natgillin/translations-raw huggingface dataset:
A bioequivalence study in healthy subjects demonstrated that the Efficib (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets. 
Ispitivanje bioekvivalencije u zdravih ispitanika pokazalo je da su Efficib (sitagliptin/metforminklorid) kombinirane tablete bioekvivalentne istodobnoj primjeni pojedinačnih tableta sitagliptinfosfata i metforminklorida.
When Efficib is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4). 
Kad se Efficib primjenjuje u kombinaciji s inzulinom, možda će biti potrebno sniziti dozu inzulina kako bi se smanjio rizik od razvoja hipoglikemije (vidjeti dio 4.4).
Efficib combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class. 
Efficib sadrži kombinaciju dva antihiperglikemijska lijeka s komplementarnim mehanizmima djelovanja koji poboljšavaju regulaciju glikemije u bolesnika s dijabetesom tipa 2: sitagliptinfosfat, inhibitor dipeptidil peptidaze 4 (DPP-4), i metforminklorid, lijek iz skupine bigvanida.
When Efficib is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4). 
Kad se Efficib primjenjuje u kombinaciji sa sulfonilurejom, možda će biti potrebno sniziti dozu sulfonilureje kako bi se smanjio rizik od razvoja hipoglikemije (vidjeti dio 4.4).
Efficib must therefore not be used in women who are breast-feeding (see section 4.3). 
Stoga dojilje ne smiju uzimati Efficib (vidjeti dio 4.3).
If bullous pemphigoid is suspected, Efficib should be discontinued. 
Pri sumnji na bulozni pemfigoid treba prekinuti liječenje lijekom Efficib.
tel.: +39 06 91393303 addendapharma@legalmail.it 
Addenda Pharma S.r.l. tel.: +39 06 91393303 addendapharma@legalmail.it
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Efficib. 
Ako niste sigurni odnosi li se nešto od gore navedenog na Vas, prije uzimanja lijeka Efficib obratite se svom liječniku ili ljekarniku.
How to store Efficib 
Kako čuvati Efficib
Efficib is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. 
Efficib je indiciran kao dopuna dijeti i tjelovježbi za poboljšanje regulacije glikemije u bolesnika u kojih ista nije odgovarajuće regulirana primjenom najviše podnošljive doze samo metformina ili u onih koji se već liječe kombinacijom sitagliptina i metformina.
For the different doses on metformin, Efficib is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride. 
Za različite doze metformina, Efficib je dostupan u jačinama od 50 mg sitagliptina i 850 mg metforminklorida ili 1000 mg metforminklorida.
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Efficib (see section 4). 
U bolesnika koji su primali Efficib prijavljeni su slučajevi upale gušterače (pankreatitis) (pogledajte dio 4.).
Efficib is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control. 
Efficib je također indiciran kao dodatak inzulinu (tj. kao dio trojne kombinirane terapije), a kao dopuna dijeti i tjelovježbi, za poboljšanje regulacije glikemije u bolesnika u kojih stabilna doza inzulina i samo metformin ne omogućavaju odgovarajuću regulaciju glikemije.
See section 2, Do not take Efficib. 
Nemojte uzimati Efficib.
Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Efficib who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis. 
Ako se razviju laboratorijski nalazi koji odstupaju od normalnih vrijednosti ili klinička bolest (posebno nejasna i loše definirana bolest) u bolesnika s prethodno dobro reguliranim dijabetesom tipa 2 lijekom Efficib, treba odmah potražiti znakove ketoacidoze ili laktacidoze.
Efficib must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.3 and 4.4). 
Primjena lijeka Efficib se mora prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna (vidjeti dijelove 4.3 i 4.4).
depending on how your kidneys are working - if you have recently had a heart attack or have severe circulatory problems, such as ‘shock' or breathing difficulties - if you have liver problems - if you drink alcohol to excess (either every day or only from time to time) - if you are breast-feeding 
Morat ćete prestati uzimati Efficib u vrijeme rendgenskog snimanja i 2 ili više dana nakon njega, što će odrediti Vaš liječnik ovisno o tome kako Vam rade bubrezi. - ako ste nedavno imali srčani udar ili imate teške probleme s cirkulacijom kao što su šok ili teškoće pri disanju - ako imate problema s jetrom - ako pijete previše alkohola (bilo svaki dan ili samo povremeno) - ako dojite
Efficib is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. 
Efficib je indiciran kao dio trojne kombinirane terapije s agonistom receptora za aktivator proliferacije peroksisoma-gama (engl. peroxisome proliferator-activated receptor gamma, PPAR) (tj. tiazolidindionom) kao dopuna dijeti i tjelovježbi u bolesnika koji nisu odgovarajuće regulirani primjenom najviše podnošljive doze metformina i agonista PPAR.
Efficib is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. 
Efficib je indiciran u kombinaciji sa sulfonilurejom (tj. kao dio trojne kombinirane terapije) kao dopuna dijeti i tjelovježbi u bolesnika koji nisu odgovarajuće regulirani primjenom najviše podnošljive doze metformina i sulfonilureje.
EU/1/08/457/008 14 film-coated tablets EU/1/08/457/009 28 film-coated tablets EU/1/08/457/010 56 film-coated tablets EU/1/08/457/021 60 film-coated tablets EU/1/08/457/011 112 film-coated tablets EU/1/08/457/012 168 film-coated tablets EU/1/08/457/022 180 film-coated tablets EU/1/08/457/013 196 film-coated tablets EU/1/08/457/014 50 x 1 film-coated tablets EU/1/08/457/016 196 (2 x 98) film-coated tablets EU/1/08/457/018 168 (2 x 84) film-coated tablets 
EU/1/08/457/008 14 filmom obloženih tableta EU/1/08/457/009 28 filmom obloženih tableta EU/1/08/457/010 56 filmom obloženih tableta EU/1/08/457/021 60 filmom obloženih tableta EU/1/08/457/011 112 filmom obloženih tableta EU/1/08/457/012 168 filmom obloženih tableta EU/1/08/457/022 180 filmom obloženih tableta EU/1/08/457/013 196 filmom obloženih tableta EU/1/08/457/014 50 x 1 filmom obložena tableta EU/1/08/457/016 196 (2 x 98) filmom obloženih tableta EU/1/08/457/018 168 (2 x 84) filmom obloženih tableta
Efficib 50 mg/850 mg film-coated tablets 
Efficib 50 mg/850 mg filmom obložene tablete
EU/1/08/457/001 14 film-coated tablets EU/1/08/457/002 28 film-coated tablets EU/1/08/457/003 56 film-coated tablets EU/1/08/457/019 60 film-coated tablets EU/1/08/457/004 112 film-coated tablets EU/1/08/457/005 168 film-coated tablets EU/1/08/457/020 180 film-coated tablets EU/1/08/457/006 196 film-coated tablets EU/1/08/457/007 50 x 1 film-coated tablets EU/1/08/457/015 196 (2 x 98) film-coated tablets EU/1/08/457/017 168 (2 x 84) film-coated tablets 
EU/1/08/457/001 14 filmom obloženih tableta EU/1/08/457/002 28 filmom obloženih tableta EU/1/08/457/003 56 filmom obloženih tableta EU/1/08/457/019 60 filmom obloženih tableta EU/1/08/457/004 112 filmom obloženih tableta EU/1/08/457/005 168 filmom obloženih tableta EU/1/08/457/020 180 filmom obloženih tableta EU/1/08/457/006 196 filmom obloženih tableta EU/1/08/457/007 50 x 1 filmom obložena tableta EU/1/08/457/015 196 (2 x 98) filmom obloženih tableta EU/1/08/457/017 168 (2 x 84) filmom obloženih tableta
Efficib 50 mg/1,000 mg film-coated tablets 
Efficib 50 mg/1000 mg filmom obložene tablete
Talk to your doctor or pharmacist before taking Efficib: - if you have or have had a disease of the pancreas (such as pancreatitis) - if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood. 
Obratite se svom liječniku ili ljekarniku prije nego uzmete Efficib: - ako imate ili ste imali bolest gušterače (kao što je pankreatitis).
Efficib 50 mg/1,000 mg tablets sitagliptin/metformin HCl 
Efficib 50 mg/1000 mg tablete sitagliptin/metforminklorid
Efficib 50 mg/850 mg tablets sitagliptin/metformin HCl 
Efficib 50 mg/850 mg tablete sitagliptin/metforminklorid
Efficib 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride 
Efficib 50 mg/1000 mg filmom obložene tablete sitagliptin/metforminklorid
This is sometimes called insulin-dependent diabetes - if you have or have had an allergic reaction to sitagliptin, metformin, or Efficib (see section 4) - if you are taking a sulphonylurea or insulin, diabetes medicines, together with Efficib, as you may experience low blood sugar levels (hypoglycaemia). 
- ako imate ili ste imali alergijsku reakciju na sitagliptin, metformin ili Efficib (pogledajte dio 4.).
Efficib 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride 
Efficib 50 mg/850 mg filmom obložene tablete sitagliptin/metforminklorid
Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Efficib) or during post-approval use of Efficib or sitagliptin alone or with other diabetes medicines: 
Neki bolesnici koji su u kliničkim ispitivanjima uzimali samo sitagliptin (jednu od djelatnih tvari lijeka Efficib), kao i bolesnici koji su koristili Efficib ili sitagliptin, nakon njihova stavljanja u promet, same ili s drugim lijekovima za šećernu bolest, imali su sljedeće nuspojave: Često: nizak šećer u krvi, glavobolja, infekcija gornjih dišnih puteva, začepljen nos ili curenje iz nosa i grlobolja, osteoartritis, bolovi u rukama ili nogama Manje često: omaglica, zatvor, svrbež
In case of long term treatment (more than 6 months): 
U slučaju dugotrajnog liječenja (dulje od 6 mjeseci):
• Allergic reactions which can, rarely, be serious 
• alergijske reakcije koje u rijetkim slučajevima mogu biti ozbiljne
All symptoms resolved completely within a few hours. 
Svi su se simptomi za nekoliko sati u potpunosti povukli.
Response rates varied between 43 and 80% depending on the studies and the criteria to define a response. 
Stopa odgovora bila je između 43 i 80%, ovisno o studiji i kriterijima kojima se definira odgovor.
Careful monitoring. 
Pažljivo praćenje.
• Intolerance to alcohol 
• intolerancija na alkohol
Not recommended unless necessary. 
Ne preporučuje se osim ako je neophodno.
Effects on human reproduction cannot be excluded. 
Ne može se isključiti utjecaj na humanu reprodukciju.
Escape phenomenon 
Fenomen bijega
• Loss of appetite or increased appetite 
• gubitak apetita ili povećan apetit
Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made. 
Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2, no ne mogu se dati preporuke za doziranje.
If you forget to take one dose, take this dose as soon as you remember. 
Ako zaboravite uzeti jednu dozu, uzmite je čim se sjetite.
Cmax and AUC increase more than proportionally with dose. 
Cmax i AUC povećavaju se više od proporcionalnog povećanja s dozom.
• Change in laboratory markers 
• promjena laboratorijskih markera
There are no data suggesting a need for a specific dose adjustment in this population. 
Nema podataka koji bi ukazivali na potrebu posebne prilagodbe doze u ovoj populaciji.
Then go on with regular schedule as prescribed. 
Zatim lijek nastavite uzimati prema uobičajenom rasporedu kako je propisano.
About 200 patients were treated for more than 6 months and some of them were treated for several years. 
Oko 200 bolesnika liječeno je dulje od 6 mjeseci, a neki su liječeni i nekoliko godina.
Plasma elimination is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter. 
Eliminacija iz plazme je bifazična s poluvijekom od 2 sata tijekom prvih 10 sati i 8 sati nakon toga.
Associated with a decrease in corresponding values for the active metabolite 
Povezan sa smanjenjem odgovarajućih vrijednosti za aktivni metabolit
About 13% of the dose is excreted in the urine, of which 2 to 4% is unchanged medicinal product. 
Oko 13 % doze izlučuje se urinom, od čega 2 do 4 % kao nepromijenjen lijek.
This medicine is not recommended for children under 12 years due to the lack of data in these patients. 
Ovaj lijek ne preporučuje se za djecu mlađu od 12 godina zbog nedostatnih podataka o primjeni lijeka u ovih bolesnika.
Tell your doctor or phamacist if you are taking, have recently taken or might take any other medicines. 
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Frequency of hepatotoxicity could be higher in adolescents than in adults. 
Učestalost hepatotoksičnosti mogla bi biti viša u adolescenata nego u odraslih.
Do not take this medicinal product during pregnancy. 
Ovaj lijek se ne smije uzimati u trudnoći.
Dose reduction of indinavir to 600 mg every 8 hours should be considered. 
Treba razmotriti smanjenje doze indinavira na 600 mg svakih 8 sati.
In a retrospective study conducted in several French centres, 200 patients with Cushing's disease were followed between 1995 and 2012. 
U retrospektivnoj studiji provedenoj u nekoliko francuskih centara od 1995. do 2012. godine praćeno je 200 bolesnika s Cushingovom bolesti.
• Distortion of the sense of taste 
• poremećen osjećaj okusa
Women must be provided with comprehensive information on pregnancy prevention. 
Ženama moraju biti pružene sveobuhvatne informacije o sprječavanju začeća.
Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Courron d‘Auvergne France 
Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Courron d‘Auvergne Francuska ili
This can result in an increase and/or prolongation of their effects, including adverse reactions. 
Posljedica toga može biti povećanje i/ili produljenje njihova učinka, uključujući nuspojave.
In vitro, the plasma protein binding is about 99% mainly to the albumin fraction. 
In vitro, vezanje na proteine u plazmi iznosi približno 99 %, uglavnom na albuminsku frakciju.
If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Ako mislite da ste trudni ili planirate zatrudnjeti, obratite se svom liječniku za savjet prije nego što uzmete ovaj lijek.
An ECG should be performed: 
EKG treba obaviti:
The maximal dose that was used for treatment of Cushing's syndrome is 1,600 mg/day. 
Maksimalna doza korištena za liječenje Cushingovog sindroma iznosi 1600 mg/dan.
Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known: 
Skupine učestalosti definirane su prema sljedećoj konvenciji: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Use in Cushing's disease 
Uporaba kod Cushingove bolesti
Hepatotoxicity does not appear to be dose dependent. 
Čini se da hepatotoksičnost ne ovisi o dozi.
Alcohol intolerance, anorexia, increased appetite 
Intolerancija na alkohol, anoreksija, pojačan apetit
Treatment of juvenile rats for 30 day beginning at 21 days of age delayed the puberty onset. 
Liječenje mladih štakora tijekom 30 dana od 21. dana života uzrokovalo je odgodu pojave puberteta.
Bone fragility and broken legs were reported in rats but were not observed in other species. 
Slučajevi lomljivih kosti i prijeloma nogu prijavljeni su u štakora, no nisu primijećeni u drugih vrsta.
The safety and efficacy of Ketoconazole HRA in children aged less than 12 years have not been established. 
Sigurnost i djelotvornost Ketoconazolea HRA u djece mlađe od 12 godina nisu ustanovljene.
However no modifications of ECG were recorded in dogs at daily doses up to 40 mg/kg administered for 12 months. 
Međutim, nisu zabilježene promjene na EKG-a u pasa pri dnevnim dozama do 40 mg/kg primjenjivanim tijekom 12 mjeseci.
HRA Pharma Rare Diseases 200 avenue de Paris 92320 CHATILLON France 
HRA Pharma Rare Diseases 200 avenue de Paris 92320 CHATILLON Francuska
Ketoconazole was stopped, but she deteriorated rapidly and died. 
Ketokonazol je ukinut, no njezino se stanje rapidno pogoršavalo te je umrla.
Aripiprazole dose should be reduced to approximatively one-half of its prescribed dose. 
Dozu aripiprazola treba smanjiti na približno upola manju od propisane.
The requirements for submission of PSURsfor this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Careful monitoring as it may cause an earlier onset and/or an increased severity of side-effects. 
Pažljivo praćenje jer mogu uzrokovati raniju pojavu i/ili veću težinu nuspojava.
• Aversion to light 
• odbojnost prema svjetlu
Speak with your doctor if you have a history of liver disease. 
Obavijestite liječnika ako imate bolest jetre u povijesti bolesti.
Alfentanil, fentanyl 
Alfentanil, fentanil
Use in ectopic Adrenocorticotropic Hormone (ACTH) syndrome 
Uporaba kod ektopičnog sindroma adrenokortikotropnog hormona (ACTH)
Side effects with frequency not known (frequency cannot be estimated from the available data): 
Nuspojave čija je učestalost nepoznata (učestalost se ne može procijeniti iz dostupnih podataka):
Careful monitoring of digoxin levels is recommended. 
Preporučuje se pažljivo praćenje razina digoksina.
Table 2: Incidence of adverse reactions and marked laboratory abnormalities reported in the literature in adults and adolescents patients 
Tablica 2: Incidencija nuspojava i značajnih laboratorijskih abnormalnosti objavljenih u literaturi u odraslih i adolescentnih bolesnika
Nevirapine: plasma levels: ↑1.15-1.28fold compared to historical controls 
Nevirapin: plazmatske razine: ↑ 1,151,28 puta u usporedbi s povijesnim kontrolama
Serious hepatic toxicity caused by ketoconazole treatment is rare (1/15000). 
Ozbiljna oštećenja jetre uzrokovana ketokonazolom su rijetka (1/15 000).
In approximately 10 to 15 % of ketoconazole treated patients, an "escape phenomenon" is observed and reinforces the need for a long-term clinical and biochemical follow-up of these patients. 
U približno 10 % do 15 % bolesnika liječenih ketokonazolom uočen je „fenomen bijega” koji zahtijeva dugotrajno kliničko i biokemijsko praćenje tih bolesnika.
Increases in liver enzymes (≤ 5N and > 5N) were observed in ~13.5 % and ~2.5% of patients respectively occurring mostly within the first 6 months of treatment. 
Povišene vrijednosti jetrenih enzima (≤ 5N i > 5N) uočene su u ~13,5 % odnosno ~2,5 % bolesnika, najčešće unutar prvih 6 mjeseci liječenja.
Insomnia, nervousness 
Nesanica, nervoza
Maraviroc dose should be decreased to 150 mg twice daily. 
Dozu maraviroka treba smanjiti na 150 mg dvaput na dan.
Studies in animals have shown effects on male and female reproductive parameters (see section 5.3). 
Ispitivanja na životinjama pokazala su učinke na muške i ženske reproduktivne parametre (vidjeti dio 5.3).
If these occur, treatment should be stopped immediately and liver function tests should be performed. 
Ako se ovi simptomi pojave, treba odmah prekinuti liječenje i provesti pretrage funkcije jetre.
Beta Blockers Nadolol 
Beta-blokatori Nadolol
In the event of accidental overdose, treatment consists of supportive measures. 
U slučaju nenamjernog predoziranja liječenje se sastoji od potpornih mjera.
Careful monitoring INR (international normalised ratio) monitoring recommended. 
Preporučuje se praćenje INR-a (međunarodnog normaliziranog omjera).
Careful monitoring of adverse reactions (respiratory depression, sedation) is recommended. 
Preporučuje se pažljivo praćenje nuspojava (respiratorne depresije, sedacije).
Block and replace regimen 
Režim liječenja blokadom i nadomještanjem
Data on the use of ketoconazole in patients older than 65 years are limited, but there is no evidence to suggest that specific dose adjustment is required in these patients (see section 5.2). 
Podaci o primjeni ketokonazola u bolesnika starijih od 65 godina su ograničeni, ali nema dokaza koji bi ukazivali na to da je kod tih bolesnika potrebno posebno prilagođavanje doze (vidjeti dio 5.2).
- Prior to the start of ketoconazole - Within one week after the beginning of the treatment - As clinically indicated thereafter. 
- prije početka primjene ketokonazola - unutar tjedan dana nakon početka liječenja - nakon toga prema kliničkoj indikaciji.
• Erectile dysfunction 
• erektilna disfunkcija
At the last visit, 78 patients (49.3%) were controlled, 37 patients (23.4%) had partial control with at least 50% decrease of UFC (without normalisation), and 43 patients (27.2%) had unchanged UFC levels. 
Na posljednjem posjetu u 78 je bolesnika (49,3 %) postignuta kontrola bolesti, u 37 bolesnika (23,4 %) djelomična kontrola sa smanjenjem UFC-a za najmanje 50 % (bez normalizacije), a u 43 bolesnika (27,2 %) razine UFC-a bile su nepromijenjene.
Transient decrease of testosterone concentrations 
Prolazno smanjenje koncentracija testosterona
At doses > 400 mg/day, half-lives of 3 to 10 hours have been reported. 
Pri dozama > 400 mg/dan prijavljen je poluvijek od 3 do 10 sati.
Ketoconazole is not carcinogenic. 
Ketokonazol nije karcinogen.
No studies were performed with albumin bound nanoparticules. 
Nisu provedena ispitivanja s nanočesticama vezanim na albumin.
However, the genotoxic potential was not properly determined for the proposed dosing regimen in the treatment of endogenous Cushing's syndrome. 
Međutim, genotoksični potencijal nije u potpunosti utvrđen za predviđeni režim doziranja u liječenju endogenog Cushingovog sindroma.
The major identified metabolic pathways are oxidation and degradation of the imidazole and piperazine rings, oxidative O-dealkylation and aromatic hydroxylation. 
Glavni identificirani metabolički putevi su oksidacija i degradacija imidazolnih i piperazinskih prstenova, oksidativna O-dealkilacija i aromatska hidroksilacija.
Table 1 Interactions and recommendations for co-administration. 
Tablica 1:Interakcije i preporuke za istovremenu primjenu
Potential interaction with medicinal products 
Potencijalne interakcije s drugim lijekovima
Data of inhibition indicate that risk of interaction with BCRP substrates cannot be excluded at the systemic level with very high doses of ketoconazole. 
Podaci o inhibiciji ukazuju na to da se rizik od interakcije sa supstratima BCRP-a ne može isključiti na sistemskoj razini pri vrlo visokim dozama ketokonazola.