FrancophonIA/ELRC3.0 huggingface dataset:
English: The first 18 weeks of therapy with nevirapine are a critical period which requires close monitoring of patients to disclose the potential appearance of severe and life-threatening skin reactions (including cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) and serious hepatitis/hepatic failure.
Croatian: Prvih 18 tjedana terapije nevirapinom je kritično razdoblje koje zahtijeva pomno praćenje bolesnika kako bi se otkrila mogućnost pojava teških i po život opasnih kožnih reakcija (uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN)) i ozbiljni hepatitis/zatajenje jetre.
English: Rifabutin 150 or 300 mg QD
Croatian: Rifabutin 150 ili 300 mg 1x/dan
English: Nevirapine must be permanently discontinued in any patient experiencing severe rash or a rash accompanied by constitutional symptoms (such as fever, blistering, oral lesions, conjunctivitis, facial oedema, muscle or joint aches, or general malaise), including Stevens-Johnson syndrome, or toxic epidermal necrolysis.
Croatian: Liječenje nevirapinom mora se trajno prekinuti u bolesnika kod kojih se pojavi teški osip ili osip popraćen općim simptomima (kao što su vrućica, stvaranje mjehurića, oralne lezije, konjunktivitis, edem lica, bolovi u mišićima ili zglobovima ili opće loše stanje), uključujući Stevens-Johnsonov sindrom ili toksičnu epidermalnu nekrolizu.
English: The side effects described below have been experienced by patients given Viramune:
Croatian: Nuspojave opisane u nastavku su imali bolesnici kojima je davan Viramune:
English: Maraviroc AUC  1.01 (0.6 -1.55) Maraviroc Cmin ND Maraviroc Cmax  1.54 (0.94-2.52) compared to historical controls
Croatian: Maravirok AUC  1,01 (0,6 -1,55) Maravirok Cmin NO Maravirok Cmax  1,54 (0,94-2,52) u usporedbi s povijesnom kontrolom
English: 2NN Three-year follow-up-study
Croatian: Trogodišnje praćenje bolesnika u 2NN studiji
English: Nevirapine Cmin  1.28
Croatian: Nevirapin Cmin  1,28
English: No specific drug-drug interaction study has been performed.
Croatian: Nisu provedena specifična ispitivanja interakcija.
English: There are no new adverse drug reactions for Viramune prolonged-release tablets that have not been previously identified for Viramune immediate-release tablets and oral suspension.
Croatian: Nisu zabilježene nove nuspojave za Viramune tablete s produljenim oslobađanjem koje nisu prethodno opažene za Viramune tablete s trenutnim oslobađanjem i oralnu suspenziju.
English: Some risk factors for developing serious cutaneous reactions have been identified; they include failure to follow the initial dosing of 200 mg daily during the lead-in period and a long delay between the initial symptoms and medical consultation.
Croatian: Prepoznati su određeni faktori rizika za razvoj ozbiljnih kožnih reakcija; oni uključuju propuste provođenja početnog doziranja od 200 mg dnevno tijekom uvodnog razdoblja te dugog odgađanja javljanja liječniku nakon pojave početnih simptoma.
English: Approximately half of the patients had at least 3 years of prior exposure to Viramune immediate-release prior to entering study
Croatian: Oko polovine bolesnika je imalo najmanje 3 godine prethodnog izlaganja Viramuneu s trenutnim oslobađanjem prije ulaska u ispitivanje 1100.1526.
English: Fertility In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
Croatian: U ispitivanjima reproduktivne toksičnosti na štakorima su uočeni poremećaji plodnosti.
English: You should continue to take Viramune for as long as instructed by your doctor.
Croatian: Potrebno je nastaviti uzimati Viramune toliko dugo koliko to kaže liječnik.
English: Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Croatian: Viramune oralna suspenzija sadrži metilparahidroksibenzoat i propilparahidroksibenzoat.
English: The pharmacokinetics of autoinduction is characterised by an approximately 1.5 to 2 fold increase in the apparent oral clearance of nevirapine as treatment continues from a single dose to two-to-four weeks of dosing with 200-400 mg/day.
Croatian: Farmakokinetička autoindukcija karakterizirana je povećanjem vidljivog oralnog klirensa nevirapina za 1,5-2 puta kako se liječenje nastavlja od jednokratne doze do doziranja od 200-400 mg/dan tijekom dva do četiri tjedna.
English: Week 48 (mean) n=419
Croatian: 48 tjed. (srednja vrijednos t) n=419
English: Table 3 shows outcomes at 48-weeks in study 1100.1486 (after randomization) by baseline viral load.
Croatian: Tablica 3 pokazuje ishode nakon 48 tjedana u ispitivanju 1100.1486 (nakon randomizacije) prema početnom virusnom opterećenju.
English: The use of Viramune has not been evaluated within a specific study on PEP, especially in term of treatment duration and therefore, is strongly discouraged.
Croatian: Ne postoje posebne studije o primjeni Viramunea u indikaciji PEP-a, osobito u smislu trajanja liječenja, te se stoga takva primjena izričito ne preporučuje.
English: Nevirapine had no antiviral activity in cell culture against group O HIV-1 isolates or HIV-2 isolates.
Croatian: U staničnim kulturama protiv skupine O HIV-izolata ili HIV-2 izolata nevirapin nije imao antivirusnu aktivnost.
English: Viramune 100 mg prolonged-release tablets are supplied in bottles with 90 prolongedrelease tablets.
Croatian: Viramune 100 mg tablete s produljenim oslobađanjem dostupne su u bočicama s 90 tableta s produljenim oslobađanjem.
English: For smaller children an oral suspension liquid form is available.
Croatian: Za manju djecu dostupna je oralna suspenzija u tekućem obliku.
English: The following adverse reactions which may be causally related to the administration of Viramune prolonged-release tablets have been reported.
Croatian: Prijavljene sljedeće nuspojave mogu biti uzročno povezane s primjenom Viramune tableta s produljenim oslobađanjem.
English: However, in some patients a rash, which appears as a blistering skin reaction, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and deaths have been recorded.
Croatian: Međutim, u nekih bolesnika osip, koji se pojavljuje u obliku mjehurića na koži, može biti težak i po život opasan (Stevens-Johnsonov sindrom i toksična epidermalna nekroliza), a zabilježeni su i smrtni ishodi.
English: Geometric mean steady-state plasma Viramune prolonged-release pre-dose trough concentrations were 3,880 ng/ml, 3,310 ng/ml and 5,350 ng/ml in age groups 3 to <6 years, 6 to <12 years, and 12 to <18 years of age, respectively.
Croatian: Geometrijski prosjek doze na kraju dozirnog intervala Viramunea s produljenim oslobađanjem u plazmi pri stanju dinamičke ravnoteže bio je 3880 ng/ml, 3 310 ng/ml odnosno 5350 ng/ml u dobnim skupinama 3 do <6 godina, 6 do <12 godina, i 12 do <18 godina starosti.
English: The limited data available from a phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV Cmin.
Croatian: Ograničeni podaci dostupni iz ispitivanja faze IIA na bolesnicima inficiranih HIV-om pokazali su klinički beznačajno 20%-tno smanjenje Cmin tipranavira.
English: Viramune should be used within 2 months of opening the bottle.
Croatian: Viramune se mora upotrijebiti unutar 2 mjeseca od otvaranja bočice.
English: Patients have experienced oedema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, increase in transaminases and weight decrease.
Croatian: Bolesnici su dobili edeme, erythema nodosum, umor, vrućicu, glavobolju, nesanicu, mučninu, plućne infiltrate, osip, vrtoglavicu, povraćanje, povišenje transaminaza i smanjenje težine.
English: The dose for adults is 20 ml (200 mg) once a day for the first 14 days of treatment (”lead in” period).
Croatian: Doza za odrasle je 20 ml (200 mg) jednom na dan prvih 14 dana liječenja (”uvodno” razdoblje).
English: 3 in adult males) at the initiation of nevirapine therapy are associated with a greater risk of hepatic adverse reactions if the patient has detectable plasma HIV-1 RNA - i.e. a concentration ≥ 50 copies/ml - at the initiation of nevirapine.
Croatian: 3 u odraslih muškaraca) imaju na početku terapije nevirapinom i povišeni rizik jetrenih nuspojava ako pri tome bolesnici imaju HIV-1 RNK u plazmi - tj. koncentraciju ≥50 kopija/ml.
English: Nevirapine should not be used in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
Croatian: Nevirapin se ne smije primjenjivati u bolesnika s teškim oštećenjem jetre (Child-Pugh C, vidjeti dio 4.3).
English: Excipients: includes sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate (see leaflet for further information)
Croatian: Pomoćne tvari: sadrži saharozu, sorbitol, metilparahidroskibenzoat, propilparahidroksibenzoat (vidjeti uputu o lijeku za dodatne informacije)
English: Sorbitol: Viramune oral suspension contains 162 mg of sorbitol per ml.
Croatian: Sorbitol: Viramune oralna suspenzija sadrži 162 mg sorbitola u 1 ml.
English: Only take Viramune prolonged-release tablets by mouth.
Croatian: Viramune tablete s produljenim oslobađanjem uzimajte samo kroz usta.
English: The mean peak plasma concentration of nevirapine was 2,060 ng/ml measured at a mean 24.5 hours after administration of 400 mg Viramune prolongedrelease tablets.
Croatian: Srednja vrijednost vršne koncentracije nevirapina u plazmi bila je 2 060 ng/ml mjereno u prosjeku nakon 24,5 sati iza primjene 400 mg Viramune tableta s produljenim oslobađanjem.
English: These adverse reactions are commonly associated with other antiretroviral agents and may be expected to occur when nevirapine is used in combination with other agents; however it is unlikely that these adverse reactions are due to nevirapine treatment.
Croatian: Ove nuspojave su obično povezane s drugim antiretrovirusnim lijekovima te se mogu očekivati kada se nevirapin primjenjuje u kombinaciji s drugim lijekovima; međutim, nije izgledna povezanost ovih nuspojava s liječenjem nevirapinom.
English: Table 2: Maintenance phase of Viramune prolonged-release
Croatian: Tablica 2: razdoblje održavanja Viramuneom s produljenim oslobađanjem
English: The medicinal product should be used within 2 months of opening.
Croatian: Lijek se mora upotrijebiti unutar 2 mjeseca nakon otvaranja.
English: Because nevirapine induces its own metabolism with multiple dosing, this single dose study may not reflect the impact of hepatic impairment on multiple dose pharmacokinetics (see section 4.4).
Croatian: S obzirom da nevirapin inducira svoj vlastiti metabolizam višestrukim doziranjem, ovo ispitivanje jednokratnom dozom ne može odražavati utjecaj oštećenja jetre na farmakokinetiku višestrukih doza (vidjeti dio 4.4).
English: Adefovir and Viramune may be coadministered without dose adefovir (see section 5.1), this has not been confirmed in clinical trials and reduced efficacy is not expected.
Croatian: Adefovir i Viramune se mogu istodobno primjenjivati bez adefovirom (vidjeti dio 5.1), što nije povrđeno kliničkim ispitivanjima te se ne očekuje smanjena djelotvornost.
English: As with rash symptoms, please inform your doctor of any side effects.
Croatian: Kao i u slučaju simptoma pojave osipa, molimo, obavijestite liječnika o svakoj nuspojavi.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Croatian: U bolesnika inficiranih HIV-om s teškom imunodeficijencijom u vrijeme početka kombinirane antiretrovirusne terapije (CART), može doći do pojave upalne reakcije do asimptomatske ili rezidualne oportunističke infekcije.
English: Viramune should be combined with at least two additional antiretroviral agents.
Croatian: Viramune se kombinira s najmanje dva dodatna antiretrovirusna lijeka.
English: Viramune is also available as a 200 mg tablet for patients 16 years and older, or for older children, particularly adolescents, weighing 50 kg or more or whose BSA is above 1.25 m
Croatian: Viramune je također dostupan u obliku tableta od 200 mg za bolesnike u dobi 16 i više godina starosti, osobito adolescente koji teže 50 ili više kg ili čiji je BSA (tjelesna površina) iznad 1,25 m
English: Nevirapine plasma levels were not altered by co-administration of tenofovir.
Croatian: Razine nevirapina u plazmi nisu bile promijenjene istodobnom primjenom tenofovira.
English: If co-administered with Viramune, an adjustment in the telaprevir dose should be considered.
Croatian: Ako se primjenjuje istodobno s Viramuneom, potrebno je razmotriti prilagodbu doze telaprevira.
English: Female gender and higher CD4 counts at the initiation of nevirapine therapy in treatment-naïve patients is associated with increased risk of hepatic adverse reactions.
Croatian: Žene i bolesnici s povišenim brojem CD4 na početku terapije nevirapinom, prethodno neliječenih, povezan je s povećanim rizikom nastanka jetrenih nuspojava.
English: The pharmacokinetics of Viramune prolonged-release has also been studied in a multiple dose pharmacokinetics study (study 1100.1489) in 24 HIV-1 infected patients who switched from chronic Viramune immediate-release therapy to Viramune prolonged-release.
Croatian: Farmakokinetika Viramunea s produljenim oslobađanjem također je ispitivana u studiji farmakokinetike višekratnih doza (ispitivanje 1100.1489) na 24 bolesnika inficirana s HIV-1 koji su se prebacili sa kronične terapije Viramuneom s trenutnim oslobađanjem na Viramune s produljenim oslobađanjem.
English: Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate).
Croatian: Jedan ml oralne suspenzije sadrži 10 mg nevirapina (u obliku hemihidrata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE CARTON LABEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA KUTIJI BOČICE
English: Viramune 200 mg Tablets
Croatian: Viramune 200 mg tablete
English: Nevirapine exhibited additive to synergistic anti-HIV-1 activity in combination with the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, saquinavir and tipranavir, and the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir and zidovudine.
Croatian: Kombinacije nevirapina s inhibitorima proteaze, amprenavirom, atazanavirom, indinavirom, lopinavirom, sakvinavirom i tipranavirom te s NRTI-ima, abakavirom, didanozinom, emtricitabinom, lamivudinom, stavudinom, tenofovirom i zidovudinom rezultiraju aditivnim do sinergističkom antivirusnom aktivnošću.
English: Most of the cases of both severe rash and mild/moderate rash occur in the first six weeks of treatment.
Croatian: Većina slučajeva, i teškog kao i blagog/umjerenog osipa se javlja u prvih šest tjedana liječenja.
English: However, patients with ESRD requiring dialysis exhibited a 43.5 % reduction in nevirapine AUC over a one-week exposure period.
Croatian: Međutim, bolesnici s ESRD-om koji zahtijevaju dijalizu pokazali su smanjenje od 43,5% za AUC nevirapina u odnosu na jednotjedno razdoblje izlaganja.
English: The patients studied were receiving antiretroviral therapy containing Viramune 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 Viramune 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: There are no data available on interchangeability for 400 mg prolonged-release tablets and 100 mg prolonged-release tablets.
Croatian: Nisu dostupni podaci o međusobnoj zamjenjivosti 400 mg tableta s produljenim oslobađanjem i 100 mg tableta s produljenim oslobađanjem.
English: Readministration to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
Croatian: Ponovna primjena u bolesnika u kojih je prethodno liječenje trajno prekinuto zbog teškog osipa, osipa popraćenog općim simptomima, reakcije preosjetljivosti ili kliničkog hepatitisa zbog nevirapina.
English: Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Sorbitol
Croatian: 6.1 Popis pomoćnih tvari karbomer metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) sorbitol saharoza polisorbat 80 natrijev hidroksid (za podešavanje pH) pročišćena voda
English: If you have any rash during this period, do not increase the dose but consult your doctor.
Croatian: Ako imate osip tijekom ovog razdoblja, nemojte povisivati dozu, već se posavjetujte s liječnikom.
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: Data concerning the pharmacokinetics of nevirapine have been derived from two major sources: a 48 week paediatric study in South Africa (BI 1100.1368) involving 123 HIV-1 positive, antiretroviral naïve patients aged 3 months to 16 years; and a consolidated analysis of five Paediatric AIDS Clinical Trials Group (PACTG) protocols comprising 495 patients aged 14 days to 19 years.
Croatian: Podaci o farmakokinetici nevirapina potječu iz dva velika izvora: 48-tjedno pedijatrijsko ispitivanje u Južnoj Africi (BI 1100.1368) u koje je bilo uključeno 123 HIV-1-pozitivna, antiretrovirusno prethodno neliječena bolesnika u dobi od 3 mjeseca do 16 godina; i skupna analiza pet studija iz programa pedijatrijskih kliničkih ispitivanja AIDS-a (PACTG), uključujući protokole 495 bolesnika u dobi od 14 dana do 19 godina.
English: Viramune tablets and oral suspension have been shown to be comparably bioavailable and interchangeable at doses up to 200 mg.
Croatian: Bioraspoloživost Viramune tableta usporedna je bioraspoloživosti oralne suspenzije, te se mogu primjenjivati naizmjenično s oralnom suspenzijom u dozama do 200 mg.
English: Female patients tend to have higher (approximately 20 - 30 %) trough concentrations in both Viramune prolonged-release and Viramune immediate-release treatment groups.
Croatian: Žene su imale veću tendenciju k višim (oko 20-30%) koncentracijama na kraju dozirnog intervala i u skupinama na Viramuneu s produljenim oslobađanjem i Viramuneu s trenutnim oslobađanjem.
English: The active substance of your medicine is called nevirapine.
Croatian: Djelatna tvar ovog lijeka je nevirapin.
English: Make sure that the adapter is fitted tightly.
Croatian: Budite sigurni da ste čvrsto namjestili nastavak.
English: 1,216 antiretroviral-therapy naïve patients with plasma HIV-1 RNA > 5,000 copies/ml at baseline were assigned to Viramune 400 mg once daily, Viramune 200 mg twice daily, efavirenz 600 mg once daily, or Viramune (400 mg) and efavirenz (800 mg) once daily, plus stavudine and lamivudine for 48 weeks.
Croatian: 1 216 bolesnika prethodno neliječenih antiretrovirusnim lijekovima s HIV-1 RNK u plazmi >5000 kopija/ml primali su Viramune 400 mg jednom dnevno, Viramune 200 mg dvaput dnevno, efavirenz 600 mg jednom dnevno ili Viramune (400 mg) i efavirenz (800 mg) jednom dnevno, plus stavudin i lamivudin tijekom 48 tjedana.
English: The nevirapine AUC0-24,ss and Cmin,ss measured after 19 days of fasted dosing of Viramune 400 mg prolonged-release tablets once daily were approximately 80 % and 90 %, respectively, of the AUC0-24,ss and Cmin,ss measured when patients were dosed with Viramune 200 mg immediate-release tablets twice daily.
Croatian: AUC0-24,ss i Cmin,ss nevirapina mjereni nakon 19 dana doziranja Viramune 400 mg tableta s produljenim oslobađanjem natašte jednom dnevno bili su oko 80 % odnosno 90 %, u odnosu na AUC0-24,ss i Cmin,ss mjerene kada su bolesnici primali Viramune 200 mg tablete s trenutnim oslobađanjem dvaput dnevno.
English: In a retrospective review of predominantly patients with a plasma HIV-1 viral load of 50 copies/ml or higher, women with CD4 counts >250 cells/mm
Croatian: U retrospektivnom pregledu uglavnom bolesnika s HIV-1 virusnim opterećenjem od 50 kopija/ml ili više u plazmi, žene s brojem CD4 >250 stanica/mm
English: How to store Viramune
Croatian: Kako čuvati Viramune
English: The most frequently reported adverse reactions related to Viramune prolonged-release therapy in treatment naïve patients (including lead-in phase with immediate-release) in clinical study 1100.1486 (VERxVE) were rash, nausea, liver function test abnormal, headache, fatigue, hepatitis, abdominal pain, diarrhoea and pyrexia.
Croatian: Najčešće prijavljene nuspojave povezane s terapijom Viramuneom tableta s produljenim oslobađanjem u liječenju prethodno neliječenih bolesnika (uključujući uvodno razdoblje i liječenje formulacijom s trenutnim oslobađanjem) u kliničkom ispitivanju 1100.1486 (VERxVE) bile su osip, mučnina, abnormalnosti u testovima jetrene funkcije, glavobolja, umor, hepatitis, bol u abdomenu, proljev i pireksija.
English: Package leaflet: Information for the user Viramune 50 mg/5 ml oral suspension nevirapine
Croatian: Uputa o lijeku: Informacije za korisnika Viramune 50 mg/5 ml oralna suspenzija nevirapin
English: The side effects described below have been experienced by patients given Viramune 200 mg tablets during the 14 day lead-in phase:
Croatian: Nuspojave opisane u nastavku su imali bolesnici kojima su davane Viramune 200 mg tablete tijekom 14-dnevnog uvodnog razdoblja:
English: As serious and life threatening hepatotoxicity has been observed in controlled and uncontrolled studies predominantly in patients with a plasma HIV-1 viral load of 50 copies/ml or higher, nevirapine should not be initiated in adult females with CD4 cell counts greater than 250 cells/mm
Croatian: S obzirom na slučajeve teške i po život opasne hepatotoksičnosti opažene u kontroliranim i nekontroliranim studijama, uglavnom u bolesnika s HIV-1 virusnim opterećenjem u plazmi od 50 kopija/ml ili više, primjena nevirapina ne smije se početi u odraslih žena s brojem CD4 većim od 250 stanica/mm
English: If your child develops any rash during this period, do not start taking Viramune prolonged-release tablets but consult your child's doctor.
Croatian: Ako Vaše dijete razvije bilo kakav osip tijekom tog razdoblja, ne počinjite s uzimanjem Viramune tableta s produljenim oslobađanjem, već se posavjetujte s liječnikom.
English: Women of childbearing potential / Contraception in males and females Women of childbearing potential should not use oral contraceptives as the sole method for birth control, since nevirapine might lower the plasma concentrations of these medicinal products (see sections 4.4 & 4.5).
Croatian: U žena reproduktivne dobi oralni kontraceptivi ne smiju se primjenjivati kao jedina metoda kontrole začeća jer nevirapin može sniziti koncentracije tih lijekova u plazmi (vidjeti dijelove 4.4 i 4.5).
English: Week 48 (mean) n=407
Croatian: 48 tjed. (srednja vrijednost) n=407
English: Patients should be instructed that a major toxicity of nevirapine is rash.
Croatian: Bolesnike treba upozoriti da je osip važna manifestacija toksičnosti nevirapina.
English: It is very important that your child takes Viramune oral suspension only once a day for the first 14 days (“lead-in” period).
Croatian: Vrlo je važno da Vaše dijete uzima Viramune oralnu suspenziju samo jednom na dan prvih 14 dana („uvodno“ razdoblje).
English: Didanosine AUC  1.08 (0.92-1.27) Didanosine Cmin ND Didanosine Cmax  0.98 (0.79-1.21)
Croatian: Didanozin AUC  1,08 (0,92-1,27) Didanozin Cmin NO Didanozin Cmax  0,98 (0,79-1,21)
English: Metabolite 25-O-desacetylrifabutin AUC  1.24 (0.84-1.84) Metabolite 25-O-desacetylrifabutin Cmin  1.22 (0.86-1.74) Metabolite 25-O-desacetylrifabutin Cmax  1.29 (0.98-1.68)
Croatian: Metabolit 25-O-dezacetilrifabutin AUC  1,24 (0,84-1,84) Metabolit 25-O-dezacetilrifabutin Cmin  1,22 (0,86-1,74) Metabolit 25-O-dezacetilrifabutin Cmax  1,29 (0,98-1,68)