FrancophonIA/ELRC3.0 huggingface dataset:
English: - Medicines used to treat fungal infections (antifungals): Itraconazole or posaconazole.
Danish: - Medicin til behandling af svampeinfektioner (svampemiddel): Itraconazol eller posaconazol.
English: These patients should be carefully monitored for rises in viral load and, since the safety profile of efavirenz differs from that of protease inhibitors, for adverse reactions.
Danish: Disse patienter skal monitoreres omhyggeligt for bivirkninger og stigning i viræmi, da sikkerhedsprofilen for efavirenz er forskellig fra proteasehæmmeres sikkerhedsprofil.
English: Appropriate antihistamines and/or corticosteroids may improve tolerability and hasten the resolution of rash.
Danish: Relevante antihistaminer og/eller kortikosteroider kan forbedre tolerabiliteten og fremskynde udslættets forsvinden.
English: No data are available on the safety and efficacy of Atripla in combination with other antiretroviral agents.
Danish: Der foreligger ingen data om sikkerheden og virkningen af Atripla i kombination med andre antiretrovirale lægemidler.
English: • difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
Danish: • Søvnbesvær, unormale drømme, koncentrationsbesvær, døsighed
English: The frequency category was estimated from a statistical calculation based on the total number of patients treated with efavirenz in clinical trials (n = 3,969) or exposed to emtricitabine in randomised controlled clinical trials (n = 1,563) or exposed to tenofovir disoproxil in randomised controlled clinical trials and the expanded access programme (n = 7,319).
Danish: Frekvenskategorien blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter behandlet med efavirenz i kliniske studier (n=3.969) eller eksponeret for emtricitabin i randomiserede, kontrollerede kliniske studier - (n=1.563) eller eksponeret for tenofovirdisoproxil i randomiserede, kontrollerede, kliniske studier og i programmet for forlænget adgang (n=7.319).
English: - Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Danish: - Sertralin, medicin til behandling af depression, fordi Deres læge kan finde det nødvendigt at ændre Deres sertralindosis.
English: Table 5: Maintenance of pure virologic response (Kaplan Meier % (Standard Error) [95%CI]) at week 48 for treatment-experienced patients with baseline HIV-1 RNA < 75 copies/ml who had therapy switched to Atripla according to the type of prior antiretroviral regimen (Kaiser Permanente patient database)
Danish: Tabel 5: Opretholdelse af rent virologisk respons (Kaplan Meier % (standardfejl) [95%CI]) i uge 48 hos behandlingserfarne patienter med hiv-1-rna < 75 kopier/ml ved baseline, som skiftede behandling til Atripla ifølge typen af tidligere antiretroviral behandling (Kaiser Permanente patient database) Tidligere Atriplakomponenter (N=299)
English: 1 Other efavirenz resistance mutations included A98G (n=1), K103E (n=1), V179D (n=1), and M230L (n=1).
Danish: 1 Andre efavirenz resistensmutationer omfattede A98G (n=1), K103E (n=1), V179D (n=1), og M230L (n=1).
English: Co-administration of efavirenz with atorvastatin, pravastatin, or simvastatin did not affect efavirenz AUC or Cmax values.
Danish: Samtidig administration af efavirenz og atorvastatin, pravastatin eller simvastatin påvirkede ikke efavirenz' AUC eller Cmax værdier.
English: Emtricitabine displayed antiviral activity against HIV-1 clades A, B, C, D, E, F, and G. Tenofovir displayed antiviral activity against HIV-1 clades A, B, C, D, E, F, G, and O. Both emtricitabine and tenofovir showed strain specific activity against HIV-2 and antiviral activity against HBV.
Danish: Emtricitabin viste antiviral aktivitet mod hiv-1 grupperne A, B, C, D, E, F og G. Tenofovir viste antiviral aktivitet mod hiv-1 grupperne A, B, C, D, E, F, G og O. Både emtricitabin og tenofovir viste stammespecifik aktivitet mod hiv-2 og antiviral aktivitet mod HBV.
English: Atripla can reduce the amount of statins in your blood.
Danish: Atripla kan nedsætte mængden af statiner i blodet.
English: Psychiatric side effects in addition to those listed above include delusions (false beliefs), neurosis.
Danish: Psykiske bivirkninger ud over de ovenfor nævnte omfatter vrangforestillinger og neuroser.
English: - Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): You must also use a reliable barrier method of contraception (see Pregnancy and breast-feeding).
Danish: - Hormonal prævention, såsom p-piller, injiceret prævention (for eksempel Depo-Provera) eller præventivt implantat (for eksempel Implanon): De skal også anvende pålidelig barriereprævention (se Graviditet og amning).
English: Efavirenz significantly decreases voriconazole plasma concentrations while voriconazole also significantly increases efavirenz plasma concentrations.
Danish: Efavirenz reducerer plasmakoncentrationen af voriconazol signifikant, mens voriconazol også reducerer plasmakoncentrationen af efavirenz signifikant.
English: Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Danish: Emtricitabin og tenofovir, individuelt og i kombinationsbehandling, har udvist aktivitet mod HBV i farmakodynamiske studier (se pkt.
English: A multiple-dose study of efavirenz showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh-Turcotte Class A) compared with controls.
Danish: Et studie af efavirenz med multiple doser viste ingen signifikant påvirkning af efavirenz' farmakokinetik hos patienter med let nedsat leverfunktion (Child-Pugh-Turcotte klasse A) sammenlignet med kontrolgruppen.
English: Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Danish: Efter oral administration var tenofovirs eliminationshalveringstid ca. 12-18 timer.
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, tåltes kombinationen ikke godt (f.eks. forekom svimmelhed, kvalme, paræstesi og forhøjede leverenzymer).
English: No dose recommendation can be made for the use of Atripla with carbamazepine.
Danish: Der kan ikke gives doseringsanbefaling for anvendelsen af Atripla sammen med carbamazepin.
English: Elderly: Atripla has not been studied in patients over the age of 65.
Danish: Ældre: Atripla er ikke blevet undersøgt hos patienter over 65 år.
English: - Medicines used to treat malaria: Atovaquone/proguanil or artemether/lumefantrine.
Danish: - Medicin til behandling af malaria: Atovaquon/proguanil eller artemether/lumefantrin.
English: Combination of emtricitabine and tenofovir disoproxil: Genotoxicity and repeated-dose toxicity studies of one month or less with the combination of these two components found no exacerbation of toxicological effects compared to studies with the separate components.
Danish: Kombination af emtricitabin og tenofovirdisoproxil: I studier af en måneds varighed eller derunder af genotoksicitet og af toksicitet efter gentagne doser med en kombination af disse to indholdsstoffer blev der ikke fundet nogen forværring af toksikologiske virkninger, sammenlignet med studier med de separate indholdsstoffer.
English: Atazanavir/ritonavir: Insufficient data are available to make a dosing recommendation for atazanavir/ritonavir in combination with Atripla.
Danish: Atazanavir/ritonavir: Der er ikke tilstrækkelig dokumentation til en doseringsanbefaling for atazanavir/ritonavir i kombination med Atripla.
English: Your doctor may consider giving you the components of Atripla separately if you are having problems or need your dose adjusted.
Danish: Lægen kan overveje at give Dem de aktive stoffer i Atripla hver for sig, hvis De har problemer eller det er nødvendigt at justere Deres dosis.
English: Two additional cases (1 prospective and 1 retrospective) including events consistent with neural tube defects have been reported with the fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil.
Danish: Der er rapporteret om yderligere to tilfælde (1 prospektivt og 1 retrospektivt), herunder hændelser svarende til neuralrørsdefekter, med fastdosis-kombinationstabletten indeholdende efavirenz, emtricitabin og tenofovirdisoproxil.
English: Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Atripla with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Danish: Renalt eliminerede lægemidler: Da emtricitabin og tenofovir primært elimineres via nyrerne, kan samtidig administration af Atripla og lægemidler, der reducerer nyrefunktionen eller konkurrerer om aktiv tubulær udskillelse (f.eks. cidofovir) øge serumkoncentrationen af emtricitabin, tenofovir og/eller de samtidigt administrerede lægemidler.
English: If Atripla is stopped, speak to your doctor before you restart taking Atripla tablets.
Danish: Hvis De holder op med at tage Atripla, skal De kontakte Deres læge, før De begynder at tage Atripla-tabletter igen.
English: Please refer to the Summary of Product Characteristics for the individual components for additional information regarding in vivo resistance with these medicinal products.
Danish: For yderligere information se produktresuméerne for de individuelle komponenter med henblik på in vivo-resistens i forbindelse med disse lægemidler.
English: Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Danish: Emtricitabintriphosphat og tenofovirdiphosphat hæmmer kompetitivt hiv-1 revers transkriptase, hvilket resulterer i dna-kædeblokering.
English: After oral administration, emtricitabine is widely distributed throughout the body.
Danish: Efter oral administration fordeles emtricitabin bredt i hele kroppen.
English: Patients with mild liver disease (Child-Pugh-Turcotte (CPT), Class A) may be treated with the normal recommended dose of Atripla (see sections 4.3, 4.4 and 5.2).
Danish: Patienter med let leversygdom (Child-Pugh-Turcotte (CPT), klasse A) kan behandles med den dosis, der normalt anbefales for Atripla (se pkt.
English: The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Danish: Nedbrydning af muskelvæv, kalktab fra knoglerne (med knoglesmerter, som nogle gange resulterer i knoglebrud), muskelsmerter, muskelsvaghed og nedsat kalium- eller phosphatniveau i blodet kan forekomme på grund af skader på celler i nyrerne (de tubulære celler).
English: Limited clinical experience suggests that emtricitabine and tenofovir disoproxil have an anti-HBV activity when used in antiretroviral combination therapy to control HIV infection.
Danish: Begrænset klinisk erfaring tyder på, at emtricitabin og tenofovirdisoproxil har anti-HBV-aktivitet, når de anvendes i antiretroviral kombinationsbehandling til at kontrollere hiv-infektion.
English: Severe hepatic impairment (CPT, Class C) (see section 5.2).
Danish: Svært nedsat leverfunktion (CPT klasse C) (se pkt.
English: Clinically significant interactions are not expected since vigabatrin and gabapentin are exclusively eliminated unchanged in the urine and are unlikely to compete for the same metabolic enzymes and elimination pathways as efavirenz.
Danish: Der forventes ingen klinisk signifikant interaktion, da vigabatrin og gabapentin udelukkende elimineres uændret i urinen, og det er usandsynligt, at de vil konkurrere om de samme metaboliske enzymer og eliminationsveje som efavirenz.
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
Danish: Hos nogle patienter med fremskreden leversygdom eller cirrose bør behandlingen ikke ophøre, fordi det kan medføre en forværring af Deres hepatitis, hvilket kan være livstruende.
English: Atripla must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
Danish: Atripla skal seponeres hos patienter, der udvikler svært udslæt ledsaget af blæredannelse, afskalning, mucosapåvirkning eller feber.
English: Pharmacokinetic parameters were determined following administration of single doses of the individual preparations of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected patients with varying degrees of renal impairment.
Danish: De farmakokinetiske parametre blev fastslået efter administration af enkeltdoser af de individuelle lægemidler emtricitabin 200 mg eller tenofovirdisoproxil 245 mg til ikke-hiv-inficerede patienter med varierende grader af nedsat nyrefunktion.
English: Patients with HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either an M41L or an L210W substitution in RT showed reduced susceptibility to tenofovir disoproxil.
Danish: Patienter, hvis hiv-1 udtrykte 3 eller flere tymidinanalog-forbundne mutationer (TAMer), som omfattede enten en M41L- eller en L210W-substitution i RT, udviste reduceret følsomhed over for tenofovirdisoproxil.
English: Patients had never experienced virological failure on a previous antiretroviral therapy, had no known HIV-1 mutations that confer resistance to any of the three components within Atripla, and had been virologically suppressed for at least three months at baseline.
Danish: Patienterne have aldrig oplevet virologisk svigt i forbindelse med tidligere antiretroviral behandling, havde ingen kendte hiv-1-mutationer, som giver resistens over for en eller flere af komponenterne i Atripla og havde været virologisk supprimeret i mindst tre måneder ved baseline.
English: Psychiatric adverse reactions have been reported in patients treated with efavirenz.
Danish: Psykiatriske bivirkninger er indberettet hos patienter behandlet med efavirenz.
English: The in vitro studies suggest that CYP3A4 and CYP2B6 are the major isozymes responsible for efavirenz metabolism and that it inhibits CYP isozymes 2C9, 2C19, and 3A4.
Danish: In vitro-studierne tyder på, at CYP3A4 og CYP2B6 er de isozymer, der hovedsageligt er ansvarlige for efavirenz-metaboliseringen, og at det hæmmer CYP-isozymerne 2C9, 2C19 og 3A4.
English: Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz during pregnancy.
Danish: Der er set alvorlige misdannelser hos fostre fra dyr og hos nyfødte børn, hvis mødre blev behandlet med efavirenz under graviditeten.
English: • softening of the bones (with bone pain and sometimes resulting in fractures) which may occur due to damage to the kidney tubule cells
Danish: • Kalktab fra knoglerne (med knoglesmerter, som nogle gange resulterer i knoglebrud), som kan forekomme på grund af beskadigelse af de tubulære celler i nyrerne
English: The systemic clearance of emtricitabine averaged 307 ml/min.
Danish: Emtricitabins systemiske clearance var i gennemsnit 307 ml/min.
English: Immune Reactivation Syndrome: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Danish: Immunreaktiveringssyndrom: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af CART opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
English: Interaction only studied with sofosbuvir/velpatasvir.
Danish: Interaktion er kun undersøgt med sofosbuvir/velpatasvir.
English: - Medicines used to lower blood fats (also called statins): Atorvastatin, pravastatin,
Danish: - Medicin til nedsættelse af fedtindholdet i blodet (kaldet statiner): Atorvastatin, pravastatin,
English: If you are affected, do not drive and do not use any tools or machines.
Danish: Kør ikke bil eller motorcykel og lad være med at cykle og lad være med at arbejde med værktøj eller maskiner, hvis De føler Dem påvirket.
English: Atripla can be reinitiated in patients interrupting therapy because of rash.
Danish: Behandling med Atripla kan genoptages hos patienter, der afbryder behandlingen på grund af udslæt.
English: The apparent clearance of tenofovir averaged approximately 307 ml/min.
Danish: Tenofovirs tilsyneladende clearance var i gennemsnit ca. 307 ml/min.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og
English: Plasma concentrations and effects of warfarin or acenocoumarol are potentially increased or decreased by efavirenz.
Danish: Warfarins eller acenocoumarols plasmakoncentrationer og virkninger kan muligvis forhøjes eller reduceres af efavirenz.
English: The potential for cross-resistance between efavirenz and PIs is low because of the different enzyme targets involved.
Danish: Risikoen for krydsresistens mellem efavirenz og PIer er lille på grund af de forskellige involverede enzymangrebspunkter.
English: Compounds or herbal preparations (for example Ginkgo biloba extracts and St. John's wort) which induce these enzymes may give rise to decreased plasma concentrations of efavirenz.
Danish: Stoffer eller naturlægemidler (for eksempel Ginkgo biloba-ekstrakt og perikon), som inducerer disse enzymer, kan medføre reducerede plasmakoncentrationer af efavirenz.
English: Hepatitis C antivirals Elbasvir/Grazoprevir + Efavirenz
Danish: Hepatitis C antivirale lægemidler Elbasvir/grazoprevir + efavirenz
English: In general, emtricitabine pharmacokinetics in HBV infected patients were similar to those in healthy subjects and in HIV infected patients.
Danish: Generelt var emtricitabins farmakokinetik hos HBV-inficerede patienter den samme som hos raske forsøgspersoner og hos hiv-inficerede patienter.
English: In a single-dose study of efavirenz, half-life was doubled in the single patient with severe hepatic impairment (Child-Pugh-Turcotte Class C), indicating a potential for a much greater degree of accumulation.
Danish: I et enkeltdosisstudie fordobledes efavirenz' halveringstid hos den eneste patient med svær nedsat leverfunktion (Child-Pugh-Turcotte klasse C), hvilket tyder på potentiale for en meget højere grad af akkumulering.
English: Since decreased concentrations of artemether, dihydroartemisinin, or lumefantrine may result in a decrease of antimalarial efficacy, caution is recommended when Atripla and artemether/lumefantrine tablets are co-administered.
Danish: Da nedsatte koncentrationer af artemether, dihydroartemisinin eller lumefantrin kan føre til en nedsat virkning mod malaria, bør der udvises forsigtighed, når Atripla og artemether/ lumefantrintabletter administreres samtidigt.
English: If serum phosphate is < 1.5 mg/dl (0.48 mmol/l) or creatinine clearance is decreased to < 50 ml/min in any patient receiving Atripla, renal function must be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Danish: Hvis serumphosphat er < 1,5 mg/dl (0,48 mmol/l) eller kreatininclearance er reduceret til < 50 ml/min hos patienter, der får Atripla, skal nyrefunktionen revurderes inden for en uge, herunder måling af glucose- og kaliumkoncentrationen i blodet samt glucosekoncentrationen i urinen (se pkt.
English: Phenytoin, Phenobarbital, and other anticonvulsants that are substrates of CYP isozymes
Danish: Phenytoin, phenobarbital og andre krampestillende lægemidler, som er substrater for CYP-isozymer
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 et 3-måneders interaktionsstudie var der ingen signifikante forskelle i de farmakokinetiske parametre for MPA mellem de patienter, der fik efavirenzholdig antiretroviral behandling og de patienter, der ikke fik antiretroviral behandling.
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected patients with varying degrees of hepatic impairment defined according to CPT classification.
Danish: En enkelt dosis på 245 mg tenofovirdisoproxil blev administreret til ikke-hiv-inficerede patienter med varierende grader af nedsat leverfunktion, som var defineret i henhold til CPT-klassifikationen.
English: In addition, a K70E substitution in HIV-1 RT has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, lamivudine and tenofovir.
Danish: Desuden er en K70E-substitution i hiv-1-RT blevet selekteret af tenofovir, hvilket fører til en nedsat følsomhed for abacavir, emtricitabin, lamivudin og tenofovir på lavt niveau.
English: - if you are allergic to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis De er allergisk over for efavirenz, emtricitabin, tenofovir, tenofovirdisoproxil eller et af de øvrige indholdsstoffer i Atripla (angivet i punkt 6).
English: Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
Danish: Knogleproblemer (som nogle gange resulterer i knoglebrud) kan også forekomme på grund af skader på celler i nyrerne (tubulære celler) (se punkt 4, Bivirkninger).
English: This loss is due to significant decreases in elbasvir/grazoprevir plasma concentrations caused by CYP3A4 or P-gp induction.
Danish: Dette skyldes signifikante fald i plasmakoncentrationerne af elbasvir/grazoprevir på grund af CYP3A4- eller P-gpinduktion.
English: Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Danish: Både emtricitabintriphosphat og tenofovirdiphosphat er svage hæmmere af mammale dnapolymeraser, og der var intet tegn på toksicitet over for mitokondrier in vitro eller in vivo.
English: Patients with a prior history of psychiatric disorders appear to be at greater risk of serious psychiatric adverse reactions.
Danish: Patienter med psykiatriske lidelser i anamnesen synes at have større risiko for alvorlige psykiatriske bivirkninger.
English: Efavirenz may also cause impaired concentration and/or somnolence.
Danish: Efavirenz kan også forårsage nedsat koncentrationsevne og/eller døsighed.
English: Women of childbearing potential (see below and section 5.3)
Danish: Kvinder i den fertile alder (se nedenfor og pkt.
English: Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism, which may be clinically relevant in some patients.
Danish: Det er påvist, at efavirenz inducerer CYP3A4 og CYP2B6, hvilket medfører induktion af dets egen metabolisme og kan være klinisk relevant hos nogle patienter.
English: Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving and operating machinery.
Danish: Patienterne bør instrueres i at undgå potentielt farlige opgaver, såsom at føre motorkøretøj eller betjene maskiner, hvis de oplever disse symptomer.
English: Norelgestromin (active metabolite):
Danish: Norelgestromin (aktiv metabolit):
English: Swallow Atripla whole with water.
Danish: Atripla skal sluges hel sammen med vand.
English: There have been occasional post-marketing reports of contraceptive failure with etonogestrel in efavirenz-exposed patients.
Danish: Efter markedsføring har der lejlighedsvis været rapporteret kontraceptiva-svigt med etonogestrel hos patienter eksponeret for efavirenz.