FrancophonIA/ELRC3.0 huggingface dataset:
English: In SINGLE, 833 subjects were randomized and received at least one dose of either dolutegravir 50 mg once daily with fixed-dose abacavir-lamivudine (DTG + ABC/3TC) or fixed-dose efavirenz-tenofoviremtricitabine (EFV/TDF/FTC).
Danish: I SINGLE blev 833 personer randomiseret og fik mindst én dosis af enten 50 mg dolutegravir en gang daglig med abacavir-lamivudin (DTG + ABC/3TC) i faste doser eller efavirenz-tenofovir-emtricitabin (EFV/TDF/FTC) i faste doser.
English: Therefore, Tivicay is recommended to be taken with food by patients infected with HIV with integrase class resistance (see section 4.2).
Danish: Derfor anbefales det, at hiv-inficerede patienter med resistens over for integrasehæmmere tager Tivicay i forbindelse med et måltid (se pkt.
English: Effect of dolutegravir on the pharmacokinetics of other agents
Danish: Dolutegravirs virkning på farmakokinetikken af andre lægemidler
English: To what extent dolutegravir provides added efficacy in the presence of such integrase class resistance is uncertain (see section 5.2).
Danish: Det vides ikke i hvilken udstrækning dolutegravir har øget effekt ved forekomst af denne integrasehæmmereresistens (se pkt.
English: Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls)
Danish: Dolutegravir  AUC  7 % Cmax  5 % Cτ  8 % Boceprevir ↔ (historiske kontroller)
English: Other medicines and Tivicay Tell your doctor if you are taking, have recently taken or are planning to take any other medicines.
Danish: Brug af anden medicin sammen med Tivicay Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Each 25 mg tablet contains 2 mg sodium.
Danish: Hver 25 mg tablet indeholder 2 mg natrium.
English: No dosage adjustment is considered necessary for patients with renal impairment.
Danish: Det vurderes ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion.
English: Tivicay tablets on a weight-band basis (20 mg, 25 mg, 35 mg, 50 mg) in children of at least 6 years of age weighing at least 15 kg provides comparable exposure to that observed in adults (50 mg), with the lowest weight band of 15 to <20 kg corresponding to 20 mg daily.
Danish: Yderligere viste populationsfarmakokinetisk modellering og simulerings-analyse, at dosering af Tivicaytabletter baseret på vægt (20 mg, 25 mg, 35 mg, 50 mg) hos børn, som var mindst 6 år, og som vejede mindst 15 kg, giver en eksponering, som er sammenlignelig med den observerede eksponering hos voksne (50 mg), med den laveste vægtgruppe på 15 til < 20 kg svarende til 20 mg dagligt.
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-4celler 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: Once the bottle has been opened keep the desiccant in the bottle, do not remove it.
Danish: Tørremidlet skal forblive i beholderen efter åbning, det må ikke fjernes.
English: It is not known whether the ingredients of Tivicay can pass into your breast milk.
Danish: Det vides ikke, om indholdsstofferne i Tivicay udskilles i mælken.
English: Q148 +≥2 secondary mutations 3
Danish: Q148 + ≥ 2 sekundære mutationer3
English: Not everyone responds to treatment with Tivicay in the same way.
Danish: Behandlingen med Tivicay virker ikke ens på alle.
English: In the double blind, placebo controlled VIKING-4 study (ING116529), 30 HIV-1 infected, ART-experienced adults with primary genotypic resistance to INIs at Screening, were randomised to receive either dolutegravir 50 mg twice daily or placebo with the current failing regimen for 7 days followed by an open label phase with all subjects receiving dolutegravir.
Danish: I det dobbeltblindede, placebokontrollerede studie VIKING-4 (ING116529) blev 30 hiv-1-inficerede, ARTerfarne voksne med primær genotypisk resistens over for INI'er ved screeningen randomiseret til at få enten 50 mg dolutegravir to gange daglig eller placebo med det aktuelt svigtende regimen i 7 dage, og dette blev efterfulgt af en ublindet fase, hvor alle forsøgspersoner fik dolutegravir.
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.40 times the 50 mg twice daily human clinical exposure based on AUC).
Danish: Hos kaniner blev der observeret maternel toksicitet (nedsat fødeindtagelse, sparsom/ingen fæces/urin, hæmmet vægtøgning) ved 1.000 mg/kg (0,40 gange den humane kliniske eksponering ved 50 mg to gange daglig baseret på AUC).
English: Each 50 mg tablet contains 4 mg sodium.
Danish: Hver 50 mg tablet indeholder 4 mg natrium.
English: Common Depression
Danish: Almindelig Træthed
English: Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it (see also Section 3).
Danish: Tag ikke calciumtilskud, jerntilskud eller multivitaminer i 6 timer før du tager Tivicay, eller i mindst 2 timer efter at du har taget Tivicay (se også punkt 3).
English: Animal studies indicate no effects of dolutegravir on male or female fertility (see section 5.3).
Danish: I dyreforsøg er der ikke set nogen virkning af dolutegravir på fertiliteten hos hanner eller hunner (se pkt.
English: When co-administered with dolutegravir 50mg twice daily:
Danish: Ved administration sammen med dolutegravir 50 mg to gange daglig:
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of dolutegravir with metformin, to maintain glycaemic control (see section 4.5).
Danish: Justering af metformindosis bør overvejes ved opstart eller ophør af samtidig administration af dolutegravir og metfomin for at opretholde glykæmisk kontrol (se pkt.
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 effekt af alder på eksponeringen for dolutegravir.
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 (27 times the 50 mg twice daily human clinical exposure based on AUC).
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 (27 gange den humane kliniske eksponering ved 50 mg to gange daglig baseret på AUC).
English: Multivitamin
Danish: Multivitaminer
English: Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Danish: Daclatasvir bevirkede ingen klinisk relevant ændring i plasmakoncentrationen af dolutegravir.
English: The bottle contains a desiccant to reduce moisture.
Danish: Beholderen indeholder et tørremiddel for at mindske fugtindholdet.
English: RAL 400 mg Twice Daily + 2 NRTI N=411
Danish: 400 mg RAL to gange daglig + 2 NRTI N = 411
English: How to take Tivicay
Danish: Sådan skal du tage Tivicay
English: This leaflet was last revised in {month YYYY}.
Danish: Denne indlægsseddel blev senest ændret
English: At baseline, in the pooled analysis, median patient age was 33 years, 15% were female, 32% non-white, 6% had hepatitis C co-infection and 9% were CDC Stage 3.
Danish: Ved baseline, i den samlede analyse, var den mediane patientalder 33 år, 15 % var kvinder, 32 % var ikke-hvide, 6 % havde infektion med hepatitis C og 9 % var CDC fase 3.
English: Patients with prior treatment failure, but not exposed to the integrase class In the international multicentre, double-blind SAILING study (ING111762), 719 HIV-1 infected, antiretroviral therapy (ART)-experienced adults were randomized and received either dolutegravir 50 mg once daily or raltegravir 400 mg twice daily with investigator selected background regimen consisting of up to 2 agents (including at least one fully active agent).
Danish: Patienter med tidligere behandlingssvigt, som ikke var blevet eksponeret for integrasehæmmere I det internationale, dobbeltblindede multicenterstudie SAILING (ING111762) blev 719 hiv-1-inficerede voksne, der tidligere havde fået antiretroviral behandling (ART), randomiseret og fik enten 50 mg dolutegravir én gang daglig eller 400 mg raltegravir 2 gange daglig med et af investigator udvalgt baggrundsregime, som bestod af op til 2 stoffer (med mindst ét fuldt aktivt stof).
English: Baseline with ongoing RAL/EVG
Danish: RAL/EVG
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 (0.40 times the 50 mg twice daily human clinical exposure based on AUC).
Danish: Oral administration af dolutegravir til drægtige kaniner i doser op til 1.000 mg/kg dagligt fra dag 6-18 i drægtighedsperioden udløste ikke udviklingstoksicitet eller teratogenicitet (0,40 gange den humane kliniske eksponering ved 50 mg to gange daglig baseret på AUC).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Tivicay 10 mg film-coated tablets
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Tivicay 10 mg filmovertrukne tabletter
English: At baseline, median patient age was 43 years, 32% were female, 50% non-white, 16% had hepatitis B and/or C co-infection, and 46% were CDC Class C. All patients had at least two class ART resistance, and 49% of subjects had at least 3-class ART resistance at baseline.
Danish: Ved baseline var patienternes medianalder 43 år, 32 % var kvinder, 50 % var ikke-hvide, 16 % var co-inficeret med hepatitis B- og/eller C-virus, og 46 % var CDC-klasse C. Alle patienter var resistente over for mindst to klasser af ART, og 49 % af personerne var resistente over for mindst tre klasser af ART ved baseline.
English: Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets dolutegravir
Danish: Tivicay 10 mg filmovertrukne tabletter Tivicay 25 mg filmovertrukne tabletter Tivicay 50 mg filmovertrukne tabletter dolutegravir
English: Lopinavir/ritonavir + etravirine
Danish: Lopinavir/ritonavir + etravirin
English: Derived IN mutation group at
Danish: Afledt IN mutationsgruppe ved baseline med igangværende
English: Efavirenz ↔ (historical controls) (induction of UGT1A1 and CYP3A enzymes)
Danish: Efavirenz  (historiske kontroller) (induktion af UGT1A1 og CYP3A-enzymer)
English: Mean increase in CD4+ T cell (cells/mm3) ‡ Adjusted for baseline stratification factors.
Danish: hiv-undertype Clade B Clade C Andre† Middelstigning i CD4+ T-celletallet (celler/mm3) ‡Justeret for stratificeringsfaktorer ved baseline.
English: Dolutegravir did not change daclatasvir plasma concentration.
Danish: Dolutegravir påvirkede ikke plasmakoncentrationen af daclatasvir.
English: • increase in the level of liver enzymes
Danish: • øget niveau af leverenzymer
English: *particularly in patients with a pre-existing history of depression or psychiatric illness.
Danish: Selvmordstanker*, selvmordsforsøg* *særligt hos patienter med depression eller psykisk sygdom i anamnesen
English: Do not give this medicine to children under 6 years of age, weighing less than 15 kg or with HIV infection that is resistant to other medicines similar to Tivicay.
Danish: Børn under 6 år, som vejer under 15 kg, eller som har hiv-infektion, der er resistent (modstandsdygtig) over for andre lægemidler af samme type som Tivicay, må ikke få denne medicin.
English: At baseline, median patient age was 48 years, 23% were female, 29% non-white, and 20% had hepatitis B and/or C co-infection.
Danish: Ved baseline var patienternes medianalder 48 år, 23 % var kvinder, 29 % var ikke-hvide, og 20 % var co-inficeret med hepatitis B- og/eller C-virus.
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: At 144 weeks in the openlabel phase of SINGLE, virologic suppression was maintained, the dolutegravir + ABC/3TC arm (71%) was superior to the EFV/TDF/FTC arm (63%), treatment difference was 8.3% (2.0, 14.6).
Danish: I den åbne fase af SINGLE-studiet var virologisk suppression opretholdt ved uge 144; dolutegravir +ABC/3 TC-armen (71 %) var superior i forhold til EFV/TDF/FTC-armen (63 %); behandlingsforskellen var
English: Dolutegravir 50 mg Once Daily + 2 NRTI N=411
Danish: 50 mg dolutegravir en gang daglig + 2 NRTI N = 411
English: Don't stop taking Tivicay without advice from your doctor Take Tivicay for as long as your doctor recommends.
Danish: Tag Tivicay så længe, som lægen anbefaler.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 January 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Median baseline CD4+ was 160 cells/mm3, median duration of prior ART was 13 years, and 63% were CDC Class C. Subjects showed multiple class ART resistance at baseline: 80% had ≥2 NRTI, 73% ≥1 NNRTI, and 67% ≥2 PI major mutations; 83% had non-R5 virus.
Danish: Median-baseline-CD4+ var 140 celler/mm3, medianvarigheden af tidligere ART var 14 år, og 56 % var CDC-klasse C. Personerne var resistente over for flere klasser af ART ved baseline: 79 % havde ≥ 2 større NRTI-mutationer, 75 % ≥ 1 større NNRTI-mutationer og 71 % ≥ 2 større PI-mutationer; 62 % havde non-R5-virus.
English: Acute hepatic failure
Danish: Akut leversvigt
English: Darunavir/ritonavir + etravirine
Danish: Darunavir/ritonavir + etravirin
English: INFORMATION IN BRAILLE tivicay 10 mg
Danish: INFORMATION I BRAILLESKRIFT tivicay 10 mg
English: Dolutegravir ↔ AUC ↑ 33% Cmax ↑ 29% Cτ ↑ 45% Daclatasvir ↔
Danish: Dolutegravir  AUC  33 % Cmax  29 % C  45 % Daclatasvir 
English: The use of Tivicay in children under 6 or weighing less than 15 kg has not yet been studied.
Danish: Tivicay er endnu ikke blevet undersøgt hos børn under 6 år og børn, som vejer under 15 kg.
English: Dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% Rilpivirine ↔
Danish: Dolutegravir  AUC  12 % Cmax  13 % Cτ  22 % Rilvipirin 
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir.
Danish: Den anbefalede dosis af dolutegravir til voksne er 50 mg to gange daglig, når det administreres samtidigt med tipranavir/ritonavir.
English: Patients with prior treatment failure that included an integrase inhibitor (and integrase class resistance) In the multicentre, open-label, single arm VIKING-3 study (ING112574), HIV-1 infected, ART-experienced adults with virological failure and current or historical evidence of raltegravir and/or elvitegravir resistance received Tivicay 50 mg twice daily with the current failing background regimen for 7 days but with optimised background ART from Day 8.
Danish: I det ublindede multicenterstudie VIKING-3 (ING112574) med en enkelt arm fik hiv-1-inficerede, ARTerfarne voksne med virologisk svigt og påvist nuværende eller historisk resistens over for raltegravir og/eller elvitegravir 50 mg Tivicay to gange daglig med det aktuelt svigtende baggrundsregime i 7 dage, men med optimeret baggrunds-ART fra dag 8.
English: INFORMATION IN BRAILLE tivicay 25 mg
Danish: INFORMATION I BRAILLESKRIFT tivicay 25 mg
English: Derived IN Mutation Group
Danish: Udledt INmutationsgruppe
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: Hos nogle personer, der var coinficeret med hepatitis B- og/eller C-virus, blev der i starten af behandlingen med dolutegravir observeret forhøjede leverkemiparametre, som stemte overens med immunrekonstitutionssyndrom, særligt hos de personer, hvis behandling mod hepatitis B var blevet seponeret (se pkt.
English: Tivicay 25 mg and 50 mg film-coated tablets
Danish: Tivicay 25 mg og 50 mg filmovertrukne tabletter
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin in the absence of integrase class resistance.
Danish: Den anbefalede dosis af dolutegravir til voksne er 50 mg to gange daglig, når det administreres samtidigt med rifampicin ved fravær af integrasehæmmereresistens.
English: Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it.
Danish: Tag ikke tilskud af kalk (calcium) eller jern eller multivitamin i 6 timer før du tager Tivicay, og i mindst 2 timer efter, at du har taget Tivicay.
English: INFORMATION IN BRAILLE tivicay 50 mg
Danish: INFORMATION I BRAILLESKRIFT tivicay 50 mg
English: Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions)
Danish: Dolutegravir  AUC  33 % Cmax  35 % C24  0,32 % (Kompleksbinding til polyvalente ioner)
English: At baseline, median patient age was 34 years, 15% were female, 28% non-white, 10% had hepatitis B and/or C co-infection, and 3% were CDC Class C; these characteristics were similar between treatment groups.
Danish: Ved baseline var den mediane patientalder 34 år, 15 % var kvinder, 28 % var ikke-hvide, 10 % havde samtidig infektion med hepatitis B og/eller C og 3 % var CDC klasse C. Disse karakteristika var sammenlignelige mellem behandlingsgrupperne.
English: Liver biochemistry 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 ved starten af behandlingen med dolutegravir observeret forhøjede biokemiske leverparametre, som var i overensstemmelse med immunrekonstitutionssyndrom, hos nogle patienter, der var co-inficeret med hepatitis B- og/eller C-virus.
English: Mean change in CD4 count from baseline at Week 48, c/ mm3 a adjusted for BL stratification factors: Plasma HIV-1 RNA (≤100,000 c/mL vs. >100,000 c/mL) and CD4+ cell count (≤200 cells/mm3 vs. >200 cells/mm3).
Danish: Som BL hiv-1 RNA ≤ 100.000 kopier/ml > 100.000 kopier/ml Som CD4+ ≤ 200 kopier/mm3 > 200 kopier/mm3 Som hiv-1 subtype B Non-B Rebound op til uge 48 b Median ændring i CD4-tal fra baseline i uge 48, celler/mm3 a justeret for BL stratificeringsfaktorer: Plasma hiv-1 RNA (≤ 100.000 celler/ml vs. > 100.000 celler/ml) og CD4+ celletal (≤ 200 celler/mm3 vs. > 200 celler/mm3).
English: Atazanavir ↔ (historical controls) (inhibition of UGT1A1 and CYP3A enzymes)
Danish: Atazanavir  (historiske kontroller) (hæmning af UGT1A1 og CYP3A-enzymer)
English: Atazanavir ↔ Ritonavir ↔ (inhibition of UGT1A1 and CYP3A enzymes)
Danish: Atazanavir  Ritonavir  (hæmning af UGT1A1 og CYP3A-enzymer)
English: At baseline, median patient age was 35 years, 16% were female, 32% nonwhite, 7% had hepatitis C co-infection and 4% were CDC Class C, these characteristics were similar between treatment groups.
Danish: Ved baseline var patienternes medianalder 35 år, 16 % var kvinder, 32 % var ikke-hvide, 7 % var co-inficeret med hepatitis C-virus, og 4 % var CDC-klasse C. Disse karakteristika var omtrent de samme mellem behandlingsgrupperne.
English: Alternative combinations that do not include St. John's wort should be used where possible in INI-resistant patients.
Danish: Om muligt bør alternative kombinationer, som ikke inkluderer perikon, anvendes til INI-resistente patienter.
English: Calcium supplements Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
Danish: Dolutegravir  AUC  39 % Cmax  37 % C24  39 % (Kompleksbinding til polyvalente ioner)
English: • For the treatment of HIV that is resistant to other medicines similar to Tivicay, the usual dose of
Danish: • Ved behandling af hiv, der er resistent over for andre lægemidler af samme type som Tivicay, er den sædvanlige dosis Tivicay én 50 mg tablet 2 gange daglig.
English: • stiffness in the joints
Danish: • ubehag i maven
English: GlaxoSmithKline, s.r.o.
Danish: Česká republika GlaxoSmithKline, s.r.o.
English: Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of race on the exposure of dolutegravir.
Danish: Farmakokinetiske populationsanalyser, hvor der blev brugt sammenlagte farmakokinetiske data fra fase IIbog fase III-studier af voksne, viste ingen klinisk relevant effekt af race på eksponeringen for dolutegravir.
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with etravirine without boosted protease inhibitors.
Danish: Den anbefalede dolutegravirdosis til voksne er 50 mg 2 gange daglig ved administration sammen med etravirin uden boostede proteasehæmmere.
English: No dose adjustment is necessary of either agent.
Danish: Det er ikke nødvendigt at justere dosis af nogen af stofferne.
English: At baseline, median patient age was 36 years, 14% were female, 15% non-white, 11% had hepatitis B and/or C co-infection and 2% were CDC Class C, these characteristics were similar between treatment groups.
Danish: Ved baseline var patienternes medianalder 36 år, 14 % var kvinder, 15 % var ikke-hvide, 11 % var co-inficeret med hepatitis B- og/eller C-virus, og 2 % var CDC-klasse C. Disse karakteristika var de samme mellem behandlingsgrupperne.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/892/001
English: GlaxoSmithKline AS Tlf: + 47 22 70 20 00
Danish: GlaxoSmithKline AS Tlf: + 47 22 70 20 00 firmapost@gsk.no
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/892/005
English: Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of gender on the exposure of dolutegravir.
Danish: Farmakokinetiske populationsanalyser, hvor der blev brugt sammenlagte farmakokinetiske data fra fase IIbog fase III-studier af voksne, viste ingen klinisk relevant effekt af køn på eksponeringen for dolutegravir.
English: Tivicay should not be dosed higher than 50 mg twice daily in combination with atazanavir (see section 5.2) due to lack of data.
Danish: Ved kombination med atazanavir bør dosis af Tivicay ikke overstige 50 mg to gange daglig (se pkt.
English: In the presence of integrase class resistance alternative combinations that do not include efavirenz should be considered (see section 4.4).
Danish: Ved resistens over for integrasehæmmere bør der, hvor det er muligt, overvejes andre kombinationer uden efavirenz (se pkt.
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers.
Danish: Den anbefalede dolutegravirdosis til voksne er 50 mg to gange daglig ved administration sammen med disse metaboliske inducere.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/892/003
English: HIV-1 RNA <50 copies/mL by baseline covariates
Danish: Hiv-1-RNA < 50 kopier/ml ved baseline kovariater Viral belasting ved baseline (kopier/ml)
English: Netherlands.
Danish: Holland
English: In the presence of integrase class resistance alternative combinations that do not include nevirapine should be considered (see section 4.4).
Danish: Ved resistens over for integrasehæmmere bør der, hvor det er muligt, overvejes andre kombinationer uden nevirapin (se pkt.
English: This medicinal product does not require any special storage conditions.
Danish: Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.