FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients co-infected with HIV and HBV who discontinue Biktarvy should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Danish: Patienter med hiv-infektion, som samtidig er inficerede med HBV, og som ophører med Biktarvy, bør monitoreres tæt med både klinisk og laboratorisk opfølgning i mindst adskillige måneder efter behandlingen er ophørt.
English: Thirty-five percent of the dose was recovered from urine and consisted primarily of the glucuronide of bictegravir and other minor oxidative metabolites and their phase II conjugates.
Danish: Femogtredive procent af dosen blev genfundet i urinen og bestod primært af glukuronidet af bictegravir og andre mindre oxidative metabolitter og disses fase II-konjugater.
English: Although kidney problems have not been observed with Biktarvy, there is a possibility that you may experience kidney problems when taking Biktarvy over a long period of time.
Danish: Selvom der ikke er observeret nyreproblemer i forbindelse med Biktarvy, kan De muligvis opleve nyreproblemer, når De tager Biktarvy i en langvarig periode.
English: No interaction is expected with bictegravir and emtricitabine.
Danish: Der forventes ingen interaktion med bictegravir og emtricitabin.
English: Biktarvy can cause dizziness.
Danish: Biktarvy kan forårsage svimmelhed.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Danish: Hos nogle patienter med fremskreden hiv-infektion (aids) og tidligere opportunistiske infektioner (infektioner, der forekommer hos personer med et svagt immunsystem) kan der forekomme tegn og symptomer på betændelse fra tidligere infektioner kort tid efter behandlingen mod hiv startes.
English: • swelling of the face, lips, tongue or throat (angioedema)
Danish: • hævelse af ansigt, læber, tunge eller svælg (angioødem)
English: Blood and lymphatic system disorders Uncommon:
Danish: Blod og lymfesystem Ikke almindelig:
English: Some patients taking combination antiretroviral medicines such as Biktarvy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, der tager antiretroviral kombinationsmedicin, såsom Biktarvy kan udvikle en knoglesygdom, der kaldes osteonekrose (knoglevævsdød, forårsaget af manglende blodforsyning til knoglerne).
English: 1 This study was conducted using bictegravir 75 mg single dose.
Danish: 1 Dette studie blev udført med bictegravir 75 mg som enkeltdosis.
English: • If you have liver problems or a history of liver disease, including hepatitis.
Danish: • Hvis De har eller har haft leverproblemer, herunder hepatitis.
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Danish: Silicagel-tørremidlet er i et separat brev eller en separat beholder og må ikke sluges.
English: No virologic data at Week 48 window
Danish: Ingen virologiske data ved ude 48vinduet
English: Renal excretion of intact bictegravir is a minor pathway (~1% of dose).
Danish: Renal udskillelse af intakt bictegravir er en mindre betydelig eliminationsvej (~1 % af dosis).
English: Do not use if the seal over the bottle opening is broken or missing.
Danish: Må ikke anvendes, hvis forseglingen over beholderens åbning er brudt eller mangler.
English: Or you can take Biktarvy with food at least 2 hours after.
Danish: Ellers skal De tage Biktarvy sammen med mad mindst 2 timer efter.
English: 5 Maximum strength antacid contained 80 mg aluminium hydroxide, 80 mg magnesium hydroxide, and 8 mg simethicone per mL.
Danish: 5 Den højeste styrke af antacida indeholdt 80 mg aluminiumhydroxid, 80 mg magnesiumhydroxid og 8 mg simethicon pr. ml.
English: Patients must have been stably suppressed (HIV-1 RNA < 50 copies/mL) on their baseline regimen for at least 3 months prior to study entry.
Danish: Patienterne skulle have haft stabil supprimering (hiv 1-rna < 50 kopier/ml) med deres regime ved baseline i mindst 3 måneder, før de gik ind i studiet.
English: Metabolism is the major clearance pathway for bictegravir in humans.
Danish: Metabolisme er den primære clearancevej for bictegravir hos mennesker.
English: SEDATIVES/HYPNOTICS Midazolam (2 mg, oral syrup, single dose),
Danish: SEDATIVA/HYPNOTIKA Midazolam (2 mg, oral sirup, enkeltdosis),
English: Mean systemic emtricitabine exposure was higher in patients with severe renal impairment (CrCl < 30 mL/min) (33.7 µg•h/mL) than in subjects with normal renal function (11.8 µg•h/mL).
Danish: Gennemsnitlig systemisk emtricitabin-eksponering var højere hos patienter med svært nedsat nyrefunktion (CrCl < 30 ml/min) (33,7 µg•t/ml) end hos personer med normal nyrefunktion (11,8 µg•t/ml).
English: Studies in animals with bictegravir have shown no evidence of teratogenicity or an effect on reproductive function.
Danish: Dyrestudier med bictegravir har ikke vist nogen evidens for teratogenicitet eller nogen indvirkning på reproduktionsfunktionen.
English: Macrolides Azithromycin Clarithromycin
Danish: Makrolider Azithromycin Clarithromycin
English: The plasma bictegravir half-life was 17.3 hours.
Danish: Bictegravirs halveringstid i plasma var 17,3 timer.
English: • immunosuppressants used to control your body's immune response after a transplant, containing ciclosporin
Danish: • immunundertrykkende midler, der anvendes til at kontrollere kroppens immunrespons efter en transplantation, såsom ciclosporin
English: suicidal behaviour, anxiety, sleep disorders
Danish: selvmordsadfærd, angst, søvnforstyrrelser
English: Bictegravir has been shown to increase serum creatinine due to inhibition of tubular secretion of creatinine, however these changes are not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate.
Danish: Ændringer i serum-kreatinin Bictegravir har vist sig at øge serumkreatinin på grund af hæmning af den tubulære sekretion af kreatinin; disse ændringer vurderes imidlertid ikke at være af klinisk relevans, da de ikke afspejler nogen ændring i den glomerulære filtrationshastighed.
English: Biktarvy may be co-administered with substrates of OCT2 and MATE1.
Danish: Biktarvy kan administreres samtidig med substrater for OCT2 og MATE1.
English: Pharmacokinetics of bictegravir, emtricitabine, and tenofovir have not been fully evaluated in the elderly (≥ 65 years of age).
Danish: Farmakokinetikken af bictegravir, emtricitabin og tenofovir er ikke blevet vurderet til fulde hos ældre (≥ 65 år).
English:  If you notice these or any symptoms of inflammation or infection, tell your doctor immediately.
Danish:  Hvis de bemærker disse eller andre symptomer på betændelse eller infektion, skal De straks fortælle det til Deres læge.
English: Tenofovir alafenamide is transported by P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Danish: Tenofoviralafenamid transporteres af P-glykoprotein (P-gp) og brystcancer-resistensprotein (BCRP).
English: Co-administration of Biktarvy with the OCT2 and MATE1 substrate metformin did not result in a clinically significant increase in metformin exposure.
Danish: Samtidig administration af Biktarvy og OCT2- og MATE1-substratet metformin resulterede ikke i en klinisk signifikant stigning i eksponeringen for metformin.
English: Emtricitabine has demonstrated low carcinogenic potential in mice and rats.
Danish: Emtricitabin har vist lav karcinogenicitet hos mus og rotter.
English: No dose adjustment is required upon co-administration in patients with normal renal function.
Danish: Dosisjustering er ikke nødvendig ved samtidig administration hos patienter med normal nyrefunktion.
English: Biktarvy is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults.
Danish: Biktarvy er en enkelt tablet til behandling af infektion med humant immundefekt virus 1 (hiv 1) hos voksne.
English: In patients with moderate renal impairment, close monitoring should be considered when starting co-administration of bictegravir with metformin, due to the increased risk for lactic acidosis in these patients.
Danish: Hos patienter med moderat nedsat nyrefunktion bør tæt monitorering overvejes ved opstart af samtidig administration af bictegravir og metformin på grund af den øgede risiko for laktatacidose hos sådanne patienter.
English: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), iron oxide black (E172).
Danish: Polyvinylalkohol, titandioxid (E171), macrogol, talcum, jernoxid, rød (E172), jernoxid, sort (E172).
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (~9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (~4% of dose).
Danish: Emtricitabins biotransformation omfatter oxidation af thiolandelen til at danne 3'-sulfoxid-diastereomere (~ 9 % af dosen) og forbindelse med glucuronsyre til at danne 2'-O-glucuronid (~ 4 % af dosen).
English: Hepatobiliary toxicity was described in a 39-week study at a dosage of 1,000 mg/kg/day, which resulted in exposures of approximately 16 times the exposure in humans at the recommended human dose, and was partially reversible after a 4-week recovery period.
Danish: Toksiciteten i lever og galdeveje er beskrevet i et 39-ugers studie med en dosering på 1.000 mg/kg/dag, hvilket resulterede i eksponeringer, der var cirka 16 gange højere end eksponeringen hos mennesker ved brug af den anbefalede dosis til mennesker, og var delvist reversibel efter en 4-ugers restitutionsperiode.
English: Biktarvy can be taken with or without food (see section 5.2).
Danish: Biktarvy kan tages sammen med eller uden mad (se pkt.
English: In a separate study, site-directed mutants with G118R and T97A+G118R had 3.4- and 2.8-fold reduced susceptibility to bictegravir, respectively.
Danish: I et separat studie havde site-directed mutanter med G118R og T97A+G118R hhv. 3,4- og 2,8-foldigt reduceret følsomhed for bictegravir.
English: (11%) and Grade 2 (4%) (≥1.0 to 2.5 x Upper Limit of Normal [ULN]), and were not associated with hepatic adverse reactions or other liver related laboratory abnormalities.
Danish: Stigningerne var primært af grad 1 (11 %) og grad 2 (4 %) (≥1,0 til 2,5 x øvre normalgrænse [ULN]), og de var ikke forbundet med hepatiske bivirkninger eller andre leverrelaterede laboratorieabnormiteter.
English: Signs of osteonecrosis are: joint stiffness joint aches and pains (especially of the hip, knee and shoulder) difficulty with movement
Danish: Tegn på osteonekrose er: stivhed i led smerter (især i hofter, knæ og skuldre) bevægelsesbesvær
English: HIV-1 isolates with reduced susceptibility to bictegravir have been selected in cell culture.
Danish: Hiv 1-isolater med reduceret følsomhed over for bictegravir er blevet selekteret i cellekultur.
English: No human data on the effect of Biktarvy on fertility are available.
Danish: Der foreligger ingen data om Biktarvys virkning på menneskers fertilitet.
English: - azithromycin, clarithromycin, rifabutin or rifapentine
Danish: - azithromycin, clarithromycin, rifabutin eller rifapentin
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
Danish: 3 Studie udført med yderligere voxilaprevir 100 mg for at opnå de voxilaprevir-eksponeringer, der forventes hos
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 normalt ville forbinde med hepatitis B-infektion.
English: A large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine.
Danish: Data fra et stort antal gravide kvinder (mere end 1000 eksponerede forsøgspersoner) indikerer ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med emtricitabin.
English: Biktarvy through 96 weeks, the most frequently reported adverse reactions were headache (5%), diarrhoea (5%) and nausea (4%).
Danish: I kliniske studier med behandlingsnaive patienter, der fik Biktarvy igennem 96 uger, var de hyppigst indberettede bivirkninger hovedpine (5 %), diarré (5 %) og kvalme (4 %).
English: Do not stop taking Biktarvy Do not stop taking Biktarvy without talking to your doctor.
Danish: Hold ikke op med at tage Biktarvy Hold ikke op med at tage Biktarvy uden at tale med Deres læge.
English: The number of patients co-infected with HIV and HBV treated with B/F/TAF is limited.
Danish: Antallet af patienter med samtidig hiv- og HBV-infektion, der er blevet behandlet med B/F/TAF, er begrænset.
English: There are no or limited data (less than 300 pregnancy outcomes) from the use of bictegravir or tenofovir alafenamide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af bictegravir eller tenofoviralafenamid til gravide kvinder.
English: Patients co-infected with HIV and HBV
Danish: Patienter, der er co-inficeret med hiv og HBV
English: 2 This adverse reaction was not observed in the clinical studies of emtricitabine + tenofovir alafenamide-containing products but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
Danish: 2 Denne bivirkning blev ikke observeret i kliniske studier med lægemidler indeholdende emtricitabin+tenofoviralafenamid men blev identificeret i kliniske studier eller fra erfaring efter markedsføring for emtricitabin ved anvendelse sammen med andre antiretrovirale midler.
English: Stopping Biktarvy can seriously affect how future treatment works.
Danish: Biktarvy, kan det i alvorlig grad påvirke virkningen af fremtidig behandling.
English: The safety and efficacy of Biktarvy in patients with significant underlying liver disorders have not been established.
Danish: Biktarvys sikkerhed og virkning hos patienter med signifikant underliggende leversygdom er ikke klarlagt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Biktarvy in one or more subsets of the paediatric population in the treatment of human HIV-1 infection (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Biktarvy i en eller flere undergrupper af den pædiatriske population ved behandlingen af human hiv 1-infektion (se pkt.
English: Tenofovir alafenamide and tenofovir have a median plasma half-life of 0.51 and 32.37 hours, respectively.
Danish: Tenofoviralafenamid og tenofovir har en median halveringstid i plasma på hhv. 0,51 og 32,37 timer.
English: A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).
Danish: En mulig risiko for nefrotoksicitet som følge af kronisk eksponering over for lave niveauer af tenofovir fra doseringen med tenofoviralafenamid kan ikke udelukkes (se pkt.
English: • If you are allergic to bictegravir, emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis De er allergisk over for bictegravir, emtricitabin, tenofoviralafenamid eller et af de øvrige indholdsstoffer i Biktarvy (angivet i punkt 6 i denne indlægsseddel).
English: No special hazard for humans was revealed in conventional studies of carcinogenic potential and toxicity to reproduction and development.
Danish: Ingen speciel risiko for mennesker blev vist i konventionelle studier af karcinogenicitet og reproduktions- og udviklingstoksicitet.
English: Following a single dose oral administration of [14C]-bictegravir, ~60% of the dose from faeces included unchanged parent, desfluoro-hydroxy-BIC-cysteine-conjugate, and other minor oxidative metabolites.
Danish: Efter oral administration af en enkelt dosis [14C]-bictegravir indeholdt dosen fra fæces på ~60 % uændret moderstof, desfluoro-hydroxy-BIC-cystein-konjugat og andre mindre oxidative metabolitter.
English: Bictegravir inhibits organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter 1 (MATE1) in vitro.
Danish: Bictegravir hæmmer organisk kationtransportør 2 (OCT2) og multilægemiddel- og toksinekstrusionstransportør 1 (MATE1) in vitro.
English: There are limited safety and efficacy data for Biktarvy in patients co-infected with HIV-1 and hepatitis C virus (HCV).
Danish: Der er begrænsede data vedrørende sikkerheden og virkningen af Biktarvy hos patienter med samtidig infektion med hiv 1- og hepatitis C-virus (HCV).
English: However, tenofovir disoproxil fumarate reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
Danish: Tenofovirdisoproxilfumarat reducerede imidlertid afkommets levedygtighed og vægt i peri-postnatale toksicitetsstudier ved doser, der var toksiske for moderen.
English: As bictegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis.
Danish: Da bictegravir har en høj bindingsgrad til plasmaproteiner, fjernes det sandsynligvis ikke i betydelig grad ved hæmodialyse eller peritonealdialyse.
English: Because there is a lower tenofovir exposure in rats and mice after the administration of tenofovir alafenamide compared to tenofovir disoproxil fumarate, carcinogenicity studies and a rat peri-postnatal study were conducted only with tenofovir disoproxil fumarate.
Danish: Da der er en lavere eksponering for tenofovir hos rotter og mus efter administration af tenofoviralafenamid sammenlignet med tenofovirdisoproxilfumarat, blev der kun udført karcinogenicitetsstudier og et peri-postnatalt studie hos rotter med tenofovirdisoproxilfumarat.
English: The EC50 values for emtricitabine were in the range of 0.0013 to 0.64 µM.
Danish: EC50-værdierne for emtricitabin var i intervallet fra 0,0013 til 0,64 µM.
English: Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine triphosphate.
Danish: Emtricitabin fosforyleres af celleenzymer til at danne emtricitabintriphosphat.
English: Biktarvy contains tenofovir alafenamide, which is active against hepatitis B virus (HBV).
Danish: Biktarvy indeholder tenofoviralafenamid, som er aktivt mod hepatitis B-virus (HBV).
English:  Do not stop taking Biktarvy if you have hepatitis B. Talk to your doctor first.
Danish:  De må ikke stoppe med at tage Biktarvy, hvis De har hepatitis B. Kontakt lægen først.
English: Tabulated summary of adverse reactions The adverse reactions in Table 2 are listed by system organ class and frequency.
Danish: Bivirkningerne i tabel 2 er opstillet pr. systemorganklasse og hyppighed.
English: Biktarvy should not be taken simultaneously with supplements containing magnesium and/or aluminium due to the expected substantial decrease of bictegravir exposure (see section 4.4).
Danish: Biktarvy bør ikke tages samtidig med tilskud indeholdende magnesium og/eller aluminium på grund af den forventede, betydelige reduktion i eksponeringen for bictegravir (se pkt.
English: Emtricitabine systemic exposure was unaffected when emtricitabine was administered with food and B/F/TAF can be administered with or without food.
Danish: Den systemiske eksponering for emtricitabin blev ikke påvirket, når emtricitabin blev administreret med mad, og B/F/TAF kan administreres sammen med eller uden mad.
English: For more details, see section 3, Do not stop taking Biktarvy.
Danish: De finder yderligere oplysninger i punkt 3, Hold ikke op med at tage Biktarvy.
English: Once you start taking Biktarvy, look out for:
Danish: Når De begynder med at tage Biktarvy, skal De holde øje med:
English: Of those, 9 of the 14 isolates had additional mutations at L74M, T97A, or E138A/K.
Danish: isolater yderligere mutationer ved L74M, T97A eller E138A/K.
English: • Signs of inflammation or infection • Joint pain, stiffness or bone problems
Danish: • Tegn på betændelse eller infektion • Ledsmerter, stivhed eller knogleproblemer
English: Initiation of Biktarvy is not recommended in patients with estimated CrCl below 30 mL/min, as there are insufficient data available regarding the use of Biktarvy in this population (see section 5.2).
Danish: Det frarådes at opstarte behandling med Biktarvy hos patienter med estimeret CrCl under 30 ml/min, da der er utilstrækkelige data vedrørende brug af Biktarvy i denne population (se pkt.
English: • anticonvulsants used to treat epilepsy, containing: - carbamazepine, oxcarbazepine, phenobarbital or phenytoin
Danish: • antikonvulsiva, der anvendes til at behandle epilepsi, og som indeholder: - carbamazepin, oxcarbazepin, phenobarbital eller phenytoin
English: Co-administration of ciclosporin (IV or oral use) is not recommended.
Danish: Samtidig administration af ciclosporin (intravenøs eller oral anvendelse) frarådes.
English: At screening, 15% of patients were receiving abacavir/lamivudine plus atazanavir or darunavir (boosted by either cobicistat or ritonavir) and 85% of patients were receiving emtricitabine/tenofovir disoproxil fumarate plus atazanavir or darunavir (boosted by either cobicistat or ritonavir).
Danish: Ved screeningen fik 15 % af patienterne abacavir/lamivudin plus atazanavir eller darunavir (boostet med enten cobicistat eller ritonavir), og 85 % af patienterne fik emtricitabin/tenofovirdisoproxilfumarat plus atazanavir eller darunavir (boostet med enten cobicistat eller ritonavir).
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Danish: Hos patienter med tidligere tilfælde af leverdysfunktion, herunder kronisk aktiv hepatitis, er der en forhøjet forekomst af unormal leverfunktion under antiretroviral kombinationsbehandling (CART, combination antiretroviral therapy), og disse patienter skal monitoreres i henhold til standardprocedurer.
English: The safety and efficacy of Biktarvy in children under the age of 18 years have not yet been established.
Danish: Biktarvys sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Bictegravir demonstrated equivalent antiviral activity against 5 nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistant, 3 NRTI-resistant, and 4 protease inhibitor (PI)-resistant HIV-1 mutant clones compared with the wild-type strain.
Danish: Bictegravir udviste ækvivalent antiviral aktivitet mod 5 non-nukleosid revers transkriptasehæmmer (NNRTI)-resistente, 3 NRTI-resistente og 4 proteasehæmmer (PI)-resistente hiv 1-mutantkloner sammenlignet med vildtype-stammen.
English: Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may increase concentrations of emtricitabine, and/or the co-administered medicinal product.
Danish: Samtidig administration af emtricitabin og lægemidler, der elimineres ved aktiv tubulær sekretion, kan øge koncentrationerne af emtricitabin og/eller det samtidigt administrerede lægemiddel.
English: Biktarvy comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Danish: Biktarvy fås i tabletbeholdere med 30 tabletter samt i pakninger med 3 tabletbeholdere hver med 30 tabletter.
English: Eighteen percent of patients had baseline viral loads greater than 100,000 copies/mL.
Danish: 18 % af patienterne havde en virusmængde over 100.000 kopier/ml ved baseline.
English: Co-administration is not recommended due to the expected decrease of tenofovir alafenamide.
Danish: Samtidig administration er frarådet på grund af det forventede fald i tenofoviralafenamid.