FrancophonIA/ELRC3.0 huggingface dataset:
English: These changes are linked to the inhibiting effect of dolutegravir on renal tubular transporters of creatinine.
Danish: Disse ændringer er forbundet med den hæmmende effekt af dolutegravir på renal-tubulære transportere af kreatinin.
English: → Read the information ‘Allergic reactions' in section 4 of this leaflet.
Danish: → Læs oplysningerne under "Allergiske reaktioner" i punkt 4 i denne indlægsseddel.
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Danish: For lipider er der i nogle tilfælde evidens for en behandlingseffekt, mens der for vægtøgning ikke er nogen stærk evidens forbundet med nogen speciel behandling.
English: The lamivudine AUC(0-∞) was not affected by a high fat meal.
Danish: Lamivudins AUC(0-∞) blev ikke påvirket af et måltid med højt fedtindhold.
English: The mean ratio of CSF/serum lamivudine concentrations 2-4 hours after oral administration was approximately 12%.
Danish: Det gennemsnitlige forhold mellem lamivudinkoncentrationen i CSF og serum 2-4 timer efter oral administration var ca. 12 %.
English: Delay in stopping treatment with Dovato or other suspect active substances after the onset of hypersensitivity may result in a life-threatening allergic reaction.
Danish: Forsinket afbrydelse af behandlingen med Dovato eller andre mistænkte aktive stoffer efter indtrædelsen af overfølsomhed kan resultere i en livstruende allergisk reaktion.
English: • aches and pains in the joints (especially in the hip, knee or shoulder)
Danish: • ømhed og smerter i leddene (særligt i hofter, knæ eller skuldre)
English: The pharmacokinetics of dolutegravir following single dose oral administration to Japanese subjects appear similar to observed parameters in Western (US) subjects.
Danish: Farmakokinetikken af dolutegravir efter oral administration af en enkeltdosis til japanske personer synes at svare til de parametre, der er observeret hos vestlige (amerikanske) personer.
English: Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity.
Danish: Da gastrointestinal (GI) intolerance anses for at skyldes lokal administration af det aktive stof, er måleenhederne mg/kg eller mg/m2 hensigtsmæssige i forbindelse med beskrivelse af sikkerhed for denne toksicitet.
English: Gender Male Female Race White African-American/African Heritage/Other Age (years)
Danish: Afroamerikansk/afrikansk oprindelse/andre Alder (år)
English: The observed lamivudine half-life of elimination is 18 to 19 hours.
Danish: Den observerede eliminationshalveringstid af lamivudin er 18 til 19 timer.
English: It is unknown whether dolutegravir is excreted in human milk.
Danish: Det er ukendt, om dolutegravir udskilles i human mælk.
English: This increase is not considered clinically relevant.
Danish: Denne stigning anses ikke for klinisk relevant.
English: Exposure to dolutegravir was generally similar between healthy subjects and HIV-1-infected subjects.
Danish: Eksponering for dolutegravir var generelt den samme hos raske personer og hiv-1-inficerede personer.
English: Repeated dose toxicity
Danish: Toksicitet efter gentagne doser
English: Lamivudine was not teratogenic in animal studies but there were indications of an increase in early embryonic deaths in rabbits at relatively low systemic exposures, comparable to those achieved in humans.
Danish: Lamivudin var ikke teratogent i dyrestudier, men der var indikationer på et øget antal tilfælde af tidlig embryonal død hos kaniner efter relativt lave systemiske eksponeringer, som kunne sammenlignes med den, der opnås hos mennesker.
English: • rifampicin, to treat tuberculosis (TB) and other bacterial infections
Danish: • rifampicin til behandling af tuberkulose (TB) og andre bakterieinfektioner
English: The apparent oral clearance (CL/F) is approximately 1 L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Danish: Den angivelige orale clearance (CL/F) er cirka 1 l/t hos hiv-inficerede patienter baseret på en farmakokinetisk populationsanalyse.
English: Some medicines can affect how Dovato works or make it more likely that you will have side effects.
Danish: Nogle lægemidler kan påvirke virkningen af Dovato eller gøre det mere sandsynligt, at du får bivirkninger.
English: • a low red blood cell count (anaemia) or low white blood cell count (neutropenia).
Danish: • lavt antal røde blodceller (anæmi) eller lavt antal hvide blodceller (neutropeni).
English: Your doctor may decide to adjust your dose or that you need extra check ups.
Danish: Lægen kan beslutte at justere din dosis eller, at du har brug for flere kontroller.
English: Lamivudine monotherapy is generally not considered an adequate treatment for hepatitis B, since the risk for hepatitis B resistance development is high.
Danish: Monoterapi med lamivudin anses generelt ikke for tilstrækkelig behandling af hepatitis B, da risikoen for at udvikle hepatitis B-resistens er høj.
English: Effects on electrocardiogram
Danish: Effekt på elektrokardiogram
English: The adverse reactions from clinical study and post-marketing experience are listed in Table 2 by body system, organ class and absolute frequency.
Danish: Bivirkninger i kliniske studier og efter markedsføringen er anført i tabel 2 efter kropssystem, organklasse og absolut hyppighed.
English: If the patient misses a dose of Dovato, the patient should take Dovato as soon as possible, providing the next dose is not due within 4 hours.
Danish: Hvis patienten glemmer en dosis Dovato, skal patienten tage Dovato så hurtigt som muligt, forudsat at den næste dosis ikke skal tages inden for 4 timer.
English: Increases in serum creatinine occurred within the first four weeks of treatment with dolutegravir plus lamivudine and remained stable through 48 weeks.
Danish: Niveauet af serumkreatinin steg i løbet af de første fire uger af behandlingen med dolutegravir plus lamivudin, og det forblev stabilt igennem 48 uger.
English: The concentration of active substance necessary to effect viral replication by 50% (IC50 - half maximal inhibitory concentration) varied according to virus and host cell type.
Danish: Den koncentration af det aktive stof, der var nødvendig for at hæmme viral replikation med 50 % (IC50 - halv maksimal hæmmende koncentration), varierede afhængigt af virus og værtscelletype.
English: Patients should be advised that dolutegravir, lamivudine 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: Patienterne bør informeres om, at dolutegravir, lamivudin eller en hvilken som helst anden antiretroviral behandling ikke kurerer hiv-infektion, og at de stadig kan udvikle opportunistiske infektioner og andre komplikationer fra hiv-infektion.
English: Dovato includes lamivudine, which is active against hepatitis B. Dolutegravir lacks such activity.
Danish: Dovato indeholder lamivudin, som er aktivt mod hepatitis B. Dolutegravir mangler denne aktivitet.
English: The effect of prolonged daily treatment with high doses of dolutegravir has been evaluated in repeat oral dose toxicity studies in rats (up to 26 weeks) and in monkeys (up to 38 weeks).
Danish: Effekten af daglig behandling med høje doser af dolutegravir over længere tid er blevet vurderet i studier af toksicitet efter gentagne orale doser hos rotter (op til 26 uger) og hos aber (op til 38 uger).
English: • emtricitabine, etravirine, efavirenz, nevirapine or tipranavir/ritonavir, to treat HIV infection
Danish: • emtricitabin, etravirin, efavirenz, nevirapin eller tipranavir/ritonavir til behandling af hiv-infektion
English: A large amount of data on the use of lamivudine in pregnant women (more than 3000 outcomes from first trimester) indicates no malformative toxicity.
Danish: En stor datamængde om brugen af lamivudin til gravide (flere end 3.000 resultater fra første trimester) indikerer ingen misdannelsestoksicitet.
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, antivirale midler til behandling af hiv-infektioner, kombinationer.
English: The frequency of this is unknown (see section 4.4).
Danish: Hyppigheden af dette kendes ikke (se pkt.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Der er rapporteret tilfælde af osteonekrose, særligt hos patienter med alment kendte risikofaktorer, fremskreden hiv-sygdom eller langvarig eksponering for CART.
English: Dolutegravir has not been studied in patients on dialysis, though differences in exposure are not expected.
Danish: Dolutegravir er ikke undersøgt hos patienter i dialyse, men der forventes ikke forskelle i eksponering.
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Danish: Det anbefales, at hiv-inficerede kvinder under ingen omstændigheder ammer deres spædbørn, så overførsel af hiv undgås.
English: Dovato should be prescribed by physicians experienced in the management of HIV infection.
Danish: Dovato skal ordineres af læger med erfaring i behandling af hiv-infektion.
English: • increase in the level of enzymes produced in the muscles (creatine phosphokinase).
Danish: • øget niveau af enzymer, der dannes i musklerne (kreatinfosfokinase).
English: As neural tube defects occur within the first 4 weeks of foetal development (at which time the neural tubes are sealed) this potential risk would concern women exposed to dolutegravir at the time of conception and in early pregnancy.
Danish: Da neuralrørsdefekten opstår inden for de første 4 uger af fostrets udvikling (på det tidspunkt neuralrørene lukkes), vil denne potentielle risiko berøre kvinder, der eksponeres for dolutegravir på undfangelsestidspunktet og i den tidlige graviditet.
English: The higher lamivudine Cmax, is not considered clinically relevant.
Danish: Det højere lamivudin Cmax anses ikke for klinisk relevant.
English: Metabolism and nutrition disorders: Very rare:
Danish: Metabolisme og ernæring: Meget sjælden:
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance 45- 59 mL/min) and a cautious approach is recommended.
Danish: Denne kombination kan øge risikoen for laktacidose hos patienter med moderat nedsat nyrefunktion (stadie 3a kreatininclearence 45-59 ml/min), og forsigtighed anbefales.
English: No data are available in patients with severe hepatic impairment (Child-Pugh grade C); therefore Dovato should be used with caution in these patients (see section 5.2).
Danish: Der er ingen tilgængelige data om patienter med svært nedsat leverfunktion (Child-Pugh-klasse C); derfor bør Dovato anvendes med forsigtighed hos disse patienter (se pkt.
English: Discontinued for other reasons and ≥50 copies/mL
Danish: Seponeret af andre årsager og ≥50 kopier/ml
English: The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births (0.05-0.1%).
Danish: Forekomsten af neuralrørsdefekt i den almene befolkning varierer fra 0,5-1 tilfælde pr. 1.000 levende fødsler (0,05-0,1 %).
English: Dolutegravir has been associated with an increase in serum creatinine occuring in the first week of treatment when administered with other antiretroviral medicinal products.
Danish: Dolutegravir er blevet forbundet med en stigning i serumkreatinin, der opstod i den første behandlingsuge, når det blev administreret sammen med andre antiretrovirale lægemidler.
English: Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk.
Danish: Kvinder, der er hiv-positive, må ikke amme deres børn, da hiv-infektionen kan overføres til barnet gennem mælken.
English: If you forget to take Dovato
Danish: Hvis du har glemt at tage Dovato
English: Interaction studies have only been performed in adults.
Danish: Pædiatrisk population Interaktionsstudier er kun udført hos voksne.
English: Relevant examples are Cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Danish: Relevante eksempler omfatter cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis jirovecii-pneumoni (ofte kaldet PCP).
English: • if you have a kidney problem.
Danish: • hvis du har nyreproblemer.
English: depression, anxiety, insomnia, abnormal dreams
Danish: depression, angst, insomni, unormale drømme
English: Antihistamines (histamine H2 receptor antagonists) Ranitidine
Danish: Antihistaminer (histamin H2-receptorantagonister) Ranitidin
English: Dolutegravir and lamivudine are present in cerebrospinal fluid (CSF).
Danish: Dolutegravir og lamivudin er til stede i cerebrospinalvæsken (CSF).
English: → Read the information ‘Other possible side effects' in section 4 of this leaflet.
Danish: → Læs oplysningerne under "Andre mulige bivirkninger" i punkt 4 i denne indlægsseddel.
English: nausea, diarrhoea
Danish: kvalme, diarré
English: Medicinal products that induce those enzymes or transporters may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir.
Danish: Lægemidler, der inducerer disse enzymer eller transportere, kan reducere plasmakoncentrationen af dolutegravir og reducere dolutegravirs terapeutiske effekt.
English: The stated reductions in dolutegravir exposure were observed with the intake of dolutegravir and these supplements during fasted conditions.
Danish: De angivne reduktioner i dolutegravir-eksponeringen blev observeret ved indtagelse af dolutegravir og disse tilskud under fastede forhold.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring, as necessary.
Danish: I tilfælde af overdosering skal patienten have understøttende behandling og monitoreres efter behov.
English: Lamivudine was not significantly metabolised by CYP enzymes.
Danish: Lamivudin blev ikke signifikant metaboliseret af CYP-enzymer.
English: Group O isolates from antiviral naïve patients tested for lamivudine activity were highly sensitive.
Danish: Gruppe O-isolater fra antiviralt naive patienter testet for lamivudin-aktivitet var meget følsomme.
English: After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation.
Danish: Efter start af behandling bliver immunforsvaret stærkere og kan angribe infektionerne, hvilket kan give symptomer på infektion og betændelse.
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Danish: Nogle personer, der får kombinationsbehandling mod hiv-infektion, udvikler en tilstand, der kaldes osteonekrose.
English: For patients receiving lamivudine 300 mg once daily, the terminal intracellular half-life of lamivudine-TP was 16 to 19 hours.
Danish: Hos patienter, der fik 300 mg lamivudin én gang dagligt, var den terminale intracellulære halveringstid af lamivudin-TP 16 til 19 timer.
English: The film-coated tablets are provided in bottles closed with child-resistant closures.
Danish: De filmovertrukne tabletter fås i tabletbeholdere, der er lukket med børnesikret lukke.
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
Danish: • lægemidler (normalt væsker), der indeholder sorbitol og andre sukkeralkoholer (som f.eks. xylitol, mannitol, lactitol eller maltitol), hvis de tages regelmæssigt
English: Adults and adolescents (above 12 years of age weighing at least 40 kg).
Danish: Voksne og unge (over 12 år, som vejer mindst 40 kg).
English: There is no specific treatment for an overdose of Dovato.
Danish: Der findes ingen specifik behandling mod overdosering med Dovato.
English: Data in window and ≥50 copies/mL
Danish: Data i vindue og ≥50 kopier/ml
English: Trimethoprim (an inhibitor of these transporters) has been shown to increase lamivudine plasma concentrations, however the resulting increase was not clinically significant (see Table 1).
Danish: Det er påvist, at trimethoprim (en hæmmer af disse transportere) øger plasmakoncentrationen af lamivudin, men den resulterende stigning var ikke klinisk signifikant (se tabel 1).
English: The adjusted difference was -2.6 (95% CI: -6.7; 1.5) for GEMINI-1 and0.7 (95% CI: -4.3; 2.9) for GEMINI-2 with a prespecified non-inferiority margin of 10%.
Danish: Den justerede forskel var -2,6 (95 % CI: -6,7; 1,5) for GEMINI-1 og -0,7 (95 % CI: -4,3; 2,9) for GEMINI-2 med en præspecificeret non-inferioritetsmargen på 10 %.
English: Dovato may be administered with or without food.
Danish: Dovato kan administreres med eller uden mad.
English: The apparent volume of distribution of dolutegravir (Vd/F) is 17-20 L. Intravenous studies with lamivudine showed that the mean apparent volume of distribution is 1.3 L/kg.
Danish: Det tilsyneladende fordelingsvolumen af dolutegravir (Vd(F) er 17-20 l. Intravenøse studier med lamivudin viste, at det gennemsnitlige tilsyneladende fordelingsvolumen er 1,3 l/kg.
English: The clinical status of the patient and the adverse reaction profile of Dovato should be borne in mind when considering the patient's ability to drive or operate machinery.
Danish: Der skal tages hensyn til patientens kliniske status og Dovatos bivirkningsprofil ved vurdering af patientens evne til at føre motorkøretøjer og betjene maskiner.
English: • if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk (overfølsom) over for dolutegravir eller lamivudin eller et af de øvrige indholdsstoffer i Dovato (angivet i punkt 6).
English: It is unknown if all or part of this is due to unabsorbed active substance or biliary excretion of the glucuronidate conjugate, which can be further degraded to form the parent compound in the gut lumen.
Danish: Det vides ikke, om alt eller dele af dette skyldes ikke-absorberet aktivt stof eller biliær udskillelse af glukuronidkonjugatet, som kan blive yderligere nedbrudt til moderforbindelsen i tarmlumen.
English: Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine.
Danish: Dovato er et lægemiddel, der indeholder to aktive stoffer, som anvendes til behandling af infektion med hiv (human immundefekt virus): dolutegravir og lamivudin.
English: Total blood and plasma drugrelated radioactivity concentration ratios averaged between 0.441 to 0.535, indicating minimal association of radioactivity with blood cellular components.
Danish: Forholdet mellem den samlede koncentration af lægemiddelrelateret radioaktivitet i blod og plasma lå i gennemsnit fra 0,441 til 0,535, hvilket tyder på minimal association af radioaktivitet med cellulære blodkomponenter.
English: If you take too many tablets of Dovato contact your doctor or pharmacist for advice.
Danish: Hvis du tager for mange Dovato-tabletter, skal du kontakte lægen eller apotekspersonalet for vejledning.
English: In vitro, lamivudine was an inhibitor of OCT1 and OCT2; the clinical consequences are not known.
Danish: In vitro var lamivudin en hæmmer af OCT1 og OCT2; de kliniske konsekvenser er ikke kendte.
English: Dolutegravir is the predominant circulating compound in plasma; renal elimination of unchanged active substance is low (< 1% of the dose).
Danish: Dolutegravir er den overvejende cirkulerende forbindelse i plasma; renal elimination af uomdannet aktivt stof er lav (<1 % af dosis).
English: Adolescents aged between 12 and 17 years and weighing at least 40 kg can take the adult dose of one tablet once a day.
Danish: Unge i alderen mellem 12 og 17 år, som vejer mindst 40 kg, kan tage den samme dosis som voksne på 1 tablet én gang dagligt.
English: In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients.
Danish: In vivo blev et 10-14 % fald i kreatininclearancen (sekretionsfraktion afhænger af OCT2- og MATE-1-transport) observeret hos patienterne.
English: Studies with lamivudine show that plasma concentrations (AUC) are increased in patients with renal dysfunction due to decreased clearance.
Danish: Studier med lamivudin viser, at plasmakoncentrationer (AUC) er forhøjede hos patienter med nedsat nyrefunktion på grund af nedsat clearance.
English: Stopping Dovato can affect your health and how future treatment works.
Danish: Hvis du stopper med Dovato, kan det påvirke dit helbred, og hvordan din behandling vil virke i fremtiden.
English: Lipid disorders should be managed as clinically appropriate.
Danish: Lipidforstyrrelser skal håndteres efter passende klinisk metode.
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Danish: Baseret på mere end 200 moder/barn-par behandlet for hiv er serumkoncentrationen af lamivudin hos ammede børn, hvis mor er behandlet for hiv, meget lav (<4 % af moderens serumkoncentration) og falder progressivt til et ikke-detekterbart niveau, når de ammede spædbørn når en alder på 24 uger.
English: Dolutegravir was not carcinogenic in long term studies in the mouse and rat.
Danish: Dolutegravir var ikke karcinogent i længerevarende studier hos mus og rotter.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Danish: Patienterne bør rådes til at søge lægehjælp, hvis de oplever ømme og smertende led, stive led eller bevægelsesbesvær.
English: Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir (a component of Dovato) at the time of conception compared with mothers exposed to non-dolutegravir containing regimens (0.1%).
Danish: Foreløbige data fra et overvågningsstudie tyder på en øget forekomst af neuralrørsdefekt (0,9 %) hos mødre, der eksponeres for dolutegravir (en komponent i Dovato) på undfangelsestidspunktet, sammenlignet med mødre, der udsættes for regimer, der ikke indeholder dolutegravir (0,1 %).
English: If you could get pregnant while taking Dovato, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral contraceptive (the pill) or other hormonal contraceptives (for example, implants or injections), to prevent pregnancy.
Danish: Hvis der er risiko for, at du kan blive gravid, mens du tager Dovato, skal du bruge en pålidelig metode til barriereprævention (f.eks. et kondom) sammen med andre præventionsformer, herunder p-piller eller anden hormonprævention (f.eks. implantater eller injektioner) for at forhindre graviditet.
English: Oral contraceptives Ethinyl estradiol (EE) and Norgestromin (NGMN)/Dolutegravir
Danish: Orale kontraceptiva Ethinylestradiol (EE) og norgestromin (NGMN)/dolutegravir
English: • lack of energy (fatigue)
Danish: • manglende energi (træthed)
English: Dolutegravir is primarily metabolized via UGT1A1 with a minor CYP3A component (9.7% of total dose administered in a human mass balance study).
Danish: Dolutegravir metaboliseres primært via UGT1A1 med en mindre CYP3A-komponent (9,7 % af den samlede dosis administreret i et massebalancestudie hos mennesker).
English: No dose adjustment is necessary when Dovato is combined with tenofovir, didanosine, stavudine or zidovudine.
Danish: Dosisjustering er ikke nødvendig, når Dovato kombineres med tenofovir, didanosin, stavudin eller zidovudin.