FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be advised that dolutegravir 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, 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: - This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Danish: - Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natriumfrit.
English: The most commonly seen treatment emergent adverse reactions were nausea (13%), diarrhoea (18%) and headache (13%).
Danish: De bivirkninger, der hyppigst opstod under behandlingen, var kvalme (13 %), diarré (18 %) og hovedpine (13 %).
English: Some medicines can affect how Tivicay works, or make it more likely that you will have side effects.
Danish: Nogle lægemidler kan påvirke virkningen af Tivicay eller gøre det mere sandsynligt, at du får bivirkninger.
English: These mutations were not selected in patients treated with dolutegravir in the clinical studies.
Danish: Disse mutationer blev ikke selekteret hos patienter, der blev behandlet med dolutegravir i de kliniske studier.
English: Week 24 (N=161)
Danish: Uge 24 (N = 161)
English: As a result of that, it also increases the CD4 cell count in your blood.
Danish: På grund af dette øger Tivicay også antallet af CD4-celler i dit blod.
English: Some people taking medicines for HIV infection develop other conditions, which can be serious.
Danish: Nogle personer, der tager lægemidler mod hiv-infektion, får andre tilstande, der kan være alvorlige.
English: Co-infection with Hepatitis B or C
Danish: Co-infektion med hepatitis B- eller C-virus
English: Delay in stopping treatment with dolutegravir or other suspect active substances after the onset of hypersensitivity may result in a life-threatening allergic reaction.
Danish: Forsinket afbrydelse af behandlingen med dolutegravir eller andre mistænkte aktive stoffer efter indtrædelsen af overfølsomhed kan resultere i en livstruende allergisk reaktion.
English: A clinically relevant phenotypic cut-off value (FC vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Danish: En klinisk relevant fænotypisk skæringsværdi (FC vs. vildtypevirus) er ikke blevet fastlagt; genotypisk resistens var en bedre indikator for udfaldet.
English: The effect by the Q148-mutations (H/R/K) was also verified in passage experiments with site directed mutants.
Danish: Effekten af Q148-mutationerne (H/R/K) blev også verificeret i passage-eksperimenter med stedspecifikke mutanter.
English: Integrase class resistance of particular concern
Danish: Integrasehæmmereresistens af særlig betydning
English: The exposure to dolutegravir was decreased by approximately 40% in subjects with severe renal impairment.
Danish: Eksponeringen for dolutegravir blev reduceret med omkring 40 % hos personer med alvorligt nyresvigt.
English: Co-treatment with atazanavir increases the exposure of dolutegravir markedly, and should not be used in combination with this high dose, since safety with the resulting dolutegravir exposure has not been established.
Danish: Samtidig behandling med atazanavir øger eksponeringen for dolutegravir betydeligt og bør ikke anvendes ved denne høje dosis, da sikkerheden ved den resulterende eksponering for dolutegravir ikke er fastlagt.
English: This regimen is only suitable for the treatment of HIV-1 infection where there is no known or suspected resistance to the integrase inhibitor class, or to lamivudine.
Danish: Dette regime er kun egnet til behandling af hiv-1-infektion, hvor der ikke er kendt eller formodet resistens over for integrasehæmmere eller over for lamivudin.
English: The study enrolled 183 patients, 133 with INI-resistance at Screening and 50 with only historical evidence of resistance (and not at Screening).
Danish: I studiet blev der inkluderet 183 patienter, hvor 133 havde INI-resistens ved screeningen, og 50 kun havde påvist historisk resistens (ikke ved screeningen).
English: → Talk to your doctor about the risks and benefits of taking Tivicay.
Danish:  Tal med lægen om risiciene og fordelene ved at tage Tivicay.
English: Using strain NL432, mutations E92Q (FC 3) and G193E (also FC 3) were selected.
Danish: Ved brug af stamme NL432, blev mutationerne E92Q (FC 3) og G193E (også FC 3) selekteret.
English: Over the preweaning treatment period, mean body weight gain was decreased in this group and the decrease persisted throughout the entire study for females during the postweaning period.
Danish: I løbet af præ-afvænningsperioden faldt den gennemsnitlige vægtøgning i denne gruppe, og nedgangen fortsatte igennem hele studiet hos hunner i postafvænningsperioden.
English: The adverse reactions considered at least possibly related to dolutegravir are listed by body system, organ class and absolute frequency.
Danish: De bivirkninger, der som minimum anses for muligvis at være relateret til dolutegravir, er anført efter kropssystem, organklasse og absolut hyppighed.
English: The overall susceptibility score (OSS) of the optimised background regimen (OBR) was not associated with Week 24 response, nor with the week 48 response.
Danish: Den samlede følsomhedsscore (OSS) i forbindelse med det optimerede baggrundsregime (OBR) havde ingen sammenhæng med uge 24-responset eller uge 48-responset.
English: The specific dosage recommendation for the 10 mg tablet, as specified in Table 1, should be followed.
Danish: De specifikke dosisanbefalinger for 10 mg tabletten, som er anført i tabel 1, skal følges.
English: TIVICAY ~1 mg/kg Once Daily + OBR
Danish: TIVICAY ~1 mg/kg én gang daglig + OBR
English: Currently available data are described in section 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives anbefalinger vedrørende dosering.
English: There is no clinical data on the safety or efficacy of the 100 mg twice daily dose.
Danish: Der findes ingen kliniske data vedrørende sikkerheden og virkningen af en dosis på 100 mg 2 gange daglig.
English: Dolutegravir has a less than or equal to 10 FC against 94% of the 705 clinical isolates.
Danish: Dolutegravir har en FC, der er mindre eller lig med 10 mod 94 % af de 705 kliniske isolater.
English: In addition, no antagonistic effects were seen for dolutegravir and adefovir, and ribavirin had no apparent effect on dolutegravir activity.
Danish: Derudover blev der ikke set nogen antagonistisk virkning for dolutegravir og adefovir og ribavirin havde ingen åbenlys virkning på aktiviteten af dolutegravir.
English: R263K was reported from two ART experienced, INI naive individual patients with subtypes B and C in the clinical program, but without effects on dolutegravir susceptibility in vitro.
Danish: R263K blev rapporteret fra to ART erfarne, INI naive individuelle patienter med undertyper B og C i det kliniske program, men uden effekt på følsomheden over for dolutegravir in vitro.
English: Bioequivalence has not been unequivocally shown for 1x50 mg tablet compared to 5x10 mg tablets.
Danish: Bioækvivalens er ikke entydigt påvist for 1x50 mg tablet sammenlignet med 5x10 mg tabletter.
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 højere 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: • if you are taking another medicine called dofetilide (to treat heart conditions).
Danish: • hvis du tager et andet lægemiddel, der kaldes dofetilid (til behandling af hjertelidelser).
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Danish: Patienter bør rådes til at søge lægehjælp, hvis de oplever ømme og smertende led, stive led eller bevægelsesbesvær.
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: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals, ATC code: J05AX12
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, andre antivirale midler, ATC-kode: J05AX12.
English: Raltegravir/elvitegravir was part of the current failing regimen in 98/183 patients (part of prior failing therapies in the others).
Danish: Raltegravir/elvitegravir var en del af det aktuelt svigtende regime hos 98 ud af de 183 patienter (en del af de tidligere svigtende behandlinger hos de øvrige).
English: Table 7 Virologic response (day 8) after 7 days of functional monotherapy, in patients with RAL/EVG as part of current failing regimen, VIKING 3
Danish: Tabel 7 Virologisk respons (dag 8) efter 7 dages funktionel monoterapi, hos patienter med RAL/EVG som del af nuværende svigtende regime, VIKING-3
English: • if you are allergic to dolutegravir or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for dolutegravir eller et af de øvrige indholdsstoffer i Tivicay (angivet i punkt 6)
English: With 50 mg twice daily, the exposure over 24 hours was approximately doubled compared to 50 mg once daily.
Danish: Med 50 mg to gange daglig var eksponeringen over 24 timer omkring fordoblet sammenlignet med 50 mg en gang daglig.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumoni forårsaget af Pneumocystis jirovecii.
English: This is supported by 96 week data from an open-label, randomized and activecontrolled study FLAMINGO (ING114915) and additional data from the open-label phase of SINGLE to 144 weeks.
Danish: Dette understøttes af 96-ugers data fra et åbent, randomiseret og aktivt kontrolleret studie, FLAMINGO (ING114915), samt yderligere data fra den åbne fase af SINGLEstudiet til 144 uger.
English: Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir at the time of conception compared with mothers exposed to nondolutegravir containing regimens (0.1%).
Danish: Foreløbige data fra et overvågningsstudie peger på øget forekomst af neuralrørsdefekter (0,9 %) hos mødre, der eksponeres for dolutegravir på undfangelsestidspunktet, sammenholdt med mødre, der eksponeres for regimer, som ikke indeholder dolutegravir (0,1 %).
English: Patients should be informed that dizziness has been reported during treatment with dolutegravir.
Danish: Patienten bør informeres om, at der er rapporteret svimmelhed under behandling med dolutegravir.
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Danish: Yderligere behandling skal ske i henhold til, hvad der er klinisk indikation for, eller hvad de nationale giftlinjer/-centraler anbefaler, hvis tilgængelige.
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: • if they are also taking anti-inflammatory medicines called corticosteroids
Danish: • hvis man også tager en form for antiinflammatorisk (betændelsesdæmpende) medicin, der kaldes kortikosteroider
English: • hyperactivity (excessive restlessness and movement)
Danish: • hyperaktivitet (udtalt rastløshed og bevægelse)
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 behandlingen bliver immunforsvaret stærkere og kan bekæmpe infektioner, hvilket kan give symptomer som infektion eller betændelse.
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 vivo hæmning af OAT1 usandsynlig.
English: Median Percent Change from Baseline
Danish: Median ændring fra baseline i %
English: People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Danish: Personer med fremskreden hiv-infektion (aids) har et svækket immunforsvar og har større risiko for at udvikle alvorlige infektioner (opportunistiske infektioner).
English: In subtype C (n=2) and A/G (n=2) isolates the integrase substitution R263K was selected in one isolate, and G118R in two isolates.
Danish: I isolater af undertype C (n = 2) og A/G (n = 2) blev integrasesubstitutionen R263K selekteret i ét isolat og G118R i to isolater.
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance [CrCl] 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 [CrCl] 45 - 59 ml/min), og forsigtighed anbefales.
English: No relevant effects were seen on the QTc interval, with doses exceeding the clinical dose by approximately three fold.
Danish: Der blev ikke set nogen relevante effekter på QTc-intervallet med doser, som var ca. 3 gange den kliniske dosis.
English: For children aged between 6 and 12 years your doctor will decide on the correct dose of Tivicay, depending on the weight of your child.
Danish: Hos børn fra 6 år op til 12 år vil lægen afgøre, hvilken dosis af Tivicay der er den rigtige i forhold til barnets vægt.
English: In further selection experiments using clinical isolates of subtype B, mutation R263K was seen in all five isolates (after 20 weeks and onwards).
Danish: I yderligere selektionseksperimenter, hvor der blev brugt kliniske isolater af undertype B, blev mutation R263K set i alle fem isolater (efter 20 uger og fremefter).
English: Treatment-emergent mutations observed were consistent with those observed in the VIKING-3 study.
Danish: De mutationer, som opstod under behandlingen, var konsistente med mutationer observeret i VIKING 3-studiet.
English: Tivicay has not been studied in patients on dialysis.
Danish: Tivicay er ikke blevet undersøgt hos patienter i dialysebehandling.
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pgp, and BCRP; therefore medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 2).
Danish: Dolutegravir er også substrat for UGT1A3, UGT1A9, CYP3A4, Pgp og BCRP; derfor kan lægemidler, der inducerer disse enzymer reducere plasmakoncentrationen af dolutegravir og reducere den terapeutiske effekt af dolutegravir (se tabel 2).
English: Oxcarbazepine Phenytoin Phenobarbital
Danish: Oxcarbazepin Phenytoin Phenobarbital
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 transfertrinnet i integrationen af retroviral deoxyribonukleinsyre (DNA), hvilket er essentielt for hiv's replikationscyklus.
English: No data are available in patients with severe hepatic impairment (Child-Pugh grade C); therefore dolutegravir should be used with caution in these patients (see section 5.2).
Danish: Der er ingen tilgængelige data om patienter med svær nedsat leverfunktion (Child-Pughklasse C); derfor skal dolutegravir anvendes med forsigtighed hos disse patienter (se pkt.
English: There are no data available on the use of dolutegravir plus lamivudine as a two-drug regimen in paediatric patients.
Danish: Der er ingen tilgængelige data om brugen af dolutegravir plus lamivudin som en to-stof behandling hos paediatriske patienter.
English: Don't take Tivicay:
Danish: Tag ikke Tivicay:
English: → Don't take a double dose to make up for a missed dose.
Danish:  Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: • palpitations (rapid or irregular heartbeat) or tremor
Danish: • hjertebanken (hurtig eller uregelmæssig puls) eller rysten
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 amerikanske personer.
English: Azole anti-fungal agents Ketoconazole Fluconazole Itraconazole Posaconazole Voriconazole
Danish: Azol-antimykotika Ketoconazol Fluconazol Itraconazol Posaconazol Voriconazol
English: Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age.
Danish: Tivicay er i kombination med andre antiretrovirale lægemidler indiceret til behandling af humant immundefektvirus (hiv)-inficerede voksne, unge og børn over 6 år.
English: There is no specific treatment for an overdose of dolutegravir.
Danish: Der findes ingen specifik behandling mod overdosering med dolutegravir.
English: The E92Q mutation has been selected in patients with pre-existing raltegravir resistance who were then treated with dolutegravir (listed as a secondary mutation for dolutegravir).
Danish: E92Q-mutationen er blevet selekteret hos patienter med præeksisterende raltegravir-resistens, som så blev behandlet med dolutegravir (anført som en sekundær mutation for dolutegravir).
English: Tivicay should not be used in children and adolescents with HIV infection that is resistant to other medicines similar to Tivicay.
Danish: Tivicay bør ikke anvendes til børn og unge med hiv-infektion, der er resistent over for andre lægemidler af samme type som Tivicay.
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: Dofetilide ↑ (Not studied, potential increase via inhibition of OCT2 transporter)
Danish: Dofetilid  (Ikke undersøgt, potentielt stigning via hæmning af OCT2-transporter)
English: The PK variability of dolutegravir is low to moderate.
Danish: PK-variabiliteten af dolutegravir er lav til moderat.
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 kan elimineres væsentligt ved dialyse.
English: • etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, to treat HIV infection
Danish: • etravirin, efavirenz, fosamprenavir/ritonavir, nevirapin eller tipranavir/ritonavir, til behandling af hiv-infektion.
English: Tivicay should be prescribed by physicians experienced in the management of HIV infection.
Danish: Tivicay skal ordineres af læger med erfaring i behandling af hiv-infektion.
English: The clinical status of the patient and the adverse reaction profile of dolutegravir 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 dolutegravirs bivirkningsprofil ved vurdering af patientens evne til at føre motorkøretøjer og betjene maskiner.
English: If the patient misses a dose of Tivicay, the patient should take Tivicay as soon as possible, providing the next dose is not due within 4 hours.
Danish: Hvis patienten glemmer en dosis Tivicay, skal patienten tage Tivicay så hurtigt som muligt, forudsat at den næste dosis ikke skal tages inden for 4 timer.
English: In contrast, starting with mutants harbouring mutation Q148H (FC 1), a variety of secondary mutations were seen with a consequent increase of FC to values >10.
Danish: Blev der derimod startet med mutanter, som husede mutation Q148H (FC 1), blev der set en række sekundære mutationer med en resulterende øgning af FC til værdier > 10.
English: The apparent volume of distribution is 17 L to 20 L in HIV-infected patients, based on a population pharmacokinetic analysis.
Danish: Det angivelige fordelingsvolumen er 17 l til 20 l hos hiv-inficerede patienter baseret på en farmakokinetisk populationsanalyse.
English: Baseline CD4+ (cells/ mm3) 200 to <350 NRTI backbone ABC/3TC
Danish: Baseline-CD4+ (celler/ mm3) 200 til < 350 NRTI-backbone ABC/3TC
English: Your doctor may decide to adjust your dose or that you need extra check ups.
Danish: Lægen vil beslutte, om din dosis skal ændres, eller om du har brug for flere kontroller.
English: Your doctor will decide on the correct dose of Tivicay for you.
Danish: Lægen vil afgøre, hvilken dosis Tivicay, der er den rigtige til dig.
English: The effect of severe hepatic impairment on the pharmacokinetics of Tivicay has not been studied.
Danish: Effekten af svært nedsat leverfunktion på farmakokinetikken af Tivicay er ikke blevet undersøgt.
English: In 100% human serum, the mean protein fold shift was 75 fold, resulting in protein adjusted IC90 of 0.064 µg/mL.
Danish: I 100 % humant serum var den gennemsnitlige ændring i proteinfoldning en faktor 75, hvilket resulterede i en proteinjusteret IC90-værdi på 0,064 mikrog/ml.
English: 4.6 Fertility, pregnancy and lactation Women of childbearing potential
Danish: 4.6 Fertilitet, graviditet og amning
English: Limited experience of single higher doses (up to 250 mg in healthy subjects) revealed no specific symptoms or signs, apart from those listed as adverse reactions.
Danish: Begrænsede data med højere enkeltdoser (op til 250 mg hos raske personer) medførte ingen specifikke symptomer eller tegn ud over de tegn og symptomer, der er anført som bivirkninger.
English: DTG 50 mg BID N=88* n Mean (SD) Plasma HIV-1 RNA log10 c/mL
Danish: DTG 50 mg BID N = 88* n Gennemsnitlig (SD) plasma hiv-1 RNA log10 c/ml
English: Dose recommendations according to weight are presented in table 1.
Danish: De anbefalede doser i henhold til barnets vægt er angivet i tabel 1.
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 på 50 mg/kg 10 dage post partum, blev der påvist dolutegravir i mælken i koncentrationer, som typisk var højere end i blodet.
English: Metformin is eliminated renally and, therefore, it is of importance to monitor renal function when co-treated with dolutegravir.
Danish: Metformin elimineres renalt, og det er derfor vigtigt at monitorere nyrefunktionen ved administration sammen med dolutegravir.
English: † Includes subjects who changed BR to new class or changed BR not permitted per protocol or due to lack of efficacy prior to Week 48 (for SPRING-2 only), subjects who discontinued prior to Week 48 for lack or loss of efficacy and subjects who are ≥50 copies in the 48 week window.
Danish: †Omfatter personer, der ændrede BR til en ny klasse, eller som ændrede BR på en måde, der ikke var tilladt i henhold til protokollen, eller som ændrede BR på grund af manglende effekt, før uge 48 (kun for SPRING-2), personer, der fik seponeret behandlingen før uge 48 på grund af manglende eller tab af effekt, og personer med  50 kopier inden for tidsrammen på de 48 uger.