FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric population Children three years and older and adolescents
Slovenian: Pediatrična populacija Otroci, starejši od 3 let in mladostniki
English: Median age was 34 years and about 64 % were male patients, median CD4 cell count was 170 and 190 cells per mm
Slovenian: Srednja starost je bila 34 let, približno 64 % bolnikov je bilo moških, srednje število celic CD4 je bilo 170 celic na mm
English: No specific drug-drug interaction study has been performed.
Slovenian: Specifičnih študij medsebojnega delovanja zdravil niso izvedli.
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.
Slovenian: Nevirapinovi presnovki: raziskave, v katerih so uporabili človeške jetrne mikrosome, so pokazale, da na nastajanje nevirapinovih hidroksiliranih presnovkov ne vplivajo dapson, rifabutin, rifampicin in kombinacija trimetoprima in sulfametoksazola.
English: • are  8 years of age and weigh 43.8 kg or more or
Slovenian: • so stari  8 let in imajo telesno maso 43,8 kg ali več ali
English: In addition, Viramune has not been shown to cause glucose disturbances.
Slovenian: Poleg tega se ni pokazalo, da bi zdravilo Viramune povzročalo motnje glukoze.
English: Patients should be instructed to seek medical attention promptly if these occur.
Slovenian: Bolnike je treba poučiti, da se morajo takoj posvetovati z zdravnikom, če se pojavijo.
English: Adult patients:
Slovenian: Odrasli bolniki :
English: Data on potential symptoms of hepatic events were prospectively collected in this study.
Slovenian: Podatke o možnih simptomih jetrnih dogodkov so zbirali prospektivno.
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.
Slovenian: Ker režim z nevirapinom in efavirenzem ni imel dodatnega učinka in je povzročal več neželenih dogodkov kot posamezni zdravili, ga ne priporočajo.
English: Norethindrone (NET) 1.0 mg QD
Slovenian: Noretindron (NET) 1,0 mg na dan
English: Approximately half of the patients had tenofovir + emtricitabine as their background therapy, with the remaining patients receiving abacavir sulfate + lamivudine or zidovudine + lamivudine.
Slovenian: Približno polovica bolnikov je imela osnovno zdravljenje sestavljeno iz tenofovirja + emtricitabina, preostali pa so jemali abakavir sulfat + lamivudin ali zidovudin + lamivudin.
English: Adefovir did not influence any of the common CYP isoforms known to be involved in human drug metabolism and is excreted renally.
Slovenian: Adefovir ni vplival na nobeno od pomembnih izooblik CYP, za katere je znano, da pri človeku sodelujejo v presnovi zdravil, izloča pa se skozi ledvice.
English: CONTRACEPTIVES Depomedroxyprogesterone acetate (DMPA) 150 mg every 3 months
Slovenian: KONTRACEPTIVI Depo medroksiprogesteron acetat (DMPA), 150 mg vsake 3 mesece
English: Viramune prolonged-release tablets should only be used after a two-week treatment with another type of Viramune (immediate-release tablets or suspension) unless you are currently on Viramune and are switching to the prolonged-release form.
Slovenian: Zdravilo Viramune tablete s podaljšanim sproščanjem je treba uporabiti le po dvotedenskem uvajalnem zdravljenju z drugo vrsto zdravila Viramune (s takojšnjim sproščanjem ali suspenzijo), razen če se trenutno zdravite z zdravilom Viramune in ste prešli na obliko s podaljšanim sproščanjem.
English: If you are taking or are prescribed rifampicin to treat tuberculosis please inform your doctor before taking this medicine with Viramune.
Slovenian: Če jemljete ali so vam predpisali rifampicin za zdravljenje tuberkuloze, obvestite svojega zdravnika preden boste to zdravilo vzeli skupaj z zdravilom Viramune.
English: Therefore, caution should be recommended when driving a car or operating machinery.
Slovenian: Priporočati je treba previdnost pri vožnji avtomobila ali upravljanju strojev.
English: In carcinogenicity studies, nevirapine induces hepatic tumours in rats and mice.
Slovenian: V raziskavah o kancerogenosti povzroča nevirapin pri podganah in miših tumorje na jetrih.
English: Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine.
Slovenian: Tablete s podaljšanim sproščanjem niso primerne za zdravljenje v 14-dnevnem uvajalnem obdobju pri bolnikih, ki začnejo jemati nevirapin.
English: Clinical studies with prolonged-release tablets
Slovenian: Klinične študije s tabletami s podaljšanim sproščanjem
English: Viramune is also available as smaller prolonged-release tablets (for children 3 years of age and above after the lead-in period) or as an oral suspension (for all age groups).
Slovenian: Zdravilo Viramune je na voljo tudi v obliki tablet s podaljšanim sproščanjem v nižji jakosti (za otroke, starejše od 3 let, po končanem uvajalnem obdobju) ali peroralne suspenzije (za vse starostne skupine).
English: Based on the data available so far, this has not been shown to affect the therapeutic response.
Slovenian: Dosegljivi podatki kažejo, da pojav ne vpliva na terapevtski odziv.
English: There were no differences based on the formulation taken (immediate-release twice daily or prolonged-release once daily).
Slovenian: Razlik, ki bi bile povezane s farmacevtsko obliko (dvakrat na dan oblika s takojšnjim sproščanjem ali enkrat na dan oblika s podaljšanim sproščanjem).
English: Telaprevir is metabolised in the liver by CYP3A and is a P-glycoprotein substrate.
Slovenian: Telaprevir se presnavlja v jetrih s CYP3A in je substrat P-glikoproteina.
English: What you need to know before you take Viramune
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Viramune
English: The available pharmacokinetic data suggest that the concomitant use of rifampicin and nevirapine is not recommended.
Slovenian: Farmakokinetični podatki kažejo, da sočasna uporaba rifampicina in nevirapina ni priporočljiva.
English: Shake the bottle well before you take your medicine.
Slovenian: Pred jemanjem zdravila stekleničko dobro pretresite.
English: There were no significant differences in demographic and baseline characteristics between the treatment groups.
Slovenian: Skupini se nista pomembno razlikovali po demografskih podatkih in izhodiščnih značilnostih.
English: Percent change n=406
Slovenian: Sprememba v odstotkih* n = 406
English: Careful monitoring of the therapeutic effectiveness of P450 metabolised medicinal products is recommended when taken in combination with nevirapine.
Slovenian: Priporočamo skrbno spremljanje terapevtskega učinka zdravil, ki se presnavljajo prek P450, kadar jih bolnik jemlje v kombinaciji z nevirapinom.
English: Taking all doses at the appropriate times: - greatly increases the effectiveness of your combination antiretroviral medicines - reduces the chances of your HIV infection becoming resistant to your antiretroviral medicines.
Slovenian: Če ste prenehali jemati zdravilo Viramune Redno jemanje odmerkov ob ustreznem času: - zelo poveča učinkovitost vam predpisane kombinacije protiretrovirusnih zdravil - zmanjša verjetnost, da bo okužba s HIV pri vas postala odporna proti protiretrovirusnim zdravilom, ki jih jemljete.
English: Viramune is not a cure for HIV infection.
Slovenian: Zdravilo Viramune ne ozdravi okužbe s HIV.
English: Always follow the exact instructions given by your child's doctor.
Slovenian: Natančno upoštevajte navodila otrokovega zdravnika.
English: • have a body surface area of 1.17 m2 or above according to the Mosteller formula.
Slovenian: • je njihova telesna površina po Mostellerjevi formuli 1,17 m2 ali več.
English: Similarly the potential for cross-resistance between nevirapine and NRTIs is low because the molecules have different binding sites on the reverse transcriptase.
Slovenian: Podobno je majhna možnost navzkrižne odpornosti med nevirapinom in nukleozidnimi zaviralci reverzne transkriptaze, ker imajo molekule različna vezavna mesta na reverzni transkriptazi.
English: The overall incidence of adverse events was significantly lower (61 patients, or 41 %) in the abacavir group than in the nevirapine group (83 patients, or 54 %) or the efavirenz group (89 patients, or 57 %).
Slovenian: Skupna pogostnost neželenih učinkov je bila značilno manjša pri skupini z abakavirjem (61 bolnikov ali 41 %) kot pri skupini z nevirapinom (83 bolnikov ali 54 %) ali efavirenzem (89 bolnikov ali 57 %).
English: Ketoconazole and erythromycin significantly inhibited the formation of nevirapine hydroxylated metabolites.
Slovenian: Ketokonazol in eritromicin sta nastajanje nevirapinovih hidroksiliranih presnovkov pomembno zavirala.
English: Each ml of oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl parahydroxybenzoate and 0.24 mg of propyl parahydroxybenzoate.
Slovenian: En ml peroralne suspenzije vsebuje 150 mg saharoze, 162 mg sorbitola, 1,8 mg metilparahidroksibenzoata in 0,24 mg propilparahidroksibenzoata.
English: The recommended weight-based paediatric dose is dependent upon the patient's age, with different recommended doses for children from 3 to < 8 years of age and children 8 years or older.
Slovenian: Priporočeni otroški odmerek, določen na podlagi telesne mase, je odvisen od bolnikove starosti in se razlikuje za otroke od 3. do 8. leta in starejše od 8. leta starosti.
English: The safety data include all patient visits up to the time of the last patient's completion of study week 144.
Slovenian: Podatki o varnosti zajemajo vse kontrolne obiske do trenutka, ko je zadnji bolnik končal 144 teden študije.
English: Taking Viramune with food and drink There are no restrictions on taking Viramune with food and drink.
Slovenian: Zdravilo Viramune skupaj s hrano in pijačo Za jemanje zdravila Viramune s hrano in pijačo ni nobenih omejitev.
English: reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children.
Slovenian: Zmanjšanje števila rdečih krvničk (anemija), ki je lahko povezana z zdravljenjem z nevirapinom, je prav tako pri otrocih pogostnejša.
English: The prolonged-release tablets shall be taken with liquid, and should not be broken or chewed.
Slovenian: Tablete s podaljšanim sproščanjem je treba jemati s tekočino, ne sme se jih drobiti ali žvečiti.
English: The following data were generated using the Viramune immediate-release tablets but are expected to apply to all dosage forms.
Slovenian: Naslednji podatki so bili pridobljeni pri uporabi zdravila Viramune tablete s takojšnjim sproščanjem, predvideva se, da veljajo za vse farmacevtske oblike.
English: Percent change n=419
Slovenian: Sprememba v odstotkih* n = 419
English: Biotransformation and elimination: In vivo studies in humans and in vitro studies with human liver microsomes have shown that nevirapine is extensively biotransformed via cytochrome P450 (oxidative) metabolism to several hydroxylated metabolites.
Slovenian: Biotransformacija in izločanje: raziskave in vivo pri človeku ter raziskave in vitro s človeškimi jetrnimi mikrosomi so pokazale, da se nevirapin obsežno presnavlja prek citokroma P450 (oksidacijsko) v več hidroksiliranih presnovkov.
English: In an open-label clinical study (ACTG 180) granulocytopenia assessed as medicinal product-related occurred in 5/37 (13.5 %) of patients.
Slovenian: V odprti klinični študiji (ACTG 180), se je granulocitopenija, ki je bila po oceni raziskovalcev povezana z zdravilom, pojavila pri 5/37 (13,5 %) bolnikov.
English: 6.6 Special precautions for disposal and other handling Instructions for administration:
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Navodila za dajanje:
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Slovenian: Kliničnega izida zmanjšanja najmanjše koncentracije boceprevirja pred naslednjim odmerkom niso neposredno ocenjevali.
English: However, approximately 15 % of these patients with hepatic fibrosis had nevirapine trough concentrations above 9,000 ng/ml (2 fold the usual mean trough).
Slovenian: Toda pri približno 15 % bolnikov z jetrno fibrozo je bila koncentracija nevirapina pred naslednjim odmerkom večja od 9,000 ng/ml (2-kratna običajna srednja koncentracija pred naslednjim odmerkom).
English: Nevirapine had no antiviral activity in cell culture against group O HIV-1 isolates or HIV-2 isolates.
Slovenian: Nevirapin v celični kulturi ni učinkoval protivirusno na izolate HIV-1 iz skupine O ali izolate HIV-2.
English: Pay special attention to any rashes that your child develops.
Slovenian: Bodite posebno pozorni na vsak izpuščaj pri otroku.
English: Results of DDI studies of telaprevir with efavirenz indicate that caution should be exercised when co-administering telaprevir with P450 inducers.
Slovenian: Izsledki raziskav o DDI, v katerih so proučevali telaprevir in efavirenz, kažejo, da je pri hkratnem dajanju telaprevirja in induktorjev P450 potrebna previdnost.
English: 3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
Slovenian: 3, in izmerljivo ravnijo HIV-1 RNA v plazmi razen, če je korist zdravljenja večja od njegovega tveganja.
English: For adults
Slovenian: Za odrasle
English: The following adverse reactions were identified in other nevirapine studies or by post-marketing surveillance but not observed in the randomised, controlled clinical study 1100.1486.
Slovenian: Sledeče neželene učinke so odkrili v drugih študijah nevirapina ali v času spremljanja zdravila po začetku trženja, ne pa tudi v nadzorovani klinični študiji pri naključno izbranih bolnikih 1100.1486.
English: Children less than three years old
Slovenian: Otroci, mlajši od treh let
English: Viramune is also available as tablets.
Slovenian: Zdravilo Viramune je na voljo tudi v obliki tablet.
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.
Slovenian: Nevirapin je deloval in vitro v kombinaciji z efavirenzom od močno antagonistično na HIV-1 (glejte poglavje 4.5) in aditivno do antagonistično z zaviralcem proteaze ritonavirjem ali s fuzijskim zaviralcem enfuvirtidom.
English: Clinical chemistry tests, which include liver function tests, should be performed prior to initiating nevirapine therapy and at appropriate intervals during therapy.
Slovenian: Klinične kemijske preiskave, ki vključujejo jetrne preiskave, je treba opraviti pred začetkom zdravljenja z nevirapinom in v ustreznih razmikih med zdravljenjem.
English: Female patients showed a 13.8 % lower clearance of nevirapine than did male patients.
Slovenian: Pri njih je bil nevirapinov očistek za 13,8 % manjši kot pri moških bolnikih.
English: The primary endpoint, treatment failure, was defined as less than 1 log10 decline in plasma HIV-1 RNA in the first 12 weeks, or two consecutive measurements of more than 50 copies/ ml from week 24 onwards, or disease progression.
Slovenian: Primarni opazovani dogodek, to je neuspešnost zdravljenja, je bil opredeljen kot manjši upad plazemske koncentracije HIV-1 RNA od 1 log10 prvih 12 tednov ali dve zaporedni izmerjeni vrednosti več kot 50 kopij/ml po 24. tednu ali napredovanje bolezni.
English: Genotypic analysis showed mutations in the HIV-1 RT gene Y181C and/or V106A depending upon the virus strain and cell line employed.
Slovenian: Genotipska analiza je pokazala mutacje genov Y181C in/ali V106A pri RT virusa HIV-1, odvisno od virusnega seva in uporabljene celične linije.
English: In study 1100.1526 (TRANxITION) no Grade 3 or 4 clinical hepatic events were observed in either treatment group.
Slovenian: V študiji 1100.1526 (TRANxITION) v nobeni zdravljeni skupini bolnikov niso zasledili kliničnih jetrnih dogodkov 3. ali 4. stopnje.
English: Viramune oral suspension can be taken by children of all age groups.
Slovenian: Zdravilo Viramune peroralna suspenzija lahko jemljejo otroci vseh starosti.
English: Do not take Viramune after an exposure to HIV unless you have been diagnosed with HIV and instructed to do so by your doctor.
Slovenian: Ne vzemite zdravila Viramune, če ste bili izpostavljeni HIV, oziroma ga vzemite samo, če so vam postavili diagnozo okužbe s HIV in vam je tako naročil vaš zdravnik.
English: Viramune oral suspension is a white to off-white homogenous suspension.
Slovenian: Peroralna suspenzija Viramune je bela homogena suspenzija.
English: Triglycerides (mg/dL) * Percent change is the median of within-patient changes from baseline for patients with both baseline and week 48 values and is not a simple difference of the baseline and week 48 mean values, respectively.
Slovenian: Trigliceridi (mg/dl) * Spremenjeni odstotki pomenijo mediano spremembo pri enem bolniku v primerjavi z izhodiščno vrednostjo za bolnike z izhodiščnimi vrednostmi in vrednostmi po 48 tednih, in ne enostavno razliko med izhodiščnimi vrednostmi in vrednostmi po 48 tednih.
English: As hepatotoxicity is more frequent in women with CD4 cell counts above 250 cells/mm
Slovenian: Ker je hepatotoksičnost pogostejša pri ženskah s številom celic CD4 nad 250 celic/mm
English: If you are taking oral contraceptives (e.g. „pill“) or other hormonal methods of birth control during treatment with Viramune, you should use a barrier contraception (e.g. condoms) in addition to prevent pregnancy and further HIV transmission.
Slovenian: Če med zdravljenjem z zdravilom Viramune jemljete peroralne kontraceptive (npr. "tabletko") ali druge hormonske metode za preprečevanje zanositve, bi morali dodatno uporabljati mehansko kontracepcijo (npr. kondom) za preprečevanje zanositve in nadaljnjega prenašanja HIV.
English: Nevirapine pharmacokinetics in HIV-1 infected adults does not appear to change with age (range 19-68 years) or race (Black, Hispanic, or Caucasian).
Slovenian: Ne kaže, da bi se nevirapinova farmakokinetika pri s HIV-1 okuženih odraslih spreminjala s starostjo (v razponu od 19 do 68 let) ali glede na raso (črnci, Latinoameričani ali belci).
English: Co-administration of boceprevir with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure.
Slovenian: Pri hkratnem dajanju boceprevirja in zdravil, ki inducirajo ali zavirajo CYP3A4/5, bi se lahko izpostavljenost povečala ali zmanjšala.
English: Monotherapy with Viramune has been associated with the development of NNRTI resistance.
Slovenian: Monoterapijo z zdravilom Viramune povezujejo z razvojem odpornosti proti NNRTI.
English: Dosage:
Slovenian: Odmerek:
English: Randomisation was stratified by screening HIV-1 RNA level (<100,000 copies/ml and >100,000 copies/ml).
Slovenian: Stratifikacijo pri naključni razvrstitvi so izvedli s presejanjem ravni HIV-1 RNK (< 100.000 kopij/ml in > 100.000 kopij/ml).
English: However the risk continues past this period and monitoring should continue at frequent intervals throughout treatment.
Slovenian: Tveganje je možno tudi po tem obdobju, zato moramo zdravljenje ves čas spremljati s pogostimi pregledi.
English: Abnormal liver function tests have been reported with nevirapine, some in the first few weeks of therapy.
Slovenian: Za nevirapin poročajo o nenormalnih izvidih preiskav jetrne funkcije, o nekaterih v prvih tednih zdravljenja.
English: Fit the plastic adapter onto the open bottle neck by first pressing and then screwing the adapter.
Slovenian: Na vrat odprte plastenke namestite plastični adapter, tako da ga najprej potisnite navzdol, nato privijte.
English: Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code J05AG01.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih okužb, nenukleozidni zaviralci reverzne transkriptaze, oznaka ATC: J05AG01.
English: Single dose nevirapine in mothers or infants may lead to reduced efficacy if an HIV treatment regimen using nevirapine is later instituted within 6 months or less in these patients.
Slovenian: Enkratni odmerek nevirapina lahko pri materah ali dojenčkih zmanjša učinkovitost zdravljenja, če jim pozneje v 6 mesecih ali že prej uvedemo režim zdravljenja HIV, ki zajema nevirapin.
English: Clinical results
Slovenian: Klinični izsledki
English: Although these may appear normal (for example nappy rash), they might be rashes due to Viramune.
Slovenian: Čeprav je videti kot običajen izpuščaj (npr. plenični izpuščaj), je lahko v resnici posledica jemanja zdravila Viramune.
English: Measure the exact dose using the measuring syringe and adapter supplied as follows:
Slovenian: Odmerite natančno po spodnjih navodilih s priloženo merilno brizgo in adapterjem:
English: Close monitoring of anticoagulation levels is warranted.
Slovenian: Natančno je treba spremljati antikoagulacijo.
English: The following patients are at increased risk of developing liver problems: - women - infected with hepatitis B or C - abnormal liver function tests
Slovenian: Možnost razvoja jetrnih težav je povečana pri naslednjih bolnikih: - ženskah - pri okužbi z virusom hepatitisa B ali C - pri nenormalnih jetrnih testih
English: Studies in treatment-experienced patients
Slovenian: Študije pri že zdravljenih bolnikih
English: These outcomes include all patients who were randomised after the 14 day lead-in with Viramune immediate-release and received at least one dose of blinded medicinal product.
Slovenian: Podatki zajemajo vse bolnike, ki so jih naključno razvrstili po 14-dnevnem uvajalnem zdravljenju z zdravilom Viramune s takojšnjim sproščanjem in so prejeli vsaj en odmerek prikritega zdravila.
English: All patients received tenofovir + emtricitabine as background therapy.
Slovenian: Vsi bolniki so kot osnovno zdravljenje jemali tenofovir + emtricitabin.
English: Dividing a 200 mg total dose into four 50 mg doses rather than two 100 mg doses produced a 7-11 % greater overall absorption, but with comparable medicinal product release rates.
Slovenian: Če so skupni odmerek po 200 mg razdelili na štiri odmerke po 50 mg, in ne na dva odmerka po 100 mg, je bila skupna absorpcija za 7 do 11 % večja, toda pri primerljivi hitrosti sproščanja.
English: Viramune should only be used with at least two other antiretroviral agents (see section 5.1).
Slovenian: Zdravilo Viramune smemo uporabljati samo hkrati z najmanj dvema drugima protivirusnima zdraviloma (glejte poglavje 5.1).
English: At 12 months, the Kaplan-Meier estimates of the likelihood of reaching the endpoint were 10 % in the Viramune group, 6 % in the efavirenz group, and 13 percent in the abacavir group (P=0.10 according to an intention-to-treat analysis).
Slovenian: Po 12 mesecih so bile Kaplan-Meierjeve ocene verjetnosti za doseganje opazovanega dogodka 10 % v skupini z zdravilom Viramune, 6 % v skupini z efavirenzem in 14 % v skupini z abakavirjem (P = 0,10 po podatkih iz analize vseh vključenih bolnikov (ITT - Intention to treat).
English: Since neither body weight nor Body Mass Index (BMI) had influence on the clearance of nevirapine, the effect of gender cannot be explained by body size.
Slovenian: Ker na nevirapinov očistek nista vplivala niti telesna masa niti indeks telesne mase (ITM), tudi vpliva spola ni bilo možno pojasniti s telesno velikostjo.
English: Autoinduction also results in a corresponding decrease in the terminal phase half-life of nevirapine in plasma from approximately 45 hours (single dose) to approximately 25-30 hours following multiple dosing with 200-400 mg/day.
Slovenian: Posledica samoindukcije je tudi ustrezno skrajšanje razpolovnega časa nevirapina v plazmi v končni fazi od približno 45 ur (enkratni odmerek) do približno 25 do 30 ur po večkratnem dajanju odmerkov po 200 do 400 mg na dan.