natgillin/translations-raw huggingface dataset:
Hiv-1-isolater med reduceret følsomhed (100-250 gange) over for nevirapin forekommer i cellekultur. 
HIV-1 isolates with reduced susceptibility (100-250-fold) to nevirapine emerge in cell culture.
Genotypiske analyser viste mutationer i hiv-1 RT-genet Y181C og/eller i genet V106A afhængigt af virusstammen og af selve cellelinjen. 
Genotypic analysis showed mutations in the HIV-1 RT gene Y181C and/or V106A depending upon the virus strain and cell line employed.
Forsigtighed bør udvises ved ordinering af nevirapin til gravide kvinder (se pkt. 
Caution should be exercised when prescribing nevirapine to pregnant women (see section 4.4).
Valg af anden behandling efter ophør af Viramune bør baseres på klinisk erfaring og test af resistens (se pkt. 
The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Viramune tabletter er i blisterpakninger med 14, 60 eller 120 tabletter i hver æske. 
Viramune tablets are supplied in blisters, with 14, 60 or 120 tablets per carton.
Den inducerede virkning kan fortsætte i mindst 2 uger efter ophør af behandling med perikon. 
The inducing effect may persist for at least 2 weeks after cessation of treatment with St. John‘s Wort.
Døgndosis bør ikke overskride 400 mg for nogen patient. 
The total daily dose should not exceed 400 mg for any patient.
Produktet bør bruges inden 6 måneder efter åbning. 
The medicinal product should be used within 6 months of opening.
Nevirapin: Der var ingen signifikant forskel i nevirapins farmakokinetiske parametre. 
Nevirapine: there was no significant difference in nevirapine pharmacokinetic parameters.
Prospektivt blev indsamlet data om potentielle symptomer på hepatiske hændelser. 
Data on potential symptoms of hepatic events were prospectively collected in this study.
Nevirapin er lipofilt og er essentielt ikke-ioniseret ved fysiologisk pH. 
Distribution: Nevirapine is lipophilic and is essentially nonionized at physiologic pH.
Nevirapin inducerer CYP3A og potentielt CYP2B6 med maksimal induktion indenfor 2-4 uger efter flerdosis behandling er startet. 
Nevirapine is an inducer of CYP3A and potentially CYP2B6, with maximal induction occurring within 2-4 weeks of initiating multiple-dose therapy.
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Patienter bør underrettes om, at en alvorlig toksicitet ved nevirapin er udslæt. 
Patients should be instructed that a major toxicity of nevirapine is rash.
Til pædiatriske patienter på 3 år og ældre fås 100-mg-depottabletter. 
For paediatric patients aged 3 years and older, 100 mg prolonged-release tablets are available.
Itraconazol AUC  0,39 Itraconazol Cmin  0,13 
Itraconazole AUC  0.39 Itraconazole Cmin  0.13
3, som har detekterbar hiv-1-rna i plasma, medmindre fordelene opvejer risiciene. 
3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC {nummer} [produktkode] 
PC {number} [product code]
Der er størst risiko for sådanne reaktioner i de første 6 uger af behandlingen. 
You are at greatest risk of such a reaction during the first 6 weeks of treatment.
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. 
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.
Itraconazol Cmax  0,62 
Itraconazole Cmax  0.62
Ketoconazol og erytromycin hæmmer signifikant dannelsen af hydroxylerede metabolitter af nevirapin. 
Ketoconazole and erythromycin significantly inhibited the formation of nevirapine hydroxylated metabolites.
Generelt anbefales det ikke at amme, da hivinfektionen kan overføres til barnet via brystmælken. 
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.
Kombination af andre antiretrovirale lægemidler med enkelt dosis nevirapin sænker forekomsten af nevirapinresistens. 
Combination of other antiretrovirals with single-dose nevirapine attenuates the emergence of nevirapine resistance.
Tag ikke Viramune hvis du er allergisk over for nevirapin eller et af de øvrige indholdsstoffer i Viramune (angivet i punkt 6). 
Do not take Viramune - if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section
Viramune oral suspension er en flydende suspension, der skal indtages gennem munden. 
Viramune oral suspension is in a liquid suspension form and should only be taken by mouth.
Der blev ikke rapporteret nogle livstruende (grad 4) udslæt relateret til Viramune under randomiseringsfasen.. Seks tilfælde af Stevens-Johnsons syndrom blev indberettet; alle, undtagen ét, indtraf inden for de første 30 dage af nevirapinbehandlingen. 
No life-threatening (Grade 4) rash events considered related to Viramune were reported during the randomised phase of this study.Six cases of Stevens-Johnson Syndrome were reported in the study; all but one occurred within the first 30 days of nevirapine treatment.
Det er ikke vist, at Viramune forårsager forstyrrelser i blodglucose. 
In addition, Viramune has not been shown to cause glucose disturbances.
En reduktion af røde blodlegemer (anæmi), der kan være relateret til behandling med nevirapin, forekommer også hyppigere hos børn. 
A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children.
Methylparahydroxybenzoat (E218) Propylparahydroxybenzoat (E216) Sorbitol 
Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Sorbitol
Sørg for at få klar besked af lægen om, hvilken dosis du skal give dit barn. 
Make sure that your child's doctor clearly tells you what dose you must give to your child.
Alle patienter yngre end 16 år, som tager Viramune oral suspension, bør kontrolvejes eller have kontrolleret deres legemsoverfladeareal regelmæssigt for at vurdere om dosisjustering er nødvendig. 
All patients less than 16 years of age receiving Viramune oral suspension should have their weight or BSA checked frequently to assess if dose adjustments are necessary.
Interaktionsdata er angivet som en geometrisk gennemsnitsværdi med et 90 % konfidensinterval (90 % CI) når disse data er tilgængelige. 
The interaction data is presented as geometric mean value with 90% confidence interval (90 % CI) whenever these data were available.
Interaktionsdata er angivet som en geometrisk gennemsnitsværdi med et 90% konfidensinterval (90% CI) når disse data er tilgængelige. 
The interaction data is presented as geometric mean value with 90% confidence interval (90% CI) whenever these data were available.
Andre nevirapin formuleringer, såsom tabletter eller oral suspension, bør benyttes (se pkt. 
Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used (see section 4.2).
Viramune kan også fås i flydende form som oral suspension. 
Viramune is also available in liquid form as an oral suspension.
Desuden fås til alle aldersgrupper til administration to gange dagligt en oral suspension (se det pågældende produktresumé). 
Furthermore, an immediate-release oral suspension dosage form is available for all age groups for a twice daily administration (please refer to the respective Summary of Product Characteristics).
Følgende bivirkninger har været rapporteret, når nevirapin har været brugt i kombination med andre antiretrovirale midler: Pancreatitis, perifer neuropati og trombocytopeni. 
The following adverse reactions have also been reported when nevirapine has been used in combination with other anti-retroviral agents: pancreatitis, peripheral neuropathy and thrombocytopaenia.
Viramune er blevet evalueret i både behandlingsnaive og tidligere behandlede patienter. 
Viramune has been evaluated in both treatment-naïve and treatment-experienced patients.
Hos børn bør det overvejes at øge dosis af lopinavir/ritonavir til 300/75 mg/m2 gange dagligt sammen med mad når det coadministreres med Viramune, specielt hos patienter, hvor der er mistanke om en reduceret følsomhed for lopinavir/ritonavir. 
For children, increase of the dose of lopinavir/ritonavir to 300/75 mg/m twice daily with food should be considered when used in combination with Viramune, particularly for patients in whom reduced susceptibility to lopinavir/ritonavir is suspected.
Vær sikker på, at sprøjten sidder fast. 
Make sure that the syringe is tightly inserted.
Samtidig administration af boceprevir og medicin, der inducerer eller hæmmer CYP3A4/5, kan reducere eller øge eksponeringen. 
Co-administration of boceprevir with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure.
Viramune depottabletter må kun bruges til børn i alderen tre år og derover. 
Viramune prolonged-release tablets are only to be used for children three years of age and above.
Nevirapins og de fem oxidative metabolitters farmakokinetik blev ikke ændret i dette studie. 
In this study, the multiple dose pharmacokinetic disposition of nevirapine and the five oxidative metabolites were not altered.
Nevirapin: plasmakoncentrationer:  1,15-1,28 sammenlignet med historiske kontroller. 
Nevirapine: plasma levels:  1.151.28 compared to historical controls.
Tabel 1: Optrapningsfase med Viramune med umiddelbar frigivelse 
Table 1: Lead-in phase with Viramune immediate-release
Må ikke tygges, deles eller knuses 
Swallow whole, do not chew, divide or crush
Interaktionen mellem nevirapin og warfarin er kompleks med potentiale for både stigning og fald i koagulationstiden. 
The interaction between nevirapine and the antithrombotic agent warfarin is complex, with the potential for both increases and decreases in coagulation time when used concomitantly.
Disse tilfælde er normalt forbundet med andre antiretrovirale midler og må forventes at opstå, når Viramune tages i kombination med andre midler; det er dog usandsynligt, at disse tilfælde opstår på grund af behandling med Viramune. 
These events are commonly associated with other antiretroviral agents and may be expected to occur when Viramune is used in combination with other agents; however, it is unlikely that these events are due to treatment with Viramune.
Derefter vil dit barn skifte til en dosering 2 gange dagligt og lægen vil fastsætte den korrekte dosis baseret på enten barnets vægt eller legemsoverfladeareal. 
Thereafter your child will be switched to a twice daily dosing schedule and your child's doctor will decide the right dose based either on your child's weight or body surface area.
Hormonel kontraceptiva, bortset fra depo-medroxyprogesteronacetat (DMPA) bør ikke bruges som eneste antikonception af kvinder, som tager Viramune, da nevirapin kan sænke plasmakoncentrationen af disse lægemidler. 
Hormonal methods of birth control other than Depo-medroxyprogesterone acetate (DMPA) should not be used as the sole method of contraception in women taking Viramune, since nevirapine might lower the plasma concentrations of these medicinal products.
Patienterne bør underrettes om, at leverreaktioner er en alvorlig toksicitet ved nevirapin som kræver en tæt monitorering i de første 18 uger. 
Patients should be informed that hepatic reactions are a major toxicity of nevirapine requiring a close monitoring during the first 18 weeks.
Viramune tabletter og oral suspension har sammenlignelig biotilgængelighed, og skift mellem de to formuleringer kan foregå i doser op til 200 mg. 
Viramune tablets and oral suspension have been shown to be comparably bioavailable and interchangeable at doses up to 200 mg.
Ved administration sammen med Viramune bør justering af telaprevirdosis overvejes. 
If co-administered with Viramune, an adjustment in the telaprevir dose should be considered.
Fulminant hepatitis (som kan være letal) 
Rare hepatitis fulminant (which may be fatal)
Samlet set var eksponeringen hos børn den samme som hos voksne, der fik Viramune i depotform i henhold til studie 1100.1486. 
Overall, the exposure in children was similar to that observed in adults receiving Viramune prolonged-release in study 1100.1486.
I dette studie sås i Viramune-gruppen en signifikant reduktion i transmission efter en enkelt dosis nevirapin (13,1 % (n = 310), versus 25,1 % (n = 308) i den ultra-korte zidovudin-gruppe (p = 0,00063)). 
This study demonstrated a significant reduction in transmission using single dose nevirapine (13.1 % (n = 310) in the Viramune group, versus 25.1 % (n = 308) in the ultra-short zidovudine group (p = 0.00063)).
Viramune 100 mg depottabletter er gule, runde og bikonvekse. 
Viramune 100 mg prolonged-release tablets are yellow, round and biconvex.
Meget almindelig (kan forekomme hos mere end 1 ud af 10 patienter): - udslæt 
Very common (may affect more than 1 in 10 people): - rash
Du skal tage Viramune sammen med andre antiretrovirale hiv-lægemidler. 
You must take Viramune together with other antiretroviral medicines.
Dog, kan nogle patienter på grund af stor interpatient-variation opleve store stigninger i rifabutineksponeringen og kan derfor have øget risiko for rifabutintoksicitet. 
However, due to the high interpatient variability some patients may experience large increases in rifabutin exposure and may be at higher risk for rifabutin toxicity.
Hvis du har glemt at tage Viramune 
If you forget to take Viramune
Der er rapporteret letale tilfælde af SJS, TEN og lægemiddelreaktion med eosinifili og systemiske symptomer. 
Fatal cases of SJS, TEN and drug reaction with eosinophilia and systemic symptoms have been reported.
Udslættet bør overvåges nøje (se pkt. 
The isolated rash should be closely monitored (see section 4.4).
Ingen forandringer af lamivudin tilsyneladende clearance og fordelingsvolumen, hvilket tyder på, at nevirapin ikke inducerer lamivudin clearance. 
No changes to lamivudine apparent clearance and volume of distribution, suggesting no induction effect of nevirapine on lamivudine clearance.
Nedsat nyrefunktion (let, moderat og svær) resulterede ikke i en signifikant ændring i nevirapins farmakokinetik. 
Renal impairment (mild, moderate and severe) resulted in no significant change in the pharmacokinetics of nevirapine.
Din læge vil nøje kontrollere virkningen af Viramune og den nævnte medicin ovenfor, hvis du bliver behandlet med flere slags medicin på samme tid. 
Your doctor will carefully monitor the effect of Viramune and any of these medicines if you are taking them together.
Nevirapins relative biotilgængelighed, ved indgift af én 400 mg Viramune depottablet i forhold til to Viramune 200 mg tabletter, var på ca. 75 %. 
The relative bioavailability of nevirapine when dosed as one 400 mg Viramune prolonged-release tablet, relative to two 200 mg Viramune immediaterelease tablets, was approximately 75 %.
Depottabletter er ikke egnede til 14-dages lead-in perioden for patienter, der starter i nevirapinbehandling. 
Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine.
Plasmakoncentrationen af clarithromycin var signifikant reduceret, og plasmakoncentrationen af 14-OH metabolit var øget. 
Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
I uge 48 blev der observeret en markant forbedring i CD4+-celle-procenten hos begge doseringsgrupper. 
A marked improvement in the CD4+ cell percent was observed through Week 48 for both dose groups.
In vitro studier med humane levermikrosomer indikerer, at oxidativ metabolisme af nevirapin er medieret primært af cytokrom P450 isozymer fra CYP3A-familien, selvom andre isozymer kan have en sekundær rolle. 
In vitro studies with human liver microsomes suggest that oxidative metabolism of nevirapine is mediated primarily by cytochrome P450 isozymes from the CYP3A family, although other isozymes may have a secondary role.
Hvis du tager eller får ordineret rifampicin til behandling af tuberkulose, skal du tale med din læge, før du tager Viramune. 
If you are taking or are prescribed rifampicin to treat tuberculosis please inform your doctor before taking this medicine with Viramune.
Risikoen fortsætter dog udover denne periode og overvågning med hyppige intervaller bør fortsættes under behandlingen. 
However the risk continues past this period and monitoring should continue at frequent intervals throughout treatment.
Det primære endepunkt, behandlingssvigt, var defineret som mindre end 1 log10 fald i plasma hiv1-RNA i de første 12 uger eller mere end 50 kopier/ml i to på hinanden følgende målinger efter uge 24, eller sygdomsprogression. 
The primary endpoint, treatment failure, was defined as less than 1 log10 decline in plasma HIV-1 RNA in the first 12 weeks, or two consecutive measurements of more than 50 copies/ ml from week 24 onwards, or disease progression.
Under hiv-behandling kan der forekomme vægtstigning samt forhøjede koncentrationer af lipider og glukose i blodet. 
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Konsulter lægen, hvis du har taget mere Viramune end du skal. 
Consult your doctor if you have taken more Viramune than you should.
Methyl- og propylparahydroxybenzoater: Viramune oral suspension indeholder methyl- og propylparahydroxybenzoat, der kan give allergiske reaktioner (muligvis forsinket). 
Methyl and propyl parahydroxybenzoates: Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reaction (possibly delayed).
Hjælpestoffer, som behandleren skal være opmærksom på En ml oral suspension indeholder 150 mg saccharose, 162 mg sorbitol, 1,8 mg methylparahydroxybenzoat og 0,24 mg propylparahydroxybenzoat. 
Each ml of oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl parahydroxybenzoate and 0.24 mg of propyl parahydroxybenzoate.
I beregningen indgår dit barns alder, legemsvægt eller legemsoverfladeareal. 
The calculation will include your child's age and body weight, or body surface area.
- Aktivt stof: Nevirapin. 
- The active substance is nevirapine.
Saquinavir/ritonavir De begrænsede data, der er tilgængelige for saquinavir soft gel kapslen boosted med ritonavir, indikerer, at der ikke skulle være klinisk signifikante interaktioner mellem saquinavir boosted med ritonavir og nevirapin. 
Saquinavir/ritonavir The limited data available with saquinavir soft gel capsule boosted with ritonavir do not suggest any clinically relevant interaction between saquinavir boosted with ritonavir and nevirapine.
Troughplasmakoncentrationen af boceprevir blev reduceret, når det blev coadministreret med en NNRTI med en lignende metaboliseringsvej som nevirapin. 
Plasma trough concentrations of boceprevir were decreased when administered with an NNRTI with a similar metabolic pathway as nevirapine.
Den samlede analyse af Paediatric aids Clinical Trials Group (PACTG)'s protokoller 245, 356, 366, 377 og 403 tillod evaluering at pædiatriske patienter yngre end 3 måneder (n=17) i disse PACTGstudier. 
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.
Der bør udvises forsigtighed ved co-administration af telaprevir og nevirapin. 
Caution should be exercised when co-administering telaprevir with nevirapine.
Uge 48 (gennemsnit) n = 407 
Week 48 (mean) n=407
Efter uge 48 var den gennemsnitlige ændring i CD4-celletallet i forhold til baseline, på henholdsvis 184 celler/mm 
At week 48, mean change from baseline in CD4 cell count was 184 cells/mm
Monitorering af levertests bør foretages hver anden uge i løbet af de første 2 måneder af behandlingen, efter 3 måneders behandling og derefter regelmæssigt. 
Monitoring of hepatic tests should be done every two weeks during the first 2 months of treatment, at the 3
Disse fund er højst sandsynligt relateret til, at nevirapin er en stærk inducer af leverenzymer, og ikke tegn på genotoksicitet. 
These findings are most likely related to nevirapine being a strong inducer of liver enzymes, and not due to a genotoxic mode of action.
Der blev ikke rapporteret nogle livstruende (grad 4) udslæt relateret til Viramune under randomiseringsfasen. 
No life-threatening (Grade 4) rash events considered related to Viramune were reported during the randomised phase of this study.
Ribavirin hæmmer ikke CYP-enzymer, og fra toksicitetesstudier er der ingen tegn på, at ribavirin inducerer leverenzymer. 
Ribavirin does not inhibit cytochrome P450 enzymes, and there is no evidence from toxicity studies that ribavirin induces liver enzymes.
Til pædiatriske patienter kan Viramune doseres enten efter legemsoverfladeareal eller efter legemsvægt som følger: Ved legemsoverfladearealet beregnet efter Mostellerformlen er den anbefalede orale dosis til pædiatriske patienter i alle aldre 150 mg/m² en gang dagligt i to uger efterfulgt af 150 mg/m² to gange dagligt. 
Viramune may be dosed in paediatric patients either by body surface area (BSA) or by body weight as follows: By BSA using the Mosteller formula the recommended oral dose for paediatric patients of all ages is 150 mg/m2 once daily for two weeks followed by 150 mg/m2 twice daily thereafter.
Viramune bør ikke anvendes som eneste aktive antiretrovirale behandling, da det er påvist, at monoterapi med antiretrovirale stoffer resulterer i viral resistens. 
Viramune should not be used as the sole active antiretroviral, as monotherapy with any antiretroviral has shown to result in viral resistance.
Hovedparten af udslæt i forbindelse med nevirapin opstår inden for de første 6 uger efter behandlingsstart. 
The majority of rashes associated with nevirapine occur within the first 6 weeks of initiation of therapy.
Du bør nøje læse indlægssedlerne for de andre typer hiv-medicin, som du skal tage i kombination med Viramune. 
Carefully read the package leaflet of all other HIV medicines you are taking in combination with Viramune.
Alle disse hændelser fortog sig efter ophør af nevirapin. 
All of these effects subsided following discontinuation of nevirapine.
Én-gang dagligt vedligeholdelsesdosis med Viramune depottabletter (efter optrapnings perioden): Dosis til pædiatriske patienter udregnet efter deres legemsoverfladeareal fremgår af tabellen nedenfor. 
Once daily maintenance dosing with Viramune prolonged-release tablets (after the lead-in): The recommended oral doses for paediatric patients based upon their BSA are described in the table below.
Uge 48 (gennemsnit) n = 419 
Week 48 (mean) n=419
I carcinogenicitetsstudier, øger nevirapin hepatiske tumorer i rotter og mus. 
In carcinogenicity studies, nevirapine induces hepatic tumours in rats and mice.
Efter 14 dage, er dosis 20 ml (200 mg) 2 gange daglig. 
After 14 days, the usual dose is 20 ml (200 mg) twice a day.
Overholdelse af dosis er obligat, specielt i den 14 dages optrapningsperiode (se pkt. 
The dose must be strictly adhered to, especially the 14-days lead-in period (see section 4.2).
Prednison bør ikke anvendes til behandling af udslæt forårsaget af Viramune. 
Prednisone should not be used to treat a rash related to Viramune.
Depottabletterne skal tages med væske og må ikke knuses eller tygges. 
The prolonged-release tablets shall be taken with liquid, and should not be broken or chewed.
Den præcise dosis afmåles ved hjælp af den medfølgende sprøjte og adaptor. 
Measure the exact dose using the measuring syringe and adapter supplied as follows:
Det er derfor vigtigt, at du regelmæssigt kommer til kontrol hos din læge. 
You should therefore remain in regular contact with your doctor.
Vægtinterval (kg) for patienter  8 år 
Weight Range (kg) for patients  8 years of age