natgillin/translations-raw huggingface dataset:
INFORMATION I BRAILLESKRIFT Viramune 50 mg/5 ml 
INFORMATION IN BRAILLE Viramune 50 mg/5 ml
Viramune oral suspension indeholder methylparahydroxybenzoat og propylparahydroxybenzoat. 
Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Den kliniske betydning heraf er dog ukendt, da der ikke er udført specifikke studier. 
However, in the absence of specific studies, the clinical impact of these findings is not known.
To nye substitutioner baseret på codoner, der tidligere er blevet forbundet med nevirapin-resistens, blev set: én patient med Y181I af dem behandlet med Viramune i depotform, og én patient med Y188N af dem behandled med Viramune 200 mg; ud fra fænotype kunne resistens over for nevirapin bekræftes. 
Two new substitutions on codons previously associated with nevirapine resistance were observed: one patient with Y181I in the Viramune prolonged-release group and one patient with Y188N in the Viramune immediate-release group; resistance to nevirapine was confirmed by phenotype.
En ml oral suspension indeholder 10 mg nevirapin (som hemihydrat). 
Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate).
Disse resultater omfatter alle patienter randomiseret efter 14 dages optrapningsperiode med Viramune 200 mg tabletter, og som fik mindst én dosis blindet lægemiddel. 
These outcomes include all patients who were randomised after the 14 day lead-in with Viramune immediate-release and received at least one dose of blinded medicinal product.
Maraviroc AUC  1,01 (0,6 -1,55) Maraviroc Cmin ND Maraviroc Cmax  1,54 (0,94-2,52) Sammenlignet med historiske kontroller 
Maraviroc AUC  1.01 (0.6 -1.55) Maraviroc Cmin ND Maraviroc Cmax  1.54 (0.94-2.52) compared to historical controls
Viramune depottabletter bør doseres ud fra patientens vægt eller legemsoverfladeareal. 
Viramune prolonged-release tablets may be dosed based on a patient's weight or body surface area (BSA).
Det er vigtigt, at du fortsætter med at tage Viramune korrekt, som anført ovenfor, medmindre din læge anbefaler dig at stoppe. 
It is important that you continue taking Viramune correctly, as described above, unless your doctor instructs you to stop.
Efter flere doser stiger peakplasmakoncentrationen for nevirapin lineært i dosisområdet 200-400 mg daglig. 
Following multiple doses, nevirapine peak concentrations appear to increase linearly in the dose range of 200 to 400 mg/day.
Hos mænd sås der en øget risiko ved detekterbart hiv-1-rna i plasma og CD4-celletal > 400 celler/mm 
An increased risk was observed in men with detectable HIV-1 RNA in plasma and CD4 counts > 400 cells/mm
Nevirapin AUC  0,42 
Nevirapine AUC  0.42
Dog havde ca. 15 % af patienterne med hepatisk fibrose en nevirapin trough koncentration på over 9,000 ng/ml (dobbelt så meget som den almindelige trough gennemsnitsværdi). 
However, approximately 15 % of these patients with hepatic fibrosis had nevirapine trough concentrations above 9,000 ng/ml (2 fold the usual mean trough).
Patienter med før-eksisterende leverfunktionssvigt inklusive kronisk aktiv hepatitis har en højere risiko for leverfunktions abnormaliteter under antiretroviral kombinationsbehandling og bør monitoreres ifølge standard i praksis. 
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
3 i henholdsvis ”Viramune to gange daglig”-gruppen og i efavirenzgruppen. 
3 in the Viramune twice daily and efavirenz groups, respectively.
24 uger efter randomisering til TRANxITION-studiet havde 92,6 % og 93,6 % af de patienter, der fik enten Viramune 200 mg to gange dagligt eller Viramune 400 mg i depotform én gang dagligt, fortsat hiv-1-rna < 50 kopier/ml. 
At 24 weeks after randomisation in the TRANxITION study, 92.6 % and 93.6 % of patients receiving Viramune 200 mg immediate-release twice daily or Viramune 400 mg prolonged-release once daily, respectively, continued to have HIV-1 RNA < 50 copies/ml.
Viramune 100 mg depottabletter kan anvendes til børn i alderen 3 år og derover. 
Viramune 100 mg prolonged-release tablets can be taken by children three years of age and above.
Tabel 1: Karakteristika for demografi og sygdom ved baseline i studie 1100.1486 Viramune 
Table 1: Demographic and Baseline Disease Characteristics in study 1100.1486
Interaktionsdata er fra Viramune 200 mg tabletter, men forventes at gælde for alle doseringsformer. 
The following data were generated using the Viramune immediate-release tablets but are expected to apply to all dosage forms.
På isolater fra de 86 antiretroviralnaive patienter, der udgik af VERxVE-studiet (1100.1486) på grund af virologisk svigt (rebound, delvist respons), eller en bivirkning, eller forbigående øget virusbelastning i løbet af studiet, blev der foretaget genotypeanalyse. 
Genotypic analysis was performed on isolates from 86 antiretroviral naïve patients who discontinued the VERxVE study (1100.1486) after experiencing virologic failure (rebound, partial response) or due to an adverse event or who had transient increase in viral load during the course of the study.
Disse tilfælde omfatter Stevens-Johnsons syndrom toksisk epidermal nekrolyse og overfølsomhedsreaktioner karakteriseret ved udslæt, konstitutionelle symptomer og andre organpåvirkninger. 
These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterised by rash, constitutional findings and visceral involvement.
Tallet 793 er antallet af behandlings-respondenter efter uge 48 (384 fik Viramune 200 mg tabletter, og 409 fik Viramune depottabletter). 
The numerator 793 is the number of patients who were treatment responders at 48 weeks (384 from immediate-release and 409 from prolonged-release treatment groups).
Lægen vil beregne barnets dosis. 
Your child's doctor will calculate the dose for your child.
Hvis patienter udvikler et udslæt, der kan være forbundet med nevirapin, bør der udføres leverfunktionstests. 
If patients present with a suspected nevirapine-associated rash, liver function tests should be performed.
Data der er rapporteret i litteraturen fra 20 hiv-inficerede patienter antyder et Cmax ved steady state på 5,74 μg/ml (5,00-7,44) og Cmin på 3,73 μg/ml (3,20-5,08) med AUC på 109,0 h*μg/ml (96,0-143,5) hos patienter, der indtager 200 mg af nevirapine 2 gange daglig. 
Data reported in the literature from 20 HIV-infected patients suggest a steady state Cmax of 5.74 µg/ml (5.00-7.44) and Cmin of 3.73 µg/ml (3.20-5.08) with an AUC of 109.0 h*µg/ml (96.0-143.5) in patients taking 200 mg of nevirapine bid.
I stedet bruges Viramune 400 mg depottabletter efter optrapningsperioden. 
Instead Viramune 400 mg prolonged-release tablets should be used after the lead-in period.
Hos patienter med dialysekrævende ESRD, fandt man en 43,5 % reduktion af nevirapins AUC over en afprøvningsperiode på 1 uge. 
However, patients with ESRD requiring dialysis exhibited a 43.5 % reduction in nevirapine AUC over a one-week exposure period.
På grund af risiko for forøget eksponering af Viramune, bør der udvises forsigtighed, hvis produkterne gives samtidigt, og patienterne bør monitoreres nøje. 
exposure to Viramune, caution should be exercised if the medicinal products are given concomitantly and patients should be monitored closely.
Flasken kan opbevares tillukket med plastikadaptorens låg. 
The bottle can be kept sealed with the lid of the plastic adapter.
Granulocytopeni er en almindelig bivirkning ved zidovudin. 
Granulocytopenia is commonly associated with zidovudine.
Hos patienter med dialysekrævende ESRD fandt man en 43,5 % reduktion af nevirapins AUC over en afprøvningsperiode på 1 uge. 
However, patients with ESRD requiring dialysis exhibited a 43.5% reduction in nevirapine AUC over a one-week exposure period.
Nogle risikofaktorer for at udvikle alvorlige kutane reaktioner er blevet identificeret og inkluderer undladelse i at følge den første dosismængde på 200 mg om dagen (4 mg/kg eller 150 mg/m² til pædiatriske patienter) i løbet af optrapningsperioden og en lang forsinkelse mellem de første symptomer og lægekonsultation. 
Some risk factors for developing serious cutaneous reactions have been identified, they include failure to follow the initial dosing of 200 mg daily (4 mg/kg or 150 mg/m2 for paediatric patients) during the lead-in period and a long delay between the initial symptoms and medical consultation.
Farmakokinetiske resultater antyder, at man bør udvise forsigtighed med at ordinere nevirapin til patienter med moderat nedsat leverfunktion (Child-Pugh B). 
Pharmacokinetic results suggest caution should be exercised when nevirapine is administered to patients with moderate hepatic dysfunction (Child-Pugh B).
Generelt er stigende ASAT- eller ALAT-niveauer > 2,5 ULN og/eller samtidig infektion med hepatitis B og/eller C ved starten af antiretroviral behandling forbundet med større risiko for leverbivirkninger under antiretroviral behandling inklusive regimer indeholdende nevirapin. 
Increased ASAT or ALAT levels > 2.5 ULN and/or co-infection with hepatitis B and/or C at the start of antiretroviral therapy is associated with greater risk of hepatic adverse reactions during antiretroviral therapy in general, including nevirapine containing regimens.
De første 18 uger af behandlingen er en kritisk periode, som kræver tæt monitorering (se pkt. 
The first 18 weeks of treatment is a critical period which requires close monitoring (see section 4.4).
Den almindeligste kliniske toksisitet ved nevirapin er udslæt, idet Viramune var årsag til udslæt hos 12,5 % af patienterne i kombinationsregimer i kontrollede studier. 
The most common clinical toxicity of nevirapine is rash, with Viramune attributable rash occurring in 12.5 % of patients in combination regimens in controlled studies.
Studier med behandlingsnaive patienter 
Studies in treatment-naïve patients
Viramune bør kun anvendes sammen med mindst to andre antiretrovirale lægemidler (se pkt. 
Viramune should only be used with at least two other antiretroviral agents (see section 5.1).
Norethindrone (NET) 1.0 mg 4 gange daglig 
Norethindrone (NET) 1.0 mg QD
I tabel 2 vises 48 ugers-resultaterne fra VERxVE-studiet (1100.1486). 
Table 2 describes week 48 outcomes in the VERxVE study (1100.1486).
3, havde 12 gange større risiko for symptomatisk leverpåvirkning sammenlignet med kvinder med CD4-celletal <250 celler/mm versus 0,9 %). 
3 had a 12 fold higher risk of symptomatic hepatic adverse reactions compared to women with CD4 counts <250 cells/mm versus 0.9 %).
Genadministration til patienter, hvor permanent seponering har været krævet pga. alvorligt udslæt, udslæt ledsaget af konstitutionelle symptomer, overfølsomhedsreaktioner eller klinisk hepatitis pga. nevirapin. 
Readministration to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
Resultater fra in vitro studier viste en svag antagonisme fra adefovir på nevirapin (se pkt. 
Results of in vitro studies showed a weak antagonism of nevirapine by
I gruppen med grad 3 eller 4 leverrelateret laboratorietoksicitet var andelen, som samtidig havde hepatitis B henholdsvis hepatitis C-virus 6,7 % og 20,0 % i ”nevirapin 2 gange daglig” gruppen, og 5,6 % og 11,1 % i efavirenz gruppen. 
Of the patients with grade 3 or 4 liver-associated laboratory toxicity, the proportions coinfected with hepatitis B or hepatitis C virus were 6.7 % and 20.0 % in the nevirapine twice daily group, 5.6 % and 11.1 % in the efavirenz group.
De hyppigst rapporterede bivirkninger relateret til behandling med Viramune depottabletter hos behandlingsnaive patienter (herunder optrapningsfasen med en formulering med umiddelbar frigivelse) i det kliniske studie 1100.1486 (VERxVE) var udslæt, kvalme, leverfunktionstest uden for normalområdet, hovedpine, træthed, hepatitis, abdominalsmerter, diarré og pyreksi. 
The most frequently reported adverse reactions related to Viramune prolonged-release therapy in treatment naïve patients (including lead-in phase with immediate-release) in clinical study 1100.1486 (VERxVE) were rash, nausea, liver function test abnormal, headache, fatigue, hepatitis, abdominal pain, diarrhoea and pyrexia.
Ældre Nevirapin har ikke været afprøvet på patienter over 65 år. 
Elderly Nevirapine has not been specifically investigated in patients over the age of 65.
Denne øgede risiko for toksicitet baseret på CD4-celletal niveauer, er ikke set hos patienter med en udetekterbar viral belastning i plasma - dvs. < 50 kopier/ml. 
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.
Der har ingen observerbar teratogenicitet været i reproduktionsstudier, hvori der indgik drægtige rotter og kaniner. 
No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits (see section 5.3).
Det multinationale 2NN studie, indeholdt et farmakokinetisk substudie med 1.077 patienter, hvoraf de 391 var kvinder. 
In the multinational 2NN study, a population pharmacokinetic substudy of 1,077 patients was performed that included 391 females.
Viramune 100 mg depottabletter er ikke beregnet til voksne. 
Viramune 100 mg prolonged-release tablets should not be used by adults.
Oral hormonel antikonception bør ikke anvendes, som den eneste svangerskabsforebyggende metode hos kvinder, der behandles med Viramune (se pkt. 
Oral hormonal contraceptives should not be used as the sole method of contraception in women taking Viramune (see section 4.4).
Amning Nevirapin passerer placenta hurtigt og findes i modermælk. 
Breast-feeding Nevirapine readily crosses the placenta and is found in breast milk.
Hvis du får alvorlige lever-, hud- eller overfølsomhedsreaktioner under behandling med Viramune må du ALDRIG tage Viramune igen, medmindre det er ordineret af lægen. 
If you develop severe liver, skin or hypersensitivity reactions whilst taking Viramune, NEVER TAKE VIRAMUNE again without referring to your doctor.
Der er ingen nye bivirkninger for Viramune depottabletter, som ikke tidligere er blevet identificeret for Viramune 200 mg tabletter og oral suspension. 
There are no new adverse drug reactions for Viramune prolonged-release tablets that have not been previously identified for Viramune immediate-release tablets and oral suspension.
Det forsvandt spontant indenfor en uge uden kliniske komplikationer. 
Mild isolated neutropenia and hyperlactataemia was observed, which spontaneously disappeared within one week without any clinical complications.
Nevirapin tilhører en gruppe af anti-hiv-lægemidler kaldet non-nukleosid revers transkriptasehæmmere (NNRT-hæmmere). 
Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Resultater fra interaktionsstudier med telaprevir og efavirenz indikerer, at der bør udvises forsigtighed, når telaprevir co-administreres med CYP inducere. 
Results of DDI studies of telaprevir with efavirenz indicate that caution should be exercised when co-administering telaprevir with P450 inducers.
Cobicistat, en CYP-3A-hæmmer, hæmmer signifikant leverenzymer samt andre metaboliseringsveje. 
Cobicistat, a cytochrome P450 3A inhibitor significantly inhibits hepatic enzymes, as well as other metabolic pathways.
Overfølsomhed (anafylaktisk reaktion, angioødem og urticaria) er blevet rapporteret. 
Hypersensitivity (anaphylactic reaction, angioedema and urticaria) have been reported.
Nogle patienter, der får flere antiretrovirale lægemidler på samme tid, kan udvikle en knoglesygdom kaldet knoglenekrose (knoglevævet dør på grund af blodmangel til knoglerne). 
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Dette naturlægemiddel kan medføre, at Viramune ikke virker optimalt. 
This herbal substance may stop Viramune from working properly.
• børnene er  8 år og vejer 43,8 kg eller mere eller 
• are  8 years of age and weigh 43.8 kg or more or
Læge vil løbende kontrollere barnets alder, kropsvægt og legemsoverfladeareal for at sikre, at doseringen forbliver korrekt. 
Your child's doctor will continually check your child's age, weight or body surface area to ensure the correct dose.
Viramune må ikke readministreres til patienter, hvor en seponering af nevirapin har været begrundet i klinisk hepatitis. 
Viramune must not be readministered to patients who have required permanent discontinuation for clinical hepatitis due to nevirapine.
Ved postmenopausal hormonbehandling bør den terapeutiske virkning monitoreres når der samtidig behandles med nevirapin. 
Additionally, when postmenopausal hormone therapy is used during administration of nevirapine, its therapeutic effect should be monitored.
Sorbitol: Viramune oral suspension indeholder 162 mg sorbitol pr. ml. 
Sorbitol: Viramune oral suspension contains 162 mg of sorbitol per ml.
Tilfælde af overdosering med Viramune 200 mg tabletter efter indtagelse af doser mellem 800-6000 mg/dag i op til 15 dage har været rapporteret. 
Cases of overdose with Viramune immediaterelease at doses ranging from 800 to 6,000 mg per day for up to 15 days have been reported.
De hyppigst rapporterede bivirkninger relateret til Viramune behandling, på tværs af alle kliniske studier, var udslæt, allergiske reaktioner, hepatitis, leverfunktionstests uden for normalområdet, kvalme, opkastninger, diarré, abdominalsmerter, træthed, feber, hovedpine og myalgi. 
The most frequently reported adverse reactions related to Viramune therapy, across all clinical studies, were rash, allergic reactions, hepatitis, abnormal liver function tests, nausea, vomiting, diarrhoea, abdominal pain, fatigue, fever, headache and myalgia.
Du skal stoppe amningen, hvis du tager Viramune. 
You should stop breast-feeding if you are taking Viramune.
Efter optrapningsperioden var incidensen af symptomatiske hepatiske hændelser 2,4 % i gruppen, der fik Viramune 200 mg, og 1,6 % i gruppen, der fik Viramune i depotform. 
After the lead-in period the incidence of symptomatic hepatic events was 2.4 % in the Viramune immediate-release group and 1.6% in the Viramune prolonged-release group.
Den forudbestemte sammenligning af den primære virkning var mellem ”Viramune to gange daglig”gruppen og efavirenzgruppen. 
The predetermined primary efficacy comparison was between the Viramune twice daily and the efavirenz treatment groups.
Risikoen for leverpåvirkning fortsætter dog ud over denne periode og monitorering med hyppige intervaller bør fortsættes. 
However, the risk of any hepatic event continues past this period and monitoring should continue at frequent intervals.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/055/007 (30 tabletter, plastbeholder) EU/1/97/055/008 (30 tabletter, blister) EU/1/97/055/009 (90 tabletter, blister) 
MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/007 (30 tablets, bottle) EU/1/97/055/008 (30 tablets, blister) EU/1/97/055/009 (90 tablets, blister)
Tabel 3 viser resultaterne efter uge 48 i studie 1100.1486 (efter randomisering) pr. baselinevirusbelastning. 
Table 3 shows outcomes at 48-weeks in study 1100.1486 (after randomization) by baseline viral load.
Det har vist sig, at en 14-dages optrapningsperiode mindsker risikoen for hududslæt. 
The 14-day”lead-in” period has been shown to lower the risk of skin rash.
Indvirkningen af køn på farmakokinetikken for Viramune i depotform blev undersøgt i studie 1100.1486. 
The effects of gender on the pharmacokinetics of Viramune prolonged-release have been investigated in study 1100.1486.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Boehringer Ingelheim International GmbH Binger Strasse 173 
MARKETING AUTHORISATION HOLDER Boehringer Ingelheim International GmbH Binger Strasse 173
Nevirapin må ikke gives til patienter med ASAT eller ALAT > 5 ULN før baseline ASAT/ALAT er stabiliseret < 5 ULN (se pkt. 
Nevirapine must not be administered to patients with pretreatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN (see section
• er < 8 år og vejer 25 kg eller mere, eller 
• are < 8 years of age and weigh 25 kg or more or
Tenofovir plasmakoncentrationer forbliver uændret ved coadministration med nevirapin. 
Tenofovir plasma levels remain unchanged when co-administered with nevirapine.
Nevirapin Cmin  0,32 
Nevirapine Cmin  0.32
Viramune i depotform n = 508* 
Viramune prolonged-release n=508*
Derefter, skiftes over til Viramune depottabletter én gang dagligt, og dit barns læge vil bestemme den korrekte dosis og tabletstyrke baseret på enten vægt eller legemsoverfladeareal. 
Thereafter your child will be switched to Viramune prolonged-release tablets once a day and your child's doctor will decide the right dose and prolonged-release tablet strength based either on your child's weight or body surface area.
Viramune oral suspension indeholder 162 mg sorbitol pr. ml. 
Viramune oral suspension contains 162 mg sorbitol per ml.
* Omfatter patienter, der efter randomisering fik mindst én dosis blindet lægemiddel. 
* Includes patients who received at least one dose of blinded medicinal product after randomisation.
EU/1/97/055/003 [120 tabletter] 
EU/1/97/055/003 [120 tablets]
Der er en tendens til, at kvindelige patienter har højere (ca. 20-30 %) koncentration umiddelbart før næste dosis (trough-koncentrationer) i behandlingsgruppen med Viramune depottabletter såvel som i behandlingsgruppen med Viramune med umiddelbar frigivelse. 
Female patients tend to have higher (approximately 20 - 30 %) trough concentrations in both Viramune prolonged-release and Viramune immediate-release treatment groups.
3 for kvinder og < 400 celler/mm 
3 for women and <400 cells/mm
Incidensen af symptomatiske hepatiske hændelser i optrapningsfasen med Viramune 200 mg tabletter var 0,5 %. 
The incidence of symptomatic hepatic events during the Viramune immediate-release lead-in phase was 0.5 %.
Patienter har oplevet ødemer, erythema nodosum, træthed, feber, hovedpine, søvnmangel, kvalme, lungeinfiltrater, udslæt, svimmelhed, opkastninger, stigning i transaminaser og vægttab. 
Patients have experienced oedema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, increase in transaminases and weight decrease.
Afhængig af resultaterne beslutter lægen om du skal fortsætte eller afbryde behandlingen. 
Depending on the outcome your doctor may decide to interrupt or stop your Viramune treatment.
De begrænsede data fra et fase IIa studie hos hiv patienter har vist en 20 % reduktion af TPV Cmin, der ikke var klinisk signifikant. 
The limited data available from a phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV Cmin.
De begrænsede data fra et fase IIa studie hos hiv patienter har vist en 20% reduktion af TPV Cmin, der ikke var klinisk signifikant. 
The limited data available from a phase IIa study in HIV-infected patients have shown a clinically non significant 20 % decrease of TPV Cmin.
På grund af metaboliseringen forventes der ingen klinisk signifikante farmakokinetiske interaktioner mellem enfuvirtid og nevirapin. 
Due to the metabolic pathway no clinically significant pharmacokinetic interactions are expected between enfuvirtide and nevirapine.
Patienterne skal instrueres i at dosis ikke må øges, hvis der opstår nogen form for udslæt i løbet af to-ugers optrapningsperioden, før udslættet er forsvundet. 
Patients should be instructed that dose escalation is not to occur if any rash occurs during the two-week lead-in dosing period, until the rash resolves.