FrancophonIA/ELRC3.0 huggingface dataset:
English: If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, the benefit of continued therapy with efavirenz needs to be weighed against the potential risks of significant liver toxicity.
Danish: Hvis der er tegn på forværring af leversygdom eller persisterende forhøjelser af serumtransaminaser til mere end 5 gange den øvre grænse for normalområdet, skal fordelen ved fortsat behandling med efavirenz vurderes i forhold til de ukendte risici ved signifikant levertoksicitet.
English: Body Weight
Danish: Kropsvægt
English: Recommendation concerning co-administration with efavirenz
Danish: Anbefaling vedrørende samtidig administration med efavirenz
English: An empty stomach is commonly defined as 1 hour before or 2 hours after a meal.
Danish: På tom mave betyder almindeligvis 1 time før eller 2 timer efter et måltid.
English: The potential for cross-resistance between efavirenz and NRTIs is low because of the different binding sites on the target and mechanism of action.
Danish: Potentialet for krydsresistens mellem efavirenz og NRTI´ere er lille på grund af de forskellige bindingssteder på målet og virkningsmekanismen.
English: Greater than 100-fold loss of susceptibility was observed against HIV variants expressing K103N in addition to other amino acid substitutions in RT.
Danish: Mere end 100 gange mindre følsomhed sås over for hiv-varianter, der eksprimerer K103N foruden andre aminosyresubstitutioner i RT.
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Danish: For at undgå overførsel af hiv anbefales det, at hiv-smittede kvinder ikke ammer deres børn under nogen omstændigheder.
English: In one study, nervous system symptoms often occurred during the first 1-3 hours after taking a dose.
Danish: I én undersøgelse opstod symptomerne fra nervesystemet ofte i løbet af de første 1-3 timer efter indtagelse af en dosis.
English: Women should not get pregnant during treatment with SUSTIVA and for 12 weeks thereafter.
Danish: Kvinder bør ikke blive gravide under behandling med SUSTIVA og i 12 uger efter ophørt behandling.
English: Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ or δ).
Danish: Efavirenz er en nonkompetetiv hæmmer af hiv-1 reverse transkriptase (RT) og hæmmer ikke signifikant hiv-2 RT eller cellulære DNA-polymeraser (α, β, γ eller δ).
English: As a result, the amounts of SUSTIVA or other medicines in your blood may be affected.
Danish: Derfor kan mængden af SUSTIVA eller anden medicin i blodet blive påvirket.
English: Neither aluminium/magnesium hydroxide antacids nor famotidine altered the absorption of efavirenz.
Danish: Hverken aluminium/magnesiumhydroxidantacida eller famotidin ændrede absorptionen af efavirenz.
English: SUSTIVA must be taken with other medicines that act against the HIV virus.
Danish: SUSTIVA skal tages sammen med andre lægemidler, der virker mod hiv-virus.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Ud over de opportunistiske infektioner kan autoimmune lidelser (skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter De er begyndt at tage medicin til behandling af Deres hiv-infektion.
English: itraconazole.
Danish: itraconazol.
English: The potency of efavirenz in cell culture against viral variants with amino acid substitutions at positions 48, 108, 179, 181 or 236 in RT or variants with amino acid substitutions in the protease was similar to that observed against wild type viral strains.
Danish: Ved cellekultur var potensen af efavirenz over for virusvarianter med aminosyresubstitutioner på positionerne 48, 108, 179, 181 eller 236 i RT eller varianter med aminosyresubstitutioner i proteasen lig den, der sås over for vildtype-virusstammer.
English: This mutation was observed in 90% of patients receiving efavirenz with virological failure.
Danish: Denne mutation blev observeret hos 90% af de patienter, som fik efavirenz, og som havde virologisk svigt.
English: SUSTIVA taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood.
Danish: SUSTIVA taget sammen med anden antiretroviral behandling reducerer mængden af virus i blodet.
English: You must remain under the care of your doctor while taking SUSTIVA.
Danish: De skal fortsat tilses af Deres læge, mens De tager SUSTIVA.
English: Hepatobiliary disorders common aspartate aminotransferase (AST) increased*, alanine aminotransferase (ALT) increased*, gamma-glutamyltransferase (GGT) increased*
Danish: Forhøjet aspartataminotransferase (ASAT)*, forhøjet alaninaminotransferase (ALAT)*, forhøjet gamma-glutamyltransferase (GGT)*
English: NFV + NRTIs
Danish: NFV + NRTI´ere
English: If you see any signs of a severe rash with blistering or fever, stop taking SUSTIVA and tell your doctor at once.
Danish: Hvis De har tegn på alvorligt hududslæt med blæredannelse eller feber, skal De stoppe med at tage SUSTIVA og straks fortælle det til lægen.
English: The pattern of amino acid substitutions in RT associated with resistance to efavirenz was independent of the other antiviral medicines used in combination with efavirenz.
Danish: Mønstret for aminosyresubstitutioner i RT, der er forbundet med resistens over for efavirenz var uafhængigt af de andre antivirale medicintyper, der anvendtes i kombination med efavirenz.
English: †These adverse reactions were identified through post-marketing surveillance; however, the frequencies were determined using data from 16 clinical trials (n=3,969).
Danish: †Disse bivirkninger blev identificeret efter markedsføring; hyppigheden er dog bestemt på baggrund af data fra 16 kliniske undersøgelser (n=3.969).
English: When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
Danish: Når efavirenz blev givet sammen med ritonavir 500 mg eller 600 mg to gange dagligt, var kombinationen ikke veltolereret (bl.a. forekom svimmelhed, kvalme, paræstesier og forhøjede leverenzymer).
English: Patients with a prior history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions.
Danish: Patienter med psykiatriske lidelser i anamnesen synes at have større risiko for disse alvorlige psykiatriske bivirkninger.
English: Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
Danish: Moderate eller mere alvorlige bivirkninger, hvor der mindst er en mulig forbindelse til behandlingsregimet (baseret på investigator tilskrivning), som er rapporteret i kliniske undersøgelser for efavirenz i anbefalede doser i kombinationsbehandling (n = 1.008) er anført nedenfor.
English: Coadministration of higher doses of either efavirenz or carbamazepine has not been studied.
Danish: Samtidig administration af højere doser af enten efavirenz eller carbamazepin er ikke undersøgt.
English: A causal relationship of these events to the use of efavirenz has not been established, and the denominator is unknown.
Danish: Der er ikke konstateret årsagssammenhæng mellem disse hændelser og brugen af efavirenz, og fællesnævneren er ukendt.
English: No effect (↔) equals a decrease in mean ratio estimate of ≤20% or increase in mean ratio estimate of
Danish: Ingen indvirkning (↔) svarer til et fald i estimeret gennemsnitsratio på ≤20% eller stigning i estimeret gennemsnitsratio på ≤25%
English: d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
Danish: EFV, efavirenz; ZDV, zidovudin, 3TC, lamivudin; IDV, indinavir.
English: Dose adjustment of warfarin or acenocoumarol may be required.
Danish: Dosisjustering af warfarin eller acenocoumarol kan være nødvendig.
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the cytochrome P450 system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Danish: Humane undersøgelser og in vitro-undersøgelser med anvendelse af humane levermikrosomer har vist, at efavirenz hovedsageligt metaboliseres til hydroxylerede metabolitter af cytokrom P450-systemet med efterfølgende glucuronidering af disse hydroxylerede metabolitter.
English: If you take these two medicines together, the dose of voriconazole must be increased and the dose of efavirenz must be reduced.
Danish: Hvis De tager disse to lægemidler sammen, skal dosis af voriconazol øges og dosis af efivarenz nedsættes.
English: Five of these NNRTI-resistant isolates were found to have K103N or a valine-toisoleucine substitution at position 108 (V108I) in RT. Three of the efavirenz treatment failure isolates tested remained sensitive to efavirenz in cell culture and were also sensitive to nevirapine and delavirdine.
Danish: Man fandt, at 5 af disse NNRTI-resistente isolater havde K103N- eller en valin-til-isoleucin-substitution på position 108 (V108I) i RT. 3 af de testede efavirenz-behandlingssvigtisolater forblev følsomme over for efavirenz ved cellekultur og var også følsomme over for nevirapin og delavirdin.
English: Use of appropriate antihistamines and/or corticosteroids is recommended when efavirenz is restarted.
Danish: Anvendelse af passende antihistaminer og/eller kortikosteroider anbefales, hvis efavirenzbehandling genoptages.
English: It is an antiretroviral medicine that fights human immunodeficiency virus (HIV-1) infection by reducing the amount of the virus in blood.
Danish: Det er en antiretroviral medicin, som bekæmper humant immundefektvirus (HIV-1)-infektion ved at reducere mængden af virus i blodet.
English: Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
Danish: Patienter, som får krampestillende lægemidler, der hovedsageligt metaboliseres i leveren, som fx phenytoin, carbamazepin og phenobarbital, kan have brug for periodisk monitorering af plasmaniveauer.
English: EXPIRY DATE EXP
Danish: UDLØBSDATO EXP
English: These immunosuppressants are not anticipated to affect exposure of efavirenz.
Danish: Disse immunsuppressiva forventes ikke at påvirke efavirenz' eksponering.
English: 12 Add another small amount (approximately 2 teaspoons) of the food to the empty mixing container (illustration a).
Danish: 12 Tilsæt yderligere en lille mængde (ca. 2 teskefulde) mad til den tomme blandeskål (illustration a).
English: The free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudineresistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/monocyte cultures.
Danish: Den frie koncentration af efavirenz, der er nødvendig for 90 - 95% hæmning af vildtype- eller zidovudinresistente laboratorieisolater og kliniske isolater in vitro var fra 0,46 til 6,8 nM i lymfoblastoide cellelinier, perifere mononukleare blodlegemer (PBMCer) og makrofag/monocytkulturer.
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Danish: Med hensyn til monitorering af lipider og glucose i blodet refereres til eksisterende behandlingsguidelines for hiv.
English: Dose related increases in Cmax and AUC were seen for doses up to 1,600 mg; the increases were less than proportional suggesting diminished absorption at higher doses.
Danish: Der blev set dosisrelaterede stigninger i Cmax og AUC for doser på op til 1.600 mg. Stigningerne var mindre end proportionale, hvilket tyder på formindsket absorption ved højere doser.
English: Sertraline dose increases should be guided by clinical response.
Danish: Øgning af sertralindosis bør baseres på klinisk respons.
English: The dose for children weighing 40 kg or more is 600 mg once daily.
Danish: Dosis til børn, der vejer 40 kg eller mere er 600 mg 1 gang dagligt.
English: The clinical significance of these changes in clarithromycin plasma levels is not known.
Danish: Den kliniske betydning af disse ændringer i clarithromycins plasmakoncentration er ikke kendt.
English: Psychiatric symptoms
Danish: Psykiatriske symptomer
English: Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risks of continued therapy outweigh the benefits (see section 4.8).
Danish: Patienterne bør rådes til straks at kontakte deres læge, hvis de oplever symptomer såsom svær depression, psykose eller selvmordstanker, med henblik på vurdering af, om symptomerne er relaterede til brugen af efavirenz, og hvis dette er tilfældet, for at beslutte hvorvidt risici ved fortsat behandling overstiger fordelene (se pkt.
English: Patients with severe hepatic impairment (Child Pugh Class C) (see section 5.2).
Danish: Patienter med svær leverinsufficiens (Child Pugh klasse C) (se pkt.
English: Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme; psychiatric adverse reactions including severe depression, death by suicide, and psychosis like behaviour; and seizures have been reported in patients treated with efavirenz.
Danish: Svære hudreaktioner som Stevens Johnsons syndrom og erythema multiforme; psykiske bivirkninger inklusive svær depression, selvmord og psykoselignende adfærd samt krampeanfald er rapporteret hos patienter, der er blevet behandlet med efavirenz.
English: No additional food should be consumed for up to 2 hours after administration of efavirenz.
Danish: Der bør ikke indtages yderligere føde i op til 2 timer efter indgivelse af efavirenz.
English: Concomitant administration of sofosbuvir/velpatasvir with efavirenz resulted in a reduction (approximately 50%) in the systemic exposure of velpatasvir.
Danish: Samtidig administration af sofosbuvir/velpatasvir med efavirenz medførte et fald (ca. 50%) ved systemisk eksponering af velpatasvir.
English: atovaquone/proguanil: SUSTIVA may reduce the amount of atovaquone/proguanil in your blood.
Danish: atovaquon/proguanil: SUSTIVA kan nedsætte mængden af atovaquon/proguanil i blodet.
English: Approximately 14 - 34% of a radiolabelled dose of efavirenz was recovered in the urine and less than 1% of the dose was excreted in urine as unchanged efavirenz.
Danish: Ca. 14 - 34% af en isotopmærket dosis af efavirenz blev genfundet i urinen, og mindre end 1% af dosis blev udskilt i urinen som uomdannet efavirenz.
English: What you need to know before you take SUSTIVA 3.
Danish: Det skal De vide, før De begynder at tage SUSTIVA 3.
English: ‡These adverse reactions were identified through post-marketing surveillance but not reported as drugrelated events for efavirenz-treated patients in 16 clinical trials.
Danish: Disse bivirkninger blev identificeret efter markedsføring, men blev ikke indberettet som lægemiddelrelaterede hændelser hos efavirenzbehandlede patienter i 16 kliniske undersøgelser.
English: The clinical effect of this dose adjustment has not been adequately evaluated.
Danish: Den kliniske effekt af denne dosisjustering er ikke blevet tilstrækkeligt evalueret.
English: Studies were conducted in healthy subjects unless otherwise noted.
Danish: Undersøgelserne er udført hos raske forsøgspersoner, hvis ikke andet er angivet.
English: if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Danish: - hvis De tidligere har haft en mental sygdom, herunder depression, eller stofmisbrug eller alkoholmisbrug.
English: Efavirenz has been shown to be excreted in human milk.
Danish: Efavirenz udskilles i human mælk.
English: It is important to tell your doctor or pharmacist if you are taking any of the following:
Danish: Det er vigtigt, at De fortæller det til lægen eller til apotekspersonalet, hvis De tager følgende:
English: - severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
Danish: - alvorlig forstyrrelse af elektrolytbalancen, fx hypokaliæmi eller hypomagnesiæmi.
English: Taking these medicines with SUSTIVA could create the potential for serious and/or life-threatening side-effects or stop SUSTIVA from working properly.
Danish: Hvis De tager disse lægemidler sammen med SUSTIVA, kan der opstå alvorlige og/eller livstruende bivirkninger eller SUSTIVA kan holde op med at virke på den rigtige måde.
English: if you have a heart condition, such as changes in the rhythm or rate of the heart beat, a slow heart beat, or severe heart disease.
Danish: hvis De har en hjertelidelse, såsom ændringer i hjerterytmen eller hastigheden af hjertets slag, langsomt hjerteslag eller alvorlig hjertesygdom.
English: No dose recommendation can be made.
Danish: Dosisrekommandation kan ikke gives.
English: Opening the capsule and taking the contents with a small amount of food may be considered for children who cannot swallow the hard capsule.
Danish: Åbning af kapsler og indtagelse af indholdet sammen med en lille mængde fast føde, kan overvejes for børn, der ikke kan sluge hårde kapsler.
English: If you had a rash while taking another NNRTI, you may be at a higher risk of getting a rash with SUSTIVA.
Danish: Hvis De får udslæt, mens De tager en anden NNRTI, kan De have større risiko for at få udslæt med SUSTIVA.
English: The clinical significance of asymptomatic increases in serum amylase is unknown.
Danish: Den kliniske betydning af den asymptomatiske stigning af serumamylase kendes ikke.
English: Anencephaly and unilateral anophthalmia with secondary enlargement of the tongue were observed in one foetus, microophthalmia was observed in another foetus, and cleft palate was observed in a third foetus.
Danish: Anencefali og unilateral anophthalmia med sekundær forstørrelse af tungen sås hos ét foster, microphthalmia hos et andet foster og ganespalte hos et tredje foster.
English: There have been occasional postmarketing reports of contraceptive failure with etonogestrel in efavirenzexposed patients.
Danish: Der har efter markedsføring været enkelte rapporter om kontraceptivt svigt af etonogestrel hos efavirenzeksponerede patienter.
English: A multipledose study showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh Class A) compared with controls.
Danish: En undersøgelse med multiple doser viste ingen signifikant effekt på efivarenz' farmakokinetik hos patienter med mild leverinsufficiens (Child Pugh klasse A) sammenlignet med kontrolgrupperne.
English: In a 3-month drug interaction study, no significant differences in MPA pharmacokinetic parameters were found between subjects receiving efavirenz-containing antiretroviral therapy and subjects receiving no antiretroviral therapy.
Danish: I en 3-måneders interaktionsundersøgelse af lægemidlerne sås ingen signifikante forskelle i MPA's farmakokinetiske parametre mellem de forsøgspersoner, der fik antiretroviral behandling indeholdende efavirenz og de forsøgspersoner, der ikke fik antiretroviral behandling.
English: Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz or a combination medicine containing efavirenz, emtricitabine and tenofovir during pregnancy.
Danish: Der er set alvorlige misdannelser hos ufødte dyr og hos spædbørn, hvis mødre i løbet af graviditeten er blevet behandlet med efavirenz eller et kombinationslægemiddel, der indeholder efavirenz, emtricitabin og tenofovir.
English: 3, or after failure of protease inhibitor (PI) containing regimens.
Danish: 3, eller efter svigtende effekt af proteasehæmmerregimer (PI).
English: *lower than recommended doses; similar findings are expected with recommended doses.
Danish: *lavere end anbefalede doser.
English: It is recommended to hold the capsule with the cap facing up and to pull the cap away from the body of the capsule, and to mix the capsule contents with food in a small container.
Danish: Det anbefales, at man holder kapslen med toppen vendt opad, mens man trækker kapslens top af og blander kapslens indhold med føden i en lille beholder.
English: Efavirenz plasma exposure may be increased in patients with the homozygous G516T genetic variant of the CYP2B6 isoenzyme.
Danish: Efavirenz plasmaeksponering kan øges hos patienter med homozygot-G516T, der er en genetisk variant af CYP2B6-isoenzymet.
English: Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine, and tenofovir disoproxil.
Danish: Der er ikke udført specifikke interaktionsundersøgelser med efavirenz og NRTIer ud over lamivudin, zidovudin og tenofovirdisoproxil.
English: Study ACTG 364 enrolled 196 patients who had been treated with NRTIs but not with PIs or NNRTIs.
Danish: Undersøgelse ACTG 364 omfattede 196 patienter, som havde fået NRTI behandling men ikke PI eller NNRTI behandling.
English: Bioavailability of hard capsule contents mixed with food vehicles
Danish: Biotilgængeligheden af indholdet i hårde kapsler i blandinger med føde som bindemidler
English: In these studies the dose of efavirenz was 600 mg once daily; the dose of indinavir was 1,000 mg every 8 hours when used with efavirenz and 800 mg every 8 hours when used without efavirenz.
Danish: I disse undersøgelser var efavirenzdosis 600 mg en gang dagligt; indinavirdosis på 1.000 mg hver 8. time blev anvendt i kombination med efavirenz og 800 mg hver 8. time blev anvendt uden efavirenz.
English: Two of three delavirdineresistant clinical isolates examined were cross-resistant to efavirenz and contained the K103N substitution.
Danish: To ud af tre undersøgte delavirdinresistente, kliniske isolater var krydsresistente over for efavirenz og indeholdt K103Nsubstitutionen.
English: Medicines used to treat fungal infections (antifungals): voriconazole.
Danish: Medicin til behandling af svampeinfektioner (antimykotikum): voriconazol.
English: Pregnancies have occurred in women taking SUSTIVA while using a contraceptive implant, although it has not been established that the SUSTIVA therapy caused the contraceptive to fail.
Danish: Graviditet kan forekomme hos kvinder, der tager SUSTIVA, mens de bruger et kontraceptivt implantat, selvom det ikke er fastslået, at behandling med SUSTIVA har bevirket, at det kontrceptive middel ikke virkede.
English: Patients with a history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions with frequencies ranging from 0.3% for manic reactions to 2.0% for both severe depression and suicidal ideation.
Danish: Patienter med psykiske lidelser i anamnesen synes at have en større risiko for disse alvorlige, psykiske bivirkninger med en hyppighed for hver af de ovennævnte hændelser, der varierer fra 0,3% for maniske reaktioner til 2,0% for både svær depression og suicidale tanker.
English: Outer carton PC:
Danish: Ydre pakning: PC:
English: The effect of efavirenz on the QTc interval was evaluated in an open-label, positive and placebo controlled, fixed single sequence 3-period, 3-treatment crossover QT study in 58 healthy subjects enriched for CYP2B6 polymorphisms.
Danish: Virkningen af efavirenz på QTc-intervallet blev vurderet i et åbent, positivt og placebo-kontrolleret QT-overkrydsningsstudie med faste enkeltsekvenser, 3 perioder, 3 behandlinger, hos 58 raske forsøgspersoner beriget for CYP2B6 polymorfismer.
English: Responder rates (NC = Fa) Plasma HIV-RNA
Danish: Respons hyppigheder (NC = Fa) Plasma hiv-RNA
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 niveauer af lipider og glukose i blodet.