natgillin/translations-raw huggingface dataset:
Since the patient populations treated in the three indications are not comparable and bleeding events are distributed over several System Organ Classes (SOC), a summary description of major and any bleeding are broken down by indication and given in tables 5 and 6 below.
S obzirom da skupine bolesnika, liječene u tri indikacije, nisu usporedive, a događaji krvarenja su raspoređeni u više skupina organskih sustava (SOC), pregledni opis velikih i svih krvarenja je prikazan prema indikaciji, te se daje u tablicama 5 i 6 u nastavku teksta.
Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with infliximab is not established, the risk and benefits to the individual patients must be carefully reviewed and consideration should be given to discontinuation of therapy.
Budući da u bolesnika s novodijagnosticiranom displazijom koji su liječeni infliksimabom nije utvrđena mogućnost povećanog rizika od razvoja karcinoma, mora se pažljivo procijeniti rizik i koristi za svakog bolesnika te razmotriti eventualni prekid terapije.
Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with infliximab is not established, the risk and benefits to the individual patients must be carefully reviewed and consideration should be given to discontinuation of therapy.
Budući da u bolesnika s novodijagnosticiranom displazijom koji su liječeni lijekom infliksimab nije utvrđena mogućnost povećanog rizika od razvoja karcinoma, mora se pažljivo procijeniti rizik i koristi te razmotriti eventualni prekid liječenja.
Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with Remicade is not established, the risk and benefits to the individual patients must be carefully reviewed and consideration should be given to discontinuation of therapy.
Budući da u bolesnika s novodijagnosticiranom displazijom koji su liječeni lijekom Remicade nije utvrđena mogućnost povećanog rizika od razvoja karcinoma, mora se pažljivo procijeniti rizik i koristi za svakog bolesnika te razmotriti eventualni prekid terapije.
Since the primary therapeutic effect of Starlix is to reduce mealtime glucose, (a contributor to HbA1c), the therapeutic response to Starlix may also be monitored with 1–2 hour post-meal glucose.
Budući da je primarni terapijski učinak Starlixa snižavanje glukoze u vrijeme obroka (koja doprinosi HbA1c), terapijski odgovor na Starlix može se pratiti i mjerenjem glukoze 1-2 sata nakon obroka.
Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a sufficient quantity of colostrum within 6 hours of birth.
Budući da se zaštita prasadi postiže putem kolostruma, svako prase treba posisati dovoljnu količinu kolostruma unutar 6 sati od rođenja.
Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a sufficient quantity of colostrum within 6 hours of birth.
Budući da se zaštita prasadi postiže putem kolostruma, svako prase treba posisati dovoljnu količinukolostruma unutar 6 sati od rođenja.
Since the proteolytic enzymes responsible for Oncaspar metabolism are ubiquitously distributed in tissues the exact role of the liver is unknown: however any decrease in liver function is not expected to present clinical relevant problems in the use of Oncaspar.
Budući da su protelitički enzimi odgovori za metabolizam Oncaspara široko rasprostranjeni u tkivima, točna uloga jetre nije poznata: međutim, ne očekuje se da će ikakvo smanjenje jetrene funkcije predstavljati klinički relevantne probleme u primjeni Oncaspara.
Since the recommended dose of
fenitoin/dolutegravir
Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with etravirine (without boosted protease inhibitors), efavirenz, nevirapine, rifampicin, tipranavir/ritonavir, carbamazepine, phenytoin, phenobarbital and St. John’s wort, the use of Triumeq is not recommended for patients taking these medicines (see section 4.5).
Budući da pri istodobnoj primjeni s etravirinom (bez pojačanih inhibitora proteaze), efavirenzom, nevirapinom, rifampicinom, tipranavirom/ritonavirom, karbamazepinom, fenitoinom, fenobarbitalom i gospinom travom, preporučena doza dolutegravira iznosi 50 mg dvaput na dan, primjena lijeka Triumeq ne preporučuje se u bolesnika koji uzimaju te lijekove (vidjeti dio 4.5).
Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with St. John’s wort, DTG/ABC/3TC FDC is not recommended.
S obzirom da je preporučena doza dolutegravira 50 mg dvaput na dan kad se primjenjuje istodobno s gospinom travom, fiksna kombinacija dolutegravir/abakavir/lamivudin se ne preporučuje.
Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir, the co- administration of tipranavir/ritonavir with Triumeq is not recommended.
Budući da preporučena doza dolutegravira pri istodobnoj primjeni s tipranavirom/ritonavirom iznosi 50 mg dvaput na dan, ne preporučuje se istodobna primjena tipranavira/ritonavira i lijeka Triumeq.
Since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment.
Budući da je izlučivanje lopinavira i ritonavira kroz bubrege zanemarivo, u bolesnika oštećenjem bubrega ne očekuje se povišenje koncentracije lijeka u plazmi.
Since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment.
S obzirom da je bubrežni klirens lopinavira i ritonavira zanemariv, u bolesnika s oštećenjem funkcije bubrega se ne očekuju povišene koncentracije u plazmi.
Since the use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications, the risk being higher in low purity preparations, the use of factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC).
Budući da se korištenje koncentrata kompleksa faktora IX povijesno povezuje s razvojem tromboembolijskih komplikacija, uz povećan rizik za pripravke niske čistoće, korištenje lijekova koji sadrže faktor IX može potencijalno biti opasno u pacijenata sa znakovima fibrinolize i pacijenata s diseminiranom intravaskularnom koagulacijom (DIK).
Since the VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.
Budući da virusu slične čestice ne sadržavaju virusnu DNA, one ne mogu inficirati stanicu, razmnožavati se niti uzrokovati bolest.
Since there have been no cases of overdose reported to date, neither signs nor symptoms of overdose have been identified.
Budući da do sada nije bilo zabilježenih slučajeva predoziranja, niti znakovi niti simptomi predoziranja nisu identificirani.
Since there is a potential for an increase in dose- related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Budući da postoji mogućnost povećanja nuspojava povezanih s dozom, možda bude potrebno sniziti dozu pioglitazona kod istodobne primjene gemfibrozila.
Since there is no available data in patients with mild to moderate liver impairment, Siklos should be used with caution.
Budući da nema dostupnih podataka u bolesnika s blagim do umjerenim oštećenjem jetre, Siklos treba uzimati s oprezom.
Since there is no significant impact of nucleoside and nucleotide analogues on the P450 enzyme system no dosage adjustment of Aptivus is required when co-administered with these agents.
S obzirom da nukleozidni i nukleotidni analozi nemaju značajan utjecaj na P450 enzimski sustav, nije potrebno podešavanje doza APTIVUSA kad se primjenjuje istodobno s ovim lijekovima.
Since there is no significant impact of nucleoside and nucleotide analogues on the P450 enzyme system no dosage adjustment of Aptivus is required when co-administered with these agents.
S obzirom da nukleozidni i nukleotidni analozi nemaju značajan utjecaj na P450 enzimski sustav, nije potrebno podešavanje doza APTIVUSA kada se primjenjuje istodobno s ovim lijekovima.
Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
Budući da se ove reakcije dobrovoljno prijavljuju iz populacije čija veličina nije sigurna, nije moguće pouzdano procijeniti njihovu učestalost koja se zbog toga kategorizira kao nepoznata.
Since thiotepa is mainly metabolized through the liver, caution needs to be exercised when thiotepa is used in patients with pre-existing impairment of liver function, especially in those with severe hepatic impairment.
Budući da se tiotepa uglavnom metabolizira putem jetre, treba biti oprezan kada se ista koristi kod bolesnika s već postojećim oštećenjem funkcije jetre, posebice kod onih s teškim oštećenjem funkcije jetre.
Since thiotepa is mainly metabolized through the liver, caution needs to be observed when thiotepa is used in patients with pre-existing impairment of liver function, especially in those with severe hepatic impairment.
Budući da se tiotepa uglavnom metabolizira putem jetre, treba biti oprezan kada se ista koristi kod bolesnika s već postojećim oštećenjem funkcije jetre, posebice kod onih s teškim oštećenjem funkcije jetre.
Since this decrease related to age is smaller than the observed inter-subject variability of 30-40 % in exposure parameters for sufentanil, this effect is not considered to be of clinical relevance, particularly given that Zalviso is only used on an ‘as-needed’ basis.
Budući da je smanjenje povezano s dobi manje od uočene interindividualne varijabilnosti od 30-40% u parametrima izloženosti za sufentanil, ovaj učinak se ne smatra klinički značajnim, naročito s obzirom na to da se Zalviso primjenjuje samo prema potrebi.
since this dose adjustment
Nije potrebno prilagođavati dozu raltegravira.
Since this is below the predefined threshold of one infection per year, this indicates that the medicine is effective as replacement therapy.
Budući da je to ispod unaprijed utvrđene granične vrijednosti od jedne infekcije godišnje, to znači da je lijek djelotvoran kao terapija nadomještanja.
Since this may be of clinical significance this co- administration should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.4).
Budući da to može biti klinički značajno, ovi se lijekovi smiju primjenjivati istodobno samo kad koristi jasno premašuju rizike, uz pažljiv nadzor toksičnosti amfotericin B dezoksikolata (vidjeti dio 4.4).
Since this medicine may reduce your urge to vomit, there is a chance that it may mask the body’s normal response to ingestion of toxic substances or other medical conditions.
Budući da ovaj lijek može smanjiti nagon na povraćanje, postoji mogućnost da prikrije normalan odgovor organizma na unos otrovnih tvari ili druge bolesti.
Since this medicine works primarily in the brain, interference from other medicines (or alcohol) that work in the brain can cause an exaggeration of side effects such as sleepiness or other effects on the brain such as other psychiatric medications, opioids, antihistamines and sleep medication.
Budući da ovaj lijek prvenstveno djeluje u mozgu, utjecaj drugih lijekova (ili alkohola) koji djeluju u mozgu može izazvati prekomjerno izražene nuspojave poput pospanosti ili druge učinke na mozak poput drugih psihijatrijskih lijekova, opioida, antihistaminika i lijekova za spavanje.
Since this product does not contain a preservative, it is recommended to pay special attention to prevent contamination.
Budući da ovaj proizvod ne sadrži konzervans, preporučuje se primjena posebnog opreza kako bi se spriječila kontaminacija.
Since this product will be used during your knee surgery, the hospital staff is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal.
Budući da će se ovaj proizvod upotrijebiti tijekom kirurškog zahvata na Vašem koljenu, bolničko osoblje odgovorno je za pravilno čuvanje proizvoda prije i tijekom njegove primjene, kao i za njegovo propisno odlaganje.
Since those patients were retreated with the 8 mg dose only, there are no data available allowing comparison with the zoledronic acid 4 mg dose.
Budući da su ti bolesnici bili ponovno liječeni samo dozom od 8 mg, nema dostupnih podataka koji bi omogućili usporedbu s dozom od 4 mg zoledronatne kiseline.
Since Toujeo is a solution, it does not require resuspension before use.
Budući da je Toujeo otopina, nije ga potrebno resuspendirati prije uporabe.
Since Translarna has been granted a conditional approval, the company that markets Translarna shall provide further data on the effectiveness and safety of the medicine from an ongoing confirmatory study in DMD patients with the nonsense mutation.
Budući da je lijek Translarna dobio uvjetno odobrenje, tvrtka koja lijek Translarna stavlja u promet mora dostaviti dodatne podatke o djelotvornosti i sigurnosti lijeka iz potvrdnog ispitivanja koje se provodi na DMD bolesnicima s besmislenom mutacijom.
Since treatment with methotrexate can lead to severe and possibly irreversible disorders in spermatogenesis, men should seek advice about the possibility of sperm preservation before starting therapy.
Budući da liječenje metotreksatom može dovesti do teških i moguće ireverzibilnih poremećaja spermatogeneze, muškarci moraju potražiti savjet o mogućoj pohrani sperme prije početka terapije.
Since treatment with methotrexate may lead to infertility, it may be advisable to get advice about sperm preservation before starting treatment (see also section “Warnings and precautions”).
Budući da liječenje metotreksatom može dovesti do neplodnosti, preporučljivo je dobiti savjet o pohrani sperme prije početka liječenja (vidjeti također dio “Upozorenja i mjere opreza”).
Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of fever and heat stroke if you are exposed to high environmental temperatures.
Budući da liječenje oksibutininom može prouzročiti smanjenje znojenja, postoji povećani rizik od vrućice i toplinskog udara ako ste izloženi visokim temperaturama okruženja.
Since Triumeq contains abacavir some patients taking Triumeq may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if treatment with Triumeq is continued.
Budući da Triumeq sadrži abakavir, u nekih bolesnika koji uzimaju Triumeq može se razviti reakcija preosjetljivosti (ozbiljna alergijska reakcija) koja može biti opasna po život ako se liječenje lijekom Triumeq nastavi.
Since your ability to drive a car or operate machinery may be affected by Parkinson’s disease, you should discuss this with your doctor.
Budući da Vaša sposobnost vožnje automobila ili rada sa strojevima može biti pogođena Parkinsonovom bolešću, trebate o tome razgovarati sa svojim liječnikom.
Since YTRACIS is administered by a doctor under strictly controlled conditions there is little chance of possible overdose.
Kako YTRACIS primjenjuje liječnik u strogo kontroliranim uvjetima, predoziranje je malo vjerojatno.
Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct-acting and/or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Budući da se zoledronatna kiselina ne metabolizira u ljudi, a utvrđeno je da ima malu ili nikakvu sposobnost da, djelujući direktno i/ili kao ireverzibilni inhibitor ovisan o metabolizmu P450 enzima, nije vjerojatno da će zoledronatna kiselina smanjiti metabolički klirens lijekova koje se metaboliziraju putem enzimskih sustava citokroma P450.
Since Zykadia has been granted a conditional approval, the company that markets Zykadia will provide results of a further study comparing Zykadia with other cancer medicines (chemotherapy) in patients with ALK-positive NSCLC previously treated with crizotinib.
Budući da je za lijek Zykadia izdano uvjetno odobrenje, tvrtka koja stavlja u promet lijek Zykadia dostavit će rezultate daljnjih ispitivanja u kojima se lijek Zykadia uspoređuju s drugim protutumorskim lijekovima (kemoterapijom) u bolesnika s ALK-pozitivnim NSCLC-om koji su prethodno liječeni krizotinibom.
Since, the pharmacokinetics of rufinamide are not altered in older people (see section 5.2), dosage adjustment is not required in patients over 65 years of age.
Budući da farmakokinetika rufinamida u starijih osoba nije promijenjena (vidjeti dio 5.2), nije potrebna prilagodba doze u bolesnika u dobi od 65 ili više godina.
Single 10 ml injection vial.
Jedna bočica za injekcije od 10 ml.
Single 30 ml dose of antacid
Jedna doza od 30 ml
Single administration of 0.2 mg meloxicam/kg bodyweight (i.e.
Jednokratna primjena 0,2 mg meloksikama/kg tjelesne mase (tj.
Single administration of 0.3 mg meloxicam/kg bodyweight (i.e.
Jednokratna primjena 0,3 mg meloksikama/kg tjelesne mase (tj.
Single arm study to examine whether genetic/genomic markers (alone or
Provesti studiju s jednom skupinom kako bi se ispitalo mogu li se
Single Centre Trial N=12
Monocentrično ispitivanje N=12
Single clinical event suggestive of multiple sclerosis
Jednokratan klinički događaj koji upućuje na multiplu sklerozu
Single components of the primary composite endpoint for the pharmaco-invasive strategy versus primary PCI respectively were observed with the following frequencies:
Pojedine komponente primarnog kompozitnog ishoda za farmakoinvazivnu strategiju naspram primarnog PCI-a primijećene su uz sljedeću učestalost:
Single dose (N=140)
Jednostru ka doza (N=140)
Single dose = 2 mg/50 microlitres Extractable content = 4 mg/100 microlitres
Pojedinačna doza = 2 mg/50 mikrolitara Sadržaj bočice = 4 mg/100 mikrolitara
Single dose administration only. for intravenous use
Samo za jednokratnu primjenu. za primjenu u venu
Single dose disposable Type I glass syringes containing one dose (l ml) of vaccine.
Jednokratne štrcaljke od stakla tipa 1 koje sadrže jedu dozu (l ml) cjepiva.
Single dose pharmacokinetics of rFVIIa, 15 and 30 μg per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters:
Farmakokinetika pojedinačne doze rFVIIa, 15 i 30 µg po kg tjelesne težine, iskazana u parametrima neovisnim o dozi nije pokazala značajnu razliku između dviju doza:
Single dose studies demonstrate linearity of pharmacokinetics in the therapeutic dose range.
Ispitivanja jednokratne doze pokazuju da je farmakokinetika u terapijskom rasponu doza linearna.
Single dose studies demonstrate linearity of pharmacokinetics in the therapeutic dose range.
Ispitivanja jednokratne doze pokazuju linearnost farmakokinetike u terapijskom rasponu doza.
Single dose syringe
Šprica s pojedinačnom dozom
Single dose syringe
Štrcaljka s pojedinačnom dozom
Single dose syringe (0.5ml)
Jednodozna štrcaljka (0,5 ml)
Single dose versus multiple doses
Jednokratna doza u odnosu na višekratno doziranje
Single dose vial
Bočice s jednom dozom
Single dose vial, pack of 1
Jednodozna bočica, pakiranje od 1
single dose)
dozi)
single dose)/
jednokratnoj dozi)/grazoprevir
single dose)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
doza)/elvitegravir (150 mg jedanput
Single dose: 0.3 mg/90 µl
Jedna doza: 0,3 mg/90 µl
Single dose: 2 mg/0.05 ml Excess volume to be expelled.
Pojedinačna doza: 2 mg/0,05 ml Suvišan volumen treba istisnuti.
Single doses of 1500 mg/kg (9000 mg/m2) and 720 mg/kg (14,400 mg/m2) were tolerated without significant toxicity in rats and dogs, respectively.
Štakori su podnosili jednokratne doze od 1500 mg/kg (9000 mg/m2), a psi od 720 mg/kg (14 400 mg/m2) bez značajne toksičnosti.
Single doses of 240 mg or 360 mg Tecfidera did not have any effect on the QTc interval when compared to placebo in a QTc study.
Pojedinačne doze od 240 mg ili 360 mg Tecfidere nisu imale nikakvog utjecaja na QTc interval u usporedbi s placebom u QTc ispitivanju.
Single doses of 80 mg/kg of the deferasirox dispersible tablet formulation (corresponding to a dose of 56 mg/kg film-coated tablets) in iron-overloaded thalassaemic patients caused mild nausea and diarrhoea.
Jednokratne doze od 80 mg/kg deferasiroksa u formulaciji tablete za oralnu suspenziju (što odgovara dozi od 56 mg/kg filmom obloženih tableta) u bolesnika s talasemijom i preopterećenjem željezom uzrokovale su blagu mučninu i proljev.
Single doses of 80 mg/kg of the deferasirox dispersible tablet formulation in iron-overloaded thalassaemic patients caused mild nausea and diarrhoea.
Jednokratne doze od 80 mg/kg deferasiroksa u formulaciji tablete za oralnu suspenziju u bolesnika s talasemijom i preopterećenjem željezom uzrokovale su blagu mučninu i proljev.
Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
Ispitivanje jednokratnih doza od 800 mg orlistata i višestrukih doza do 400 mg tri puta dnevno tijekom 15 dana, na normalno teškim i pretilim osobama, nije pokazalo značajne štetne učinake.
Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant clinical findings.
Istražene su jednokratne doze od 800 mg i višekratne doze do 400 mg orlistata triput na dan tijekom 15 dana u ispitanika s urednom tjelesnom težinom i pretilih ispitanika i nije bilo klinički značajnih nalaza.
Single doses of up to 1500 mg were administered intravenously in a clinical trial to patients with eosinophilic disease without evidence of dose-related toxicities.
U jednom su kliničkom ispitivanju bolesnicima s eozinofilnom bolešću intravenski primijenjene pojedinačne doze do 1500 mg i nije bilo znakova toksičnosti povezane s dozom.
Single doses up to 1200 mg and daily doses up to 1800 mg of Ziagen have been administered to patients in clinical studies.
Bolesnicima u kliničkim ispitivanjima primijenjene su pojedinačne doze do 1200 mg i dnevne doze do 1800 mg lijeka Ziagen.
Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.
Pojedinačne doze do 200 mg i dnevne doze od 50 mg tijekom 10 uzastopnih dana bile su primjenjivanje na ograničenom broju ispitanica i nisu prijavljene ozbiljne ili teške nuspojave.
Single doses up to 80 times the recommended dose (0.5 mg) were well tolerated in healthy volunteers.
Pojedinačne doze do 80 puta veće od preporučene doze (0,5 mg) zdravi dobrovoljci su dobro podnosili.
Single intramuscular (IM) injection of one dose (1 ml) to pigs, irrespective of body weight.
Jednokratno se i.m. injicira jedna doza (1 ml), bez obzira na tjelesnu masu.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e.
Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne mase (tj.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e.
Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne težine (tj.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e.
Jednokratno intramuskularno davanje u dozi od 0.4 mg meloksikama / kg tjelesne mase (tj.
Single intramuscular injection at a dose of 0.4 mg meloxicam/kg body weight (i.e.
Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne težine (tj.
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e.
Jedna intravenska injekcija u dozi od 0,6 mg meloksikama/kg tjelesne mase (tj.
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e.
Jedna intravenska injekcija u dozi od 0,6 mg meloksikama/kg tjelesne težine (tj.
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e.
Jednokratno intravensko davanje u dozi od 0.6 mg meloksikama / kg tjelesne mase (tj.