natgillin/translations-raw huggingface dataset:
Etravirin uden boostede proteasehæmmere reducerer plasmakoncentrationen af dolutegravir.
Etravirine without boosted protease inhibitors decreased plasma dolutegravir concentration.
Hver tablet indeholder dolutegravirnatrium svarende til 10 mg, 25 mg eller 50 mg dolutegravir.
Each tablet contains dolutegravir sodium equivalent to 10 mg, 25 mg or 50 mg dolutegravir.
Det vurderes ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion.
No dosage adjustment is considered necessary for patients with mild to moderate hepatic impairment.
50 mg dolutegravir + ABC/3TC en gang daglig N = 414
Dolutegravir 50 mg + ABC/3TC Once Daily N=414
Ved administration sammen med dolutegravir 50 mg én gang daglig:
When co-administered with dolutegravir 50mg once daily:
Derfor må en dosis på 50 mg én gang daglig ikke gives som fem 10 mg tabletter.
Therefore, the 50 mg once daily dose should not be given as five 10 mg tablets.
Virologisk hæmning (hiv-1-RNA < 50 kopier/ml) i dolutegravir-gruppen (90 %) var superior til virologisk hæmning i DRV/r-gruppen (83 %) ved 48 uger.
Virologic suppression (HIV-1 RNA <50 copies/mL) in the dolutegravir group (90%) was superior to the DRV/r group (83%) at 48 weeks.
Justering af metformindosis bør overvejes ved administration sammen med dolutegravir hos patienter med moderat nedsat nyrefunktion pga. øget risiko for laktacidose, som følge af den øgede metforminkoncentration (se pkt.
In patients with moderate renal impairment a dose adjustment of metformin should be considered when coadministered with dolutegravir, because of the increased risk for lactic acidosis in patients with moderate renal impairment due to increased metformin concentration (section 4.4).
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.
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).
Derfor anbefales det, at hiv-inficerede patienter med resistens over for integrasehæmmere tager Tivicay i forbindelse med et måltid (se pkt.
Therefore, Tivicay is recommended to be taken with food by patients infected with HIV with integrase class resistance (see section 4.2).
Dolutegravirs virkning på farmakokinetikken af andre lægemidler
Effect of dolutegravir on the pharmacokinetics of other agents
Det vides ikke i hvilken udstrækning dolutegravir har øget effekt ved forekomst af denne integrasehæmmereresistens (se pkt.
To what extent dolutegravir provides added efficacy in the presence of such integrase class resistance is uncertain (see section 5.2).
Dolutegravir  AUC  7 % Cmax  5 % Cτ  8 % Boceprevir ↔ (historiske kontroller)
Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls)
Brug af anden medicin sammen med Tivicay Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
Other medicines and Tivicay Tell your doctor if you are taking, have recently taken or are planning to take any other medicines.
Hver 25 mg tablet indeholder 2 mg natrium.
Each 25 mg tablet contains 2 mg sodium.
Det vurderes ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion.
No dosage adjustment is considered necessary for patients with renal impairment.
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.
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.
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).
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).
Tørremidlet skal forblive i beholderen efter åbning, det må ikke fjernes.
Once the bottle has been opened keep the desiccant in the bottle, do not remove it.
Det vides ikke, om indholdsstofferne i Tivicay udskilles i mælken.
It is not known whether the ingredients of Tivicay can pass into your breast milk.
Q148 + ≥ 2 sekundære mutationer3
Q148 +≥2 secondary mutations 3
Behandlingen med Tivicay virker ikke ens på alle.
Not everyone responds to treatment with Tivicay in the same way.
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.
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.
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).
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).
Hver 50 mg tablet indeholder 4 mg natrium.
Each 50 mg tablet contains 4 mg sodium.
Almindelig Træthed
Common Depression
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).
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).
I dyreforsøg er der ikke set nogen virkning af dolutegravir på fertiliteten hos hanner eller hunner (se pkt.
Animal studies indicate no effects of dolutegravir on male or female fertility (see section 5.3).
Ved administration sammen med dolutegravir 50 mg to gange daglig:
When co-administered with dolutegravir 50mg twice daily:
Justering af metformindosis bør overvejes ved opstart eller ophør af samtidig administration af dolutegravir og metfomin for at opretholde glykæmisk kontrol (se pkt.
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).
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.
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.
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).
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).
Multivitaminer
Multivitamin
Daclatasvir bevirkede ingen klinisk relevant ændring i plasmakoncentrationen af dolutegravir.
Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Beholderen indeholder et tørremiddel for at mindske fugtindholdet.
The bottle contains a desiccant to reduce moisture.
400 mg RAL to gange daglig + 2 NRTI N = 411
RAL 400 mg Twice Daily + 2 NRTI N=411
Sådan skal du tage Tivicay
How to take Tivicay
Denne indlægsseddel blev senest ændret
This leaflet was last revised in {month YYYY}.
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.
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.
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).
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).
RAL/EVG
Baseline with ongoing RAL/EVG
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).
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).
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Tivicay 10 mg filmovertrukne tabletter
QUALITATIVE AND QUANTITATIVE COMPOSITION Tivicay 10 mg film-coated tablets
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.
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.
Tivicay 10 mg filmovertrukne tabletter Tivicay 25 mg filmovertrukne tabletter Tivicay 50 mg filmovertrukne tabletter dolutegravir
Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets dolutegravir
Afledt IN mutationsgruppe ved baseline med igangværende
Derived IN mutation group at
Efavirenz  (historiske kontroller) (induktion af UGT1A1 og CYP3A-enzymer)
Efavirenz ↔ (historical controls) (induction of UGT1A1 and CYP3A enzymes)
hiv-undertype Clade B Clade C Andre† Middelstigning i CD4+ T-celletallet (celler/mm3) ‡Justeret for stratificeringsfaktorer ved baseline.
Mean increase in CD4+ T cell (cells/mm3) ‡ Adjusted for baseline stratification factors.
Dolutegravir påvirkede ikke plasmakoncentrationen af daclatasvir.
Dolutegravir did not change daclatasvir plasma concentration.
• øget niveau af leverenzymer
• increase in the level of liver enzymes
Selvmordstanker*, selvmordsforsøg* *særligt hos patienter med depression eller psykisk sygdom i anamnesen
*particularly in patients with a pre-existing history of depression or psychiatric illness.
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.
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.
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.
At baseline, median patient age was 48 years, 23% were female, 29% non-white, and 20% had hepatitis B and/or C co-infection.
Dolutegravir  AUC  54 % Cmax  57 % C24  56 % (Kompleksbinding til polyvalente ioner)
Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
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
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).
50 mg dolutegravir en gang daglig + 2 NRTI N = 411
Dolutegravir 50 mg Once Daily + 2 NRTI N=411
Tag Tivicay så længe, som lægen anbefaler.
Don't stop taking Tivicay without advice from your doctor Take Tivicay for as long as your doctor recommends.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 January 2014
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.
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.
Akut leversvigt
Acute hepatic failure
INFORMATION I BRAILLESKRIFT tivicay 10 mg
INFORMATION IN BRAILLE tivicay 10 mg
Dolutegravir  AUC  33 % Cmax  29 % C  45 % Daclatasvir 
Dolutegravir ↔ AUC ↑ 33% Cmax ↑ 29% Cτ ↑ 45% Daclatasvir ↔
Tivicay er endnu ikke blevet undersøgt hos børn under 6 år og børn, som vejer under 15 kg.
The use of Tivicay in children under 6 or weighing less than 15 kg has not yet been studied.
Dolutegravir  AUC  12 % Cmax  13 % Cτ  22 % Rilvipirin 
Dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% Rilpivirine ↔
Den anbefalede dosis af dolutegravir til voksne er 50 mg to gange daglig, når det administreres samtidigt med tipranavir/ritonavir.
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir.
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.
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.
INFORMATION I BRAILLESKRIFT tivicay 25 mg
INFORMATION IN BRAILLE tivicay 25 mg
Udledt INmutationsgruppe
Derived IN Mutation Group
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.
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).
Tivicay 25 mg og 50 mg filmovertrukne tabletter
Tivicay 25 mg and 50 mg film-coated tablets
Den anbefalede dosis af dolutegravir til voksne er 50 mg to gange daglig, når det administreres samtidigt med rifampicin ved fravær af integrasehæmmereresistens.
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin in the absence of integrase class resistance.
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.
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.
INFORMATION I BRAILLESKRIFT tivicay 50 mg
INFORMATION IN BRAILLE tivicay 50 mg
Dolutegravir  AUC  33 % Cmax  35 % C24  0,32 % (Kompleksbinding til polyvalente ioner)
Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions)
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.
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.
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.
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.
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).
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).
Atazanavir  (historiske kontroller) (hæmning af UGT1A1 og CYP3A-enzymer)
Atazanavir ↔ (historical controls) (inhibition of UGT1A1 and CYP3A enzymes)
Atazanavir  Ritonavir  (hæmning af UGT1A1 og CYP3A-enzymer)
Atazanavir ↔ Ritonavir ↔ (inhibition of UGT1A1 and CYP3A enzymes)
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.
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.
Om muligt bør alternative kombinationer, som ikke inkluderer perikon, anvendes til INI-resistente patienter.
Alternative combinations that do not include St. John's wort should be used where possible in INI-resistant patients.
Dolutegravir  AUC  39 % Cmax  37 % C24  39 % (Kompleksbinding til polyvalente ioner)
Calcium supplements Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
• 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.
• For the treatment of HIV that is resistant to other medicines similar to Tivicay, the usual dose of
• ubehag i maven
• stiffness in the joints
Česká republika GlaxoSmithKline, s.r.o.
GlaxoSmithKline, s.r.o.
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.
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.
Den anbefalede dolutegravirdosis til voksne er 50 mg 2 gange daglig ved administration sammen med etravirin uden boostede proteasehæmmere.
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with etravirine without boosted protease inhibitors.
Det er ikke nødvendigt at justere dosis af nogen af stofferne.
No dose adjustment is necessary of either agent.
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.
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.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/892/001
MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/001
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/892/005
MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/005
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.
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.
Ved kombination med atazanavir bør dosis af Tivicay ikke overstige 50 mg to gange daglig (se pkt.
Tivicay should not be dosed higher than 50 mg twice daily in combination with atazanavir (see section 5.2) due to lack of data.
Ved resistens over for integrasehæmmere bør der, hvor det er muligt, overvejes andre kombinationer uden efavirenz (se pkt.
In the presence of integrase class resistance alternative combinations that do not include efavirenz should be considered (see section 4.4).
Den anbefalede dolutegravirdosis til voksne er 50 mg to gange daglig ved administration sammen med disse metaboliske inducere.
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/892/003
MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/003
Hiv-1-RNA < 50 kopier/ml ved baseline kovariater Viral belasting ved baseline (kopier/ml)
HIV-1 RNA <50 copies/mL by baseline covariates
Holland
Netherlands.
Ved resistens over for integrasehæmmere bør der, hvor det er muligt, overvejes andre kombinationer uden nevirapin (se pkt.
In the presence of integrase class resistance alternative combinations that do not include nevirapine should be considered (see section 4.4).
Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.
This medicinal product does not require any special storage conditions.
Hver filmovertrukken tablet indeholder dolutegravirnatrium svarende til 10 mg dolutegravir.
Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir.