FrancophonIA/ELRC3.0 huggingface dataset:
English: 1,216 antiretroviral-therapy naïve patients with plasma HIV-1 RNA > 5,000 copies/ml at baseline were assigned to nevirapine 400 mg once daily, nevirapine 200 mg twice daily, efavirenz 600 mg once daily, or nevirapine (400 mg) and efavirenz (800 mg) once daily, plus stavudine and lamivudine for 48 weeks.
Slovenian: 1216 bolnikov, ki se še niso zdravili s protiretrovirusnimi zdravili in so imeli izhodiščno plazemsko koncentracijo HIV-1 RNA > 5000 kopij/ml so razvrstili v skupine zdravljenje z nevirapinom po 400 mg enkrat na dan ali po 200 mg dvakrat na dan, efavirenzem po 600 mg enkrat na dan ali nevirapinom (400 mg) in efavirenzem (800 mg) enkrat na dan, skupaj s stavudinom in lamivudinom, ki je trajalo 48 tednov.
English: The most frequently reported adverse reactions related to nevirapine therapy, across all clinical studies, were rash, allergic reactions, hepatitis, abnormal liver function tests, nausea, vomiting, diarrhoea, abdominal pain, fatigue, fever, headache and myalgia.
Slovenian: Neželene reakcije o katerih so najpogosteje poročali v povezavi z zdravljenjem z nevirapinom, so bili v vseh kliničnih študijah izpuščaj, alergijske reakcije, hepatitis, nenormalni jetrni izvidi, slabost, bruhanje, driska, trebušna bolečina, utrujenost, vročina, glavobol in mialgija.
English: Taking all doses at the appropriate times: - greatly increases the effectiveness of your combination antiretroviral medicines.
Slovenian: Če ste prenehali jemati zdravilo Nevirapin Teva Redno jemanje odmerkov ob ustreznem času: - zelo poveča učinkovitost vam predpisane kombinacije protiretrovirusnih zdravil,
English: Contains lactose: see leaflet for further information.
Slovenian: Vsebuje laktozo: pred uporabo preberite priloženo navodilo!
English: Currently available data on pregnant women indicate no malformative or foeto/ neonatal toxicity.
Slovenian: Nosečnost Razpoložljivi podatki pri nosečnicah ne kažejo na anomalije ali okvare pri zarodku oziroma novorojenčku zaradi toksičnosti.
English: Nevirapine Teva 200 mg
Slovenian: Nevirapin Teva 200 mg
English: Contact your doctor if you notice changes in body fat (see section 4 “Possible side effects”).
Slovenian: Če opazite spremembe telesnega maščevja, se pogovorite z zdravnikom (glejte poglavje »Neželeni učinki«).
English: Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not have their Nevirapine Teva dose increased until the rash has resolved.
Slovenian: Pri bolnikih, pri katerih se med 14-dnevnim uvajalnim obdobjem z odmerki po 200 mg na dan pojavi izpuščaj, odmerka zdravila Nevirapin Teva ne smemo povečati, dokler izpuščaj ne izzveni.
English: Adult patients:
Slovenian: Starejši bolniki
English: Blood and lymphatic system disorders Common granulocytopenia Uncommon anaemia
Slovenian: Bolezni krvi in limfatičnega sistema pogosti granulocitopenija občasni anemija
English: Gastrointestinal disorders Common nausea, vomiting, abdominal pain, diarrhoea Hepatobiliary disorders Common hepatitis (including severe and life-threatening hepatotoxicity) (1.9%) Uncommon jaundice
Slovenian: Bolezni prebavil pogosti slabost, bruhanje, driska, trebušna bolečina Bolezni jeter, žolčnika in žolčevodov pogosti hepatitis (tudi huda in življenjsko nevarna hepatotoksičnost) (1,9 %)
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 ob uporabi nevirapina, 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 HIV1RNA in pri bolnikih z večjim številom celic CD4 je v uvajalnem obdobju zdravljenja z nevirapinom povečano tveganje simptomatskih jetrnih dogodkov.
English: The isolated rash should be closely monitored (see section 4.4).
Slovenian: Posamezna mesta z izpuščajem je potrebno natančno opazovati (glejte poglavje 4.4).
English: Studies in treatment-experienced patients
Slovenian: Študija pri nezdravljenih bolnikih
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
English: Otherwise patients with CLcr ≥ 20 ml/min do not require an adjustment in nevirapine dosing.
Slovenian: Bolnikom s CLcr ≥ 20 ml/min odmerka nevirapina sicer ni potrebno prilagajati.
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 pojavile hude in življenjsko nevarne kožne reakcije, tudi s smrtnim izidom, zlasti v prvih 6 tednih zdravljenja.
English: The 200 mg once daily dosing regimen should not be continued beyond 28 days at which point in time an alternative treatment should be sought due to the possible risk of underexposure and resistance.
Slovenian: Zdravljenje z 200 mg odmerkom enkrat na dan sme trajati največ 28 dni, nato je potrebno poiskati alternativni način zdravljenja, zaradi izpostavljenosti premajhnemu odmerku zdravila in s tem možnemu tveganju za razvoj odpornosti.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Nevirapine Teva.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden boste vzeli zdravilo Nevirapin Teva.
English: Alternatives to clarithromycin, such as azithromycin should be considered.
Slovenian: Presoditi je potrebno o uporabi alternativnih zdravil namesto klaritromicina, na primer azitromicina.
English: Nevirapine Cmin ↓ 0.32
Slovenian: Cmin nevirapina ↓ 0,32
English: Coadministration with herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine (see section 4.5).
Slovenian: Sočasno jemanje zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum), ker lahko zmanjšajo koncentracijo nevirapina v plazmi in njegove klinične učinke (glejte poglavje 4.5).
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Slovenian: Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.4).
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.
Slovenian: Nevirapin je potrebno dokončno ukiniti vsem bolnikom, pri katerih so se pojavili hud izpuščaj ali izpuščaj ob hkratnih splošnih simptomih (npr. povišani temperaturi, mehurčkih, lezijah v ustni votlini, konjunktivitisu, obraznem edemu, mišičnih ali sklepnih bolečinah ali splošnem slabem počutju), vključujoč Stevens-Johnsonov sindrom ali toksično epidermalno nekrolizo.
English: Ketoconazole Cmin ND
Slovenian: Cmin ketokonazola ND
English: The side effects described below have been experienced by patients given nevirapine:
Slovenian: Našteti neželeni učinki so se pojavili pri bolnikih, ki so jemali nevirapin:
English: Metabolite 25-O-desacetylrifabutin
Slovenian: AUC presnovka 25-Odezacetilrifabutina
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Slovenian: Tega zdravila Nevirapin Teva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu za oznako EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: If a patient is already taking St. John‘s Wort check nevirapine and if possible viral levels and stop St John‘s Wort.
Slovenian: Če bolnik že jemlje šentjanževko, je potrebno preveriti raven nevirapina in po možnosti virusa, bolnik pa naj šentjanževko preneha jemati.
English: Patients should be instructed that a major toxicity of nevirapine is rash.
Slovenian: Bolnikom je potrebno povedati, da je glavni toksični pojav pri uporabi nevirapina izpuščaj.
English: There are toxicities that require interruption of Nevirapine Teva therapy (see section 4.4).
Slovenian: Pojavijo se lahko toksični učinki, zaradi katerih je potrebno zdravljenje z zdravilom Nevirapin Teva prekiniti (glejte poglavje 4.4).
English: 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).
Slovenian: Ženske v rodni dobi / kontracepcija pri moških in ženskah Ženske v rodni dobi peroralnih kontraceptivov ne smejo uporabljati kot edine metode za nadzor rojstev, ker lahko nevirapin zmanjša njihovo koncentracijo v plazmi (glejte poglavji 4.4 in 4.5).
English: Nevirapine co-administration did not alter the ovulation suppression effects of DMPA.
Slovenian: Nevirapin Teva se zaviralni učinki DMPA na ovulacijo niso spremenili.
English: No significant effect on rifabutin and nevirapine mean PK parameters is seen.
Slovenian: Ni pomembnega učinka na srednje vrednosti farmakokinetičnih parametrov rifabutina in nevirapina.
English: If you develop severe liver, skin or hypersensitivity reactions whilst taking Nevirapine Teva, NEVER TAKE Nevirapine Teva again without referring to your doctor.
Slovenian: Če se pri vas med jemanjem zdravila Nevirapin Teva razvijejo hude jetrne, kožne ali preobčutljivostne reakcije, NE NADALJUJTE z jemanjem zdravila Nevirapin Teva, ne da bi se prej posvetovali z zdravnikom.
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
Slovenian: Nevirapin ob večkratnem odmerjanju inducira svoje lastno presnavljanje, zato ta študija, v kateri so uporabili enkratno odmerjanje, ni pokazala vpliva jetrne okvare na farmakokinetiko, kot se sicer dogaja ob večkratnem dajanju zdravila (glejte poglavje 4.4).
English: If you notice that you have missed a dose within 8 hours of when it was due, take the missed dose as soon as possible.
Slovenian: Če se spomnite, da ste pozabili vzeti odmerek v 8 urah, vzemite naslednji odmerek, takoj ko je to mogoče.
English: If patients present with a suspected nevirapine-associated rash, liver function tests should be performed.
Slovenian: Bolnikom, pri katerih se sumi na pojav izpuščaja, ki je povezan z uporabo nevirapina, je potrebno opraviti preiskave jetrne funkcije.
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.
Slovenian: Ponovno dajanje bolnikom, pri katerih je bilo potrebno zdravljenje z njim dokončno ukiniti zaradi hudega izpuščaja, izpuščaja s sočasnimi splošnimi simptomi, pojava preobčutljivostnih reakcij ali klinične oblike hepatitisa zaradi nevirapina.
English: These events are commonly associated with other antiretroviral agents and may be expected to occur when Nevirapine Teva is used in combination with other agents; however, it is unlikely that these events are due to treatment with Nevirapine Teva.
Slovenian: Ta stanja so večinoma povezana z drugimi protivirusnimi zdravili in se lahko pojavijo, kadar jemljete tablete Nevirapin Teva v kombinaciji z drugimi zdravili, ni pa verjetno, da jih povzroča samo zdravljenje s tabletami Nevirapin Teva.
English: Additionally, when postmenopausal hormone therapy is used during administration of nevirapine, its therapeutic effect should be monitored.
Slovenian: Pri uporabi hormonskega nadomestnega zdravljenja v pomenopavzi, je potrebno med jemanjem nevirapina spremljati njihov terapevtski učinek.
English: Nevirapine should not be used in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
Slovenian: Nevirapina ne smemo dajati bolnikom s hudo jetrno okvaro (Child-Pugh C., glejte poglavje 4.3).
English: Hepatic dysfunction: 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.
Slovenian: bolnikov, ki so imeli: blago (n = 17: ocena 1 do 2 po Ishaku), zmerno (n = 20; ocena 3 do 4 po Ishaku) ali hudo (n = 9; ocena 5 do 6 po Ishaku, Child-Pugh A pri 8 bolnikih, pri 1 bolniku ocene po ChildPughu niso uporabili) jetrno fibrozo, ki je veljala kot merilo za jetrno okvaro.
English: Very common rash (12.5 %)
Slovenian: Bolezni kože in podkožja zelo pogosti izpuščaj (12,5 %)
English: 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 should discontinue the medicinal product and immediately seek medical evaluation.
Slovenian: Bolniki, pri katerih se pojavi hud izpuščaj ali izpuščaj ob hkratnih splošnih simptomih, kot so povišana temperatura, pojav mehurčkov, lezije v ustni votlini, konjunktivitis, obrazni edem, mišične ali sklepne bolečine ali splošno slabo počutje, morajo prekiniti z jemanjem zdravila, njihovo stanje pa mora nemudoma oceniti zdravnik.
English: AUC ↑ 1.42 (1.16-1.73)
Slovenian: 14-OH ↑ 1,42 (1,16-1,73)
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
Slovenian: Ponovno dajanje bolnikom, ki so imeli raven AST ali ALT med prejšnjim zdravljenjem z nevirapinom > 5-krat večjo od zgornje meje normalne laboratorijske vrednosti in pri katerih so se motnje jetrne funkcije ob ponovnem dajanju nevirapina ponovile (glejte poglavje 4.4).
English: What Nevirapine Teva looks like and contents of the pack
Slovenian: Izgled zdravila Nevirapin Teva in vsebina pakiranja
English: The consolidated analysis of Paediatric AIDS Clinical Trials Group (PACTG) protocols 245, 356, 366, 377, and 403 allowed for the evaluation of paediatric patients less than 3 months of age (n=17) enrolled in these PACTG studies.
Slovenian: Zbirna analiza protokolov PACTG (Paediatric AIDS Clinical Trials Group) 245, 356, 366, 377 in 403
English: DMPA AUC ↔ DMPA Cmin ↔ DMPA Cmax ↔
Slovenian: AUC DMPA ↔ Cmin DMPA ↔ Cmax DMPA ↔ AUC nevirapina ↑ 1,20 Cmax nevirapina ↑ 1,20
English: Maraviroc Cmin ND Maraviroc Cmax ↔ 1.54 (0.94-2.52) compared to historical controls
Slovenian: Cmax maraviroka ↔ 1,54 (0,94-2,52) v primerjavi s prejšnjimi, kontrolnimi vrednostmi
English: Paediatric patients:
Slovenian: Posebne skupine bolnikov:
English: Nevirapine had a median EC50 value (50% inhibitory concentration) of 63 nM against a panel of group M HIV-1 isolates from clades A, B, C, D, F, G, and H, and circulating recombinant forms (CRF), CRF01_AE, CRF02_AG and CRF12_BF replicating in human embryonic kidney 293 cells.
Slovenian: Srednja vrednost EC50 nevirapina (ob 50 % zaviralni koncentraciji) je bila 63 nM proti naboru izolatov HIV-1 iz skupine M genotipskih skupin A, B, C, D, F, G in H ter rekombinantnim oblikam v obtoku
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(i) UPORABE ZDRAVILA
English: Isolated cases of Stevens-Johnson syndrome or Stevens-Johnson/toxic epidermal necrolysis transition syndrome have been reported in this population.
Slovenian: Pri tej populaciji so poročali o posamičnih primerih Stevens-Johnsonovega sindroma ali sindroma prehoda Stevens-Johnsonovega sindroma v toksično epidermalno nekrolizo.
English: How to take Nevirapine Teva
Slovenian: Kako jemati zdravilo Nevirapin Teva
English: Nevirapine is about 60 % bound to plasma proteins in the plasma concentration range of 1-10 μg/ml.
Slovenian: Približno 60 % nevirapina se pri razponu plazemskih koncentracij 1 do
English: The use of nevirapine has not been evaluated within a specific study on PEP, especially in term of treatment duration and therefore, is strongly discouraged.
Slovenian: Specifične raziskave o profilaktični uporabi po izpostavljenosti okužbi, zlasti glede na trajanje takšnega zdravljenja, z zdravilom Nevirapin Teva niso opravili, zato se tako uporabo močno odsvetuje.
English: If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of Nevirapine Teva.
Slovenian: Če se zdravite z dializo, bo zdravnik presodil o potrebni prilagoditvi odmerka zdravila Nevirapin Teva.
English: Nevirapine Cmin ↑ 1.07
Slovenian: Cmin nevirapina ↑ 1,07
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Bolnikom z blago do zmerno jetrno okvaro odmerka ni treba prilagajati (glejte poglavji 4.4 in
English: You must take the dose of Nevirapine Teva as prescribed by your doctor.
Slovenian: Zdravilo Nevirapin Teva morate jemati tako dolgo, kot vam je naročil zdravnik.
English: Musculoskeletal and connective tissue disorders Uncommon arthralgia, myalgia
Slovenian: Bolezni kosti, sklepov, mišic in vezivnega tkiva občasni artralgija, mialgija
English: Methadone AUC ↓ 0.40 (0.31 - 0.51)
Slovenian: AUC metadona ↓ 0,40 (0,31-0,51)
English: The dose must be strictly adhered to, especially the 14-days lead-in period (see section 4.2).
Slovenian: Natančno je potrebno upoštevati navodila o odmerjanju, zlasti 14-dnevno uvajalno obdobje
English: Prednisone should not be used to treat a rash related to Nevirapine Teva.
Slovenian: Prednizona ne smemo uporabljati za zdravljenje izpuščaja, povezanega z jemanjem zdravila Nevirapin
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/mm3 or in adult males with CD4 cell counts greater than 400 cells/mm3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
Slovenian: Ker so v nadzorovanih in nenadzorovanih raziskavah poročali o resnih in življenjsko nevarnih hepatotoksičnosti pretežno pri bolnikih z virusnim bremenom s HIV-1 50 kopij/ml ali večjim, ne smemo uvesti nevirapina pri odraslih ženskah s številom celic CD4 nad 250 celic/mm3 in odraslih moških s številom celic CD4 nad 400 celic/mm3, in izmerljivo ravnijo
English: EE AUC ↓ 0.80 (0.67 - 0.97)
Slovenian: AUC EE ↓ 0,80 (0,67-0,97)
English: Nevirapine readily crosses the placenta and is found in breast milk.
Slovenian: Nevirapin brez težav prehaja preko posteljice in je prisoten v materinem mleku.
English: Maraviroc AUC ↔ 1.01 (0.6 -1.55)
Slovenian: AUC maraviroka ↔ 1,01 (0,6 -1,55)
English: Cmax ↑ 1.47 (1.21-1.80) Nevirapine AUC ↑ 1.26
Slovenian: 14-OH ↑ 1,47 (1,21-1,80) AUC nevirapina ↑ 1,26
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.
Slovenian: Pri ženskah z večjim številom celic CD4 na začetku zdravljenja z nevirapinom je pri prvič zdravljenih bolnikih povečano tveganje neželenih jetrnih reakcij.
English: Non-clinical data reveal no special hazard for humans other than those observed in clinical studies based on conventional studies of safety, pharmacology, repeated dose toxicity, and genotoxicity.
Slovenian: Neklinični podatki iz standardnih raziskav o varnosti, farmakologiji, toksičnosti ponavljajočih se odmerkov in genotoksičnosti niso odkrili posebnega tveganja za človeka, ki bi se razlikovalo od tistega, ki so ga pokazale klinične raziskave.
English: Clarithromycin 500 mg BID
Slovenian: Klaritromicin 500 mg 2-krat na dan
English: NET Cmax ↓ 0.84 (0.73 - 0.97)
Slovenian: Cmax NET ↓ 0,84 (0,73-0,97)
English: However, patients should be advised that they may experience adverse reactions such as fatigue during treatment with Nevirapine Teva.
Slovenian: Bolnikom je treba povedati, da se lahko med zdravljenjem z zdravilom Nevirapin Teva pojavijo neželeni učinki, na primer utrujenost.
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 se ne sme dajati bolnikom, ki imajo pred zdravljenjem raven AST ali ALT > 5-kratne zgornje laboratorijske mejne vrednosti, dokler se začetna raven AST/ALT ne stabilizira na < 5-kratno zgornjo mejno vrednost (glejte poglavje 4.3).
English: Caution should be exercised when prescribing nevirapine to pregnant women (see section 4.4).
Slovenian: Nosečnicam je potrebno nevirapin predpisovati previdno (glejte poglavje 4.4).
English: Nevirapine has been evaluated in both treatment-naïve and treatment-experienced patients.
Slovenian: Nevirapin so ocenjevali pri že zdravljenih kot nezdravljenih bolnikih.
English: Patients with CLcr ≥ 20 ml/min do not require a dose adjustment, see section 5.2.
Slovenian: Bolnikom s CLcr ≥ 20 ml/min odmerka ni treba prilagajati;
English: Nevirapine Cmin ↑ 1.28
Slovenian: Cmin nevirapina ↑ 1,28
English: NET AUC ↓ 0.81 (0.70 - 0.93)
Slovenian: AUC NET ↓ 0,81 (0,70-0,93)
English: Rifampicin AUC ↔ 1.11 (0.96-1.28)
Slovenian: AUC rifampicina ↔ 1,11 (0,96-1,28)
English: Ketoconazole AUC ↓ 0.28 (0.20
Slovenian: AUC ketokonazola ↓ 0,28 (0,20-0,40)
English: Fosamprenavir 1,400 mg BID
Slovenian: Fosamprenavir 1400 mg 2-krat na dan
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/mm3 had a 12 fold higher risk of symptomatic hepatic adverse reactions compared to women with CD4 counts < 250 cells/mm3 (11.0 %
Slovenian: V retrospektivnem pregledu podatkov, ki je večinoma zajel bolnike z virusnim bremenom s HIV-1 v plazmi 50 kopij/ml ali več, je bilo tveganje simptomatskih neželenih jetrnih reakcij pri ženskah s številom celic CD4 > 250 celic/mm3 12-krat večje, kot pri ženskah s številom celic CD4 < 250 celic/mm3 (11,0 % proti 0,9 %).
English: Tél: +(34) 91 387 32 80
Slovenian: Teva Pharma, S.L.U Tél: +(34) 91 387 32 80
English: Therefore coadministration would likely result in altered plasma levels of cobicistat and Nevirapine Teva.
Slovenian: Pri sočasnem dajanju bi se verjetno spremenile ravni kobicistata in zdravila Nevirapin Teva v plazmi.
English: EE Cmax ↔ 0.94 (0.79 - 1.12)
Slovenian: Cmax EE ↔ 0,94 (0,79-1,12)
English: anaphylactic reaction, angioedema, urticaria) Uncommon anaphylactic reaction Rare drug reaction with eosinophilia and systemic symptoms Nervous system disorders
Slovenian: občasni anafilaktična reakcija redki reakcija na zdravilo z eozinofilijo in sistemskimi simptomi
English: The most frequently observed laboratory test abnormalities are elevations in liver function tests (LFTs), including ALAT, ASAT, GGT, total bilirubin and alkaline phosphatase.
Slovenian: Najpogostnejša sprememba laboratorijskih izvidov je povečanje ALT, AST, GGT, skupnega bilirubina in alkalne fosfataze pri preiskavah jetrne funkcije.