FrancophonIA/ELRC3.0 huggingface dataset:
English: Nevirapine is a non-competitive inhibitor of the HIV-1 reverse transcriptase, but it does not have a biologically significant inhibitory effect on the HIV-2 reverse transcriptase or on eukaryotic DNA polymerases , , , or .
Danish: Nevirapin er en nonkompetitiv inhibitor af hiv-1 revers transkriptase, men har ikke nogen signifikant biologisk hæmmende effekt på hiv-2 revers transkriptase eller på eukaryotisk DNA polymeraser , ß, , eller .
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 February 1998
Danish: Dato for første markedsføringstilladelse: 5. februar 1998
English: Hypersensitivity (incl.
Danish: Overfølsomhed (inkl.
English: In these patients nevirapine must not be restarted.
Danish: Disse patienter må ikke genstartes på nevirapin.
English: 3 (6.3 % versus 1.2 % for men with CD4 counts <400 cells/mm
Danish: 3 (6,3 % versus 1,2 % for mænd med CD4-celletal < 400 celler/mm
English: Nevirapine: exposure: 100% compared with historical data where nevirapine was administered alone.
Danish: Nevirapin: eksponering: 100% sammenlignet med historiske data, hvor nevirapin blev administreret alene.
English: The overall percentage of treatment responders observed in study 1100.1486 (including lead-in phase), regardless of the formulation is 793/1,068 = 74.3%.
Danish: Den samlede procentdel af behandlingsrespondenter set i studie 1100.1486 (herunder optrapningsfasen) uanset formulering, er 793/1.068 = 74,3 %.
English: Nevirapine had no antiviral activity in cell culture against group O HIV-1 isolates or HIV-2 isolates.
Danish: Nevirapin havde ingen antiviral aktivitet i cellekulturer mod isolater fra gruppe O hiv-1 eller hiv-2.
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.
Danish: Triglycerider (mg/dl) * Ændring hos den enkelte patient fra baseline til uge 48-værdier og er ikke blot en simpel forskel mellem henholdsvis de gennemsnitlige baselineværdier og uge 48-værdierne.
English: PHARMACEUTICAL FORM Oral suspension
Danish: LÆGEMIDDELFORM Oral suspension.
English: The primary study endpoint was death, progression to the acquired immunodeficiency syndrome, or an increase in HIV-1 RNA levels to 200 copies or more per millilitre.
Danish: Det primære endepunkt var død, progression af det erhvervede immundefektsyndrom eller en stigning i hiv-1-RNA niveau til 200 kopier eller mere pr. ml.
English: YOU SHOULD DISCONTINUE TAKING VIRAMUNE AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death.
Danish: SKAL DU STRAKS STOPPE MED AT TAGE VIRAMUNE OG STRAKS KONTAKTE din læge, da sådanne bivirkninger kan være livstruende eller medføre døden.
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.
Danish: Når man tager alle doser på det rigtige tidspunkt, - så øger det i høj grad effekten af kombinationsbehandlingen - mindsker det risikoen for at hiv-infektionen bliver resistent over for den antiretrovirale behandling.
English: Otherwise patients with CLcr  20 ml/min do not require an adjustment in nevirapine dosing.
Danish: Ellers kræver patienter med CLcr ≥ 20 ml/min ikke justering i nevirapindoseringen.
English: 3 and 197 cells/mm
Danish: 3 og 197 celler/mm
English: Median age was 34 years and about 64 % were male patients, median CD4 cell count was 170 and 190 cells per mm
Danish: Medianalderen var 34 år og omkring 64 % af patienterne var mænd, median CD4-celletallet var 170 og 190 celler pr mm
English: Therefore coadministration would likely result in altered plasma levels of cobicistat and Viramune.
Danish: Derfor vil co-administration sandsynligvis resultere i ændrede plasmakoncentrationer af Viramune og cobicistat.
English: There are no specific studies about the ability to drive vehicles and use machinery.
Danish: Der er ikke foretaget specifikke undersøgelser af virkningen på evnen til at føre motorkøretøjer og betjene maskiner.
English: As with rash symptoms, please inform your doctor of any side effects.
Danish: Som ved symptomer på udslæt, bør du her informere din læge om enhver bivirkning.
English: Fertility In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
Danish: Fertilitet I reproduktionstoksikologiske studier fandt man evidens for nedsat fertilitet hos rotter.
English: - Africa
Danish: - Afrika
English: Each bottle contains 240 ml of oral suspension.
Danish: Hver flaske indeholder 240 ml oral suspension.
English: Nevirapine is about 60 % bound to plasma proteins in the plasma concentration range of 1-10 µg/ml.
Danish: Nevirapin er ca. 60 % bundet til plasmaproteiner i plasmakoncentrationsområdet 1-10 g/ml.
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).
Danish: Nevirapinfarmakokinetikken hos hiv-1 smittede voksne synes ikke at ændre sig med alderen (indenfor 19-68 år) eller race (farvede, latinamerikanere eller hvide).
English: The observed pharmacokinetic difference between the 50 mg and 100 mg Viramune prolonged-release tablets is not clinically relevant, and the 50 mg prolonged-release tablet can be used as an alternative to the slightly larger 100 mg tablet.
Danish: Den observerede farmakokinetiske forskel mellem Viramune depottabletterne på henholdsvis 50 mg og 100 mg er ikke klinisk relevant, og 50-mg-depottabletten kan anvendes, som et alternativ til den lidt større 100 mg tablet.
English: Skin and subcutaneous tissues
Danish: Hud og subkutant væv
English: Cross-resistance between nevirapine and either HIV protease inhibitors, HIV integrase inhibitors or HIV entry inhibitors is unlikely because the enzyme targets involved are different.
Danish: Krydsresistens mellem nevirapin og enten hiv-proteasehæmmere, hivintegrasehæmmere eller hiv-entryhæmmere er usandsynlig, fordi de involverede enzymmål er forskellige.
English: Telaprevir is metabolised in the liver by CYP3A and is a P-glycoprotein substrate.
Danish: Telaprevir metaboliseres i leveren af CYP3A og er et P-glykoprotein substrat.
English: The dose of Viramune may need adjusting.
Danish: Viramune dosering skal muligvis justeres.
English: The lead-in period is not required if the patient is already on chronic Viramune 200 mg tablets or Viramune oral suspension twice daily treatment.
Danish: Optrapningsperioden er ikke nødvendig, hvis patienten allerede er i kronisk behandling med Viramune 200 mg tabletter eller Viramune oral suspension to gange dagligt.
English: Inform your doctor about all other medicines you are taking before you start taking Viramune.
Danish: Fortæl lægen om al anden medicin, du tager, før du begynder at tage Viramune.
English: You may experience fatigue when taking Viramune.
Danish: Du kan blive træt, når du tager Viramune.
English: The first 18 weeks of treatment is a critical period which requires close monitoring.
Danish: De første 18 uger af behandlingen er en kritisk periode, som kræver nøje overvågning.
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Danish: For lipider er der i visse tilfælde fundet evidens for en behandlingsrelateret effekt, mens der ikke er tydelig evidens for relation mellem vægtøgning og en specifik behandling.
English: Viramune oral suspension should be used within 6 months after first opening of the bottle.
Danish: Viramune oral suspension bør bruges inden 6 måneder efter åbning af flasken.
English: White high density polyethylene (HDPE) bottle with two piece child-resistant closure (outer shell white high density polyethylene, inner shell natural polypropylene) with a low density polyethylene (LDPE) foam liner.
Danish: Hvid high density polyethylene (HDPE) flaske med todelt børnesikringslåg (ydre skal hvid high density polyethylene, inderskal naturel polypropylen) med low density polyethylene (LDPE) skumforing.
English: Nevirapine pharmacokinetics in HIV-1 infected adults does not appear to change with age (range 1868 years).
Danish: Nevirapins farmakokinetik hos hiv-1-inficerede voksne synes ikke at ændres med alderen (i intervallet 18-68 år).
English: Safety data included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial.
Danish: Sikkerhedsdata omfattede alle patientbesøg indtil det tidspunkt, hvor den sidste patient fuldførte 144 uger i studiet.
English: Each 5 ml contains 50 mg of the active substance nevirapine (as hemihydrate).
Danish: 5 ml indeholder 50 mg af det aktive stof nevirapin (som hemihydrate).
English: Nevirapine: Co-administration of ritonavir does not lead to any clinically relevant change in nevirapine plasma levels.
Danish: Nevirapin: Co-administration af ritonavir giver ingen klinisk relevante ændringer i plasmakoncentrationen af nevirapin.
English: Viramune is also supplied as 200 mg tablets for older children and adults.
Danish: Viramune kan også fås som 200 mg tabletter til ældre børn og voksne.
English: - Europe
Danish: - Europa
English: Primary study endpoints (percentage of patients with treatment failures) and secondary study endpoints as well as backbone therapy were similar to the original 2NN study.
Danish: Både det primære endepunkt (procent af patienter med behandlingssvigt) og det sekundære endepunkt såvel som grundbehandlingen var de samme, som i det oprindelige 2NN studie.
English: The score line is not intended for breaking the tablet.
Danish: Formålet med markeringslinjen er ikke at kunne brække tabletten over.
English: Asymptomatic GGT elevations are not a contraindication to continue therapy.
Danish: Asymptomatiske GGT- elevationer er ikke en kontraindikation for fortsættelse af behandling.
English: Percent change n=419
Danish: Ændring i procentpoint n = 419
English: Nevirapine concentrations in human cerebrospinal fluid (n = 6) were 45 % ( 5 %) of the concentrations in plasma; this ratio is approximately equal to the fraction not bound to plasma protein.
Danish: Nevirapinkoncentrationen i human cerebrospinalvæske (n=6) er 45 % (±5 %) af koncentrationen i plasma; denne ratio er tilnærmelsesvis lig med fraktionen, som ikke er bundet til plasmaprotein.
English: PHARMACEUTICAL FORM AND CONTENTS 240 ml oral suspension
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 240 ml oral suspension
English: A clinically not relevant increase in the apparent clearance of nevirapine (by 9%) compared to historical data was reported.
Danish: Der sås en klinisk ikke relevant stigning i clearance af nevirapin (med 9%) sammenlignet med historiske farmakokinetiske data.
English: For children
Danish: Til børn
English: Nevirapine has not been specifically investigated in patients over the age of 65.
Danish: Nevirapin er ikke specifikt blevet undersøgt hos patienter over 65 år.
English: Six cases of Stevens-Johnson Syndrome were reported in the study; all but one occurred within the first 30 days of nevirapine treatment.
Danish: Seks tilfælde af Stevens-Johnsons syndrom blev indberettet; alle, undtagen ét, indtraf inden for de første 30 dage af nevirapinbehandlingen.
English: Patients who discontinued treatment during the lead-in period are excluded.
Danish: Patienter udgået af behandlingen under optrapningsperioden, er ikke inkluderet.
English: Randomisation was stratified by screening HIV-1 RNA level (<100,000 copies/ml and >100,000 copies/ml).
Danish: Randomiseringen var stratificeret efter niveauet af hiv-1-rna ved screening (≤ 100.000 kopier/ml og > 100.000 kopier/ml).
English: The frequencies estimated are based on pooled clinical study data for adverse reactions considered related to Viramune treatment.
Danish: De estimerede frekvenser er baseret på poolede data fra de kliniske studier og omfatter hændelser, der er vurderet til at være relateret til Viramune behandling.
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Danish: Den kliniske betydning af denne observerede reduktion af troughkoncentrationen af boceprevir er ikke blevet direkte vurderet.
English: Asymptomatic elevations of liver enzymes are frequently described and are not necessarily a contraindication to use nevirapine.
Danish: Asymptomatiske elevationer af leverenzymer beskrives ofte og er ikke en nødvendigvis en kontraindikation ved brugen af nevirapin.
English: Always follow the exact instructions given by your child's doctor.
Danish: Følg altid den anvisning, som barnets læge har givet.
English: The most common clinical toxicity of nevirapine is rash.
Danish: Den almindeligste kliniske toksicitet ved nevirapin er udslæt.
English: Cartons containing 2 blister cards (14 tablets).
Danish: Æsker indeholdende 2 blisterark (14 tabletter).
English: Percent change n=406
Danish: Ændring i procentpoint n = 406
English: Dose adjustment of Viramune is not required when co-administered with lopinavir.
Danish: Dosisjustering for Viramune er ikke påkrævet når der coadministreres med lopinavir.
English: Viramune oral suspension is a white to off-white homogenous suspension.
Danish: Viramune oral suspension er en hvid til råhvid homogen suspension.
English: If Viramune has been prescribed for your child, please note that all information in this leaflet is addressed to your child (please read “your child” instead of “you”).
Danish: Hvis Viramune er ordineret til dit barn, så bemærk, at denne information er beregnet til dit barn, og du skal erstatte ”du” med ”dit barn”.
English: Viramune is also available as an oral suspension.
Danish: Viramune kan også fås som oral suspension
English: ANTI-INFECTIVES ANTIRETROVIRALS NRTIs
Danish: ANTI-INFEKTIVA ANTIVIRALE LÆGEMIDLER NRTIs
English: Patients should be closely monitored if an isolated rash occurs.
Danish: Patienter skal monitoreres tæt, hvis et isoleret tilfælde af udslæt opstår.
English: Women appear to be at higher risk than men of developing rash, whether receiving nevirapine or nonnevirapine containing therapy.
Danish: Kvinder synes at have en større risiko end mænd for udvikling af udslæt, hvad enten de får behandling indeholdende nevirapin eller ej.
English: In this 48week study no unexpected safety findings were observed in either dosing group.
Danish: I dette 48-ugers studie var der ingen uventede bivirkninger i nogen af doseringsgrupperne.
English: Abnormal liver function tests have been reported with nevirapine, some in the first few weeks of therapy.
Danish: Unormale leverfunktionstests har været rapporteret med nevirapin, nogle i de første få uger af behandlingen.
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.
Danish: Følgende bivirkninger er blevet identificeret i andre nevirapin undersøgelser eller ved postmarketing overvågning, men er ikke observeret i det randomiserede, kontrollerede kliniske studie 1100.1486.
English: Some patients have reported the occurrence of remnants in faeces which may resemble intact tablets.
Danish: Nogle patienter har rapporteret om, at der i fæces kan forekomme rester, der ligner hele tabletter.
English: Because of the risk of increased exposure to Viramune, caution should be exercised if the medicinal products are given concomitantly and patients should be monitored closely.
Danish: På grund af risikoen for forøget eksponering af Viramune, bør der udvises forsigtighed, hvis produkterne gives samtidigt, og patienterne bør monitoreres nøje.
English: Cimetidine: no significant effect on cimetidine PK parameters is seen.
Danish: Cimetidin: Ingen signifikant virkning på cimetidin PK parametre er observeret.
English: Depending on resistance testing results, an etravirine-containing regimen may be used subsequently.
Danish: Afhængig af resultater fra resistenstestning kan et regime med bl.a. etravirine formenligt anvendes.
English: Most of the cases of both severe rash and mild/moderate rash occur in the first six weeks of treatment.
Danish: De fleste tilfælde af både alvorligt hududslæt og mildt/moderat hududslæt opstår i de første 6 uger af behandlingen.
English: LIST OF EXCIPIENTS Excipients: includes lactose (see leaflet for further information)
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: Indeholder lactose (se indlægssedlen for mere information)
English: All patients received tenofovir + emtricitabine as background therapy.
Danish: Alle patienter fik desuden tenofovir + emtricitabin.
English: Paediatric population Children three years and older and adolescents
Danish: Pædiatrisk population Børn på tre år og derover samt unge
English: Each bottle contains 2.4 g of nevirapine (as hemihydrate) in 240 ml of Viramune oral suspension.
Danish: En flaske indeholder 2,4 g nevirapin (som hemihydrat) i 240 ml Viramune oral suspension.
English: Try not to miss a dose.
Danish: Undgå at springe en dosis over.
English: The opposite side is marked with the company symbol.
Danish: Den modsatte side er markeret med firmalogo.
English: Nevirapine: compared to historical controls, levels appeared to be unchanged.
Danish: Nevirapin: Sammenlignet med historiske kontroller, var plasmakoncentrationen tilsyneladende uændret.
English: The difference in nevirapine pharmacokinetics observed when Viramune prolonged-release tablets are dosed under fasted or fed conditions is not considered clinically relevant.
Danish: Forskellen i nevirapins farmakokinetik, når Viramune depottabletter indgives fastende over for ikke-fastende, betragtes ikke som klinisk relevant.
English: One side is marked with the code “54 193”, with a single bisect separating the “54” and “193”.
Danish: Den ene side er præget med koden ”54 193”, med en markeringslinje mellem ”54” og ”193”.
English: A dose increase for itraconazole should be considered when these two agents are administered concomitantly.
Danish: En dosisøgning af itraconazol bør overvejes når disse to stoffer anvendes sammen.
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 %).
Danish: I abacavirgruppen var forekomsten af hændelser signifikant lavere (61 patienter, eller 41 %) end i nevirapingruppen (83 patienter, eller 54 %) og i efavirenzgruppen (89 patienter, eller 57 %).
English: Virologic responder (HIV-1 RNA <50 copies/ml)
Danish: Virologisk responder (hiv-1-rna < 50 kopier/ml)
English: Talk to your doctor or pharmacist before taking Viramune.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Viramune.
English: Very common rash (12.5 %)
Danish: Udslæt (12,5 %)
English: In a panel of 2,923 predominantly subtype B HIV-1 clinical isolates, the mean EC50 value was 90nM.
Danish: I et panel med 2.923 altovervejende undergruppe B hiv-1 kliniske isolater var den gennemsnitlige EC50værdi 90 nM.
English: HIV-1 isolates with reduced susceptibility (100-250-fold) to nevirapine emerge in cell culture.
Danish: Hiv-1-isolater med reduceret følsomhed (100-250 gange) over for nevirapin forekommer i cellekultur.
English: Genotypic analysis showed mutations in the HIV-1 RT gene Y181C and/or V106A depending upon the virus strain and cell line employed.
Danish: Genotypiske analyser viste mutationer i hiv-1 RT-genet Y181C og/eller i genet V106A afhængigt af virusstammen og af selve cellelinjen.
English: Caution should be exercised when prescribing nevirapine to pregnant women (see section 4.4).
Danish: Forsigtighed bør udvises ved ordinering af nevirapin til gravide kvinder (se pkt.
English: The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Danish: Valg af anden behandling efter ophør af Viramune bør baseres på klinisk erfaring og test af resistens (se pkt.
English: Viramune tablets are supplied in blisters, with 14, 60 or 120 tablets per carton.
Danish: Viramune tabletter er i blisterpakninger med 14, 60 eller 120 tabletter i hver æske.
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St. John‘s Wort.
Danish: Den inducerede virkning kan fortsætte i mindst 2 uger efter ophør af behandling med perikon.
English: The total daily dose should not exceed 400 mg for any patient.
Danish: Døgndosis bør ikke overskride 400 mg for nogen patient.
English: The medicinal product should be used within 6 months of opening.
Danish: Produktet bør bruges inden 6 måneder efter åbning.
English: Nevirapine: there was no significant difference in nevirapine pharmacokinetic parameters.
Danish: Nevirapin: Der var ingen signifikant forskel i nevirapins farmakokinetiske parametre.
English: Data on potential symptoms of hepatic events were prospectively collected in this study.
Danish: Prospektivt blev indsamlet data om potentielle symptomer på hepatiske hændelser.
English: Distribution: Nevirapine is lipophilic and is essentially nonionized at physiologic pH.
Danish: Nevirapin er lipofilt og er essentielt ikke-ioniseret ved fysiologisk pH.
English: Nevirapine is an inducer of CYP3A and potentially CYP2B6, with maximal induction occurring within 2-4 weeks of initiating multiple-dose therapy.
Danish: Nevirapin inducerer CYP3A og potentielt CYP2B6 med maksimal induktion indenfor 2-4 uger efter flerdosis behandling er startet.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Patients should be instructed that a major toxicity of nevirapine is rash.
Danish: Patienter bør underrettes om, at en alvorlig toksicitet ved nevirapin er udslæt.
English: For paediatric patients aged 3 years and older, 100 mg prolonged-release tablets are available.
Danish: Til pædiatriske patienter på 3 år og ældre fås 100-mg-depottabletter.
English: Itraconazole AUC  0.39 Itraconazole Cmin  0.13
Danish: Itraconazol AUC  0,39 Itraconazol Cmin  0,13
English: 3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
Danish: 3, som har detekterbar hiv-1-rna i plasma, medmindre fordelene opvejer risiciene.
English: PC {number} [product code]
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC {nummer} [produktkode]
English: You are at greatest risk of such a reaction during the first 6 weeks of treatment.
Danish: Der er størst risiko for sådanne reaktioner i de første 6 uger af behandlingen.
English: The analysis of these samples of patients receiving Viramune immediate-release twice daily or Viramune prolonged-release once daily in combination with tenofovir and emtricitabine showed that isolates from 50 patients contained resistance mutations expected with a nevirapine-based regimen.
Danish: Analysen af disse prøver fra patienter, der fik Viramune 200 mg tabletter to gange dagligt eller Viramune depottabletter én gang dagligt i kombination med tenofovir og emtricitabin, viste, at isolater fra 50 patienter indeholdt resistensmutationer forventeligt fra et nevirapin-baseret regime.
English: Itraconazole Cmax  0.62
Danish: Itraconazol Cmax  0,62
English: Ketoconazole and erythromycin significantly inhibited the formation of nevirapine hydroxylated metabolites.
Danish: Ketoconazol og erytromycin hæmmer signifikant dannelsen af hydroxylerede metabolitter af nevirapin.
English: It is in general recommended that you do not breast-feed if you have HIV infection because it is possible that your baby can become infected with HIV through your breast milk.
Danish: Generelt anbefales det ikke at amme, da hivinfektionen kan overføres til barnet via brystmælken.
English: Combination of other antiretrovirals with single-dose nevirapine attenuates the emergence of nevirapine resistance.
Danish: Kombination af andre antiretrovirale lægemidler med enkelt dosis nevirapin sænker forekomsten af nevirapinresistens.