R-CHOP] bio je relativno sukladan onom zapaženom u bolesnika s multiplim mijelomom s glavnim razlikama koje su opisane ispod.
The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Sigurnosni profil bortezomiba u 240 bolesnika s MCLom liječenih s 1,3 mg/m2 bortezomiba u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BzR-CAP), naspram 242 bolesnika liječenih s rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom i prednizonom [R-CHOP] bio je relativno sukladan onom zapaženom u bolesnika s multiplim mijelomom s glavnim razlikama koje su opisane ispod.
The safety profile of busulfan combined with fludarabine (FB) has been examined through a review of adverse events reported in published data from clinical trials in RIC regimen.
Sigurnosni profil lijeka busulfan u kombinaciji s fludarabinom (FB) ispitan je putem pregleda nuspojava zabilježenih u objavljenim podacima iz kliničkih ispitivanja protokola kondicioniranja smanjenog intenziteta.
The safety profile of co-administered alogliptin and metformin was consistent with that of the individual components as demonstrated in clinical trials for alogliptin and from the comprehensive data available for metformin.
Sigurnosni profil istodobno primijenjenih alogliptina i metformina sukladan je sigurnosnim profilima pojedinih komponenti potvrđenim u kliničkim ispitivanjima alogliptina i u opsežnim podacima dostupnim za metformin.
The safety profile of co-administered alogliptin and pioglitazone was consistent with that of the individual components as demonstrated in clinical trials for alogliptin and from the comprehensive data available for pioglitazone.
Sigurnosni profil istodobno primijenjenih alogliptina i pioglitazona sukladan je sigurnosnim profilima pojedinačnih sastojaka potvrđenim u kliničkim ispitivanjima alogliptina i u opsežnim podacima dostupnim za pioglitazon.
The safety profile of Coagadex was considered satisfactory based on available data, with side effects that were manageable and of mild or moderate intensity.
Sigurnosni profil lijeka Coagadex na temelju dostupnih podataka smatra se zadovoljavajućim uz nuspojave koje se mogu kontrolirati i koje su blagog do umjerenog intenziteta.
The safety profile of combination therapy (deferiprone and deferoxamine) observed in clinical trials, post-marketing experience or published literature was consistent with that characterized for monotherapy.
Sigurnosni profil kombinacijske terapije (deferipron i deferoksamin) koji je primijećen u kliničkim ispitivanjima, nakon stavljanja lijeka u promet ili u objavljenoj literaturi bio je u skladu s onim koji je opisan za monoterapiju.
The safety profile of Cyramza is in line with what is expected for other medicines blocking VEGFR activity and considered manageable.
Sigurnosni profil lijeka Cyramza u skladu je s onim što se očekuje za druge lijekove koji inhibiraju djelovanje VEGFR-a te se smatra prihvatljivim.
The safety profile of DUTREBIS is based on the safety data from the individual components of DUTREBIS (lamivudine and raltegravir).
Sigurnosni profil lijeka DUTREBIS temelji se na podacima o sigurnosti primjene pojedinačnih komponenti lijeka DUTREBIS (lamivudina i raltegravira).
The safety profile of emtricitabine and tenofovir disoproxil fumarate in these studies was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Sigurnosni profil emtricitabina i tenofovirdizoproksilfumarata u tim je ispitivanjima bio dosljedan prethodnom iskustvu s tim lijekovima kad se svaki primjenjivao s drugim antiretrovirusnim lijekovima.
The safety profile of emtricitabine and tenofovir disoproxil fumarate in this study was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Profil sigurnosti primjene emtricitabina i tenofovirdizoproksilfumarata u tom ispitivanju odgovarao je prethodnom iskustvu kada se svaki od tih lijekova primjenjivao s drugim antiretrovirusnim lijekovima.
The safety profile of Feraccru is considered acceptable, with side effects which are mostly mild to moderate in intensity and in line with those of other iron preparations.
Sigurnosni profil lijeka Feraccru smatra se prihvatljivim, a intenzitet nuspojava uglavnom je blag do umjeren te je u skladu s nuspojavama ostalih pripravaka koji sadrže željezo.
The safety profile of filgrastim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Profil sigurnosti primjene filgrastima uočen u tim kliničkim ispitivanjima bio je podudaran s onim referentnog lijeka korištenog u tim ispitivanjima.