natgillin/translations-raw huggingface dataset:
In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
Osim toga, u dvostruko slijepom, placebom kontroliranom ispitivanju kod odraslih bolesnika koji su primali osnovnu terapiju metotreksatom, opaženo je da bolesnici koji su liječeni Enbrelom i anakinrom imaju povećanu stopu ozbiljnih infekcija (7%) i neutropenije u odnosu na bolesnike liječene samo Enbrelom (vidjetidijelove 4.4 i 4.8).
In addition, in children with ITP the most common side effects also included colds, nasopharyngitis (inflammation of the nose and throat), rhinitis (inflammation of the lining of the nose), pain in the tummy or in the mouth and throat, toothache, rash, runny nose and abnormal blood levels of certain liver enzymes (AST).
Osim toga, kod djece s ITP-om najčešće nuspojave također su među ostalim bile prehlade, nazofaringitis (upala nosa i grla), rinitis (upala sluznice nosa), bol u trbuhu ili ustima i grlu, zubobolja, osip, hunjavica i abnormalne razine nekih enzima jetre (AST).
In addition, in fewer patients of the group treated with enoxaparin it was necessary to carry out revascularisation by using the method of percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) (reduction of the risk of recurrent coronary heart disease, myocardial infarction or death by 15.8% on day 30 of treatment).
Nadalje, u manjem broju bolesnika u skupini liječenoj enoksaparinom bilo je potrebno izvesti revaskularizaciju pomoću perkutane transluminalne koronarne angioplastike (PTCA, engl. percutaneous transluminal coronary angioplasty) ili koronarne premosnice (CABG, coronary artery bypass graft (smanjenje rizika povrata koronarne bolesti srca, infarkta miokarda ili smrti za 15,8% na 30. dan liječenja).
In addition, in fewer patients of the group treated with enoxaparin it was necessary to carry out revascularisation by using the method of percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) (reduction of the risk of recurrent coronary heart disease, myocardial infarction or death by 15.8% on day 30 of treatment).
Nadalje, u manjem broju bolesnika u skupini liječenoj enoksaparinom bilo je potrebno izvesti revaskularizaciju pomoću perkutane transluminalne koronarne angioplastike (PTCA, engl. percutaneous transluminal coronary angioplasty) ili koronarne premosnice (CABG, coronary artery bypass graft) (smanjenje rizika povrata koronarne bolesti srca, infarkta miokarda ili smrti za 15,8 % na 30. dan liječenja).
In addition, in fewer patients of the group treated with enoxaparin it was necessary to carry out revascularisation by using the method of percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) (reduction of the risk of recurrent coronary heart disease, myocardial infarction or death by 15.8% on day 30 of treatment).
Nadalje, u manjem broju bolesnika u skupini liječenoj enoksaparinom bilo je potrebno izvesti revaskularizaciju pomoću perkutane transluminalne koronarne angioplastike (PTCA, engl. percutaneous transluminal coronary angioplasty) ili koronarne premosnice (CABG, coronary artery bypass graft) (smanjenje rizika povrata koronarne bolesti srca, infarkta miokarda ili smrti za 15,8% na 30. dan liječenja).
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic acid Teva Pharma administration (see section 4.2)
D. Osim toga, u bolesnika s Pagetovom bolešću posebno se savjetuje osigurati uzimanje kalcija u obliku odgovarajućeg dodatka prehrani koji odgovara količini od najmanje 500 mg elementarnog kalcija, dvaput na dan, najmanje tijekom 10 dana nakon primjene Zoledronatne kiseline Teva Pharma (vidjeti dio 4.2).
In addition, in patients, ambrisentan had no overall effect on the weekly warfarin-type anticoagulant dose, prothrombin time (PT) and international normalised ratio (INR).
Uz to, u bolesnika ambrisentan sveukupno nije imao učinak na tjednu dozu antikoagulansa varfarinskog tipa, kao ni na protrombinsko vrijeme (PV) i internacionalni normalizirani omjer (INR).
In addition, in such patients more events of elevated potassium and greater increases in serum creatinine and blood urea nitrogen (BUN) were reported (see section 4.8).
Dodatno, u takvih bolesnika prijavljeno je više događaja povišenog kalija i veće povišenje serumskog kreatinina i dušika iz ureje u krvi (BUN) (vidjeti dio 4.8).
In addition, in the context of myocarditis being a potentially life-threatening event that can be misdiagnosed, the PRAC recommended that the existing warning on left ventricular ejection fraction (LVEF) reduction/Left ventricular dysfunction should be updated to include specific reference to these cases of myocarditis in order to raise awareness of the possibility of this adverse reaction amongst prescribers, and highlight that stopping treatment resolved the myocarditis.
Dodatno, u kontekstu miokarditisa kao događaja potencijalno ugrožavajućeg za život koji može biti pogrešno dijagnosticiran, PRAC je preporučio da se postojeće upozorenje o smanjenju ejekcijske frakcije lijeve klijetke (LVEF)/ disfunkciji lijeve klijetke mora dopuniti kako bi se uključile specifične reference na ove slučajeve miokarditisa u svrhu podizanja svijesti među propisivačima o mogućnosti ove nuspojave, te istaknulo da je prekid liječenja doveo do povlačenja miokarditisa.
In addition, in the first study involving 25 patients, Replagal effected a significant reduction in cardiac mass after 12 to 18 months of maintenance therapy (p<0.001).
Osim toga, u prvom ispitivanju koje je uključivalo 25 bolesnika utvrđena je značajna redukcija srčane mase nakon 12 - 18 mjeseci terapije održavanja Replagalom (p<0,001).
In addition, in the RAISE study, 42% of patients with baseline platelet count ≤ 15,000/μl treated with eltrombopag responded at the end of the 6 month treatment period.
Osim toga, u RAISE studiji 42% bolesnika s početnim brojem trombocita ≤ 15 000/μl liječenih eltrombopagom odgovorilo je na kraju šestomjesečnog perioda ispitivanja.
In addition, in view of the current safety profile of Ranexa the PRAC considered that the PSUR cycle should be extended from 2 years to 3 years.
Dodatno, s obzirom na trenutačni sigurnosni profil lijeka Ranexa, PRAC smatra da se ciklus PSUR-ova treba produljiti sa 2 godine na 3 godine.
In addition, in vivo, obinutuzumab mediates a low degree of complement dependent cytotoxicity (CDC).
Osim toga, in vivo obinutuzumab manjim dijelom posreduje u citotoksičnosti ovisnoj o komplementu(engl. complement dependent cytotoxicity, CDC).
In addition, independent observational studies have not supported an increased risk of serious neuropsychiatric events in patients treated with varenicline compared to patients prescribed nicotine replacement therapy (NRT) or bupropion.
Uz to, neovisna opservacijska ispitivanja nisu poduprlapovećani rizik od ozbiljnih neuropsihijatrijskih događaja u bolesnika liječenih vareniklinom u usporedbi s bolesnicima kojima je propisana nikotinska zamjenska terapija ili bupropion.
In addition, indinavir with ritonavir must not be administered with alfuzosin, meperidine, piroxicam, propoxyphene, bepridil, encainide, flecanide, propafenone, quinidine, fusidic acid, clozapine, clorazepate, diazepam, estazolam and flurazepam.
Osim toga, kombinacija indinavira i ritonavira ne smije se primjenjivati s alfuzosinom, meperidinom, piroksikamom, propoksifenom, bepridilom, enkainidom, flekanidom, propafenonom, kinidinom, fusidatnom kiselinom, klozapinom, klorazepatom, diazepamom, estazolamom i flurazepamom.
In addition, indinavir with ritonavir should not be administered with alfuzosin, meperidine, piroxicam, propoxyphene, bepridil, encainide, flecanide, propafenone, quinidine, fusidic acid, clozapine, clorazepate, diazepam, estazolam and flurazepam.
Osim toga, indinavir i ritonavir se ne smiju primjenjivati s alfuzosinom, meperidinom, piroksikamom, propoksifenom, bepridilom, enkainidom, flekanidom, propafenonom, kvinidinom, fusidatnom kiselinom, klozapinom, klorazepatom, diazepamom, estazolamom i flurazepamom.
In addition, individuals who experienced thrombocytopenia with the first dose of
Osim toga, osobe u kojih se razvila trombocitopenija pri primjeni prve doze cjepiva
In addition, infection with or without fever, diarrhoea, and / or mucositis may be seen.
Uz to je moguća i pojava infekcije, sa ili bez vrućice, te proljev i/ili mukozitis.
In addition, injections do not need to be given frequently because the implant stays in the eye for several months.
Pored toga, injekcije ne treba davati često jer implantat ostaje u oku tijekom nekoliko mjeseci.
In addition, instructions for hygiene and cleaning of the nebulisers provided by the device manufacturers should be followed carefully.
Dodatno, treba pažljivo slijediti upute za higijenu i čišćenje atomizatora priložene od strane njegovog proizvođača.
In addition, Insuman Implantable was studied in adult patients with type 1 diabetes.
Osim toga, Insuman Impalantable ispitivan je kod odraslih bolesnika s dijabetesom tipa 1.
In addition, iritis, haemolytic anaemia, amylase elevations, multi- organ failure, and pneumonitis have been reported in patients treated with ipilimumab 3 mg/kg + gp100 peptide vaccine in MDX010-20.
Osim toga, iritis, hemolitička anemija, povišene vrijednosti amilaze, višestruko zatajenje organa i pneumonitis zabilježeni su u bolesnika koji su primali ipilimumab u dozi od 3 mg/kg + gp100 peptidnog cjepiva u ispitivanju MDX010-20.
In addition, iritis, haemolytic anemia, amylase elevations, multi- organ failure, and pneumonitis have been reported in patients treated with ipilimumab 3 mg/kg in combination with gp100 peptide vaccine.
Osim toga, iritis, hemolitička anemija, povišene razine amilaze, višestruko zatajenje organa i pneumonitis zabilježeni su u bolesnika liječenih ipilimumabom u dozi od 3 mg/kg u kombinaciji s gp100 peptidnim cjepivom.
In addition, it has been shown that ticks detach more quickly from treated dogs, which indirectly reduces the risk of transmission of certain tick- borne diseases to dogs from infected ticks.
Nadalje, dokazano je da se krpelji brže odvajaju od tretiranih pasa, što neizravno smanjuje rizik od prijenosa određenih bolesti koje se prenose krpeljima na pse sa zaraženih krpelja.
In addition, it is contraindicated in patients with a history of an immediate and severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (see section 4.3).
Osim toga, kontraindiciran je i u bolesnika koji su imali trenutnu i tešku reakciju preosjetljivosti (npr. anafilaktičku reakciju) na bilo koju drugu vrstu beta-laktamskih antibiotika (vidjeti dio 4.3).
In addition, it is especially important to tell your doctor if you are also using any of the following medicines: immunisation with live vaccines within three months of completing your leukaemia treatment.
Pored toga, jako je važno da liječniku kažete ako koristite i bilo koji od sljedećih lijekova: cijepljenje živim cjepivom unutar tri mjeseca nakon dovršetka liječenja leukemije.
In addition, it must not be used in patients with unexplained vaginal bleeding or patients with endometrial hyperplasia (abnormal thickening of the lining of the womb).
Nadalje, ne smije se koristiti u bolesnica s neobjašnjenim vaginalnim krvarenjem ili u bolesnica s endometrijalnom hiperplazijom (abnormalnim zadebljanjem ovojnice maternice).
In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β- carbolines.
Također djelomično poništava smanjenje GABA- i glicin-posredovanih protoka, inducirano cinkom i β-karbolinima.
In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and -carbolines.
Također djelomično poništava smanjenje GABA- i glicin-posredovanih protoka, inducirano cinkom i β-karbolinima.
In addition, Kinzalkomb should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Nadalje, Kinzalkomb se mora primjenjivati s oprezom kod bolesnika s oštećenom jetrenom funkcijom ili progresivnom bolesti jetre, s obzirom da manje promjene u ravnoteži tekućine i elektrolita mogu precipitirati hepatičku komu.
In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid.
Nadalje, levetiracetam ne utječe na glukuronidaciju valproične kiseline in vitro.
In addition, limited clinical data indicate that the addition of delamanid to regimens for treating MDR-TB that were resistant to rifampicin and isoniazid but otherwise susceptible, gave the highest efficacy whereas use of delamanid as part of the best available regimens that could be constructed for treating XDR-TB was associated with the lowest efficacy.
Pored toga, ograničeni klinički podaci pokazuju da dodavanje delamanida režimima za liječenje MDR-TB rezistentne na rifampicin i izoniazid, ali inače osjetljive, ima najveću djelotvornost, dok je primjena delamanida kao dijela najboljih dostupnih režima sastavljenih za liječenje XDR-TB (engl. extensively drug- resistant tuberculosis) povezana s najnižom djelotvornosti.
In addition, Lyrica is available in an HDPE bottle containing 200 capsules for the 75 mg, 150 mg and 300 mg strengths.
Osim toga, Lyrica u dozama od 75 mg, 150 mg i 300 mg dostupna je u bočici od polietilena visoke gustoće (HDPE) koja sadrži 200 kapsula.
In addition, malformations of the lung (absent accessory lobe of the lung) and increased post-implantation loss were observed in the rabbit at systemic exposures 14-fold higher than observed at the MHRD, while in the rat reversible effects on ossification were noted (wavy ribs, delayed ossification, decreased number of ossified sternebrae, metacarpi or metatarsi) at systemic exposures 22-fold higher than observed at the MHRD.
Uz to utvrĎene su malformacije pluća (nedostatak akcesornog lobusa pluća) te gubitak zametka nakon implantacije u kunića nakon sustavnog izlaganja 14 puta većeg od onog kod MHRD, dok su kod štakora, zabilježeni reverzibilni učinci osifikacija (neravna rebra i zakašnjela osifikacija sternebra, metakarpusa i metatarzusa) pri sustavnim izloženostima 22 puta većim od onih kod MHRD.
In addition, median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebo- treated patients.
Nadalje, medijan dnevne doze opioida nije se značajno razlikovao od ishodišne vrijednosti bilo kod bolesnika liječenih metilnaltreksonbromidom, ili kod bolesnika koji su primili placebo.
In addition, medicinal products formulated at a basic or neutral pH may be incompatible with oritavancin (see section 6.6).
Osim toga, lijekovi formulirani u bazičnom ili neutralnom pH području mogu biti inkompatibilni s oritavancinom (vidjeti dio 6.6.).
In addition, methotrexate causes embryotoxicity, abortion and foetal defects in humans.
Uz to, metotreksat uzrokuje embriotoksičnost, pobačaj i fetalna oštećenja u ljudi.
In addition, MicardisPlus should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Nadalje, MicardisPlus se mora primjenjivati se s oprezom kod bolesnika s oštećenom jetrenom funkcijom ili progresivnom bolesti jetre, s obzirom da manje promjene u ravnoteži tekućine i elektrolita mogu precipitirati hepatičku komu.
In addition, more babies who were given caffeine citrate had at least eight days with no apnoea: 22% of babies given caffeine citrate compared with none of babies who were given placebo.
Nadalje, više djece koja su primila kofeincitrat imalo je najmanje osam dana bez apneje: 22% djece primilo je kofeincitrat u usporedbi s niti jednim djetetom koje je primalo placebo.
In addition, more patients had a partial or complete clearing of their cancer with the Empliciti combination (79% of patients) than with only the other two medicines (66% of patients).
Osim toga, djelomičan ili potpuni nestanak raka zabilježen je kod više bolesnika koji su primali terapiju koja je uključivala kombinaciju s lijekom Empliciti (79 % bolesnika) nego kod bolesnika koji su uzimali samo druga dva lijeka (66 % bolesnika).
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154 % and 87 %, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Osim toga, vrijednosti AUC-a i Cmax N-dezmetil metabolita bile su značajno povećane (154% odnosno 87%) u ispitanika s cirozom u odnosu na ispitanike s normalnom funkcijom jetre.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154 % and 87 %, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Osim toga, vrijednosti AUC-a i Cmax N-dezmetil metabolita bile su značajno povećane (154% odnosno 87%) u ispitanika s cirozom u odnosu na ispitanike s normalnom jetrenom funkcijom.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200 % and 79 % respectively in subjects with severe renal impairment compared to subjects with normal renal function.
Osim toga, vrijednosti AUC-a i Cmax N-dezmetil metabolita bile su značajno povećane (200% odnosno 79%) u ispitanika s teškim oštećenjem bubrega u odnosu na ispitanike s normalnom bubrežnom funkcijom.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200 % and 79 % respectively in subjects with severe renal impairment compared to subjects with normal renal function.
Osim toga, vrijednosti AUC-a i Cmax N-dezmetil metabolita bile su značajno povećane (200% odnosno 79%) u ispitanika s teškim oštećenjem bubrega u odnosu na ispitanike s normalnom funkcijom bubrega.
In addition, no antibodies to canakinumab were detected in these studies.
Osim toga, u tim ispitivanjima nisu bila detektirana protutijela na kanakinumab.
In addition, no clinically significant effects on cardiac rhythm were observed on 24-hour Holter monitoring in 53 patients with COPD who were treated with umeclidinium/vilanterol 55/22 micrograms once daily in one 6-month study, or in a further 55 patients who received umeclidinium/vilanterol 113/22 micrograms once daily in another 6-month study and 226 patients who received 113/22 micrograms once daily in the 12-month study.
Osim toga, nisu primijećeni klinički značajni učinci na srčani ritam pri 24-satnom Holter snimanju u 53 bolesnika s KOPB-om liječenih umeklidinijem/vilanterolom u dozi od 55/22 mikrograma jedanput na dan u jednom 6-mjesečnom ispitivanju niti u dodatnih 55 bolesnika koji su primali umeklidinij/vilanterol u dozi od 113/22 mikrograma jedanput na dan u drugom 6-mjesečnom ispitivanju i 226 bolesnika koji su primali dozu od 113/22 mikrograma jedanput na dan u mjesečnom ispitivanju.
In addition, no improvement was observed for IKERVIS compared to vehicle at Month 6 for other secondary endpoints, including ocular discomfort score, Schirmer test, use of concomitant artificial tears, investigator’s global evaluation of efficacy, tear break-up time, lissamine green staining, quality of life score, and tear osmolarity.
Dodatno, nije uočeno poboljšanje uz IKERVIS u usporedbi s vehikulumom u 6. mjesecu za druge sekundarne ciljne točke uključujući rezultat procjene očne nelagode, Schirmerov test, istovremenu primjenu umjetnih suza, opću procjenu djelotvornosti od strane ispitivača, vrijeme prekida suznog filma, lissamin green bojenje, procjenu kvalitete života i osmolarnost suza.
In addition, no induction of CYP1A2, CYP2B6 or CYP3A4 was observed.
Nadalje, nije uočena indukcija CYP1A2, CYP2B6 ili CYP3A4.
In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during Humira trials in paediatric patients with Crohn’s disease.
Dodatno, nisu primijećene zloćudne bolesti u 192 pedijatrijska bolesnika s izloženošću od 498,1 bolesnik-godina u ispitivanjima lijeka Humira u pedijatrijskih bolesnika s Crohnovom bolešću.
In addition, no safety and tolerability concerns were identified in this study up to the highest dose given (150 mg).
Osim toga, u tom ispitivanju ni uz najveću primijenjenu dozu (150 mg) nisu identificirani nikakvi sigurnosni problemi niti problemi s podnošljivošću.
In addition, one case of malignant hibernoma was found at the highest dose in a 2-year rat carcinogenicity study.
Nadalje, jedan slučaj malignog hibernoma utvrđen je u najvišoj dozi u 2- godišnjem ispitivanju karcinogenosti u štakora.
In addition, one study found more birth defects when the mother had received Enbrel in pregnancy, compared with mothers who had not received Enbrel or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Nadalje, jedno ispitivanje je zabilježilo više prirođenih mana kada je majka primila Enbrel u trudnoći, u usporedbi s majkama koje nisu primile Enbrel ili druge slične lijekove (antagoniste TNF-a), ali nije zabilježeno o kojem se točno tipu prijavljenih prirođenih mana radi.
In addition, one study found more birth defects when the mother had received etanercept in pregnancy, compared with mothers who had not received etanercept or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Nadalje, jedno ispitivanje je zabilježilo više prirođenih mana kada je majka primila etanercept u trudnoći, u usporedbi s majkama koje nisu primile etanercept ili druge slične lijekove (antagoniste TNF-a), ali nije zabilježeno o kojem se točno tipu prijavljenih prirođenih mana radi.
In addition, Orencia given by injection under the skin has been compared with Orencia infusion in a study involving around 1,371 patients with rheumatoid arthritis.
Nadalje, lijek Orencia koji se primjenjivao injekcijom pod kožu uspoređen je s infuzijom lijeka Orencia u ispitivanju koje je obuhvatilo 1 371 bolesnika s reumatoidnim artritisom.
In addition, patients should also refrain from taking St. John’s Wort.
Osim toga, bolesnici ne bi smjeli uzimati gospinu travu.
In addition, patients treated with MACI had fewer side effects compared with microfracture- treated patients.
Nadalje, bolesnici liječeni implantatom MACI imali su manji broj nuspojava u usporedbi s bolesnicima podvrgnutima metodi mikrofraktura.
In addition, patients were instructed to perform penile modeling at home for six weeks after each treatment cycle.
Bolesnicima su dodatno date upute kako da provode modeliranje penisa kod kuće tijekom 6 tjedana nakon svakog ciklusa liječenja.
In addition, patients’ self-reported quality of sleep, number of awakenings and morning alertness significantly improved with Circadin compared to placebo.
Uz to, ispitanici koji su uzimali Circadin u usporedbi s onima koji su uzimali placebo naveli su značajno poboljšanje kvalitete sna, manje prekida sna i veću jutarnju budnost.
In addition, Perjeta mediates antibody-dependent cell-mediated cytotoxicity (ADCC).
Osim toga, Perjeta posreduje u staničnoj citotoksičnosti ovisnoj o protutijelima.
In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck’s recombinant hepatitis B vaccine in healthy adults.
Osim toga, trajnost cjepivom potaknute imunološke memorije za površinski antigen virusa hepatitisa B (HBsAg) pokazana je anamnestičkim odgovorom protutijela na docjepljivanje dozom prethodne formulacije Merckovog rekombinantnog cjepiva protiv hepatitisa B u zdravih odraslih osoba.
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.
Nadalje, fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu dokazana je do 48 sati u ne-PVC vrećici pri temperaturi od 2 do 8°C.