FrancophonIA/ELRC3.0 huggingface dataset:
English: In rats, ossification changes in the spinal column and sternebrae of fetuses occurred at a dose that produced significant maternal toxicity.
Danish: Hos rotter opstod der ossifikationsændringer i rygsøjle og sternum hos fostre ved en dosis, der medførte signifikant maternel toksicitet.
English: Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at mean concentrations at least 10-fold higher than the human exposure at the recommended 150 mg daily dose.
Danish: Ex vivo-studier af kaniner og in vivo-studier hos hunde tyder på, at cobicistat har et lavt potentiale for QT-forlængelse og kan forlænge PR-intervallet let og reducere venstre ventrikelfunktion ved gennemsnitskoncentrationer, der er mindst 10 gange højere end den humane eksponering ved den anbefalede daglige dosis på 150 mg.
English: The median increases from baseline were greater in the D/C/F/TAF group compared with the DRV/ cobicistat (COBI)+F/ tenofovir disoproxil fumarate (TDF) group at Week 48.
Danish: Middelstigningerne fra baseline var større i D/C/F/TAF-gruppen sammenlignet med DRV/cobicistat (COBI)+F/tenofovirdisoproxilfumarat (TDF)-gruppen ved uge 48.
English: Emerging Resistance in AMBER and EMERALD Trial (Week 96)
Danish: Ny resistens i AMBER- og EMERALD-studiet (uge 96)
English: Maximum plasma concentrations of darunavir, cobicistat, emtricitabine and tenofovir alafenamide were achieved at 4.00, 4.00, 2.00, and 1.50 hours after dosing, respectively.
Danish: Maksimale plasmakoncentrationer af darunavir, cobicistat, emtricitabin og tenofoviralafenamid blev opnået henholdsvis 4,00, 4,00, 2,00 og 1,50 timer efter dosering.
English: The absolute bioavailability of a single 600 mg dose of darunavir alone was approximately 37% and increased to approximately 82% in the presence of 100 mg twice daily ritonavir.
Danish: Den absolutte biotilgængelighed af en enkelt dosis darunavir på 600 mg alene var ca. 37 % og øgedes til ca. 82 % ved kombination med 100 mg ritonavir to gange dagligt.
English: The data from these studies showed that the overall safety profile of components of Symtuza in paediatric patients aged 12 to < 18 years and weighing at least 40 kg was similar to that observed in the adult population (see section 5.1).
Danish: Data fra disse studier viste, at den generelle sikkerhedsprofil for komponenterne i Symtuza hos pædiatriske patienter i alderen 12 til < 18 år og med en vægt på mindst 40 kg svarede til den, der ses hos den voksne population (se pkt.
English: Virologic response was defined as a decrease in plasma HIV-1 RNA viral load of at least 1.0 log10 versus baseline (see Table 7).
Danish: Virologisk respons blev defineret som et fald i hiv-1 RNA virusbelastning i plasma på mindst 1,0 log10 vs baseline (se tabel 7).
English: Expected interactions between Symtuza with potential concomitant medicinal products are listed in Table 1 below and are based on the studies conducted with the components of Symtuza, as individual agents or combined, or are potential drug interactions that may occur.
Danish: Forventede interaktioner mellem Symtuza og potentielle samtidige lægemidler er anført i tabel 1 nedenfor og er baseret på de studier, der er udført med komponenterne i Symtuza som individuelle midler eller i kombination, eller er potentielle lægemiddelinteraktioner, der kan forekomme.
English: However, tenofovir disoproxil reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
Danish: Tenofovirdisoproxil reducerede imidlertid afkommets levedygtighed og vægt i et peri-postnatalt toksicitetsstudie ved maternelt toksiske doser.
English: Following administration of [
Danish: Efter administration af [
English: There are pharmacokinetic data for the (individual) components of Symtuza.
Danish: Der findes farmakokinetiske data for de enkelte komponenter i Symtuza.
English: Third trimester of pregnancy N = 6
Danish: Tredje trimester af graviditeten (n = 6)
English: Symtuza is indicated for use as a complete regimen for the treatment of HIV-1 infection and should not be administered with other antiretroviral products (see section 4.5).
Danish: Symtuza er indiceret til brug som et komplet regime til behandling af hiv-1-infektion, og det bør ikke administreres sammen med andre antiretrovirale lægemidler (se pkt.
English: There are some medicines that you must not combine with Symtuza.
Danish: Der findes visse typer medicin, som du ikke må tage sammen med Symtuza.
English: Its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
Danish: Du må kun bruge disse lægemidler efter en lægelig vurdering og under tæt lægelig overvågning for kortikosteroid-bivirkninger.
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Danish: Patienter, som anvender østrogener som hormonerstatningsbehandling, skal monitoreres klinisk for tegn på østrogenmangel.
English: The dosage of other medicines might need to be changed since either their own or Symtuza's therapeutic effect or side effects may be influenced when combined.
Danish: Doseringen af anden medicin skal muligvis ændres, da virkningen eller bivirkningerne af enten denne eller Symtuza kan blive påvirket, når de kombineres.
English: This effect on serum creatinine, leading to a decrease in the estimated creatinine clearance, should be taken into consideration when Symtuza is administered to patients, in whom the estimated creatinine clearance is used to guide aspects of their clinical management,including adjusting doses of co-administered medicinal products.
Danish: Denne effekt på serumkreatinin, der fører til et fald i den estimerede kreatininclearance, skal tages i betragtning, når Symtuza administreres til patienter, for hvem den estimerede kreatininclearance anvendes som vejledning for den kliniske behandling, herunder dosisjustering af samtidigt administrerede lægemidler.
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Danish: Tegnene på osteonekrose omfatter stivhed, ømhed og smerter i led (især hofter, knæ og skuldre) samt problemer med at bevæge sig.
English: C]-darunavir trial in healthy volunteers showed that a majority of the radioactivity in plasma after a single 400/100 mg darunavir with ritonavir dose was due to the parent active substance.
Danish: C]-darunavir-studie med raske, frivillige forsøgspersoner viste, at størstedelen af radioaktiviteten i plasma efter en enkelt dosis darunavir med ritonavir på 400/100 mg skyldtes det overordnede aktive stof.
English: Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 x 10
Danish: Darunavir er en hæmmer af dimer-dannelsen og af den katalytiske aktivitet af hiv-1-proteasen (KD på 4,5 x 10
English: Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or fetal parameters.
Danish: Studier af reproduktionstoksicitet udført hos rotter og kaniner viste ingen virkninger hverken på parrings-, fertilitets-, graviditets- eller fosterparametre.
English: NARCOTIC ANALGESICS/TREATMENT OF OPIOID DEPENDENCE Buprenorphine/naloxone
Danish: NARKOTISKE ANALGETIKA/BEHANDLING AF OPIOIDAFHÆNGIGHED Buprenorphin/naloxon
English: Norethindrone drospirenone AUC ↑ 58% drospirenone Cmax ↑ 15% drospirenone Cmin ND
Danish: Drospirenon AUC ↑ 58 % drospirenon Cmax ↑ 15 % drospirenon Cmin ND
English: Your doctor may evaluate how severe your liver disease is before deciding if you can take Symtuza.
Danish: Din læge vil muligvis undersøge, hvor alvorlig din leversygdom er, før han eller hun beslutter, om du kan tage Symtuza.
English: Darunavir, emtricitabine and tenofovir alafenamide demonstrated additive to synergistic antiviral effects in two-drug combination studies in cell culture.
Danish: Darunavir, emtricitabin og tenofoviralafenamid viste additiv til synergistisk antiviral aktivitet i studier med to lægemiddler i kombination i cellekultur.
English: Limited PK information is available in the elderly (age ≥ 65 years of age) for Symtuza as well as its individual components.
Danish: Der foreligger kun begrænsede farmakokinetiske oplysninger fra ældre (alder ≥ 65 år) for Symtuza såvel som dets individuelle komponenter.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Danish: Hvis overdosering skulle forekomme, skal patienten overvåges for tegn på toksicitet (se pkt.
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Danish: Silicagel-tørremidlet er i en separat pose eller en separat beholder og må ikke sluges.
English: It is not an inhibitor of CYP3A4 in vivo.
Danish: Det hæmmer ikke CYP3A4 in vivo.
English: ART-naïve patients The recommended dose regimen is one film-coated tablet of Symtuza once daily taken with food.
Danish: Det anbefalede dosisregime er en filmovertrukket Symtuza-tablet én gang dagligt, der tages sammen med mad.
English: Studies in animals do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudier har ikke påvist nogen direkte skadelige virkninger med hensyn til drægtighed, embryo-/fosterudvikling, fødsel eller postnatal udvikling (se pkt.
English: Patients were virologically suppressed for at least 2 months and no more than once had a viral load elevation above 50 HIV-1 RNA copies/mL during the year prior to enrollment.
Danish: Patienterne var virologisk supprimerede i mindst 2 måneder og havde højst én gang en forhøjelse af den virale belastning på mere end 50 hiv-1 RNA-kopier/ml i løbet af et år forud for rekruttering.
English: Week 48 D/C + F/TDF
Danish: Uge 48 D/C + F/TDF
English: Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites.
Danish: Tretten procent af emtricitabindosen blev genfundet i urinen som tre metabolitter.
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Danish: Emtricitabins biotransformation omfatter oxidation af thioldelen, hvorved der dannes 3'-sulfoxiddiastereomere (ca. 9 % af dosen), og konjugering med glukuronsyre, hvorved der dannes 2'-O-glukuronid (ca. 4 % af dosen).
English: Because there is a lower tenofovir exposure in rats and mice after the administration of tenofovir alafenamide compared to tenofovir disoproxil, carcinogenicity studies and a rat peri-postnatal study were conducted only with tenofovir disoproxil.
Danish: Da der er en lavere eksponering for tenofovir hos rotter og mus efter administration af tenofoviralafenamid sammenlignet med tenofovirdisoproxil, blev karcinogenicitetsstudier og et peri-postnatalt studie af rotter kun udført med tenofovirdisoproxil.
English: Patients were on a stable ARV regimen (for at least 6 months), consisting of a boosted protease inhibitor [either darunavir once daily or atazanavir (both boosted with ritonavir or cobicistat), or lopinavir with ritonavir] combined with emtricitabine and TDF.
Danish: Patienterne var på et stabilt ARV-regime (i mindst 6 måneder) bestående af en boostet proteasehæmmer [enten darunavir en gang dagligt eller atazanavir (begge boostet med ritonavir eller cobicistat), eller lopinavir med ritonavir] kombineret med emtricitabin og TDF.
English: For the treatment of pulmonary arterial hypertension Sildenafil Tadalafil
Danish: Til behandling af pulmonal arteriel hypertension Sildenafil Tadalafil
English: Symtuza reduces HIV-1 in your body and this will improve your immune system (your body's natural defences) and reduce the risk of developing illnesses linked to HIV infection but Symtuza is not a cure for HIV infection.
Danish: Symtuza reducerer hiv-1 i kroppen, og dette forbedrer dit immunforsvar (kroppens naturlige forsvarssystem) og nedsætter risikoen for at udvikle sygdomme, der er forbundet med hiv-infektion.
English: Systemic dexamethasone should be used with caution when combined with Symtuza.
Danish: Systemisk dexamethason skal anvendes med forsigtighed ved kombination med Symtuza.
English: Reduced susceptibility to emtricitabine is associated with M184V/I mutations in HIV-1 RT.
Danish: Nedsat følsomhed over for emtricitabin er associeret med 184V/I-mutationer i hiv-1 RT.
English: For emtricitabine, the Cmax was 1.26-fold higher in a fasted condition, while the AUC was comparable in fed and fasted condition.
Danish: For emtricitabin var Cmax 1,26 gange højere i fastende tilstand, mens AUC var sammenlignelig i ikke-fastende og fastende tilstand.
English: Cobicistat has no detectable antiviral activity against HIV-1 and does not antagonise the antiviral effect of darunavir, emtricitabine, or tenofovir.
Danish: Cobicistat har ingen påviselig antiviral aktivitet over for hiv-1 og antagoniserer ikke darunavirs, emtricitabins eller tenofovirs antivirale virkning.
English: Cobicistat is 97% to 98% bound to human plasma proteins and the mean plasma to blood-drug concentration ratio was approximately 2.
Danish: Cobicistat er 97-98 % bundet til humane plasmaproteiner, og forholdet mellem gennemsnitlig lægemiddelkoncentration i plasma og blod var cirka 2.
English: Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of Symtuza treatment.
Danish: Øget overvågning af ASAT/ALAT skal overvejes hos patienter med underliggende kronisk hepatitis eller cirrose og hos patienter med forhøjede aminotransferaser før behandlingen - specielt i de første måneder af Symtuza-behandling.
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 glomerulær filtration og aktiv tubulær sekretion.
English: It is important not to stop taking Symtuza without talking to your doctor first.
Danish: Det er vigtigt ikke at holde op med at tage Symtuza uden først at tale med lægen.
English: • a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung].
Danish: • en reaktion kaldet DRESS [et alvorligt udslæt, der kan være ledsaget af feber, træthed, hævelser af ansigtet eller lymfekirtler, øgning i antallet af eosinofile celler (en type hvide blodlegemer) samt påvirkning af lever, nyrer eller lunger].
English: C]-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of [
Danish: C]-darunavir med ritonavir i en dosis på 400/100 mg kunne ca. 79,5 % og 13,9 % af det administrerede [
English: Do not stop taking Symtuza without talking to your doctor first
Danish: Du må ikke holde op med at tage Symtuza uden først at tale med din læge
English: Darunavir and cobicistat are metabolised by CYP3A.
Danish: Darunavir og cobicistat metaboliseres af CYP3A.
English: INHALED BETA AGONISTS Salmeterol
Danish: INHALEREDE BETA-AGONISTER Salmeterol
English: At Week 48 changes from baseline were smaller with D/C/F/TAF than D/C+F/TDF.
Danish: Ved uge 48 var ændringerne fra baseline mindre med D/C/F/TAF end med D/C+F/TDF.
English: Your doctor should do blood tests before you start Symtuza.
Danish: Din læge skal tage nogle blodprøver, før du starter på Symtuza.
English: The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and OATP1B3.
Danish: Fordelingen af tenofoviralafenamid i kroppen kan påvirkes af aktiviteten af OATP1B1 og OATP1B3.
English: C]-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
Danish: C]-darunavir med ritonavir viste, at ca. 7,7 % af den administrerede darunavirdosis udskilles uomdannet i urinen.
English: Symtuza might reduce its effectiveness.
Danish: Symtuza kan nedsætte virkningen af disse.
English: Median Increase From Baseline at Week 48 D/C/F/TAF
Danish: Middelstigning fra baseline ved Uge 48 D/C/F/TAF
English: Patients co-infected with hepatitis B and/or hepatitis C virus Limited information is available on the use of Symtuza components in patients co-infected with hepatitis B and/or C virus.
Danish: Patienter co-inficeret med hepatitis B- og/eller hepatitis C-virus Der foreligger kun begrænsede oplysninger om brugen af komponenterne i Symtuza hos patienter, der er co-inficeret med hepatitis B og/eller hepatitis C-virus.
English: These findings were attributed to the immaturity of the liver enzymes and of the blood brain barrier.
Danish: Disse resultater blev tilskrevet de umodne leverenzymer og den umodne blod-hjernebarriere.
English: Tenofovir alafenamide is active against hepatitis B virus (HBV).
Danish: Tenofoviralafenamid er virksomt over for hepatitis B-virus (HBV).
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Danish: Med hensyn til monitorering af lipider og glucose i blodet henvises der til eksisterende behandlingsguidelines for hiv.
English: Dose adjustment for buprenorphine may not be necessary when co-administered with Symtuza, but a careful clinical monitoring for signs of opiate toxicity is recommended.
Danish: Dosisjustering af buprenorphin er muligvis ikke nødvendig ved co-administration med Symtuza, men omhyggelig klinisk monitorering for tegn på opioidtoksicitet anbefales.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Sildenafil Tadalafil Vardenafil
Danish: PHOSPHODIESTERASE TYPE 5 (PDE-5)-HÆMMERE Til behandling af erektil dysfunktion Sildenafil Tadalafil Vardenafil
English: Autoimmune disorders may occur many months after the start of treatment.
Danish: Autoimmune lidelser kan opstå, mange måneder efter påbegyndt behandling.
English: The Symtuza tablets are available in packs containing one bottle or three bottles per carton.
Danish: Symtuza-tabletterne fås i pakninger med én beholder eller tre beholdere pr. karton.
English: In the Phase 3 trial of Symtuza in treatment-naïve patients, increases in serum creatinine and decreases in eGFRCG occurred at the first on-treatment assessment (Week 2) and remained stable through 96 weeks.
Danish: I fase 3-studiet med Symtuza af behandlingsnaive patienter opstod der stigninger i serumkreatinin og fald i eGFRCG ved den første evaluering i behandling (uge 2) og forblev stabile over 96 uger.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
Danish: Omend ætiologien anses for at være multifaktoriel (herunder kortikosteroidbehandling, alkoholforbrug, alvorlig immunsuppression, højt BMI), er der rapporteret tilfælde af osteonekrose, især hos patienter med fremskreden hiv-sygdom og/eller langvarig eksponering for antiretroviral kombinationsbehandling (CART).
English: Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed if they are receiving Symtuza.
Danish: Både på grund af risikoen for hiv-transmission og på grund af risikoen for bivirkninger hos det ammede spædbarn skal moderen instrueres i ikke at amme, hvis hun behandles med Symtuza.
English: A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Symtuza is required.
Danish: Dosisreduktion eller afbrydelse af behandlingen med colchicin anbefales hos patienter med normal nyre- og leverfunktion, hvis behandling med Symtuza er nødvendig.
English: Rash was mostly mild to moderate, often occurring within the first four weeks of treatment and resolving with continued dosing (see section 4.4).
Danish: Udslættet var for det meste let til moderat og opstod ofte inden for de første fire ugers behandling og fortog sig under den fortsatte behandling (se pkt.
English: Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Danish: Det er påvist, at cobicistat nedsætter den estimerede kreatininclearance på grund af hæmning af den tubulære sekretion af kreatinin.
English: The intravenous clearance of darunavir alone (150 mg) and in the presence of low dose (100 mg) ritonavir was 32.8 l/h and 5.9 l/h, respectively.
Danish: Den intravenøse clearance af darunavir alene (150 mg) og ved tilstedeværelse af lavdosis (100 mg) ritonavir var henholdsvis 32,8 l/t og 5,9 l/t.
English: It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis.
Danish: Det vides ikke, om emtricitabin eller tenofovir kan fjernes med peritonealdialyse.
English: ANTIFUNGALS Clotrimazole Fluconazole Itraconazole
Danish: ANTIMYKOTIKA Clotrimazol Fluconazol Itraconazol
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 potentiel risiko for nefrotoksicitet som følge af kronisk eksponering over for lave koncentrationer af tenofovir på grund af dosering af tenofoviralafenamid kan ikke udelukkes (se pkt.
English: Co-administration of Symtuza and medicinal products primarily metabolised by CYP3A may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
Danish: Co-administration af Symtuza med lægemidler, der primært metaboliseres af CYP3A, kan forårsage øget systemisk eksponering for sådanne lægemidler, hvilket kan øge eller forlænge både den terapeutiske virkning og bivirkninger.
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: Co-administration af emtricitabin med lægemidler, der elimineres ved aktiv tubulær sekretion, kan øge koncentrationerne af emtricitabin og/eller det samtidigt administrerede lægemiddel.
English: Lipid Parameter Baseline Median
Danish: Lipidparameter Middelværdi ved baseline
English: Rosuvastatin (10 mg once daily): rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND
Danish: Rosuvastatin (10 mg en gang dagligt): rosuvastatin AUC ↑ 93 % rosuvastatin Cmax ↑ 277 % rosuvastatin Cmin ND
English: Symtuza should not be initiated in patients with eGFRCG < 30 mL/min, as there are no data available regarding the use of Symtuza in this population (see sections 5.1 and 5.2).
Danish: Symtuza bør ikke initieres hos patienter med eGFRCG< 30 ml/min, eftersom der ikke findes nogen data vedrørende brugen af Symtuza hos denne population (se pkt.
English: Baseline CD4+ cell count < 200 cells/mm ≥ 200 cells/mm
Danish: Baseline-CD4+-celletal <200 celler/mm ≥200 celler/mm
English: This may be more likely with long-term HIV treatment, more severe damage to the immune system, being overweight, or the use of alcohol or medicines called corticosteroids.
Danish: Dette er mere sandsynligt ved langvarig hiv-behandling, alvorlig svækkelse af immunforsvaret, ved overvægt eller brug af alkohol eller lægemidler, der kaldes kortikosteroider (binyrebarkhormoner).
English: Amiodarone Dronedarone Ivabradine Quinidine Ranolazine
Danish: Amiodaron Dronedaron Ivabradin Kinidin Ranolazin
English: Subjects with PDVF, n (%)
Danish: Forsøgsdeltagere med PDVF, n (%)