natgillin/translations-raw huggingface dataset:
The administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Će primjena veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu i iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
The administration of two concurrent Xiapex injections into Dupuytren’s cords in the same hand was evaluated in clinical study AUX-CC-867, a historically-controlled, open-label multi-centre trial in 715 adult subjects (1450 Xiapex injections) with Dupuytren’s contracture.
Istovremena primjena dvije injekcije Xiapexa u Dupuytrenove tračke na istoj šaci bila je procijenjena u kliničkom ispitivanju AUX-CC-867, multicentričnom ispitivanju otvorenog tipa s kontrolnom skupinom iz prošlosti, koje je provedeno u 715 odraslih ispitanika (1450 injekcija Xiapexa) s Dupuytrenovom kontrakturom.
The administration of vandetanib with substances known to prolong the ECG QTc interval is contraindicated or not recommended (see sections 4.3 and 4.5).
Primjena vandetaniba s lijekovima za koje je poznato da produljuju QTc-interval je kontraindicirana ili se ne preporučuje (vidjeti dijelove 4.3 i 4.5).
The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall.
Injicirati treba naizmjenično lijevo i desno u anterolateralni (prednji bočni) ili posterolateralni (stražnji bočni) dio trbušne stijenke.
The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall.
Injicirati treba naizmjenično lijevo i desno u anterolateralni ili posterolateralni dio trbušne stijenke.
The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall.
Ubrizgavati treba naizmjenično lijevo i desno u anterolateralni (prednji bočni) ili posterolateralni (stražnji bočni) dio trbušne stijenke.
The administration system also includes a power pack (plastic), a body sensor (plastic) and a body interface (polyethylene carrier with acrylic adhesive).
Sustav za primjenu sadrži još i sustav za napajanje (plastika), senzor za tijelo (plastika) i sučelje za tijelo (polietilenski nosač s akrilnim ljepilom).
The administration system and the battery should be disposed of in accordance with local requirements.
Sustav za primjenu i bateriju treba zbrinuti sukladno lokalnim propisima.
The administration system cannot be restarted once this error occurs.
Sustav za primjenu se ne može ponovno pokrenuti nakon što dođe do ove pogreške.
The administration system contains 600 mg of trastuzumab in 5 mL.
Sustav za primjenu sadrži 600 mg trastuzumaba u 5ml.
The administration system is for single use only.
Sustav za primjenu je namijenjen samo za jednokratnu uporabu.
The administration system is for single-use only.
Sustav za primjenu je namijenjen samo za jednokratnu primjenu.
The administration system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
Sustav za primjenu namijenjen je za uporabu u elektromagnetskom okruženju u kojem se kontroliraju smetnje uzrokovane RF zračenjem.
The administration system is intended for use in the electromagnetic environment specified below.
Sustav za primjenu namijenjen je za uporabu u elektromagnetskom okruženju opisanom u nastavku.
The administration system is suitable for use in all establishments, including domestic establishments.
Sustav za primjenu pogodan je za uporabu u svim objektima, uključujući domaćinstva.
The administration system should not be allowed to come into contact with water.
Sustav za primjenu ne smije doći u doticaj s vodom.
The administration system should not be exposed to direct sunlight or warmed up in any other way (e.g. heat source exposure), as this can degrade the medicine.
Ne smije se izlagati izravnoj sunčevoj svjetlosti niti zagrijavati na neki drugi način (npr. izlagati izvoru topline) jer to može uzrokovati gubitak svojstava lijeka.
The administration system should not be used if it has been dropped, or if it is visibly damaged.
Sustav za primjenu ne smije se upotrijebiti ako je pao ili ako je vidno oštećen.
The administration system should not be used near powerful sources of electromagnetic radiation such as X-ray and MRI equipment in a medical facility.
Sustav za primjenu ne smije se koristiti u blizini snažnih izvora elektromagnetskog zračenja, kao što su uređaji za rendgensko snimanje i MR oslikavanje u medicinskim ustanovama.
The administration system uses RF energy only for its internal function.
Sustav za primjenu koristi RF energiju samo za vlastitu unutrašnju funkciju.
The ADRs are listed by system organ class (SOC) and frequency.
Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti.
The ADRs are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Nuspojave su navedene prema MedDRA preferiranim pojmovima i razvrstane po MedDRA klasifikaciji organskih sustava.
The ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “not known”.
Nuspojave utvrđene samo tijekom postmarketinškog nadzora, i za koje učestalost nije mogla biti procijenjena, navedene su pod učestalosti „nepoznata“.
The ADRs in the pJIA and sJIA patients treated with tocilizumab are described below and are presented in the Table 2 by system organ class and frequency categories, defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to <1/100)
Nuspojave kod bolesnika s pJIA i sJIA liječenih tocilizumabom opisane su u nastavku i navedene u Tablici 2 prema klasifikaciji organskih sustava i učestalosti, koja se definirala sljedećim kategorijama: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10) ili manje često (≥ 1/1000 i < 1/100).
The ADRs in1871 patients treated with trastuzumab emtansine are presented in Table 6.
Nuspojave lijeka u 1871 bolesnika liječena trastuzumab emtanzinom prikazane su u Tablici 6.
The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the MabThera group.
Nuspojave navedene u Tablici 3 su sve nuspojave koje su se javile s incidencijom od ≥ 5% u skupini koja je primala lijek MabThera.
The ADRs reported in fourtrials are summarised and categorised according to the MedDRA system organ class and frequency below.
Nuspojave zabilježene u četiri ispitivanja sažete su i kategorizirane prema organskom sustavu MedDRA i učestalosti navedenima u nastavku.
The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2.
Doza Kaletra tableta za odrasle (400/100 mg dvaput na dan) može se koristiti kod djece s 40 ili više kg ili s površinom tijela (PT)* većom od 1,4 m2.
The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2.
Doza za odrasle (400/100 mg dva puta dnevno) može se dati djeci od 40 kg ili više ili s površinom tijela (PT)* većom od 1,4 m².
The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2.
Doza za odrasle (400/100 mg dva puta dnevno) može se dati djeci od 40 kg ili više ili s površinom tijela (PT)* većom od 1.4 m².
The adult dose of lopinavir/ritonavir tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2.
Doza za odrasle (400/100 mg dva puta dnevno) može se dati djeci od 40 kg ili više ili s površinom tijela (PT)* većom od 1,4 m².
The adult dose of PREZISTA/ritonavir (600/100 mg twice daily or 800/100 mg once daily) may be used in paediatric patients of 40 kg or more.
Doza PREZISTA/ritonavir (600/100 mg dva puta na dan ili 800/100 mg jedanput na dan) za odrasle može se primjenjivati u pedijatrijskih bolesnika težine 40 kg ili više.
The adult dose of Telzir tablet 700 mg twice daily with ritonavir 100 mg twice daily may be used in children weighing at least 39 kg and able to swallow tablets.
Kod djece čija je tjelesna težina barem 39 kg i koja mogu progutati tablete može se primijeniti doza Telzir tableta za odrasle, 700 mg 2 puta dnevno s ritonavirom 100 mg također 2 puta dnevno.
The adult effective dose resulting from the administration of a maximal recommended activity of 185 MBq dose for an adult weighing 70 kg is approximately 5.9 mSv.
Učinkovita doza za odrasle osobe koja rezultira primjenom maksimalne preporučene aktivnosti od 185 MBq po dozi za odraslu osobu mase 70 kg je otprilike 5,9 mSv.
The adult patients reported in the published literature were treated with either 400 mg (4cases) or 800 mg (1case) imatinib daily.
Odrasli bolesnici navedeni u objavljenoj literaturi su liječeni ili s 400 mg (4 slučaja) ili s 800 mg (1 slučaj) imatiniba na dan.
The adult patients reported in the published literature were treated with either 400 mg (4cases) or 800 mg (1case) imatinib daily.
Odrasli bolesnici navedeni u objavljenoj literaturi su liječeni ili s 400 mg (4 slučaja) ili s 800 mg (1 slučaj) imatinibana dan.
The adult studies of peginterferon alfa-2a in combination with telaprevir and ribavirin or with boceprevir and ribavirin showed that these combinations significantly increased the proportion of patients who responded to treatment compared with peginterferon alfa-2a plus ribavirin.
Ispitivanja pefinterferona alfa 2a na odraslima u kombinaciji s telaprevirom i ribavirinom pokazala su da ove kombinacije značajno povisuju udio bolesnika koji su reagirali na liječenje u usporedbi s bolesnicima koji su primali peginterferon alfa-2a i ribavirin.
The ADVANCE MPI 1 and ADVANCE MPI 2 studies, individually and combined, demonstrated that Rapiscan is similar to adenosine in assessing the extent of reversible perfusion abnormalities:
Ispitivanjima ADVANCE MPI 1 i ADVANCE MPI 2, pojedinačno I kombinirano, utvrđeno je da je Rapiscan sličan adenozinu za procjenu opsežnosti reverzibilnih defekata perfuzije:
The ADVANCE-PD study was a 22-week study consisting of a 3-week dose adjustment of pre-study immediate release levodopa/carbidopa treatment prior to a 6-week conversion to Numient.
Ispitivanje ADVANCE-PD bilo je ispitivanje u trajanju od 22 tjedna koje se sastojalo od 3 tjedna prilagodbe doze prethodnog liječenja levodopom/karbidopom s trenutnim oslobađanjem prije 6- tjednog prijelaza na Numient.
The adverse drug reactions (ADRs) described in this section were identified during treatment and follow up in the two pivotal clinical studies, BO21004/CLL11, N=781, and GAO4753g, N=396 patients, in previously untreated CLL patients, and indolent Non Hodgkin Lymphoma (iNHL) patients (81.1% of the patients had FL) who had no response to or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
Nuspojave opisane u ovom dijelu zabilježene su tijekom liječenja i praćenja u sklopu dvaju ključnih kliničkih ispitivanja, BO21004/CLL11 (N = 781) i GAO4753g (N = 396), provedenih u prethodno neliječenih bolesnika s KLL-om odnosno u bolesnika s indolentnim ne-Hodgkinovim limfomom (iNHL) (81,1% bolesnika imalo je FL) koji nisu odgovorili na prethodno liječenje rituksimabom ili protokolom koji je sadržavao rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja.
The adverse drug reactions (ADRs) most frequently reported in clinical trials were insomnia, headache, anxiety, upper respiratory tract infection, injection site reaction, parkinsonism, weight increased, akathisia, agitation, sedation/somnolence, nausea, constipation, dizziness, musculoskeletal pain, tachycardia, tremor, abdominal pain, vomiting, diarrhoea, fatigue, and dystonia.
Najčešće nuspojave zabilježene u kliničkim ispitivanjima bile su insomnija, glavobolja, anksioznost, infekcija gornjih dišnih puteva, reakcija na mjestu injekcije, parkinsonizam, povećana težina, akatizija, agitacija, sedacija/somnolencija, mučnina, konstipacija, omaglica, mišićno-koštana bol, tahikardija, tremor, bol u abdomenu, povraćanje, umor i distonija.
The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Nuspojave lijeka (Tablica 1) su poredane prema učestalosti, pri čemu su najčešće navedene prve, na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
The adverse drug reactions are ranked by frequency with the most frequent reactions first.
Nuspojave su svrstane po učestalosti, od najučestalijih prema manje učestalima.
The adverse drug reactions are ranked by frequency with the most serious reactions first.
Nuspojave su svrstane po učestalosti, od najtežih prema manje teškima.
The adverse drug reactions listed below reflect the initial study period (up to week 32) with equivalent exposure to ruxolitinib and Best Available Therapy (BAT), corresponding to a median duration of exposure to Jakavi of 7.8 months.
Nuspojave na lijek navedene u nastavku obuhvaćaju početno razdoblje ispitivanja (do 32. tjedna) s ekvivalentnom izloženošću ruksolitinibu i najboljoj dostupnoj terapiji (NDT), što odgovara medijanu trajanja izloženosti Jakaviju od 7,8 mjeseci.
The adverse drug reactions observed from the 533 patients with metastatic colorectal cancer, treated with a starting dose of 35 mg/m2/dose of Lonsurf, in the placebo-controlled Phase III (RECOURSE) clinical trial, are shown in Table 5.
Nuspojave prijavljene u 533 bolesnika s metastatskim kolorektalnim karcinomom liječenih početnom dozom od 35 mg/m2/dozi Lonsurfa u placebom kontroliranom kliničkom ispitivanju faze III (RECOURSE) prikazani su u Tablici 5.
The adverse drug reactions reported in clinical trials in patients treated with Stivarga are shown in Table 3.
Nuspojave prijavljene u kliničkima ispitivanjima bolesnika liječenih lijekom Stivarga prikazane su u tablici 3.
The adverse drug reactions reported in the table below are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Nuspojave lijeka zabilježene u donjoj tablici su one koje su se pojavile u 0,1% ili više bolesnika liječenih prampeksolom, te su znatno češće prijavljivane kod bolesnika koji su uzimali pramipeksol s obzirom na bolesnike na placebu, ili tamo gdje se pojava smatrala klinički značajnom.
The adverse drug reactions reported in the table below are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Nuspojave lijeka zabilježene u donjoj tablici su one koje su se pojavile u 0,1% ili više bolesnika liječenih prampeksolom, te su znatno češće prijavljivane u bolesnika koji su uzimali pramipeksol s obzirom na bolesnike na placebu ili tamo gdje se pojava smatrala klinički značajnom.
The adverse drug reactions reported in these tables are those events that occurred in 0.1 % or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Nuspojave zabilježene u ovim tabelama su pojave koje su se pojavile u 0,1% ili više bolesnika liječenih pramipeksolom te su znatno češće prijavljivane kod bolesnika koji su uzimali pramipeksol nego placebo, ili tamo gdje se pojava smatrala klinički značajnom.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Nuspojave zabilježene u ovim tabelama su pojave koje su se pojavile u 0,1% ili više bolesnika liječenih pramipeksolom te su znantno češće prijavljivane kod bolesnika koji su uzimali pramipeksol nego placebo, ili tamo gdje se pojava smatrala klinički značajnom.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Nuspojave zabilježene u ovim tablicama su pojave koje su se pojavile u 0,1% ili više bolesnika liječenih pramipeksolom te su znantno češće prijavljivane kod bolesnika koji su uzimali pramipeksol nego placebo, ili tamo gdje se pojava smatrala klinički značajnom.
The adverse drug reactions were determined based on data from the apremilast clinical development programme.
Nuspojave na lijek određene su na temelju podataka dobivenih u programu kliničkog razvoja apremilasta.
The adverse embryofoetal effects of Neparvis are attributed to the angiotensin receptor antagonist activity (see section 4.6).
Štetni embriofetalni učinci Neparvisa pripisuju se antagonističkoj aktivnosti prema angiotenzinskom receptoru (vidjeti dio 4.6).
The adverse event profile for topotecan when given in combination with cisplatin in the cervical cancer clinical trials is consistent with that seen with topotecan monotherapy.
U kliničkim ispitivanjima kombinacije topotekana i cisplatina u liječenju raka vrata maternice profil nuspojava bio je isti kao i pri monoterapiji topotekanom.
The adverse event profile of ofatumumab in bulky fludarabine refractory CLL patients who had failed at least 2 prior therapies was consistent with the overall established safety profile from other CLL studies, as described in the tabulated list below.
Profil štetnih događaja ofatumumaba u bolesnika s izraženijim KLL-om refraktornim na fludarabin, u kojih su barem dvije prethodne terapije bile neuspješne, bio je konzistentan sa sveukupnim utvrđenim sigurnosim profilom iz ostalih KLL ispitivanja kako je opisano u tabličnom prikazu u nastavku.
The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) were similar to those observed in adults.
Nuspojave zapažene u ispitivanju farmakokinetike i podnošljivosti koje je uključivalo bolesnike u dobi od 3 mjeseca do 16 godina starosti (n=65) bile su slične onima zapaženima u odraslih.
The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) were similar to those observed in adults.
Štetni događaji zapaženi u ispitivanju farmakokinetike i podnošljivosti koje je uključivalo bolesnike u dobi od 3 mjeseca do 16 godina (n=65) bili su slični onima zapaženima u odraslih.
The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) were similar to those observed in adults.
Štetni događaji zapaženi u ispitivanju farmakokinetike i podnošljivosti koje je uključivalo bolesnike u dobi od 3 mjeseca do 16 godina starosti (n=65) bili su slični onima zapaženima u odraslih.
The adverse events seen with Panretin gel are similar to those seen with other topical retinoids.
Nuspojave primijećene s Panretinom slične su nuspojavama primijećenima pri primjeni drugih topikalnih retinoida.
The adverse events, considered to be at least possibly related to treatment, are listed below by body system, organ class, and absolute frequency.
Nuspojave, za koje se smatra da je moguća povezanost s liječenjem, navedene su prema organskim sustavima i apsolutnoj učestalosti.
The adverse reaction described in this section is gathered from a combination of adverse reactions from clinical trial data and the post-marketing experience of Oncaspar in ALL patients.
Nuspojave opisane u ovom dijelu prikupljene su iz kombinacije nuspojava iz podataka kliničkih ispitivanja i iskustva s Oncasparom kod bolesnika s ALL-om nakon stavljanja lijeka u promet.
The adverse reaction most commonly leading to discontinuation (≥2% in the perampanel group and greater than placebo) was dizziness.
Nuspojava koja je najčešće dovela do prekida liječenja (≥2% u skupini koja je primala perampanel i više nego u skupini koja je primala placebo) bila je omaglica.
The adverse reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medicinal products.
Profil nuspojava povezanih s imunosupresivnim lijekovima često je teško utvrditi zbog podležeće bolesti i istovremene primjene više lijekova.
The adverse reaction profile of efavirenz, emtricitabine and tenofovir disoproxil fumarate in patients co-infected with HIV/HBV or HIV/HCV was similar to that observed in patients infected with HIV without co-infection.
Profil nuspojava efavirenza, emtricitabina i tenofovirdizoproksilfumarata u pacijenata s istovremenom infekcijom HIV/HBV ili HIV/HCV bio je sličan profilu koji je zapažen u pacijenata zaraženih virusom HIV-a bez istovremene druge infekcije.
The adverse reaction profile of emtricitabine and tenofovir disoproxil in a limited number of HIV- infected patients in study GS-01-934 who were co-infected with HBV (n=13) or HCV (n=26) was similar to that observed in patients infected with HIV without co-infection.
Profil nuspojava emtricitabina i tenofovirdizoproksila kod ograničenog broja bolesnika zaraženih HIV-om iz ispitivanja GS-01-934 koji su istodobno bili zaraženi HBV-om (n=13) ili HCV-om (n=26) bio je sličan profilu primijećenom u bolesnika zaraženih HIV-om bez druge istodobne infekcije.
The adverse reaction profile of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil fumarate in patients co-infected with HIV/HBV or HIV/HCV was similar to that observed in patients infected with HIV without co-infection.
Profil nuspojava emtricitabina, rilpivirinklorida i tenofovirdizoproksilfumarata u pacijenata istovremeno infekcijom HIV/HBV ili HIV/HCV bio je sličan profilu koji je zapažen u pacijenata zaraženih virusom HIV-a bez istovremene druge infekcije.
The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications.
Profil štetnog događaja levetiracetama općenito je sličan u svim dobnim skupinama i u svim odobrenim indikacijama epilepsije.
The adverse reaction profile of Telzir should be borne in mind when considering the patient’s ability to drive or operate machinery (see section 4.8).
Pri razmatranju bolesnikove sposobnosti upravljanja vozilima i rada sa strojevima treba uzeti u obzir profil nuspojava lijeka Telzir.
The adverse reaction profile of tolvaptan in the ADPKD indication is based on a clinical trial database of 1444 treated patients (961 patients treated with tolvaptan, 483 treated with placebo) and is consistent with the pharmacology of the active substance.
Profil nuspojava tolvaptana za indikaciju ADPBB-a temelji se na bazi podataka kliničkog ispitivanja na 1444 liječena bolesnika (961 bolesnik liječen je tolvaptanom, 483 su primala placebo) i u skladu je s farmakologijom djelatne tvari.
The adverse reaction profile of tolvaptan is based on a clinical trials database of 3294 tolvaptan- treated patients and is consistent with the pharmacology of the active substance.
Profil nuspojava tolvaptana bazira se na bazi podataka kliničkih ispitivanja koja sadrži 3294 bolesnika liječena tolvaptanom i konzistentan je sa farmakologijom djelatne tvari.