FrancophonIA/ELRC3.0 huggingface dataset:
English: Atripla comes in bottles of 30 tablets (with a silica gel sachet that must be kept in the bottle to help protect your tablets).
Danish: Atripla leveres i beholdere à 30 tabletter (med en silicagelpose, der skal blive i beholderen for at beskytte tabletterne).
English: Atripla contains sodium
Danish: Atripla indeholder natrium
English: Patients should be monitored for seizure control.
Danish: Patienterne skal monitoreres for kontrol af kramper.
English: Reproductive toxicity studies showed increased foetal resorptions in rats.
Danish: Studier af reproduktionstoksicitet viste øget føtal resorption hos rotter.
English: Because of interpatient variability in these parameters and concerns regarding development of resistance, HIV treatment guidelines should be consulted, also taking into consideration the reason for discontinuation.
Danish: På grund af den individuelle variabilitet i disse parametre samt risikoen for resistensudvikling bør anbefalingerne for hiv-behandling konsulteres, idet årsagen til seponering også tages med i overvejelserne.
English: Modified LOCF: Post-hoc analysis where patients who failed virologically or discontinued for adverse events were treated as failures; for other drop-outs, the LOCF (last observation carried forward) method was applied
Danish: Modificeret LOCF: Post-hoc-analyse, hvor patienterne med virologisk „failure“ eller som afsluttede pga. bivirkninger, blev behandlet som „failures“; for andre „drop-outs“ blev LOCF-metoden (last observation carried forward) brugt.
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping emtricitabine or tenofovir disoproxil (two of the three components of Atripla).
Danish: Nogle patienter har fået taget blodprøver eller har symptomer, som viser, at deres hepatitis er forværret, efter de er holdt op med at tage emtricitabin eller tenofovirdisoproxil (to af de tre aktive stoffer i Atripla).
English: K103N was the most frequently observed RT substitution in viral isolates from patients who experienced rebound in viral load during clinical studies of efavirenz.
Danish: K103N var den hyppigst observerede RT-substitution i virale isolater fra patienter, som oplevede rebound viræmi under de kliniske studier med efavirenz.
English: If you see any signs of a severe rash with blistering or fever, stop taking Atripla and tell your doctor at once.
Danish: Hvis De ser tegn på alvorligt udslæt med blærer eller feber, skal De stoppe med at tage Atripla og straks fortælle det til lægen.
English: If you accidentally take too many Atripla tablets you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Danish: Hvis De ved et uheld har taget for mange Atripla-tabletter, kan De have en forhøjet risiko for at opleve mulige bivirkninger med denne medicin (se punkt 4, Bivirkninger).
English: Since fluoxetine shares a similar metabolic profile with paroxetine, i.e. a strong CYP2D6 inhibitory effect, a similar lack of interaction would be expected for fluoxetine.
Danish: Da fluoxetin har samme metaboliske profil som paroxetin, dvs. en stærk CYP2D6-hæmmende virkning, kan en lignende mangel på interaktion forventes for fluoxetin.
English: - a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
Danish: - En anamnese med symptomatiske hjertearytmier eller med klinisk relevant bradykardi eller med kongestiv hjerteinsufficiens ledsaget af nedsat venstre ventrikel uddrivningsfraktion.
English: It is important not to miss a dose of Atripla.
Danish: Det er vigtigt, at De ikke springer en dosis Atripla over.
English: Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with HBV.
Danish: Læger bør holde sig til de aktuelle hiv-behandlingsretningslinjer for optimal håndtering af hiv-infektion hos patienter med samtidig infektion med HBV.
English: Adults The recommended dose of Atripla is one tablet taken orally once daily.
Danish: Den anbefalede dosis af Atripla er én tablet, taget oralt, én gang dagligt.
English: Renal clearance has been estimated to be approximately 210 ml/min, which is in excess of the glomerular filtration rate.
Danish: Renal clearance er beregnet til at være ca. 210 ml/min, hvilket er over den glomerulære filtrationshastighed.
English: Emtricitabine: Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Danish: Emtricitabin: Prækliniske data for emtricitabin viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the CYP system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Danish: Humane studier og in vitro-studier med anvendelse af humane levermikrosomer har vist, at efavirenz hovedsageligt metaboliseres til hydroxylerede metabolitter af CYP-systemet med efterfølgende glukuronidering af disse hydroxylerede metabolitter.
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Danish: Biotransformation af emtricitabin omfatter oxidering af thioldelen til dannelse af 3'-sulphoxid diastereomer (ca. 9% af dosis) samt konjugation med glukuronsyre til dannelse af 2'-O-glukuronid (ca. 4% af dosis).
English: These side effects may start in the first 1 or 2 days of treatment and usually go away after the first 2 to 4 weeks.
Danish: Disse bivirkninger kan starte i løbet af de første 1-2 dage af behandlingen og forsvinder som regel efter de første 2-4 uger.
English: • increased levels of creatine kinase in the blood that may result in muscle pain and weakness
Danish: • Øget indhold af kreatinkinase i blodet som kan medføre muskelsmerter og -svaghed
English: Contraindications of concomitant use
Danish: Kontraindikationer for samtidig brug
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available (mechanism)
Danish: Virkning på lægemiddelkoncentration Gennemsnitlig ændring (%) i AUC, Cmax, Cmin med 90% konfidensintervaller hvis muligt (mekanisme)
English: See ritonavir row below.
Danish: Se afsnittet om ritonavir nedenfor.
English: Atripla should not be taken with any of these medicines.
Danish: De bør ikke tage Atripla sammen med nogle af disse lægemidler.
English: • itchy rash to the skin caused by a reaction to sunlight
Danish: • Kløende udslæt på huden fremkaldt af en reaktion på sollys
English: - Bupropion, a medicine used to treat depression or to help you stop smoking, as your doctor may need to change your dose of bupropion.
Danish: - Bupropion, medicin til behandling af depression eller til at hjælpe Dem med at holde op med at ryge, fordi Deres læge kan finde det nødvendigt at ændre Deres bupropiondosis.
English: Concomitant administration with Atripla should be avoided due to the risk for QTc prolongation (see section
Danish: Samtidig administration med Atripla bør undgås pga. risikoen for QTc-forlængelse (se pkt.
English: Clarithromycin 14-hydroxymetabolite:
Danish: Clarithromycin 14-hydroxymetabolit:
English: Simvastatin acid:
Danish: Simvastatinsyre:
English: Efavirenz, one of the active components of Atripla, may remain in your blood for a time after therapy is stopped.
Danish: Efavirenz, som er et af de aktive stoffer i Atripla, kan blive i blodet i et stykke tid efter, at behandlingen er stoppet.
English: The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms.
Danish: Methadondosis blev i gennemsnit øget 22% for at mildne abstinenssymptomerne.
English: If you had a rash while taking another NNRTI, you may be at higher risk of getting a rash with Atripla.
Danish: Hvis De har haft udslæt, mens De tog en anden NNRTI, kan der være større risiko for, at De får udslæt med Atripla.
English: Pharmacokinetic studies have not been performed with efavirenz, emtricitabine or tenofovir in elderly patients (over 65 years of age).
Danish: Der er ikke udført farmakokinetiske studier med efavirenz, emtricitabin eller tenofovir hos ældre patienter (over 65 år).
English: Most frequent side effects
Danish: Hyppigste bivirkninger
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 medicin, der primært metaboliseres i leveren, som f.eks. phenytoin, carbamazepin og phenobarbital, kan have brug for periodisk monitorering af plasmakoncentrationerne.
English: In HIV infected patients, peak efavirenz plasma concentrations were attained by 5 hours and steady-state concentrations reached in 6 to 7 days.
Danish: De højeste efavirenz-plasmakoncentrationer hos hiv-inficerede patienter blev opnået efter 5 timer og steady-state-koncentrationerne blev nået på 6-7 dage.
English: However, in some patients, declines in creatinine clearance did not completely resolve despite tenofovir disoproxil discontinuation.
Danish: Hos nogle patienter gik reduktionen i kreatininclearance imidlertid ikke helt væk, trods seponering af tenofovirdisoproxil.
English: If you think that you may have any of these serious side effects, talk to your doctor.
Danish: Hvis De tror, at De kan have en af disse alvorlige bivirkninger, skal De tale med lægen.
English: Tenofovir concentrations not measured, no effect is expected.
Danish: Tenofovirkoncentrationer er ikke målt, der forventes ingen virkning.
English: (UGT1A1 induction)
Danish: (UGT1A1-induktion)
English: hypokalaemia2
Danish: Hypokaliæmi2
English: Atripla has not been evaluated in the presence of food.
Danish: Atripla er ikke blevet vurderet sammen med mad.
English: - Once you start taking Atripla, look out for: - signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming.
Danish: - Når De begynder at tage Atripla, skal De holde øje med: Tegn på svimmelhed, søvnbesvær, døsighed, koncentrationsbesvær eller unormale drømme.
English: Data on the clinical translation of the decrease in pharmacokinetic exposure are not available.
Danish: Data vedrørende den kliniske fortolkning af den reducerede farmakokinetiske eksponering er ikke tilgængelige.
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Danish: Den kliniske konsekvens af denne observerede reduktion i dalboceprevir-koncentrationen er ikke blevet vurderet direkte.
English: Efavirenz plasma exposure may be increased in patients with homozygous G516T genetic variant of the CYP2B6 isozyme.
Danish: Efavirenz plasmaeksponering kan øges hos patienter med homozygot-G516T, der er en genetisk variant af CYP2B6-isozymet.
English: The mean plasma to blood concentration ratio was approximately 1.0 and the mean semen to plasma concentration ratio was approximately 4.0.
Danish: Den gennemsnitlige plasma/blod koncentrationsratio var ca. 1,0 og den gennemsnitlige sæd/plasma koncentrationsratio var ca. 4,0.
English: In vitro binding of emtricitabine to human plasma proteins is < 4% and independent of concentrations over the range of 0.02 to 200 µg/ml.
Danish: In vitro-binding af emtricitabin til humane plasmaproteiner er < 4% og uafhængig af koncentrationer i området 0,02 til 200 µg/ml.
English: Rare osteomalacia (manifested as bone pain and infrequently contributing to fractures)2,4, myopathy2
Danish: Osteomalaci (manifesteret som knoglesmerter og i sjældne tilfælde medvirkende årsag til frakturer)2,4, myopati2
English: These are listed under Do not take Atripla, at the start of section 2.
Danish: Tag ikke Atripla i begyndelsen af punkt 2.
English: Efavirenz exposure may be increased when given with medicinal products (for example ritonavir) or food (for example, grapefruit juice) which inhibit CYP3A4 or CYP2B6 activity.
Danish: Eksponeringen af efavirenz kan øges, når det administreres sammen med lægemidler (f.eks. ritonavir) eller mad (f.eks. grapefrugtjuice), som hæmmer aktiviteten af CYP3A4 eller CYP2B6.
English: If appropriate, resumption of antihepatitis B therapy may be warranted.
Danish: Genoptagelse af hepatitis B-behandling kan være nødvendig.
English: In clinical controlled studies of efavirenz, nervous system symptoms of moderate to severe intensity were experienced by 19% (severe 2%) of patients, and 2% of patients discontinued therapy due to such symptoms.
Danish: I kliniske, kontrollerede studier med efavirenz fik 19% af patienterne symptomer fra nervesystemet i moderat til svær grad (svær 2%), og 2% af patienterne ophørte med behandlingen på grund af sådanne symptomer.
English: Patients must not have experienced failure of a previous HIV therapy.
Danish: Patienterne oplevetbehøver ikke at have være udsat for, at en tidligere hiv-behandling ikke har virket.
English: Atripla should not be used during pregnancy unless the clinical condition of the woman requires treatment with efavirenz/emtricitabine/tenofovir disoproxil.
Danish: Atripla bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med efavirenz/emtricitabin/tenofovirdisoproxil.
English: After oral administration, tenofovir is widely distributed throughout the body.
Danish: Efter oral administration fordeles tenofovir bredt i hele kroppen.
English: Atripla may affect your kidneys.
Danish: Atripla kan påvirke Deres nyrer.
English: Sertraline:
Danish: Sertralin:
English: Approximately 14 to 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 efavirenzdosis blev genfundet i urinen, og mindre end 1% af dosis blev udskilt i urinen som uomdannet efavirenz.
English: In uninfected volunteers, multiple doses of 200 to 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 to 42% lower) and a shorter terminal half-life of 40 to 55 hours (single dose half-life 52 to 76 hours).
Danish: Hos ikke-inficerede frivillige resulterede multiple doser på 200-400 mg per dag i 10 dage i en lavere grad af akkumulation (22-42% lavere) end forudset samt kortere terminal halveringstid på 40-55 timer (halveringstid for enkeltdosis 52-76 timer).
English: Some patients accidentally taking 600 mg efavirenz twice daily have reported increased nervous system symptoms.
Danish: Nogle patienter, der ved et uheld havde taget 600 mg 2 gange dagligt, rapporterede om forøgede symptomer fra nervesystemet.
English: When you start or stop taking Atripla your doctor will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
Danish: Når De begynder eller ophører med at tage Atripla, vil Deres læge nøje kontrollere niveauet af det immunsupprimerende lægemiddel i Deres blod og vil måske justere dosis.
English: Co-administration 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 blevet undersøgt.
English: Substantial decrease in lopinavir exposure, necessitating dosage adjustment of lopinavir/ritonavir.
Danish: Væsentligt fald i lopinavireksponeringen, hvilket nødvendiggør justering af lopinavir-/ritonavirdosis.
English: Refer to the Summary of Product Characteristics for elbasvir/grazoprevir for more information.
Danish: Se produktresuméet for elbasvir/grazoprevir for yderligere oplysninger.
English: - Diltiazem or similar medicines (called calcium channel blockers): When you start taking
Danish: - Diltiazem eller lignende medicin (kaldet calciumblokkere): Når De begynder at tage Atripla,
English: You do not need to take another tablet if you were sick more than 1 hour after taking Atripla.
Danish: De behøver ikke tage en ny tablet, hvis De kastede op mere end en time efter, De tog Atripla.
English: Also, emtricitabine did not inhibit uridine 5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Danish: Heller ikke emtricitabin hæmmede uridin 5'-diphosphoglukuronyltransferase, det enzym der er ansvarligt for glukuronidering.
English: Stopping Atripla can seriously affect your response to future treatment.
Danish: Atripla, kan det have alvorlig indvirkning på, hvordan De reagerer på fremtidig behandling.
English: Atripla may make hormonal contraceptives less likely to work.
Danish: Atripla kan forårsage, at hormonale præventionsmidler ikke virker så godt.
English: In vitro studies have determined that neither tenofovir disoproxil nor tenofovir are substrates for the CYP enzymes.
Danish: In vitro-studier har afgjort, at hverken tenofovirdisoproxil eller tenofovir er substrater for CYP-enzymerne.
English: Decreases in bone mineral density of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks.
Danish: Fald i knoglemineraltætheden i rygsøjlen samt ændringer i knoglebiomarkørerne fra baseline var signifikant større i tenofovirdisoproxil-behandlingsgruppen ved 144 uger.
English: • forgetfulness, confusion, fitting (seizures), incoherent speech, tremor (shaking)
Danish: • Glemsomhed, forvirring, krampeanfald, usammenhængende tale, rysten (tremor)
English: 2 Thymidine analogue associated mutations included D67N (n=1) and K70R (n=1).
Danish: 2 Thymidin-analogassocierede mutationer omfattede D67N (n=1) og K70R (n=1).
English: Findings in repeated-dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use include renal and bone toxicity and a decrease in serum phosphate concentration.
Danish: Resultater fra toksicitetsstudier efter gentagne doser hos rotter, hunde og aber ved eksponeringsniveauer højere end eller lig med kliniske eksponeringsniveauer og med mulig relevans for klinisk anvendelse omfatter nyre- og knogletoksicitet og et fald i serum-phosphatkoncentrationen.
English: Your doctor will check your cholesterol levels and will consider changing the dose of your statin, if needed.
Danish: Deres læge vil kontrollere kolesterolindholdet og overveje at ændre Deres statindosis, hvis det er nødvendigt.
English: Emtricitabine is rapidly absorbed with peak plasma concentrations occurring at 1 to 2 hours post-dose.
Danish: Emtricitabin absorberes hurtigt, og de højeste plasmakoncentrationer forekom 1-2 timer efter dosering.
English: • anaemia (low red blood cell count)
Danish: • Blodmangel (lavt antal røde blodlegemer)
English: After 96 weeks of Atripla treatment, HIV-1 RNA plasma concentrations remained < 50 copies/ml in 82% of patients and < 400 copies/ml in 85% of patients (intention to treat analysis (ITT), missing=failure).
Danish: Efter 96 uger med Atripla-behandling forblev hiv-1-rnaplasmakoncentrationerne < 50 kopier/ml hos 82% af patienterne, og < 400 kopier/ml hos 85% af patienterne (intention to treat-analyse (ITT), missing = failure).
English: • a feeling of spinning or tilting (vertigo), whistling, ringing or other persistent noise in the ears
Danish: • Snurrende eller gyngende fornemmelse (svimmelhed), piben, ringen eller anden vedblivende støj i ørerne
English: What you need to know before you take Atripla Do not take Atripla
Danish: Det skal De vide, før De begynder at tage Atripla Tag ikke Atripla
English: Since use of two NNRTIs proved not beneficial in terms of efficacy and safety, co-administration of Atripla and another NNRTI is not recommended.
Danish: Da anvendelse af to NNRTIere ikke viste sig at være gavnligt mht. virkning og sikkerhed anbefales samtidig administration af Atripla og en anden NNRTIer ikke.
English: • back pain caused by kidney problems, including kidney failure.
Danish: • Smerter i ryggen forårsaget af nyreproblemer inklusive nyresvigt.
English: Atripla is not recommended if you have moderate to severe kidney disease.
Danish: Atripla bør ikke anvendes, hvis De har moderat til alvorlig nyresygdom.
English: For patients at increased risk of Torsade de Pointes or who are receiving drugs with a known risk for Torsade de Pointes, consider alternatives to Atripla.
Danish: For patienter, som har øget risiko for Torsade de Pointes, eller som får lægemidler, der er forbundet med kendt risiko for Torsade de Pointes, bør alternativer til Atripla overvejes.
English: Dosing at bedtime seems to improve the tolerability of these symptoms (see section 4.2).
Danish: Dosering ved sengetid synes at forbedre tolerabiliteten af disse symptomer (se pkt.
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 Atripla needs to be weighed against the potential risks of significant liver toxicity.
Danish: Ved tegn på forværring af leversygdom eller vedvarende forhøjelse af serumaminotransferaser til mere end 5 gange den øvre normalgrænse, skal fordelen ved fortsat behandling med Atripla vurderes i forhold til de potentielle risici ved signifikant levertoksicitet.
English: • breakdown of muscle, muscle pain or weakness
Danish: • Nedbrydning af muskelvæv, muskelsmerter eller -svaghed
English: The potential for interactions with efavirenz and other azole antifungals, such as ketoconazole, has not been studied.
Danish: Potentialet for interaktion mellem efavirenz og andre azolantimykotiske lægemidler, såsom ketoconazol, er ikke undersøgt.
English: Co-administration with other medicinal products
Danish: Samtidig administration med andre lægemidler
English: Rosuvastatin is largely excreted unchanged via the faeces, therefore interaction with efavirenz is not expected.
Danish: Rosuvastatin udskilles primært uomdannet via fæces, derfor forventes der ingen interaktion med efavirenz.
English: Ethinyloestradiol:
Danish: Ethinylestradiol:
English: Co-administration of atazanavir/ritonavir with tenofovir resulted in increased exposure to tenofovir.
Danish: Samtidig administration af atazanavir/ritonavir og tenofovir medførte øget eksponering for tenofovir.
English: Atripla in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Danish: Atripla i kombination med darunavir/ritonavir 800/100 mg en gang dagligt kan medføre suboptimal darunavir Cmin.
English: Efavirenz demonstrated antiviral activity against most non-clade B isolates (subtypes A, AE, AG, C, D, F, G, J, and N) but had reduced antiviral activity against group O viruses.
Danish: Efavirenz udviste antiviral aktivitet mod de fleste nongruppe-B isolater (undergrupper A, AE, AG, C, D, F, G, J og N) men havde reduceret antiviral aktivitet mod gruppe-O vira.
English: In vitro binding of tenofovir to human plasma or serum protein is < 0.7% and 7.2%, respectively over the tenofovir concentration range 0.01 to 25 µg/ml.
Danish: In vitro-binding af tenofovir til humane plasma- eller serumproteiner ligger henholdsvis < 0,7% og 7,2% over tenofovirs koncentrationsområde på 0,01 til 25 µg/ml.
English: - if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
Danish: Hvis De har en hjertelidelse, såsom et unormalt elektrisk signal kaldet forlænget QT-interval.
English: Monitoring of renal function may be indicated, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents.
Danish: Monitorering af nyrefunktionen kan være indiceret, især hos patienter med underliggende systemisk sygdom eller nyresygdom, eller hos patienter, som får nefrotoksiske lægemidler.
English: Efavirenz: no clinically significant interaction.
Danish: Efavirenz: ingen klinisk signifikant interaktion.