natgillin/translations-raw huggingface dataset:
The safety profile of Focetria was similar to that of the H5N1 mock up vaccines.
Sigurnosni profil Focetrie bio je sličan onomu „mock-up“ cjepivima za H5N1.
The safety profile of Herceptin subcutaneous formulation (evaluated in 298 and 297 patients treated with the intravenous and subcutaneous formulations respectively) from the pivotal trial BO22227 in EBC was overall similar to the known safety profile of the intravenous formulation.
Sigurnosni profil supkutane formulacije lijeka Herceptin (ocijenjen u 298 bolesnika liječenih intravenskom formulacijom i 297 bolesnika liječenih supkutanom formulacijom) iz pivotalnog ispitivanja BO22227 u ranom raku dojke općenito je bio sličan poznatom sigurnosnom profilu intravenske formulacije lijeka.
The safety profile of Ilaris appeared similar to that in patients aged 2 years and above.
Sigurnosni profil Ilarisa činio se sličan onome u bolesnika u dobi od 2 i više godina.
The safety profile of ipilimumab 3 mg/kg in chemotherapy-naive patients pooled across Phase 2 and 3 clinical trials (N= 75; treated) and in treatment-naive patients in two retrospective observational studies (N= 273 and N= 157) was similar to that in previously-treated advanced melanoma.
Sigurnosni profil ipilimumaba u dozi od 3 mg/kg u objedinjenoj populaciji bolesnika iz kliničkih ispitivanja faze II i III koji prethodno nisu primali kemoterapiju (N = 75; liječeni) te u bolesnika iz dvaju retrospektivnih opservacijskih ispitivanja koji prethodno nisu bili liječeni (N =273 i N=157) bilo je sličan onome u bolesnika s prethodno liječenim uznapredovalim melanomom.
The safety profile of ISENTRESS was based on the pooled safety data from two Phase III clinical studies in treatment-experienced adult patients and one Phase III clinical study in treatment-naïve adult patients.
Sigurnosni profil lijeka ISENTRESS temelji se na objedinjenim podacima o sigurnosti primjene iz dva klinička ispitivanja faze III, u prethodno liječenih odraslih bolesnika i jednog kliničkog ispitivanja faze III, u odraslih bolesnika koji prethodno nisu bili liječeni.
The safety profile of IXIARO was compared to control vaccines Havrix (Hepatitis A vaccine, paediatric 720 EL.U./0.5 mL formulation) and Prevenar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 protein]).
Sigurnosni profil cjepiva IXIARO uspoređen je s kontrolnim cjepivima Havrix (cjepivo protiv hepatitisa A, pedijatrijska formulacija 720 EL.U./0,5 ml) i Prevenar (pneumokokno 7-valentno konjugirano cjepivo [Diphtheria CRM197 protein]).
The safety profile of Izba seemed more favourable than that of the higher-strength solution, as side effects were less frequent with Izba.
Sigurnosni profil lijeka Izba čini se povoljniji od profila za otopine više koncentracije budući da su nuspojave bile rjeđe od onih kod lijeka Izba.
The safety profile of Keytruda in lung cancer patients is similar to that in melanoma patients and its overall safety compares well with that of docetaxel.
Sigurnosni profil lijeka Keytruda u bolesnika oboljelih od raka pluća sličan je profilu u bolesnika oboljelih od melanoma, a ukupna sigurnost lijeka usporediva je s docetakselom.
The safety profile of LAVENTAIR 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 LAVENTAIR 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 MabThera in patients with moderate to severe rheumatoid arthritis (RA) is summarized in the sections below.
Sigurnosni profil lijeka MabThera u bolesnika sa srednje teškim ili teškim reumatoidnim artritisom (RA) sažeto je prikazan u nastavku.
The safety profile of maraviroc is based on 1,374 HIV-1 infected patients who has received at least one dose of maraviroc during Phase 2b/3 clinical studies.
Sigurnosni profil maraviroka temelji se na podacima dobivenim od 1374 bolesnika inficiranih virusom HIV-1 koji su tijekom kliničkih ispitivanja faze 2b/3 dobili najmanje jednu dozu lijeka.
The safety profile of maraviroc is based on 1,374 HIV-1 infected patients who received at least one dose of maraviroc during Phase 2b/3 clinical studies.
Sigurnosni profil maraviroka temelji se na podacima dobivenim od 1374 bolesnika inficiranih virusom HIV-1 koji su tijekom kliničkih ispitivanja faze 2b/3 dobili najmanje jednu dozu lijeka.
The safety profile of naltrexone / bupropion (NB) presented below is based on clinical studies performed with the fixed-dose combination (adverse reactions at an incidence of at least 0.1% and twice that of placebo).
Sigurnosni profil naltrekson / bupropiona (NB) prikazan u nastavku temelji se na kliničkim ispitivanjima provedenim s fiksnom kombinacijom doze (nuspojave s incidencijom od najmanje 0,1 % te dvostruko višom od one s placebom).
The safety profile of NovoEight was also considered similar to other factor VIII products.
Sigurnosni profil lijeka NovoEight smatra se također sličnim lijekovima koji sadrže faktor VIII.
The safety profile of Nuwiq was also considered similar to other factor VIII products.
Sigurnosni profil lijeka Nuwiq također se smatrao sličan drugim lijekovima koji sadrže čimbenik VIII.
The safety profile of OLYSIO 150 mg in combination with peginterferon alfa and ribavirin in a phase 3 study conducted in Asian patients in China and South-Korea is comparable to non-Asian patients from a pooled phase 3 population from global studies, except for higher frequencies for ‘blood bilirubin increased’ events (see table 8).
Sigurnosni profil lijeka OLYSIO 150 mg u kombinaciji s peginterferonom alfa i ribavirinom u ispitivanju faze 3 provedenom na bolesnicima azijatskog porijekla u Kini i Južnoj Koreji može se usporediti s onim u bolesnika koji nisu azijatskog porijekla iz objedinjenih globalnih ispitivanja faze 3, osim većih učestalosti događaja ‘povišenog bilirubina u krvi’ (vidjeti tablicu 8).
The safety profile of pasireotide intramuscular use was consistent with the somatostatin analogue class, except for the higher degree and frequency of hyperglycaemia seen with pasireotide intramuscular use.
Sigurnosni profil pasireotida koji se primjenjuje intramuskularno bio je dosljedan sa skupinom analoga somatostatina, osim što je uočen veći stupanj i učestalost hiperglikemije uz pasireotid primijenjen intramuskularno.
The safety profile of prucalopride in this 24 week study was consistent with that seen in the previous 12 week studies.
Sigurnosni profil lijeka Resolor u tom 24-tjednom ispitivanju u skladu je s opaženim u prethodnim 12-tjednim ispitivanjima.
The safety profile of Ratiograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Profil sigurnosti primjene Ratiograstim određen u tim kliničkim ispitivanjima bio je podudaran s onim referentnog pripravka korištenog u tim ispitivanjima.
The safety profile of Ratiograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Profil sigurnosti primjene Ratiograstima određen u tim kliničkim ispitivanjima bio je podudaran s onim referentnog pripravka korištenog u tim ispitivanjima.
The safety profile of SANCUSO is derived from controlled clinical trials and from post-marketing experience.
Sigurnosni profil lijeka SANCUSO rezultat je kontroliranih kliničkih ispitivanja i iskustva nakon stavljanja gotovog lijeka u promet.
The safety profile of SIMBRINZA was similar to that of the individual components (brinzolamide 10 mg/mL and brimonidine 2 mg/mL).
Profil sigurnosti SIMBRINZE bio je sličan onome pojedinačnih sastojaka (brinzolamid 10 mg/ml i brimonidin 2 mg/ml).
The safety profile of simeprevir in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 infection is based on the pooled data from the phase 2 studies and phase 3 studies C205, C206, C208, C216 and HPC3007 which included 924 patients who received simeprevir 150 mg once daily for 12 weeks and 540 patients who received placebo with peginterferon alfa and ribavirin.
Sigurnosni profil simeprevira u kombinaciji s peginterferonom alfa i ribavirinom u bolesnika s infekcijom HCV genotipa 1 temelji se na objedinjenim podacima iz ispitivanja faze 2 i ispitivanja faze 3 C205, C206, C208, C216 i HPC3007 koja su uključivala 924 bolesnika koji su primali simeprevir od 150 mg jedanput na dan tijekom 12 tjedana i 540 bolesnika koji su primali placebo s peginterferonom alfa i ribavirinom.
The safety profile of Spedra is based on 2436 subjects exposed to avanafil during the clinical development program.
Sigurnosni profil za Spedru temelji se na podacima za 2436 ispitanika izloženih avanafilu tijekom programa kliničkog razvoja.
The safety profile of Tevagrastim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Profil sigurnosti primjene Tevagrastim određen u tim kliničkim ispitivanjima bio je podudaran s onim referentnog pripravka korištenog u tim ispitivanjima.
The safety profile of Tevagrastim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Profil sigurnosti primjene Tevagrastima određen u tim kliničkim ispitivanjima bio je podudaran s onim referentnog pripravka korištenog u tim ispitivanjima.
The safety profile of these patients did not differ from that of patients receiving the recommended dose, with no patient reporting SAEs.
Sigurnosni profil ovih bolesnika nije se razlikovao od profila bolesnika koji su primili preporučenu dozu, s time da niti jedan bolesnik nije prijavio ozbiljnu nuspojavu.
The safety profile of VELCADE in 240 MCL patients treated with VELCADE at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-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 VELCADEa u 240 bolesnika s MCLom liječenih s 1,3 mg/m2 VELCADEa u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (VcR-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 VELCADE in 240 MCL patients treated with VELCADE at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-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 VELCADEa u 240 bolesnika s MCLom liječenih s 1,3 mg/m2 VELCADEa u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (VcR-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 Zinforo was similar to that observed in previous pooled Phase III studies with the exception of both a greater incidence of rash in Asian patients (see below) and a greater incidence of DAGT seroconversion (see section 4.4).
Sigurnosni profil lijeka Zinforo bio je sličan onom opaženom u prethodnim objedinjenim studijama faze III, uz iznimku veće incidencije osipa u azijskih bolesnika (vidjeti niže) i veće incidencije serokonverzije DAGT-a (vidjeti dio 4.4).
The safety profile presented below is based on a pooled analysis of events per dose from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule (n=5,683) or the accelerated 0, 7, 21 days schedule (n=320).
Sigurnosni profil, koji je naveden u nastavku, temelji se na zbirnoj analizi događaja po dozi, na više od 6000 ispitanika koji su primili cjepivo ili po standardnoj shemi 0, 1, 6 mjeseci (n=5683) ili po ubrzanoj shemi 0., 7., 21. dan (n=320).
The safety profile presented below is based on a pooled analysis on 9,621 subjects who have been vaccinated with one dose of Nimenrix in clinical studies.
Niže navedeni sigurnosni profil cjepiva temelji se na kumulativnoj analizi 9621 ispitanika koji su u kliničkim ispitivanjima primili jednu dozu cjepiva Nimenrix.
The safety profile presented below is based on data from approximately 800 subjects.
Sigurnosni profil, koji je naveden u nastavku, temelji se na podacima dobivenim na oko 800 ispitanika.
The safety profile represented by approximately 1,500 patients for the combination of Victrelis with peginterferon alfa-2b and ribavirin was based on pooled safety data in two clinical trials: one in patients who were previously untreated, and one in patients who had failed prior therapy (see section 5.1).
Sigurnosni profil kombinacije lijeka Victrelis s peginterferonom alfa-2b i ribavirinom, kojeg predstavlja oko 1500 bolesnika, temelji se na zbirnim podacima o sigurnosti primjene iz dva klinička ispitivanja: jednog u bolesnika koji prethodno nisu bili liječeni i jednog u bolesnika koji nisu odgovorili na prethodnu terapiju (vidjeti dio 5.1).
The safety profile was considered favourable compared with other treatment, including ipilimumab and chemotherapy, and side effects appear manageable.
Zaključeno je da je sigurnosni profil povoljan u usporedbi s drugim terapijama, uključujući ipilimumab i kemoterapiju, a nuspojave se mogu kontrolirati.
The safety profile was generally similar to that seen in the aprepitant table above.
Sigurnosni profil uglavnom je bio sličan onom prikazanom u gornjoj tablici za aprepitant.
The safety profile was generally similar to the Adverse Event Monitoring Substudy of the SPS.
Sigurnosni profil bio je općenito sličan onome u Podispitivanju praćenja štetnih događaja u sklopu ispitivanja SPS.
The safety profile was similar when comparing patients receiving intravenous Sivextro alone to patients who received oral administration alone, except for a higher reported rate of gastrointestinal disorders associated with oral administration.
Sigurnosni profil bio je sličan kada se usporede bolesnici koji su primali samo intravenski Sivextro s bolesnicima koji su primali lijek samo peroralno, osim za višu prijavljenu stopu poremećaja probavnog sustava povezanih s peroralnom primjenom.
The safety report prepared by the Innovator MAH contained several cases very suggestive of a causal association between levetiracetam and encephalopathy.
Izvješće o neškodljivosti koje je pripremio nositelj odobrenja inovativnog lijeka sadržavalo je nekoliko slučajeva s vrlo sugestivnom uzročnom povezanošću između levetiracetama i encefalopatije.
The safety results for 29 paediatric patients (those  17 years old) included in the PID studies were evaluated.
Procijenjeni su sigurnosni rezultati za 29 pedijatrijskih bolesnika (onih u dobi  17 godina) uključenih u PID ispitivanja.
The safety results for 4 paediatric patients (those  17 years old) included in the PID study and the results for the 12 children (aged 3 to 16 years old) included in the ITP study were evaluated.
Procijenjeni su rezultati o sigurnosti primjene za 4 pedijatrijska bolesnika (onih u dobi  17 godina) uključena u PID ispitivanje i rezultati za 12-ero djece (u dobi od 3 do 16 godina) uključene u ITP ispitivanje.
The safety results in this subgroup of patients undergoing PCI were comparable to the overall safety results.
Rezultati sigurnosti u ovoj podgrupi bolesnika koji su podvrgnuti perkutanom koronarnom zahvatu bili su usporedivi s ukupnim rezultatima sigurnosti.
The safety shield on the pen is now locked to prevent any needle stick injuries.
Sigurnosni štitnik na brizgalici sada je zaključan kako bi se spriječili ozljede uslijed uboda iglom.
The safety shield will remain in the position you set (see picture 4)
Sigurnosni štitnik ostat će u položaju u koji ste ga postavili (vidjeti sliku 4).
The safety, efficacy and pharmacokinetics of nintedanib have not been studied in patients with severe hepatic impairment (Child Pugh C).
Sigurnost, djelotvornost i farmakokinetika nintedaniba nisu ispitani u bolesnika s teškim oštećenjem funkcije jetre (Child Pugh C).
The safety, efficacy and population pharmacokinetics of Kuvan were studied in a multicentre, open-label, randomised, controlled study in children <4 years old with a confirmed diagnosis of PKU.
Sigurnost, djelotvornost i populacijska farmakokinetika Kuvana bile su ispitane u multicentričnom otvorenom, randomiziranom, kontroliranom ispitivanju u djece u dobi <4 godine s potvrđenom dijagnozom PKU.
The safety, efficacy and quality of life of pazopanib versus sunitinib has been evaluated in a randomised, open-label, parallel group Phase III non-inferiority study (VEG108844).
Sigurnost, djelotvornost i kvaliteta života tijekom liječenja pazopanibom u odnosu na one tijekom liječenja sunitinibom procjenjivani su u randomiziranom, otvorenom ispitivanju neinferiornosti faze III s paralelnim skupinama (VEG108844).
The safety, efficacy, and pharmacokinetics of ALPROLIX was evaluated in 2 multinational, open-label, pivotal studies; a phase 3 study, referred to as study I and a phase 3 paediatric study, referred to as study II (see Paediatric population).
Sigurnost, djelotvornost i farmakokinetika lijeka ALPROLIX bile su procijenjene u 2 multinacionalna, ključna ispitivanja otvorenog tipa: jednom ispitivanju faze 3, koje se naziva ispitivanje I i jednom pedijatrijskom ispitivanju faze 3, koje se naziva ispitivanje II (vidjeti Pedijatrijska populacija).
The safety, efficacy, and pharmacokinetics of ELOCTA was evaluated in 2 multinational, open-label, pivotal studies; a phase 3 study, referred to as study I and a phase 3 paediatric study, referred to as study II (see Paediatric population).
Sigurnost, djelotvornost i farmakokinetika lijeka ELOCTA bile su procijenjene u 2 multinacionalna, ključna ispitivanja otvorenog tipa: jednom ispitivanju faze 3, koje se naziva ispitivanje I i jednom pedijatrijskom ispitivanju faze 3, koje se naziva ispitivanje II (vidjeti Pedijatrijska populacija).
The safety, tolerability and pharmacokinetics of Votubia were evaluated in two single oral dose studies of Votubia tablets in 8 and 34 adult subjects with impaired hepatic function relative to subjects with normal hepatic function.
Sigurnost primjene, podnošljivost i farmakokinetika Votubie ocjenjivane su u dva ispitivanja jednokratne peroralne doze tableta Votubia provedena u 8 odnosno 34 odrasla ispitanika s oštećenom funkcijom jetre u odnosu na ispitanike s normalnom funkcijom jetre.
The safety/efficacy of mannitol in patients with asthma has not been properly studied.
Sigurnost/djelotvornost manitola u pacijenata s astmom nije dovoljno ispitana.
The Salmeterol Multi-center Asthma Research Trial (SMART)
Multicentrično kliničko istraživanje salmeterola kod astme (The Salmeterol Multi-center Asthma Research Trial - SMART)
The same adverse reactions may occur in the paediatric population.
Iste nuspojave mogu se javiti i u pedijatrijskoj populaciji.
The same decrease was observed for the number of hospital admissions and the number of days of hospitalisation in the treated groups.
Jednako smanjenje uočeno je i u broju prijemau bolnicu te u broju dana hospitalizacije za liječene skupine.
The same dose adjustments, which are based on pharmacokinetic data in volunteers including PK modelling results, are recommended for patients on haemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD).
Bolesnicima na hemodijalizi ili na kontinuiranoj ambulantnoj peritonejskoj dijalizi preporučuje se jednako prilagođavanje doziranja, temeljeno na farmakokinetičkim podacima u skupini dobrovoljaca uključujući i rezultate farmakokinetičkih modela.
The same first dose monitoring as for treatment initiation is recommended when treatment is interrupted for:
Isti oblik praćenja prve doze kao i kod početka liječenja preporučuje se ako se liječenje prekida na:
The same first dose monitoring as for treatment initiation is recommended when treatment is interrupted for:
Preporučuje se isti oblik praćenja prve doze kao i kod početka liječenja ako se liječenje prekida na:
The same interactions may occur in the elderly population.
Jednake interakcije mogu se javiti i u starijoj populaciji.
The same interactions may occur in the paediatric population.
Jednake interakcije mogu se javiti i u pedijatrijskoj populaciji.
The same proportion of subjects (3/9) receiving placebo and mepolizumab intravenously reported clinically significant exacerbations; no exacerbations were reported in those receiving mepolizumab subcutaneously.
Klinički značajne egzacerbacije prijavio je jednak udio ispitanika (3/9) koji su primali placebo i mepolizumab primijenjen intravenski; u onih koji su mepolizumab primali supkutano nije prijavljena niti jedna egzacerbacija.
The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
Ista publikacija je objavila i podatke dugotrajnog praćenja 12 bolesnika s MDS/MPB- om s preuredbom gena za PDGFR (5 bolesnika iz studije B2225).
The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
Ista publikacija je objavila i podatke dugotrajnog praćenja od 12 bolesnika s MDS/MPB-om s preuredbom gena za PDGFR (5 bolesnika iz studije B2225).
The same recommendations apply as in adults (see above).
Vrijede iste preporuke kao i za odrasle (vidjeti gore).
The same recommendations apply to re- introduction of STAYVEER after treatment interruption (see section 4.4).
Iste preporuke vrijede i pri ponovnom uvođenju liječenja STAYVEEROM nakon prekida terapije (vidjeti dio 4.4).
The same recommendations apply to re- introduction of Tracleer after treatment interruption (see section 4.4).
Iste preporuke vrijede i pri ponovnom uvođenju liječenja Tracleerom nakon prekida terapije (vidjeti dio 4.4).
The same recommendations apply to re-introduction of STAYVEER after treatment interruption (see section 4.4).
Iste preporuke vrijede i pri ponovnom uvođenju liječenja STAYVEEROM nakon prekida terapije (vidjeti dio 4.4).
the same temperature range should be maintained throughout the duration of storage until administration. the storage time in the syringe at ambient temperature up to 25°C cannot exceed 2.5 hours for 106 (1 million) PFU/mL and 4 hours for 108 (100 million) PFU/mL (see table 6). o the maximum cumulative storage time (storage time in vial plus storage time in syringe) cannot exceed the durations in table 7.
tijekom cijelog perioda čuvanja treba se održavati isti raspon temperature, sve do primjene. vrijeme čuvanja u štrcaljki pri sobnoj temperaturi do najviše 25°C ne smije prekoračiti 2,5 sati za 106 (1 milijun) PFU/ml i 4 sata za 108 (100 milijuna) PFU/ml (vidjeti tablicu 6). maksimalno kumulativno vrijeme čuvanja (vrijeme čuvanja u bočici plus vrijeme čuvanja u štrcaljki) ne smije prekoračiti period naveden u tablici 7.
The same types of adverse reactions that are attributable to oral carbonic inhibitors (i.e., acid- base disturbances) may occur with topical administration (see section 4.5).
Isti tip nuspojava koje se povezuju s oralnim inhibitorima karboanhidraze (poremećaji acidobazne ravnoteže) mogu se pojaviti kod topikalne primjene (vidjeti dio 4.5).
The same warnings and precautions apply to the elderly population.
Ista se upozorenja i mjere opreza odnose i na stariju populaciju.
The same warnings and precautions apply to the paediatric population.
Ista se upozorenja i mjere opreza odnose i na pedijatrijsku populaciju.