FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with Atripla.
Danish: Deres læge kan bede Dem om at tage en graviditetstest for at sikre, at De ikke er gravid, før De starter behandling med Atripla.
English: Patients either changed to Atripla (N=203) or continued on their original antiretroviral treatment regimen (N=97).
Danish: Patienterne blev enten skiftet til Atripla (n=203) eller fortsatte med deres oprindelige antiretrovirale behandlingsregime (n=97).
English: - You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: - Du kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: Table 3: Development of resistance in study GS-01-934 through week 144
Danish: Tabel 3: Resistensudvikling i studie GS-01-934 til og med uge 144
English: Efavirenz is highly bound (> 99%) to human plasma proteins, predominantly albumin.
Danish: Efavirenz har en høj bindingsgrad (> 99%) til humane plasmaproteiner, fortrinsvis albumin.
English: The clinical significance of these effects is not known.
Danish: Den kliniske signifikans af disse virkninger er ukendt.
English: Test: single fixed-dose combination tablet taken under fasted conditions.
Danish: Test: Enkelt fastdosis-kombinationstablet taget under faste.
English: Contains sodium, see leaflet for further information.
Danish: Indeholder natrium, se indlægssedlen for yderligere information.
English: - if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
Danish: - hvis Deres læge har fortalt Dem, at de har et højt eller lavt indhold af elektrolytter, såsom kalium eller magnesium, i blodet.
English: The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births.
Danish: Forekomsten af neuralrørsdefekt i befolkningen generelt er 0,5-1 tilfælde pr. 1.000 levendefødsler.
English: The mechanism of tumour formation and the potential relevance for humans are not known.
Danish: Tumordannelsesmekanismen og dens potentielle relevans for mennesker er ikke kendt.
English: However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Danish: Som det kunne forventes, forekom ASAT- og ALAT-forhøjelser imidlertid hyppigere hos denne patientpopulation end hos den generelle hiv-inficerede population.
English: abnormal dreams, insomnia
Danish: Abnorme drømme, søvnløshed
English: 1 The predominant circulating metabolite of sofosbuvir.
Danish: 1 Den primære cirkulerende metabolit af sofosbuvir.
English: hepatic steatosis, hepatitis
Danish: Steatosis hepatis, hepatitis
English: However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Danish: Der var imidlertid ingen øget risiko for frakturer eller tegn på klinisk relevante knogleabnormiteter i løbet af de 144 uger.
English: It is recommended that Atripla be taken on an empty stomach, preferably at bedtime.
Danish: Det anbefales, at Atripla tages på tom mave, helst ved sengetid.
English: Atripla tablets should be swallowed whole with water, once daily.
Danish: Atripla-tabletter skal synkes hele sammen med vand, én gang dagligt.
English: 1 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Danish: 1 Anæmi var almindelig og misfarvning af huden (øget pigmentering) meget almindelig, når emtricitabin blev administreret til pædiatriske patienter.
English: Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking Atripla.
Danish: Derfor bør De fortsætte med at tage præventive forholdsregler, som nævnt ovenfor, i 12 uger efter De er holdt op med at tage Atripla.
English: Decreases in bone mineral density of the hip were significantly greater in this group until 96 weeks.
Danish: Fald i knoglemineraltætheden i hoften var signifikant større i denne gruppe indtil uge 96.
English: Table 1: Interactions between Atripla or its individual components and other medicinal products
Danish: Tabel 1: Interaktion mellem Atripla eller dets individuelle komponenter og andre lægemidler
English: In addition, your doctor may consider giving you an additional dose of efavirenz to treat your HIV infection.
Danish: Desuden kan lægen overveje at give Dem en højere dosis efavirenz til behandling af Deres hiv-infektion.
English: (CYP3A induction - effect on boceprevir) *0-8 hours
Danish: (CYP3A-induktion - virkning på boceprevir) *0-8 timer
English: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses (see also data from bioequivalence study described above) and 40 to 55 hours after multiple doses.
Danish: Efavirenz har en forholdsvis lang terminal halveringstid på mindst 52 timer efter enkeltdoser (se også data fra bioekvivalensstudiet beskrevet ovenfor) og 40-55 timer efter multiple doser.
English: Other macrolide antibiotics, such as erythromycin, have not been studied in combination with Atripla.
Danish: Andre makrolide antibiotika, så som erythromycin, er ikke blevet undersøgt i kombination med Atripla.
English: Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects).
Danish: Fortæl det straks til Deres læge, hvis De føler Dem deprimeret, har selvmordstanker eller mærkelige tanker (se punkt 4, Bivirkninger).
English: Your doctor will carefully consider whether to treat you with medicines containing tenofovir and didanosine.
Danish: Deres læge vil nøje overveje, om det er nødvendigt at behandle Dem med medicin, der indeholder tenofovir og didanosin.
English: These problems tend to occur more often in those who have a history of mental illness.
Danish: Disse problemer synes at forekomme oftere hos personer, der tidligere har haft en psykisk sygdom.
English: No human data on the effect of Atripla are available.
Danish: Der foreligger ingen humane data vedrørende virkningen af Atripla.
English: No effect (↔) equals a decrease in mean ratio estimate of ≤ 20% or increase in mean ratio estimate of
Danish: Ingen virkning (↔) er lig en reduktion i den estimerede gennemsnitlige ratio på ≤ 20% eller en stigning i den estimerede gennemsnitlige ratio på
English: • increased fatty acids (triglycerides), bilirubin or sugar levels in the blood
Danish: • Forhøjet indhold af fedtsyrer (triglycerider), bilirubin eller sukker i blodet
English: Interrupting treatment with Atripla should also be considered in case of progressive decline of renal function when no other cause has been identified.
Danish: Det bør også overvejes at afbryde behandlingen med Atripla i tilfælde af progressiv forværring af nyrefunktionen, når der ikke er identificeret andre årsager.
English: - if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Danish: Hvis De tidligere har haft en psykisk sygdom, herunder depression, eller stof- eller alkoholmisbrug.
English: Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”,
Danish: nedenfor (stigning er angivet som „↑“, fald som „↓“, ingen ændring som „↔“, to gange dagligt som
English: Carbamazepine plasma levels should be monitored periodically.
Danish: Carbamazepins plasmakoncentrationer bør monitoreres regelmæssigt.
English: Refer to section 2 “Atripla contains sodium”.
Danish: Se punkt 2 „Atripla indeholder natrium“.
English: Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of Atripla is recommended.
Danish: På grund af efavirenz' lange halveringstid anbefales det at tage hensigtsmæssige kontraceptive forholdsregler i 12 uger efter seponering af Atripla.
English: This may make some side effects (for example, dizziness, drowsiness) less troublesome.
Danish: Dette kan gøre nogle bivirkninger (f.eks. svimmelhed, døsighed) mindre generende.
English: patients with HIV-1 RNA < 50 copies/ml
Danish: Patienter med hiv-1-rna < 50 kopier/ml
English: The clinical effect of this dose adjustment has not been adequately evaluated.
Danish: Den kliniske virkning af denne dosisjustering er ikke blevet tilstrækkeligt evalueret.
English: The silica gel desiccant is contained in a separate sachet and should not be swallowed.
Danish: Silicageltørstoffet er i en lille separat pose og må ikke sluges.
English: EU/1/07/430/001 30 film-coated tablets EU/1/07/430/002 90 (3 bottles of 30) film-coated tablets
Danish: EU/1/07/430/001 30 filmovertrukne tabletter EU/1/07/430/002 90 (3 beholdere med 30) filmovertrukne tabletter
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Danish: Disse fund påvirker ikke de aktuelle nationale anbefalinger vedrørende antiretroviral behandling hos gravide med henblik på at undgå vertikal hiv-overførsel.
English: In the open-label extended phase of study GS-01-934, where patients received Atripla on an empty stomach, 3 additional cases of resistance were seen.
Danish: I den åbne forlængelsesfase af studie GS-01-934, hvor patienterne fik Atripla på tom mave, blev der observeret yderligere 3 tilfælde af resistens.
English: Efavirenz does not bind to cannabinoid receptors.
Danish: Efavirenz binder ikke til cannabinoidreceptorer.
English: If you are pregnant, you should take Atripla only if you and your doctor decide it is clearly needed.
Danish: må De kun tage Atripla, hvis De og Deres læge beslutter, at det er klart nødvendigt.
English: Both the K65R and M184V/I mutation remain fully susceptible to efavirenz.
Danish: Både K65R- og M184V/I-mutationer forbliver fuldt ud følsomme over for efavirenz.
English: Resistance analysis by week 144 On-therapy genotypes Efavirenz resistance1 K103N K101E G190A/S Y188C/H V108I P225H M184V/I K65R K70E TAMs2
Danish: Resistensanalyse i uge 144 Behandlingsgenotyper Efavirenzresistens1 K103N K101E G190A/S Y188C/H V108I P225H M184V/I K65R K70E TAMs2
English: -3.3 (-8.3% to 2.7%) patients with HIV-1 RNA < 200 copies/ml
Danish: -3,3% (-8,3% til 2,7%) Patienter med hiv-1-rna < 200 kopier/ml
English: Refer to the Summary of Product Characteristics for the medicinal product containing maraviroc.
Danish: Se produktresuméet for det lægemiddel, der indeholder maraviroc.
English: - if you have a history of liver disease, including chronic active hepatitis.
Danish: Hvis De tidligere har haft en leversygdom, herunder kronisk aktiv hepatitis.
English: Taking these medicines with Atripla could cause serious or life-threatening side effects or stop these medicines from working properly.
Danish: At tage disse lægemidler sammen med Atripla kan give alvorlige eller livstruende bivirkninger eller stoppe den hensigtsmæssige virkning af disse lægemidler.
English: If it is almost time (less than 12 hours) for your next dose anyway, do not take the missed dose.
Danish: Hvis det næsten allerede er tidspunktet (mindre end 12 timer før) Deres næste dosis, skal De ikke tage den glemte dosis.
English: Since no dose recommendation can be made for itraconazole when used with Atripla, an alternative antifungal treatment should be considered.
Danish: Da der ikke kan gives nogen doseringsanbefaling for itraconazol, når det anvendes sammen med Atripla, bør en alternativ antimykotisk behandling overvejes.
English: • low white blood cell count (a reduced white blood cell count can make you more prone to infection)
Danish: • Lavt antal hvide blodlegemer (et nedsat antal hvide blodlegemer kan gøre Dem mere modtagelig over for infektioner)
English: - bone problems.
Danish: Knogleproblemer.
English: Cholesterol levels should be periodically monitored.
Danish: Kolesterolkoncentrationerne bør monitoreres regelmæssigt.
English: Symptoms of your hepatitis may become worse after discontinuation of Atripla.
Danish: Symptomerne på Deres hepatitis kan blive værre, efter De er holdt med at tage Atripla.
English: in the evening without efavirenz.
Danish: om aftenen uden efavirenz.
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted patients was approximately 25%.
Danish: Tenofovirs orale biotilgængelighed fra tenofovirdisoproxil hos patienter i faste var ca. 25%.
English: This medicinal product contains 23.6 mg sodium per dose, equivalent to 1.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 23,6 mg natrium pr. dosis svarende til 1,2 % af den af WHO anbefalede maksimale daglige indtagelse på 2 g natrium for en voksen.
English: Both HIV and the ingredients of Atripla may pass through breast milk and cause serious harm to your baby.
Danish: Både hiv og indholdsstofferne i Atripla kan gå over i mælken og forårsage alvorlig skade på Deres barn.
English: The clinical significance of these changes in clarithromycin plasma levels is not known.
Danish: Den kliniske signifikans af disse ændringer i clarithromycins plasmakoncentrationer er ukendt.
English: The safety and efficacy of Atripla have not been studied for the treatment of chronic HBV infection.
Danish: Sikkerhed og virkning af Atripla er ikke undersøgt til behandling af kronisk HBV-infektion.
English: Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Danish: Patienterne bør informeres om, at disse almindelige bivirkninger sandsynligvis bedres ved fortsat behandling, og at de ikke betyder, at der efterfølgende vil opstå nogle af de mindre hyppige psykiatriske symptomer.
English: If you have taken Atripla during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis De har taget Atripla under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: In particular, severe depression was more common in those with a history of depression.
Danish: Specielt har svær depression været mere hyppig hos patienter med depression i anamnesen.
English: Administration to patients with: - a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.
Danish: Administration til patienter med: - En familieanamnese med pludseligt dødsfald eller med kongenit forlængelse af QTcintervallet på elektrokardiogrammer eller med andre kliniske tilstande, som vides at forlænge QTc-intervallet.
English: (CYP3A4 induction) Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin.
Danish: (CYP3A4-induktion) Udslæt udvikledes hos 46% af de ikke-inficerede frivillige, der fik efavirenz og clarithromycin.
English: - You must remain under the care of your doctor while taking Atripla.
Danish: - De skal fortsat være i behandling hos Deres læge, mens De tager Atripla.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandlingen bør initieres af en læge, der har erfaring med behandling af hiv-infektion.
English: Each of these active substances, also known as antiretroviral medicines, work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply.
Danish: Hvert af disse stoffer, også kendt som antiretroviral medicin, virker ved at hæmme et enzym (revers transkriptase), som er nødvendigt for at virus kan formere sig.
English: - severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
Danish: - Svær forstyrrelse i elektrolytbalancen, f.eks. hypokaliæmi eller hypomagnesiæmi.
English: The daily dose of rifabutin should be increased by 50% when given with Atripla.
Danish: Den daglige rifabutindosis bør øges med 50%, når det gives sammen med Atripla.
English: Atripla [outer packaging only]
Danish: Atripla [kun på ydre pakning]
English: There have also been post-marketing reports of severe depression, death by suicide, delusions, psychosis-like behaviour, and catatonia.
Danish: Efter markedsføring har der ligeledes været indberetninger vedrørende svær depression, selvmord, vrangforestillinger, psykose-lignende adfærd og katatoni.
English: Cannabinoid test interaction
Danish: Interaktion med cannabinoid-test
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling af hepatitis B eller C henvises der også til de relevante produktresuméer for disse lægemidler.
English: Use of appropriate antihistamines and/or corticosteroids is recommended when Atripla is restarted.
Danish: Anvendelse af passende antihistaminer og/eller kortikosteroider anbefales, når behandling med Atripla genoptages.
English: Your doctor may then conduct blood tests at regular intervals in order to check how well your liver is working (see section 3, If you stop taking Atripla).
Danish: Deres læge kan så tage blodprøver med regelmæssige mellemrum for at kontrollere, hvordan Deres lever fungerer (se punkt 3, Hvis De holder op med at tage Atripla).
English: Individual tolerability and virological response should be considered when making the dose adjustment (see section 5.2).
Danish: Individuel tolerabilitet og virologisk respons bør tages i betragtning, når dosis justeres (se pkt.
English: Cross-resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Danish: Krydsresistensprofilerne for efavirenz, neviparin og delavirdin in vitro har vist, at K103Nsubstitutionen medfører et tab af følsomhed over for alle tre NNRTIer.
English: Uncommon: - dry mouth - incoherent speech - increased appetite - libido decreased - myalgia
Danish: Ikke almindelig: - Mundtørhed - Usammenhængende tale - Øget appetit - Nedsat libido - Myalgi
English: Patients receiving Atripla or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Danish: Patienter, der får Atripla eller anden antiretroviral behandling, kan fortsat udvikle opportunistiske infektioner og andre hiv-relaterede komplikationer og bør derfor fortsætte under tæt klinisk observation af læger, der har erfaring med behandling af patienter med hiv-associerede sygdomme.
English: If you forget to take Atripla
Danish: Hvis De har glemt at tage Atripla
English: There were insufficient data to determine whether moderate or severe hepatic impairment (Child-Pugh-Turcotte Class B or C) affects efavirenz pharmacokinetics.
Danish: Der var utilstrækkelige data til at bestemme, om moderat eller svær nedsat leverfunktion (Child-Pugh-Turcotte klasse B eller C) påvirker farmakokinetikken af efavirenz.
English: (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Danish: (CYP3A4-induktion) Øgningen af efavirenz' farmakokinetiske parametre anses ikke for klinisk signifikant.
English: Despite the decrease in buprenorphine exposure, no patients exhibited withdrawal symptoms.
Danish: På trods af reduktionen i eksponering for buprenorphin, udviste ingen af patienterne abstinenssymptomer.
English: This medicine contains 23.6 mg sodium (main component of cooking/table salt) in each tablet.
Danish: Dette lægemiddel indeholder 23,6 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. tablet.
English: Stayed on original treatment regimen (N=97) n/N (%)
Danish: Blev i originalt behandlingsregime (n=97) n/N (%)
English: (induction of metabolism)
Danish: (induktion af metabolisme)
English: If you stop taking Atripla Don't stop taking Atripla without talking to your doctor.
Danish: Hvis De holder op med at tage Atripla Hold ikke op med at tage Atripla uden at tale med Deres læge.
English: A positive relationship between efavirenz concentration and QTc prolongation was observed.
Danish: Der sås et positivt forhold mellem koncentrationen af efavirenz og forlængelsen af QTc-intervallet.
English: Atripla film-coated tablets are pink, capsule shaped tablets, engraved on one side with the number “123” and plain on the other side.
Danish: Atripla filmovertrukne tabletter er lyserøde, kapselformede tabletter, på den ene side præget med tallet „123“ og glatte på den anden side.
English: (ng∙h/ml)
Danish: (ng∙t/ml)
English: - Warfarin or acenocoumarol (medicines used to reduce clotting of the blood): Your doctor may need to adjust your dose of warfarin or acenocoumarol.
Danish: - Warfarin eller acenocoumarol (medicin, der anvendes til at hindre dannelse af blodpropper): Deres læge kan finde det nødvendigt at ændre Deres dosis af warfarin eller acenocoumarol.
English: In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
Danish: I andre studier (prospektive studier og tværsnitsstudier) sås de mest udtalte reduktioner i BMD hos patienter, der blev behandlet med tenofovirdisoproxil som del af et regime indeholdende en boostet proteasehæmmer.
English: However, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on exposure to efavirenz is likely to be minimal.
Danish: Dog udskilles mindre end 1% af en efavirenzdosis uændret i urinen, så indvirkningen af nedsat funktion på efavirenz-eksponeringen er sandsynligvis minimal.
English: High rates of virologic suppression were maintained by subjects from both initial treatment groups who then received Atripla in the open-label extended phase of the study.
Danish: Høje rater af virologisk suppression blev opretholdt af patienterne fra begge de initiale behandlingsgrupper, der så fik Atripla i den åbne forlængelsesfase af studiet.
English: Tenofovir is primarily excreted by the kidneys by both filtration and an active tubular transport system with approximately 70 to 80% of the dose excreted unchanged in urine following intravenous administration.
Danish: Tenofovir udskilles primært af nyrerne både ved filtration og et aktivt tubulært transportsystem, hvor ca. 70-80% af dosen udskilles uomdannet i urinen efter intravenøs administration.
English: Symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported undesirable effects in patients receiving efavirenz 600 mg daily in clinical studies.
Danish: Symptomer, der inkluderer, men ikke er begrænset til, svimmelhed, søvnløshed, døsighed, nedsat koncentrationsevne og abnorme drømme er hyppigt indberettede bivirkninger hos patienter i kliniske studier i behandling med efavirenz 600 mg dagligt.
English: Use of Atripla in combination with saquinavir as the sole protease inhibitor is not recommended.
Danish: Anvendelse af Atripla i kombination med saquinavir som den eneste protease-hæmmer frarådes.
English: Data are available from 286 patients who switched to Atripla: 160 had previously received efavirenz, emtricitabine and tenofovir disoproxil, and 126 had previously received Combivir and efavirenz.
Danish: Data er tilgængelige fra 286 patienter, der skiftede til Atripla: 160 havde tidligere fået efavirenz, emtricitabin og tenofovirdisoproxil, og 126 havde tidligere fået Combivir og efavirenz.
English: Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Danish: Op til 30% af emtricitabindosis og ca. 10% af tenofovirdosis kan fjernes ved hæmodialyse.