FrancophonIA/ELRC3.0 huggingface dataset:
English: As explained in 'Warnings and precautions', above, your doctor will monitor you with liver tests or for undesirable effects such as rash.
Slovenian: Kot je opisano v poglavju ”Opozorila in previdnostni ukrepi”, bo zdravnik vaše stanje spremljal s preiskavami delovanja jeter ali za pojav neželenih učinkov, kot je izpuščaj.
English: Viramune is also available as an oral suspension.
Slovenian: Zdravilo Viramune je na voljo tudi v obliki peroralne suspenzije.
English: Patients were enrolled with CD4 counts <250 cells/mm
Slovenian: Bolnice so imele ob sprejemu v raziskavo število CD4 < 250 celic/mm
English: Total cholesterol.
Slovenian: antikoagulacijo.
English: Maraviroc 300 mg QD
Slovenian: Maravirok 300 mg na dan
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.
Slovenian: Med jemanjem zdravila Viramune v kombinaciji z drugimi protivirusnimi zdravili so poročali še o naslednjih pojavih: - zmanjšanju števila rdečih krvničk ali krvnih ploščic - vnetju trebušne slinavke - zmanjšani ali spremenjeni občutljivosti kože.
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.
Slovenian: Bolniki, ki se zdravijo z zdravilom Viramune s takojšnjim sproščanjem, ki ga jemljejo dvakrat dnevno: Bolnikom, ki se že zdravijo z zdravilom Viramune s takojšnjim sproščanjem, ki ga jemljejo dvakrat dnevno v kombinaciji z drugimi protiretrovirusnimi zdravili, lahko zdravilo brez uvajalnega zdravljenja z zdravilom Viramune s takojšnjim sproščanjem zamenjamo za zdravilo Viramune 400 mg tablete s podaljšanim sproščanjem, ki jih jemljejo enkrat dnevno dan v kombinaciji z drugimi protiretrovirusnimi zdravili.
English: Viramune oral suspension contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Slovenian: Peroralna suspenzija Viramune vsebuje manj kot 1 mmol (23 mg) natrija na na enoto odmerka, kar v bistvu pomeni ‘brez natrija'.
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.
Slovenian: Geometrične sredine najmanjših koncentracij v plazmi v ravnotežnem stanju pred naslednjim odmerkom so bile pri zdravilu Viramune s podaljšanim sproščanjem v starostnih skupinah od 3 do 6 let, 6 do 12 let in 12 do 18 let 3.880 ng/ml, 3.310 ng/ml in 5.350 ng/ml.
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.
Slovenian: V klinični študiji 1100.1486 (VERx VE) so se pri bolnikih, ki zdravila še niso prejemali, med zdravljenjem z zdravilom Viramune s podaljšanim sproščanjem (vključno z uvajalnim obdobjem zdravljenja z obliko zdravila s takojšnjim sproščanjem) najpogosteje pojavili naslednji neželeni učinki: izpuščaj, slabost, nenormalni jetrni izvidi, glavobol, utrujenost, hepatitis, trebušna bolečina, driska in vročina.
English: Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see section 4.2).
Slovenian: Zdravilo Viramune je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje s HIV-1 okuženih odraslih, mladostnikov in otrok, starih tri leta in starejših, ki lahko tablete pogoltnejo (glejte poglavji 4.2).
English: Viramune 200 mg tablets nevirapine
Slovenian: Viramune 200 mg tablete nevirapin
English: Lopinavir/ritonavir (oral solution) 300/75 mg/m2 BID
Slovenian: Lopinavir/ritonavir (peroralna raztopina) 300/75 mg/m2 2-krat na dan
English: Women have a three fold higher risk than men for symptomatic, often rash-associated, hepatic events (5.8 % versus 2.2 %), and treatment-naïve patients of either gender with detectable HIV-1 RNA in plasma with higher CD4 counts at initiation of nevirapine therapy are at higher risk for symptomatic hepatic events with nevirapine.
Slovenian: Pri ženskah je tveganje simptomatskih jetrnih dogodkov z nevirapinom, ki jih pogosto spremlja izpuščaj, trikrat večje kot pri moških (5,8 % proti 2,2 %), pri prvič zdravljenih bolnikih obeh spolov, ki imajo v plazmi izmerljivo raven HIV-1RNA in pri bolnikih z večjim številom celic CD4 je na začetku zdravljenja z nevirapinom povečano tveganje simptomatskih jetrnih dogodkov.
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.
Slovenian: Bolniki so v sklopu protiretrovirusnega zdravljenja prejemali zdravilo Viramune 200 mg tablete s takojšnim sproščanjem dvakrat na dan, najmanj 6 tednov pred jemanjem vzorcev za farmakokinetičnim vzorčenjem.
English: No clinically relevant drug-drug interaction is expected.
Slovenian: Klinično pomembne interakcije med zdraviloma ni pričakovati.
English: If a dose is missed and it is more than 12 hours later, the patient should only take the next dose at the usual time.
Slovenian: Če bolnik pozabi vzeti odmerek in je preteklo že več kot 12 ur, naj ob običajnem času vzame samo naslednji odmerek.
English: Bottles contain 30 prolonged-release tablets.
Slovenian: Plastenka vsebuje 30 tablet s podaljšanim sproščanjem.
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.
Slovenian: Bolniki so v sklopu protiretrovirusnega zdravljenja prejemali zdravilo Viramune v odmerkih po 200 mg, dvakrat na dan, najmanj 6 tednov pred jemanjem vzorcev za farmakokinetičnim vzorčenjem.
English: 3 and 197 cells/mm
Slovenian: 400 celic/mm
English: Weight and metabolic parameters:
Slovenian: Telesna masa in presnovni parametri
English: There are no data available on interchangeability for 400 mg prolonged-release tablets and 100 mg prolonged-release tablets.
Slovenian: O zamenljivosti 400 mg tablet s podaljšanim sproščanjem in 100 mg tablet s podaljšanim sproščanjem ni podatkov.
English: The nevirapine postmarketing experience has shown that the most serious adverse reactions are Stevens-Johnson syndrome/toxic epidermal necrolysis, serious hepatitis/hepatic failure, and drug reaction with eosinophilia and systemic symptoms, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Slovenian: Izkušnje z nevirapinom po pridobitvi dovoljenja za promet kažejo, da so najresnejši neželeni učinki Stevens-Johnsonov sindrom/toksična epidermalna nekroliza, hude oblike hepatitisa/jetrna odpoved in reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, za katere sta značilna izpuščaj s splošnimi simptomi, kot so vročina, artralgija, mialgija in limfadenopatija, in prizadetost visceralnih organov, ki se kaže kot hepatitis, eozinofilija, granulocitopenija in motnje ledvične funkcije.
English: Due to the metabolic pathway of telbivudine, no clinically relevant drug-drug interaction is expected.
Slovenian: Glede na presnovno pot telbivudina ni pričakovati klinično pomembnih interakcij med zdraviloma.
English: Zidovudine 100-200 mg TID
Slovenian: 100-200 mg 3-krat na dan
English: Clear polypropylene 5 ml dispensing syringe with silicone rubber piston seal.
Slovenian: Prozorna merilna brizga iz polipropilena po 5 ml z batnim tesnilom iz silikonske gume Prozoren adapter iz polietilena nizke gostote za brizgo in plastenko.
English: Cases of hepatitis (severe and life-threatening hepatotoxicity, including fatal fulminant hepatitis) have been reported in patients treated with nevirapine.
Slovenian: Pri bolnikih, ki so prejemali nevirapin, poročajo o primerih hepatitisa (hude in življenjsko nevarne toksičnosti za jetra, tudi fulminantnega hepatitisa s smrtnim izidom).
English: Nevirapine AUC  1.27 (1.12-1.44) Nevirapine Cmin  1.47 (1.20-1.82) Nevirapine Cmax  1.18 (1.02-1.37)
Slovenian: AUC nevirapina  1,27 (1,12-1,44) Cmin nevirapina  1,47 (1,20-1,82) Cmax nevirapina 1,18 (1,02-1,37)
English: Do not take more Viramune than prescribed by your doctor and described in this leaflet.
Slovenian: Če ste vzeli večji odmerek zdravila Viramune, kot bi smeli Ne prekoračite odmerka zdravila Viramune, ki vam ga je predpisal zdravnik in je naveden v tem navodilu.
English: The prolonged-release tablets are approximately 9 mm in diameter, debossed with V01 on one side and the company logo on the other side.
Slovenian: Tablete s podaljšanim sproščanjem imajo premer približno 9 mm in imajo na eni strani oznako V01, na drugi pa znak podjetja.
English: The postmarketing experience has shown that the most serious adverse reactions are Stevens-Johnson syndrome/ toxic epidermal necrolysis, serious hepatitis/hepatic failure, and drug reaction with eosinophilia and systemic symptoms, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Slovenian: Izkušnje po pridobitvi dovoljenja za promet kažejo, da so najresnejši neželeni učinki Stevens-Johnsonov sindrom/toksična epidermalna nekroliza, hude oblike hepatitisa/jetrna odpoved in reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, za katere sta značilna izpuščaj s splošnimi simptomi, kot so vročina, artralgija, mialgija in limfadenopatija, in prizadetost visceralnih organov, ki se kaže kot hepatitis, eozinofilija, granulocitopenija in motnje ledvične funkcije.
English: You may take Viramune with or without food.
Slovenian: Zdravilo Viramune lahko jemljete s hrano ali brez nje.
English: If it has been more than 12 hours since the dose was due only take the next dose at the usual time.
Slovenian: Če je od takrat, ko bi ga morali vzeti, preteklo že več kot 12 ur, vzemite ob običajnem času samo naslednji odmerek.
English: Bottles contain 90 prolonged-release tablets.
Slovenian: Plastenka vsebuje 90 tablet s podaljšanim sproščanjem.
English: Amprenavir Cmin  0.81 (0.69-0.96) Amprenavir Cmax  0.97 (0.85-1.10)
Slovenian: Cmin amprenavirja  0,81 (0,69-0,96) Cmax amprenavirja  0,97 (0,85-1,10)
English: Asymptomatic elevations of GGT levels are the most frequent.
Slovenian: Najpogostnejše je nesimptomatično povečanje ravni GGT.
English: Maraviroc AUC  1.01 (0.6 -1.55) Maraviroc Cmin ND Maraviroc Cmax  1.54 (0.94-2.52) compared to historical controls
Slovenian: AUC maraviroka  1,01 (0,6 -1,55) Cmin maraviroka ND Cmax maraviroka  1,54 (0,94-2,52) v primerjavi s prejšnjimi, kontrolnimi
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of nevirapine (as anhydrous).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 200 mg nevirapina (v brezvodni obliki).
English: Due to the metabolic pathway of entecavir, no clinically relevant drug-drug interaction is expected.
Slovenian: Glede na presnovno pot entekavirja ni pričakovati klinično pomembnih interakcij med zdraviloma.
English: Post-Exposure-Prophylaxis: Serious hepatotoxicity, including liver failure requiring transplantation, has been reported in HIV-uninfected individuals receiving multiple doses of Viramune in the setting of post-exposure-prophylaxis (PEP), an unapproved use.
Slovenian: Profilaksa po izpostavljenosti okužbi: pri posameznih osebah, ki sicer niso bile okužene s HIV, a so prejele več odmerkov zdravila Viramune v sklopu profilakse po izpostavljenosti okužbi, kar sicer ni odobrena uporaba, so poročali o resnih toksičnih učinkih na jetra, tudi o jetrni odpovedi, zaradi katere je bila potrebna transplantacija.
English: ANTIFUNGALS Fluconazole 200 mg QD
Slovenian: Antimikotiki Flukonazol 20 mg na dan
English: Nevirapine AUC  1.29 (1.19-1.40) Nevirapine Cmin  1.34 (1.21-1.49) Nevirapine Cmax  1.25 (1.14-1.37)
Slovenian: AUC nevirapina  1,29 (1,19-1,40) Cmin nevirapina  1,34 (1,21-1,49) Cmax nevirapina  1,.25 (1,14-1,37)
English: Nevirapine plasma levels were not altered by co-administration of tenofovir.
Slovenian: Raven nevirapina v plazmi se pri sočasnem dajanju tenofovirjem ni spremenila.
English: General disorders and administration site conditions Common fatigue, pyrexia
Slovenian: Splošne težave in spremembe na mestu aplikacije Pogosti utrujenost, pireksija
English: Viramune oral suspension contains 150 mg sucrose per ml.
Slovenian: Peroralna suspenzija Viramune vsebuje 150 mg saharoze v enem mililitru.
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.
Slovenian: Črnci (n = 80/skupino) so v študiji 1100.1486 dosegli v 48 tednih med zdravljenjem z odmerki po 400 mg na dan za približno 30 % večje koncentracije pred naslednjim odmerkom kot belci (250 do 325 bolnikov/skupino) v prvi skupini, ki je jemala zdravilo Viramune s takojšnjim sproščanjem, in v drugi, ki je jemala zdravilo Viramune s podaljšanim sproščanjem.
English: VERxVE (study 1100.1486) is a phase 3 study in which treatment-naïve patients received Viramune 200 mg immediate-release once daily for 14 days and then were randomised to receive either Viramune 200 mg immediate-release twice daily or Viramune 400 mg prolonged-release once daily.
Slovenian: VERxVE (1100.1486) je študija 3. faze, v kateri so prvič zdravljeni bolniki 14 dni jemali zdravilo Viramune s takojšnjim sproščanjem v odmerkih po 200 mg enkrat na dan, nato so jih naključno razvrstili v skupino za zdravljenje z odmerjanjem zdravila Viramune s takojšnjim sproščanjem po 200 mg dvakrat na dan ali z odmerjanjem zdravila Viramune s podaljšanim sproščanjem po 400 mg enkrat na dan.
English: Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not have their Viramune dose increased until the rash has resolved.
Slovenian: Bolnikom, pri katerih se med 14-dnevnim uvajalnim obdobjem z odmerki po 200 mg na dan pojavi izpuščaj, odmerka zdravila Viramune ne smemo povečati, dokler le-ta ne mine.
English: By weight the recommended oral dose for paediatric patients up to 8 years of age is 4 mg/kg once daily for two weeks followed by 7 mg/kg twice daily thereafter.
Slovenian: Na podlagi telesne mase določeni odmerek za otroke do 8. leta starosti je 4 mg/kg enkrat na dan, dva tedna, nato sledi odmerjanje 7 mg/kg dvakrat na dan. Za otroke, stare 8 let in starejše, je priporočeni odmerek 4 mg/kg enkrat na dan, dva tedna, nato sledi odmerjanje 4 mg/kg dvakrat na dan.
English: Viramune prolonged-release tablets dose (mg)
Slovenian: Odmerek zdravila Viramune tablete s podaljšanim sproščanjem (mg)
English: anaphylactic reaction, angioedema, urticaria), drug reaction with eosinophilia and systemic symptoms, anaphylactic reaction
Slovenian: Bolezni imunskega sistema občasni preobčutljivost (tudi anafilaktična reakcija, angioedem, urtikarija), reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, anafilaktična reakcija
English: It is very important that you take only 20 ml of Viramune a day for the first 14 days (“lead-in” period).
Slovenian: Zelo pomembno je, da vzamete prvih 14 dni samo 20 ml zdravila Viramune na dan (”uvajalno” obdobje).
English: Atazanavir/r AUC  0.58 (0.48-0.71) Atazanavir/r Cmin  0.28 (0.20-0.40) Atazanavir/r Cmax  0.72 (0.60-0.86)
Slovenian: AUC atazanavirja/r  0,58 (0,48Cmin atazanavirja/r  0,28 (0,20-0,40) Cmax atazanavirja/r  0,72 (0,60-0,86)
English: Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173 - 55216 Ingelheim am Rhein Germany
Slovenian: KG Binger Strasse 173 - 55216 Ingelheim am Rhein Nemčija
English: Viramune oral suspension is supplied in plastic bottles of suspension for oral use, with 240 ml suspension per bottle.
Slovenian: Peroralna suspenzija Viramune je na voljo v plastenkah po 240 ml. Za pravilno odmerjanje je priložena plastična merilna brizga.
English: Patients should be intensively monitored during the first 18 weeks of treatment.
Slovenian: Zato je treba bolnike prvih 18 tednov zdravljenja skrbno spremljati in natančno opazovati, če se pojavi izoliran izpuščaj.
English: Thus cytochrome P450 metabolism, glucuronide conjugation, and urinary excretion of glucuronidated metabolites represent the primary route of nevirapine biotransformation and elimination in humans.
Slovenian: Primarna pot presnavljanja in izločanja nevirapina pri človeku je torej presnova prek citokroma P450, nastanek glukuronidnih konjugatov in izločanje s sečem v obliki glukuroniziranih presnovkov.
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.
Slovenian: Nevirapin je treba trajno ukiniti tudi vsem bolnikom, pri katerih se je pojavila preobčutljivostna reakcija (z izpuščajem in splošnimi simptomi ob hkratni prizadetosti visceralnih organov, npr. hepatitisu, eozinofiliji, granulocitopeniji in motnjah ledvične funkcije); glejte poglaje 4.4.
English: EXP Use within 2 months after 1
Slovenian: EXP Odprto zdravilo porabite v 2 mesecih.
English: No life-threatening (Grade 4) rash events considered related to Viramune were reported during the randomised phase of this study.
Slovenian: V fazi naključne razvrstitve v tej raziskavi niso poročali o življenjsko nevarnih primerih izpuščaja (4. stopnji), ki bi bili povezani z zdravilom Viramune.
English: Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adolescents and children three years and above and able to swallow tablets (see section
Slovenian: Zdravilo Viramune je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje s HIV-1 okuženih mladostnikov in otrok, starejših od 3 let, ki lahko tablete pogoltnejo (glejte poglavji
English: An oral suspension dosage form, which can be dosed according to body weight or body surface area, is available for children in this age group weighing less than 50 kg or whose body surface area is below 1.25 m2 (please refer to the
Slovenian: Za otroke iz te starostne skupine, ki tehtajo manj kot 50 kg ali katerih telesna površina ne dosega 1,25 m2, je na voljo peroralna suspenzija, katere odmerek lahko prilagajamo telesni masi ali površini (poglejte v Povzetek glavnih značilnosti Viramune peroralna suspenzija).
English: Severe and life-threatening hepatotoxicity, including fatal fulminant hepatitis, has occurred in patients treated with nevirapine.
Slovenian: Pri z nevirapinom zdravljenih bolnikih so se pojavili hudi in življenjsko nevarni toksični učinki na jetra, tudi fulminantni hepatitis s smrtnim izidom.
English: Polyvinyl chloride (PVC)/aluminium foil push-through blister units (blister card of 7 tablets).
Slovenian: Pretisni omoti iz polivinilklorida (PVC) in aluminijaste folije (7 tablet v pretisnem omotu).
English: Severe and life-threatening skin reactions, including fatal cases, have occurred in patients treated with nevirapine mainly during the first 6 weeks of therapy.
Slovenian: Pri z nevirapinom zdravljenih bolnikih so se (pretežno prvih 6 tednov zdravljenja) pojavile hude in življenjsko nevarne kožne reakcije, tudi s smrtnim izidom.
English: In adult patients with renal dysfunction requiring dialysis an additional 200 mg dose of nevirapine immediate-release following each dialysis treatment is recommended.
Slovenian: Pri odraslih bolnikih z ledvično disfunkcijo, ki se zdravijo z dializo, priporočamo dodaten odmerek nevirapina s takojšnim sproščanjem po 200 mg po vsaki dializi.
English: This herbal substance may stop Viramune from working properly.
Slovenian: Ta zdravilna rastlina lahko spremeni delovanje zdravila Viramune.
English: Severe rash occurred in 1.4 % and 0.2 % of the Viramune immediate-release and Viramune prolonged-release groups respectively during the randomised phase.
Slovenian: Hud izpuščaj se je pojavil pri 1,4 % in 0,2 % bolnikov, ki so v obdobju po naključni razvrstitvi v skupine jemali zdravilo Viramune s takojšnjim sproščanjem ali zdravilo Viramune s podaljšanim sproščanjem.
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.
Slovenian: Pri bolnikih z nedoločljivim virusnim bremenom v plazmi (tj. < 50 kopij/ml) ni bilo povečano tveganje toksičnosti, ki je povezano z mejnim številom celic CD4.
English: If a dose is missed and it is more than 8 hours later, the patient should only take the next dose at the usual time.
Slovenian: Če bolnik pozabi vzeti odmerek in je preteklo že več kot 8 ur, naj vzame naslednji odmerek ob običajnem času.
English: Calculation of the volume of Viramune oral suspension (50 mg/5 ml) required for paediatric dosing after the two weeks lead-in period.
Slovenian: ® (50 mg/5 ml) peroralna suspenzija potrebnega za odmerjanje pri otrocih po dvotedenskem uvajalnem obdobju:
English: Mosteller Formula: BSA (m
Slovenian: Mostellerjeva formula: telesna površina (m kg masa telesna cm višina
English: The nevirapine twice daily regimen and the efavirenz regimen were not significantly different (p= 0.091) in terms of efficacy as measured by treatment failure, or any component of treatment failure including virological failure.
Slovenian: Režim z dvema odmerkoma nevirapina in režim z efavirenzem se po učinkovitosti, določeni na podlagi neuspeha zdravljenja, alikaterekoli sestavine neuspeha zdravljenja, vključno z virološkim neuspehom.
English: Efavirenz AUC  0.72 (0.66-0.86) Efavirenz Cmin  0.68 (0.65-0.81) Efavirenz Cmax  0.88 (0.77-1.01)
Slovenian: AUC efavirenza  0,72 (0,66-0,86) Cmin efavirenza  0,68 (0,65-0,81) Cmax efavirenza  0,88 (0,77-1,01)
English: Sucrose: Viramune oral suspension contains 150 mg of sucrose per ml.
Slovenian: Saharoza: Zdravilo Viramune peroralna suspenzija vsebuje 150 mg saharoze v mililitru.
English: Nevirapine AUC  1.14 (1.05-1.24) Nevirapine Cmin  1.22 (1.10-1.35) Nevirapine Cmax  1.13 (1.03-1.24)
Slovenian: AUC nevirapina  1,14 (1,05-1,24) Cmin nevirapina  1,22 (1,10-1,35) Cmax nevirapina  1,13 (1,03-1,24)
English: NAME OF THE MEDICINAL PRODUCT Viramune 200 mg tablets
Slovenian: IME ZDRAVILA Viramune 200 mg tablete
English: Because of the risk of increased
Slovenian: Glede na presnovno pot
English: Nevirapine must not be administered to patients with pretreatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN (see section
Slovenian: Nevirapin ne smemo dajati bolnikom, ki imajo pred zdravljenjem raven ASAT ali ALAT > 5-kratne zgornje laboratorijske mejne vrednosti, dokler se začetna raven ASAT/ALAT ne stabilizira na < 5-kratno zgornjo mejno vrednost (glejte poglavje 4.3).
English: The concomitant administration of Viramune with NNRTIs is not recommended (see section 4.4).
Slovenian: Sočasnega dajanja zdravila Viramune in NNRTI ne priporočajo (glejte poglavje 4.4).
English: anaphylactic reaction, angioedema, urticaria) Uncommon anaphylactic reaction Rare drug reaction with eosinophilia and systemic symptoms Nervous system disorders
Slovenian: neznana anafilaktična reakcija redki reakcija na zdravilo z eozinofilijo in sistemskimi simptomi