FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET TIL FLASKE
English: In a meta-analysis using pharmacogenomics samples collected in clinical studies in healthy subjects, subjects with UGT1A1 (n=7) genotypes conferring poor dolutegravir metabolism had a 32% lower clearance of dolutegravir and 46% higher AUC compared with subjects with genotypes associated with normal metabolism via UGT1A1 (n=41).
Danish: I en metaanalyse, hvor der blev brugt farmakogenomiske prøver indsamlet i kliniske studier af raske personer, havde personer med UGT1A1-genotyper (n=7), der medførte dårlig metabolisering af dolutegravir, en 32 % lavere clearance af dolutegravir og et 46 % større AUC sammenlignet med personer med genotyper, der var forbundet med normal metabolisering via UGT1A1 (n=41).
English: In vitro, dolutegravir demonstrated no direct, or weak inhibition (IC50>50 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A, UGT1A1 or UGT2B7, or the transporters Pgp, BCRP, BSEP, organic anion transporting polypeptide (OATP) 1B1, OATP1B3, OCT1, MATE2-K, multidrug resistance-associated protein (MRP) 2 or MRP4.
Danish: In vitro har dolutegravir ikke direkte, eller kun svagt, vist hæmning (IC50 >50 µM) af enzymerne cytokrom P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, UGT1A1 eller UGT2B7 eller transporterne Pgp, BCRP, BSEP, organisk aniontransporterende polypeptid (OATP) 1B1, OATP1B3, OCT1, MATE2-K, multilægemiddelresistens-associeret protein (MRP) 2 eller MRP4.
English: In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting.
Danish: In vitro hæmmer lamivudin den intracellulære fosforylering af cladribin, hvilket kan medføre en potentiel risiko for manglende effekt af cladribin, hvis kombinationen anvendes klinisk.
English: Dovato can make you dizzy, and have other side effects that make you less alert.
Danish: Trafik- og arbejdssikkerhed Dovato kan gøre dig svimmel og give dig andre bivirkninger, der gør dig mindre opmærksom.
English: In vitro, lamivudine did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrated no or weak inhibition of OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 or MATE2-K. Lamivudine is therefore not expected to affect the plasma concentrations of medicinal products that are substrates of these enzymes or transporters.
Danish: In vitro hæmmede eller inducerede lamivudin CYP-enzymer (som f.eks. CYP3A4, CYP2C9 eller CYP2D6) og udviste ingen eller svag hæmning af OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 eller MATE2-K. Lamivudin forventes derfor ikke at påvirke plasmakoncentrationen af lægemidler, der er substrater for disse enzymer eller transportere.
English: Uncommon suicidal ideation*, suicide attempt* *particularly in patients with a pre-existing history of depression or psychiatric illness.
Danish: Ikke almindelig selvmordstanker*, selvmordsforsøg* *særligt hos patienter med depression eller psykisk sygdom i anamnesen.
English: Baseline Plasma Viral Load (copies/mL)
Danish: Viral belastning i plasma ved baseline (kopier/ml)
English: • sensation of weakness in the limbs.
Danish: • en følelse af svaghed i arme og ben.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 90 (3 pakninger med 30) tabletter
English: creatine phosphokinase (CPK) elevations alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations
Danish: forhøjet niveau af kreatininfosfokinase (CPK) forhøjet niveau af alaninaminotransferase (ALAT) og/eller aspartataminotransferase (ASAT)
English: AUC in semen was 7% and 17% in rectal tissue of those in corresponding plasma at steady state.
Danish: AUC i sæd var 7 %, og AUC i rektalt væv 17 % af AUC-værdierne i tilsvarende plasma ved steady state.
English: No dose adjustment is necessary (see section 5.2).
Danish: Dosisjustering er ikke nødvendig (se pkt.
English: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Danish: Der kan ske en vægtøgning og stigning i niveauet af lipider i blodet samt glucose under antiretroviral behandling.
English: In a randomized, dose-ranging trial, HIV-1-infected subjects treated with dolutegravir monotherapy (ING111521) demonstrated rapid and dose-dependent antiviral activity, with mean decline in HIV-1 RNA of 2.5 log10 at day 11 for 50 mg dose.
Danish: I et randomiseret, dosisbestemmende studie udviste hiv-1-inficerede personer behandlet med monoterapi med dolutegravir (ING111521) hurtig og dosisafhængig antiviral aktivitet med et gennemsnitligt fald i hiv-1-RNA på 2,5 log10 på dag 11 ved en dosis på 50 mg.
English: The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 28.5 and 1.1 times the 50 mg human clinical exposure following single dose in the fasted state based on AUC, respectively.
Danish: Den primære effekt af dolutegravir var gastrointestinal intolerance eller irritation hos rotter og aber ved doser, der medfører systemiske eksponeringer på henholdsvis ca. 28,5 og 1,1 gange den humane kliniske eksponering ved 50 mg baseret på AUC efter enkeltdosis i fastende tilstand.
English: The primary efficacy endpoint for each GEMINI trial was the proportion of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48 (Snapshot algorithm for the ITT-E population).
Danish: Det primære effektendepunkt for hvert GEMINI-studie var andelen af personer med hiv-1-RNA <50 kopier/ml i plasma ved uge 48 (snapshot-algoritme for ITT-E-populationen).
English: The most severe adverse reaction reported with dolutegravir was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4).
Danish: De sværeste bivirkninger, som er rapporteret med dolutegravir, var en overfølsomhedsreaktion, som omfattede udslæt og svære leverpåvirkninger (se pkt.
English: Polyvalent cationcontaining antacids are recommended to be taken 2 hours after or 6 hours before Dovato (see section 4.5).
Danish: Det anbefales, at polyvalente kationholdige antacida tages 2 timer efter eller 6 timer før Dovato (se pkt.
English: Nervous system disorders: Very common:
Danish: Nervesystemet: Meget almindelig:
English: Like all medicines, this medicine can cause side effects, although not everybody gets them, so it is very important to talk to your doctor about any changes in your health.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Single dose lamivudine oral solution 300 mg. Lamivudine:
Danish: Enkelt dosis med lamivudin oral opløsning 300 mg. Lamivudin:
English: • suicidal thoughts (particularly in patients who have had depression or mental health problems before).
Danish: • selvmordstanker (særligt hos patienter, som tidligere har haft depression eller psykiske problemer).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1370/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1370/001
English: Based on in vivo and/or in vitro data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of any major enzyme or transporter such as CYP3A4, CYP2C9 and P-gp (for more information see section 5.2).
Danish: På baggrund af in vivoog/eller in vitro-data forventes dolutegravir ikke at påvirke farmakokinetikken af lægemidler, der er substrater for vigtige enzymer eller transportere, som f.eks. CYP3A4, CYP2C9 og P-gp (se pkt.
English: People taking combination therapy for HIV may get other side effects.
Danish: Andre mulige bivirkninger Personer, der tager kombinationsbehandling mod hiv, kan få andre bivirkninger.
English: Lamivudine is predominately cleared by renal excretion of unchanged lamivudine.
Danish: Lamivudin udskilles hovedsageligt ved renal udskillelse af uomdannet lamivudin.
English: Look out for important symptoms Some people taking medicines for HIV infection develop other conditions, which can be serious.
Danish: Nogle personer, der tager medicin mod hiv-infektion, udvikler andre tilstande, der kan være alvorlige.
English: The median or mean IC50 values for lamivudine against lab-strains of HIV-1 ranged from 0.007 to 2.3 µM.
Danish: Median eller middel IC50-værdierne for lamivudin mod laboratoriestammer af hiv-1 varierede fra 0,007 til 2,3 µM.
English: Uncommon side effects that may show up in blood tests are:
Danish: Ikke almindelige bivirkninger, der muligvis kan ses i blodprøver, er:
English: Cytotoxics Cladribine/Lamivudine
Danish: Cytotoksiske lægemidler Cladribin/lamivudin
English: Based on the lamivudine data, Dovato is not recommended for patients with creatinine clearance of < 50 mL/min.
Danish: På baggrund af data om lamivudin frarådes Dovato til patienter med kreatininclearance <50 ml/min.
English: Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it (see also section 3, ‘How to take Dovato')
Danish: Tag ikke et antacid i 6 timer, før du tager Dovato, eller i mindst 2 timer efter at du har taget Dovato (se også punkt 3, "Sådan skal du tage Dovato")
English: Dolutegravir was shown to cross the placenta in animals.
Danish: Det viste sig, at dolutegravir passerer placenta hos dyr.
English: When possible, avoid chronic coadministration of Dovato with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (eg: xylitol, mannitol, lactitol, maltitol).
Danish: Undgå kronisk samtidig administration af Dovato og lægemidler, der indeholder sorbitol eller andre osmotisk virkende polyalkoholer eller monosakkaridalkoholer (f.eks. xylitol, mannitol, lactitol, maltitol).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACKS ONLY - WITH BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (KUN MULTIPAKNINGER - MED BLUE BOX)
English: The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to 17 years) showed that dolutegravir 50 mg once daily dosage resulted in dolutegravir exposure comparable to that observed in adults who received dolutegravir 50 mg once daily.
Danish: Farmakokinetikken for dolutegravir hos 10 hiv-1-inficerede unge (12 til 17 år) med antiretroviral behandlingserfaring viste, at en dosis af dolutegravir på 50 mg én gang dagligt resulterede i dolutegravireksponering, som kunne sammenlignes med den, der blev observeret hos voksne, som fik dolutegravir 50 mg én gang dagligt.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: Dovato can be taken with or without food (see section 5.2).
Danish: Dovato kan tages med eller uden mad (se pkt.
English: Dolutegravir ↔ No dosage adjustment necessary.
Danish: Dolutegravir ↔ Dosisjustering er ikke nødvendig.
English: In reproductive toxicity studies in animals, dolutegravir and lamivudine were shown to cross the placenta.
Danish: I dyreforsøg vedrørende reproduktionstoksicitet viste det sig, at dolutegravir og lamivudin passerer placenta.
English: • inflammation of the pancreas (pancreatitis)
Danish: • betændelse i bugspytkirtlen (pancreatitis)
English: In 13 treatment-naïve subjects on a stable dolutegravir plus abacavir/lamivudine regimen, dolutegravir concentration in CSF averaged 18 ng/mL (comparable to unbound plasma concentration, and above the IC50).
Danish: Hos 13 behandlingsnaive personer på et stabilt regime med dolutegravir plus abacavir/lamivudin lå koncentrationen af dolutegravir i CSF i gennemsnit på 18 ng/ml (sammenligneligt med ubundet plasmakoncentrationen og over IC50).
English: Multipacks containing 90 (3 packs of 30) film-coated tablets.
Danish: Multipakninger, der indeholder 90 (3 pakninger med 30) filmovertrukne tabletter.
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Danish: Vægten og niveauet af lipider i blodet samt glucose kan stige under antiretroviral behandling (se pkt.
English: Fertility studies in rats have shown that dolutegravir or lamivudine have no effect on male or female fertility.
Danish: Fertilitetsstudier med rotter har vist, at dolutegravir eller lamivudin ikke har nogen effekt på fertiliteten hos hanner eller hunner.
English: Population pharmacokinetic analysis indicated that hepatitis C virus co-infection had no clinically relevant effect on the exposure to dolutegravir.
Danish: Farmakokinetiske populationsanalyser tydede på, at co-infektion med hepatitis C-virus ikke havde nogen klinisk relevant effekt på eksponeringen for dolutegravir.
English: Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of Dovato.
Danish: Kvinder i den fertile alder skal have taget en graviditetstest før start af behandling med Dovato.
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Dovato with metformin, to maintain glycaemic control.
Danish: Justering af metformindosis bør overvejes ved opstart eller ophør af samtidig administration af Dovato og metformin for at opretholde glykæmisk kontrol.
English: Dolutegravir ↓ (Not studied, a similar reduction in exposure as observed with efavirenz is expected, due to induction)
Danish: Dolutegravir ↓ (Ikke undersøgt; et lignende fald i eksponering som set med efavirenz forventes pga. induktion)
English: Not everyone responds to treatment with Dovato in the same way.
Danish: Behandlingen med Dovato virker ikke ens på alle.
English: Some people taking Dovato or other combination treatments for HIV are more at risk of serious side effects than others.
Danish: Advarsler og forsigtighedsregler Nogle personer, der tager Dovato eller anden kombinationsbehandling mod hiv, har større risiko for bivirkninger end andre.
English: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Danish: Det er påvist in vitro og in vivo, at nukleosid- og nukleotidanaloger i forskellig udstrækning forårsager mitokondrieskader.
English: Nucleoside reverse transcriptase inhibitors (NRTIs) Tenofovir disoproxil
Danish: Nukleosid revers transkriptasehæmmere (NRTI'er) Tenofovirdisoproxil
English: If Dovato is administered under fasting conditions, supplements or multivitamins containing calcium, iron or magnesium are recommended to be taken 2 hours after or 6 hours before Dovato (see section 4.5).
Danish: Hvis Dovato administreres under fastetilstand anbefales det, at tilskud eller multivitaminer, der indeholder calcium, jern eller magnesium, tages 2 timer efter eller 6 timer før Dovato (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1370/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1370/002
English: Dolutegravir ↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected).
Danish: Dolutegravir ↓ (Ikke undersøgt; fald er forventet pga. induktion af UGT1A1- og CYP3A-enzymer, en lignende reduktion i eksponering som observeret for carbamazepin forventes).
English: The effect of severe hepatic impairment on the pharmacokinetics of dolutegravir has not been studied.
Danish: Effekten af svært nedsat leverfunktion på dolutegravirs farmakokinetik er ikke undersøgt.
English: The recommended dose of dolutegravir is 50 mg twice daily for patients taking etravirine without boosted protease inhibitors.
Danish: Den anbefalede dosis af dolutegravir er 50 mg to gange dagligt for patienter, der tager etravirin uden boostede proteasehæmmere.
English: There is no evidence that common polymorphisms in drug metabolising enzymes alter dolutegravir pharmacokinetics to a clinically meaningful extent.
Danish: Polymorfismer i lægemiddelmetaboliserende enzymer Der er ingen tegn på, at almindelige polymorfismer i lægemiddelmetaboliserende enzymer ændrer dolutegravirs farmakokinetik i klinisk betydningsfuldt omfang.
English: • a decreased number of cells involved in blood clotting (thrombocytopenia)
Danish: • nedsat antal blodceller, der bidrager til, at blodet størkner (trombocytopeni)
English: Metformin ↑ Dolutegravir ↔ When co-administered with dolutegravir 50 mg QD:
Danish: Metformin ↑ Dolutegravir ↔ Ved samtidig administration af dolutegravir 50 mg QD (en gang dagligt):
English: Phenobarbital/Dolutegravir Phenytoin/Dolutegravir Oxcarbazepine/Dolutegravir
Danish: Phenobarbital/dolutegravir Phenytoin/dolutegravir Oxcarbazepin/dolutegravir
English: General disorders and administration site conditions: Common:
Danish: Almene symptomer og reaktioner på administrationsstedet: Almindelig:
English: Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Danish: Data indhentet fra patienter med moderat til svært nedsat leverfunktion viser, at lamivudins farmakokinetik ikke påvirkes signifikant af nedsat leverfunktion.
English: The mean IC50 against lab-strains of HIV-2 (LAV2 and EHO) ranged from 0.16 to 0.51 µM for lamivudine.
Danish: Middel IC50 mod laboratoriestammer af hiv-2 (LAV2 og EHO) varierede fra 0,16 til 0,51 µM for lamivudin.
English: Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls)
Danish: Dolutegravir ↔ AUC ↑ 7 % Cmax ↑ 5 % Cτ ↑ 8 % Boceprevir ↔ (historiske kontroller)
English: Each bottle contains 30 film-coated tablets.
Danish: Hver tabletbeholder indeholder 30 filmovertrukne tabletter.
English: Lamivudine was not mutagenic in bacterial tests, but consistent with other nucleoside analogues, inhibits cellular DNA replication in in vitro mammalian tests such as the mouse lymphoma assay.
Danish: Lamivudin var ikke mutagent i bakterieforsøg, men i overensstemmelse med andre nukleosidanaloger hæmmer det cellulær dna-replikation i in vitro-test med celler fra pattedyr, som f.eks. i lymfetesten udført på mus.
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues, these have predominantly concerned treatment with regimens containing zidovudine.
Danish: Der er rapporteret om mitokondriel dysfunktion hos hivnegative spædbørn, som har været eksponeret for nukleosidanaloger in utero og/eller postnatalt, hovedsageligt i forbindelse med behandling med regimer indeholdende zidovudin.
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir (see section 4.5).
Danish: Den anbefalede dosis af dolutegravir er 50 mg to gange dagligt ved samtidig administration af rifampicin, carbamazepin, oxcarbazepin, phenytoin, phenobarbital, perikon, etravirin (uden boostede proteasehæmmere), efavirenz, nevirapin eller tipranavir/ritonavir (se pkt.
English: Virologic Outcomes of Randomised Treatment at Week 48 (Snapshot algorithm) GEMINI-1 and GEMINI-2 Pooled Data*
Danish: Tabel 3 Virologiske resultater af randomiserede behandlinger i uge 48 (snapshot-algoritme) Sammenlagte data* fra GEMINI-1 og GEMINI-2 DTG + 3TC N=716
English: In vitro, dolutegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
Danish: Dolutegravir inducerede ikke CYP1A2, CYP2B6 eller CYP3A4 in vitro.
English: - If you get any side effects, talk to your doctor, or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Dovato has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Dovato påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: 1 This adverse reaction was identified through post-marketing surveillance for dolutegravir in combination with other ARVs.
Danish: 1 Denne bivirkning blev identificeret ved overvågning af dolutegravir i kombination med andre antiretrovirale lægemidler efter markedsføring.
English: Interaction not studied containing products, since both lamivudine (in Dovato) and emtricitabine are cytidine analogues (i.e. risk for intracellular interactions, (see section 4.4).
Danish: Dovato frarådes i kombination med produkter, der indeholder emtricitabin, da både lamivudin (i Dovato) og emtricitabin er cytidinanaloger (dvs. risiko for intracellulære interaktioner, se pkt.
English: If you get any symptoms of infection or if you notice any of the symptoms above:
Danish: Hvis du får nogen symptomer på infektion, eller hvis du bemærker nogen af ovennævnte symptomer: → Fortæl det omgående til lægen.
English: In vitro, dolutegravir inhibited the renal transporters OCT2 and MATE1.
Danish: In vitro hæmmede dolutegravir de renale transportere OCT2 og MATE1.
English: Psychiatric disorders: Common:
Danish: Psykiske forstyrrelser: Almindelig:
English: Etravirine without boosted protease inhibitors decreased plasma dolutegravir concentration.
Danish: Etravirin uden boostede proteasehæmmere reducerede plasmakoncentrationen af dolutegravir.
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).
Danish: Der er rapporteret om mitokondriel dysfunktion hos hiv-negative spædbørn, som har været eksponeret for nukleosidanaloger in utero og/eller postnatalt (se pkt.
English: Immune system disorders: Uncommon:
Danish: Immunsystemet: Ikke almindelig:
English: • medicines called antacids, to treat indigestion and heartburn.
Danish: • lægemidler kaldet antacida (syreneutraliserende lægemidler) til behandling af fordøjelsesbesvær og halsbrand.
English: Dolutegravir did not change daclatasvir plasma concentration.
Danish: Dolutegravir ændrede ikke daclatasvirs plasmakoncentration.
English: Antidiabetics Metformin/Dolutegravir
Danish: Antidiabetika Metformin/dolutegravir
English: A separate preparation of dolutegravir is available where a dose adjustment is indicated due to drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir, see sections 4.4 and 4.5).
Danish: Der findes et separat præparat med dolutegravir, hvor en dosisjustering er indiceret på grund af lægemiddelinteraktioner (f.eks. rifampicin, carbamazepin, oxcarbazepin, phenytoin, phenobarbital, perikon, etravirin (uden boostede proteasehæmmere), efavirenz, nevirapin eller tipranavir/ritonavir, se pkt.
English: No dosage adjustment is considered necessary for patients with mild to moderate hepatic impairment.
Danish: Det anses ikke for nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion.
English: • metformin, to treat diabetes
Danish: • metformin til behandling af diabetes (sukkersyge)
English: Protease inhibitors Atazanavir/Dolutegravir
Danish: Proteasehæmmere Atazanavir/dolutegravir
English: Dolutegravir was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Danish: Dolutegravir var ikke mutagent eller klastogent i tests udført in vitro på bakterier og dyrkede pattedyrsceller og i en mikronukleusanalyse udført in vivo hos gnavere.