FrancophonIA/ELRC3.0 huggingface dataset:
English: Nevirapine metabolites: Studies using human liver microsomes indicated that the formation of nevirapine hydroxylated metabolites was not affected by the presence of dapsone, rifabutin, rifampicin, and trimethoprim/sulfamethoxazole.
Danish: Anden information: Nevirapin-metabolitter: Studier med humane levermikrosomer indikerede, at dannelsen af hydroxylerede metabolitter af nevirapin ikke var påvirket af tilstedeværelsen af dapson, rifabutin, rifampicin, og trimethoprim/sulfamethoxazol.
English: This is because Nivirapine Teva can be partly washed out of your blood by dialysis.
Danish: Årsagen er, at Nevirapin Teva i en vis udstrækning kan fjernes fra blodet under dialysen.
English: No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits (see section 5.3).
Danish: Der har ingen observerbar teratogenicitet været i reproduktionsstudier, hvori der indgik drægtige rotter og kaniner (se pkt.
English: Fertility In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
Danish: Fertilitet I reproduktionstoksikologiske studier fandt man tilfælde af nedsat fertilitet hos rotter.
English: Monotherapy with nevirapine has been associated with the development of NNRTI resistance.
Danish: Monoterapi med nevirapin er blevet forbundet med udvikling af NNRTI-resistens.
English: The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing (see section 5.1).
Danish: Valg af anden behandling efter ophør af nevirapin bør baseres på klinisk erfaring og test af resistens (se pkt.
English: Do not take more Nevirapine Teva than prescribed by your doctor and described in this leaflet.
Danish: Tag ikke mere Nevirapin Teva, end lægen har foreskrevet, og som er beskrevet i denne indlægsseddel.
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 hiv-1RNA i de første 12 uger eller mere end 50 kopier/ml i to på hinanden følgende målinger efter uge 24, eller sygdomsprogression.
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: 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 plasmakoncentrationerne af nevirapin.
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: Because nevirapine induces its own metabolism with multiple dosing, this single dose study may not reflect the impact of hepatic impairment on multiple dose pharmacokinetics (see section
Danish: Fordi nevirapin fremkalder sin egen metabolisme ved multipel dosering, viser dette enkeltdosisstudie ikke nødvendigvis den påvirkning af leveren, som ses for farmakokinetikken ved multipel dosering (se pkt.
English: The tablets shall be taken with liquid, and should not be crushed or chewed.
Danish: Tabletterne skal tages med væske og må ikke knuses eller tygges.
English: Median age was 34 years and about 64% were male patients, median CD4 cell count was 170 and 190 cells per mm3 in the nevirapine twice daily and efavirenz groups, respectively.
Danish: Medianalderen var 34 år og omkring 64 % af patienterne var mænd, median CD4-celletallet var 170 og 190 celler pr mm3 i henholdsvis ”nevirapin to gange daglig”-gruppen og i efavirenzgruppen.
English: Nevirapine Teva should be administered by physicians who are experienced in the treatment of HIV infection.
Danish: Nevirapin Teva bør ordineres af læger med erfaring i behandling af hiv-infektion.
English: The recommended dose of Nevirapine Teva is one 200 mg tablet daily for the first 14 days (this leadin period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents.
Danish: Den anbefalede dosis Nevirapin Teva er én 200 mg tablet daglig i de første 14 dage (denne optrapningsperiode bør benyttes, idet den har vist sig at mindske hyppigheden af udslæt) efterfulgt af én 200 mg tablet 2 gange daglig i kombination med mindst to antiretrovirale lægemidler.
English: The following adverse reactions which may be causally related to the administration of nevirapine have been reported.
Danish: Følgende bivirkninger, som kan være forårsaget af indgivelsen af nevirapin, er blevet rapporteret.
English: However, patients with ESRD requiring dialysis exhibited a 43.5 % reduction in nevirapine AUC over a one-week exposure period.
Danish: Hos patienter med dislysekrævende ESRD fandt man en 43,5 % reduktion af nevirapin for AUC over en afprøvningsperiode på 1 uge.
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 eosinofili og systemiske symptomer.
English: Combination therapy with nevirapine is not a curative treatment of patients infected with HIV-1; patients may continue to experience illnesses associated with advanced HIV-1 infection, including opportunistic infections.
Danish: Kombinationsbehandling med nevirapin er ikke en kurativ behandling af patienter smittet med hiv-1; nogle patienter kan fortsat udvikle sygdom i forbindelse med fremskreden hiv-1 infektion, inkl.
English: The active substance of your medicine is called nevirapine.
Danish: Det aktive stof i din medicin er nevirapin.
English: If ASAT and ALAT return to baseline values and if the patient had no clinical signs or symptoms of hepatitis, rash, constitutional symptoms or other findings suggestive of organ dysfunction, it may be possible to reintroduce nevirapine, on a case by case basis, at the starting dose regimen of 200 mg/day for 14 days followed by 400 mg/day.
Danish: Hvis ASAT og ALAT vender tilbage til baselineværdier, og hvis patienten ikke har nogle kliniske tegn eller symptomer på hepatitis, udslæt, konstitutionelle symptomer eller andre fund, der tyder på organpåvirkning, er det muligt at genintroducere nevirapin efter en individuel patientvurdering, med en startdosis på 200 mg/dag i 14 dage efterfulgt af 400 mg/dag.
English: Readministration to patients who previously had ASAT or ALAT > 5 ULN during nevirapine therapy and had recurrence of liver function abnormalities upon readministration of nevirapine (see section
Danish: Genadministration til patienter, som tidligere havde ASAT eller ALAT > 5 ULN under nevirapinbehandling og havde tilbagevenden af leverfunktionsabnormaliteter efter genadministration af nevirapin (se pkt.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (AIDS defining illness), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Danish: Hos nogle patienter med fremskreden hiv-infektion (aids), som tidligere har haft opportunistisk infektion (sygdom, der tyder på aids), kan tegn og symptomer på betændelse fra tidligere infektioner forekomme kort efter, at anti-hiv-behandlingen er startet.
English: You must take Nevirapine Teva together with other antiretroviral medicines.
Danish: Du skal tage Nevirapin Teva sammen med andre antiretrovirale hiv-lægemidler.
English: Results of a 48-week analysis of the South African study BI 1100.1368 confirmed that the 4/7 mg/kg and 150 mg/m2 nevirapine dose groups were well tolerated and effective in treating antiretroviral naive paediatric patients.
Danish: Resultatet af et 48-ugers sydafrikansk studie BI1100.1368 bekræftede, at i patientgrupperne doseret med 4 mg/kg og 150 mg/m² nevirapin var dosis veltolerereret og effektiv i behandlingen af antiretroviralnaive pædiatriske patienter.
English: The predetermined primary efficacy comparison was between the nevirapine twice daily and the efavirenz treatment groups.
Danish: Den forudbestemte sammenligning af den primære virkning var mellem ”nevirapin to gange daglig”-gruppen og efavirenzgruppen.
English: The absorption of nevirapine is not affected by food, antacids or medicinal products which are formulated with an alkaline buffering agent.
Danish: Absorptionen af nevirapin er ikke påvirket af fødeindtagelse, antacida eller lægemidler, der indeholder en basisk buffer.
English: The results suggest that supplementing nevirapine therapy with an additional 200 mg dose of nevirapine following each dialysis treatment would help offset the effects of dialysis on nevirapine clearance.
Danish: Resultatet tyder på, at ved at supplere nevirapinbehandlingen med en ekstra dosis på 200 mg nevirapin efter hver dialysebehandling, kan effekten af dialyse på nevirapinclearance afhjælpes.
English: Microcrystalline cellulose Lactose (as monohydrate) Povidone K25
Danish: Cellulose, mikrokrystallinsk Lactose (som monohydrat) Povidon K25
English: Therefore coadministration would likely result in altered plasma levels of cobicistat and Nevirapine Teva.
Danish: Derfor vil co-administration sandsynligvis resultere i ændrede plasmakoncentrationer af Nevirapin Teva og cobicistat.
English: Elderly Nevirapine has not been specifically investigated in patients over the age of 65.
Danish: Nevirapin Teva er ikke specifikt blevet undersøgt hos patienter over 65 år.
English: An increase in the dose of lopinavir/ritonavir to 533/133 mg (4 capsules) or 500/125 mg (5 tablets with 100/25 mg each) twice daily with food is recommended in combination with Nevirapine Teva.
Danish: En dosisøgning af lopinavir/ritonavir til 533/133 mg (4 kapsler) eller 500/125 mg (5 tabletter a 100/25 mg) 2 gange daglig i kombination med Nevirapin Teva indtaget sammen med mad anbefales.
English: Nevirapine co-administration did not alter the ovulation suppression effects of DMPA.
Danish: Nevirapin co-administration ændrede ikke DMPA's suppression af ovulation.
English: The frequencies estimated are based on pooled clinical study data for adverse reactions considered related to nevirapine 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 nevirapinbehandling.
English: Patients with rare hereditary problems of galactose intolerance e.g. galactosaemia, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp lactase deficiency) eller glucose- og galactosemalabsorption bør ikke tage dette lægemiddel.
English: Nevirapine Teva should not be used as the sole active antiretroviral, as monotherapy with any antiretroviral has shown to result in viral resistance.
Danish: Nevirapin Teva bør ikke anvendes som eneste aktive antiretrovirale behandling, da det er påvist, at monoterapi med antivirale stoffer resulterer i viral resistens.
English: Genotypic analysis of isolates from antiretroviral naïve patients experiencing virologic failure (n=71) receiving nevirapine once daily (n=25) or twice daily (n=46) in combination with lamivudine and stavudine for 48 weeks showed that isolates from 8/25 and 23/46 patients, respectively, contained one or more of the following NNRTI resistance-associated substitutions:
Danish: Genotypisk analyse af isolater fra antiretroviralnaive patienter, der havde oplevet virulogisk svigt (n=71) med nevirapin administreret en gang daglig (n=25) eller to gange daglig (n=46) i kombination med lamivudin og stavudin i 48 uger, viste, at isolater fra 8/25 henholdsvis 23/46 patienter indeholdt en eller flere af de følgende NNRTI-resistens-associerede substitutioner:
English: A reduction in white blood cells (granulocytopenia) can occur, which is more common in children.
Danish: Den reduktion i antallet af hvide blodlegemer (granulocytopeni), der kan forekomme, ses oftere hos børn.
English: Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction.
Danish: Kontakt straks lægen hvis du får udslæt og en af de nævnte overfølsomhedsreaktioner (allergiske reaktioner).
English: This study demonstrated a significant reduction in transmission using single dose nevirapine (13.1 % (n = 310) in the nevirapine group, versus 25.1 % (n = 308) in the ultra-short zidovudine group (p = 0.00063)).
Danish: I dette studie sås i nevirapin-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
English: Inform your doctor about all other medicines you are taking before you start taking Nevirapine Teva.
Danish: Fortæl lægen om al anden medicin, du bruger, før du starter behandling med Nevirapin Teva.
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 bivirkninger signifikant lavere (61 patienter eller 41 %) end i nevirapingruppen (83 patienter eller 54 %) og i efavirenzgruppen (89 patienter eller 57 %).
English: Data concerning the pharmacokinetics of nevirapine have been derived from two major sources: a 48 week paediatric study in South Africa (BI 1100.1368) involving 123 HIV-1 positive, antiretroviral naïve patients aged 3 months to 16 years; and a consolidated analysis of five Paediatric AIDS Clinical Trials Group (PACTG) protocols comprising 495 patients aged 14 days to 19 years.
Danish: Farmakokinetiske data på nevirapin er baseret på to store kilder: Dels et 48-ugers pædiatrisk studie i Sydafrika (BI 1100.1368) med 123 hiv-1-positive, antiretroviralt naive patienter i en alder fra 3 måneder og op til 16 år samt en samlet analyse af fem Paediatric AIDS Clinical Trials Group (PACTG)-protokoller, der omfatter 495 patienter i alderen fra 14 dage op til 19 år.
English: Nevirapine Teva administration above the recommended dose might increase the frequency and seriousness of skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Danish: Administration af Nevirapin Teva i højere doser end anbefalet kan forøge frekvensen og alvorligheden af hudreaktioner, såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse.
English: Ketoconazole and erythromycin significantly inhibited the formation of nevirapine hydroxylated metabolites.
Danish: Ketoconazol og erytromycin hæmmede signifikant dannelsen af hydroxylerede metabolitter af nevirapin.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med kronisk hepatitis B eller C, som er i behandling med antiretroviral kombinationsbehandling, har en højere risiko for alvorlige og potentielle letale hepatiske bivirkninger.
English: Carefully read the package leaflet of all other HIV medicinal products you are taking in combination with Nevirapine Teva.
Danish: Du bør nøje læse indlægssedlerne for de andre typer hiv-medicin, som du skal tage i kombination med Nevirapin Teva.
English: The 200 mg once daily dosing regimen should not be continued beyond 28 days at which point in time an alternative treatment should be sought due to the possible risk of underexposure and resistance.
Danish: 200 mg som dagsdosis bør ikke administreres i mere end 28 dage, da der er risiko for undereksponering og resistens, og en alternativ medicinsk behandling bør vælges.
English: These events are commonly associated with other antiretroviral agents and may be expected to occur when Nevirapine Teva is used in combination with other agents; however, it is unlikely that these events are due to treatment with Nevirapine Teva.
Danish: Disse tilfælde er normalt forbundet med andre antiretrovirale midler og må forventes at opstå, når Nevirapin Teva tages i kombination med andre midler; det er dog usandsynligt, at disse tilfælde opstår på grund af behandling med Nevirapin Teva.
English: No drug-drug interaction study of telaprevir with nevirapine has been conducted, however, interaction studies of telaprevir with an NNRTI with a similar metabolic pathway as nevirapine demonstrated reduced levels of both.
Danish: Der er ikke udført lægemiddelinteraktionsstudier med telaprevir og nevirapin, men interaktionsstudier med telaprevir og en NNRTI med lignende metaboliseringsvej som nevirapin viste reducerede niveauer af begge.
English: Plasma trough concentrations of boceprevir were decreased when administered with an NNRTI with a similar metabolic pathway as nevirapine.
Danish: Trough-plasmakoncentrationen af boceprevir blev reduceret, når det blev co-administreret med en NNRTI med en lignende metaboliseringsvej som nevirapin.
English: Rare (may affect up to 1 in 1000 people): - sudden and intense inflammation of the liver (fulminant hepatitis) - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 patienter): - pludselig og kraftig leverbetændelse (fulminant leverbetændelse) - lægemiddelforårsaget reaktion med systemiske symptomer (lægemiddelforårsaget reaktion med eosinofili og systemiske symptomer)
English: Furthermore, combining the following compounds with Nevirapine Teva is not recommended: efavirenz, ketoconazole, delavirdine, etravirine, rilpivirine, elvitegravir (in combination with cobicistat), atazanavir (in combination with ritonavir), boceprevir; fosamprenavir (if not co-administered with low dose ritonavir) (see section 4.5).
Danish: Desuden anbefales det ikke at tage Nevirapin Teva i kombination med følgende stoffer: efavirenz, ketoconazol, delavirdin, etravirin, rilpivirin, elvitegravir (i kombination med cobicistat), atazanavir (i kombination med ritonavir), boceprevir og fosamprenavir (hvis det ikke administreres samtidig med lav-dosis ritonavir) (se pkt.
English: The pharmacokinetics of autoinduction is characterised by an approximately 1.5 to 2 fold increase in the apparent oral clearance of nevirapine as treatment continues from a single dose to two-to-four weeks of dosing with 200-400 mg/day.
Danish: Farmakokinetikken af autoinduktionen karakteriseres ved en tilnærmelsesvis 1,5-2 gange stigning i den åbenbare perorale clearance af nevirapin når en behandling fortsættes fra en enkeltdosis til 2-4 ugers behandling med 200-400 mg daglig.
English: Nevirapine Teva 200 mg tablets, following the dosing schedule described above, are suitable for larger children, particularly adolescents, below the age of 16 who weigh more than 50 kg or whose body surface area is above 1.25 m2 according to the Mosteller formula.
Danish: Nevirapin Teva 200 mg tabletter, kan anvendes i den ovenfor beskrevne dosering til større børn, specielt unge, der er yngre end 16 år, og som vejer mere end 50 kg, eller hvis legemsoverfladeareal er mere end 1,25 m² i henhold til Mosteller-formlen.
English: Rhabdomyolysis has been observed in patients experiencing skin and/or liver reactions associated with nevirapine use.
Danish: Rhabdomyolyse er observeret hos patienter med hud- og/eller leverpåvirkning i forbindelse med nevirapinbehandling.
English: If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of Nevirapine Teva.
Danish: Hvis du er i dialysebehandling, vil din læge muligvis justere dosis af Nevirapin Teva.
English: Absolute bioavailability in 12 healthy adults following single-dose administration was 93 ± 9% (mean SD) for a 50 mg tablet and 91 ± 8 % for an oral solution.
Danish: Absolut biotilgængelighed hos 12 raske voksne efter en enkelt dosis var 93 ± 9 % (gennemsnitlig SD) efter en 50 mg tablet og 91 ± 8 % efter peroral opløsning.
English: Nevirapine exhibited additive to synergistic anti-HIV-1 activity in combination with the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, saquinavir and tipranavir, and the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir and zidovudine.
Danish: Nevirapin viste additiv synergistisk anti-hiv-1-aktivitet i kombination med proteasehæmmerne amprenavir, atazanavir, indinavir, lopinavir, saquinavir og tipranavir og NRTI'erne abacavir, didanosin, emtricitabin, lamivudin, stavudin, tenofovir og zidovudin.
English: Nevirapine Teva is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age.
Danish: Nevirapin Teva bruges til behandling af hiv-1-smittede voksne, unge og børn i alle aldre.
English: Rashes are usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or without pruritus, located on the trunk, face and extremities.
Danish: Udslæt er ofte lette til moderate, makulopapuløse erytematøse hududslæt med eller uden kløe, lokaliseret til truncus, ansigt og ekstremiteterne.
English: Maraviroc Cmin ND Maraviroc Cmax ↔ 1.54 (0.94-2.52) compared to historical controls
Danish: Maraviroc Cmin ND Maraviroc Cmax ↔ 1,54 (0,94-2,52) sammenlignet med historiske kontroller
English: In addition, nevirapine has not been shown to cause glucose disturbances.
Danish: Det er ikke vist, at nevirapin forårsager forstyrrelser i blodglucose.
English: Tell your doctor if you experience any of the following clinical symptoms of liver damage: - loss of appetite - feeling sick (nausea) - vomiting - yellow skin (jaundice)
Danish: Informer din læge, hvis du oplever nogen af de følgende kliniske symptomer på leverskade: - appetitløshed - kvalme - opkastning - huden bliver gul (gulsot) - mavesmerter.
English: 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.
Danish: Data der er rapporteret i litteraturen fra 20 hiv-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 nevirapin 2 gange daglig.
English: An increased risk was observed in men with detectable HIV-1 RNA in plasma and CD4 counts > 400 cells/mm3 (6.3 % versus 1.2 % for men with CD4 counts < 400 cells/mm3).
Danish: Hos mænd sås der en øget risiko ved detekterbart hiv-1-RNA i plasma og CD4-celletal > 400 celler/mm3 (6,3 % versus 1,2 % for mænd med CD4-celletal < 400 celler/mm3).
English: The anti-HIV-1 activity of nevirapine was antagonized by the anti-HBV medicinal product adefovir and by the anti-HCV medicinal product ribavirin in vitro.
Danish: Nevirapins anti-hiv-1aktivitet blev in vitro hæmmet af anti-HBV-midlet adefovir og af anti-HCV-midlet ribavirin.
English: The proportion of patients with at least one grade 3 or 4 liver-associated laboratory toxicity was 8.3% for nevirapine twice daily and 4.5% for efavirenz.
Danish: Andelen af patienter med mindst én grad 3 eller 4 leverrelateret laboratorietoksicitet var 8,3 % for ”nevirapin 2 gange daglig” og 4,5 % for efavirenz.
English: Sodium starch glycolate (Type A) Colloidal silicon dioxide Magnesium stearate
Danish: Natriumstivelsesglycolat (Type A) Kolloid silicadioxid Magnesiumstearat