FrancophonIA/ELRC3.0 huggingface dataset:
English: Viramune prolonged-release tablets can be taken with or without food.
Croatian: Viramune tablete s produljenim oslobađanjem mogu se uzimati s hranom ili bez nje.
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: Rapid emergence of HIV-strains which are cross-resistant to NNRTIs has been observed in vitro.
Croatian: Brza pojava sojeva HIV-a s ukriženom rezistencijom na NNRTI opažena je in vitro.
English: This increased risk for toxicity based on CD4 count thresholds has not been detected in patients with undetectable (i.e. < 50 copies/ml) plasma viral load.
Croatian: Ovaj povećan rizik toksičnosti koji se temelji na broju CD4 nije uočen u bolesnika s nedetektabilnim (tj. < 50 kopija/ml) virusnim opterećenjem u plazmi.
English: The proportion of patients with at least one grade 3 or 4 liver-associated laboratory toxicity was 8.3 % for nevirapine twice daily and 4.5 % for efavirenz.
Croatian: Udio bolesnika s najmanje jednim laboratorijskim nalazom povezanim s oštećenjem jetre stupnja 3 ili 4 bio je 8,3% za nevirapin primjenjen dvaput dnevno, a 4,5% za efavirenz.
English: Viramune tablets contain lactose (milk sugar).
Croatian: Viramune tablete sadrže laktozu (mliječni šećer).
English: Weight Range (kg) for patients  8 years of age on a body weight basis receiving 4 mg/kg.
Croatian: Raspon težine (kg) za bolesnike  8 godina na osnovi tjelesne težine koji primaju 4 mg/kg.
English: For smaller children smaller prolonged-release tablets or an oral suspension liquid form are available.
Croatian: Za manju djecu dostupne su tablete s produljenim oslobađanjem ili oralna suspenzija u tekućem obliku.
English: LIST OF EXCIPIENTS Excipients: includes lactose (see leaflet for further information)
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: sadrži laktozu (vidjeti uputu o lijeku za dodatne informacije)
English: Genotypic analysis was performed on isolates from 86 antiretroviral naïve patients who discontinued the VERxVE study (1100.1486) after experiencing virologic failure (rebound, partial response) or due to an adverse event or who had transient increase in viral load during the course of the study.
Croatian: Genotipska analiza provedena je na izolatima dobivenima od 86 prethodno neliječenih bolesnika u liječenju antiretrovirusnom terapijom koji su se povukli iz ispitivanja VERxVE (1100.1486) nakon virološkog neuspjeha (“rebound”/povratni učinak, djelomični odgovor) ili zbog nuspojave ili zbog prolaznog povećanja virusnog opterećenja tijekom ispitivanja.
English: All the randomised studies addressing this issue specifically excluded pregnant women, and pregnant women were under-represented in cohort studies as well as in meta-analyses.
Croatian: Sva randomizirana ispitivanja nevirapina eksplicitno nisu uključivala trudnice, a osim toga, trudnice su tek sporadično zastupljene i u kohortnim ispitivanjima i metaanalizama.
English: The prolonged-release tablet should not be divided.
Croatian: Tablete s produljenim oslobađanjem se ne smiju dijeliti.
English: Nevirapine: plasma levels:  1.151.28 compared to historical controls.
Croatian: Nevirapin: razine u plazmi  1,15-1,28 u usporedbi s povijesnom kontrolom
English: Thereafter your child will be switched to Viramune prolonged-release tablets once a day and your child's doctor will decide the right dose and prolonged-release tablet strength based either on your child's weight or body surface area.
Croatian: Nakon toga će se Vaše dijete prebaciti na Viramune tablete s produljenim oslobađanjem jedanput dnevno, a djetetov liječnik će odlučiti o ispravnoj dozi i jačini tablete s produljenim oslobađanjem na osnovi ili djetetove težine ili površine tijela.
English: Calculation of the volume of Viramune oral suspension (50 mg/5 ml) required for paediatric dosing after the two weeks lead-in period.
Croatian: Izračun volumena Viramune oralne suspenzije (50 mg/5 ml) potrebnog za pedijatrijsko doziranje nakon dva tjedna uvodnog razdoblja.
English: The most frequently observed laboratory test abnormalities are elevations in liver function tests (LFTs), including ALAT, ASAT, GGT, total bilirubin and alkaline phosphatase.
Croatian: Najčešći opaženi poremećaji laboratorijskih testova su povišene vrijednosti pokazatelja jetrene funkcije, uključujući ALT, AST, GGT, ukupni bilirubin i alkalnu fosfatazu.
English: In single dose, parallel group bioavailability studies (studies 1100.1517 and 1100.1531), the Viramune 50 and 100 mg prolonged-release tablets exhibited extended release characteristics of prolonged absorption and lower maximal concentrations, similar to the findings when a 400 mg prolongedrelease tablet was compared to the Viramune immediate-release 200 mg tablet.
Croatian: U ispitivanju bioraspoloživosti s jednokratnom dozom na paralelnim skupinama (ispitivanja 1100.1517 i 1100.1531), Viramune 50 i 100 mg tablete s produljenim oslobađanjem pokazale su svojstva produljene apsorpcije u skladu s produljenim oslobađanjem, kao i niže maksimalne koncentracije, što je slično otkrićima kada su 400 mg tablete s produljenim oslobađanjem uspoređivane s Viramune 200 mg tabletama s trenutnim oslobađanjem.
English: As the regimen of nevirapine plus efavirenz did not have additional efficacy and caused more adverse events than each medicinal product separately, this regimen is not recommended.
Croatian: Kako kombinacija nevirapina i efavirenza nije imala dodatnu djelotvornost, a učestalost nuspojava bila je viša nego za svaki lijek zasebno, ova se kombinacija ne preporučuje.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/007 (30 tablets, bottle) EU/1/97/055/008 (30 tablets, blister) EU/1/97/055/009 (90 tablets, blister)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/055/007 (30 tableta, bočica) EU/1/97/055/008 (30 tableta, blister) EU/1/97/055/009 (90 tableta, blister)
English: Total * Includes patients who received at least one dose of blinded medicinal product after randomisation.
Croatian: Ukupno * Uključuje bolesnike koji su primili najmanje jednu dozu lijeka “naslijepo” nakon randomizacije.
English: One side is marked with the code “54 193”, with a single bisect separating the “54” and “193”.
Croatian: Na jednoj strani je oznaka „54 193” s razdjelnikom koji odvaja „54“ i „193“.
English: In ACTG 245, a double-blind placebo controlled study, the frequency of serious medicinal product-related granulocytopenia was 5/305 (1.6%).
Croatian: U ACTG-u 245, dvostruko-slijepom, placebom kontroliranom ispitivanju, učestalost teške granulocitopenije povezane s lijekom bila je 5/305 (1,6%).
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, ukazujući na široku distribuciju nevirapina kod ljudi.
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: Literaturni podaci temeljeni na 20 HIVom 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: 3 or in adult males with CD4 cell counts greater than 400 cells/mm
Croatian: 3 ili u odraslih muškaraca s brojem CD4 stanica većim od 400 stanica/mm
English: Your child's doctor will calculate the dose for your child.
Croatian: Liječnik Vašeg djeteta izračunat će dozu za Vaše dijete.
English: As hepatotoxicity is more frequent in women with CD4 cell counts above 250 cells/mm
Croatian: S obzirom da je hepatotoksičnost češća u žena s brojem CD4 stanica iznad 250 stanica/mm
English: Where other antiretroviral medicines are accessible, the single dose Viramune regimen should be combined with additional effective antiretroviral medicines (as recommended in internationally recognized guidelines).
Croatian: Viramunea se mora kombinirati s dodatnim učinkovitim antiretrovirusnim lijekovima (u skladu s preporukama međunarodno priznatih smjernica).
English: Viramune 100 mg prolonged-release tablets can be taken by children three years of age and above.
Croatian: Viramune 100 mg tablete s produljenim oslobađanjem mogu uzimati djeca u dobi tri godine i stariji.
English: Safety data included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial.
Croatian: Podaci o sigurnosti uključivali su sve posjete bolesnika do trenutka kada je posljednji bolesnik ispunio 144 tjedna ispitivanja.
English: EXP To be used within 6 months after opening the bottle
Croatian: EXP Upotrijebiti unutar 6 mjeseci nakon otvaranja boce
English: If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of Viramune.
Croatian: Ako ste podvrgnuti dijalizi bubrega, liječnik može razmotriti prilagođavanje doze Viramunea.
English: Your child's doctor will continually check your child's age, weight or body surface area to ensure the correct dose.
Croatian: Djetetov liječnik će redovito provjeravati djetetovu dob, težinu ili površinu tijela kako bi osigurao ispravnu dozu.
English: Female patients showed a 13.8 % lower clearance of nevirapine than did male patients.
Croatian: Ukupni klirens nevirapina u žena bio je za 13,8% niži nego u muških bolesnika.
English: The observed pharmacokinetic difference between the 50 mg and 100 mg Viramune prolonged-release tablets is not clinically relevant, and the 50 mg prolonged-release tablet can be used as an alternative to the slightly larger 100 mg tablet.
Croatian: Opažena farmakokinetička razlika između 50 mg i 100 mg Viramunea s produljenim oslobađanjem nije klinički značajna, a 50 mg tableta s produljenim oslobađanjem se može primijeniti kao alternativno liječenje za nešto veću tabletu od 100 mg.
English: The pharmacokinetics of nevirapine has been studied in a single dose study (study 1100.1485) of Viramune prolonged-release in 17 healthy volunteers.
Croatian: Farmakokinetika nevirapina je ispitivana u ispitivanju jednokratne doze (ispitivanje 1100.1485) Viramunea s produljenim oslobađanjem na 17 zdravih dobrovoljaca.
English: Similarly the potential for cross-resistance between nevirapine and NRTIs is low because the molecules have different binding sites on the reverse transcriptase.
Croatian: Također, potencijal ukrižene reaktivnosti nevirapina i NRTI je nizak budući da se ti lijekovi vežu na različita mjesta na reverznoj transkriptazi.
English: For patients less than 3 years and for all other age groups, an immediate-release oral suspension dosage form is available (please refer to the respective Summary of Product Characteristics).
Croatian: Za bolesnike mlađe od 3 godine i za sve druge dobne skupine, dostupno je doziranje u obliku oralne suspenzije s trenutnim oslobađanjem (molimo, pogledajte odgovarajući sažetak opisa svojstava lijeka).
English: White, oval, biconvex tablets.
Croatian: Bijele, ovalne, bikonveksne tablete.
English: Female gender and higher CD4 counts (>250/mm
Croatian: Žene i bolesnici s povišenim brojem CD4 (> 250/mm
English: It is recommended that HIV-infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV and that mothers should discontinue breast-feeding if they are receiving nevirapine.
Croatian: Majkama inficiranim HIV-om ne preporučuje se dojenje kako bi se izbjegao rizik postnatalnog prijenosa HIV-a te im se preporučuje prekid dojenja ako primaju nevirapin.
English: Patients with moderate to severe elevations (ASAT or ALAT > 5 ULN) should be permanently discontinued from nevirapine.
Croatian: Bolesnici s umjerenim do teškim elevacijama (AST ili ALT >5 x GGN) moraju trajno obustaviti terapiju nevirapinom.
English: Therefore, caution should be recommended when driving a car or operating machinery.
Croatian: Stoga se preporuča oprez prilikom upravljanja vozilima i rada sa strojevima.
English: - The active substance is nevirapine.
Croatian: - Djelatna tvar je nevirapin.
English: For younger children starting from birth an oral suspension is available.
Croatian: Za mlađu djecu, od rođenja je dostupna oralna suspenzija.
English: Calculation of the volume of Viramune oral suspension (50 mg/5 ml) required for paediatric dosing on a body surface basis of 150 mg/m
Croatian: Izračun volumena Viramune oralne suspenzije (50 mg/5 ml) potrebnog za pedijatrijsko doziranje na osnovi tjelesne površine je 150 mg/m
English: The risk of hepatic reactions is greatest in the first 6 weeks of therapy.
Croatian: Rizik od jetrenih reakcija najveći je u prvih 6 tjedana terapije.
English: Monitoring of hepatic tests should be done every two weeks during the first 2 months of treatment, at the 3
Croatian: Jetrene testove treba ponavljati svaka dva tjedna tijekom prva 2 mjeseca liječenja, u trećem mjesecu i zatim redovito nakon toga.
English: The medicinal product should be used within 6 months of opening.
Croatian: Lijek se mora upotrijebiti unutar 6 mjeseci od otvaranja.
English: If you experience fatigue you should avoid potentially hazardous tasks such as driving or using any tools or machines.
Croatian: Ako osjetite umor, morate izbjegavati potencijalno opasne radnje kao što su upravljanje vozilima i rad s alatima ili strojevima.
English: High density polyethylene (HDPE) plastic bottle, with a plastic cap and an induction foil seal liner.
Croatian: Plastična bočica od polietilena visoke gustoće (HDPE), s plastičnim zatvaračem i pokrovom od zaštitne folije.
English: Clear polypropylene 5 ml dispensing syringe with silicone rubber piston seal.
Croatian: Prozirna polipropilenska dozirna štrcaljka od 5 ml zatvorena silikonskim gumenim klipom.
English: EU/1/97/055/003 [120 tablets]
Croatian: EU/1/97/055/003 [120 tableta]
English: Depending on the outcome your doctor may decide to interrupt or stop Viramune treatment.
Croatian: Zavisno od rezultata, Vaš liječnik odlučit će o mogućem prekidu ili prestanku liječenja Viramuneom.
English: Severe and life-threatening skin reactions have occurred in patients treated with nevirapine, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Croatian: Teške i po život opasne kožne reakcije dogodile su se u bolesnika liječenih nevirapinom, uključujući Stevens Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN).
English: You may take Viramune with or without food.
Croatian: Možete uzimati Viramune s hranom ili bez nje.
English: The isolated rash should be closely monitored (see section 4.4).
Croatian: Izolirani se osip mora pomno pratiti (vidjeti dio 4.4).
English: At week 48, mean change from baseline in CD4 cell count was 184 cells/mm
Croatian: Nakon 48 tjedna, srednja vrijednost promjene broja CD4 stanica u odnosu na početak bila je 184 stanica/mm
English: Prednisone should not be used to treat a rash related to Viramune.
Croatian: Prednizon se ne smije primjenjivati u liječenju osipa povezanog s Viramuneom.
English: Due to the metabolic pathway no clinically significant pharmacokinetic interactions are expected between enfuvirtide and nevirapine.
Croatian: Zbog metaboličkog puta ne očekuju se klinički značajne farmakokinetičke interakcije između enfuvirtida i nevirapina.
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 hepatitis); međutim, vrijeme do nastupa događaja varira te može proći više mjeseci od početka liječenja do njihove pojave (vidjeti dio 4.4).
English: How to take Viramune
Croatian: Kako uzimati Viramune
English: Norethindrone (NET) 1.0 mg QD
Croatian: Noretindron (NET) 1,0 mg 1x/ dan
English: Nevirapine AUC  0.42
Croatian: Nevirapin AUC  0,42
English: Your child's doctor will continually check your child's weight or body surface area to ensure the correct dose.
Croatian: Djetetov liječnik nastavit će provjeravati težinu ili površinu tijela kako bi osigurao ispravnu dozu.
English: If you notice any symptoms of infection, please inform your doctor immediately.
Croatian: Ako primijetite simptome infekcije, molimo, odmah obavijestite liječnika.
English: Viramune co-administration did not alter the ovulation suppression effects of DMPA.
Croatian: Istodobna primjena Viramunea nije promijenila učinke ovulacijske supresije DMPA.
English: The 14-day ”lead-in” period has been shown to lower the risk of skin rash.
Croatian: Pokazalo se da 14-dnevno „uvodno” razdoblje smanjuje rizik od kožnog osipa.
English: Two new substitutions on codons previously associated with nevirapine resistance were observed: one patient with Y181I in the Viramune prolonged-release group and one patient with Y188N in the Viramune immediate-release group; resistance to nevirapine was confirmed by phenotype.
Croatian: Opažene su dvije nove supstitucije na kodonima koje su se prethodno povezivale s rezistencijom na nevirapin: jedan bolesnika s Y181I u skupini na Viramuneu s produljenim oslobađanjem i jedan bolesnik s Y188N u skupini na Viramuneu s trenutnim oslobađanjem; rezistencija na nevirapin potvrđena je fenotipom.
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 i testove jetrenih funkcija.
English: - Latin America
Croatian: - Južna Amerika
English: The pharmacokinetics of Viramune prolonged-release was assessed in study 1100.1518.
Croatian: Farmakokinetika Viramunea s produljenim oslobađanjem ocjenjivana je u ispitivanju 1100.1518.
English: They should be advised to promptly notify their physician of any rash and avoid delay between the initial symptoms and medical consultation.
Croatian: Također ih je potrebno upozoriti da odmah obavijeste liječnika o pojavi osipa te na taj način izbjegnu odgodu savjetovanja s liječnikom nakon pojave prvih simptoma.
English: If bottles are taken the medicinal product should be used within 2 months of opening.
Croatian: Ako se lijek nalazi u bočicama, mora se upotrijebiti unutar 2 mjeseca nakon otvaranja.
English: Nevirapine AUC  1.26
Croatian: Nevirapin AUC  1,26
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC {broj} [oznaka lijeka]
English: However, the risk of any hepatic event continues past this period and monitoring should continue at frequent intervals.
Croatian: Međutim, rizik od jetrenih poremećaja postoji i nakon ovog razdoblja te treba nastaviti praćenje u redovitim intervalima.
English: Weight Range (kg) for patients < 8 yrs of age on a body weight basis receiving 7 mg/kg.
Croatian: Raspon težine (kg) za bolesnike < 8 godina na osnovi tjelesne težine koji primaju 7 mg/kg.
English: No changes to lamivudine apparent clearance and volume of distribution, suggesting no induction effect of nevirapine on lamivudine clearance.
Croatian: Bez promjena vidljivog klirensa i volumena distribucije lamivudina što ukazuje na odsustvo indukcijskog učinka nevirapina na klirens lamivudina.
English: The total daily dose should not exceed 400 mg for any patient.
Croatian: Ukupna dnevna doza niti u jednog bolesnika ne smije prelaziti 400 mg.
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: The study randomly assigned 460 adults who were taking two nucleoside reverse-transcriptase inhibitors and at least one PI and whose plasma HIV-1 RNA levels had been less than 200 c/ml for at least the previous six months to switch from the PI to Viramune (155 patients), efavirenz (156), or abacavir (149).
Croatian: Uključeno je 460 odraslih koji su prethodno uzimali dva nukelozidna inhibitora reverzne transkriptaze i najmanje jedan inhibitor proteaza i koji su tijekom najmanje 6 prethodnih mjeseci imali razine HIV-1 RNK <200 kopija/ml te su prebačeni na Viramune (155 bolesnika), efarvirenz (156) ili abakavir (149).
English: Tenofovir plasma levels remain unchanged when co-administered with nevirapine.
Croatian: Razine tenofovira u plazmi ostaju nepromijenjene kada se primjenjuje istodobno s nevirapinom.
English: Nevirapine Cmin  0.32
Croatian: Nevirapin Cmin  0,32
English: This lead-in period should be used because it has been found to lessen the frequency of rash.
Croatian: Ovo uvodno razdoblje je potrebno zbog otkrića da se smanjuje učestalost osipa.
English: After 14 days, the usual dose is one 200 mg tablet twice a day.
Croatian: Nakon 14 dana, uobičajena doza je jedna tableta od 200 mg dvaput na dan.
English: Viramune is also available as an oral suspension, tablets or as prolonged-release tablets with higher strength.
Croatian: Viramune je također dostupan u obliku oralne suspenzije, tableta ili tableta s produljenim oslobađanjem veće jačine.
English: Table 1: Demographic and Baseline Disease Characteristics in study 1100.1486 Viramune immediate-release
Croatian: Tablica 1: Demografska svojstva i početne vrijednosti u ispitivanju 1100.1486 Viramune s trenutnim oslobađanjem
English: Viramune should not be used as the sole active antiretroviral, as monotherapy with any antiretroviral has shown to result in viral resistance.
Croatian: Viramune se ne smije primjenjivati kao monoterapija aktivnim antiretrovirusnim lijekom, jer monoterapija bilo kojim antiretrovirusnim lijekom rezultira virusnom rezistencijom.
English: Based on clinical study experience of 361 paediatric patients the majority of which received combination treatment with ZDV or/and ddI, the most frequently reported adverse events related to nevirapine were similar to those observed in adults.
Croatian: Na temelju iskustva kliničkog ispitivanja s 361 pedijatrijskim bolesnikom, od kojih je većina primala kombinirano liječenje sa zidovudinom i/ili didanozinom, najčešće prijavljene nuspojave povezane s nevirapinom bile su slične onima opaženih u odraslih osoba.
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: Nevirapine Cmin  1.07
Croatian: Nevirapin Cmin  1,07
English: - The other ingredients are: microcrystalline cellulose, lactose (as monohydrate), povidone K25, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.
Croatian: - Drugi sastojci su: mikrokristalična celuloza, laktoza (u obliku hidrata), povidon K25, natrijev škroboglikolat, koloidni silicijev dioksid i magnezijev stearat.
English: Viramune is contraindicated in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
Croatian: Viramune je kontraindiciran u bolesnika s teškim jetrenim poremećajima (ChildPugh C, vidjeti dio 4.3).
English: Lactose: Viramune prolonged-release tablets contain 400 mg of lactose per maximum recommended daily dose.
Croatian: Laktoza: Viramune tablete s produljenim oslobađanjem sadrže 400 mg laktoze u maksimalnoj preporučenoj dnevnoj dozi.