FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose reduction is required for patients with creatinine clearance < 50 mL/min (see section 4.2).
Danish: En dosisreduktion er nødvendig til patienter med kreatininclearance <50 ml/min (se pkt.
English: There is no evidence that a dose adjustment of dolutegravir or lamivudine would be required based on the effects of race on PK parameters.
Danish: Der er ingen tegn på, at det vil være nødvendigt at justere dosis af dolutegravir eller lamivudin på baggrund af effekterne af race på farmakokinetiske parametre.
English: In patients with moderate renal impairment a dose adjustment of metformin should be considered when coadministered with Dovato, because of the increased risk for lactic acidosis in patients with moderate renal impairment due to increased metformin concentration (section 4.4).
Danish: Justering af metformindosis bør overvejes ved samtidig administration af Dovato hos patienter med moderat nedsat nyrefunktion pga. øget risiko for laktacidose som følge af den øgede metforminkoncentration (se pkt.
English: In vitro, dolutegravir inhibited the renal uptake organic anion transporters (OAT)1 and OAT3.
Danish: In vitro hæmmede dolutegravir de renale organiske anion-optagelsestransportere (OAT)1 og OAT3.
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”).
Danish: Interaktioner mellem dolutegravir, lamivudin og samtidigt administrerede lægemidler er anført i tabel 1 (stigning er angivet som "↑", fald som "↓", ingen ændring som "↔", arealet under koncentrations-tids-kurven som "AUC", den observerede maksimumskoncentration som "Cmax").
English: • joint pain, stiffness and bone problems.
Danish: • ledsmerter, stive led og knogleproblemer.
English: There are no data on the effects of dolutegravir or lamivudine on human male or female fertility.
Danish: Der foreligger ingen data om dolutegravirs eller lamivudins indvirkning på fertiliteten hos mænd eller kvinder.
English: There is no evidence that a dose adjustment of dolutegravir or lamivudine would be required based on the effects of gender on PK parameters.
Danish: Der er ingen tegn på, at det vil være nødvendigt at justere dosis af dolutegravir eller lamivudin på baggrund af effekterne af køn på farmakokinetiske parametre.
English: • numbness, tingly feelings in the skin (pins and needles)
Danish: • følelsesløshed, snurrende fornemmelse i huden (prikken og stikken)
English: Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14).
Danish: Dolutegravirs IC50 i forskellige laboratoriestammer var ved brug af PBMC 0,5 nM og lå ved brug af MT-4-celler i intervallet 0,7-2 nM. Der blev set tilsvarende IC50-værdier for kliniske isolater uden nogen større forskel mellem undertyperne; i et panel på 24 hiv-1-isolater af clade A, B, C, D, E, F og G og gruppe O var den gennemsnitlige IC50-værdi 0,2 nM (interval 0,02-2,14).
English: Animal studies indicate no effects of dolutegravir or lamivudine on male or female fertility (see section 5.3).
Danish: Dyreforsøg viser ingen effekt af dolutegravir eller lamivudin på fertiliteten hos mænd eller kvinder (se pkt.
English: No dose adjustment is required in patients with mild renal impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let nedsat nyrefunktion.
English: When administered in fasted state, bioequivalence regarding Cmax was achieved for dolutegravir, when comparing Dovato to dolutegravir 50 mg co-administered with lamivudine 300 mg. Dolutegravir AUC0-t was 16% higher for Dovato than for dolutegravir 50 mg co-administered with lamivudine 300 mg.
Danish: Ved administration i fastetilstand blev bioækvivalens for Cmax opnået for dolutegravir ved sammenligning mellem Dovato og dolutegravir 50 mg administreret sammen med lamivudin 300 mg. Dolutegravir AUC0-t var 16 % højere for Dovato end for dolutegravir 50 mg administreret sammen med lamivudin 300 mg.
English: When administered in fasted state, bioequivalence was achieved for lamivudine AUC, when comparing Dovato to lamivudine 300 mg co-administered with dolutegravir 50 mg. Lamivudine Cmax for Dovato was 32% higher than lamivudine 300 mg co-administered with dolutegravir 50 mg.
Danish: Ved administration i fastetilstand blev bioækvivalens for lamivudins AUC opnået ved sammenligning mellem Dovato og lamivudin 300 mg administreret sammen med dolutegravir 50 mg. Lamivudins Cmax for Dovato var 32 % højere end lamivudin 300 mg administreret sammen med dolutegravir 50 mg.
English: Don't stop taking Dovato without advice from your doctor Take Dovato for as long as your doctor recommends.
Danish: Tag Dovato så længe, som lægen anbefaler.
English: Rare acute hepatic failure1
Danish: Sjælden akut leversvigt1
English: The likelihood of metabolic drug interactions with lamivudine is low due to the small extent of hepatic metabolism (5-10%).
Danish: Sandsynligheden for metaboliske lægemiddelinteraktioner med lamivudin er lav på grund af den begrænsede metabolisering i leveren
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INDIVIDUAL PACKS ONLY)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (KUN ENKELTPAKNINGER)
English: What Dovato contains
Danish: Dovato indeholder:
English: Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some subjects with hepatitis B and/or C co-infection at the start of dolutegravir therapy, particularly in those whose anti-hepatitis B therapy was withdrawn (see section 4.4).
Danish: Der blev observeret forhøjede leverparametre, som var i overensstemmelse med immunrekonstitutionssyndrom, hos nogle personer med co-infektion med hepatitis B og/eller hepatitis C i begyndelsen af dolutegravirbehandlingen, særligt hos dem, hvis anti-hepatitis B-behandling blev seponeret (se pkt.
English: Rare side effects These may affect up to 1 in 1000 people:
Danish: Sjældne bivirkninger Kan forekomme hos op til 1 ud af 1000 personer:
English: Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Danish: Undersøgelser af patienter med nedsat nyrefunktion viser, at elimination af lamivudin påvirkes ved nedsat nyrefunktion.
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.55 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
Danish: Hos kaniner blev der observeret maternel toksicitet (nedsat fødeindtagelse, sparsom/ingen fæces/urin, hæmmet vægtøgning) ved 1.000 mg/kg (0,55 gange den humane kliniske eksponering ved 50 mg baseret på AUC efter enkeltdosis i fastende tilstand).
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (37.2 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
Danish: Oral administration af dolutegravir til drægtige rotter i doser op til 1.000 mg/kg dagligt fra dag 6-17 i drægtighedsperioden udløste ikke maternel toksicitet, udviklingstoksicitet eller teratogenicitet (37,2 gange den humane kliniske eksponering ved 50 mg baseret på AUC efter enkeltdosis i fastende tilstand).
English: Population pharmacokinetic analysis of dolutegravir using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir exposure.
Danish: En farmakokinetisk populationsanalyse af dolutegravir, hvor der blev brugt data om hiv-1-inficerede voksne, viste, at der ikke var nogen klinisk relevant betydning af alder på eksponeringen for dolutegravir.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder dolutegravirnatrium svarende til 50 mg dolutegravir og 300 mg lamivudin.
English: • muscle or joint aches.
Danish: • muskel- eller ledsmerter.
English: If you do not take Dovato with food, do not take a supplement or multivitamin containing calcium, iron or magnesium 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: Hvis du ikke tager Dovato sammen med mad, må du ikke tage tilskud eller multivitamin, der indeholder calcium, jern eller magnesium i 6 timer før du tager Dovato, eller i mindst 2 timer efter du har taget Dovato (se også punkt 3, "Sådan skal du tage Dovato")
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Dovato with metformin, to maintain glycaemic control (see section 4.5).
Danish: Justering af metformindosis bør overvejes ved opstart eller ophør af samtidig administration af Dovato og metformin for at opretholde glykæmisk kontrol (se pkt.
English: How to take Dovato
Danish: Sådan skal du tage Dovato
English: • lactic acidosis (excess lactic acid in the blood)
Danish: • for meget mælkesyre i blodet (laktacidose)
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (induction of UGT1A1 and CYP3A enzymes)
Danish: Dolutegravir ↓ AUC ↓ 54 % Cmax ↓ 43 % Cτ ↓ 72 % (induktion af UGT1A1- og CYP3A-enzymer)
English: → Talk to your doctor for further advice on taking supplements or multivitamins containing calcium, iron or magnesium with Dovato.
Danish: → Tal med lægen for yderligere råd om, hvordan du skal tage tilskud eller multivitaminer, der indeholder calcium, jern eller magnesium, mens du tager Dovato.
English: Joint pain, stiffness and bone problems
Danish: Ledsmerter, stive led og knogleproblemer
English: Iron supplements/Dolutegravir (fasted intake)
Danish: Jerntilskud/dolutegravir (fastetilstand)
English: Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available.
Danish: Fås også i multipakninger, der indeholder 90 filmovertrukne tabletter (3 pakninger med 30 filmovertrukne tabletter).
English: Lamivudine: AUC ↑ 43% Cmax ↑ 7%
Danish: AUC ↑ 43 % Cmax ↑ 7 %
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.55 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
Danish: Oral administration af dolutegravir til drægtige kaniner i doser op til 1.000 mg/kg dagligt fra dag 6 til 18 i drægtighedsperioden udløste ikke udviklingstoksicitet eller teratogenicitet (0,55 gange den humane kliniske eksponering ved 50 mg baseret på AUC efter enkeltdosis i fastende tilstand).
English: If you do not take Dovato with food, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you take Dovato, or for at least 2 hours after you take it.
Danish: Hvis du ikke tager Dovato sammen med mad, må du ikke tage tilskud eller multivitamin, der indeholder calcium, jern eller magnesium, i 6 timer før du tager Dovato, eller i mindst 2 timer efter du har taget Dovato.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der noget, du er i tvivl om.
English: Magnesium/ aluminium-containing antacids/Dolutegravir
Danish: Magnesium/ aluminiumholdige antacida/dolutegravir
English: - If you have any further questions, ask your doctor, or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
Danish: Hver tablet indeholder dolutegravirnatrium svarende til 50 mg dolutegravir og 300 mg lamivudin.
English: Corticosteroids Prednisone/Dolutegravir
Danish: Kortikosteroider Prednison/dolutegravir
English: Anticonvulsants Carbamazepine/Dolutegravir
Danish: Antikonvulsiva Carbamazepin/dolutegravir
English: Dovato is not recommended for use in patients with a creatinine clearance < 50 mL/min (see section 5.2).
Danish: Anvendelse af Dovato frarådes til patienter med kreatininclearance <50 ml/min (se pkt.
English: Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy.
Danish: Der blev observeret forhøjede leverparametre, som var i overensstemmelse med immunrekonstitutionssyndrom, hos nogle patienter med co-infektion med hepatitis B og/eller hepatitis C i begyndelsen af dolutegravirbehandlingen.
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 tabletter.
English: Population PK analyses using pooled pharmacokinetic data from clinical studies where dolutegravir or lamivudine was administered to adults in combination with other ARVs revealed no clinically relevant effect of gender on the exposure of dolutegravir or lamivudine.
Danish: Farmakokinetiske populationsanalyser, hvor der blev brugt sammenlagte farmakokinetiske data fra kliniske studier, hvor dolutegravir eller lamivudin blev administreret til voksne i kombination med andre antiretrovirale lægemidler, viste ingen klinisk relevant effekt af køn på eksponeringen for dolutegravir eller lamivudin.
English: These may affect up to 1 in 10,000 people:
Danish: Kan forekomme hos op til 1 ud af 10.000 personer:
English: NAME OF THE MEDICINAL PRODUCT Dovato 50 mg/300 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Dovato 50 mg/300 mg filmovertrukne tabletter
English: 4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: Renal impairment Pharmacokinetic data have been obtained for dolutegravir and lamivudine separately.
Danish: Nedsat nyrefunktion Der er indhentet farmakokinetiske data om dolutegravir og lamivudin separat.
English: The recommended dose of dolutegravir is 50 mg twice daily when co administered with tipranavir/ritonavir.
Danish: Den anbefalede dosis af dolutegravir er 50 mg to gange dagligt ved samtidig administration af tipranavir/ritonavir.
English: Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Danish: Daclatasvir medførte ingen klinisk relevant ændring i dolutegravirs plasmakoncentration.
English: Proton pump inhibitors Omeprazole
Danish: Protonpumpehæmmere Omeprazol
English: Dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% Rilpivirine ↔
Danish: Dolutegravir ↔ AUC ↑ 12 % Cmax ↑ 13 % Cτ ↑ 22 % Rilpivirin ↔
English: • difficulty breathing.
Danish: • vejrtrækningsbesvær.
English: Concomitant use of Dovato with cladribine is not recommended (see section 4.4).
Danish: Samtidig brug af Dovato og cladribin frarådes (se pkt.
English: Population PK analyses using pooled pharmacokinetic data from clinical studies where dolutegravir was administered to adults in combination with other ARVs revealed no clinically relevant effect of race on the exposure of dolutegravir.
Danish: Farmakokinetiske populationsanalyser, hvor der blev brugt sammenlagte farmakokinetiske data fra kliniske studier, hvor dolutegravir blev administreret til voksne i kombination med andre antiretrovirale lægemidler, viste ingen klinisk relevant effekt af race på eksponeringen for dolutegravir.
English: When taken with food, Dovato and supplements or multivitamins containing calcium, iron or magnesium can be taken at the same time.
Danish: Ved indtagelse sammen med mad kan Dovato og tilskud eller multivitaminer, der indeholder calcium, jern eller magnesium, tages samtidig.
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: The combination of Dovato with cladribine is not recommended (see section 4.5).
Danish: Kombinationen af Dovato og cladribin frarådes (se pkt.
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
Danish: Dolutegravir ↓ AUC ↓ 54 % Cmax ↓ 57 % C24 ↓ 56 % (Kompleksbinding til polyvalente ioner)
English: Drug Interactions Medicinal products by therapeutic areas
Danish: Lægemidler efter terapeutiske områder Interaktion geometrisk middelændring
English: If you take Dovato with food, you can take supplements or multivitamins containing calcium, iron or magnesium at the same time as Dovato.
Danish: Hvis du tager Dovato sammen med mad, kan du tage tilskud eller multivitaminer, der indeholder calcium, jern eller magnesium samtidig med Dovato.
English: What you need to know before you take Dovato 3.
Danish: Det skal du vide, før du begynder at tage Dovato Tag ikke Dovato:
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Danish: Der henvises til vedtagne retningslinjer for hivbehandling for monitorering af lipider i blodet samt glucose.
English: Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions)
Danish: Dolutegravir ↓ AUC ↓ 33 % Cmax ↓ 35 % C24 ↓ 32 % (Kompleksbinding til polyvalente ioner)
English: • skin rash
Danish: • stive led
English: Antimycobacterials Rifampicin/Dolutegravir
Danish: Antimykobakterielle midler Rifampicin/dolutegravir
English: If you take more Dovato than you should
Danish: Hvis du har taget for meget Dovato
English: peripheral neuropathy, paraesthesia Gastrointestinal disorders:
Danish: perifer neuropati, paræstesi
English: hypersensitivity (see section 4.4), immune reconstitution syndrome (see section 4.4)
Danish: 4.4), immunrekonstitutionssyndrom (se pkt.
English: → If you think this applies to you, tell your doctor.
Danish: → Kontakt lægen, hvis du tror, at dette gælder for dig.
English: • wind (flatulence)
Danish: • luftafgang fra tarmen (flatulens)
English: Marketing Authorisation Holder ViiV Healthcare BV Huis ter Heideweg 62
Danish: Indehaver af markedsføringstilladelsen ViiV Healthcare BV
English: NAME OF THE MEDICINAL PRODUCT Dovato 50 mg/300 mg tablets dolutegravir/lamivudine
Danish: LÆGEMIDLETS NAVN Dovato 50 mg/300 mg tabletter dolutegravir/lamivudin
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers.
Danish: Den anbefalede dosis af dolutegravir er 50 mg to gange dagligt ved samtidig administration af disse metaboliske inducere.
English: Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine
Danish: Dovato 50 mg/300 mg filmovertrukne tabletter dolutegravir/lamivudin
English: Although lamivudine is a substrate of BCRP and P-gp in vitro, given its high absolute bioavailability, (see section 5.2), inhibitors of these efflux transporters are unlikely to result in a clinically relevant impact on lamivudine concentrations.
Danish: Selvom lamivudin er et substrat for BCRP og P-gp in vitro på grund af den høje absolutte biotilgængelighed (se pkt.
English: dizziness, somnolence
Danish: svimmelhed, døsighed
English: Nevirapine/Dolutegravir
Danish: Nevirapin/dolutegravir
English: Efavirenz ↔ (historical controls) (induction of UGT1A1 and CYP3A enzymes)
Danish: Efavirenz ↔ (historiske kontroller) (induktion af UGT1A1- og CYP3A-enzymer)
English: Reasons
Danish: Diverse
English: AUC ↓ 14%; 32%; 36% Cmax ↓ 28%; 52%, 55%.
Danish: Cmax ↓ 28 %; 52 %,
English: Lopinavir ↔ Ritonavir ↔ Etravirine ↔
Danish: Lopinavir ↔ Ritonavir ↔ Etravirin ↔
English: • feeling sick (nausea).
Danish: • diarré • kvalme.
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin.
Danish: Den anbefalede dosis af dolutegravir er 50 mg to gange dagligt ved samtidig administration af rifampicin.
English: Atazanavir ↔ (historical controls) (inhibition of UGT1A1 and CYP3A enzymes)
Danish: Atazanavir ↔ (historiske kontroller) (hæmning af UGT1A1- og CYP3A-enzymer)
English: When co-administered with dolutegravir 50 mg BID:
Danish: Cmax ↑ 66 % Ved samtidig administration af dolutegravir 50 mg BID (2 gange dagligt):
English: NAME OF THE MEDICINAL PRODUCT Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine
Danish: LÆGEMIDLETS NAVN Dovato 50 mg/300 mg filmovertrukne tabletter dolutegravir/lamivudin
English: Dolutegravir ↔ AUC ↓ 5%
Danish: AUC ↓ 2 %
English: Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes)
Danish: Dolutegravir ↔ AUC ↓ 5 % Cmax ↑ 16 % Cτ ↓ 30 % (induktion af UGT1A1- og CYP3A-enzymer)
English: Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
Danish: Calciumtilskud/dolutegravir (fastetilstand) Dolutegravir ↓ AUC ↓ 39 % Cmax ↓ 37 % C24 ↓ 39 % (Kompleksbinding til polyvalente ioner)
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz.
Danish: Den anbefalede dosis af dolutegravir er 50 mg to gange dagligt ved samtidig administration af efavirenz.
English: Etravirine ↔ (induction of UGT1A1 and CYP3A enzymes)
Danish: Etravirin ↔ (induktion af UGT1A1- og CYP3A-enzymer)
English: • stomach (abdominal) pain or discomfort
Danish: • smerter eller ubehag i maven
English: Rilpivirine/Dolutegravir
Danish: Rilpivirin/dolutegravir
English: • diarrhoea
Danish: • hududslæt
English: Darunavir ↔ Ritonavir ↔ Etravirine ↔
Danish: Darunavir ↔ Ritonavir ↔ Etravirin ↔
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with nevirapine.
Danish: Den anbefalede dosis af dolutegravir er 50 mg to gange dagligt ved samtidig administration af nevirapin.
English: Tipranavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Danish: Tipranavir ↔ Ritonavir ↔ (induktion af UGT1A1- og CYP3A-enzymer)
English: Fosamprenavir↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Danish: Fosamprenavir↔ Ritonavir ↔ (induktion af UGT1A1- og CYP3A-enzymer)
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Danish: Autoimmune lidelser (såsom Graves' sygdom og autoimmun hepatitis) er også rapporteret at forekomme i forbindelse med immunreaktivering.
English: rhabdomyolysis
Danish: Immunresponssyndrom
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the tipranavir/ritonavir co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Danish: Da Dovato er en fastdosistablet, skal der administreres yderligere en 50 mg dolutegravir-tablet ca. 12 timer efter Dovato i hele den periode, hvor der samtidig gives tipranavir/ritonavir (der findes en separat formulering af dolutegravir til denne dosisjustering, se pkt.
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the etravirine without boosted protease inhibitor co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section
Danish: Da Dovato er en fastdosistablet, skal der administreres yderligere en 50 mg dolutegravir-tablet ca. 12 timer efter Dovato i hele den periode, hvor der samtidig gives etravirin uden boostede proteasehæmmere (der findes en separat formulering af dolutegravir til denne dosisjustering, se pkt.
English: Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
Danish: Det anbefales at monitorere leverparametre hos patienter, der er co-inficerede med hepatitis B- og/eller C. (Se "Leversygdom" tidligere i dette afsnit, og se også pkt.
English: • feeling drowsy
Danish: • mavepine