FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Danish: Hver filmovertrukket tablet indeholder 300 mg aliskiren (som hemifumarat), 5 mg amlodipin (som besylat) og 12,5 mg hydrochlorthiazid.
English: Rasitrio 300 mg/10 mg/12.5 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide
Danish: Rasitrio 300 mg/10 mg/12,5 mg filmovertrukne tabletter Aliskiren/amlodipin/hydrochlorthiazid
English: • itching, itchy rash (urticaria)
Danish: • kløe, kløende udslæt (nældefeber)
English: • weight decrease.
Danish: Stærkt nedsat leverfunktion.
English: Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide
Danish: Rasitrio 300 mg/5 mg/12,5 mg filmovertrukne tabletter Aliskiren/amlodipin/hydrochlorthiazid
English: The combination of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) and is not recommended in other patients (see sections 4.3,
Danish: Kombination af aliskiren med ARB'er eller ACE-hæmmere er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) og frarådes til andre patienter (se pkt.
English: • severe upper stomach pain
Danish: • kraftig smerte i øvre del af maven
English: (medicines used to treat heart problems) and some antipsychotics.
Danish: Diuretika bruges også til behandling af visse hjerteproblemer (hjertesvigt) eller ophobning af væske (ødem).
English: • swelling
Danish: Horsham
English: • dizziness.
Danish: • alment udslæt
English: • abdominal discomfort
Danish: • ubehag i maven
English: • itching; rash
Danish: • kløe; udslæt
English: - if you suffer from a disease called lupus erythematosus (also called “lupus” or “SLE”).
Danish: - hvis du har leverproblemer (nedsat leverfunktion) - hvis du har sukkersyge (diabetes, højt blodsukker) - hvis du har et højt niveau af kolesterol eller triglycerider i blodet - hvis du lider af en sygdom kaldet lupus erythematosus (også kaldet ”lupus” eller ”SLE”) - hvis du har allergi eller astma - hvis du tager nogen af følgende typer medicin, som anvendes til at behandle for højt blodtryk:
English: 1 or more bags each with 1 luer spike interconnector
Danish: 1 eller flere poser med hver 1 luer-lock sammenkobling
English: EU/1/16/1097/001 Strimvelis million cells/ml
Danish: EU/1/16/1097/001
English: Patient specific up to 50 ml max
Danish: Intravenøs anvendelse pose (EVA) Patientspecifik op til højst 50 ml
English: MA (EU) number Invented name Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: One tablet to be taken once daily.
Danish: Én tablet tages én gang dagligt.
English: The disease may then become harder to treat.
Danish: Sygdommen kan så blive sværere at behandle.
English: • If you are currently taking any of the following medicines:
Danish: • Hvis De for tiden tager et af disse lægemidler:
English: Date of first authorisation: 21 June 2018
Danish: Dato for første markedsføringstilladelse: 21 juni 2018
English: B/F/TAF was non-inferior to the control regimen in both studies.
Danish: B/F/TAF var non-inferiør i forhold til kontrolregimet i begge studier.
English: No other metabolites were identifiable.
Danish: Ingen andre metabolitter kunne identificeres.
English: Then take the next dose as usual.
Danish: Derefter tages den næste dosis som sædvanligt.
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Danish: Hyppigheden af de følgende bivirkninger er ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: Other effects that may be seen during HIV treatment
Danish: Andre bivirkninger, der kan observeres under hiv-behandling
English: Changes in bilirubin
Danish: Ændringer i bilirubin
English: Biktarvy contains three active substances:
Danish: Biktarvy indeholder tre aktive stoffer:
English: Each tablet is approximately 15 mm × 8 mm.
Danish: Hver tablet er cirka 15 mm × 8 mm.
English: This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Danish: Dette er meget vigtigt, da virusmængden igen kan begynde at stige, hvis medicinen stoppes, selv i kort tid.
English: Wait and take the next dose at your usual time.
Danish: Vent og tag den næste dosis til sædvanlig tid.
English: In some cases, your doctor may need to adjust your dose or check your blood levels.
Danish: I nogle tilfælde kan det være nødvendigt, at lægen justerer Deres dosis eller kontrollerer Deres blod.
English: This medicine is not a cure for HIV infection.
Danish: Denne medicin helbreder ikke hiv-infektionen.
English: This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection.
Danish: Dette vil forbedre Deres immunsystem og nedsætte risikoen for at udvikle sygdomme forbundet med hiv-infektionen.
English: The clinical relevance of this feature is not established.
Danish: Den kliniske relevans af denne egenskab er ikke klarlagt.
English: Renal clearance of the unchanged parent was minimal.
Danish: Den renale clearance af uændret moderstof var minimal.
English: Biktarvy should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Biktarvy bør kun anvendes under graviditet, hvis den potentielle fordel berettiger den potentielle risiko for fosteret.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: • Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De tager dette lægemiddel.
English: There are limited data on the use of Biktarvy in patients aged 65 years and over.
Danish: Der er begrænsede data vedrørende brug af Biktarvy hos patienter på 65 år og derover.
English: If you have taken Biktarvy 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 Biktarvy under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: If the combination is needed, clinical and biological monitoring, notably renal function, is recommended.
Danish: Hvis kombinationen er nødvendig, anbefales klinisk og biologisk monitorering, især af nyrefunktionen.
English: Children and adolescents Do not give this medicine to children and adolescents under 18 years of age.
Danish: Børn og unge Denne medicin må ikke gives til børn og unge under 18 år.
English: (may affect up to 1 in 100 people)
Danish: (kan forekomme hos op til 1 ud af 100 personer)
English: • suicidal behaviour
Danish: • selvmordsadfærd
English: In order to avoid transmission of HIV to the infant it is recommended that HIV-infected women do not breast-feed their infants under any circumstances.
Danish: For at undgå overførsel af hiv til spædbørn anbefales det, at hiv-inficerede kvinder under ingen omstændigheder ammer deres børn.
English: • If you have hepatitis B infection.
Danish: • Hvis De har hepatitis B-infektion.
English: Frequencies are defined as follows: common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Danish: Hyppighed er defineret som følger: almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1000 til < 1/100).
English: Biktarvy reduces the amount of HIV in your body.
Danish: Biktarvy nedsætter mængden af hiv i Deres krop.
English: • problems with digestion resulting in discomfort after meals (dyspepsia)
Danish: • problemer med fordøjelsen, som resulterer i ubehag efter måltider (dyspepsi)
English: It is thought that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Det menes, at disse symptomer skyldes en forbedring af kroppens immunreaktion, hvilket gør kroppen i stand til at bekæmpe infektioner, der kan have været til stede uden nogen tydelige symptomer.
English: b Week 96 window was between Day 631 and 714 (inclusive).
Danish: b Uge 96-vindue var fra dag 631 til 714 (inklusive).
English: Blood tests may also show: • higher levels of substances called bilirubin and/or serum creatinine in the blood
Danish: Blodprøver kan også vise: • højere niveauer af stofferne bilirubin og/eller serumkreatinin i blodet
English: Table 1: Interactions between Biktarvy or its individual component(s) and other medicinal products
Danish: Tabel 1: Interaktioner mellem Biktarvy eller dets individuelle indholdsstof(fer) og andre lægemidler
English: Patients must have been stably suppressed on their baseline regimen for at least 6 months and must not have been previously treated with any INSTI.
Danish: Patienterne skulle have haft stabil supprimering med deres regime ved baseline i mindst 6 måneder og måtte ikke have modtaget tidligere behandling med nogen INSTI.
English: Medicinal product by therapeutic areas/possible mechanism of interaction
Danish: terapeutisk område/mulig interaktionsmekanisme
English: Increases in serum creatinine occurred by Week 4 of treatment and remained stable through Week 96.
Danish: Stigninger i serumkreatinin forekom ved uge 4 af behandlingen og forblev stabil til og med uge 96.
English: • Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines for HIV infection.
Danish: • Autoimmunsygdomme, når immunsystemet angriber sundt kropsvæv, kan også opstå, efter De begynder at tage lægemidler for hiv-infektion.
English: Treatment of overdose with Biktarvy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Danish: Behandling af overdosering med Biktarvy består af generel støttebehandling, herunder overvågning af vitale tegn og observation af patientens kliniske status.
English: The assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies with Biktarvy and from post-marketing experience.
Danish: Vurderingen af bivirkninger er baseret på sikkerhedsdata fra alle fase 2- og 3-studier med Biktarvy samt på erfaringer efter markedsføring.
English: The mean absolute bioavailability of emtricitabine from 200 mg hard capsules was 93%.
Danish: Den gennemsnitlige absolutte biotilgængelighed af emtricitabin fra 200 mg hårde kapsler var 93 %.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after {EXP}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og tabletbeholderen efter {EXP}.
English: Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease.
Danish: Indtagelse af denne type medicin i lang tid, indtagelse af binyrebarkhormoner, indtagelse af alkohol, et meget svagt immunsystem og overvægt kan være nogle af de mange risikofaktorer for at udvikle denne sygdom.
English: Keep or take the tablet bottle with you so that you can easily describe what you have taken.
Danish: Tag tabletbeholderen med, så De let kan vise, hvad De har taget.
English: Missing data during window but on study drug
Danish: Manglende data i tidsvinduet, men får studiemedicin
English: IMMUNOSUPPRESSANTS Ciclosporin (IV or oral use)
Danish: IMMUNSUPPRESSIVA Ciclosporin (intravenøs eller oral anvendelse)
English: (Chelation with polyvalent cations)
Danish: (Kelation med polyvalente kationer)
English: The relevance of these in vitro cross-resistance data remains to be established in clinical practice.
Danish: Relevansen af disse in vitro-data vedrørende krydsresistens er endnu ikke klarlagt i klinisk praksis.
English: Emtricitabine is excreted in human milk.
Danish: Emtricitabin udskilles i human mælk.
English: • antibiotics used to treat bacterial infections, containing:
Danish: • antibiotika, der anvendes til at behandle bakterieinfektioner, og indeholder:
English: The susceptibility of bictegravir was tested against 64 INSTI-resistant clinical isolates (20 with single substitutions and 44 with 2 or more substitutions).
Danish: Følsomheden over for bictegravir blev testet mod 64 INSTI-resistente kliniske isolater (20 med enkelte substitutioner og 44 med 2 eller flere substitutioner).
English: Therefore patients should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Danish: Derfor skal patienterne forblive under tæt klinisk observation af læger med erfaring i behandling af hiv-associerede sygdomme.
English: • rifampicin used to treat some bacterial infections such as tuberculosis
Danish: • rifampicin anvendes til at behandle visse bakterieinfektioner som f.eks. tuberkulose
English: Ελλάδα Gilead Sciences Ελλάς Μ.ΕΠΕ.
Danish: Gilead Sciences Ελλάς Μ.ΕΠΕ.
English: There is no specific antidote for overdose with Biktarvy.
Danish: Der er ingen specifik antidot mod overdosering med Biktarvy.
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
Danish: Hvis De har hepatitis B-infektion, vil lægen overveje nøje, hvilken behandling, der er bedst for Dem.
English: The film-coated tablets should not be chewed, crushed or split.
Danish: Den filmovertrukne tablet må ikke tygges, knuses eller deles.
English: It is also recommended that you do not breast-feed to avoid passing the virus to the baby in breast milk.
Danish: Det anbefales, at De ikke ammer for at undgå at overføre virus til barnet via mælken.
English: Emtricitabine can be removed by hemodialysis, which removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of emtricitabine dosing.
Danish: Emtricitabin kan fjernes ved hæmodialyse, som fjerner cirka 30 % af emtricitabindosen i løbet af en 3-timers dialyseperiode, der opstartes inden for 1,5 time efter dosering af emtricitabin.
English: depression, abnormal dreams
Danish: depression, unormale drømme
English: Thirteen percent of the dose was recovered in the urine as three putative metabolites.
Danish: 13 % af dosis blev genfundet i urinen som tre formodede metabolitter.
English: One patient had missing HBV DNA data at Week 48.
Danish: Der manglede HBV-dna-data for én patient ved uge 48.
English: Oxcarbazepine Phenobarbital Phenytoin
Danish: Oxcarbazepin Phenobarbital Phenytoin
English: Four patients administered Biktarvy (1%) had grade 3 bilirubin increases that were not considered related to study drug.
Danish: Fire patienter, som fik Biktarvy (1 %) havde grad 3 stigninger i bilirubin, der ikke blev anset som relateret til studielægemidlet.
English: Biktarvy and calcium-containing supplements can be taken together, without regard to food.
Danish: Biktarvy og calciumholdige tilskud kan tages sammen, uden hensyntagen til mad.
English: Adults: one tablet each day with or without food Do not chew, crush or split the tablet.
Danish: Voksne: en tablet om dagen sammen med eller uden mad Tabletten må ikke tygges, knuses eller deles.
English: Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.
Danish: Tenofovir fjernes effektivt ved hæmodialyse med en ekstraktionskoefficient på ca. 54 %.
English: Ask your doctor or pharmacist for advice before taking any medicine when pregnant.
Danish: Spørg Deres læge eller apotekspersonalet til råds, før De tager nogen form for medicin under graviditet.
English: As a result, the amounts of Biktarvy or other medicines in your blood may change.
Danish: Som et resultat heraf kan mængden af Biktarvy eller anden medicin i Deres blod påvirkes.
English: HIV-1 infected, treatment-naïve patients
Danish: Hiv 1-inficerede, behandlingsnaive patienter
English: In animal studies it has been shown that tenofovir is excreted in milk.
Danish: Det er blevet vist i dyrestudier, at tenofovir udskilles i mælk.
English: Look out for any symptoms of infection or other symptoms such as: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity
Danish: Vær opmærksom på symptomer på infektion eller andre symptomer, såsom: muskelsvaghed svaghed, der begynder i hænder og fødder og bevæger sig op mod selve kroppen hjertebanken, rysten eller hyperaktivitet
English: g Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Danish: g Omfatter patienter, som afbrød behandlingen som følge af en AE eller død på et tidspunkt fra dag 1 og i løbet af tidsvinduet, hvis dette ikke resulterede i virologiske data om behandlingen i løbet af det specificerede tidsvindue.
English: • mineral supplements or vitamins containing magnesium or iron
Danish: • mineraltilskud eller vitaminer, der indeholder magnesium eller jern
English: If you have both HIV infection and hepatitis B, it is especially important not to stop your Biktarvy treatment without talking to your doctor first.
Danish: Hvis De har både hiv-infektion og hepatitis B, er det særlig vigtigt ikke at ophøre med behandlingen med Biktarvy uden først at konsultere Deres læge.
English: In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving emtricitabine with other medicinal products is low.
Danish: In vitro- og kliniske farmakokinetiske lægemiddelinteraktionsstudier har vist, at potentialet for CYP-medierede interaktioner, der involverer emtricitabin og andre lægemidler, er lav.
English: A dose adjustment of metformin should be considered if required.
Danish: Om nødvendigt bør det overvejes at justere dosen af metformin.
English: Effects on medicinal product levels.
Danish: Virkning på lægemiddelkoncentrationer.
English: The plasma emtricitabine half-life was approximately 10 hours.
Danish: Emtricitabins halveringstid i plasma var cirka 10 timer.
English: (Inhibition of OCT2/MATE1)
Danish: (Hæmning af OCT2/MATE1)
English: Autoimmune disorders may occur many months after the start of treatment.
Danish: Autoimmunsygdomme kan opstå mange måneder efter behandlingsstart.
English: Medicines that must never be taken with Biktarvy:
Danish: Lægemidler, der aldrig må tages sammen med Biktarvy:
English: In children whose mothers took nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Danish: For de børn, hvis mødre har taget nukleosid-revers transkriptase-hæmmere (NRTI'er) i løbet af graviditeten, opvejede fordelen ved beskyttelse mod hiv risikoen ved bivirkningerne.
English: If you take more than the recommended dose of Biktarvy you may be at higher risk of side effects of this medicine (see section 4, Possible side effects).
Danish: Hvis De ved et uheld tager mere end den anbefalede dosis Biktarvy, kan De have højere risiko for at få bivirkninger med denne medicin (se punkt 4, Bivirkninger).
English: Medicinal products that decrease renal function may increase concentrations of emtricitabine.
Danish: Lægemidler, der nedsætter nyrefunktionen, kan øge koncentrationerne af emtricitabin.
English: Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets.
Danish: Hver tabletbeholder indeholder et silicagel-tørremiddel, der skal opbevares i tabletbeholderen for at hjælpe med at beskytte tabletterne.
English: The protein-adjusted EC95 of bictegravir was 361 nM (0.162 µg/mL) for wild type HIV-1 virus.
Danish: Det proteinjusterede EC95 af bictegravir var 361 nM (0,162 µg/ml) for vildtype-hiv 1-virus.
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: 1 With the exception of angioedema, anaemia and urticaria (see footnotes 2, 3 and 4), all adverse reactions were identified from Biktarvy clinical studies.
Danish: 1 Med undtagelse af angioødem, anæmi og urticaria (se fodnote 2, 3 og 4) blev alle bivirkninger identificeret på baggrund af kliniske studier med Biktarvy.
English: Treatment outcomes between treatment groups were similar across subgroups by age, sex, race, and region.
Danish: Behandlingsresultaterne mellem behandlingsgrupperne var ensartede på tværs af undergrupper ud fra alder, køn, race og region.
English: Biktarvy should not be co-administered with other antiretroviral medicinal products.
Danish: Biktarvy bør ikke administreres samtidig med andre antiretrovirale lægemidler.
English: No virologic data at week 48 or 96 window Discontinued study drug due to AE or deathg
Danish: Ingen virologiske data ved uge 48- eller 96-vinduet Seponerede studiemedicin som følge af AE eller dødg
English: • mineral supplements or vitamins containing magnesium or iron  See section 2 for more information on taking these medicines with Biktarvy.
Danish: • mineraltilskud eller vitaminer, der indeholder magnesium eller jern  Se punkt 2 for yderligere oplysninger om brug af disse lægemidler sammen med Biktarvy.
English: Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Danish: Relevante eksempler omfatter cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og Pneumocystis jirovecii pneumoni.
English: Liver problems may become worse after you stop taking Biktarvy.
Danish: Leverproblemer kan forværres, når De stopper med at tage Biktarvy.
English: • ulcer-healing medicines containing sucralfate  Tell your doctor if you are taking any of these medicines.
Danish: • lægemidler til heling af mavesår, der indeholder sucralfat  Fortæl det til lægen, hvis De tager nogen af disse lægemidler.
English: While taking Biktarvy you may still develop infections or other illnesses associated with HIV infection.
Danish: Mens De tager Biktarvy, kan De stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.
English: Following administration of [14C]-emtricitabine, complete recovery of the emtricitabine dose was achieved in urine (~86%) and faeces (~14%).
Danish: Efter administration af [14C]-emtricitabin blev hele emtricitabin-dosis genfundet i urin (~ 86 %) og i fæces (~ 14 %).
English: Bictegravir is both a P-gp and a BCRP substrate.
Danish: Bictegravir er både et P-gp- og et BCRP-substrat.
English: The 50% effective concentration (EC50) values for bictegravir were in the range of < 0.05 to 6.6 nM.
Danish: De 50 % effektive koncentrationsværdier (EC50) for bictegravir var i intervallet < 0,05 til 6,6 nM.
English: Bictegravir is primarily eliminated by hepatic metabolism.
Danish: Bictegravir elimineres primært via hepatisk metabolisme.
English: EU/1/18/1289/001 30 film-coated tablets EU/1/18/1289/002 90 (3 bottles of 30) film-coated tablets
Danish: EU/1/18/1289/001 30 filmovertrukne tabletter EU/1/18/1289/002 90 (3 tabletbeholdere med 30) filmovertrukne tabletter
English: If Biktarvy is stopped for any reason, speak to your doctor before you restart taking Biktarvy tablets.
Danish: Hvis Biktarvy stoppes uanset årsagen, skal De tale med Deres læge, før De igen begynder at tage Biktarvy tabletter.
English: Patients should be advised that Biktarvy or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Danish: Patienter skal informeres om, at Biktarvy eller anden antiretroviral behandling ikke kurerer hivinfektion, og at de stadig kan udvikle opportunistiske infektioner og andre komplikationer forbundet med hiv-infektion.