FrancophonIA/ELRC3.0 huggingface dataset:
English: → Tell your doctor or pharmacist if you are taking any of these.
Danish: → Fortæl lægen eller apotekspersonalet, hvis du tager nogle af disse lægemidler.
English: Dovato is used to treat HIV in adults and adolescents over 12 years old who weigh at least 40 kg.
Danish: Dovato bruges til behandling af hiv hos voksne og unge over 12 år, som vejer mindst 40 kg.
English: A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh class B) and to 8 matched healthy adult controls.
Danish: En enkelt dosis på 50 mg dolutegravir blev administreret til 8 personer med moderat nedsat leverfunktion (Child-Pugh-klasse B) og til 8 tilsvarende raske voksne kontroller.
English: The mean systemic clearance of lamivudine is approximately 0.32 L/h/kg, predominantly by renal clearance (> 70%) via the organic cationic transport system.
Danish: Den gennemsnitlige systemiske clearance af lamivudin er ca. 0,32 l/t/kg, hovedsageligt ved renal clearance (>70 %) via systemet til transport af organiske kationer.
English: Dovato should not be co-administered with polyvalent cation-containing antacids.
Danish: Dovato må ikke administreres sammen med polyvalente kationholdige antacida.
English: People with advanced HIV infection or AIDS have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Danish: Personer med fremskreden hiv-infektion eller aids har et svækket immunforsvar og har større risiko for at udvikle alvorlige infektioner (opportunistiske infektioner).
English: arthralgia, muscle disorders (including myalgia)
Danish: artralgi, muskelsygdomme (inklusive myalgi)
English: HIV-1 RNA <50 copies/mL Treatment Difference† (95% confidence intervals) Virologic non response
Danish: Hiv-1-RNA <50 kopier/ml Behandlingsforskel† (95 % konfidensintervaller) Manglende virologisk respons Årsager
English: The true extent of CNS penetration of lamivudine and its relationship with any clinical efficacy is unknown.
Danish: Det sande omfang af lamivudins penetration af CNS og sammenhængen med klinisk effekt kendes ikke.
English: Metabolism of lamivudine is a minor route of elimination.
Danish: Metabolisering af lamivudin er en mindre betydelig eliminationsvej.
English: Dolutegravir is primarily metabolized and eliminated by the liver.
Danish: Dolutegravir metaboliseres og elimineres primært i leveren.
English: More than 1000 outcomes from second and third trimester exposure to dolutegravir in pregnant women indicate no evidence of increased risk of malformative and foeto/neonatal negative effects.
Danish: Mere end 1.000 resultater af eksponering for dolutegravir i andet og tredje trimester hos gravide indikerer ingen evidens for øget risiko for misdannelser og negative føto-/neonatalpåvirkninger.
English: If Dovato is used in patients co-infected with hepatitis B an additional antiviral is therefore generally needed.
Danish: Hvis Dovato bruges til patienter, der samtidig er inficeret med hepatitis B, er der derfor almindeligvis behov for yderligere et antiviralt lægemiddel.
English: Changes in laboratory biochemistries
Danish: Ændringer i biokemiske laboratorieparametre
English: Anti-infective products Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160 mg/800 mg once daily for 5 days/300 mg single dose)
Danish: Lægemidler mod infektioner Trimethoprim/sulfamethoxazol (Co-trimoxazol)/lamivudin (160 mg/800 mg én gang dagligt i 5 dage/300 mg enkeltdosis)
English: Lamivudine is also substrate of the hepatic uptake transporter OCT1.
Danish: Lamivudin er også et substrat for den hepatiske optagstransporter OCT1.
English: The recommended dose of Dovato in adults and adolescents is one 50 mg/300 mg tablet once daily.
Danish: Den anbefalede dosis af Dovato hos voksne og unge er én 50 mg/300 mg tablet én gang dagligt.
English: • palpitations (rapid or irregular heartbeat) or tremor
Danish: • hjertebanken (hurtigt eller uregelmæssigt hjerteslag) eller rysten
English: Dolutegravir had no pharmacodynamic effect on Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and progesterone.
Danish: Dolutegravir havde ingen farmakodynamisk virkning på luteiniseringshormon (LH), follikelstimulerende hormon (FSH) og progesteron.
English: In long-term oral carcinogenicity studies in rats and mice, lamivudine did not show any carcinogenic potential.
Danish: I længerevarende karcinogenicitetsstudier hos rotter og mus havde oralt administreret lamivudin intet karcinogent potentiale.
English: Clinical status including liver aminotransferases and bilirubin should be monitored.
Danish: Den kliniske status, herunder niveauet af leveraminotransferaser og bilirubin, bør overvåges.
English: If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Danish: Hvis den næste dosis skal tages inden for 4 timer, skal patienten ikke tage den glemte dosis, men blot genoptage den sædvanlige doseringsplan.
English: Patients should be informed that dizziness and somnolence has been reported during treatment with dolutegravir.
Danish: Patienterne skal informeres om, at der er rapporteret svimmelhed og døsighed under behandling med dolutegravir.
English: Don't take other medicines for the infection without your doctor's advice.
Danish: Tag ikke andre lægemidler mod infektionen, medmindre lægen har sagt det.
English: Dolutegravir and lamivudine have been shown to inhibit replication of lab-strains and clinical isolates of HIV in a number of cell types, including transformed T cell lines, monocyte/macrophage derived lines and primary cultures of activated peripheral blood mononuclear cells (PMBCs) and monocyte/macrophages.
Danish: Dolutegravir og lamivudin har vist sig at hæmme replikation af laboratoriestammer og kliniske isolater af hiv i en række celletyper, herunder transformerede T-cellelinjer, linjer stammende fra monocytter/makrofager og primærkulturer af aktiverede mononukleære celler fra perifert blod (PMBC'er) samt monocytter/makrofager.
English: Hypersensitivity reactions have been reported with dolutegravir, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions.
Danish: Der er rapporteret overfølsomhedsreaktioner over for dolutegravir, og de var karakteriseret ved udslæt, konstitutionelle fund og nogle gange organdysfunktion, herunder alvorlige leverreaktioner.
English: • breakdown of muscle tissue.
Danish: • nedbrydning af muskelvæv.
English: • symptoms of infections and inflammation
Danish: • symptomer på infektioner og betændelse
English: Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied.
Danish: Da lamivudin kan elimineres ved dialyse, kan kontinuerlig hæmodialyse benyttes ved behandling af overdosering, skønt dette ikke er undersøgt.
English: For Dovato, the median time to maximal plasma concentration (tmax) is 2.5 hours for dolutegravir and 1.0 hour for lamivudine, when dosed under fasted conditions.
Danish: For Dovato er mediantiden til maksimal plasmakoncentration (tmax) 2,5 timer for dolutegravir og 1,0 time for lamivudin ved dosering under fastetilstand.
English: The absolute bioavailability of dolutegravir has not been established.
Danish: Den absolutte biotilgængelighed af dolutegravir er ikke klarlagt.
English: There are no clinical study data on the effects of Dovato in the paediatric population.
Danish: Der foreligger ingen data fra kliniske studier vedrørende effekterne af Dovato hos den pædiatriske population.
English: Dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OAT3.
Danish: Dolutegravir kan øge plasmakoncentrationen af lægemidler, hvis udskillelse er afhængig af OAT3.
English: WOCBP who are taking Dovato should use effective contraception throughout treatment.
Danish: Kvinder i den fertile alder, som tager Dovato, skal bruge effektiv kontraception under hele behandlingen.
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 flasken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Investigations: Common:
Danish: Undersøgelser: Almindelig:
English: Pharmacokinetic data for dolutegravir and lamivudine in subjects >65 years of age are limited.
Danish: Farmakokinetiske data om dolutegravir og lamivudin hos personer >65 år er begrænsede.
English: But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time.
Danish: Men hvis din næste dosis skal tages inden for 4 timer, skal du springe den glemte dosis over og tage den næste på det sædvanlige tidspunkt.
English: Hypromellose (E464)
Danish: Hypromellose (E464) Macrogol
English: Sulfamethoxazole: AUC ↔
Danish: Sulfamethoxazol: AUC ↔
English: • depression (feelings of deep sadness and unworthiness)
Danish: • depression (følelse af dyb bedrøvelse eller af at være værdiløs)
English: In fed state, the changes in exposure following intake together with calcium or iron supplements were modified by the food effect, resulting in an exposure similar to that obtained with dolutegravir administered in the fasted state.
Danish: Ikke fastende blev ændringerne i eksponering efter indtagelse sammen med calcium eller jerntilskud ændret ved fødevareeffekten, hvilket resulterede i en eksponering svarende til den, der blev opnået med dolutegravir indgivet i fastende tilstand.
English: amylase elevations
Danish: forhøjet niveau af amylase
English: Some clinical findings also support a possible interaction between lamivudine and cladribine.
Danish: Nogle kliniske fund understøtter også en mulig interaktion mellem lamivudin og cladribin.
English: Emtricitabine, didanosine, stavudine, tenofovir alafenamide, zidovudine
Danish: Emtricitabin, didanosin, stavudin, tenofoviralafenamid, zidovudin
English: Dovato can be taken with or without food.
Danish: Dovato kan tages med eller uden mad.
English: In 100% human serum, the mean fold shift for dolutegravir activity was 75 fold, resulting in protein adjusted IC90 of 0.064 µg/mL.
Danish: I 100 % humant serum var den gennemsnitlige ændring i dolutegravirs aktivitet en faktor 75, hvilket resulterede i en proteinjusteret IC90-værdi på 0,064 µg/ml.
English: Taking Dovato at the time of becoming pregnant or during the first twelve weeks of pregnancy, may increase the risk of a birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
Danish: Hvis du tager Dovato på det tidspunkt, hvor du bliver gravid, eller i løbet af de første tolv uger af graviditeten, kan det øge risikoen for en misdannelse, der kaldes neuralrørsdefekt, f.eks. spina bifida (misdannet rygrad).
English: AUC in cervicovaginal fluid, cervical tissue and vaginal tissue were 6-10% of those in corresponding plasma at steady state.
Danish: AUC i cervicovaginal væske, cervikalt væv og vaginalt væv var 6-10 % af AUC-værdierne i tilsvarende plasma ved steady state.
English: In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase inhibitor class, or to the NRTI class was seen (n=1118 follow-up of 48-96 weeks).
Danish: Hos tidligere ubehandlede patienter, som fik dolutegravir + 2 NRTI'er i fase IIb og fase III, blev der ikke set udvikling af resistens over for integrasehæmmerklassen eller over for NRTI-klassen (n = 1118 opfølgning på 48-96 uger).
English: • difficulty moving.
Danish: • bevægelsesbesvær.
English: Magnesium/ aluminium-containing antacids should be taken well separated in time from the administration of Dovato (minimum 2 hours after or 6 hours before).
Danish: Magnesium-/aluminiumholdige antacida skal tages tidsforskudt fra administrationen af Dovato (mindst 2 timer efter eller 6 timer før).
English: As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Danish: Da dolutegravir i høj grad er bundet til plasmaproteiner, er det usandsynligt, at det vil kunne elimineres signifikant ved dialyse.
English: Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Danish: Renal clearance af uomdannet aktivt stof er en mindre vej til elimination af dolutegravir.
English: No dose adjustment of oral contraceptives is necessary when co-administered with Dovato.
Danish: Det er ikke nødvendigt at justere dosis af orale kontraceptiva, når disse administreres sammen med Dovato.
English: The efficacy of Dovato is supported by data from 2 identical 148-week, Phase III, randomised, double-blind, multicentre, parallel-group, non-inferiority controlled trials GEMINI-1 (204861) and GEMINI-2 (205543).
Danish: Virkningen af Dovato understøttes af data fra 2 identiske 148-ugers randomiserede, dobbeltblindede, non-inferiore, kontrollerede fase III-multicenterstudier med parallelle grupper, GEMINI-1 (204861) og GEMINI-2 (205543).
English: HIV-1 isolates (CRF01_AE, n=12; CRF02_AG, n=12; and Subtype C or CRF_AC, n=13) from 37 untreated patients in Africa and Asia were susceptible to lamivudine (IC50 fold changes < 3.0.
Danish: Hiv-1-isolater (CRF01_AE, n=12; CRF02_AG, n=12 og undertype C eller CRF_AC, n=13) fra 37 ubehandlede patienter i Afrika og Asien var følsomme over for lamivudin (IC50 gange ændring <3,0).
English: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Danish: Nukleosid- og nukleotidanaloger kan påvirke mitokondriefunktionen i varierende grad, hvilket er mest udtalt for stavudin, didanosin og zidovudin.
English: Based on the lack of effect on the in vivo pharmacokinetics of the OAT substrate tenofovir, in vivo inhibition of OAT1 is unlikely.
Danish: Baseret på manglende effekt på in vivo-farmakokinetikken af OAT-substratet tenofovir, er in vivohæmning af OAT1 usandsynlig.
English: A total of 1433 HIV-1 infected antiretroviral treatment-naïve adult subjects received treatment in the trials.
Danish: I alt 1.433 hiv-1-inficerede voksne personer, som ikke tidligere havde fået antiretroviral behandling, blev behandlet i studierne.
English: In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe.
Danish: In vivo havde dolutegravir ingen effekt på midazolam, en CYP3A4-probe.
English: Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine (see section 5.1).
Danish: Dovato er indiceret til behandling af infektion med Human Immundefekt Virus type 1 (hiv-1) hos voksne og unge over 12 år, der vejer mindst 40 kg, uden kendt eller formodet resistens over for integrasehæmmerklassen eller lamivudin (se pkt.
English: Effect of dolutegravir and lamivudine on the pharmacokinetics of other medicinal products
Danish: Effekt af dolutegravir og lamivudin på farmakokinetikken af andre lægemidler
English: The carcinogenic potential of a combination of dolutegravir and lamivudine has not been tested.
Danish: Det karcinogene potentiale af en kombination af dolutegravir og lamivudin er ikke undersøgt.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to CART.
Danish: Selvom ætiologien anses for at være multifaktoriel (herunder kortikosteroidforbrug, bisphosphonater, alkoholforbrug, svær immunosuppression, højere BMI), er der rapporteret tilfælde af osteonekrose hos patienter med fremskreden hiv-sygdom og/eller langvarig eksponering for CART.
English: Thirty-two percent of the total oral dose is excreted in the urine, represented by ether glucuronide of dolutegravir (18.9% of total dose), N-dealkylation metabolite (3.6% of total dose), and a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose).
Danish: 32 % af den samlede orale dosis udskilles i urinen og består af et etherglukuronid af dolutegravir (18,9 % af den samlede dosis), en metabolit, der er dannet ved N-dealkylering (3,6 % af den samlede dosis), og en metabolit, der er dannet ved oxidation ved det benzyliske carbon (3,0 % af den samlede dosis).
English: In lactating rats that received a single oral dose of 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood.
Danish: Hos diegivende rotter, som fik en enkelt oral dosis dolutegravir på 50 mg/kg 10 dage post partum, blev der påvist dolutegravir i mælken i koncentrationer, som typisk var højere end i blodet.
English: If possible, show them the Dovato pack.
Danish: Tag Dovato-pakningen med, hvis det er muligt.
English: The results from two in vivo rat micronucleus tests with lamivudine were negative.
Danish: Resultaterne af to mikronukleusanalyser udført in vivo hos rotter med lamivudin var negative.
English: Metformin is eliminated renally and, therefore, it is of importance to monitor renal function when co-treated with Dovato.
Danish: Metformin elimineres renalt, og det er derfor vigtigt at monitorere nyrefunktionen ved administration sammen med Dovato.
English: Dolutegravir is eliminated mainly through metabolism by uridine diphosphate glucuronosyl transferase (UGT) 1A1.
Danish: Dolutegravir elimineres overvejende gennem metabolisering via uridindifosfatglukuronosyltransferase (UGT) 1A1.
English: Mitochondrial dysfunction
Danish: Mitokondriel dysfunktion
English: Lamivudine triphosphate shows significantly less affinity for host cell DNA polymerases.
Danish: Lamivudintriphosphat viser signifikant mindre affinitet for værtscelle-dna-polymeraser.
English: • The active substances are dolutegravir and lamivudine.
Danish: • Aktive stoffer: dolutegravir og lamivudin.
English: Dovato film-coated tablets are oval, biconvex, white tablets debossed with 'SV 137' on one face.
Danish: Dovato filmovertrukne tabletter er ovale, bikonvekse, hvide tabletter præget med "SV 137" på den ene side.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Danish: Patienter, der i forvejen har leverdysfunktion, herunder kronisk aktiv hepatitis, oplever en øget frekvens af problemer med leverfunktionen under antiretroviral kombinationsbehandling, og disse patienter skal monitoreres i henhold til standardpraksis.
English: Antiretroviral medicinal products Non-nucleoside reverse transcriptase inhibitors Etravirine without boosted protease inhibitors /
Danish: Antiretrovirale lægemidler Non-nukleosid revers transkriptasehæmmere Etravirin uden boostede proteasehæmmere/dolutegravir
English: • cladribine, to treat leukaemia or multiple sclerosis
Danish: • cladribin til behandling af leukæmi eller multipel sclerose
English: Each pack consists of one bottle containing 30 filmcoated tablets.
Danish: Hver pakning består af en flaske, der indeholder 30 filmovertrukne tabletter.
English: • phenytoin and phenobarbital, to treat epilepsy
Danish: • phenytoin og phenobarbital til behandling af epilepsi
English: As hepatic elimination plays a minor role in the clearance of lamivudine, drug interactions due to inhibition of OCT1 are unlikely to be of clinical significance.
Danish: Da hepatisk udskillelse spiller en mindre rolle i clearance af lamivudin, er det usandsynligt, at lægemiddelinteraktioner, der skyldes hæmning af OCT1, har nogen klinisk signifikans.
English: → Talk to your doctor for further advice on taking acid-lowering medicines with Dovato.
Danish: → Tal med lægen for yderligere råd om, hvordan du skal tage syreneutraliserende lægemidler sammen med Dovato.
English: If Dovato is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
Danish: Hvis Dovato seponeres hos patienter, der samtidig er inficeret med hepatitis B, anbefales regelmæssig monitorering af både leverfunktionstests og markører for HBV-replikation, da seponering af lamivudin kan medføre akut eksacerbation af hepatitis.
English: At baseline, in the pooled analysis, the median age of subjects was 33 years, 15% were female, 68% were white, 9% were CDC Stage 3 (AIDS), 20% had HIV-1 RNA >100,000 copies/mL, and 8% had CD4+ cell count less than 200 cells per mm3; these characteristics were similar between studies and treatment arms.
Danish: Ved baseline i den sammenlagte analyse var medianalderen på personerne 33 år, 15 % var kvinder, 68 % var hvide, 9 % var i CDC stadie 3 (aids), 20 % havde hiv-1-RNA >100.000 kopier/ml, og 8 % havde CD4+-celletal under 200 celler pr. mm3; disse karakteristika var de samme i studier og behandlingsarme.
English: rash, pruritus, alopecia
Danish: udslæt, pruritus, alopeci
English: • The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).
Danish: • Øvrige indholdsstoffer: mikrokrystallinsk cellulose, natriumstivelsesglycolat, magnesiumstearat, mannitol (E421), povidon (K29/32), natriumstearylfumarat, hypromellose (E464), macrogol, titandioxid (E171).
English: • increase in the level of liver enzymes (aminotransferases)
Danish: • øget niveau af leverenzymer (aminotransferaser)
English: These findings should be considered for any child exposed in utero to nucleoside and nucleotide analogues, who presents with severe clinical findings of unknown aetiology, particularly neurologic findings.
Danish: Disse fund bør overvejes hos alle børn, der har været eksponeret for nukleosid- og nukleotidanaloger in utero, som har svære kliniske symptomer af ukendt ætiologi, især neurologiske symptomer.
English: In the pooled GEMINI studies a mean change from baseline of 10.3 µmol/L (range: -36.3 µmol/L to 55.7 µmol/L) was observed after 48 weeks of treatment.
Danish: I de sammenlagte GEMINI-studier blev der observeret en gennemsnitlig ændring i forhold til baseline på 10,3 µmol/l (interval -36,3 µmol/l til 55,7 µmol/l) efter 48 ugers behandling.
English: Dovato contains dolutegravir and lamivudine, therefore any interactions identified for these individually are relevant to Dovato.
Danish: Dovato indeholder dolutegravir og lamivudin; derfor er eventuelle identificerede interaktioner for disse individuelle aktive stoffer relevante for Dovato.
English: Ledipasvir/Sofosbuvir/ Lamvudine (with abacavir)
Danish: Ledipasvir/sofosbuvir/lamivudin (med abacavir)
English: For information around in vitro resistance, and cross resistance to other agents of the integrase- and NRTI class, please refer to the SmPCs of dolutegravir and lamivudine.
Danish: For information omkring in vitro-resistens og krydsresistens over for andre stoffer i integrase- og NRTI-klassen henvises til produktresuméerne for dolutegravir og lamivudin.
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, P-glycoprotein (P-gp), and breast cancer resistance protein (BCRP).
Danish: Dolutegravir er også et substrat for UGT1A3, UGT1A9, CYP3A4, P-glycoprotein (P-gp) og brystcancerresistensprotein (BCRP).
English: Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Danish: Dolutegravir hæmmer hiv-integrase ved at binde til det aktive sted på integrase og blokere strand transfer-trinnet i integrationen af retroviral deoxyribonukleinsyre (dna), hvilket er essentielt for hiv's replikationscyklus.