natgillin/translations-raw huggingface dataset:
Although not studied in specific interaction studies, Efient has been co-administered in the phase 3 clinical trial with low molecular weight heparin, bivalirudin, and GP IIb/IIIa inhibitors (no information available regarding the type of GP IIb/IIIa inhibitor used) without evidence of clinically significant adverse interactions.
Iako nisu provedena specifična ispitivanja interakcija, Efient se u kliničkom ispitivanju faze III primjenjivao s heparinom male molekulske mase, bivalirudinom i inhibitorima GPIIb/IIIa (nema podataka o vrsti GPIIb/IIIa inhibitora) bez znakova klinički značajnih štetnih interakcija.
Although not studied, voriconazole
Interakcija nije klinički ispitana.
Although not studied, voriconazole is likely to
Iako nije ispitivano, primjena vorikonazola vjerojatno će povećati koncentracije vinka alakloida u plazmi i dovesti do neurotoksičnosti.
Although not studied, voriconazole is likely to increase the plasma concentrations of ergot alkaloids and lead to ergotism.
Iako nije ispitivano, primjena vorikonazola vjerojatno će povisiti koncentracije ergot alakloida u plazmi i dovesti do ergotizma.
Although not studied, voriconazole is likely to significantly increase the plasma concentrations of everolimus.
Iako nije ispitivano, vorikonazol će vjerojatno povisiti koncentracije everolimusa u plazmi.
Although Orbactiv’s safety profile overall is similar to that of other glycopeptides, the CHMP noted that some side effects occurred more frequently such as abscesses and bone infections.
Iako je sigurnosni profil lijeka Orbactiv načelno sličan profilu drugih glikopeptida, CHMP je zaključio da su pojedine nuspojave, poput apscesa i koštanih infekcija, češće nastupile.
Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to ivacaftor cannot be excluded.
Iako su u nekim slučajevima bili prisutni drugi čimbenici rizika (kao što su primjena kortikosteroida i izloženost zračenju), mogući rizik koji se može pripisati ivakaftoru ne može se isključiti.
Although Pandemic influenza vaccine H5N1 MedImmune might increase wheezing in children aged 1 to 2 years, the risk is considered acceptable in a pandemic situation.
Iako cjepivo protiv pandemijske influence H5N1 MedImmune može pogoršati piskanje u djece u dobi od 1 do 2 godine, u slučaju pandemije rizik se smatra prihvatljivim.
Although patients had medical conditions that may be associated with localised or diffuse reduction of structural integrity in the wall of the GI tract (e.g., cancer, peptic ulcer, pseudo-obstruction), the use of methylnaltrexone bromide may have contributed to these events.
Iako se zdravstveno stanje bolesnika moglo dovesti u vezu s lokaliziranom ili difuznom redukcijom strukturalnog integriteta u stijenci GI trakta (npr. rak, peptički ulkus, pseudoopstrukcija), primjena metilnaltreksonbromida mogla je doprinijeti ovim stanjima.
Although PD-L1 status is predictive of response in advanced melanoma patients, durable responses have been observed in PD-L1 negative patients.
Iako se na temelju PD-L1 statusa može predvidjeti odgovor u bolesnika s uznapredovalim melanomom, primijećeni su trajni odgovori u
Although phospholipidosis has not been shown to be a risk for patients administered temsirolimus, it is possible that combined administration of temsirolimus with other amphiphilic agents such as amiodarone or statins could result in an increased risk of amphiphilic pulmonary toxicity.
Iako se pokazalo da nema rizika od fosfolipidoze u bolesnika kojima se daje temsirolimus, moguće je da kombinirana primjena temsirolimusa s drugim amfifiličnim sredstvima, kao što su amiodaron ili statini, dovede do povećanja rizika od amfifilične plućne toksičnosti.
Although pradofloxacin has in-vitro activity against a wide range of Gram-positive and Gram- negative organisms, including anaerobic bacteria, this veterinary medicinal product should only be used for the approved indications (see section 4.2) and in accordance with the prudent use recommendations in section 4.5 of this SPC.
Iako pradofloksacin ima in vitro djelovanje protiv širokog spektra Gram-pozitivnih i Gram-negativnih organizama, uključujući anaerobne bakterije, ovaj veterinarsko medicinski proizvod trebao bi se primjenjivati samo kod odobrenih indikacija (vidi odjeljak 4,2) i u skladu s preporukama za razboritu primjenu u odjeljku 4,5 ovog SPC-a.
Although pradofloxacin has in-vitro activity against a wide range of Gram-positive and Gram- negative organisms, including anaerobic bacteria, this veterinary medicinal product should only be used for the approved indications (see section 4.2) and in accordance with the prudent use recommendations in section 4.5 of this SPC.
Iako pradofloksacin ima in vitro djelovanje protiv širokog spektra Gram-pozitivnih i Gram-negativnih organizama, uključujući anaerobne bakterije, ovaj veterinarsko medicinski proizvod trebao bi se primjenjivati samo kod odobrenih indikacija (vidi odjeljak 4.2) i u skladu s preporukama za razboritu primjenu u odjeljku 4.5 ovog SPC-ja.
Although proteinuria (> 2 g/day) increased belimumab clearance and decreases in creatinine clearance decreased belimumab clearance, these effects were within the expected range of variability.
Iako je proteinurija (>2 g/dan) povisila klirens belimumaba, a smanjenja klirensa kreatinina su smanjila klirens belimumaba, ovi učinci su bili unutar očekivanog raspona varijabilnosti.
Although rare (may affect up to 1 in 1,000 people taking CELSENTRI), severe and life-threatening skin reactions and allergic reactions have been reported in some patients taking CELSENTRI.
Iako rijetke (mogu se javiti u do 1 na 1000 osoba koje uzimaju CELSENTRI), ozbiljne i po život opasne kožne reakcije te alergijske reakcije bile su prijavljene u nekih bolesnika koji su uzimali CELSENTRI.
Although rare in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.
Iako rijetko po učestalosti u kliničkim ispitivanjima, može doći do velikog ili teškog krvarenja, koje, bez obzira na mjesto, može biti onesposobljavajuće, opasno po život, ili čak fatalno.
Although rare, pancreatitis should be considered in somatropin-treated children who develop abdominal pain.
Iako je rijedak, pankreatitis treba uzeti u obzir kod djece koja se liječe somatropinom, a imaju bolove u abdomenu.
Although Revestive was not shown to have an effect on initiating tumours, the company will closely monitor the medicine’s safety and effectiveness by setting up a registry of patients.
Iako nije dokazano da lijek Revestive djeluje na nastajanje tumora, tvrtka će pomno nadzirati sigurnost i djelotvornost lijeka uspostavom registra bolesnika.
Although rilpivirine demonstrated limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to
Iako je rilpivirin pokazao ograničeno in vitro djelovanje protiv virusa HIV-2 s vrijednostima EC50 u rasponu od 2510 do
Although rilpivirine demonstrated limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to
Premda je rilpivirin pokazao ograničeno in vitro djelovanje na virus HIV-2 uz vrijednosti EC50 u rasponu od 2 510 do
Although roughly similar daily exposure to 5-FU would be expected in patients with severe renal impairment at a dose of 20 mg/m2 once daily compared to 30 mg/m2 twice daily in patients with normal renal function (see section 5.2), administration of Teysuno is not recommended due to possibly higher incidence of adverse events of the blood and lymphatic system disorders unless the benefits clearly outweigh the risks (see sections 4.4 and 4.8).
Iako bi se očekivala otprilike slična dnevna izloženost 5-FU-u u bolesnika s teškim oštećenjem bubrega kod doze od 20 mg/m2 jednom dnevno, u usporedbi s 30 mg/m2 dva puta dnevno u bolesnika s normalnom funkcijom bubrega (vidjeti dio 5.2), primjena lijeka Teysuno se ne preporučuje zbog moguće veće incidencije štetnih događaja u smislu poremećaja krvi i limfnog sustava, osim ako korist liječenja lijekom Teysuno jasno premašuje rizike (vidjeti dijelove 4.4 i 4.8).
Although safety was not compromised in this population dose adjustment may be required in view of low Cmax.
Iako sigurnost nije bila ugrožena u ovoj populaciji, moglo bi biti potrebno prilagođavanje doze s obzirom na niski Cmax.
Although side effects with Unituxin can be severe, and medication is required to prevent allergic reactions and pain, the medicine’s risks are considered acceptable given the severity of the disease.
Iako nuspojave lijeka Unituxin mogu biti ozbiljne, a lijek je potreban kako bi se spriječile alergijske reakcije i bol, rizici lijeka smatraju se prihvatljivima uzimajući u obzir ozbiljnost bolesti.
Although side effects, particularly infections, were more common with Empliciti, the risks on the whole appear manageable.
Iako se pokazalo da su nuspojave, osobito infekcije, češće kod primjene lijeka Empliciti, čini se, u cjelini, da se rizici mogu kontrolirati.
Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare.
Iako su prijavljena mala povišenja krvnog tlaka u mnogih žena koje uzimaju KOK, klinički značajni porasti su rijetki.
Although small increases of blood pressure have been reported in many women using hormonal contraceptives, clinically relevant increases are rare.
Premda je u mnogih žena koje koriste hormonske kontraceptive zabilježeno blago povišenje krvnog tlaka, klinički značajno povećanje je rijetko.
Although some antibody response to diphtheria toxoid may occur, immunisation with this vaccine does not substitute for routine diphtheria immunisation.
Iako može doći do blagog odgovora protutijela na toksoid difterije, imunizacija ovim cjepivom nije zamjena za rutinsku imunizaciju protiv difterije.
Although some foam may remain on the surface of the reconstituted solution, a sufficient excess of belatacept is included in each vial to account for withdrawal losses.
Iako može zaostati nešto pjene na površini pripremljene otopine, u svakoj se bočici nalazi dovoljna količina belatacepta da nadoknadi gubitak kod izvlačenja.
Although some foam may remain on the surface of the reconstituted solution, a sufficient excess of belatacept is included in each vial to account for withdrawal losses.
Iako može zaostati nešto pjene na površini pripremljene otopine, u svakoj se bočici nalazi dovoljna količina belatacepta da nadoknadi gubitak zbog izvlačenja.
Although some reversible effects on male and female fertilities were reported in adult rats receiving high doses of propranolol in the literature, the study performed in juvenile animals did not show any effect on fertility (see section 5.3).
Iako su u literaturi zabilježeni neki reverzibilni učinci na plodnost mužjaka i ženki kod odraslih štakora koji su primali visoke doze propranolola, studija provedena na mladunčadi životinja nije pokazala nikakav učinak na plodnost (vidjeti dio 5.3).
Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP 3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
Premda nisu provedena zasebna ispitivanja interakcija sa svim lijekovima, analiza populacijske farmakokinetike pokazala je da istodobna primjena sljedećih lijekova ne utječe na farmakokinetiku vardenafila: acetilsalicilatna kiselina, ACE inhibitori, beta blokatori, slabi inhibitori CYP3A4, diuretici i lijekovi za liječenje šećerne bolesti (derivati sulfonilureje i metformin).
Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP 3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
Premda nisu provedena zasebna ispitivanja interakcija sa svim lijekovima, analiza populacijske farmakokinetike pokazala je da istodobna primjena sljedećih lijekova ne utječe na farmakokinetiku vardenafila: acetilsalicilna kiselina, ACE inhibitori, beta blokatori, slabi inhibitori CYP3A4, diuretici i lijekovi za liječenje šećerne bolesti (derivati sulfonilureje i metformin).
Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see section 4.4).
Iako specifične interakcije nisu ispitane, druge inhibitore proteaze, poput sakvinavira, i druge inhibitore CYP3A4, poput eritromicina, klaritromicina, itrakonazola i soka od grejpa, treba primjenjivati uz oprez jer se očekuje da bi ti lijekovi mogli dovesti do povećanja koncentracije tadalafila u plazmi (vdjeti dio 4.4).
Although specific studies have not been performed, co-administration of Invirase/ritonavir with medicinal products that are mainly metabolised by CYP3A4 pathway may result in elevated plasma concentrations of these medicinal products.
Iako nisu provedena posebna ispitivanja, primjena lijekova Invirase/ritonavir s lijekovima koji se uglavnom metaboliziraju putem CYP3A4 može rezultirati povišenjem koncentracija tih lijekova u plazmi.
Although studies are limited in patients with decompensated cirrhosis, these patients may benefit from extended treatment with Harvoni and ribavirin.
Iako su ispitivanja ograničena u bolesnika s dekompenziranom cirozom, oni mogu imati koristi od produljenog liječenja lijekom Harvoni i ribavirinom.
Although studies in patients with cancer- related pain had not been conducted, based on the mechanism of action of the medicine, the benefit for these patients was not expected to be different but the safety should be closely monitored.
Iako ispitivanja nisu provedena na bolesnicima s boli povezanom s rakom, na temelju mehanizma djelovanja lijeka nije se očekivalo da će koristi za ove bolesnike biti drugačije, ali sigurnost treba pomno nadzirati.
Although sunitinib and its primary metabolite were not eliminated through hemodialysis in subjects with ESRD, the total systemic exposures were lower by 47% for sunitinib and 31% for its primary metabolite compared to subjects with normal renal function.
Premda se sunitinib i njegov primarni metabolit nisu uklonili hemodijalizom u bolesnika u terminalnoj fazi bubrežne bolesti, ukupna sustavna izloženost sunitibu bila je niža za 47%, a izloženost primarnom metabolitu za 31% u usporedbi s bolesnicima s normalnom bubrežnom funkcijom.
Although surgery remains the standard treatment for this condition, Votubia is expected to benefit patients whose tumour cannot be operated on.
Iako kirurški zahvat ostaje standardno liječenje za ovo stanje, očekuje se da će od lijeka Votubia imati koristi bolesnici čiji tumori nisu operabilni.
Although Tagrisso has only been investigated in patients with the T790M mutation who were previously treated with EGFR tyrosine kinase inhibitors, Tagrisso is also expected to be effective in patients with the T790M mutation who have not previously received these medicines.
Iako je Tagrisso proučavan samo u bolesnika s mutacijom T790M koji su prethodno liječeni inhibitorima tirozin kinaze za EGFR, očekuje se učinkovitost lijeka Tagrisso u bolesnika s mutacijom T790M koji nisu prethodno primali te lijekove.
Although the additional time spent in sunlight was small, the Committee considered the possible improvements in quality of life, the unmet medical need in patients with EPP, and the mild side effects seen during short-term treatment with the medicine in deciding to recommend approval for Scenesse in the EU.
Iako je dodatno vrijeme koje se provodi na Sunčevoj svjetlosti kratko, prilikom donošenja odluke o preporuci za izdavanje odobrenja za lijek Scenesse u EU- u Odbor je razmotrio moguća poboljšanja u kvaliteti života, neudovoljenu medicinsku potrebu u bolesnika s EPP-om, i blage nuspojave uočene tijekom kratkoročnog liječenja lijekom.
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Iako se smatra da je etiologija multifaktorska (uključujući primjenu kortikosteroida, konzumaciju alkohola, tešku imunosupresiju, veći indeks tjelesne mase), zabiljeţeni su slučajevi osteonekroze osobito u bolesnika s uznapredovalom HIV-bolešću i/ili dugotrajnom izloţenošću CART-u.
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Iako se smatra da je etiologija multifaktorska (uključujući primjenu kortikosteroida, konzumaciju alkohola, tešku imunosupresiju, veći indeks tjelesne mase), zabilježeni su slučajevi osteonekroze osobito u pacijenata s uznapredovalom HIV-bolešću i/ili dugotrajnom izloženošću CART-u.
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
Iako se pretpostavlja da može imati više čimbenika (uključujući uzimanje kortikosteroida, konzumiranje alkohola, jaku imunosupresiju, povećani indeks tjelesne mase), prijavljeni su slučajevi osteonekroze osobito u bolesnika s uznapredovalom bolesti HIV-a i/ili u bolesnika na dugotrajnom liječenju kombiniranom antivirusnom terapijom.
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Iako se smatra da je etiologija multifaktorska (uključujući primjenu kortikosteroida, konzumaciju alkohola, tešku imunosupresiju, veći indeks tjelesne mase), slučajevi osteonekroze zabilježeni su osobito u bolesnika s uznapredovalom HIV bolešću i/ili dugotrajno izloženih CART-u.
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported, particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Iako se smatra da je etiologija multifaktorska (uključujući primjenu kortikosteroida, konzumaciju alkohola, tešku imunosupresiju, veći indeks tjelesne mase), zabilježeni su slučajevi osteonekroze osobito u pacijenata s uznapredovalom HIV-bolešću i/ili dugotrajnom izloženošću CART-u.
Although the beneficial effects of Orkambi were consistent across studies and similar to medicines that treat symptoms of cystic fibrosis they were smaller than expected for a medicine that treats the mechanism of the disease rather than its symptoms.
Iako su u ispitivanjima dosljedno utvrđeni pozitivni učinci lijeka Orkambi, koji su slični pozitivnim učincima lijekova kojima se liječe simptomi cistične fibroze, ipak ih je manje nego što se očekuje od lijeka kojim se liječi mehanizam bolesti, a ne njezini simptomi.
Although the CHMP noted a small apparent increase in the rate of death for patients taking Uptravi when compared with placebo, they considered that this was due to chance or to the way the study was designed and therefore did not impact the benefits or risks of the medicine.
Iako je CHMP primijetio neznatno vidljivo povećanje stope smrtnosti bolesnika koji su uzimali lijek Uptravi u usporedbi s bolesnicima koji su dobivali placebo, smatrao je da je razlog tomu slučajnost ili način na koji je ispitivanje osmišljeno te da stoga to ne utječe na koristi ili rizike povezane s lijekom.
Although the clearance of nivolumab was increased by 25% when anti-nivolumab-antibodies were present, there was no evidence of loss of efficacy or altered toxicity profile in the presence of nivolumab antibodies based on the pharmacokinetic and exposure-response analyses for both monotherapy and combination.
Iako se klirens nivolumaba povećao za 25% u prisutnosti protutijela na nivolumab, u farmakokinetičkim analizama i analizama odgovora na izloženost nije bilo znakova gubitka djelotvornosti ili promjena u profilu toksičnosti u prisutnosti protutijela na nivolumab ni kod monoterapije ni kod kombinirane terapije.
Although the clinical trial experience with sodium oxybate in narcolepsy/cataplexy patients at therapeutic doses does not show clear evidence of a withdrawal syndrome, in rare cases, adverse reactions such as insomnia, headache, anxiety, dizziness, sleep disorder, somnolence, hallucination, and psychotic disorders were observed after GHB discontinuation.
Iako iskustvo iz kliničkog ispitivanja s natrijevim oksibatom u terapijskim dozama u bolesnika s narkolepsijom/katapleksijom ne ukazuje na mogućnost pojave simptoma ustezanja, u rijetkim slučajevima, nakon prekida primjene GHB-a zabilježene su nuspojave kao što su insomnija, glavobolja, anksioznost, omaglica, poremećaj spavanja, somnolencija, halucinacija i psihotični poremećaji.
Although the clinical trial experience with sodium oxybate in narcolepsy/cataplexy patients at therapeutic doses does not show clear evidence of a withdrawal syndrome, in rare cases, events such as insomnia, headache, anxiety, dizziness, sleep disorder, somnolence, hallucination, and psychotic disorders were observed after GHB discontinuation.
Iako iskustva iz kliničkih ispitivanja s primjenom natrijevog oksibata u terapijskim dozama u bolesnika s narkolepsijom/katapleksijom ne ukazuju na mogućnost pojave simptoma ustezanja, u rijetkim slučajevima nakon prekida primjene GHB-a zabilježeni su događaji kao što su insomnija, glavobolja, anksioznost, omaglica, poremećaj spavanja, pospanost, halucinacije i psihotični poremećaji.
Although the Committee considered that this risk could be easily monitored and managed with standard diabetes medicines, the CHMP considered that other somatostatin analogues should be tried first in patients with acromegaly and use of Signifor should be reserved for those whose condition was not controlled by these alternative medicines.
Iako je Odbor zaključio da se rizik može vrlo lako pratiti te da se njime može upravljati standardnim lijekovima protiv dijabetesa, mišljenje je CHMP-a da je potrebno prvo isprobati druge analoge somatostatina u bolesnika s akromegalijom, a uporabu lijeka Signifor treba zadržati za ona stanja koja se ne mogu kontrolirati ovim alternativnim lijekovima.
Although the Committee noted that the study in patients not on dialysis was small, it concluded that the medicine can also be used in these patients because they have the same underlying disease as those on dialysis and therefore similar effectiveness can be expected.
Iako je Odbor napomenuo da je ispitivanje provedeno u bolesnika koji nisu bili na dijalizi malo, zaključio je da se lijek može također koristiti u ovih bolesnika budući da imaju bolest u pozadini kao i bolesnici na dijalizi, te se stoga očekuje slična djelotvornost.
Although the concomitant administration of Twinrix Adult and other vaccines has not specifically been studied, it is anticipated that, if different syringes and other injection sites are used, no interaction will be observed.
Iako istovremena primjena cjepiva Twinrix Adult i drugih cjepiva nije posebno ispitivana, pretpostavlja se da, ukoliko se koriste različite štrcaljke te ako se injicira na različita mjesta, neće biti interakcija.