FrancophonIA/ELRC3.0 huggingface dataset:
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil
Danish: PHOSPHODIESTERASE TYPE 5 (PDE-5)-HÆMMERE Sildenafil
English: EU/1/15/1061/001 30 film-coated tablets EU/1/15/1061/002 90 (3 bottles of 30) film-coated tablets
Danish: EU/1/15/1061/001 30 filmovertrukne tabletter EU/1/15/1061/002 90 (3 tabletbeholdere med 30) filmovertrukne tabletter
English: Clinical monitoring is recommended due to the potential for hyperkalaemia.
Danish: Klinisk monitorering anbefales på grund af risikoen for hyperkaliæmi.
English: FTCa TAFa TFVa EVGe COBIe FTCe TAFf
Danish: EVGa COBIa FTCa TAFa TFVa EVGe COBIe FTCe TAFf
English: Do not give this medicine to children aged 5 years or under, or weighing less than 25 kg regardless of age.
Danish: Denne medicin må ikke gives til børn i alderen 5 år eller derunder eller børn, som vejer under 25 kg uanset alder.
English: It is important not to stop taking Genvoya without talking to your doctor: see section 3, Do not stop taking Genvoya.
Danish: Det er vigtigt ikke at holde op med at tage Genvoya uden at tale med lægen: se punkt 3, Hold ikke op med at tage Genvoya.
English: • heart medicines, such as:
Danish: • hjertemedicin, såsom:
English: Interactions between the components of Genvoya and potential co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Danish: Interaktioner mellem Genvoya-komponenterne og mulige samtidigt administrerede lægemidler ses i tabel 1 nedenfor (stigning er angivet som ”↑”, fald som ”↓”, ingen ændring som ”↔”).
English: 2 These studies were performed with ritonavir boosted elvitegravir.
Danish: 2 Disse studier blev udført med ritonavir-boosted elvitegravir.
English: You should not take Genvoya with medicines containing:
Danish: De må ikke tage Genvoya sammen med lægemidler, der indeholder:
English: However, 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 1.000 eksponerede forsøgspersoner) indikerer imidlertid ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med emtricitabin.
English: Thirteen percent of the dose was recovered in the urine as three putative metabolites.
Danish: Tretten procent af dosis blev genfundet i urinen som tre putative metabolitter.
English: Patients should be informed that dizziness has been reported during treatment with Genvoya.
Danish: Patienter bør informeres om, at svimmelhed er blevet indberettet under behandling med Genvoya.
English: A cumulative review of all cases related to suicide-related events showed a total of 42 valid cases reporting 48 suicide-related events for Genvoya (13 from spontaneous, 29 from clinical trials).
Danish: En kumulativ gennemgang af alle tilfælde i forbindelse med selvmordsrelaterede hændelser viste i alt 42 gyldige tilfælde med indberetning om 48 selvmordsrelaterede hændelser for Genvoya (13 spontane, 29 fra kliniske studier).
English: The median terminal plasma half-life of elvitegravir following administration of E/C/F/TDF is approximately 12.9 hours.
Danish: Den mediane terminale halveringstid i plasma for elvitegravir efter administration af E/C/F/TDF er ca. 12,9 timer.
English: In clinical studies of Genvoya, increases in serum creatinine occurred by Week 2 of treatment and remained stable through 144 weeks.
Danish: I kliniske studier af Genvoya forekom stigningen i serum-kreatinin ved uge 2 af behandlingen, og den forblev stabil til og med uge 144.
English: IMMUNOSUPPRESSANTS Ciclosporin
Danish: IMMUNSUPPRESSIVA Ciclosporin
English: It is recommended that digoxin levels be monitored when digoxin is combined with Genvoya.
Danish: Det anbefales at overvåge digoxinniveauerne, når digoxin kombineres med Genvoya.
English: In virologically suppressed patients
Danish: Hos virologisk supprimerede patienter
English: There are no or limited data (less than 300 pregnancy outcomes) from the use of Genvoya in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af Genvoya til gravide kvinder.
English: Tricyclic antidepressants (TCAs) Trazodone
Danish: Tricykliske antidepressiva (TCA'er) Trazodon
English: abnormal dreams
Danish: unormale drømme
English: The substantial reduction in elvitegravir exposure may result in virological failure and an increased risk of mother-to-child transmission of HIV infection.
Danish: Den væsentlige nedsættelse i eksponering for elvitegravir kan medføre virologisk svigt og en øget risiko for overførsel af hiv-infektion fra mor til barn.
English: Renal excretion of intact tenofovir alafenamide is a minor pathway with < 1% of the dose eliminated in urine.
Danish: Den renale udskillelse af intakt tenofoviralafenamid er en mindre metaboliseringsvej med < 1 % af dosen elimineret i urinen.
English: There were no clinically significant changes in fasting lipid laboratory tests in patients who switched to Genvoya.
Danish: Der var ingen klinisk signifikante ændringer i fastende laboratorieprøver for lipider hos patienter, som skiftede til Genvoya.
English: In treatment-naïve patients
Danish: Hos behandlingsnaive patienter
English: If the combination is needed, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example MondayWednesday-Friday).
Danish: Hvis kombinationen er nødvendig, er den anbefalede dosis rifabutin 150 mg 3 gange ugentligt på faste dage (for eksempel mandagonsdag-fredag).
English: In vitro studies indicate that emtricitabine is not an inhibitor of human CYP enzymes.
Danish: In vitro-studier indikerer, at emtricitabin ikke er en hæmmer af humane CYP-enzymer.
English: Ex vivo binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Danish: Tenofoviralafenamids binding ex vivo til humane plasmaproteiner i prøver indsamlet i løbet af kliniske studier var ca. 80 %.
English: Voriconazole3 Posaconazole3 Fluconazole
Danish: Voriconazol3 Posaconazol3 Fluconazol
English: At baseline, 80 patients (33%) had eGFRCG < 50 mL/min and 162 patients had eGFRCG ≥ 50 mL/min.
Danish: Ved baseline havde 80 patienter (33 %) eGFRCG < 50 ml/min, og 162 patienter havde eGFRCG ≥ 50 ml/min.
English: Of the 62 patients who were HBV suppressed at baseline, 59 remained suppressed and 3 had missing data.
Danish: Ud af de 62 patienter, som var HBV-supprimerede ved baseline, forblev 59 supprimerede, og 3 havde manglende data.
English: Aromatic and aliphatic hydroxylation or glucuronidation metabolites are present in very low levels, displaying considerably lower antiviral activity against HIV-1 and do not contribute to the overall antiviral activity of elvitegravir.
Danish: Metabolitter fra aromatisk og alifatisk hydroxylering og glukuronidation er kun til stede i meget lave niveauer, og udviser betragteligt lavere antiviral aktivitet mod hiv 1 og bidrager ikke til den samlede antivirale aktivitet af elvitegravir.
English: diarrhoea, vomiting, abdominal pain, flatulence
Danish: diarré, opkastning, abdominalsmerter, flatulens
English: Study GS-US-292-0106
Danish: Studie GS-US-292-0106
English: Medicines used in treating hepatitis B infection:
Danish: Lægemidler, der anvendes til behandling af infektion med hepatitis B:
English: If you accidentally take more than the recommended dose of Genvoya 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 tager mere end den anbefalede dosis Genvoya, kan De have større risiko for at få bivirkninger med denne medicin (se punkt 4, Bivirkninger).
English: Changes in serum creatinine
Danish: Ændringer i serum-kreatinin
English: As elvitegravir and cobicistat are highly bound to plasma proteins, it is unlikely that they would be significantly removed by haemodialysis or peritoneal dialysis.
Danish: Da elvitegravir og cobicistat i høj grad er bundet til plasmaproteiner, er det usandsynligt, at de i signifikant grad vil fjernes ved hæmodialyse eller peritonealdialyse.
English: For information on other acid reducing agents (e.g., H2-receptor antagonists and proton pump inhibitors), see “Studies conducted with other medicinal products”.
Danish: For information om andre syrereducerende stoffer (f.eks. H2-receptorantagonister og protonpumpehæmmere), se ”Studier, der blev udført med andre lægemidler”.
English: INR should continue to be monitored during the first weeks following ceasing treatment with Genvoya.
Danish: INR bør stadig overvåges i løbet af de første uger efter behandlingen med Genvoya stoppes.
English: • suicidal thoughts and suicide attempt (in patients who have had depression or mental health problems before), depression
Danish: • selvmordstanker og selvmordsforsøg (hos patienter, som tidligere har haft depression eller psykiske problemer), depression
English: Inhibitors of OATP and BCRP include ciclosporin.
Danish: Hæmmere af OATP og BCRP omfatter ciclosporin.
English: Medicinal products that strongly affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption.
Danish: Lægemidler, der påvirker P-gp- og BCRP-aktiviteten kraftigt, kan føre til ændringer i tenofoviralafenamids absorption.
English: Cobicistat exposures were unaffected by a light meal and although there was a modest decrease of 24% and 18% in Cmax and AUC respectively with a high-fat meal, no difference was observed in its pharmacoenhancing effect on elvitegravir.
Danish: Cobicistateksponeringer var ikke påvirket af et let måltid, og selvom der var en moderat reduktion på hhv. 24 % og 18 % i Cmax og AUC sammen med et måltid med højt fedtindhold, blev der ikke observeret nogen forskel i den farmakoforstærkende virkning på elvitegravir.
English: Women of childbearing potential / contraception in males and females
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder
English: The mean age was 48 years (range 23-64).
Danish: Gennemsnitsalderen var 48 år (interval: 23-64).
English: Some patients taking combination antiretroviral medicines such as Genvoya 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 Genvoya, kan udvikle en knoglesygdom, der kaldes osteonekrose (knoglevævsdød, forårsaget af manglende blodforsyning til knoglerne).
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 anti-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: Patients were randomised in a 2:1 ratio to either switch to Genvoya at baseline (n = 959), or stay on their baseline antiretroviral regimen (n = 477).
Danish: Patienterne blev randomiseret i forholdet 2:1 til enten skift til Genvoya ved baseline (n = 959) eller til at forblive i deres baseline antiretrovirale behandlingsregime (n = 477).
English: Cross-resistance in HIV-1 infected, treatment-naïve or virologically suppressed patients Elvitegravir-resistant viruses show varying degrees of cross-resistance to the INSTI raltegravir depending on the type and number of mutations.
Danish: Krydsresistens hos hiv 1-inficerede, behandlingsnaive eller virologisk supprimerede patienter Elvitegravir-resistente vira viser forskellige grader af krydsresistens over for INSTI raltegravir, afhængigt af typen og antallet af mutationer.
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Genvoya.
Danish: Nøje overvågning af patienten og dosisjustering af metformin anbefales for patienter, som tager Genvoya.
English: No dose adjustment of buprenorphine/naloxone is required.
Danish: Dosisjustering af buprenorphin/naloxon er ikke nødvendig.
English: Talk to your doctor before taking Genvoya: • If you have liver problems or a history of liver disease, including hepatitis.
Danish: Kontakt lægen, før De tager Genvoya: • Hvis De har leverproblemer, eller hvis De tidligere har haft en leversygdom, herunder hepatitis (gulsot).
English: Sofosbuvir metabolite GS-566500:
Danish: Sofosbuvir metabolit GS-566500:
English: atorvastatin and pitavastatin
Danish: atorvastatin og pitavastatin
English: As the effect of cationic complexation of elvitegravir cannot be excluded when Genvoya is co-administered with multivitamin supplements, it is recommended to separate Genvoya and multivitamin supplements dosing by at least 4 hours.
Danish: Da virkningen af kationisk kompleksation af elvitegravir ikke kan udelukkes, når Genvoya administreres sammen med multivitamin-tilskud, anbefales det at forskyde administrationen af Genvoya og multivitamin-tilskud med mindst 4 timer.
English: Itraconazole3
Danish: Itraconazol3
English: For elvitegravir, Cmax and AUC increased 22% and 36% with a light meal, and 56% and 91% with a high-fat meal, relative to fasting conditions.
Danish: For elvitegravir var Cmax og AUC øget med hhv. 22 % og 36 % sammen med et let måltid og 56 % og 91 % sammen med et måltid med højt fedtindhold sammenlignet med fastende tilstand.
English: Cobicistat is an inhibitor of the following transporters: P-gp, breast cancer resistance protein (BCRP), organic anion transporting polypeptide (OATP) 1B1 and OATP1B3.
Danish: Cobicistat er en hæmmer af de følgende transportere: P-gp, brystcancer-resistensprotein (BCRP), organisk aniontransporterende polypeptid (OATP) 1B1 og OATP1B3.
English: An assessment of benefit/risk ratio is recommended to justify use of voriconazole with Genvoya.
Danish: En vurdering af forholdet mellem fordele og risici anbefales for at berettige anvendelsen af voriconazol sammen med Genvoya.
English: Limited data from population pharmacokinetic analysis (n = 24) indicated that hepatitis B and/or C virus infection had no clinically relevant effect on the exposure of boosted elvitegravir.
Danish: Begrænsede data fra en populationsfarmakokinetisk analyse (n = 24) indikerede, at infektion med hepatitis B- og/eller hepatitis C-virus ikke havde nogen klinisk relevant virkning på eksponeringen for boosted elvitegravir.
English:  Tell your doctor if you are taking any of these medicines.
Danish:  Fortæl altid lægen, hvis De tager nogen af disse lægemidler.
English: Reduced susceptibility to emtricitabine is associated with M184V/I mutations in HIV-1 RT.
Danish: Nedsat følsomhed for emtricitabin er forbundet med M184V/I-mutationer i hiv 1 RT.
English: • PDE-5 inhibitors: sildenafil for the treatment of pulmonary arterial hypertension
Danish: • PDE-5-hæmmere: sildenafil til behandling af pulmonal arteriel hypertension
English: Genvoya [Outer packaging only]
Danish: Genvoya [kun på den ydre emballage]
English: It is recommended to separate Genvoya and antacid administration by at least 4 hours.
Danish: Det anbefales at forskyde administrationen af Genvoya og antacida med mindst 4 timer.
English: Based on non-CYP-mediated elimination pathways for lorazepam, no effect on plasma concentrations is expected upon co-administration with Genvoya.
Danish: Baseret på eliminationsveje ikke medieret af CYP for lorazepam forventes der ingen virkning på plasmakoncentrationer ved samtidig administration af Genvoya.
English: Co-administration with medicinal products that are substrates of P-gp, BCRP, OATP1B1 and OATP1B3 may result in increased plasma concentrations of these products.
Danish: Samtidig administration med lægemidler, der er substrater for P-gp, BCRP, OATP1B1 og OATP1B3, kan føre til øgede plasmakoncentrationer af disse præparater.
English: The safety and efficacy of Genvoya in children younger than 6 years of age, or weighing < 25 kg, have not yet been established.
Danish: Genvoyas sikkerhed og virkning hos børn under 6 år, eller der vejer < 25 kg, er endnu ikke klarlagt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Genvoya 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 Genvoya i en eller flere undergrupper af den pædiatriske population ved behandlingen af human hiv 1-infektion (se pkt.
English: • cobicistat, a booster (pharmacokinetic enhancer) of the effects of elvitegravir
Danish: • cobicistat, en booster (farmakokinetisk forstærkende stof) af elvitegravirs virkning
English: Clarithromycin dosing should be based on the patient's CrCl, taking into consideration the effect of cobicistat on CrCl and serum creatinine (see section 4.8).
Danish: Dosering med clarithromycin bør baseres på patientens CrCl, når virkningen af cobicistat på CrCl og serum-kreatinin tages i betragtning (se pkt.
English: Genvoya comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Danish: Genvoya leveres i tabletbeholdere, der indeholder 30 tabletter (med et silicagel-tørremiddel, der skal opbevares i beholderen for at hjælpe med at beskytte tabletterne).
English: One patient in the Genvoya group (1 of 22 [4.5%]) and 2 patients in the E/C/F/TDF group (2 of 20 [10%]) had reduced susceptibility to tenofovir.
Danish: En patient i Genvoya-gruppen (1 ud af 22 [4,5 %]) og 2 patienter i E/C/F/TDF-gruppen (2 ud af 20 [10 %]) havde nedsat følsomhed for tenofovir.
English: • immunosuppressants, used to control your body's immune response after a transplant, such as: ciclosporin, sirolimus and tacrolimus
Danish: • immunundertrykkende midler, anvendes til at kontrollere kroppens immunrespons efter en transplantation, såsom: - ciclosporin, sirolimus og tacrolimus
English: Most HIV-1 isolates from patients in both treatment groups who developed resistance mutations to elvitegravir developed resistance mutations to both emtricitabine and elvitegravir.
Danish: De fleste hiv 1-isolater fra patienter i begge behandlingsgrupper, der udviklede resistensmutationer over for elvitegravir, udviklede også resistensmutationer over for både emtricitabin og elvitegravir.
English: You must remain under the care of your doctor while taking Genvoya.
Danish: De skal fortsætte med at være under lægens opsyn, mens De tager Genvoya.
English: If Genvoya is stopped for any reason, speak to your doctor before you restart taking Genvoya tablets.
Danish: Hvis Genvoya stoppes uanset årsagen, skal De tale med Deres læge, før De igen begynder at tage Genvoya tabletter.
English: Non-black
Danish: Ikke sort
English: • bronchodilators, used to treat asthma and other lung-related problems: salmeterol
Danish: • bronkodilatorer, anvendes til at behandle astma og andre lungerelaterede problemer: salmeterol
English: bosentan and tadalafil
Danish: bosentan og tadalafil
English: At Week 48, the virologic response rate to Genvoya in treatment-naïve HIV-1 infected adolescents was similar to response rates in studies of treatment-naïve HIV-1 infected adults.
Danish: Ved 48 uger var den virologiske responsrate på Genvoya hos behandlingsnaive hiv 1-inficerede unge sammenlignelig med responsrater i studier af behandlingsnaive hiv 1-inficerede voksne.
English: Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI).
Danish: Elvitegravir er en hiv 1-integrase strand transfer-hæmmer (INSTI).
English: Adolescents aged 12 to < 18 years, ≥ 35 kg
Danish: Unge i alderen 12 til < 18 år, ≥ 35 kg
English: Patients co-infected with HIV and HBV who discontinue Genvoya 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 Genvoya, bør monitoreres tæt med både klinisk og laboratorisk opfølgning i mindst adskillige måneder efter, behandlingen med Genvoya ophører.
English: Elvitegravir, cobicistat, and emtricitabine have all demonstrated low carcinogenic potential in mice and rats.
Danish: Elvitegravir, cobicistat og emtricitabin har alle vist lav karcinogenicitet hos mus og rotter.
English: Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Danish: Emtricitabin udskilles primært gennem nyrerne med komplet genfinding af dosis opnået i urin (ca. 86 %) og fæces (ca. 14 %).
English: Reduced susceptibility to elvitegravir is most commonly associated with the primary integrase mutations T66I, E92Q, and Q148R.
Danish: Nedsat følsomhed for elvitegravir er hyppigst forbundet med de primære integrasemutationer T66I, E92Q og Q148R.
English: For the treatment of erectile dysfunction, it is recommended that a single dose of sildenafil no more than 25 mg in 48 hours, vardenafil no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg in 72 hours be co-administered with Genvoya.
Danish: Til behandling af erektionsproblemer anbefales det, at en enkeltdosis af sildenafil på ikke over 25 mg hver 48. time, vardenafil på ikke over 2,5 mg hver 72. time eller tadalafil på ikke over 10 mg hver 72. time administreres sammen med Genvoya.
English: Genvoya contains lactose
Danish: Genvoya indeholder lactose
English: Elvitegravir plasma concentrations are lower with antacids due to local complexation in the gastrointestinal tract and not to changes in gastric pH.
Danish: Elvitegravir plasmakoncentrationer er lavere med antacida på grund af lokal kompleksation i mave-tarmkanalen og ikke på grund af ændringer i gastrisk pH.
English: Viruses expressing the T66I/A mutations maintain susceptibility to raltegravir, while most other patterns showed reduced susceptibility to raltegravir.
Danish: Vira, der udtrykker T66I/A-mutationer, bevarer følsomhed for raltegravir, mens de fleste andre mønstre viste en nedsat følsomhed for raltegravir.
English: Cobicistat increases serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function.
Danish: Cobicistat øger serum-kreatinin på grund af hæmning af den tubulære sekretion af kreatinin, uden at den renale glomerulære funktion påvirkes.
English: Genvoya is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:
Danish: Genvoya er indiceret til behandling af infektion med humant immundefekt virus 1 (hiv 1) uden nogen kendte mutationer forbundet med resistens over for integrasehæmmerklassen, emtricitabin eller tenofovir som følger:
English: Start with the lowest possible dose of atorvastatin with careful monitoring upon co-administration with Genvoya.
Danish: Start med den lavest mulige dosis atorvastatin under nøje monitorering ved samtidig administration af Genvoya.
English: • medicines used to treat pulmonary arterial hypertension:
Danish: • lægemidler, der anvendes til at behandle pulmonal arteriel hypertension:
English: Concentrations of other benzodiazepines, including diazepam, may be increased when administered with Genvoya.
Danish: Koncentrationer af andre benzodiazepiner, herunder diazepam, kan øges ved administration med Genvoya.
English: Additional integrase mutations observed in cell culture selection included H51Y, F121Y, S147G, S153Y, E157Q, and R263K.
Danish: Yderligere integrasemutationer, som blev observeret ved cellekulturselektion, omfattede H51Y, F121Y, S147G, S153Y, E157Q og R263K.
English: Contents of the pack and other information What Genvoya contains
Danish: Pakningsstørrelser og yderligere oplysninger Genvoya indeholder:
English: Tenofovir is eliminated from the body by the kidneys by both glomerular filtration and active tubular secretion.
Danish: Tenofovir elimineres fra kroppen af nyrerne, både ved glomerulusfiltration og aktiv tubulær sekretion.