FrancophonIA/ELRC3.0 huggingface dataset:
English: A serious soft tissue infection of the genitals or the area between the genitals and the anus (see section “Warnings and precautions” for symptoms).
Croatian: Ozbiljna infekcija mekog tkiva genitalija ili područja između genitalija i anusa (za simptome, pogledajte dio „Upozorenja i mjere opreza“).
English: Further, GLP-1 does not impair the normal glucagon response to hypoglycaemia.
Croatian: Nadalje, GLP-1 ne narušava normalan odgovor glukagona na hipoglikemiju.
English: Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
Croatian: Stariji ispitanici (65 - 80 godina) imali su približno 19% više koncentracije sitagliptina u plazmi u usporedbi s mlađim ispitanicima.
English: The absolute bioavailability of sitagliptin is approximately 87%.
Croatian: Apsolutna bioraspoloživost sitagliptina iznosi približno 87%.
English: Alu/PVC/PA/Alu blisters
Croatian: Al/PVC/PA/Al blisteri.
English: Resolution of pancreatitis has been observed after discontinuation of sitagliptin (with or without supportive treatment), but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
Croatian: Nakon prekida liječenja sitagliptinom opaženo je povlačenje pankreatitisa (uz potporno liječenje ili bez njega), no prijavljeni su vrlo rijetki slučajevi nekrotizirajućeg ili hemoragijskog pankreatitisa i/ili smrti.
English: Because increases of this magnitude are not clinically relevant, dosage adjustment in these patients is not necessary.
Croatian: Budući da povećanja ovog razmjera nisu klinički relevantna, u tih bolesnika nije potrebna prilagodba doze.
English: Other medicines and Steglujan
Croatian: Drugi lijekovi i Steglujan
English: The mean age of the patients across these 3 studies ranged from 55.1 to 59.1 years (range 21 years to 85 years).
Croatian: Srednja vrijednost dobi bolesnika u tim je trima ispitivanjima iznosila 55,1 do 59,1 godinu (raspon: 21 - 85 godina).
English: Steglujan is available in Alu/PVC/PA/Alu blisters.
Croatian: Steglujan dolazi u Al/PVC/PA/Al blisterima.
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
Croatian: • jake bolove u abdomenu (području trbuha) koji ne prestaju i koji se mogu širiti u leđa, uz mučninu i povraćanje ili bez njih, jer bi to mogli biti znakovi upale gušterače (pankreatitisa)
English: Across the 3 studies, 16.2% to 29.9% of patients were ≥ 65 years of age and 2.3% to 2.8% were ≥ 75 years of age.
Croatian: U tim je trima ispitivanjima 16,2% do 29,9% bolesnika bilo u dobi od ≥ 65 godina, a 2,3% do 2,8% njih u dobi od ≥ 75 godina.
English: However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported with sitagliptin.
Croatian: Međutim, kod upravljanja vozilima ili rada sa strojevima treba uzeti u obzir da su pri primjeni sitagliptina prijavljene omaglica i somnolencija.
English: Ertugliflozin and sitagliptin are present in the milk of lactating rats.
Croatian: Ertugliflozin i sitagliptin prisutni su u mlijeku ženki štakora u laktaciji.
English: Plasma AUC of sitagliptin increased in a dose-proportional manner.
Croatian: AUC sitagliptina u plazmi povećavao se proporcionalno dozi.
English: • A serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Croatian: • ozbiljnu alergijsku reakciju (učestalost nepoznata), uključujući osip, koprivnjaču, mjehuriće na koži/ljuštenje kože te oticanje lica, usana, jezika i grla koje može uzrokovati otežano disanje ili gutanje.
English: Ertugliflozin is not expected to be effective in these patients.
Croatian: Ne očekuje se da će ertugliflozin biti učinkovit u tih bolesnika.
English: The improvement in glycaemic control observed with this medicinal product may be mediated by enhancing the levels of active incretin hormones.
Croatian: Poboljšanje regulacije glikemije opaženo kod primjene ovog lijeka moglo bi biti posredovano povećanjem razina aktivnih inkretinskih hormona.
English: Do not drive or use any tools or machines if you feel dizzy while taking Steglujan.
Croatian: Nemojte upravljati vozilima, rukovati alatima niti raditi sa strojevima ako osjećate omaglicu dok uzimate Steglujan.
English: Temporary interruption of treatment with Steglujan should be considered until the fluid loss is corrected.
Croatian: Treba razmotriti privremeni prekid liječenja lijekom Steglujan dok se gubitak tekućine ne korigira.
English: Use of dipeptidyl peptidase-4 (DPP-4) inhibitors has been associated with a risk of developing acute pancreatitis.
Croatian: Primjena inhibitora dipeptidil peptidaze 4 (DPP-4) povezuje se s rizikom od razvoja akutnog pankreatitisa.
English: What Steglujan is and what it is used for
Croatian: Što je Steglujan i za što se koristi
English: The safety and efficacy of Steglujan in patients with type 1 diabetes have not been established and Steglujan should not be used for treatment of patients with type 1 diabetes.
Croatian: Sigurnost i djelotvornost lijeka Steglujan u bolesnika s dijabetesom tipa 1 nisu ustanovljene, pa se Steglujan ne smije primjenjivati za liječenje bolesnika s dijabetesom tipa 1.
English: The incidence and type of adverse reactions in these three studies were similar to the adverse reactions seen with ertugliflozin and are described below in Table 1.
Croatian: Incidencija i vrsta nuspojava u ta tri ispitivanja bile su slične onima opaženima uz ertugliflozin i opisane su u Tablici 1 u nastavku.
English: There is limited experience with Steglujan in patients ≥ 75 years of age.
Croatian: Iskustvo s primjenom lijeka Steglujan u bolesnika u dobi od ≥ 75 godina je ograničeno.
English: See “Description of selected adverse reactions” for frequencies and see section 4.4.
Croatian: Vidjeti ‘Opis odabranih nuspojava' za učestalost i vidjeti dio 4.4.
English: Treatment with Steglujan may be restarted when the ketone values are normal and the patient's condition has stabilised.
Croatian: Liječenje lijekom Steglujan može se ponovno započeti kada se razine ketona vrate u normalu i stanje bolesnika stabilizira.
English: Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin.
Croatian: Otkriveno je šest metabolita u tragovima i ne očekuje se da će oni pridonijeti inhibicijskom djelovanju sitagliptina na DPP-4 u plazmi.
English: After a median follow up of 3 years, sitagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or the risk of hospitalisation for heart failure compared to usual care without sitagliptin in patients with type 2 diabetes (see Table 5).
Croatian: Nakon medijana praćenja od 3 godine, sitagliptin kao dodatak standardnom liječenju nije povećao rizik od velikih kardiovaskularnih štetnih događaja, kao ni rizik od hospitalizacije zbog zatajenja srca u bolesnika s dijabetesom tipa 2 u usporedbi sa standardnim liječenjem bez sitagliptina (vidjeti Tablicu 5).
English: • if you are taking other medicines that lower the amount of sugar in your blood, such as insulin or medicines that increase insulin release from the pancreas.
Croatian: • ako uzimate druge lijekove koji snižavaju razinu šećera u krvi, kao što su inzulin ili lijekovi koji pojačavaju oslobađanje inzulina iz gušterače,
English: These medical conditions can increase your chance of getting pancreatitis (see section 4).
Croatian: Ove bolesti mogu povećati vjerojatnost da dobijete pankreatitis (pogledajte dio 4.),
English: Across the 3 studies, the racial distribution ranged from 72.9% to 90.4% White, 0.0% to 20.3% Asian, 1.9% to 4.5% Black and 4.8% to 5.4% Other.
Croatian: U ta je tri ispitivanja raspodjela ispitanika po rasama uključivala 72,9% do 90,4% bijelaca, 0,0% do 20,3% Azijaca, 1,9% do 4,5% crnaca i 4,8% do 5,4% pripadnika drugih rasa.
English: In vitro, sitagliptin did not inhibit OAT3 (IC50=160 M) or p-glycoprotein (up to 250 M) mediated transport at therapeutically relevant plasma concentrations.
Croatian: In vitro sitagliptin nije inhibirao prijenos posredovan OAT3 (IC50=160 µM) ili p-glikoproteinom (do 250 µM) pri terapijski značajnim koncentracijama u plazmi.
English: Patients 65 years and older treated with ertugliflozin, had a higher incidence of adverse reactions related to volume depletion compared to younger patients.
Croatian: Bolesnici u dobi od 65 i više godina liječeni ertugliflozinom imali su veću incidenciju nuspojava povezanih s deplecijom volumena u usporedbi s mlađim bolesnicima.
English: • Steglujan lowers blood sugar levels in adult patients (aged 18 years and older) with type 2
Croatian: • Steglujan snižava razinu šećera u krvi u odraslih bolesnika (u dobi od 18 ili više godina) koji boluju od šećerne bolesti tipa 2.
English: Stop taking Steglujan and contact a doctor straight away if you notice any of the following serious side effects:
Croatian: Prestanite uzimati Steglujan i odmah se javite liječniku ako imate bilo koju od sljedećih ozbiljnih nuspojava:
English: Steglujan has not been studied in patients with severe hepatic impairment and is not recommended for use in these patients (see section 5.2).
Croatian: Steglujan nije ispitan u bolesnika s teškim oštećenjem funkcije jetre i ne preporučuje se za primjenu u tih bolesnika (vidjeti dio 5.2).
English: • bullous pemphigoid (a type of skin blister)
Croatian: • bulozni pemfigoid (vrsta mjehura na koži)
English: • osteoarthritis
Croatian: • osteoartritis
English: What Steglujan looks like and contents of the pack
Croatian: Kako Steglujan izgleda i sadržaj pakiranja
English: Coadministration of sitagliptin and metformin had an additive effect on active GLP-1 concentrations.
Croatian: Istodobna primjena sitagliptina i metformina imala je aditivan učinak na koncentracije aktivnog GLP-1.
English: If you notice any of the serious side effects above, stop taking this medicine and contact a doctor straight away.
Croatian: Ako primijetite bilo koju od gore navedenih ozbiljnih nuspojava, prestanite uzimati ovaj lijek i odmah se javite liječniku.
English: Ertugliflozin in combination with sitagliptin
Croatian: Ertugliflozin u kombinaciji sa sitagliptinom
English: Hypoglycaemia has been reported in combination with sulphonylurea (4.7%-13.8%) and insulin (9.6%) (see section 4.4).
Croatian: Hipoglikemija je prijavljena kod primjene u kombinaciji sa sulfonilurejom (4,7%-13,8%) i inzulinom (9,6%) (vidjeti dio 4.4).
English: Taking this medicine in combination with insulin or medicines that increase insulin release from the pancreas can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating or changes in vision and may affect your ability to drive and use machines.
Croatian: Uzimanje ovoga lijeka u kombinaciji s inzulinom ili lijekovima koji pospješuju oslobađanje inzulina iz gušterače može uzrokovati pad šećera u krvi do preniskih razina (hipoglikemija), što može izazvati simptome poput drhtanja, znojenja ili promjena vida te utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with sitagliptin (not reaching the 5% level, but occurring with an incidence of > 0.5% higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity.
Croatian: Dodatne nuspojave prijavljene bez obzira na uzročnu povezanost s lijekom koje su se javljale češće u bolesnika liječenih sitagliptinom (nisu dosegle razinu od 5%, ali je njihova incidencija bila > 0,5% veća u bolesnika liječenih sitagliptinom nego u kontrolnoj skupini) uključivale su osteoartritis i bol u ekstremitetima.
English: Post-prandial glucose
Croatian: Postprandijalna glukoza
English: C]sitagliptin oral dose, approximately 16% of the radioactivity was excreted as metabolites of sitagliptin.
Croatian: C]sitagliptina približno 16% radioaktivnosti izlučilo se u obliku metabolita sitagliptina.
English: For this reason, it is possible that potent CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the pharmacokinetics of sitagliptin in patients with severe renal impairment or ESRD.
Croatian: Stoga je moguće da potentni inhibitori CYP3A4 (tj. ketokonazol, itrakonazol, ritonavir, klaritromicin) mogu promijeniti farmakokinetiku sitagliptina u bolesnika s teškim oštećenjem funkcije bubrega ili onih u terminalnoj fazi bubrežne bolesti.
English: In case of conditions that may lead to fluid loss (e.g., gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving Steglujan.
Croatian: U slučaju stanja koja bi mogla dovesti do gubitka tekućine (npr. gastrointestinalna bolest), preporučuje se pažljivo praćenje volumnog statusa (npr. liječnički pregled, mjerenje krvnog tlaka, laboratorijske pretrage, uključujući određivanje hematokrita) i elektrolita u bolesnika koji primaju lijek Steglujan.
English: Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal.
Croatian: Inkretinski hormoni, uključujući peptid-1 nalik glukagonu (engl. glucagon-like peptide-1, GLP-1) i inzulinotropni polipeptid ovisan o glukozi (engl. glucose-dependent insulinotropic polypeptide, GIP), oslobađaju se u crijevima tijekom cijelog dana, a njihove se razine povećavaju u odgovoru na obrok.
English: Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11% and the plasma Cmax on average by 18%.
Croatian: Nakon istodobne primjene digoksina u dozi od 0,25 mg i sitagliptina u dozi od 100 mg na dan tijekom 10 dana, AUC digoksina u plazmi povećao se za prosječno 11%, dok se Cmax u plazmi povećao za prosječno 18%.
English: Sitagliptin is a substrate for human organic anion transporter-3 (hOAT-3), which may be involved in the renal elimination of sitagliptin.
Croatian: Sitagliptin je supstrat humanog organskog anionskog prijenosnika-3 (hOAT-3) koji bi mogao biti uključen u bubrežnu eliminaciju sitagliptina.
English: What Steglujan is Steglujan contains two active substances, ertugliflozin and sitagliptin.
Croatian: Što je Steglujan Steglujan sadrži dvije djelatne tvari, ertugliflozin i sitagliptin.
English: These included hypoglycaemia (frequency very common with the combination of sulphonylurea and metformin), influenza (common with insulin (with or without metformin)), nausea and vomiting (common with metformin), flatulence (common with metformin or pioglitazone), constipation (common with the combination of sulphonylurea and metformin), peripheral oedema (common with pioglitazone or the combination of pioglitazone and metformin), somnolence and diarrhoea (uncommon with metformin), and dry mouth (uncommon with insulin (with or without metformin)).
Croatian: Te su nuspojave uključivale hipoglikemiju (učestalost vrlo česta s kombinacijom sulfonilureje i metformina), gripu (česta s inzulinom [u kombinaciji s metforminom ili bez njega]), mučninu i povraćanje (česte s metforminom), flatulenciju (česta s metforminom ili pioglitazonom), konstipaciju (česta s kombinacijom sulfonilureje i metformina), periferni edem (česta s pioglitazonom ili kombinacijom pioglitazona i metformina), somnolenciju i proljev (manje česte s metforminom) i suha usta (manje česta s inzulinom [u kombinaciji s metforminom ili bez njega]).
English: Acute pancreatitis a,*,b,2
Croatian: akutni pankreatitis a,*,b,2
English: The clinical relevance of hOAT-3 in sitagliptin transport has not been established.
Croatian: Nije utvrđen klinički značaj hOAT-3 u prijenosu sitagliptina.
English: Analysis in the Intention-to-Treat Population
Croatian: Analiza u populaciji predviđenoj za liječenje
English: If Fournier's gangrene is suspected, Steglujan should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Croatian: Ako se sumnja na Fournierovu gangrenu, potrebno je prekinuti uzimanje lijeka Steglujan te hitno započeti s liječenjem (uključujući antibiotike i kirurški debridman).
English: It is not known if sitagliptin is dialysable by peritoneal dialysis.
Croatian: Nije poznato može li se sitagliptin ukloniti peritonejskom dijalizom.
English: If pancreatitis is suspected, Steglujan and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Steglujan should not be restarted.
Croatian: Posumnja li se na pankreatitis, mora se prekinuti primjena lijeka Steglujan i drugih lijekova za koje se sumnja da bi ga mogli izazvati; potvrdi li se akutni pankreatitis, liječenje lijekom Steglujan ne smije se ponovno započeti.
English: Monitoring of ketones is recommended in these patients.
Croatian: U tih bolesnika preporučuje se praćenje razina ketona.
English: In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of P-gp.
Croatian: U kliničkom ispitivanju sitagliptin je imao malen učinak na koncentracije digoksina u plazmi, što ukazuje na to da bi sitagliptin mogao biti blagi inhibitor P-gp-a.
English: Other potential causes for the event should be assessed, and alternative treatment for diabetes initiated.
Croatian: Potrebno je ocijeniti druge moguće uzroke za događaj te započeti liječenje dijabetesa drugim lijekovima.
English: Therefore, Steglujan should not be used during pregnancy.
Croatian: Stoga se Steglujan ne smije primjenjivati tijekom trudnoće.
English: General Steglujan should not be used in patients with type 1 diabetes mellitus.
Croatian: Općenito Steglujan se ne smije primjenjivati u bolesnika s dijabetes mellitusom tipa 1.
English: In patients where DKA is suspected or diagnosed, treatment with Steglujan should be discontinued immediately.
Croatian: U bolesnika u kojih se posumnja na DKA ili se DKA dijagnosticira, liječenje lijekom Steglujan potrebno je odmah prekinuti.
English: Before initiating ertugliflozin/sitagliptin, consider factors in the patient history that may increase the risk for amputation.
Croatian: Prije uvođenja ertugliflozina/sitagliptina, potrebno je uzeti u obzir čimbenike iz bolesnikove anamneze koji bi mogli povećati rizik od amputacije.
English: Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Croatian: Prolazni fizički znakovi povezani s liječenjem, od kojih neki upućuju na neurotoksičnost, poput disanja otvorenih usta, salivacije, povraćanja bijele pjene, ataksije, drhtanja, smanjene aktivnosti i/ili pogrbljenog držanja tijela opaženi su u pasa pri razinama izloženosti približno 23 puta većima od kliničke razine izloženosti.
English: In patients with volume depletion, correcting this condition prior to initiation of Steglujan is recommended (see section 4.4).
Croatian: U bolesnika s deplecijom volumena preporučuje se korigirati to stanje prije uvođenja lijeka Steglujan (vidjeti dio 4.4).
English: Elimination of sitagliptin occurs primarily via renal excretion and involves active tubular secretion.
Croatian: Eliminacija sitagliptina primarno se odvija izlučivanjem putem bubrega i uključuje aktivnu tubularnu sekreciju.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD24.
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti, kombinacije oralnih lijekova za snižavanje glukoze u krvi, ATK oznaka: A10BD24
English: C]-sitagliptin dose to healthy subjects, approximately 100% of the administered radioactivity was eliminated in faeces (13%) or urine (87%) within one week of dosing.
Croatian: C]sitagliptina zdravim ispitanicima, približno 100% primijenjene radioaktivnosti eliminiralo se stolicom (13%) ili mokraćom (87%) unutar jednog tjedna od primjene doze.
English: However, ciclosporin, a P-gp inhibitor, did not reduce the renal clearance of sitagliptin.
Croatian: Međutim, ciklosporin, inhibitor P-gp-a, nije smanjio bubrežni klirens sitagliptina.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 30x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 30 x 1 filmom obložena tableta 84 filmom obložene tablete 90 filmom obloženih tableta 98 filmom obloženih tableta
English: In a two-day study in healthy subjects, sitagliptin alone increased active GLP-1 concentrations, whereas metformin alone increased active and total GLP-1 concentrations to similar extents.
Croatian: U dvodnevnom ispitivanju provedenom u zdravih ispitanika, sitagliptin primijenjen samostalno povisio je koncentraciju aktivnog GLP-1, dok je metformin primijenjen samostalno povisio koncentraciju aktivnog i ukupnog GLP-1 u sličnoj mjeri.
English: If you forget to take Steglujan
Croatian: Ako ste zaboravili uzeti Steglujan
English: Steglujan should not be used to treat this condition.
Croatian: Steglujan se ne smije koristiti za liječenje te bolesti,
English: However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or use machines.
Croatian: Međutim, kod primjene sitagliptina prijavljeni su omaglica i omamljenost, što može utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Angioedema a,
Croatian: angioedem a,
English: Before initiating Steglujan, volume status should be assessed and corrected if indicated.
Croatian: Prije uvođenja lijeka Steglujan potrebno je ocijeniti volumni status i po potrebi ga korigirati.
English: For patients treated with ertugliflozin who are being switched to Steglujan, the dose of ertugliflozin can be maintained.
Croatian: U bolesnika liječenih ertugliflozinom koji prelaze na Steglujan, doza ertugliflozina može se održati.
English: Over the course of the study, the overall estimated mean (SD) difference in HbA1c between the sitagliptin and placebo groups was 0.29% (0.01), 95% CI (-0.32, -0.27); p< 0.001.
Croatian: Tijekom ispitivanja ukupna procijenjena srednja vrijednost (SD) razlike u vrijednosti HbA1c između skupine liječene sitagliptinom i one koja je primala placebo iznosila je 0,29% (0,01), 95% CI (-0,32; -0,27); p < 0,001.
English: Some adverse reactions were observed more frequently in studies of combination use of sitagliptin with other anti-diabetic medicinal products than in studies of sitagliptin monotherapy.
Croatian: Neke su nuspojave primijećene češće u ispitivanjima kombinirane primjene sitagliptina i drugih lijekova za liječenje dijabetesa nego u ispitivanjima sitagliptina u monoterapiji.
English: A no-effect level for these findings was found at an exposure 6-fold the clinical exposure level.
Croatian: Utvrđeno je da je razina bez učinka za ove nalaze bila 6 puta veća od kliničke razine izloženosti.