FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be informed that hepatic reactions are a major toxicity of nevirapine requiring 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: 14 tablets 60 tablets 120 tablets
Danish: 14 tabletter 60 tabletter 120 tabletter
English: Only a small fraction (< 5 %) of the radioactivity in urine (representing < 3 % of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound.
Danish: Kun en lille fraktion (< 5 %) af radioaktiviteten i urinen (repræsenterende < 3 % af den totale dosis) består af det oprindelige stof; derfor spiller den renale ekskretion en mindre rolle i eliminiationen af det oprindelige stof.
English: ANALGESICS/OPIOIDS
Danish: ANALGETIKA/OPIOIDER
English: The use of nevirapine has not been evaluated within a specific study on PEP, especially in term of treatment duration and therefore, is strongly discouraged.
Danish: Brugen af nevirapin er ikke blevet evalueret ved et specifikt studie på PEP, specielt med henblik på behandlingsvarighed, og frarådes derfor kraftigt.
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 interviduel variation opleve store stigninger i rifabutineksponering og kan derfor have øget risiko for rifabutintoksicitet.
English: There was also accumulation of nevirapine hydroxy-metabolites in plasma.
Danish: Der var også akkumulering af nevirapin-hydroxy-metabolitter i plasmaet.
English: In the multinational 2NN study, a population pharmacokinetic substudy of 1,077 patients was performed that included 391 females.
Danish: Det multinationale 2NN-studie indeholdt et farmakokinetisk substudie med 1.077 patienter, hvoraf de 391 var kvinder.
English: Because of the risk of increased exposure to Nevirapine Teva, caution should be exercised if the medicinal products are given concomitantly and patients should be monitored closely.
Danish: På grund af risikoen for forøget eksponering af Nevirapin Teva, bør der udvises forsigtighed, hvis produkterne gives samtidigt, og patienterne bør monitoreres nøje.
English: Nevirapine is about 60 % bound to plasma proteins in the plasma concentration range of 1-10 μg/ml.
Danish: Nevirapin er ca. 60 % bundet til plasmaproteiner i plasmakoncentrationsområdet 1-10 µg/ml.
English: Absorption: Nevirapine is readily absorbed (> 90 %) after oral administration in healthy volunteers and in adults with HIV-1 infection.
Danish: Absorption: Nevirapin absorberes hurtigt (>90 %) efter oral administration hos raske forsøgspersoner og hos voksne hiv-1-smittede.
English: White opaque PVC/PE/PVdC - Aluminium blisters or OPA/Alu/PVC - Aluminium blisters.
Danish: Hvide, uigennemsigtige PVC/PE/PVdC - aluminiumblistere eller OPA/Alu/PVC - aluminiumblistere.
English: If ASAT or ALAT ≥ 2.5 ULN before or during treatment, then liver tests should be monitored more frequently during regular clinic visits.
Danish: Hvis ASAT eller ALAT ≥ 2,5 ULN før eller under behandling, må levertests monitorers oftere ved regelmæssige kontrolbesøg.
English: The plasma nevirapine concentrations observed were within the range observed in adults and the remainder of the paediatric population, but were more variable between patients, particularly in the second month of age.
Danish: Plasmakoncentrationen af nevirapin var inden for det område, som er set hos voksne og den resterende pædiatriske population, men var mere variable blandt patienterne, især dem på to måneder.
English: Genotypic analysis showed mutations in the HIV-1 RT gene Y181C and/or V106A depending upon the virus strain and cell line employed.
Danish: Genotypisk analyse viste mutationer i hiv-1-RT-genet Y181C og/eller i genet V106A afhængigt af virusstammen og af selve cellelinjen.
English: Following intravenous administration to healthy adults, the volume of distribution (Vdss) of nevirapine was 1.21 ± 0.09 l/kg, suggesting that nevirapine is widely distributed in humans.
Danish: Efter intravenøs administration hos raske voksne er fordelingsvolumen (Vdss) af nevirapin 1,21±0,09 l/kg, hvilket indikerer, at nevirapin fordeler sig bredt hos mennesket.
English: Cartons containing 14 tablets (Calendar Pack).
Danish: Æsker, der indeholder 14 tabletter (kalenderpakning).
English: - if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section
Danish: - hvis du er allergisk over for nevirapin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Consult your doctor if you have taken more Nevirapine Teva than you should.
Danish: Konsulter lægen, hvis du har taget mere Nevirapin Teva, end du skal.
English: As Nevirapine Teva must always be taken together with other HIV antiretroviral medicines, you should follow the instructions for your other medicines carefully.
Danish: Da Nevirapin Teva altid skal tages sammen med andre hiv-antiretrovirale lægemidler, bør du nøje følge instruktionerne for de andre lægemidler.
English: Patients should be closely monitored if an isolated rash occurs.
Danish: Patienter skal monitoreres tæt hvis et isoleret tilfælde af udslæt opstår.
English: Nevirapine Teva tablets are supplied in blisters, with 14 (Calendar Pack), 60 or 120 tablets per carton.
Danish: Nevirapin Teva tabletter leveres i blisterpakninger med 14 (kalenderpakning), 60 eller 120 tabletter pr. æske.
English: Asymptomatic GGT elevations are not a contraindication to continue therapy.
Danish: Asymptomatiske GGT-elevationer er ikke en kontraindikation for fortsættelse af behandling.
English: As the regimen of nevirapine plus efavirenz did not have additional efficacy and caused more adverse events than each medicinal product separately, this regimen is not recommended.
Danish: Da regimet med nevirapin og efavirenz ikke vidste ydereligere effekt, og forårsagede flere bivirkninger end hvert lægemiddel hver for sig, kan dette regime ikke anbefales.
English: There is at present little information on the effects of Nevirapine Teva overdose.
Danish: Der er på nuværende tidspunkt kun få oplysninger om virkningerne af Nevirapin Teva ved overdosering.
English: Distribution: Nevirapine is lipophilic and is essentially nonionized at physiologic pH.
Danish: Distribution: Nevirapin er lipofilt og er essentielt ikke-ioniseret ved fysiologisk pH.
English: Nevirapine pharmacokinetics in HIV-1 infected adults does not appear to change with age (range 19-68 years) or race (Black, Hispanic, or Caucasian).
Danish: Nevirapinfarmakokinetikken hos hiv-1-smittede voksne synes ikke at ændre sig med alderen (interval 19-68 år) eller race (farvede, latinamerikanere eller hvide).
English: YOU SHOULD DISCONTINUE TAKING NEVIRAPINE TEVA AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death.
Danish: SKAL DU STRAKS STOPPE MED AT TAGE NEVIRAPIN TEVA OG STRAKS KONTAKTE din læge, da sådanne bivirkninger kan være livstruende eller medføre døden.
English: Thus cytochrome P450 metabolism, glucuronide conjugation, and urinary excretion of glucuronidated metabolites represent the primary route of nevirapine biotransformation and elimination in humans.
Danish: Cytokrom P450-metabolismen, glucuronidkonjugater og den urinære ekskretion af glucuronidmetabolitter repræsenterer således den primære rute for nevirapins biotransformation og elimination hos mennesket.
English: Currently available data on pregnant women indicate no malformative or foeto/ neonatal toxicity.
Danish: De data, der er tilgængelige for gravide kvinder, tyder ikke på misdannelser eller føtal/neonatal toksicitet.
English: Cartons containing 60 or 120 tablets.
Danish: Æsker, der indeholder 60 eller 120 tabletter.
English: Cases of nevirapine overdose at doses ranging from 800 to 6,000 mg per day for up to 15 days have been reported.
Danish: Tilfælde af nevirapin-overdosering efter indtagelse af doser mellem 800-6.000 mg/dag i op til 15 dage har været rapporteret.
English: The isolated rash should be closely monitored (see section 4.4).
Danish: Det isolerede udslæt bør monitoreres nøje (se pkt.
English: As mentioned in ‘Warnings and precautions ', above, the most important side effects of Nevirapine Teva are severe and life threatening skin reactions and serious liver damage.
Danish: Som nævnt i ”Advarsler og forsigtighedsregler” så er de mest alvorlige bivirkninger ved Nevirapin Teva alvorlige og livstruende hudreaktioner og alvorlige leverskader.
English: No specific drug-drug interaction study has been performed.
Danish: Der er ikke udført specifikke lægemiddel-interaktionsstudier.
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: In carcinogenicity studies, nevirapine induces hepatic tumours in rats and mice.
Danish: I karcinogenicitetsstudier øger nevirapin hepatiske tumorer i rotter og mus.
English: Women of childbearing potential / Contraception in males and females
Danish: Kvinder i den fødedygtige alder/Prævention til mænd og kvinder
English: Women appear to be at higher risk than men of developing rash, whether receiving nevirapine or non- nevirapine containing therapy.
Danish: Kvinder synes at have en større risiko end mænd for udvikling af udslæt, hvad enten de får behandling indeholdende nevirapin eller ej.
English: Ketoconazole Cmin ND
Danish: Ketoconazol Cmin ND
English: In a panel of 2,923 predominantly subtype B HIV-1 clinical isolates, the mean EC50 value was 90 nM.
Danish: I et panel med 2.923 altovervejende undergruppe B hiv-1 kliniske isolater var den gennemsnitlige EC50-værdi 90 nM.
English: If you stop taking Nevirapine Teva for more than 7 days your doctor will instruct you to start the 14 day 'lead-in' period (described above) once again, before returning to the twice daily dose.
Danish: Hvis du afbryder behandlingen med Nevirapin Teva i mere end 7 dage, vil din læge råde dig til at starte igen med en 14 dages "optrapningsfase" (som beskrevet ovenfor), før du igen går over til behandling 2 gange daglig.
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 lamivudinclearence.
English: In clinical studies, nevirapine has been associated with an increase in HDL- cholesterol and an overall improvement in the total to HDL-cholesterol ratio.
Danish: I kliniske studier er nevirapin blevet forbundet med en stigning i HDL-kolesterol og en overordnet forbedring af forholdet mellem total-kolesterol og HDL-kolesterol.
English: Primary study endpoints (percentage of patients with treatment failures) and secondary study endpoints as well as backbone therapy were similar to the original 2NN study.
Danish: Både det primære endepunkt (procent af patienter med behandlingssvigt) og det sekundære endepunkt såvel som grundbehandlingen var de samme, som i det oprindelige 2NN-studie.
English: Nevirapine had a median EC50 value (50% inhibitory concentration) of 63 nM against a panel of group M HIV-1 isolates from clades A, B, C, D, F, G, and H, and circulating recombinant forms (CRF), CRF01_AE, CRF02_AG and CRF12_BF replicating in human embryonic kidney 293 cells.
Danish: Nevirapin har en gennemsnitlig EC50-værdi (koncentration for 50 % hæmmet) på 63 nM mod et panel af gruppe M hiv-1-isolater fra typerne A, B, C, D, F, G og H, og de cirkulerende rekombinante former (CRF), CRF01_AE, CRF02_AG og CRF12_BF replikeret i humane embryonale nyre 293celler.
English: This is especially important within the first 14 days of treatment (see more information in “How to take Nevirapine
Danish: Det er især vigtigt i den første 14 dages periode (se flere informationer under Sådan skal du tage Nevirapin Teva.)
English: In addition, the observed trough nevirapine concentrations were comparable between the two methods.
Danish: Desuden var de observerede trough nevirapinkoncentrationer sammenlignelige med de to metoder til beregning af dosis.
English: Cimetidine: no significant effect on cimetidine PK parameters is seen.
Danish: Cimetidin: Ingen signifikant virkning på cimetidin PK-parametre er observeret.
English: Nevirapine is a non-competitive inhibitor of the HIV-1 reverse transcriptase, but it does not have a biologically significant inhibitory effect on the HIV-2 reverse transcriptase or on eukaryotic DNA polymerases α, β, γ, or δ.
Danish: Nevirapin er en nonkompetitiv inhibitor af hiv-1 revers transkriptase, men har ikke nogen signifikant biologisk hæmmende effekt på hiv-2 revers transkriptase eller på eukaryotisk DNA-polymeraser α, β, γ, eller δ.
English: This includes some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis) and liver failure, which can be both fatal.
Danish: Dette inkluderer tilfælde af leverbetændelse (hepatitis), som kan opstå pludseligt og kraftigt (fulminant leverbetændelse) eller leversvigt, som begge kan være dødelige.
English: The most common clinical toxicity of nevirapine is rash, with nevirapine attributable rash occurring in 12.5 % of patients in combination regimens in controlled studies.
Danish: Den almindeligste kliniske toksicitet ved nevirapin er udslæt, idet nevirapin var årsag til udslæt hos 12,5 % af patienterne i kombinationsregimer i kontrollerede studier.
English: Nevirapine has been evaluated in both treatment-naïve and treatment-experienced patients.
Danish: Nevirapin er blevet evalueret i både behandlingsnaive og tidligere behandlede patienter.
English: The primary study endpoint was death, progression to the acquired immunodeficiency syndrome, or an increase in HIV-1 RNA levels to 200 copies or more per millilitre.
Danish: Det primære endepunkt var død, progression af det erhvervede immundefektsyndrom eller en stigning i hiv-1 RNA-niveau til 200 kopier eller mere pr. ml.
English: A dose increase for itraconazole should be considered when these two agents are administered concomitantly.
Danish: Dosisøgning af itraconazol bør overvejes, når disse to stoffer anvendes sammen.
English: Patients with hepatic impairment should be monitored carefully for evidence of medicinal product induced toxicity.
Danish: Patienter med hepatisk dysfunktion bør monitoreres nøje med henblik på lægemiddelinduceret toksicitet.
English: The simultaneous use of nevirapine (400 mg) plus efavirenz (800 mg) was associated with the highest frequency of clinical adverse events and with the highest rate of treatment failure (53.1%).
Danish: Samtidig brug af nevirapin (400 mg) og efavirenz (800 mg) var forbundet med den højeste forekomst af kliniske bivirkninger og med den højeste forekomst af behandlingssvigt (53,1 %).
English: Biotransformation and elimination: In vivo studies in humans and in vitro studies with human liver microsomes have shown that nevirapine is extensively biotransformed via cytochrome P450 (oxidative) metabolism to several hydroxylated metabolites.
Danish: Biotransformation og elimination: Humane in vivo-studier og in vitro-studier med humane levermikrosomer har vist, at nevirapin i høj grad biotransformeres via cytokrom P450 (oxidativ) metabolisme til adskillige hydroxylerede metabolitter.
English: Special populations:
Danish: Særlige befolkningsgrupper:
English: Concomitant prednisone use (40 mg/day for the first 14 days of nevirapine administration) has been shown not to decrease the incidence of nevirapine-associated rash, and may be associated with an increase in incidence and severity of rash during the first 6 weeks of nevirapine therapy.
Danish: Samtidig prednisonbrug (40 mg/dag i de første 14 dage af nevirapin-administrationen) har vist sig ikke at nedsætte tilfældene af nevirapin-associeret udslæt, og kan være associeret med en stigning i tilfælde og alvorlighed af udslæt under de første 6 uger af nevirapinbehandlingen.
English: Nevirapine is an inducer of CYP3A and potentially CYP2B6, with maximal induction occurring within 2-4 weeks of initiating multiple-dose therapy.
Danish: Nevirapin inducerer CYP3A og potentielt CYP2B6 med maksimal induktion indenfor 2-4 uger efter flerdosisbehandling er startet.
English: It is important that you continue taking Nevirapine Teva correctly, as described above, unless your doctor instructs you to stop.
Danish: Det er derfor vigtigt, at du fortsætter med at tage Nevirapin Teva-tabletter korrekt som anført ovenfor, medmindre din læge anbefaler dig at stoppe.
English: However, approximately 15 % of these patients with hepatic fibrosis had nevirapine trough concentrations above 9,000 ng/ml (2 fold the usual mean trough).
Danish: Dog havde ca. 15 % af patienterne med hepatisk fibrose en nevirapintroughkoncentration på over 9.000 ng/ml (dobbelt så meget som den almindelige troughgennemsnitsværdi).
English: After 14 days, the recommended dose is one 200 mg tablet twice a day.
Danish: Efter 14 dage er den anbefalede dosis 1 tablet på 200 mg 2 gange dagligt.
English: At 12 months, the Kaplan-Meier estimates of the likelihood of reaching the endpoint were 10 % in the nevirapine group, 6 % in the efavirenz group, and 13 percent in the abacavir group (P=0.10 according to an intention-to-treat analysis).
Danish: Baseret på Kaplan-Meier-estimater var sandsynligheden for efter 12 måneder at opnå endepunktet 10 % i nevirapin-gruppen, 6 % i efavirenzgruppen og 13 % i abacavirgruppen (P=0,10 i henhold til intention-to-treat-analyse).
English: Asymptomatic elevations of liver enzymes are frequently described and are not necessarily a contraindication to use nevirapine.
Danish: Asymptomatiske elevationer af leverenzymer beskrives ofte og er ikke nødvendigvis en kontraindikation ved brugen af nevirapin.
English: This is a retrospective multicentre study comparing the 3-year antiviral efficacy of nevirapine and efavirenz in combination with stavudine and lamivudine in 2NN patients from week 49 to week 144.
Danish: Dette studie er et retrospektivt, multicenter studie, som sammenligner virkningen af 3-års antiviral behandling med nevirapin og efavirenz i kombination med stavudin og lamivudin hos 2NN patienter i perioden fra uge 49 til uge 144.
English: Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code J05AG01.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, non-nukleosid revers transkriptasehæmmere, ATC-kode: J05AG01
English: Depending on resistance testing results, an etravirine-containing regimen may be used subsequently.
Danish: Afhængig af resultater fra resistenstestning kan et regime med etravirin formentligt anvendes.
English: (n = 6) were 45 % (± 5 %) of the concentrations in plasma; this ratio is approximately equal to the fraction not bound to plasma protein.
Danish: Nevirapinkoncentrationen i human cerebrospinalvæske (n=6) er 45 % (±5 %) af koncentrationen i plasma; denne ratio er tilnærmelsesvis lig med fraktionen, som ikke er bundet til plasmaprotein.
English: Non-clinical data reveal no special hazard for humans other than those observed in clinical studies based on conventional studies of safety, pharmacology, repeated dose toxicity, and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: 1.28 compared to historical controls.
Danish: sammenlignet med historiske kontroller.
English: The dose must be strictly adhered to, especially the 14-days lead-in period (see section 4.2).
Danish: Overholdelse af doseringen er obligat, specielt i den 14 dages optrapningsperiode (se pkt.
English: 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.
Danish: Patienter med før-eksisterende leverfunktionssvigt inklusive kronisk aktiv hepatitis har en højere risiko for leverfunktionsabnormaliteter under antiretroviral kombinationsbehandling og bør monitoreres ifølge standardpraksis.
English: The NEFA study is a controlled prospective randomised study which evaluated treatment options for patients who switch from protease inhibitor (PI) based regimen with undetectable load to either nevirapine, efavirenz or abacavir.
Danish: NEFA-studiet er et kontrolleret, prospektivt, randomiseret studie, der evaluerede behandlingsmuligheder for patienter, som skiftede fra proteasehæmmer (PI)-baseret behandlingsregime med et ikke-detekterbar load til enten nevirapin, efavirenz eller abacavir.
English: Renal impairment (mild, moderate and severe) resulted in no significant change in the pharmacokinetics of nevirapine.
Danish: Nedsat nyrefunktion (mild, moderat og svær) resulterede ikke i en signifikant ændring i nevirapins farmakokinetik.
English: The safety and efficacy of nevirapine has not been established in patients with significant underlying liver disorders.
Danish: Sikkerheden og virkningen er ikke blevet undersøgt hos patienter med betydende underliggende leversygdomme.
English: As explained in ”Warnings and precautions”, above, your doctor will monitor you with liver tests or for undesirable effects such as rash.
Danish: Som forklaret under ”Advarsler og forsigtighedsregler” så vil din læge følge dig ved at få undersøgt leverfunktionen eller undersøge dig for bivirkninger såsom hududslæt.
English: Otherwise patients with CLcr ≥ 20 ml/min do not require an adjustment in nevirapine dosing.
Danish: Ellers kræver patienter med CLcr ≥ 20 ml/min ikke en justering i nevirapin -doseringen.
English: The limited data available from a phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV
Danish: De begrænsede data fra et fase IIastudie hos hiv-patienter har vist en 20 % reduktion af TPV Cmin, der ikke var klinisk signifikant.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (CALENDAR PACK)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER (KALENDERPAKNING)
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: Excipient with known effect: Each tablet contains 168 mg of lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: En tablet indeholder 168 mg lactose (som monohydrat).
English: Depending on the outcome your doctor may decide to interrupt or stop your Nevirapine Teva treatment.
Danish: Afhængig af resultaterne beslutter lægen, om du skal fortsætte eller afbryde behandlingen med Nevirapin Teva.
English: 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.
Danish: Patienterne skal instrueres i at dosisøgning ikke må foretages, hvis nogen form for udslæt opstår i løbet af den to-ugers optrapningsperiode, før udslættet er forsvundet.