natgillin/translations-raw huggingface dataset:
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Nositelj odobrenja će periodička izvješća o neškodljivosti podnositi ako je lijek uvršten u referentni popis datuma EU (EUDR popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Nositelj odobrenja će periodička izvješća o neškodljivosti podnositi ako je lijek uvršten u referentni popis datuma EU (EURD popis) predviđen člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljen na europskom internetskom portalu za lijekove.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Nositelj odobrenja će periodička izvješća o neškodljivosti podnositi ako je lijek uvršten u referentni popis datuma EU (EURD popis) predviđen člankom 107(c) stavkom 7 Direktive 2001/83/EZ I objavljenim na europskom internetskom portalu za lijekove.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Nositelj odobrenja će periodička izvješća o neškodljivosti podnositi ako je lijek uvršten u referentni popis datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.>
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Nositelj odobrenja će periodička izvješća o neškodljivosti podnositi ako je lijek uvršten u referentni popis datumaEU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
However, the mean single dose MPAG AUC was 3 – 6 fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Međutim, srednja vrijednost AUC MPAG-a jedne doze bila je 3-6 puta veća kod ispitanika s teškim oštećenjem bubrega nego kod ispitanika s blagim bubrežnim oštećenjem ili normalnih zdravih ispitanika u skladu s poznatom bubrežnom eliminacijom MPAG-a.
However, the mean single dose MPAG AUC was 3 – 6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Međutim, srednja vrijednost AUC MPAG-a jedne doze bila je 3-6 puta veća kod ispitanika s teškim oštećenjem bubrega nego kod ispitanika s blagim bubrežnim oštećenjem ili normalnih zdravih ispitanika u skladu s poznatom bubrežnom eliminacijom MPAG-a.
However, the minor metabolite TFMA (4-trifluoromethylaniline) caused clastogenicity and point mutations in vitro, whilst insufficient information was available on its potential to exert this effect in vivo.
Međutim, sporedni metabolit TFMA (4- trifluormetilanilin) uzrokovao je klastogenost i točkaste mutacije in vitro, dok su nedostatne informacije o njegovom potencijalu izazivanja tog učinka in vivo.
However, the minor metabolite TFMA (4-trifluoromethylaniline) caused clastogenicity and point mutations in vitro, whilst insufficient information was available on its potential to exert this effect in vivo.
Međutim, sporedni metabolit TFMA (4- trifluorometilanilin) uzrokovao je klastogenost i točkaste mutacije in vitro, dok su nedostatne informacije o njegovom potencijalu izazivanja tog učinka in vivo.
However, the number of bleeding events was lower for Pradaxa than for warfarin.
Međutim, broj krvarenja bio je niži kod lijeka Pradaxa nego kod varfarina.
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/l) and thrombocytopenias (platelet count
Međutim, pojava citopenija također je jasno ovisila o fazi bolesti, kod čega je incidencija neutropenija stupnja 3 i 4 (ABN <1,0 x 109/l) i trombocitopenija (broj trombocita <50 x 109/l) bila između 4 i
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/l) and thrombocytopenias (platelet count < 50 x 109/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Međutim, pojava citopenija također je jasno ovisila o fazi bolesti, kod čega je incidencija neutropenija i 4. stupnja (ABN <1,0 x 109/l) i trombocitopenija (broj trombocita <50 x 109/l) bila između 4 i 6 puta veća u blastičnoj krizi i ubrzanoj fazi (59-64% i 44-63% za neutropeniju odnosno trombocitopeniju) u usporedbi s novodijagnosticiranim bolesnicima u kroničnoj fazi KML-a (16,7% neutropenija i 8,9% trombocitopenija).
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/l) and thrombocytopenias (platelet count < 50 x 109/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59–64 % and 44–63 % for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7 % neutropenia and 8.9 % thrombocytopenia).
Međutim, pojava citopenija također je jasno ovisila o fazi bolesti, kod čega je učestalost neutropenija 3. ili 4. stupnja (ABN <1,0 x 109/l) i trombocitopenija (broj trombocita <50 x 109/l) bila između 4 i 6 puta veća u blastičnoj krizi i ubrzanoj fazi (59–64 % za neutropeniju i 44–63 % za trombocitopeniju) u usporedbi s novodijagnosticiranim bolesnicima u kroničnoj fazi KML-a (16,7 % neutropenija i 8,9 % trombocitopenija).
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/L) and thrombocytopenias (platelet count < 50 x 109/L) being between 4 and 6 times higher in blast crisis and accelerated phase (59–64% and 44–63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Međutim, pojava citopenija također je jasno ovisila o fazi bolesti, kod čega je učestalost neutropenija stupnja 3 i 4 (ABN <1,0 x 109/l) i trombocitopenija (broj trombocita <50 x 109/l) bila između 4 i 6 puta veća u blastičnoj krizi i ubrzanoj fazi (59-64% za neutropeniju, odnosno 44-63% za trombocitopeniju) u usporedbi s novodijagnosticiranim bolesnicima u kroničnoj fazi KML-a (16,7% neutropenija i 8,9% trombocitopenija).
However, the OPA geometric mean titres were lower than those against each of the remaining additional vaccine serotypes; the clinical relevance of this observation for protective efficacy is unknown (see section 5.1).
Međutim, vrijednost geometrijske sredine OPA (od engl. opsonophagocytic activity) titra bila je niža od vrijednosti titra protutijela na sve ostale dodatne serotipove u cjepivu; klinička važnost ovog opažanja s obzirom na djelotvornost zaštite nije poznata (vidjeti dio 5.1).
However, the patient discontinuation rates due to these adverse reactions were low (dry mouth: 0% - 0.9% and constipation: 0.6% - 2.2% for darifenacin, depending on the dose; and 0% and 0.3% for placebo, for dry mouth and constipation, respectively).
Međutim, stope prekida liječenja bolesnika zbog tih nuspojava bile su niske (suha usta: 0%-0,9% i konstipacija: 0,6%-2,2% za darifenacin, ovisno o dozi; 0% za suha usta i 0,3% za konstipaciju za placebo).
However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been investigated in children (6–12 years) and adolescents (13–17 years) with type 1 diabetes.
No, farmakokinetička i farmakodinamička svojstva otopine aspart inzulina ispitivana su u djece (6–12 godina) i adolescenata (13–17 godina) sa šećernom bolešću tipa 1.
However, the possibility of interactions with gonadotropins or products that may induce histamine release in susceptible individuals, cannot be totally excluded.
No, mogućnost interakcija s gonadotropinima ili lijekovima koji mogu inducirati oslobađanje histamina u osjetljivih osoba ne može se u potpunosti isključiti.
However, the potential for severe allergic reactions cannot be excluded.
Ipak, ne može se isključiti mogućnost teških alergijskih reakcija.
However, the potential influence of hepatic insufficiency on Pramipexole Teva pharmacokinetics has not been investigated.
Međutim, potrebno je znati da potencijalni utjecaj insuficijencije jetre na farmakokinetiku Pramipeksola Teva nije istraživan.
However, the PRAC considered unclear if the day of negative pregnancy test is counted as day 0 or as day 1.
Međutim, PRAC je utvrdio da je nejasno smatra li se dan negativnog nalaza testa na trudnoću 0. ili 1. danom.
However, the precise contribution of the individual targets to the observed pharmacodynamic profile remains unclear and caution should be applied when extrapolating animal data directly to man.
Međutim, točan doprinos učinka na pojedinačne ciljne receptore u opaženom farmakodinamičkom profilu ostaje nejasan i oprez je potreban kada se ekstrapoliraju podaci sa životinja na čovjeka
However, the predicted amount of metabolite accumulation at steady state is not pharmacodynamically important because the terminal elimination half-life is only 1–2 hours in these subjects.
Međutim, predviđena količina akumuliranog metabolita u stanju dinamičke ravnoteže ne smatra se farmakodinamički važnom jer njegov terminalni poluvijek eliminacije u tih osoba iznosi samo 1-2 sata.
However, the preparations should not be mixed and different injection sites are to be used.
Međutim, pripravci se ne smiju miješati i moraju se injicirati na različita mjesta.
However, the prepared syringe can be stored in a refrigerator (between 2°C and 8°C) for up to 6 hours before you inject.
Međutim, pripremljena se štrcaljka može čuvati u hladnjaku (između 2 °C - 8 °C) do 6 sati prije injiciranja.
However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Međutim, ako je prisutna blaža infekcija poput prehlade, nije potrebno odgađati cijepljenje.
However, the presence of a minor infection, such as a mild upper respiratory tract infection or low- grade fever, is not a contraindication for immunisation.
Međutim, prisutnost manje infekcije, kao što je blaga infekcija gornjeg dijela dišnog sustava ili subfebrilna tjelesna temperatura, nisu kontraindikacije za imunizaciju.
However, the quantity of EndolucinBeta to be used is very small and therefore these risks are considered low.
No, količina proizvoda EndolucinBeta koju je potrebno upotrijebiti vrlo je mala te se stoga i rizici smatraju malima.
However, the quantity of Lumark to be used is very small and therefore these risks are considered low.
No, količina lijeka Lumark koja će se koristiti je vrlo mala te se stoga i rizici smatraju malima.
However, the reconstituted solution can be stored at 2°C - 8°C for up to six hours, prior to injection.
Međutim, rekonstituirana otopina može se čuvati do šest sati na temperaturi od 2°C do 8°C prije injiciranja.
However, the reconstituted solution is stable for 8 hours at 5°C and 25°C stored in the original vial and/or a syringe, with a total storage time for the reconstituted medicine not exceeding 8 hours prior to administration.
Međutim, pripremljena otopina je stabilna 8 sati na temperaturi od 5 °C do 25°C kad se prije primjene čuva u originalnoj bočici i/ili štrcaljki, a ukupno vrijeme čuvanja pripremljenog lijeka, prije primjene, ne smije prijeći 8 sati.
However, the response was not life-threatening and the dogs recovered quickly upon discontinuation of treatment.
Međutim, reakcija nije bila opasan po život i psi su se brzo oporavili nakon prekida liječenja.
However, the results are uncertain due to limitations in the methods used for serum analyses of infliximab and antibodies against infliximab.
Međutim, ti rezultati nisu pouzdani zbog ograničenja metoda koje se koriste u analizi infliksimaba i protutijela na infliksimab u serumu.
However, the results of bioequivalence studies have demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets.
Međutim, rezultati ispitivanja bioekvivalencije dokazali su da su Incresync filmom obložene tablete bioekvivalentne odgovarajućim dozama alogliptina i pioglitazona istodobno primijenjenim kao dvije tablete.
However, the results of bioequivalence studies have demonstrated that Vipdomet film-coated tablets are bioequivalent to the corresponding doses of alogliptin and metformin co-administered as separate tablets.
Međutim, rezultati ispitivanja bioekvivalencije dokazali su da su Vipdomet filmom obložene tablete bioekvivalentne odgovarajućim dozama alogliptina i metformina istodobno primijenjenim u dvije zasebne tablete.
However, the role of this biomarker (tumour PD-L1 expression) has not been fully elucidated.
Međutim, uloga tog biološkog biljega (tumorske ekspresije PD-L1) nije posve razjašnjena.
However, the safety database in children is limited.
Međutim, baza sigurnosnih podataka za djecu je ograničena.
However, the second study showed that symptoms returned in 21% of the patients taking Thymanax over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
No, drugo je ispitivanje pokazalo da su se simptomi vratili u 21% bolesnika koji su uzimali lijek Thymanax tijekom 24 tjedna (34 od 165 bolesnika), u usporedbi s 41% bolesnika koji su uzimali placebo (72 od 174).
However, the second study showed that symptoms returned in 21% of the patients taking Valdoxan over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
No, drugo je ispitivanje pokazalo da su se simptomi vratili u 21% bolesnika koji su uzimali lijek Valdoxan tijekom 24 tjedna (34 od 165 bolesnika), u usporedbi s 41% bolesnika koji su uzimali placebo (72 od 174).
However, the situation is different if the vomiting occurs more than one hour after medicine intake because stiripentol is quickly absorbed.
Situacija je, međutim, drugačija ako povraćanje nastupi više od jednog sata nakon uzimanja lijeka, jer se stiripentol brzo apsorbira.
However, the solution may be use for up to 6 hours when stored in the refrigerator (2 – 8C).
Međutim otopina se može primijeniti u roku od 6 sati kad se čuva u hladnjaku (2°C – 8°C).
However, the solution may be use for up to 6 hours when stored in the refrigerator (2 – 8C).
Međutim, otopina se može primijeniti u roku od najviše 6 sati kad se čuva u hladnjaku (2°C - 8°C).
However, the solution may be used for up to 6 hours if stored in the refrigerator (2C – 8C).
Međutim, otopina se može primijeniti i do 6 sati po pripremi ako je čuvana u hladnjaku (2°C - 8°C).
However, the solution may be used for up to 6 hours if stored in the refrigerator (2C – 8C).
Međutim, otopina se može primijeniti i do 6 sati po pripremi, ako je čuvana u hladnjaku (2°C-8°C).
However, the solution may be used for up to 6 hours when stored at a temperature up to 25C.
Međutim, otopina se može primijeniti i do 6 sati po pripremi, kada je čuvana na temperaturi do 25°C.
However, the solution may be used for up to 6 hours when stored at temperatures of up to 25C.
Međutim, otopina se može primijeniti i do 6 sati po pripremi, ako je čuvana na temperaturi do 25°C.
However, the spurious signal resulting from non-specific ‘bone uptake’ in the face could lead to incorrect image interpretation.
Međutim, lažni signal zbog nespecifičnog „nakupljanja u kostima” na licu može dovesti do neispravnog tumačenja slike.
However, the subject’s HBsAg loss was ultimately confirmed at the subsequent visit.
Međutim u tog ispitanika nestanak HBsAg bio je naposlijetku potvrđen na sljedećem kontrolnom pregledu.
However, the temperature rise may be 0.5 °C higher and the swellings may be more pronounced and palpable for a longer period.
Međutim, rast temperature može biti 0,5 °C viši i otekline mogu biti izraženije i opipljive duži period.
However, the therapeutic experience in patients ≥ 75 years is very limited (see section 5.1), and in these patients 0.75 mg once weekly can be considered as a starting dose.
Međutim, kliničko iskustvo u bolesnika u dobi od ≥ 75 godina vrlo je ograničeno (vidjeti dio 5.1) pa se u tih bolesnika može razmotriti početna doza od 0,75 mg jedanput na tjedan.
However, the transdermal patch may become partially unstuck.
Međutim transdermalni flaster može se djelomično odlijepiti.
However, the trend for its benefits in preventing stroke in atrial fibrillation to be less clear in those patients with high creatinine clearance (good kidney function) was considered to require further study.
Međutim, koristi lijeka u sprječavanju moždanog udara kod fibrilacije atrija nisu jednako izražene u bolesnika s visokim klirensom kreatinina (dobra bubrežna funkcija), te su za to potrebna dodatna ispitivanja.
However, the upper limit of the confidence interval for creatinine remained within the reference range at all visits.
Međutim, gornja granica intervala pouzdanosti za kreatinin ostala je u rasponu referentnih vrijednosti na svim pregledima.
However, the use of varenicline, bupropion and NRT in the psychiatric cohort was not associated with a significantly increased risk of NPS adverse events in the composite primary endpoint compared with placebo (95% CIs included zero).
Međutim, primjena vareniklina, bupropiona i NRT-a u psihijatrijskoj kohorti nije bila povezana s značajno povećanim rizikom od NPS štetnih događaja u kompozitnom primarnom ishodu u usporedbi s placebom (95 %-tni intervali pouzdanosti uključivali su nulu).
However, the vaccine has also been shown to be safe in a field study including animals of 2 months of age.
Međutim, cjepivo se također pokazalo neškodljivim u terenskom ispitivanju na životinjama starim 2 mjeseca.
However, the vaccine has been proven to be protective against virulent challenge in the presence of maternally derived antibodies to CDV, CAV and CPV at levels equal or higher to those likely to be encountered under field conditions.
Međutim, za cjepivo je dokazano da je zaštitno u slučaju izlaganja zarazama u prisutnosti majčinskih protutijela na CDV, CAV i CLV na istim ili višim razinama od onih koji se očekuju u terenskim uvjetima.
However, there are insufficient data available to make a dose recommendation for this patient group.
Međutim, nema dovoljno dostupnih podataka na temelju kojih bi se mogla preporučiti doza za ovu skupinu bolesnika.
However, there are insufficient data available to make a dose recommendation for this patient group.
Međutim, nema dovoljno podataka na temelju kojih bi se moglo preporučiti doziranje u ovoj skupini bolesnika.
However, there are limited data regarding the long-term use of Kuvan.
Ipak, podaci o dugoročnom korištenju lijeka Kuvan su ograničeni.
However, there are no clinical data with this dose adjustment.
Međutim, nema kliničkih podataka za ovakvu prilagodbu doze.
However, there has been no evidence of an increase in the occurrence of AIDS-related infections associated with the use of CELSENTRI in clinical studies
Međutim, kod primjene lijeka CELSENTRI tijekom kliničkih ispitivanja nije uočeno povećanje pojave infekcija povezanih s AIDS-om.
However, there have also been post- marketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Ipak, nakon stavljanja lijeka u promet zaprimljene su prijave zatajenja jetre kao i manje teških poremećaja jetre koji mogu prethoditi zatajenju jetre, kao što su hepatitis, uključujući autoimuni hepatitis, u bolesnika koji su primali adalimumab.
However, there is currently very limited clinical experience with the use of these products in individuals receiving rivaroxaban.
Međutim, trenutno je kliničko iskustvo primjene ovih proizvoda u bolesnika koji primaju rivaroksaban vrlo ograničeno.
However, there is limited clinical experience of the use of sevoflurane, after propofol induction, in bitches undergoing caesarean section, without any ill effects being detected in either the bitch or the puppies.
Međutim, postoji ograničeno kliničko iskustvo uporabe sevoflurana nakon uvođenja u anesteziju propofolom kod kuja u kojih će se raditi carski rez, bez ikakvih primjetnih štetnih učinaka na kuji ili štencima.
However, there was an increase in death due to stroke in women assigned to raloxifene.
Međutim, uočen je povećan broj smrti od moždanog udara u žena koje su primale raloksifen.
However, there was an increase in death due to stroke in women assigned to raloxifene.
Međutim, uočen je povećani broj smrti od moždanog udara u žena koje su primale raloksifen.
However, there was insufficient evidence to support the use of Cubicin to treat bacteraemia in patients who did not have either right-sided infective endocarditis or complicated skin and soft-tissue infections.
Međutim, nema dovoljno dokaza koji bi poduprli primjenu Cubicina za liječenje bakteremije u bolesnika koji nisu imali infektivni endokarditis na desnoj strani srca ili komplicirane infekcije kože i mekog tkiva.
However, there was no advantage for patients whose cancer had not spread beyond the pancreas.
Međutim, nisu utvrđene koristi u bolesnika kod kojih se rak nije proširio izvan gušterače.
However, there was no delay in neonatal development following exposure in utero or via milk.
Međutim, nije bilo zastoja u neonatalnom razvoju nakon izlaganja in utero ili putem mlijeka.
However, there was no difference between the groups when cancer overall was considered and preclinical studies investigating the risk of developing cancer with Edistride did not show this risk.
No, nije uočena nikakva razlika između tih grupa kada je karcinom promatran na ukupnoj razini, a pretklinička ispitivanja rizika nastanka raka pri primjeni lijeka Edistride nisu ukazala na taj rizik.
However, there was no difference in exercise duration between the two doses (24 seconds compared to placebo; p  0.03).
Međutim, između dvije doze Ranexe nije bilo razlike u trajanju opterećenja (24 sekunde u odnosu na placebo; p  0,03).
However, there was no evidence for any selective developmental or reproductive effects in any of the laboratory studies.
Međutim, nije bilo dokaza za selektivni razvoj ili učinke na reprodukciju u bilo kojem laboratorijskom ispitivanju.