FrancophonIA/ELRC3.0 huggingface dataset:
English: Results of in vitro studies showed a weak antagonism of nevirapine by ribavirin (see section 5.1), this has not been confirmed in clinical trials and reduced efficacy is not expected.
Croatian: Rezultati in vitro ispitivanja su pokazali slab antagonizam nevirapina s ribavirinom (vidjeti dio 5.1), što nije potvrđeno kliničkim ispitivanjima te se ne očekuje smanjena djelotvornost.
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: Rezultati 48-tjedne 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: The most common clinical toxicity of nevirapine is rash, with Viramune 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 Viramuneu uz kombiniranu terapiju u kontroliranim ispitivanjima događa se kod bolesnika 12,5 %.
English: Nevirapine metabolites: Studies using human liver microsomes indicated that the formation of nevirapine hydroxylated metabolites was not affected by the presence of dapsone, rifabutin, rifampicin, and trimethoprim/sulfamethoxazole.
Croatian: Metaboliti nevirapina: Ispitivanja na mikrosomima ljudske jetre pokazale su da dapson, rifabutin, rifampicin i trimetroprim/sulfametoksazol nisu utjecali na stvaranje hidroksiliranih metabolita nevirapina, dok su ketokonazol i eritromicin značajno inhibirali stvaranje.
English: - if you have taken Viramune before and had to stop the treatment because you suffered from: - severe skin rash - skin rash with other symptoms for example: - fever
Croatian: - ako ste prije uzimali Viramune te ste morali prekinuti liječenje jer ste patili od: - teškog kožnog osipa - kožnog osipa s drugim simptomima, na primjer: - vrućica - pojava mjehurića
English: The most common clinical toxicity of nevirapine is rash, with Viramune 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 Viramuneu uz kombiniranu terapiju u kontroliranim ispitivanjima događa se kod 12,5 %.
English: Viramune oral suspension contains 162 mg sorbitol per ml.
Croatian: Viramune oralna suspenzija sadrži 162 mg sorbitola u 1 ml.
English: The following events have also been reported when Viramune has been used in combination with other antiretroviral agents: - decreased numbers of red blood cells or platelets - inflammation of the pancreas - decrease in or abnormal skin sensations.
Croatian: Sljedeći slučajevi također su prijavljeni kada se Viramune primjenjivao u kombinaciji s drugim antiretrovirusnim lijekovima: - smanjenje broja crvenih krvnih stanica ili krvnih pločica - upala gušterače - smanjenje ili abnormalnost kožnih osjeta.
English: Lactose (as monohydrate) Hypromellose Iron oxide yellow Magnesium stearate
Croatian: 6.1 Popis pomoćnih tvari laktoza (u obliku hidrata) hipromeloza željezov oksid, žuti magnezijev stearat
English: EU/1/97/055/009 [90 prolonged-release]
Croatian: EU/1/97/055/009 [90 s produljenim oslobađanjem]
English: Patients experiencing rash during the 14-day lead-in period should not initiate treatment with Viramune prolonged-release tablets until the rash has resolved.
Croatian: Bolesnici koji razviju osip tijekom 14-dnevnog uvodnog razdoblja ne smiju počinjati liječenje Viramune tabletama s produljenim oslobađanjem dok se osip ne riješi.
English: Hepatic impairment: A steady state study comparing 46 patients with mild (n=17: Ishak Score 1-2), moderate (n=20; Ishak Score 3-4), or severe (n=9; Ishak Score 5-6, Child-Pugh A in 8 pts., for 1 Child-Pugh score not applicable) liver fibrosis as a measure of hepatic impairment was conducted.
Croatian: Oštećenje jetre: Provedeno je ispitivanje u stanju dinamičke ravnoteže u 46 bolesnika s blagom (n=17; Ishak indeks 1-2), umjerenom (n=20; Ishak indeks 3-4), ili teškom (n=9; Ishak indeks 5-6, Child Pugh A u 8 bolesnika, za jednoga Child Pugh indeks nije primjenjiv) fibrozom jetre kao mjerom oštećenja jetre.
English: Viramune immediate-release
Croatian: Viramune s trenutnim oslobađanjem
English: Viramune may be taken with or without food.
Croatian: Viramune se može uzimati s hranom ili bez nje.
English: If you have any rash during this period, do not start taking Viramune prolonged-release tablets but consult your doctor.
Croatian: U slučaju pojave osipa tijekom tog razdoblja, ne počinjite s uzimanjem Viramune tableta s produljenim oslobađanjem, već se posavjetujte s liječnikom.
English: Blood and lymphatic system disorders Uncommon anaemia, granulocytopenia
Croatian: Poremećaji krvi i limfnog sustava Manje često anemija, granulocitopenija
English: The safety data include all patient visits up to the time of the last patient's completion of study week 144.
Croatian: Podaci o sigurnosti uključuju sve posjete bolesnika do završetka 144 tjedna.
English: Clarithromycin AUC  0.69 (0.62Clarithromycin Cmin  0.44 (0.30Clarithromycin Cmax  0.77 (0.69
Croatian: Klaritromicin AUC  0,69 (0,62-0,76) Klaritromicin Cmin  0,44 (0,30-0,64) Klaritromicin Cmax  0,77 (0,69-0,86)
English: Frequency is defined using 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)
Croatian: Učestalost nuspojava klasificirana je prema sljedećim definicijama: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1 000 i <1/100); rijetko (≥1/10 000 i <1/1 000); vrlo rijetko
English: The results suggest that supplementing nevirapine therapy with an additional 200 mg dose of Viramune 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 Viramunea nakon svake dijalize pomoglo uklanjanju učinka dijalize na klirens nevirapina.
English: In study 1100.1526 (TRANxITION) patients on Viramune 200 mg immediate-release twice daily treatment for at least 18 weeks were randomised to either receive Viramune 400 mg prolonged-release once daily (n=295) or remain on their Viramune immediate-release treatment (n=148).
Croatian: U ispitivanju 1100.1526 (TRANxITION) bolesnici na dvokratnom dnevnom liječenju Viramuneom 200 mg s trenutnim oslobađanjem primjenjenim dvaput dnevno u minimalnom trajanju od 18 tjedana randomizirani su za Viramune 400 mg s produljenim oslobađanjem jednom dnevno (n=295) ili za ostanak na liječenju Viramuneom s trenutnim oslobađanjem (n=148).
English: PHARMACEUTICAL FORM Oral suspension
Croatian: OBLIK Oralna suspenzija.
English: Black patients (n=80/group) in study 1100.1486 showed approximately 30 % higher trough concentrations than Caucasian patients (250-325 patients/group) in both the Viramune immediate-release and Viramune prolonged-release treatment groups over 48 weeks of treatment at 400 mg/day.
Croatian: Crnci (n=80/skupina) u ispitivanju 1100.1486 pokazali su oko 30 % više koncentracije na kraju dozirnog intervala u odnosu na bijelce (250-325 bolesnika/skupina) i u skupini na Viramuneu s trenutnim oslobađanjem i Viramuneu s produljenim oslobađanjem tijekom 48 tjedana liječenja pri 400 mg/dan.
English: Alternatively, 30 Viramune 400 mg prolonged-release tablets are supplied in bottles.
Croatian: Također, 30 Viramune 400 mg tableta s produljenim oslobađanjem dostupno je i u bočicama.
English: Baseline Plasma HIV-1 RNA (log10 copies/ml) - Mean (SD)
Croatian: Početni HIV-1 RNK u plazmi (log10 kopije/ml) - Srednja vrijednost (SD)
English: If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash) accompanied by other side effects such as - fever, - blistering, - mouth sores, - inflammation of the eye, - swelling of the face, - general swelling, - shortness of breath, - muscle or joint pain, - general feelings of illness, - or abdominal pain
Croatian: Ako dobijete teški osip ili preosjetljivost (alergijske reakcije koje se mogu pojaviti u obliku osipa) popraćene drugim nuspojavama kao što su - vrućica, - pojava mjehurića, - ranice u ustima, - upala oka, - oticanje lica, - opće oticanje, - nedostatak zraka, - bol u mišićima ili zglobovima, - opći osjećaj bolesti, - ili bol u trbuhu
English: Tenofovir 300 mg QD
Croatian: Tenofovir 300 mg 1x/dan
English: Hepatic reactions
Croatian: Kožne reakcije
English: The greatest risk of hepatic and skin reactions occurs in the first 6 weeks of therapy.
Croatian: Rizik jetrenih poremećaja i kožnih reakcija najveći je tijekom prvih 6 tjedana terapije.
English: The best predictor of a serious hepatic event was elevated baseline liver function tests.
Croatian: Najbolji prediktor teškog jetrenog poremećaja jesu povišene vrijednosti pokazatelja jetrene funkcije na početku liječenja.
English: Tipranavir/ritonavir 500/200 mg BID
Croatian: Tipranavir/ritonavir 500/200 mg 2x/dan
English: Genotypic analysis of isolates from antiretroviral naïve patients experiencing virologic failure (n=71) receiving nevirapine once daily (n=25) or twice daily (n=46) in combination with lamivudine and stavudine for 48 weeks showed that isolates from 8/25 and 23/46 patients, respectively, contained one or more of the following NNRTI resistance-associated substitutions:
Croatian: Genotipska analiza izolata dobivenih od bolesnika prethodno neliječenih, a dobili su virološki neuspjeh (n=71) liječenja nevirapinom jednom dnevno (n=25) ili dvaput dnevno (n=46) u kombinaciji s lamivudinom i stavudinom tijekom 48 tjedana, pokazala je da su izolati iz 8/25 odnosno 23/46 bolesnika sadržavali jednu ili više od sljedećih supstitucija združenih s rezistencijom NNRTI:
English: Insert the syringe into the adapter.
Croatian: Umetnite štrcaljku u nastavak.
English: Yellow, round and biconvex prolonged-release tablets.
Croatian: Žute, okrugle i bikonveksne tablete s produljenim oslobađanjem.
English: Ketoconazole AUC  0.28 (0.20Ketoconazole Cmin ND Ketoconazole Cmax  0.56 (0.42
Croatian: Ketokonazol AUC  0,28 (0,20-0,40) Ketokonazol Cmin NO Ketokonazol Cmax  0,56 (0,42-0,73)
English: Frequency is defined using 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).
Croatian: Učestalost nuspojava klasificirana je prema slijedećim definicijama: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1 000 i <1/100); rijetko (≥1/10 000 i <1/1 000); vrlo rijetko
English: Lopinavir/ritonavir (oral solution) 300/75 mg/m2 BID
Croatian: Lopinavir/ritonavir (oralna otopina) 300/75 mg/m2 2x/dan
English: The clinical efficacy of Viramune prolonged-release is based on 48-week data from a randomised, double-blind, double-dummy phase 3 study (VERxVE - study 1100.1486) in treatment-naïve patients and on 24-week data from a randomised, open-label study in patients who transitioned from Viramune immediate-release tablets administered twice daily to Viramune prolonged-release tablets administered once daily (TRANxITION - study 1100.1526).
Croatian: Klinička djelotvornost Viramunea s produljenim oslobađanjem zasniva se na 48-tjednim podacima iz randomiziranog, dvostruko-slijepog ispitivanja faze 3 na dvostrukom placebu (VERxVE - ispitivanje 1100.1486) o liječenju prethodno neliječenih bolesnika te na 24-tjednim podacima iz randomiziranog, otvorenog ispitivanja na bolesnicima koji su se prebacili s Viramune tableta s trenutnim oslobađanjem dvaput dnevno na Viramune tablete s produljenim oslobađanjem jednom dnevno (TRANxITIONispitivanje 1100.1526).
English: Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.2).
Croatian: Viramune je indiciran u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje HIV-1 infekcije u odraslih, adolescenata i djece svih dobnih skupina (vidjeti dio 4.2).
English: Readministration to patients who previously had ASAT or ALAT > 5 ULN during nevirapine therapy and had recurrence of liver function abnormalities upon readministration of nevirapine (see section
Croatian: Ponovna primjena u bolesnika koji su već imali AST ili ALT > 5 x GGN tijekom terapije nevirapinom došlo je do ponovne pojave abnormalnosti jetrene funkcije nakon ponovne primjene nevirapina (vidjeti dio 4.4).
English: Baseline CD4 count (cells/mm - Mean (SD)
Croatian: Početni broj CD4 (stanice/mm - Srednja vrijednost (SD)
English: Viramune prolonged-release tablets dose (mg)
Croatian: Doza Viramune tableta s produljenim oslobađanjem (mg)
English: The recommended dose for Viramune is 20 ml (200 mg) oral suspension once daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by 20 ml (200 mg) oral suspension twice daily, in combination with at least two additional antiretroviral agents.
Croatian: Preporučena doza Viramunea je 20 ml (200 mg) oralne suspenzije jednom dnevno tijekom prvih 14 dana (ovo uvodno razdoblje je potrebno s obzirom da primijećeno smanjuje učestalost osipa), a nakon toga 20 ml (200 mg) oralne suspenzije dvaput dnevno, u kombinaciji s najmanje dva dodatna antiretrovirusna lijeka.
English: The patients studied were receiving antiretroviral therapy containing Viramune 200 mg immediaterelease tablets 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 200 mg tablete s trenutnim oslobađanjem dvaput dnevno u trajanju najmanje od 6 tjedana prije uzimanja uzoraka za farmakokinetičku analizu, a medijan trajanja terapije bio je 3,4 godine.
English: In this open-label study, 443 patients already on an antiviral regimen containing Viramune 200 mg immediate-release twice daily with HIV-1 RNA < 50 copies/ml were randomised in a 2:1 ratio to Viramune 400 mg prolongedrelease once daily or Viramune 200 mg immediate-release twice daily.
Croatian: U ovom otvorenom ispitivanju, 443 bolesnika na antivirusnom režimu Viramuneom 200 mg s trenutnim oslobađanjem dvaput dnevno s HIV-1 RNK < 50 kopija/ml bili su randomizirani u omjeru 2:1 s obzirom na Viramune 400 mg s produljenim oslobađanjem jednom dnevno ili Viramune 200 mg s trenutnim oslobađanjem dvaput dnevno.
English: Caution should be exercised when prescribing nevirapine to pregnant women (see section 4.4).
Croatian: Stoga je nužan oprez u propisivanju nevirapina trudnicama (vidjeti dio 4.4).
English: Viramune prolonged-release
Croatian: Viramune s produljenim oslobađanjem
English: However, patients with ESRD requiring dialysis exhibited a 43.5% reduction in nevirapine AUC over a one-week exposure period.
Croatian: Međutim, boelsnici s ESRD-om koji zahtijevaju dijalizu pokazali su smanjenje od 43,5% za AUC nevirapina u odnosu na jednotjedno razdoblje izlaganja.
English: Raltegravir 400 mg BID
Croatian: Raltegravir 400 mg 2x/dan
English: 5.1 Pharmacodynamic properties
Croatian: 5.1 Farmakodinamična svojstva
English: Viramune 400 mg prolonged-release tablets are supplied in blisters, with 30 or 90 prolonged-release tablets per carton.
Croatian: Viramune 400 mg tablete s produljenim oslobađanjem dostupne su u blisterima s 30 ili 90 tableta u kutiji.
English: Viramune with NNRTIs is not recommended (see section 4.4).
Croatian: Istodobna primjena Viramunea s NNRTI-ima se ne preporučuje (vidjeti dio 4.4).
English: LIST OF EXCIPIENTS Contains lactose
Croatian: POPIS POMOĆNIH TVARI Sadrži laktozu
English: Caution should be exercised when co-administering telaprevir with nevirapine.
Croatian: Potreban je oprez u istodobnoj primjeni telaprevira s nevirapinom.
English: Methadone AUC  0.40 (0.31 - 0.51) Methadone Cmin ND Methadone Cmax  0.58 (0.50 - 0.67)
Croatian: Metadon AUC  0,40 (0,31 - 0,51) Metadon Cmin NO Metadon Cmax  0,58 (0,50 - 0,67)
English: Viramune contains sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium
Croatian: Viramune sadrži saharozu, sorbitol, metilparahidroksibenzoat, propilparahidroksibenzoat i natrij
English: Musculoskeletal and connective tissue disorders Uncommon arthralgia, myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Manje često artralgija, mijalgija
English: Bottles contain 30 prolonged-release tablets.
Croatian: Bočice sadrže 30 tableta s produljenim oslobađanjem.
English: Use caution when engaging in activities such as driving, using any tools or machines.
Croatian: Nužan je oprez ako vršite radnje kao što su upravljanje vozilima ili rad s alatima ili strojevima.
English: In a mass balance/excretion study in eight healthy male volunteers dosed to steady state with nevirapine 200 mg given twice daily followed by a single 50 mg dose of 14C-nevirapine, approximately 91.4  10.5 % of the radiolabelled dose was recovered, with urine (81.3  11.1 %) representing the primary route of excretion compared to faeces (10.1  1.5 %).
Croatian: U studiji masovnog balansa/ekskrecije na osam zdravih muških dobrovoljaca koji su primali nevirapin 200 mg dvaput dnevno do stanja dinamičke ravnoteže, a zatim su primili jednokratnu dozu od 50 mg 14C-nevirapina, povrat radioaktivnosti iznosio je otprilike 91,4±10,5% Nevirapin je izlučen primarno urinom (81,3±11,1%), a tek u manjoj mjeri stolicom (10,1±1,5%).
English: Viramune contains lactose
Croatian: Viramune sadrži laktozu
English: No life-threatening (Grade 4) rash events considered related to Viramune were reported during the randomised phase of this study.
Croatian: U ispitivanju nisu prijavljeni događaji osipa koji su smatrani opasnima po život (stupanj 4.), a povezani su s Viramuneom, tijekom razdoblja randomizacije.
English: Rifampicin AUC  1.11 (0.96-1.28) Rifampicin Cmin ND Rifampicin Cmax  1.06 (0.91-1.22)
Croatian: Rifampicin AUC  1,11 (0,96-1,28) Rifampicin Cmin NO Rifampicin Cmax  1,06 (0,91-1,22)
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 kombinaciji 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: Nevirapine must be permanently discontinued in any patient experiencing hypersensitivity reaction (characterised by rash with constitutional symptoms, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction), see section 4.4.
Croatian: Primjena nevirapina se mora trajno prekinuti u svakog bolesnika kod kojeg se pojavi reakcija preosjetljivosti (karakterizirana osipom s općim simptomima, uz visceralne poremećaje, kao što su hepatitis, eozinofilija, granulocitopenija i disfunkcija bubrega), vidjeti dio 4.4.
English: It is not recommended to coadminister fosamprenavir and Viramune if fosamprenavir is not coadministered with ritonavir (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena fosamprenavira i Viramunea, ako se fosamprenavir ne primjenjuje u kombinaciji istodobno s ritonavirom (vidjeti dio 4.4).
English: Lopinavir/ritonavir (capsules) 400/100 mg BID
Croatian: Lopinavir/ritonavir (kapsule) 400/100 mg 2x/dan
English: The prolonged-release tablets are about 9.3 x 19.1 mm, debossed with V04 on one side and the company symbol on the other side.
Croatian: Tablete s produljenim oslobađanjem su veličine oko 9,3 x 19,1 mm, s utisnutom oznakom V04 na jednoj strani i simbolom tvrtke na drugoj.
English: ANTIFUNGALS Fluconazole 200 mg QD
Croatian: ANTIFUNGICI Flukonazol 200 mg 1x/dan
English: Patients already on a regimen of Viramune immediate-release twice daily in combination with other antiretroviral agents can be switched to Viramune 400 mg prolonged-release tablets once daily in combination with other antiretroviral agents without a lead-in period of Viramune immediate-release.
Croatian: Bolesnici koji su trenutno na Viramuneu s trenutnim oslobađanjem dvaput dnevno: Bolesnici koji su već na Viramuneu s trenutnim oslobađanjem dvaput dnevno u kombinaciji s drugim antiretrovirusnim lijekovima mogu se prebaciti na Viramune 400 mg tablete s produljenim oslobađanjem jedanput dnevno u kombinaciji s drugim antiretrovirusnim lijekovima bez uvodnog razdoblja Viramunea s trenutnim oslobađanjem.
English: Accordingly, as anaemia, granulocytopenia, anaphylactic reaction, jaundice, Stevens-Johnson Syndrome/toxic epidermal necrolysis (which may be fatal), angioedema, decreased blood phosphorus and increased blood pressure during maintenance phase with Viramune prolonged-release tablets were not seen in study 1100.1486 the frequency category was estimated from a statistical calculation based on the total number of patients exposed to nevirapine prolonged-release in the maintenance phase of the randomised controlled clinical study 1100.1486 (n= 505).
Croatian: Shodno tome, s obzirom da anemija, granulocitopenija, anafilaktička reakcija, žutica, StevensJohnsonov sindrom/toksična epidermalna nekroliza (može biti fatalna), angioedem, snižene vrijednosti fosfora u krvi i povišeni krvni tlak nisu viđeni tijekom razdoblja održavanja Viramune tabletama s produljenim oslobađanjem u ispitivanju 1100.1486, kategorija učestalosti procijenjena je iz statističkog izračuna na osnovi ukupnog broja bolesnika izloženih nevirapinu s produljenim oslobađanjem u razdoblju održavanja randomiziranog kontroliranog kliničkog ispitivanja 1100.1486 (n= 505).
English: If your child develops any rash during this period, do not increase the dose but consult your child's doctor.
Croatian: Ako kod Vašeg djeteta dođe do razvoja osipa tijekom tog razdoblja, ne povećavajte dozu, već se posavjetujte s djetetovim liječnikom.
English: The NEFA study is a controlled prospective randomised study which evaluated treatment options for patients who switch from protease inhibitor (PI) based regimen with undetectable load to either Viramune, efavirenz or abacavir.
Croatian: NEFA je prospektivno, randomizirano kontrolirano ispitivanje koje je uspoređivalo opcije liječenja za bolesnike koji su s prethodnog liječenja inhibitorima proteaza prebačeni na Viramune, efavirenz ili abakavir, a pri tome su imali nedetektabilno opterećenje virusa u plazmi.
English: You must take the dose of Viramune as prescribed by your doctor.
Croatian: Viramune uzimajte u dozama koje je propisao liječnik.
English: It is important that the entire measured dose of Viramune oral suspension is administered.
Croatian: Važno je primijeniti cijelu izmjerenu dozu Viramune oralne suspenzije, uz pomoć priložene dozirne štrcaljke.
English: The dose for children is 4 mg/kg body weight or 150 mg/m2 body surface area once a day for the first
Croatian: Doza za djecu je 4 mg/kg tjelesne težine ili 150 mg/m2 tjelesne površine jednom na dan prvih 14 dana liječenja (“uvodno” razdoblje).
English: NAME OF THE MEDICINAL PRODUCT Viramune 50 mg/5 ml oral suspension
Croatian: NAZIV LIJEKA Viramune 50 mg/5 ml oralna suspenzija
English: At 24 weeks after randomisation in the TRANxITION study, 92.6 % and 93.6 % of patients receiving Viramune 200 mg immediate-release twice daily or Viramune 400 mg prolonged-release once daily, respectively, continued to have HIV-1 RNA < 50 copies/ml.
Croatian: Nakon 24 tjedna iza randomizacije, u ispitivanju TRANxITION, 92,6 % bolesnika na Viramuneu 200 mg s trenutnim oslobađanjem dvaput dnevno ili Viramuneu 400 mg s produljenim oslobađanjem jednom dnevno, i dalje je imalo HIV-1 RNK vrijednosti < 50 kopija/ml.
English: Recommendations concerning coadministration
Croatian: Preporuke s obzirom na istodobnu primjenu
English: These are supplied in the package leaflets for those medicines.
Croatian: One se nalaze u uputama koje se prilažu uz te lijekove.