FrancophonIA/ELRC3.0 huggingface dataset:
English: These immunosuppressants are not anticipated to impact exposure of efavirenz.
Danish: Disse immunsuppressiva forventes ikke at påvirke efavirenzeksponeringen.
English: In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Danish: Hos sådanne patienter bør det overvejes at afbryde eller seponere behandlingen (se pkt.
English: Common cerebellar coordination and balance disturbances3, somnolence (2.0%)3, headache (5.7%)3, disturbance in attention (3.6%)3, dizziness dizziness headache
Danish: Cerebellære koordinations- og balanceforstyrrelser3, døsighed (2,0%)3, hovedpine (5,7%)3, opmærksomhedsforstyrrelser (3,6%)3, svimmelhed (8,5%)3
English: Nervous system symptoms: Nervous system symptoms are common with efavirenz, one of the components of Atripla.
Danish: Symptomer fra nervesystemet: Symptomer fra nervesystemet er almindelige med efavirenz, et af de aktive stoffer i Atripla.
English: Genotoxicity studies revealed positive results in the in vitro mouse lymphoma assay, equivocal results in one of the strains used in the Ames test, and weakly positive results in an UDS test in primary rat hepatocytes.
Danish: Genotoksicitetsstudier viste positive resultater i in vitro-muselymfomanalysen, uklare resultater for en af de stammer, der blev anvendt i Ames-testen, og svagt positive resultater i UDS-testen i primære rottehepatocytter.
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 risk of continued therapy outweighs the benefits (see section 4.8).
Danish: Patienterne bør rådes til straks at kontakte deres læge, hvis de oplever symptomer som svær depression, psykose eller selvmordstanker, med henblik på vurdering af, om symptomerne er relateret til brugen af efavirenz, og hvis dette er tilfældet, for at beslutte hvorvidt risici ved fortsat behandling overstiger fordelene (se pkt.
English: - Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: Clarithromycin, rifabutin, rifampicin.
Danish: - Medicin til behandling af bakterieinfektioner, herunder tuberkulose og AIDS-relaterede mykobakterier: Clarithromycin, rifabutin, rifampicin.
English: Patients who completed 144 weeks of treatment with either treatment arm in study GS-01-934 were given the option to continue in an open-label extended phase of the study with Atripla on an empty stomach.
Danish: Patienter, som fuldførte 144 ugers behandling med enten den ene eller den anden af behandlingsarmene i GS-01-934, fik mulighed for at fortsætte i en åben forlængelsesfase af studiet med Atripla på tom mave.
English: - if you have a heart condition, such as an abnormal electrical signal called prolongation of the QT interval that puts you at high risk for severe heart rhythm problems (Torsade de Pointes).
Danish: - hvis De har en hjertelidelse, såsom et unormalt elektrisk signal kaldet forlænget QTinterval, som giver høj risiko for alvorlige problemer med hjerterytmen (Torsade de Pointes).
English: In some cases, your doctor may need to adjust your dose or check your blood levels.
Danish: I nogle tilfælde kan det være nødvendigt for lægen at justere Deres dosis eller kontrollere indholdet i blodet.
English: If Atripla is co-administered with an NSAID, renal function should be monitored adequately.
Danish: Hvis Atripla administreres sammen med et NSAID, skal nyrefunktionen monitoreres på tilstrækkelig vis.
English: Efavirenz was not mutagenic or clastogenic in conventional genotoxicity assays.
Danish: Efavirenz var hverken mutagent eller klastogent i konventionelle genotoksicitetsanalyser.
English: No data are available to support the combination of Atripla and other antiretroviral agents.
Danish: Der er ingen tilgængelige data til at understøtte kombinationen af Atripla og andre antiretrovirale lægemidler.
English: However, tenofovir disoproxil reduced the viability index and weight of pups in peri-postnatal toxicity studies at maternally toxic doses.
Danish: Tenofovirdisoproxil reducerede imidlertid afkommets levedygtighed og vægt i peri-postnatale toksicitetsstudier ved doser, der var toksiske for moderen.
English: Resistance to efavirenz can be selected in vitro and resulted in single or multiple amino acid substitutions in HIV-1 RT, including L100I, V108I, V179D, and Y181C.
Danish: Resistens over for efavirenz kan selekteres in vitro og resulterede i enkle eller multiple aminosyresubstitutioner i hiv-1 RT, herunder L100I, V108I, V179D og Y181C.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, der får antiretroviral kombinationsbehandling, kan udvikle en knoglesygdom, der kaldes knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: If you throw up the tablet (within 1 hour after taking Atripla), you should take another tablet.
Danish: Hvis De kaster op (inden for en time efter De har taget Atripla), bør De tage en ny tablet.
English: Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Danish: Bemærker De nogle nye eller usædvanlige symptomer efter behandlingens ophør, skal De omgående oplyse Deres læge herom, især hvis det drejer sig om symptomer, som De forbinder med hepatitis B-infektion.
English: - anorexia
Danish: - Anoreksi
English: If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking Atripla.
Danish: Hvis De tager et eller flere af disse lægemidler, kan det være nødvendigt for lægen at kontrollere indholdet af krampestillende medicin i blodet for at sikre, at det ikke bliver påvirket, når De tager Atripla.
English: Efavirenz may be an inducer of CYP2C19 and CYP2C9; however, inhibition has also been observed in vitro and the net effect of co-administration with substrates of these enzymes is not clear (see section 5.2).
Danish: Efavirenz kan være en CYP2C19- og CYP2C9-induktor, men hæmning er imidlertid også blevet observeret in vitro, og nettovirkningen ved administration sammen med substrater for disse enzymer er ikke klar (se pkt.
English: Atripla is a treatment for Human Immunodeficiency Virus (HIV) infection in adults aged 18 years and over who have previously been treated with other antiretroviral medicines and have their HIV-1 infection under control for at least three months.
Danish: Atripla er til behandling af Human Immundefekt Virus (hiv)-infektion hos voksne i alderen 18 år og derover, som tidligere er blevet behandlet med anden antiretroviral medicin, og hvis hiv-1-infektion har været under kontrol i mindst tre måneder.
English: Atripla is not usually taken with other medicines that can damage your kidneys (see Other medicines and Atripla).
Danish: Atripla tages normalt ikke sammen med anden medicin, som kan skade Deres nyrer (se Brug af anden medicin sammen med Atripla).
English: Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Danish: Brug af Atripla bør undgås med samtidig eller nylig brug af et nefrotoksisk lægemiddel.
English: Pregnancies have occurred in women taking efavirenz, a component of Atripla, while using a contraceptive implant, although it has not been established that the efavirenz therapy caused the contraceptive to fail.
Danish: Der er forekommet graviditeter hos kvinder, der tog efavirenz, en Atripla-komponent, mens de anvendte et præventivt implantat, selvom det ikke er blevet fastslået, at behandlingen med efavirenz forårsagede, at præventionen svigtede.
English: IMMUNOSUPPRESSANTS Immunosuppressants metabolised by CYP3A4 (e.g. cyclosporine, tacrolimus, sirolimus)/Efavirenz
Danish: IMMUNSUPPRESIVA Immunsuppressiva, som metaboliseres via CYP3A4 (f.eks. ciclosporin, tacrolimus, sirolimus)/efavirenz
English: Efavirenz non-competitively inhibits HIV-1 reverse transcriptase (RT) and does not significantly inhibit human immunodeficiency virus-2 (HIV-2) RT or cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, and δ).
Danish: Efavirenz er en nonkompetitiv hæmmer af hiv-1 revers transkriptase (RT) og hæmmer ikke signifikant human immundeficient virus-2 (hiv-2) RT eller cellulære deoxyribonukleinsyre (dna) polymeraser (α, β, γ eller δ).
English: Following intravenous administration the volume of distribution of emtricitabine was approximately 1.4 l/kg.
Danish: Efter intravenøs administration var emtricitabins fordelingsvolumen ca. 1,4 l/kg.
English: • swelling of the face, lips, tongue or throat
Danish: • Hævelse af ansigt, læber, tunge eller svælg
English: If Atripla is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used.
Danish: Hvis Atripla skal anvendes sammen med darunavir/ritonavir, bør regimet med darunavir/ritonavir 600/100 mg to gange dagligt anvendes.
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Danish: For lipider er der i visse tilfælde fundet evidens for en behandlingsvirkning, mens der ikke er tydelig evidens for relation mellem vægtøgning og en specifik behandling.
English: - Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in every 1,000 patients) but serious side effect that can be fatal.
Danish: - Laktatacidose (overskud af mælkesyre i blodet) er en sjælden (kan påvirke op til 1 ud af hver 1.000 patienter), men alvorlig bivirkning, som kan være livstruende.
English: All 3 subjects had received a fixed dose combination of lamivudine and zidovudine (Combivir) and efavirenz for 144 weeks and then switched to Atripla.
Danish: Alle 3 patienter havde fået en fastdosis-kombination af lamivudin og zidovudin (Combivir) og efavirenz i 144 uger og skiftede derefter til Atripla.
English: Since Atripla is a combination product and the dosing interval of the individual components cannot be altered, treatment with Atripla must be interrupted in patients with confirmed creatinine clearance < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Danish: Da Atripla er et kombinationsprodukt og dosisintervallet for de enkelte komponenter ikke kan justeres, bør behandling med Atripla seponeres hos patienter med bekræftet kreatininclearance < 50 ml/min eller fald i serumphosphat til < 1,0 mg/dl (0,32 mmol/l).
English: HIV/HBV or HCV co-infected patients: Only a limited number of patients were co-infected with HBV (n = 13) or HCV (n = 26) in study GS-01-934.
Danish: Patienter som samtidigt er inficerede med hiv+HBV eller hiv+HCV: Det var kun et begrænset antal patienter, som samtidigt var inficerede med HBV (n=13) eller HCV (n=26) i studie GS-01-934.
English: Rare renal failure (acute and chronic), acute tubular necrosis, nephritis (including acute interstitial nephritis)4, nephrogenic diabetes insipidus
Danish: Nyresvigt (akut og kronisk), akut tubulær nekrose, nefritis (herunder akut interstitiel nefritis)4, nefrogen diabetes insipidus
English: Limited data suggest that Asian and Pacific Island patients may have higher exposure to efavirenz but they do not appear to be less tolerant of efavirenz.
Danish: Begrænsede data tyder på, at patienter fra Asien og Stillehavsøerne har højere grad af påvirkning af efavirenz, men deres tolerabilitet af efavirenz synes ikke at være mindre.
English: There is no clinical experience with Atripla in patients who are experiencing virological failure in a first-line antiretroviral treatment regimen or in combination with other antiretroviral agents.
Danish: Der er ingen klinisk erfaring med Atripla til patienter, som har oplevet virologisk svigt i et first-line antiretroviralt regime eller i kombination med andre antiretrovirale lægemidler.
English: In most patients rash resolved with continuing therapy with efavirenz within one month.
Danish: Hos de fleste patienter forsvandt udslættet inden for 1 måned ved fortsat behandling med efavirenz.
English: These patients should be carefully monitored for efavirenz adverse reactions, especially nervous system symptoms.
Danish: Disse patienter bør monitoreres omhyggeligt med henblik på efavirenz-bivirkninger, især symptomer fra nervesystemet.
English: Contents of the pack and other information What Atripla contains
Danish: Pakningsstørrelser og yderligere oplysninger Atripla indeholder:
English: Your doctor may also order blood tests during treatment to monitor your kidneys.
Danish: Lægen kan også bede om blodprøver under behandlingen for at kontrollere Deres nyrer.
English: Darunavir/ritonavir should be used with caution in combination with Atripla.
Danish: Darunavir/ritonavir bør anvendes med forsigtighed sammen med Atripla.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Atripla findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
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: Risikoen for krydsresistens mellem efavirenz og NRTIer er lille på grund af de forskellige bindingssteder og virkningsmekanisme.
English: Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Danish: Efter oral administration er emtricitabins eliminationshalveringstid ca. 10 timer.
English: A similar reduction in indinavir exposures was observed when indinavir 1,000 mg q8h was given with efavirenz 600 mg q.d.
Danish: Der sås en lignende reduktion i indinavireksponering, når indinavir 1.000 mg q8t blev givet sammen med efavirenz 600 mg q.d.
English: Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine.
Danish: Deres læge vil måske tage blodprøver for at kontrollere, hvordan Deres lever fungerer, eller kan skifte Dem til anden medicin.
English: Hepatic failure with efavirenz: Hepatic failure, including cases in patients with no pre-existing hepatic disease or other identifiable risk factors, as reported post-marketing, were sometimes characterised by a fulminant course, progressing in some cases to transplantation or death.
Danish: Leversvigt med efavirenz: Leversvigt, herunder tilfælde hos patienter uden præeksisterende leversygdom eller andre identificerede risikofaktorer, blev i indberetninger efter markedsføringen nogle gange karakteriseret ved et fulminant forløb, som i nogle tilfælde progredierede til transplantation eller død.
English: Dose adjustments of the immunosuppressant may be required.
Danish: Dosisjustering af det immunsupprimerende lægemiddel kan være nødvendig.
English: 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Danish: 30 filmovertrukne tabletter 90 (3 beholdere med 30) filmovertrukne tabletter.
English: While the clinical significance of decreased indinavir concentrations has not been established, the magnitude of the observed pharmacokinetic interaction should be taken into consideration when choosing a regimen containing both efavirenz, a component of Atripla, and indinavir.
Danish: Den kliniske signifikans af reducerede indinavirkoncentrationer er ikke fastslået, men omfanget af den observerede farmakokinetiske interaktion bør overvejes, når der vælges et regime, der indeholder både efavirenz, en Atriplakomponent samt indinavir.
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).
Danish: Knogletoksicitet blev diagnosticeret som osteomalaci (aber) og nedsat knoglemineraltæthed (BMD) (rotter og hunde).
English: Atripla is not recommended for patients who have had a life-threatening cutaneous reaction (e.g., Stevens-Johnson syndrome) while taking an NNRTI.
Danish: Atripla bør ikke anvendes til patienter, som har haft en livstruende hudreaktion (f.eks. StevensJohnsons syndrom) under NNRTI-behandling.
English: Psychiatric symptoms: Patients with a history of psychiatric disorders appear to be at greater risk of serious psychiatric adverse reactions listed in the efavirenz column of Table 2.
Danish: Psykiatriske symptomer: Patienter med psykiske forstyrrelser i anamnesen synes at have større risiko for de alvorlige psykiske bivirkninger, som nævnt i efavirenzkolonnen i tabel 2.
English: Since efavirenz is principally metabolised by the CYP system, caution should be exercised in administering Atripla to patients with mild hepatic impairment.
Danish: Da efavirenz hovedsageligt metaboliseres ved hjælp af CYP-systemet, bør forsigtighed udvises ved administration af Atripla til patienter med let nedsat leverfunktion.
English: When using Atripla with low-dose ritonavir, the possibility of an increase in the incidence of efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Danish: Når Atripla anvendes sammen med lav-dosis ritonavir, bør muligheden for øget forekomst af efavirenz-associerede bivirkninger overvejes pga. mulig farmakodynamisk interaktion.
English: Efavirenz: There have been seven retrospective reports of findings consistent with neural tube defects, including meningomyelocele, all in mothers exposed to efavirenz-containing regimens (excluding any efavirenz-containing fixed-dose combination tablets) in the first trimester.
Danish: Efavirenz: Der har været 7 retrospektive rapporter om fund svarende til neuralrørsdefekter, herunder meningomyelocele, alle hos mødre, der i første trimester havde været eksponeret for efavirenzholdige regimer (eksklusive efavirenzholdige kombinationstabletter i faste doser).
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, 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 følgesygdomme, kan tegn og symptomer på betændelse fra de tidligere infektioner forekomme kort efter, at anti-hiv-behandlingen er startet.
English: A similar trend was observed in a sub-group analysis of treatment-experienced patients with baseline HIV-1 RNA < 75 copies/ml from a retrospective cohort study (data collected over 20 months, see Table 5).
Danish: En lignende tendens blev observeret i en undergruppeanalyse af behandlingserfarne patienter med hiv-1-rna < 75 kopier/ml ved baseline fra et retrospektivt kohorte-studie (data indsamlet i løbet af 20 måneder, se tabel 5).
English: Forty-eight week data showed that high levels of virologic suppression, comparable to the original treatment regimen, were maintained in patients who were randomised to change to Atripla (see Table 4).
Danish: 48-ugers data viste, at høje niveauer af virologisk suppression, som var sammenlignelige med det oprindelige behandlingsregime, blev opretholdt hos patienter, som blev randomiseret til at skifte til Atripla (se tabel 4).
English: The most frequently reported adverse reactions considered possibly or probably related to Atripla among patients treated up to 48 weeks in study AI266073 were psychiatric disorders (16%), nervous system disorders (13%), and gastrointestinal disorders (7%).
Danish: De hyppigst indberettede bivirkninger, som blev anset for at have en mulig eller sandsynlig forbindelse til Atripla, hos patienter, der blev behandlet i op til 48 uger i studie AI266073, var psykiske forstyrrelser (16%), lidelser i nervesystemet (13%) og gastrointestinale forstyrrelser (7%).
English: Other possible serious side effects
Danish: Andre mulige alvorlige bivirkninger
English: Although in vitro data suggest that efavirenz inhibits CYP2C9 and CYP2C19, there have been contradictory reports of both increased and decreased exposures to substrates of these enzymes when co-administered with efavirenz in vivo.
Danish: Selvom in vitro-data tyder på, at efavirenz hæmmer CYP2C9 og CYP2C19, har der været modsigende rapporter om både forhøjede og reducerede eksponeringer for substrater for disse enzymer in vivo, når de administreres samtidigt med efavirenz.
English: Administration of efavirenz capsules with a high fat meal increased the mean AUC and Cmax of efavirenz by 28% and 79%, respectively, compared to administration in a fasted state.
Danish: Administration af efavirenzkapsler sammen med et måltid med stort fedtindhold forhøjede gennemsnitligt AUC og Cmax af efavirenz med henholdsvis 28% og 79% sammenlignet med administration under faste.
English: Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz.
Danish: Stoffer, som er substrater for disse enzymer, kan have reducerede plasmakoncentrationer, når de administreres sammen med efavirenz.
English: Table 4: 48-week efficacy data from study AI266073 in which Atripla was administered to virologically suppressed patients on combination antiretroviral therapy
Danish: Tabel 4: 48-ugers virkningdata fra studie AI266073, hvor Atripla blev administreret til virologisk supprimerede patienter i antiretroviral kombinationsbehandling.
English: The combination of efavirenz, emtricitabine and tenofovir disoproxil has been studied in 460 patients either as the fixed-dose combination tablet Atripla (study AI266073) or as the component products (study GS-01-934).
Danish: Kombinationen af efavirenz, emtricitabin og tenofovirdisoproxil er blevet undersøgt hos 460 patienter, enten som fast-dosis kombinationstabletten Atripla (studie AI266073) eller som præparater indeholdende de aktive stoffer (studie GS-01-934).
English: Clinically significant interactions are not expected as simeprevir and emtricitabine are eliminated via different pathways.
Danish: Der forventes ingen klinisk signifikant interaktion, da simeprevir og emtricitabin elimineres via forskellige eliminationsveje.
English: Efavirenz concentrations not measured, no effect is expected.
Danish: Efavirenzkoncentrationer er ikke målt, der forventes ingen virkning.
English: Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Danish: Fund ved studier med rotter og aber viste, at der var en stofrelateret reduktion i den intestinale absorption af phosphat med potentiel, sekundær reduktion af BMD.
English: Following intravenous administration the volume of distribution of tenofovir was approximately 800 ml/kg.
Danish: Efter intravenøs administration var tenofovirs fordelingsvolumen ca. 800 ml/kg.
English: (inhibition of CYP-mediated oxidative metabolism)
Danish: (hæmning af CYP-medieret oxidativ metabolisme)
English: Patients with HIV-1 harbouring mutations
Danish: Patienter med hiv-1 med stammer som har mutationer
English: Co-administration with voriconazole.
Danish: Samtidig administration med voriconazol.
English: Emtricitabine (n=45)
Danish: Emtricitabin (n=45)
English: Please refer to the Summary of Product Characteristics for these medicinal products.
Danish: Se produktresuméet for disse lægemidler.
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: Emtricitabine-resistant viruses with the M184V/I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
Danish: Emtricitabinresistente vira med M184V/I-mutationen var krydsresistente over for lamivudin, men beholdt følsomhed over for didanosin, stavudin, tenofovir og zidovudin.