natgillin/translations-raw huggingface dataset:
In addition to the phase III ROCKET AF study, a prospective, single-arm, post-authorization, non- interventional, open-label cohort study (XANTUS) with central outcome adjudication including thromboembolic events and major bleeding has been conducted.
Dodatno uz ispitivanje faze III ROCKET AF, provedeno je prospektivno, neintervencijsko, otvoreno ispitivanje kohorte s jednom skupinom (XANTUS), nakon stavljanja lijeka u promet, s centralnom ocjenom ishoda koji su uključivali tromboembolijske događaje i veće krvarenje.
In addition to the side effects listed above, chest pain has also been reported.
Osim navedenih nuspojava, zabilježena je i bol u prsima.
In addition to the side effects listed above, chest pain has also been reported.
U bolesnika koji uzimaju irbesartan u monoterapiji, uz gore navedene nuspojave zabilježena je i bol u prsima.
In addition to the side effects listed above, chest pain has also been reported.
Uz gore navedene nuspojave zabilježena je i bol u prsima.
In addition to the side effects listed below, the following may also occur with the use of Temodal powder for solution for infusion: pain, irritation, itching, warmth, swelling or redness at the injection site; also bruising (haematoma).
Osim nuspojava navedenih u daljnjem tekstu, kod primjene lijeka Temodal prašak za otopinu za infuziju mogu se javiti još i bol, nadraženost, svrbež, toplina ili crvenilo na mjestu injiciranja; također i modrice (hematomi).
In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient.
Osim uobičajene samokontrole glukoze u krvi i/ili urinu, potrebno je da liječnik povremeno provjerava razinu glukoze u krvi bolesnika kako bi mogao odrediti minimalnu djelotvornu dozu za bolesnika.
In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient.
Osim uobičajene samokontrole glukoze u krvi i/ili urinu, potrebno je da liječnik povremeno provjerava razinu glukoze u krvi bolesnika kako bi mogao odrediti minimalnu učinkovitu dozu za bolesnika.
In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
Osim ove upute dobit ćete i Karticu s upozorenjima za bolesnika koja sadrži važne sigurnosne informacije u koje morate biti upućeni prije nego što Vam je dan TYSABRI i tijekom liječenja TYSABRIJEM.
In addition to this leaflet, you will be given a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with RoActemra.
Uz uputu o lijeku, dobit ćete i karticu s upozorenjima za bolesnike koja sadrži važne informacije o sigurnosti primjene s kojima morate biti upoznati prije i tijekom liječenja lijekom RoActemra.
In addition to this leaflet, you will find a Patient Alert Card within the box, which contains important safety information that you need to know before you are given Ranexa and during treatment with Ranexa.
Uz ovu uputu o lijeku, u kutiji ćete naći i karticu s upozorenjima za bolesnika koja sadrži važne sigurnosne informacije koje trebate znati prije početka te tijekom liječenja Ranexom.
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g. aspartate aminotransferase (AST), alanine aminotransaminase (ALT)), are recommended prior to initiation and at regular intervals following introduction of Plegridy therapy and then periodically thereafter in the absence of clinical symptoms.
Osim laboratorijskih testova koji su potrebni za normalno praćenje bolesnika s multiplom sklerozom, preporučuju se kompletna krvna slika i diferencijalna krvna slika, broj trombocita i biokemijske pretrage krvi, uključujući testove jetrene funkcije (npr. aspartat aminotransferaza (AST), alanin aminotransaminaza (ALT)), prije početka i u redovnim intervalima nakon uvođenja liječenja Plegridyjem, a zatim periodički u odsutnosti kliničkih simptoma.
In addition VFEND has been associated with phototoxicity, including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Uz to, VFEND se povezuje s fototoksičnošću, uključujući reakcije kao što su pjege, lentigo i aktinična keratoza, i pseudoporfirijom.
In addition voriconazole has been associated with phototoxicity, including reactions such as ephelides, lentigo and actinic keratosis and pseudoporphyria.
Uz to, vorikonazol se povezuje s fototoksičnošću, uključujući reakcije kao što su pjege, lentigo i aktinična keratoza, i pseudoporfirijom.
In addition when the meningococcal serogroups A, C, W-135 and Y vaccine (TT conjugate) was co- administered with a booster dose of Synflorix during the second year of life in children primed with 3 doses of Synflorix, lower antibody geometric mean concentration (GMC) and opsonophagocytic assay geometric mean titre (OPA GMT) were observed for one pneumococcal serotype (18 C).
Nadalje, kada se cjepivo protiv meningokoka serogrupa A, C, W-135 i Y (TT konjugat) primjenjivalo istodobno s dodatnom dozom cjepiva Synflorix tijekom druge godine života u djece koja su primila 3 primarne doze cjepiva Synflorix, za jedan je pneumokokni serotip (18 C) primijećena niža geometrijska srednja koncentracija (engl. geometric mean concentration, GMC) protutijela i niži geometrijski srednji titar u opsonofagocitnom testu (OPA GMT).
In addition,
Placebo tijekom
In addition,
Također,
In addition, 1 patient from the pre-authorisation phase was hospitalized due to hypertensive crisis.
Dodatno, 1 bolesnik iz pred-autorizacijske faze je bio hospitaliziran zbog hipertenzivne krize.
In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Dodatno, 101 dojenčad u dobi manjoj od 12 mjeseci bila je izložena levetiracetamu u postmarketinškoj studiji o sigurnosti.
In addition, 15 of 214 patients in the alendronate group (7.0 %) had experienced a nonvertebral fracture compared with 16 of 214 patients in the FORSTEO group (7.5 %) (p=0.84).
Nadalje, nevertebralni prijelom je imalo 15 od 214 bolesnika iz skupine liječene alendronatom (7,0%) u usporedbi sa 16 od 214 bolesnika iz skupine koja je primala FORSTEO (7,5%) (p = 0,84).
In addition, 24% of sunitinib patients had received somatostatin analogs compared with 22% of placebo patients.
Nadalje, analoge somatostatina je primilo 24% bolesnika liječenih sunitinibom u usporedbi s 22% bolesnika na placebu.
In addition, 44.8% and 56.1% of subjects in respective dose groups had a 4-fold increase in serum neutralising antibody titres from day 0 to day 42 and 96.6% and 100% of subjects had a titre of at least 1:80 at day 42.
Uz to, 44,8% i 56,1% ispitanika u odgovarajućim doznim skupinama imalo je četverostruki porast titra neutralizirajućih protutijela u serumu od 0. do 42. dana, a na 42. dan je 96,6% i 100% ispitanika imalo titar od najmanje 1:80.
In addition, 475 immunocompromised patients (including 18 children, of these 10 oseltamivir and 8 placebo) received oseltamivir or placebo for the prophylaxis of influenza.
Uz to je 475 imunokompromitiranih bolesnika (uključujući 18 djece, od kojih je 10 primalo oseltamivir, a 8 placebo) primilo oseltamivir ili placebo radi profilakse gripe.
In addition, 475 immunocompromised patients (including 18 children, of these 10 Tamiflu and 8 placebo) received Tamiflu or placebo for the prophylaxis of influenza.
Uz to je 475 imunokompromitiranih bolesnika (uključujući 18 djece, od kojih je 10 primalo Tamiflu, a 8 placebo) primilo Tamiflu ili placebo radi profilakse gripe.
In addition, 5-fluorouridine-triphosphate (FUTP) is incorporated into RNA causing disruption of RNA functions.
Dodatno, 5-fluorouridin- trifosfat (FUTP) se ugrađuje u RNA uzrokujući poremećaj funkcija RNA.
In addition, 61% of patients had normal ALT at week 48.
Osim toga, 61% pacijenata imalo je normalnu razinu ALT-a u 48. tjednu.
In addition, 64.8 % of patients receiving 3 mg every 3 months injection were identified as responders (defined as a decrease ≥ 50 % from baseline), compared with 64.9 % of patients receiving 2.5 mg daily orally.
Osim toga, na liječenje je odgovorilo 64,8% bolesnika koji su primali injekciju od 3mg svaka tri mjeseca (definirano kao smanjenje od ≥50% od početne vrijednosti), u usporedbi s 64,9% bolesnika koji su peroralno primali dozu od 2,5mg jedanput dnevno.
In addition, 7 other patients had a response of CHR on Bosulif treatment.
Osim toga, 7 drugih bolesnika imalo je odgovor CHR na liječenje Bosulifom.
In addition, 7% (29 out of 403) of patients receiving Omidria experienced moderate-to-severe pain compared with 14% (57 out of 403) of patients given placebo, and 25% (104 out of 403) were pain- free in the early period following surgery, compared with 17% (69 out of 403) of patients receiving placebo.
Nadalje, 7 % (29 od 403) bolesnika koji su primali lijek Omidria iskusilo je umjerenu do ozbiljnu bol u usporedbi s 14 % (57 od 403) bolesnika koji su primali placebo, te 25 % (104 od 403) nije osjetilo nikakvu bol u ranom razdoblju nakon kirurškog zahvata, u usporedbi sa 17 % (69 od 403) bolesnika koji su primili placebo.
In addition, 84% of physicians and 100% of parents/caregivers regarded glycopyrrolate as worthwhile compared with 41% and 56%, respectively, for placebo (p≤0.014).
Nadalje, 84 % liječnika i 100 % roditelja/njegovatelja smatra glikopirolat korisnim u odnosu na 41 % , odnosno 56 %, za placebo (p≤0,014).
In addition, 89.4% of the bleeding episodes resolved following 1 to 2 treatments with NovoEight.
Nadalje, 89,4% epizoda krvarenja povuklo se nakon 1 do 2 terapije lijekom NovoEight.
In addition, 95.2% of the bleeding episodes resolved following 1 to 2 treatments with NovoEight.
Nadalje, 95,2% epizoda krvarenja povuklo se nakon 1 do 2 terapije lijekom NovoEight.
In addition, a barrier method such as a condom should be used until she has completed 7 days of uninterrupted white tablet- taking.
Osim toga, sve dok ne završi neprekinuto 7-dnevno uzimanje bijelih tableta, mora koristiti mehaničku kontracepciju, primjerice kondom.
In addition, a cardiovascular outcomes study with 5,380 patients with type 2 diabetes mellitus and a recent acute coronary syndrome event was conducted with 2,701 randomised to alogliptin and 2,679 randomised to placebo.
Dodatno je provedeno ispitivanje kardiovaskularnih ishoda na 5380 bolesnika sa šećernom bolešću tipa 2 i nedavnim događajem akutnog koronarnog sindroma, od kojih je 2701 randomiziran na alogliptin i 2679 na placebo..
In addition, a delayed-type allergic skin reaction (cheilitis) after longer-term dermal exposure (mouthwash) has been reported.
Uz to je zabilježen i kasni tip alergijske reakcije (heilitis) nakon dugotrajne izloženosti kože (sredstvo za ispiranje usta).
In addition, a double-blind, placebo-controlled cardiovascular outcome study (ELIXA) enrolled 6,068 type 2 diabetes patients with previous acute coronary syndrome (3,034 randomised to lixisenatide, including 198 patients ≥75 years of age and 655 patients with moderate renal impairment).
Dodatno, dvostruko slijepo, placebom kontrolirano ispitivanje kardiovaskularnog ishoda (ELIXA) uključilo je 6068 bolesnika sa šećernom bolešću tipa 2 koji su ranije imali akutni koronarni sindrom (3034 randomiziranih na liksisenatid, uključujući 198 bolesnika u dobi od ≥75 godina i 655 bolesnika s umjerenim oštećenjem bubrega).
In addition, a higher exposure of trifluridine and tipiracil was observed in patients with moderate renal impairment, compared with patients with normal renal function or patients with mild renal impairment (see section 5.2).
Nadalje, kod bolesnika s umjerenim oštećenjem bubrega je primijećena veća izloženost trifluridinu i tipiracilu u usporedbi s bolesnicima s normalnom funkcijom bubrega ili bolesnicima s blagim oštećenjem bubrega (vidjeti dio 5.2).
In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, tenofovir and lamivudine.
Osim toga, supstitucija K70E u HIV-1 reverznoj transkriptazi selektivno je izdvojena tenofovirom i dovela je do niske razine smanjene osjetljivosti na abakavir, emtricitabin, tenofovir i lamivudin.
In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected clinically by tenofovir disoproxil fumarate and results in low-level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine.
Dodatno, K70E supstitucija u HIV-1 reverznoj transkriptazi klinički je izdvojena tenofovirdizoproksilfumaratom, a rezultira malim smanjenjem osjetljivosti na abakavir, emtricitabin, tenofovir i lamivudin.
In addition, a majority of patients who entered the main study were followed up for up to 24 months afterwards.
Osim toga, većina bolesnika na kojima je provedeno glavno ispitivanje, praćeni su do 24 mjeseca nakon toga.
In addition, a pharmacokinetic-pharmacodynamic (efficacy) analysis was performed in one efficacy trial for primary generalised tonic clonic seizures.
Uz to, provedena je farmakokinetičko-farmakodinamička analiza (djelotvornosti) u jednom ispitivanju djelotvornosti kod primarno generaliziranih toničko-kloničkih napadaja.
In addition, a prospective randomized cardiovascular outcomes safety study was conducted with 5,380 patients with high underlying cardiovascular risk to examine the effect of alogliptin compared with placebo (when added to standard of care) on major adverse cardiovascular events (MACE) including time to the first occurrence of any event in the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in patients with a recent (15 to 90 days) acute coronary event.
Dodatno, prospektivno randomizirano ispitivanje sigurnosti s obzirom na kardiovaskularne ishode provedeno je na 5380 bolesnika s visokim podležećim kardiovaskularnim rizikom kako bi se ispitao učinak alogliptina u usporedbi s placebom (kao dodatak standardnoj terapiji) na velike kardiovaskularne štetne događaje (engl. major adverse cardiovascular events, MACE) uključujući i vrijeme do prve pojave bilo kojeg od događaja kardiovaskularne smrti, infarkta miokarda bez smrtnog ishoda i moždanog udara bez smrtnog ishoda u bolesnika s nedavnim (15 do 90 dana) akutnim koronarnim događajem.
In addition, a prospective randomized cardiovascular outcomes safety study was conducted with 5,380 patients with high underlying cardiovascular risk to examine the effect of alogliptin compared with placebo (when added to standard of care) on major adverse cardiovascular events (MACE) including time to the first occurrence of any event in the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in patients with a recent (15 to 90 days) acute coronary event.
Dodatno,prospektivno randomizirano ispitivanje sigurnosti s obzirom na kardiovaskularne ishode provedeno je na 5380 bolesnika s visokim podležećim kardiovaskularnim rizikom kako bi se ispitao učinak alogliptina u usporedbi s placebom (kao dodatak standardnoj terapiji) na velike kardiovaskularne štetne događaje (engl. major adverse cardiovascular events, MACE) uključujući i vrijeme do prve pojave bilo kojeg od događaja kardiovaskularne smrti, infarkta miokarda bez smrtnog ishoda i moždanog udara bez smrtnog ishoda u bolesnika s nedavnim (15 do 90 dana) akutnim koronarnim događajem.
In addition, a reduction in corticosteroid dose of 5 mg daily, although modest, was considered clinically relevant, given the complications of long-term corticosteroid treatment.
Osim toga, smanjenje doze kortikosteroida od 5 mg na dan, iako skromno, smatralo se klinički značajnim s obzirom na komplikacije dugotrajnog liječenje kortikosteroidima.
In addition, a screw cap (ethylene vinyl acetate / LDPE) with syringe-port capability is provided.
Uz to, priložen je zatvarač s navojem (etilenvinilacetat / LDPE) u koji se može umetnuti štrcaljka.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Osim toga u ispitivanju jednofotonskom emisijskom računalnom tomografijom (SPECT, engl. single photon emission computed tomography) snimanja u bolesnika sa shizofrenijom otkrila su da bolesnici koji reagiraju na olanzapin imaju manju zauzetost strijatalnih D2 receptora od bolesnika koji su reagirali na neke druge antipsihotike i risperidon, dok je zauzetost bila usporediva s onom u bolesnika koji su reagirali na klozapin.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Osim toga, ispitivanje jednofotonskom emisijskom računalnom tomografijom (SPECT, engl. single photon emission computed tomography) snimanja u bolesnika sa shizofrenijom otkrila su da bolesnici koji reagiraju na olanzapin imaju manju zauzetost strijatalnih D2 receptora od bolesnika koji su reagirali na neke druge antipsihotike i risperidon, dok je zauzetost bila usporediva s onom u bolesnika koji su reagirali na klozapin.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Osim toga, ispitivanje snimanjem jednofotonskom emisijskom računalnom tomografijom (SPECT, engl. single photon emission computed tomography) snimanja u bolesnika sa shizofrenijom otkrilo je da bolesnici koji reagiraju na olanzapin imaju manju zauzetost strijatalnih D2 receptora od bolesnika koji su reagirali na neke druge antipsihotike i risperidon, dok je zauzetost bila usporediva s onom u bolesnika koji su reagirali na klozapin.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine- responsive patients.
Osim toga, ispitivanje snimanjem jednofotonskom emisijskom računalnom tomografijom (SPECT, engl. single photon emission computed tomography) u bolesnika sa shizofrenijom otkrilo je da bolesnici koji reagiraju na olanzapin imaju manju zauzetost strijatalnih D2 receptora od bolesnika koji su reagirali na neke druge antipsihotike i risperidon, dok je zauzetost bila usporediva s onom u bolesnika koji su reagirali na klozapin.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Osim toga, ispitivanje snimanjem jednofotonskom emisijskom računalnom tomografijom (SPECT, engl. single photon emission computed tomography) u bolesnika sa shizofrenijom otkrilo je da bolesnici koji reagiraju na olanzapin imaju manju zauzetost strijatalnih D2 receptora od bolesnika koji su reagirali na neke druge antipsihotike i risperidon, dok je zauzetost bila usporediva s onom u bolesnika koji su reagirali na klozapin.
In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Dodatno, analiza podskupina prema dobi ukazuje da je korist od liječenja klopidogrelom manja u bolesnika iznad 75 godina nego u onih ≤ 75 godina.
In addition, a third study is ongoing in 5,623 patients where previous treatment with another disease-modifying therapy had failed (glatiramer acetate, beta-interferon or fingolimod).
Osim toga, trenutačno se provodi treće ispitivanje na 5 623 bolesnika koji su prethodno neuspješno liječeni terapijom koja mijenja tijek bolesti (glatiramer acetat, beta-interferon ili fingolimod).
In addition, a total of 169 cases have been associated with an antidepressant and 27 cases with antipsychotics, 48,5% and 55,5% respectively, reported lack of efficacy while receiving orlistat 60 mg in association with antidepressants, antipsychotics and lithium.
Nadalje, prijavljen je izostanak djelotvornosti antidepresiva, antipsihotika i litija kada su se uzimali zajedno s orlistatom u dozi od 60 mg, i to u ukupno 169 slučajeva povezanih s antidepresivima i 27 slučajeva povezanih s antipsihoticima (48,5% odnosno 55%).
In addition, a total of 169 cases have been associated with an antidepressant and 27 cases with antipsychotics, 48.5% and 55.5% respectively, reported lack of efficacy while receiving orlistat 60 mg in association with antidepressants, antipsychotics and lithium.
Nadalje, prijavljen je izostanak djelotvornosti antidepresiva, antipsihotika i litija kada su se uzimali zajedno s orlistatom u dozi od 60 mg, i to u ukupno 169 slučajeva povezanih s antidepresivima i 27 slučajeva povezanih s antipsihoticima (48,5% odnosno 55%).
In addition, after three years the risk of new spine fractures was lower in patients who received Prolia.
Osim toga, nakon tri godine rizik novih fraktura kralježnice bio je niži u bolesnika koji su primali lijek Prolia.
In addition, aggressive behaviour was observed.
Osim toga, primijećeno je i agresivno ponašanje.
In addition, albiglutide did not significantly alter the pharmacodynamic effects of warfarin as measured by the international normalized ratio.
Osim toga, albiglutid nije značajno izmijenio farmakokinetičke učinke varfarina, mjereno internacionalnim normaliziranim omjerom.
In addition, all patients in this study received exemestane.
Osim toga, sve bolesnice koje su sudjelovale u tom ispitivanju primile su eksemestan.
In addition, although in the defibrotide studies in VOD there have been no reports of hypersensitivity, cases of hypersensitivity including anaphylaxis were reported from a previously marketed formulation of defibrotide, consequently hypersensitivity is included as an ADR
Osim toga, iako u ispitivanjima s defibrotidom u veno-okluzivnoj bolesti nisu bile prijavljene reakcije preosjetljivosti, slučajevi preosjetljivosti uključujući anafilaksiju zabilježeni su za prethodni pripravak defibrotida koji se nalazio na tržištu, pa je posljedično tome preosjetljivost uključena kao jedna od nuspojava.
In addition, although the risk for ONJ may be well known for the prescribers, further awareness on such risk is needed for the patients.
Nadalje, iako je rizik od osteonekroze čeljusti možda dobro poznat propisivačima, potrebno je dodatno osvijestiti taj rizik među bolesnicima.
In addition, an increase in hepatic adverse reactions with maraviroc was observed during studies of treatment-experienced subjects with HIV infection, although there was no overall increase in ACTG Grade 3/4 liver function test abnormalities (see section 4.8).
Osim toga, uočen je povećan broj jetrenih nuspojava povezan s uzimanjem maraviroka tijekom ispitivanja na već liječenim bolesnicima s HIV infekcijom, iako treba napomenuti da nije bilo ukupnog povećanja oštećenja jetrenih funkcija stupnja 3/4 ACTG klasifikacije (vidjeti dio 4.8).
In addition, an increased incidence of significant elevations of ALT was observed in patients treated with tolvaptan [4.4% (42/958)] compared to those receiving placebo [1.0% (5/484)].
Uz to, kod bolesnika liječenih tolvaptanom zapažen je povećana incidencija značajno povišenih ALT [4.4% (42/958)] u usporedbi s onima koji su primali placebo [1.0% (5/484)].