natgillin/translations-raw huggingface dataset:
The most frequently observed laboratory test abnormalities are elevations in liver function tests (LFTs), including ALAT, ASAT, GGT, total bilirubin and alkaline phosphatase.
Najpogostnejša sprememba laboratorijskih izvidov je povečanje ALT, AST, GGT, skupnega bilirubina in alkalne fosfataze pri preiskavah jetrne funkcije.
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:
Genotipske analize izolatov, odvzetih bolnikom, ki prej še niso prejemali protiretrovirusnih zdravil, pri katerih je prišlo do virološkega neuspeha (n = 71), prejemali pa so nevirapin enkrat na dan (n = 25) ali dvakrat na dan (n = 46) v kombinaciji z lamivudinom in stavudinom 48 tednov, so pokazale, da so izolati 8/25 oziroma 23/46 bolnikov vsebovali eno ali več naslednjih substitucij, povezanih z odpornostjo proti nenukleozidnim zaviralcem reverzne transkriptaze: Y181C, K101E, G190A/S, K103N, V106A/M, V108I, Y188C/L, A98G, F227L in M230L
A durable response to nevirapine for at least three years was documented in this study, and equivalence within a 10% range was demonstrated between nevirapine 200 mg twice daily and efavirenz with respect to treatment failure.
Med nevirapinom dvakrat na dan po 200 mg in efavirenzem so za neuspešnost zdravljenja dokazali enakovrednost v razponu 10 %.
The interaction data is presented as geometric mean value with 90% confidence interval (90% CI) whenever these data were available.
90-odstotnim intervalom zaupanja (90-odstotni IZ).
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (AIDS defining illness), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
katero definira AIDS) v anamnezi se lahko kmalu po začetku anti-HIV zdravljenja pojavijo znaki in simptomi vnetja povezani s prejšnjimi okužbami.
Dosing of nevirapine at 150 mg/m2 BID (after a two-week lead in at 150 mg/m2 QD) produced geometric mean or mean trough nevirapine concentrations between 4-6 μg/ml (as targeted from adult data).
150 mg/m2 vsak dan) je bila geometrična sredina koncentracije nevirapina ali njegova najmanjša srednja koncentracija 4 -6 μg/ml (ciljna glede na podatke za odrasle).
Stavudine AUC ↔ 0.96 (0.89-1.03)
AUC stavudina ↔ 0,96 (0,89-1,03)
Patients with severe hepatic impairment (Child-Pugh C) or pre-treatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN.
Bolniki s hudo jetrno okvaro (Child-Pugh C) in tistim, ki so pred zdravljenjem imeli raven aspartataminotransferaze (AST) ali alanin-aminotransferaze (ALT) > 5-krat večjo od zgornje meje normalne laboratorijske vrednosti, dokler se začetna vrednost AST/ALT ne stabilizira na < 5-kratni zgornji meji normalne vrednosti.
Zidovudine AUC ↓ 0.72 (0.60-0.96)
AUC zidovudina ↓ 0,72 (0,60-0,96)
As hepatotoxicity is more frequent in women with CD4 cell counts above 250 cells/mm3 with detectable HIV-1 RNA in plasma (50 or more copies/ml),
Ker je hepatotoksičnost pogostejša pri ženskah s številom celic CD4 nad 250 celic/mm3 in izmerljivo ravnijo
Uncommon (may affect up to 1 in 100 people): - allergic reaction characterised by rash, swelling of the face, difficulty breathing (bronchial spasm)
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - alergijska reakcija z izpuščajem, otekanjem obraza, s težavnim dihanjem (bronhialni krč) ali z - anafilaktičnim šokom - zmanjšanje števila rdečih krvničk (anemija),
Rashes occur alone or in the context of drug reaction with eosinophilia and systemic symptoms, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lympadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Izpuščaj se pojavi sam ali v sklopu reakcije na zdravilo z eozinofijo in sistemskimi simptomi, kjer ga značilno spremljajo splošni simptomi, kot so vročina, artralgija, mialgija in limfadenopatija, ter prizadetost visceralnih organov, npr. hepatitis, eozinofilija, granulocitopenija in motnje ledvične funkcije.
Amprenavir AUC ↔ 0.89 (0.77
AUC amprenavirja ↔ 0,89 (0,77
Methadone Cmin ND Methadone Cmax ↓ 0.58 (0.50 - 0.67)
Cmax metadona ↓ 0,58 (0,50-0,67)
This is because Nivirapine Teva can be partly washed out of your blood by dialysis.
To je potrebno, ker lahko dializa zdravilo Nevirapin Teva delno odstrani iz telesa.
Didanosine AUC ↔ 1.08 (0.92-1.27)
AUC didanozina ↔ 1,08 (0,92-1,27)
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.
Johnsonov sindrom/toksična epidermalna nekroliza, hude oblike hepatitisa oz. 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.
Do not take more Nevirapine Teva than prescribed by your doctor and described in this leaflet.
Če ste vzeli večji odmerek zdravila Nevirapin Teva, kot bi smeli Ne prekoračite odmerka zdravila Nevirapin Teva, ki vam ga je predpisal zdravnik in je naveden v tem navodilu.
Cmin ↔ 0 (0.68-1.49)
OH ↔ 0 (0,68-1,49)
Rifabutin Cmin ↔ 1.07 (0.84-1.37) Rifabutin Cmax ↑ 1.28 (1.09-1.51)
AUC rifabutina ↑ 1,17 (0,98-1,40) Cmin rifabutina ↔ 1,07 (0,84-1,37) Cmax rifabutina ↑ 1,28 (1,09-1,51)
If co-administered with Nevirapine Teva, an adjustment in the telaprevir dose should be considered.
Pri sočasnem dajanju z zdravilom Nevirapin Teva je treba presoditi o prilagoditvi odmerka telaprevirja.
Nevirapine Teva contains lactose
Zdravilo Nevirapin Teva vsebuje laktozo
Female gender and higher CD4 counts (>250/mm in adult females and >400/mm in adult males) at the initiation of nevirapine therapy are associated with a greater risk of hepatic adverse reactions if the patient has detectable plasma HIV-1 RNA - i.e. a concentration ≥ 50 copies/ml - at the initiation of nevirapine.
Pri ženskah in bolnikih z večjim številom celic CD4 (> 250/mm3 pri odraslih ženskah in > 400/mm3 pri odraslih moških) je na začetku zdravljenja z nevirapinom povečano tveganje neželenih učinkov na jetra, če imajo v plazmi izmerljivo raven
Co-administration of Nevirapine Teva with elvitegravir in combination with cobicistat is not recommended (see section 4.4).
Nevirapin Teva in elvitegravirja v kombinaciji s kobicistatom je odsvetovano (glejte poglavje 4.4).
Rare (may affect up to 1 in 1000 people): - sudden and intense inflammation of the liver (fulminant hepatitis) - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - nenadno in močno vnetje jeter (fulminantni hepatitis);
Herbal preparations containing St. John‘s Wort and Nevirapine Teva must not be co-administered (see section 4.3).
Zeliščnih pripravkov, ki vsebujejo šentjanževko, in zdravila Nevirapin Teva se ne sme uporabljati sočasno (glejte poglavje 4.3).
ANTIFUNGALS
Antimikotiki
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.
Pri bolnikih z nedoločljivim virusnim bremenom v plazmi (tj. < 50 kopij/ml) ni bilo povečano tveganje toksičnosti,
The proportion of patients with at least one grade 3 or 4 liver-associated laboratory toxicity was 8.3% for nevirapine twice daily and 4.5% for efavirenz.
povezanim z jetri, je bil 8,3 % pri jemanju dveh odmerkov nevirapina na dan, in 4,5 % pri jemanju efavirenza.
Careful monitoring of the therapeutic effectiveness of P450 metabolised medicinal products is recommended when taken in combination with nevirapine.
Priporočeno je skrbno spremljanje terapevtskega učinka zdravil, ki se presnavljajo prek
However, in the absence of specific studies, the clinical impact of these findings is not known.
klinični pomen teh izsledkov ni znan.
Studies in treatment-naïve patients
Študije pri že zdravljenih bolnikih Študija NEFA
Amprenavir Cmin ↓ 0.81 (0.69-0.96) Amprenavir Cmax ↔ 0.97 (0.85-1.10)
Cmin amprenavirja ↓ 0,81 (0,69-0,96) Cmax amprenavirja ↔ 0,97 (0,85-1,10)
This includes some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis) and liver failure, which can be both fatal.
Poročajo, da so se med jemanjem zdravila Nevirapin Teva pojavile motnje delovanja jeter, vključno z nekaj primeri vnetja jeter (hepatitisa), ki je lahko nenadno in intenzivno (fulminantni hepatitis), in jetrne odpovedi, ki se lahko končata s smrtjo.
The anti-HIV-1 activity of nevirapine was antagonized by the anti-HBV medicinal product adefovir and by the anti-HCV medicinal product ribavirin in vitro.
Na učinek nevirapina proti HIV-1 sta in vitro delovala antagonistično adefovir, zdravilo proti virusu hepatitisa B (HBV), in ribavirin, zdravilo proti virusu hepatitisa C. Odpornost
Clinical hepatitis reported as clinical adverse event occurred in 10 (2.6%) and 2 (0.5%) patients in the nevirapine twice daily and efavirenz groups respectively.
(2,6 %) v skupini, ki je jemala nevirapin dvakrat na dan, in 2 bolnika (0,5 %) v skupini, ki je jemala efavirenz.
How to store Nevirapine Teva
Shranjevanje zdravila Nevirapin Teva
Rhabdomyolysis has been observed in patients experiencing skin and/or liver reactions associated with nevirapine use.
Pri bolnikih, pri katerih so se v povezavi z uporabo nevirapina pojavile kožne in/ali jetrne reakcije, so opazili pojav rabdomiolize.
Each tablet contains 200 mg nevirapine (as nevirapine anhydrate).
Ena tableta vsebuje 200 mg nevirapina (v obliki brezvodnega nevirapina).
Fluconazole Cmin ↔ 0.93 (0.86-1.01) Fluconazole Cmax ↔ 0.92 (0.85-0.99)
AUC flukonazola ↔ 0,94 (0,88-1,01) Cmin flukonazola ↔ 0,93 (0,86-1,01) Cmax flukonazola ↔ 0,92 (0,85-0,99)
Clinical chemistry tests, which include liver function tests, should be performed prior to initiating nevirapine therapy and at appropriate intervals during therapy.
Pred začetkom zdravljenja z nevirapinom in v ustreznih razmikih med zdravljenjem je potrebno opraviti klinične kemijske preiskave, ki vključujejo jetrne preiskave.
Nevirapine exhibited additive to synergistic anti-HIV-1 activity in combination with the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, saquinavir and tipranavir, and the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir and zidovudine.
V kombinaciji z zaviralci proteaze amprenavirjem, atazanavirjem, indinavirjem, lopinavirjem, sakvinavirjem in tipranavirjem ter zaviralci nukleozidne reverzne transkriptaze (NRTI) abakavirjem, didanozinom, emtricitabinom, lamivudinom, stavudinom,
ANTITHROMBOTICS
ANTITROMBOTIKI
If ASAT and ALAT return to baseline values and if the patient had no clinical signs or symptoms of hepatitis, rash, constitutional symptoms or other findings suggestive of organ dysfunction, it may be possible to reintroduce nevirapine, on a case by case basis, at the starting dose regimen of 200 mg/day for 14 days followed by 400 mg/day.
izpuščaja, splošnih simptomov ali drugih izvidov, ki kažejo na motnje delovanja organov, lahko nevirapin ponovno uvedemo, o čemer presodimo za vsakega bolnika posamezno, in ga dajemo po shemi za začetno zdravljenje v odmerkih po 200 mg/dan 14 dni, nato 400 mg na dan.
Post-Exposure-Prophylaxis: Serious hepatotoxicity, including liver failure requiring transplantation, has been reported in HIV-uninfected individuals receiving multiple doses of nevirapine in the setting of post-exposure-prophylaxis (PEP), an unapproved use.
Profilaksa po izpostavljenosti okužbi: pri posameznih osebah, ki sicer niso bile okužene s HIV, a so prejele več odmerkov nevirapina 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.
These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterised by rash, constitutional findings and visceral involvement.
Poročajo o primerih StevensJohnsonovega sindroma, toksične epidermalne nekrolize in reakcij na zdravilo z eozinofilijo in sistemskimi simptomi s smrtnim izidom.
Common headache
- glavobol,
Atazanavir/r Cmin ↓ 0.28 (0.20-0.40) Atazanavir/r Cmax ↓ 0.72 (0.60-0.86)
AUC atazanavirja/r ↓ 0,58 (0,48Cmin atazanavirja/r ↓ 0,28 (0,20-0,40) Cmax atazanavirja/r ↓ 0,72 (0,60-0,86)
Stavudine Cmin ND Stavudine Cmax ↔ 0.94 (0.86-1.03)
Cmax stavudina ↔ 0,94 (0,86-1,03)
The opposite side is debossed with a scoreline.
Na drugi strani tablete pa je zareza.
If you stop taking Nevirapine Teva for more than 7 days your doctor will instruct you to start the 14 day 'lead-in' period (described above) once again, before returning to the twice daily dose.
Če zdravilo Nevirapin Teva prenehate jemati za dlje kot 7 dni, vam bo zdravnik naročil, da ponovite
It is not recommended to coadminister efavirenz and Nevirapine Teva (see section 4.4), because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone (for results of 2NN study, see section 5.1).
ker se toksični učinki seštevajo in v primerjavi z dajanjem enega ali drugega NNRTI samega ni dodatne koristi (za rezultate študije 2NN, glejte poglavje 5.1).
Ritonavir Cmin ↔ 0.93 (0.76-1.14) Ritonavir Cmax ↔ 0.93 (0.78-1.07)
AUC ritonavirja ↔ 0,92 (0,79-1,07) Cmin ritonavirja ↔ 0,93 (0,76-1,14) Cmax ritonavirja ↔ 0,93 (0,78-1,07)
Patients should be intensively monitored during the first 18 weeks of treatment.
Zato je potrebno bolnike prvih 18 tednov zdravljenja skrbno spremljati in natančno opazovati, če se pojavi izoliran izpuščaj.
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.
Nevirapin je potrebno trajno ukiniti pri vseh bolnikih, pri katerih se je pojavila preobčutljivostna reakcija (z izpuščajem in splošnimi simptomi ob hkratni prizadetosti visceralnih organov, npr. hepatitisu, eozinofiliji,
Emtricitabine is not an inhibitor of human CYP 450 enzymes.
Emtricitabin ni zaviralec humanih encimov CYP450.
Metabolite 14-OH clarithromycin
Cmin klaritromicinovega presnovka 14
STATEMENT OF ACTIVE SUBSTANCE(S)
Etinilestradiol (EE),
Nevirapine is a NNRTI of HIV-1.
Mehanizem delovanja Nevirapin je nenukleozidni zaviralec reverzne transkriptaze HIV-1.
Oral hormonal contraceptives should not be used as the sole method of contraception in women taking Nevirapine Teva (see section 4.4).
Nevirapin Teva, hormonskih metod kontracepcije ne smejo uporabljati kot edino metodo kontracepcije (glejte poglavje
Amprenavir Cmin ↓ 0.65 (0.49-0.85) Amprenavir Cmax ↓ 0.75 (0.63-0.89)
AUC amprenavirja↓ 0,67 (0,55-0,80) Cmin amprenavirja ↓ 0,65 (0,49-0,85) Cmax amprenavirja ↓ 0,75 (0,63-0,89)
Lopinavir/ritonavir (capsules) 400/100 mg BID
Lopinavir/ritonavir (kapsule) 400/100 mg 2-krat na dan odrasli bolniki:
Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as: - rash - swelling of the face - difficulty breathing (bronchial spasm) - anaphylactic shock
Pojavijo se lahko v obliki anafilaksije (hude oblike alergijske reakcije) s simptomi, kot so:
Efavirenz Cmin ↓ 0.68 (0.65-0.81) Efavirenz Cmax ↓ 0.88 (0.77-1.01)
AUC efavirenza ↓ 0,72 (0,66-0,86) Cmin efavirenza ↓ 0,68 (0,65-0,81) Cmax efavirenza ↓ 0,88 (0,77-1,01)
For patients who are unable to swallow tablets or who weigh less than 50 kg or whose body surface area is below 1.25 m2
- otroci, mlajši od 16 let , ki : o so težki 50 kg ali več o ali katerih telesna površina je večja od 1,25 kvadratnega metra.
This herbal substance may stop Nevirapine Teva from working properly.
Ta zdravilna rastlina lahko spremeni delovanje zdravila Navirapin Teva.
Nevirapine levels may increase on stopping St John‘s Wort.
Raven nevirapina se lahko po ukinitvi šentjanževke poveča.
Zidovudine Cmin ND Zidovudine Cmax ↓ 0.70 (0.49-1.04)
Cmax zidovudina ↓ 0,70 (0,49-1,04)
Nevirapine Cmin ↑ 1.47 (1.20-1.82) Nevirapine Cmax ↑ 1.18 (1.02-1.37)
AUC nevirapina ↑ 1,27 (1,12-1,44) Cmin nevirapina ↑ 1,47 (1,20-1,82) Cmax nevirapina↑ 1,18 (1,02-1,37)
Check with your doctor or pharmacist if you are not sure.
Posvetujte se z zdravnikom ali s farmacevtom.
If liver function abnormalities recur, nevirapine should be permanently discontinued.
je potrebno nevirapin trajno ukiniti.
The first 18 weeks of therapy with nevirapine are a critical period which requires close monitoring of patients to disclose the potential appearance of severe and life-threatening skin reactions (including cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) and serious hepatitis/hepatic failure.
Prvih 18 tednov zdravljenja z nevirapinom je kritično obdobje, v katerem moramo bolnike skrbno spremljati, da bi lahko odkrili morebitne hude in življenjsko nevarne kožne reakcije
Nevirapine AUC ↑ 1.25 (1.17-1.34)
Cmax nevirapina ↑ 1,.25 (1,14-1,37)
Driving and using machines
na primer vožnja ali uporaba orodij ali strojev.
(women more than 250 cells/mm³, men more than 400 cells/mm³) - pre-treated patients with detectable HIV-1 plasma viral load and higher CD4 cell counts at the start of nevirapine therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)
- prvič zdravljenih bolnikih, ki imajo večje števil celic CD4 na začetku zdravljenja z zdravilom Nevirapin Teva (pri ženskah več kot 250 celic/mm3, pri moških več kot 400 celic/mm3)
Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
imenovani nenukleozidni zaviralci reverzne transkriptaze (NNRTI).
See section 4.
glejte poglavje 5.2.
Nevirapine Cmax ↑ 1.20
Cmax nevirapina ↑ 1,24
If clinical hepatitis occurs, characterised by anorexia, nausea, vomiting, icterus AND laboratory findings (such as moderate or severe liver function test abnormalities (excluding GGT)), nevirapine must be permanently stopped.
nenormalnimi laboratorijskimi izvidi (zmernimi ali hudimi spremembami v jetrni funkciji (razen GGT)), je potrebno nevirapin trajno ukiniti.
Sodium starch glycolate (Type A) Colloidal silicon dioxide Magnesium stearate
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi mikrokristalna celuloza laktoza (v obliki monohidrata) povidon K25 natrijev karboksimetilškrob (tip A) koloidni silicijev dioksid magnezijev stearat
Fluconazole 200 mg QD
Flukonazol 200 mg na dan
Rifabutin and Nevirapine Teva can be coadministered without dose adjustments.
Rifabutin in zdravilo Nevirapin Teva se lahko uporablja sočasno brez prilagajanja odmerkov.
The most common clinical toxicity of nevirapine is rash, with nevirapine attributable rash occurring in 12.5 % of patients in combination regimens in controlled studies.
V nadzorovanih študijah s kombiniranim načinom zdravljenja se je pojavil pri 12,5 % bolnikov.
Tell your doctor if you experience any of the following clinical symptoms of liver damage: - loss of appetite - feeling sick (nausea) - vomiting - yellow skin (jaundice)
Povejte zdravniku, če opazite klinične simptome, ki kažejo na jetrne poškodbe:
Each tablet contains 200 mg of nevirapine (as anhydrous).
Ena tableta vsebuje 200 mg nevirapina (v brezvodni obliki).
Lopinavir/ritonavir (oral solution) 300/75 mg/m2 BID
Lopinavir/ritonavir (peroralna raztopina) 300/75 mg/m2 2-krat na dan pediatrični bolniki:
The greatest risk of hepatic and skin reactions occurs in the first 6 weeks of therapy.
Nevarnost jetrnih dogodkov in kožnih reakcij je največja prvih 6
In human liver microsomes, abacavir did not inhibit cytochrome P450 isoforms.
Abakavir ni zaviral izoform citokroma P450 v humanih jetrnih mikrosomih.
Nevirapine Cmin ↑ 1.34 (1.21-1.49) Nevirapine Cmax ↑ 1.25 (1.14-1.37)
AUC nevirapina ↑ 1,29 (1,19-1,40) Cmin nevirapina ↑ 1,34 (1,21-1,49)
Appropriate doses for hormonal contraceptives (oral or other forms of application) other than DMPA in combination with nevirapine have not been established with respect to safety and efficacy.
Varnost in učinkovitost ustreznih odmerkov hormonskih kontraceptivov (za peroralno jemanje ali druge načine uporabe)
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%).
V raziskavi o masni bilanci in izločanju pri osmih zdravih prostovoljcih, ki so do stanja dinamičnega ravnovesja prejemali odmerke nevirapina po 200 mg 2-krat na dan, nato enkratni odmerek po 50 mg 14C
A dose increase for itraconazole should be considered when these two agents are administered concomitantly.
Pri sočasnem dajanju teh zdravil je potrebno presoditi o povečanju odmerka intrakonazola.
Results of DDI studies of telaprevir with efavirenz indicate that caution should be exercised when co-administering telaprevir with P450 inducers.
kažejo, da je pri hkratnem dajanju telaprevirja in induktorjev P450 potrebna previdnost.
Clarithromycin Cmin ↓ 0.44 (0.30Clarithromycin Cmax ↓ 0.77 (0.69
AUC klaritromicina ↓ 0,69 (0,62Cmin klaritromicina ↓ 0,44 (0,30-0,64)
You may experience fatigue when taking Nevirapine Teva.
Ko boste jemali zdravilo Nevirapin Teva, boste mogoče utrujeni.
It is not recommended to coadminister ketoconazole and Nevirapine Teva (see section 4.4).
Sočasno dajanje ketokonazola in zdravila Nevirapin Teva ni priporočeno (glejte poglavje 4.4).
Name and address of the manufacturers responsible for batch release
A. IZDELOVALCI ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
Itraconazole Cmin ↓ 0.13 Itraconazole Cmax ↓ 0.62
Cmax itrakonazola ↓ 0,62
Nevirapine Cmin ↑ 1.22 (1.10-1.35) Nevirapine Cmax ↑ 1.13 (1.03-1.24)
AUC nevirapina ↑ 1,14 (1,05-1,24) Cmin nevirapina ↑ 1,22 (1,10-1,35) Cmax nevirapina ↑ 1,13 (1,03-1,24)
Each tablet contains 200 mg of nevirapine (as anhydrous)
Ena tableta vsebuje 200 mg nevirapina (v brezvodni obliki)
Stavudine: 30/40 mg BID
30/40 mg 2-krat na dan
Nevirapine Cmin ↑ 1.32 (1.22-1.43) Nevirapine Cmax ↑ 1.17 (1.09-1.25)
AUC nevirapina ↑ 1,25 (1,17-1,34) Cmin nevirapina ↑ 1,32 (1,22-1,43) Cmax nevirapina ↑ 1.17 (1,09-1,25)
Package leaflet: Information for the patient Nevirapine Teva 200 mg tablets nevirapine
Navodilo za uporabo Nevirapin Teva 200 mg tablete nevirapin
Severe and life-threatening skin reactions have occurred in patients treated with nevirapine, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
- hudi in življenjsko nevarni kožni izpuščaji (Stevens-Johnsonov sindrom/toksična epidermalna
Saquinavir/ritonavir and Nevirapine Teva can be coadministered without dose adjustments.
Sakvinavir z ritonavirjem in zdravilo Nevirapin Teva se lahko uporablja sočasno brez prilagajanja odmerkov.
NNRTIs Efavirenz 600 mg QD
600 mg na dan
Consult your doctor if you have taken more Nevirapine Teva than you should.
nemudoma obvestite svojega zdravnika, ki vam bo svetoval, ali morate zdravilo Nevirapin Teva prenehati jemati.
Darunavir Cmin ↔ 1.02 (0.79-1.32) Darunavir Cmax ↑ 1.40 (1.14-1.73)
AUC darunavirja ↑ 1,24 (0,97-1,57) Cmin darunavirja ↔ 1,02 (0,79-1,32) Cmax darunavirja ↑ 1,40 (1,14-1,73)
Dose adjustment of Nevirapine Teva is not required when co-administered with lopinavir.
Teva ni potrebno prilagoditi, če se ga daje hkrati z lopinavirjem.