FrancophonIA/ELRC3.0 huggingface dataset:
English: There are toxicities that require interruption of Nevirapine Teva therapy (see section 4.4).
Croatian: Postoje toksičnosti koje zahtijevaju prekid terapije Nevirapinom Teva (vidjeti dio 4.4).
English: CONTRACEPTIVES
Croatian: KONTRACEPTIVI
English: If ASAT or ALAT ≥ 2.5 ULN before or during treatment, then liver tests should be monitored more frequently during regular clinic visits.
Croatian: Ako su AST ili ALT ≥2,5 x GGN prije ili tijekom liječenja, testovi jetre moraju se pratiti češće na redovitim liječničkim kontrolama.
English: An increase in the dose of lopinavir/ritonavir to 533/133 mg (4 capsules) or 500/125 mg (5 tablets with 100/25 mg each) twice daily with food is recommended in combination with Nevirapine Teva.
Croatian: Povišenje doze lopinavir/ritonavira na 533/133 mg (4 kapsule) ili 500/125 mg (5 tableta s 100/25 mg svaka) dvaput dnevno s hranom preporučuje se u kombinaciji s
English: If you are receiving post-menopausal hormone therapy, ask your doctor for advice before taking this medicine.
Croatian: Ako primate hormonsku terapiju u postmenoapuzi, posavjetujte se s liječnikom prije nego počnete uzimati ovaj lijek.
English: This is a retrospective multicentre study comparing the 3-year antiviral efficacy of nevirapine and efavirenz in combination with stavudine and lamivudine in 2NN patients from week 49 to week 144.
Croatian: U ovoj retrospektivnoj multicentričnoj studiji uspoređena je antivirusna djelotvornost nevirapina i efavirenza u kombinaciji sa stavudinom i lamivudinom tijekom 3 godine u bolesnika koji su sudjelovali u 2NN studiji, od 49. do 144. tjedna.
English: Nevirapine must not be readministered to patients who have required permanent discontinuation for clinical hepatitis due to nevirapine.
Croatian: Nevirapin se ne smije ponovo primjenjivati na bolesnicima kojima je terapija bila trajno prekinuta zbog kliničkog hepatitisa uzrokovanog nevirapinom.
English: Nevirapine Cmax ↓ 0.50 compared to historical controls.
Croatian: Nevirapin Cmax ↓ 0,50 u usporedbi s povijesnom kontrolom.
English: Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs).
Croatian: Većina iskustava s nevirapinom odnosi se na kombinaciju s nukleozidnim inhibitorima reverzne transkriptaze (NRTI-i).
English: Absolute bioavailability in 12 healthy adults following single-dose administration was 93 ± 9% (mean SD) for a 50 mg tablet and 91 ± 8 % for an oral solution.
Croatian: Apsolutna bioraspoloživost u 12 zdravih odraslih osoba nakon jednokratne doze bila je 93 ± 9% (srednja vrijednost SD) za tabletu od 50 mg i 91 ± 8% za oralnu otopinu.
English: In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3%) than patients on nevirapine
Croatian: U ispitivanju 1100.1090, iz kojeg je zaprimljena većina povezanih nuspojava (n=28), incidencija granulocitopenije bila je viša u bolesnika koji su dobivali placebo (3,3%) nego u onih koji su uzimali nevirapin (2,5%).
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2).
Croatian: Nije potrebna prilagodba doze bolesnicima s blagim do umjerenim oštećenjem jetre (vidjeti dijelove 4.4. i 5.2.).
English: Women appear to be at higher risk than men of developing rash, whether receiving nevirapine or non- nevirapine containing therapy.
Croatian: Pokazalo se da su žene rizičnija skupina od muškaraca za razvoj osipa, bez obzira primaju li terapiju nevirapinom ili primaju terapiju koja ne sadrži nevirapin.
English: Physicians needing to treat patients co-infected with tuberculosis and using a Nevirapine Teva containing regimen may consider coadministration of rifabutin instead.
Croatian: Liječnici koji trebaju liječiti bolesnike istodobno inficiranih tuberkulozom koji se liječe Nevirapinom Teva mogu, umjesto toga, razmotriti istodobnu primjenu rifabutina.
English: ANTIVIRALS FOR CHRONIC HEPATITIS B AND C
Croatian: ANTIVIRUSNI LIJEKOVI ZA LIJEČENJE KRONIČNOG HEPATITISA B I C
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: Ako imate dodatna pitanja o primjeni ovog lijeka, upitajte svog liječnika ili ljekarnika.
English: Nevirapine stops reverse transcriptase from working.
Croatian: Nevirapin zaustavlja rad reverzne transkriptaze.
English: Nevirapine: Co-administration of ritonavir does not lead to any clinically relevant change in nevirapine plasma levels.
Croatian: Nevirapin: Istodobna primjena ritonavira ne vodi do klinički značajne promjene u razinama nevirapina u plazmi.
English: As Nevirapine Teva must always be taken together with other HIV antiretroviral medicines, you should follow the instructions for your other medicines carefully.
Croatian: Budući da se Nevirapin Teva uvijek mora uzimati zajedno s drugim antiretrovirusnim lijekovima protiv HIV-a, trebate pažljivo slijediti upute za uzimanje tih drugih lijekova koje su priložene uz te lijekove.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (CALENDAR PACK)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER (KALENDARSKO PAKOVANJE)
English: Cobicistat, a cytochrome P450 3A inhibitor significantly inhibits hepatic enzymes, as well as other metabolic pathways.
Croatian: inhibitor citokroma P450 3A, značajno inhibira jetrene enzime kao i druge metaboličke puteve.
English: The recommended dose of Nevirapine Teva is one 200 mg tablet daily for the first 14 days (this leadin period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents.
Croatian: Preporučena doza lijeka Nevirapin Teva je jedna tableta od 200 mg dnevno tijekom prvih 14 dana (ovo uvodno razdoblje je potrebno s obzirom da primijećeno smanjuje učestalost osipa), a nakon toga jedna tableta od 200 mg dvaput dnevno, u kombinaciji s najmanje dva dodatna antiretrovirusna lijeka.
English: Norethindrone (NET) 1.0 mg QD
Croatian: Noretindron (NET) 1,0 mg 1x/dan
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Croatian: Pored oportunističkih infekcija, također se mogu pojaviti autoimuni poremećaji (stanje koje se javlja kada imunološki sustav napada zdravo ljudsko tkivo) nakon početka primjene lijekova za liječenje HIV infekcije.
English: Patients with CLcr ≥ 20 ml/min do not require a dose adjustment, see section 5.2.
Croatian: Bolesnici s klirensom kreatinina ≥ 20 ml/min ne zahtijevaju prilagodbu doze, vidjeti dio 5.2.
English: Peak plasma nevirapine concentrations of 2 ± 0.4 μg/ml (7.5 μM) were attained by 4 hours following a single 200 mg dose.
Croatian: Vršne koncetracije nevirapina u plazmi od 2 ± 0,4 µg/ml (7,5 µM) postignute su 4 sata nakon jednokratne doze od 200 mg.
English: The results suggest that supplementing nevirapine therapy with an additional 200 mg dose of nevirapine following each dialysis treatment would help offset the effects of dialysis on nevirapine clearance.
Croatian: Rezultati ukazuju da bi nadomještanje terapije nevirapina s dodatnih 200 mg nevirapina nakon svake dijalize pomoglo uklanjanju učinka dijalize na klirens nevirapina.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza “Rok valjanosti”.
English: ENTRY INHIBITORS
Croatian: INHIBITORI ULAZA
English: If patients experience fatigue they should avoid potentially hazardous tasks such as driving or operating machinery.
Croatian: Ako bolesnik osjeti umor mora izbjegavati potencijalno opasne radnje kao što su upravljanje vozilima i rad na strojevima.
English: The most common clinical toxicity of nevirapine is rash, with nevirapine attributable rash occurring in 12.5 % of patients in combination regimens in controlled studies.
Croatian: Najčešća klinička toksičnost nevirapina je osip, a osip koji se pripisuje nevirapinu uz kombiniranu terapiju u kontroliranim ispitivanjima događa se kod bolesnika 12,5 %.
English: Following multiple doses, nevirapine peak concentrations appear to increase linearly in the dose range of 200 to 400 mg/day.
Croatian: Nakon višekratnih doza, vršne koncetracije nevirapina izgleda da povećavaju linearnost doza u rasponu od 200 do 400 mg/dan.
English: The first 18 weeks of treatment is a critical period which requires close monitoring (see section 4.4).
Croatian: Prvih 18 tjedana liječenja je kritično razdoblje koje zahtijeva pomno praćenje (vidjeti dio 4.4.).
English: They should be informed that occurrence of symptoms suggestive of hepatitis should lead them to discontinue nevirapine and immediately seek medical evaluation, which should include liver function tests.
Croatian: Također moraju biti upoznati s činjenicom da, ako primijete simptome koji ukazuju na hepatitis, moraju prekinuti terapiju nevirapinom i odmah potražiti liječničku ocjenu, što uključuje testove jetrenih funkcija.
English: The patients studied were receiving antiretroviral therapy containing nevirapine 200 mg twice daily for at least 6 weeks prior to pharmacokinetic sampling, with a median duration of therapy of 3.4 years.
Croatian: Ispitivani bolesnici dobivali su antiretrovirusnu terapiju koja je sadržavala nevirapin u dozi od 200 mg dvaput dnevno u trajanju najmanje od 6 tjedana prije uzimanja uzoraka za farmakokinetičku analizu, a medijan trajanja terapije bio je 3,4 godine.
English: Nevirapine Teva is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age.
Croatian: Nevirapin Teva se koristi u liječenju HIV-1 infekcija kod odraslih osoba, adolescenata i djece bilo koje dobi.
English: Increased ASAT or ALAT levels ≥ 2.5 ULN and/or co-infection with hepatitis B and/or C at the start of antiretroviral therapy is associated with greater risk of hepatic adverse reactions during antiretroviral therapy in general, including nevirapine containing regimens.
Croatian: Povišene razine AST ili ALT-a ≥ 2,5 x GGN i/ili istodobna infekcija hepatitisom B i/ili C na početku antiretrovirusne terapije, povezane su s povećanim rizikom jetrenih nuspojava tijekom antiretrovirusne terapije općenito, uključujući režime koje sadrže nevirapin.
English: Do not take more Nevirapine Teva than prescribed by your doctor and described in this leaflet.
Croatian: Ne uzimajte veću dozu nego što je propisao liječnik i nego što je navedeno u ovoj uputi.
English: Saquinavir/ritonavir The limited data available with saquinavir soft gel capsule boosted with ritonavir do not suggest any clinically relevant interaction between saquinavir boosted with ritonavir and nevirapine
Croatian: Ograničeni podaci dostupni za meke Sakvinavir/ritonavir i Nevirapin želatinaste kapsule sakvinavira pojačane ritonavirom ne ukazuju na klinički značajnu interakciju između sakvinavira pojačanog ritonavirom i nevirapinom
English: Hormonal methods of birth control other than Depot-medroxyprogesterone acetate (DMPA) should not be used as the sole method of contraception in women taking Nevirapine Teva, since nevirapine might lower the plasma concentrations of these medicinal products.
Croatian: Hormonska kontracepcija, osim one koja se temelji na primjeni depo-pripravaka medroksiprogesteronacetata, ne smije biti jedina metoda kontracepcije u žena koje uzimaju Nevirapin Teva, s obzirom da nevirapin može sniziti koncentracije tih lijekova u plazmi.
English: If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of Nevirapine Teva.
Croatian: Ako ste podvrgnuti dijalizi bubrega, liječnik može razmotriti prilagođavanje doze Nevirapina Teva.
English: Abnormal liver functioning has been reported with the use of Nevirapine Teva.
Croatian: Abnormalna funkcija jetre prijavljena je uz primjenu Nevirapina Teva.
English: Results of DDI studies of telaprevir with efavirenz indicate that caution should be exercised when co-administering telaprevir with P450 inducers.
Croatian: ispitivanja telaprevira s efavirenzom ukazuju na potrebu opreza u istodobnoj primjeni telaprevira s induktorima P450.
English: Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as: - rash - swelling of the face - difficulty breathing (bronchial spasm) - anaphylactic shock
Croatian: Takve se reakcije mogu javiti u obliku anafilakse (teški oblik alergijske reakcije) sa simptomima poput: - osipa - oticanja lica - otežanog disanja (bronhijalni spazam)
English: The 14-day “lead-in” period has been shown to lower the risk of skin rash.
Croatian: Pokazalo se da razdoblje “uvođenja” u trajanju od 14 dana smanjuje rizik od osipa..
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St. John‘s Wort.
Croatian: Inducirajući učinak se može održati najmanje 2 tjedna nakon prekida liječenja ospinom travom.
English: Nevirapine Teva belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection.
Croatian: Nevirapin Teva pripada skupini antiretrovirusnih lijekova koji se primjenjuju u liječenju infekcije virusom humane imunodeficijencije (HIV-1).
English: Dose adjustment of Nevirapine Teva is not required when co-administered with lopinavir.
Croatian: Prilagodba doze Nevirapina Teva nije potrebna pri istodobnoj primjeni s lopinavirom.
English: Following intravenous administration to healthy adults, the volume of distribution (Vdss) of nevirapine was 1.21 ± 0.09 l/kg, suggesting that nevirapine is widely distributed in humans.
Croatian: Nakon intravenske primjene u zdravih odraslih osoba volumen distribucije nevirapina (Vdss) bio je 1,21 ± 0,09 l/kg,
English: A durable response to nevirapine for at least three years was documented in this study, and equivalence within a 10% range was demonstrated between nevirapine 200 mg twice daily and efavirenz with respect to treatment failure.
Croatian: Ispitivanje je pokazalo dugotrajan odgovor na nevirapin tijekom najmanje 3 godine i dokazana je ekvivalencija, unutar granice 10% između nevirapina 200 mg dvaput dnevno i efavirenza u pogledu neuspjeha liječenja.
English: Nevirapine must not be restarted following severe hepatic, skin or hypersensitivity reactions (see section 4.3).
Croatian: Primjena nevirapina ne smije se ponovo započeti nakon teških jetrenih i kožnih reakcija ili reakcija preosjetljivosti (vidjeti dio 4.3.).
English: It is not recommended to coadminister efavirenz and Nevirapine Teva (see section 4.4), because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone (for results of 2NN study, see section 5.1).
Croatian: Ne preporučuje se istodobna primjena efavirenza i Nevirapin Teva (vidjeti dio 4.4.) zbog dodatne toksičnosti i izostanka koristi u odnosu na sam NNRTI (za rezultate 2NN ispitivanja, vidjeti dio 5.1).
English: You may take Nevirapine Teva with or without food.
Croatian: Možete uzimati Nevirapin Teva s hranom ili bez nje.
English: Nevirapine Teva should not be used as the sole active antiretroviral, as monotherapy with any antiretroviral has shown to result in viral resistance.
Croatian: Nevirapin Teva se ne smije primjenjivati kao monoterapija aktivnim antiretrovirusnim lijekom, jer monoterapija bilo kojim antiretrovirusnim lijekom rezultira virusnom rezistencijom.
English: Only a small fraction (< 5 %) of the radioactivity in urine (representing < 3 % of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound.
Croatian: Samo mali dio (< 5%) radioaktivnosti u urinu (koji predstavlja <3% ukupne doze)
English: Clinical hepatitis reported as clinical adverse event occurred in 10 (2.6%) and 2 (0.5%) patients in the nevirapine twice daily and efavirenz groups respectively.
Croatian: Klinički hepatitis prijavljen kao klinička nuspojava dogodio se u 10 (2,6%) bolesnika na nevirapinu dvaput dnevno i u 2 (0,5%) bolesnika na efavirenzu.
English: Nevirapine Cmax ↑ 1.24 compared to historical controls.
Croatian: Nevirapin Cmax ↑ 1,24 u usporedbi s povijesnom kontrolom.
English: The double non-nucleoside study 2 NN was a randomised, open-label, multicentre prospective study comparing the NNRTIs nevirapine, efavirenz and both medicinal products given together.
Croatian: 2 NN studija dvostrukih nenukleozida je randomizirana, otvorena, multicentrična, prospektivna studija u kojoj su uspoređena dva NNRTI-a - nevirapin i efavirenz - kao monoterapija u odnosu na kombinaciju.
English: Nevirapine Teva may be taken with or without food.
Croatian: Nevirapin Teva se može uzimati s hranom ili bez nje.
English: The predetermined primary efficacy comparison was between the nevirapine twice daily and the efavirenz treatment groups.
Croatian: Predodređena primarna djelotvornost liječenih skupina bila je uspoređena između nevirapina dvaput dnevno i efavirenza.
English: Rashes are usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or without pruritus, located on the trunk, face and extremities.
Croatian: Osipi su obično blage do umjerene makulopapularno eritematozno izbijanje kožnih promjena, s ili bez svrbeža, na trupu, licu i ekstremitetima.
English: If patients present with a suspected nevirapine-associated rash, liver function tests should be performed.
Croatian: Ako se u bolesnika sumnja na osip povezan s nevirapinom, moraju se učiniti testovi jetrene funkcije.
English: Results of a 48-week analysis of the South African study BI 1100.1368 confirmed that the 4/7 mg/kg and 150 mg/m2 nevirapine dose groups were well tolerated and effective in treating antiretroviral naive paediatric patients.
Croatian: Pedijatrijska populacija Rezultati analize studije BI 1100.1368 provedene u Južnoj Africi, potvrdili su da se doze nevirapina od 4/7 mg/kg i 150 mg/m2 dobro podnose i da su učinkovite u liječenju prethodno neliječenih pedijatrijskih bolesnika.
English: Post-Exposure-Prophylaxis: Serious hepatotoxicity, including liver failure requiring transplantation, has been reported in HIV-uninfected individuals receiving multiple doses of nevirapine in the setting of post-exposure-prophylaxis (PEP), an unapproved use.
Croatian: Postekspozicijska profilaksa: Teška hepatotoksičnost, uključujući zatajenje jetre koje zahtijeva transplataciju, prijavljena je u osoba koje nisu inficirane HIV-om, a koje su primale višekratne doze nevirapina u svrhu postekspozicijske profilakse (PEP), što nije odobrena indikacija primjene.
English: - St John's Wort (Hypericum perforatum, medicine to treat depression) - rifampicin (medicine to treat tuberculosis) - rifabutin (medicine to treat tuberculosis) - macrolides e.g. clarithromycin (medicine to treat bacterial infections) - fluconazole (medicine to treat fungal infections) - ketoconazole (medicine to treat fungal infections) - itraconazole (medicine to treat fungal infections) - methadone (medicine used for treatment of opiate addicts) - warfarin (medicine to reduce blood clotting) - hormonal contraceptives (e.g. the “pill”) - atazanavir (another medicine to treat HIV-infection) - lopinavir/ritonavir (another medicine to treat HIV-infection) - fosamprenavir (another medicine to treat HIV-infection) - efavirenz (another medicine to treat HIV-infection) - etravirine (another medicine to treat HIV-infection) - rilpivirine (another medicine to treat HIV-infection) - delavirdine (another medicine to treat HIV-infection) - zidovudine (another medicine to treat HIV-infection) - boceprevir (medicine to treat hepatitis C) - telaprevir (medicine to treat hepatitis C) - elvitegravir/cobicistat (another medicine to treat HIV-infection)
Croatian: - atazanavir (drugi lijek za liječenje HIV infekcije) - lopinavir/ritonavir (drugi lijek za liječenje HIV infekcije) - fosamprenavir (drugi lijek za liječenje HIV infekcije) - efavirenz (drugi lijek za liječenje HIV infekcije) - etravirin (drugi lijek za liječenje HIV infekcije) - rilpivirin (drugi lijek za liječenje HIV infekcije) - delavirdin (drugi lijek za liječenje HIV infekcije) - zidovudin (drugi lijek za liječenje HIV infekcije) - boceprevir (lijek za liječenje hepatitisa C) - telaprevir (lijek za liječenje hepatitisa C) - elvitegravir/kobicistat (drugi lijek za liječenje HIV infekcije)
English: Treatment initiation pack
Croatian: Pakovanje za početak liječenja
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Croatian: Također su prijavljeni autoimuni poremećaji (kao što su Gravesova bolest i autoimuni hepatits); međutim, vrijeme do nastupa varira te može proći više mjeseci od početka liječenja do njihove pojave (vidjeti dio 4.4.).
English: Of the patients with grade 3 or 4 liver-associated laboratory toxicity, the proportions coinfected with hepatitis B or hepatitis C virus were 6.7% and 20.0% in the nevirapine twice daily group, 5.6% and 11.1% in the efavirenz group.
Croatian: Među bolesnicima koji su imali laboratorijske nalaze oštećenja jetre stupnja 3 ili 4, udio onih koji su bili istodobno inficirani s virusom hepatitisa B ili C bio je 6,7% odnosno 20,0% u skupini koja je dobivala nevirapin dvaput dnevno, odnosno 5,6% i 11,1% u skupini koja je dobivala efavirenz.
English: Coadministration with herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine (see section 4.5).
Croatian: Istodobna primjena s biljnim pripravcima koji sadrže gospinu travu (Hypericum perforatum) zbog rizika od smanjenja koncentracija u plazmi te smanjenih kliničkih učinaka nevirapina (vidjeti dio 4.5.).
English: Nevirapine in combination with efavirenz exhibited a strong antagonistic anti-HIV-1 activity in vitro (see section 4.5) and was additive to antagonistic with the protease inhibitor ritonavir or the fusion inhibitor enfuvirtide.
Croatian: In vitro, nevirapin u kombinacji s efavirenzom pokazuje snažni antagonizam anti-HIV-1-aktivnosti (vidjeti dio 4.5.) te s inhibitorom proteaza ritonavirom ili inhibitorom fuzije enfurvitidom rezultira aditivnim do antagonističkim učinkom.
English: Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction.
Croatian: Odmah obavijestite liječnika ako dobijete osip ili neku drugu nuspojavu reakcije preosjetljivosti
English: Data reported in the literature from 20 HIV-infected patients suggest a steady state Cmax of 5.74 μg/ml (5.00-7.44) and Cmin of 3.73 μg/ml (3.20-5.08) with an AUC of 109.0 h*μg/ml (96.0-143.5) in patients taking 200 mg of nevirapine bid.
Croatian: om inficiranih bolesnika ukazuju na stanje dinamičke ravnoteže Cmax od 5,74 µg/ml (5,00-7,44) i Cmin od 3,73 µg/ml (3,20-5,08) te AUC od 109,0 h*μg/ml (96,0-143,5) u bolesnika koji uzimaju 200 mg nevirapina dvaput dnevno.
English: Patients who participated in the 2NN study and were still under active follow-up at week 48 when the study closed and were still being treated at the study clinic, were asked to participate in this study.
Croatian: 2NN ispitivanja, kada je ispitivanje završeno, još uvijek bili pod aktivnim praćenjem, te su nastavili liječenje u klinici uključenoj u studiju.
English: Investigations Common liver function tests abnormal (alanine aminotransferase increased; transaminases increased; aspartate aminotransferase increased; gamma-glutamyltransferase increased; hepatic enzyme increased; hypertransaminasaemia) Uncommon blood phosphorus decreased; blood pressure increased
Croatian: Često abnormalni testovi jetrene funkcije (povišena alanin-aminotransferaza, povišene transaminaze; povišena aspartat-aminotransferaza; povišena gamaglutamiltransferaza; povišeni jetreni enzimi; hipertransaminazemija)