FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Viramune - if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Viramune hvis du er allergisk over for nevirapin eller et af de øvrige indholdsstoffer i Viramune (angivet i punkt 6).
English: Viramune oral suspension is in a liquid suspension form and should only be taken by mouth.
Danish: Viramune oral suspension er en flydende suspension, der skal indtages gennem munden.
English: 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.
Danish: 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.
English: In addition, Viramune has not been shown to cause glucose disturbances.
Danish: Det er ikke vist, at Viramune forårsager forstyrrelser i blodglucose.
English: A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children.
Danish: En reduktion af røde blodlegemer (anæmi), der kan være relateret til behandling med nevirapin, forekommer også hyppigere hos børn.
English: Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Sorbitol
Danish: Methylparahydroxybenzoat (E218) Propylparahydroxybenzoat (E216) Sorbitol
English: Make sure that your child's doctor clearly tells you what dose you must give to your child.
Danish: Sørg for at få klar besked af lægen om, hvilken dosis du skal give dit barn.
English: 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.
Danish: 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.
English: The interaction data is presented as geometric mean value with 90% confidence interval (90 % CI) whenever these data were available.
Danish: Interaktionsdata er angivet som en geometrisk gennemsnitsværdi med et 90 % konfidensinterval (90 % CI) når disse data er tilgængelige.
English: The interaction data is presented as geometric mean value with 90% confidence interval (90% CI) whenever these data were available.
Danish: Interaktionsdata er angivet som en geometrisk gennemsnitsværdi med et 90% konfidensinterval (90% CI) når disse data er tilgængelige.
English: Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used (see section 4.2).
Danish: Andre nevirapin formuleringer, såsom tabletter eller oral suspension, bør benyttes (se pkt.
English: Viramune is also available in liquid form as an oral suspension.
Danish: Viramune kan også fås i flydende form som oral suspension.
English: 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).
Danish: Desuden fås til alle aldersgrupper til administration to gange dagligt en oral suspension (se det pågældende produktresumé).
English: 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.
Danish: Følgende bivirkninger har været rapporteret, når nevirapin har været brugt i kombination med andre antiretrovirale midler: Pancreatitis, perifer neuropati og trombocytopeni.
English: Viramune has been evaluated in both treatment-naïve and treatment-experienced patients.
Danish: Viramune er blevet evalueret i både behandlingsnaive og tidligere behandlede patienter.
English: 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.
Danish: 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.
English: Make sure that the syringe is tightly inserted.
Danish: Vær sikker på, at sprøjten sidder fast.
English: Co-administration of boceprevir with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure.
Danish: Samtidig administration af boceprevir og medicin, der inducerer eller hæmmer CYP3A4/5, kan reducere eller øge eksponeringen.
English: Viramune prolonged-release tablets are only to be used for children three years of age and above.
Danish: Viramune depottabletter må kun bruges til børn i alderen tre år og derover.
English: In this study, the multiple dose pharmacokinetic disposition of nevirapine and the five oxidative metabolites were not altered.
Danish: Nevirapins og de fem oxidative metabolitters farmakokinetik blev ikke ændret i dette studie.
English: Nevirapine: plasma levels:  1.151.28 compared to historical controls.
Danish: Nevirapin: plasmakoncentrationer:  1,15-1,28 sammenlignet med historiske kontroller.
English: Table 1: Lead-in phase with Viramune immediate-release
Danish: Tabel 1: Optrapningsfase med Viramune med umiddelbar frigivelse
English: Swallow whole, do not chew, divide or crush
Danish: Må ikke tygges, deles eller knuses
English: 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.
Danish: Interaktionen mellem nevirapin og warfarin er kompleks med potentiale for både stigning og fald i koagulationstiden.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Patients should be informed that hepatic reactions are a major toxicity of nevirapine requiring a close monitoring during the first 18 weeks.
Danish: Patienterne bør underrettes om, at leverreaktioner er en alvorlig toksicitet ved nevirapin som kræver en tæt monitorering i de første 18 uger.
English: Viramune tablets and oral suspension have been shown to be comparably bioavailable and interchangeable at doses up to 200 mg.
Danish: Viramune tabletter og oral suspension har sammenlignelig biotilgængelighed, og skift mellem de to formuleringer kan foregå i doser op til 200 mg.
English: If co-administered with Viramune, an adjustment in the telaprevir dose should be considered.
Danish: Ved administration sammen med Viramune bør justering af telaprevirdosis overvejes.
English: Rare hepatitis fulminant (which may be fatal)
Danish: Fulminant hepatitis (som kan være letal)
English: Overall, the exposure in children was similar to that observed in adults receiving Viramune prolonged-release in study 1100.1486.
Danish: Samlet set var eksponeringen hos børn den samme som hos voksne, der fik Viramune i depotform i henhold til studie 1100.1486.
English: 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)).
Danish: 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)).
English: Viramune 100 mg prolonged-release tablets are yellow, round and biconvex.
Danish: Viramune 100 mg depottabletter er gule, runde og bikonvekse.
English: Very common (may affect more than 1 in 10 people): - rash
Danish: Meget almindelig (kan forekomme hos mere end 1 ud af 10 patienter): - udslæt
English: You must take Viramune together with other antiretroviral medicines.
Danish: Du skal tage Viramune sammen med andre antiretrovirale hiv-lægemidler.
English: 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.
Danish: Dog, kan nogle patienter på grund af stor interpatient-variation opleve store stigninger i rifabutineksponeringen og kan derfor have øget risiko for rifabutintoksicitet.
English: If you forget to take Viramune
Danish: Hvis du har glemt at tage Viramune
English: Fatal cases of SJS, TEN and drug reaction with eosinophilia and systemic symptoms have been reported.
Danish: Der er rapporteret letale tilfælde af SJS, TEN og lægemiddelreaktion med eosinifili og systemiske symptomer.
English: The isolated rash should be closely monitored (see section 4.4).
Danish: Udslættet bør overvåges nøje (se pkt.
English: No changes to lamivudine apparent clearance and volume of distribution, suggesting no induction effect of nevirapine on lamivudine clearance.
Danish: Ingen forandringer af lamivudin tilsyneladende clearance og fordelingsvolumen, hvilket tyder på, at nevirapin ikke inducerer lamivudin clearance.
English: Nevirapine AUC  1.20 Nevirapine Cmax  1.20
Danish: Nevirapin AUC  1,20 Nevirapin Cmax  1,20
English: Renal impairment (mild, moderate and severe) resulted in no significant change in the pharmacokinetics of nevirapine.
Danish: Nedsat nyrefunktion (let, moderat og svær) resulterede ikke i en signifikant ændring i nevirapins farmakokinetik.
English: Your doctor will carefully monitor the effect of Viramune and any of these medicines if you are taking them together.
Danish: Din læge vil nøje kontrollere virkningen af Viramune og den nævnte medicin ovenfor, hvis du bliver behandlet med flere slags medicin på samme tid.
English: 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 %.
Danish: Nevirapins relative biotilgængelighed, ved indgift af én 400 mg Viramune depottablet i forhold til to Viramune 200 mg tabletter, var på ca. 75 %.
English: Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine.
Danish: Depottabletter er ikke egnede til 14-dages lead-in perioden for patienter, der starter i nevirapinbehandling.
English: Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
Danish: Plasmakoncentrationen af clarithromycin var signifikant reduceret, og plasmakoncentrationen af 14-OH metabolit var øget.
English: A marked improvement in the CD4+ cell percent was observed through Week 48 for both dose groups.
Danish: I uge 48 blev der observeret en markant forbedring i CD4+-celle-procenten hos begge doseringsgrupper.
English: 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.
Danish: 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.
English: If you are taking or are prescribed rifampicin to treat tuberculosis please inform your doctor before taking this medicine with Viramune.
Danish: Hvis du tager eller får ordineret rifampicin til behandling af tuberkulose, skal du tale med din læge, før du tager Viramune.
English: However the risk continues past this period and monitoring should continue at frequent intervals throughout treatment.
Danish: Risikoen fortsætter dog udover denne periode og overvågning med hyppige intervaller bør fortsættes under behandlingen.
English: 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.
Danish: 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.
English: During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Danish: Under hiv-behandling kan der forekomme vægtstigning samt forhøjede koncentrationer af lipider og glukose i blodet.
English: Consult your doctor if you have taken more Viramune than you should.
Danish: Konsulter lægen, hvis du har taget mere Viramune end du skal.
English: Methyl and propyl parahydroxybenzoates: Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reaction (possibly delayed).
Danish: Methyl- og propylparahydroxybenzoater: Viramune oral suspension indeholder methyl- og propylparahydroxybenzoat, der kan give allergiske reaktioner (muligvis forsinket).
English: 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.
Danish: 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.
English: The calculation will include your child's age and body weight, or body surface area.
Danish: I beregningen indgår dit barns alder, legemsvægt eller legemsoverfladeareal.
English: - The active substance is nevirapine.
Danish: - Aktivt stof: Nevirapin.
English: 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.
Danish: 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.
English: Plasma trough concentrations of boceprevir were decreased when administered with an NNRTI with a similar metabolic pathway as nevirapine.
Danish: Troughplasmakoncentrationen af boceprevir blev reduceret, når det blev coadministreret med en NNRTI med en lignende metaboliseringsvej som nevirapin.
English: The consolidated analysis of Paediatric AIDS Clinical Trials Group (PACTG) protocols 245, 356, 366, 377, and 403 allowed for the evaluation of paediatric patients less than 3 months of age (n=17) enrolled in these PACTG studies.
Danish: 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.
English: Caution should be exercised when co-administering telaprevir with nevirapine.
Danish: Der bør udvises forsigtighed ved co-administration af telaprevir og nevirapin.
English: Week 48 (mean) n=407
Danish: Uge 48 (gennemsnit) n = 407
English: At week 48, mean change from baseline in CD4 cell count was 184 cells/mm
Danish: Efter uge 48 var den gennemsnitlige ændring i CD4-celletallet i forhold til baseline, på henholdsvis 184 celler/mm
English: Monitoring of hepatic tests should be done every two weeks during the first 2 months of treatment, at the 3
Danish: Monitorering af levertests bør foretages hver anden uge i løbet af de første 2 måneder af behandlingen, efter 3 måneders behandling og derefter regelmæssigt.
English: These findings are most likely related to nevirapine being a strong inducer of liver enzymes, and not due to a genotoxic mode of action.
Danish: Disse fund er højst sandsynligt relateret til, at nevirapin er en stærk inducer af leverenzymer, og ikke tegn på genotoksicitet.
English: No life-threatening (Grade 4) rash events considered related to Viramune were reported during the randomised phase of this study.
Danish: Der blev ikke rapporteret nogle livstruende (grad 4) udslæt relateret til Viramune under randomiseringsfasen.
English: Ribavirin does not inhibit cytochrome P450 enzymes, and there is no evidence from toxicity studies that ribavirin induces liver enzymes.
Danish: Ribavirin hæmmer ikke CYP-enzymer, og fra toksicitetesstudier er der ingen tegn på, at ribavirin inducerer leverenzymer.
English: 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.
Danish: 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.
English: Viramune should not be used as the sole active antiretroviral, as monotherapy with any antiretroviral has shown to result in viral resistance.
Danish: Viramune bør ikke anvendes som eneste aktive antiretrovirale behandling, da det er påvist, at monoterapi med antiretrovirale stoffer resulterer i viral resistens.
English: The majority of rashes associated with nevirapine occur within the first 6 weeks of initiation of therapy.
Danish: Hovedparten af udslæt i forbindelse med nevirapin opstår inden for de første 6 uger efter behandlingsstart.
English: Carefully read the package leaflet of all other HIV medicines you are taking in combination with Viramune.
Danish: Du bør nøje læse indlægssedlerne for de andre typer hiv-medicin, som du skal tage i kombination med Viramune.
English: All of these effects subsided following discontinuation of nevirapine.
Danish: Alle disse hændelser fortog sig efter ophør af nevirapin.
English: 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.
Danish: Én-gang dagligt vedligeholdelsesdosis med Viramune depottabletter (efter optrapnings perioden): Dosis til pædiatriske patienter udregnet efter deres legemsoverfladeareal fremgår af tabellen nedenfor.
English: Week 48 (mean) n=419
Danish: Uge 48 (gennemsnit) n = 419
English: In carcinogenicity studies, nevirapine induces hepatic tumours in rats and mice.
Danish: I carcinogenicitetsstudier, øger nevirapin hepatiske tumorer i rotter og mus.
English: After 14 days, the usual dose is 20 ml (200 mg) twice a day.
Danish: Efter 14 dage, er dosis 20 ml (200 mg) 2 gange daglig.
English: The dose must be strictly adhered to, especially the 14-days lead-in period (see section 4.2).
Danish: Overholdelse af dosis er obligat, specielt i den 14 dages optrapningsperiode (se pkt.
English: Prednisone should not be used to treat a rash related to Viramune.
Danish: Prednison bør ikke anvendes til behandling af udslæt forårsaget af Viramune.
English: The prolonged-release tablets shall be taken with liquid, and should not be broken or chewed.
Danish: Depottabletterne skal tages med væske og må ikke knuses eller tygges.
English: Measure the exact dose using the measuring syringe and adapter supplied as follows:
Danish: Den præcise dosis afmåles ved hjælp af den medfølgende sprøjte og adaptor.
English: You should therefore remain in regular contact with your doctor.
Danish: Det er derfor vigtigt, at du regelmæssigt kommer til kontrol hos din læge.
English: Weight Range (kg) for patients  8 years of age
Danish: Vægtinterval (kg) for patienter  8 år
English: According to paediatric dose recommendations Viramune 400 mg prolonged-release tablets can be also taken by children, following the adult dosing schedule, if they
Danish: Viramune 400 mg depottabletter kan, som anført for pædiatrisk dosisrecommendation, også tages af børn efter doseringsplanen for voksne, hvis de:
English: Additional side effects in children and adolescents A reduction in white blood cells (granulocytopenia) can occur, which is more common in children.
Danish: Hos børn og unge kan endvidere ses følgende bivirkninger Den reduktion i antallet af hvide blodlegemer (granulocytopeni), der kan forekomme, ses oftere hos børn.
English: For patients 8 years and older the recommended dose is 4 mg/kg once daily for two weeks followed by 4 mg/kg twice daily thereafter.
Danish: For patienter på 8 år og derover er den anbefalede dosis 4 mg/kg en gang dagligt i 2 uger, hvorefter dosis på 4 mg/kg gives to gange dagligt.
English: Patients developing signs or symptoms of hepatitis, severe skin reaction or hypersensitivity reactions must discontinue nevirapine and seek medical evaluation immediately.
Danish: Patienter, som udvikler tegn eller symptomer på hepatitis, svært hududslæt eller overfølsomhedsreaktioner, skal stoppe nevirapin-behandling og søge lægehjælp omgående.
English: Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs).
Danish: Hovedparten af erfaringen med Viramune er i kombinationen med nukleosid reverse transkriptasehæmmere.
English: Therefore, caution should be recommended when driving a car or operating machinery.
Danish: Forsigtighed tilrådes derfor ved færdsel i trafikken eller ved betjening af maskiner.
English: Significantly fewer patients in the abacavir group (9 patients, or 6 %) than in the nevirapine group (26 patients, or 17 %) or the efavirenz group (27 patients, or 17 %) discontinued the medicinal product because of adverse events.
Danish: Signifikant færre patienter i abacavirgruppen stoppede behandlingen på grund af uønskede hændelser (9 patienter, eller 6 %) end i nevirapingruppen (26 patienter, eller 17 %) og i efavirenzgruppen (27 patienter, eller 17 %).
English: Viramune is also available as an oral suspension, tablets or as prolonged-release tablets with higher strength.
Danish: Viramune kan også fås som oral suspension, tabletter eller depottabletter med højere styrke.
English: If you are taking nevirapine and zidovudine concomitantly please inform your doctor since he might need to check your white blood cells.
Danish: Hvis du får nevirapin og zidovudin samtidigt, kan det blive aktuelt, at lægen kontrollerer dine hvide blodlegemer.
English: Isolated cases of Stevens-Johnson syndrome or Stevens-Johnson/toxic epidermal necrolysis transition syndrome have been reported in this population.
Danish: Isolerede tilfælde af Stevens-Johnsons syndrom eller Stevens-Johnsons/toksisk epidermal nekrolyse overgangssyndrom er blevet rapporteret hos denne befolkningsgruppe.
English: Viramune 50 mg/5 ml Oral suspension and Viramune 400 mg and 100 mg prolonged-release tablets
Danish: Viramune 50 mg/5 ml oral suspension og Viramune 400 mg og 100 mg depottabletter