FrancophonIA/ELRC3.0 huggingface dataset:
English: Subjects received 150 mg of maraviroc at different dose frequencies (healthy volunteers - every 12 hours; mild renal impairment - every 24 hours; moderate renal impairment - every 48 hours).
Danish: Patienterne fik 150 mg maraviroc med forskellig frekvens (raske frivillige forsøgspersoner: hver 12. time; let nedsat nyrefunktion: hver 24. time; moderat nedsat nyrefunktion: hver 48. time).
English: Primary pharmacological activity (CCR5 receptor affinity) was limited in the species studied (see section 5.3).
Danish: Primær farmakologisk aktivitet (CCR5-receptor-affinitet) var begrænset i de undersøgte arter (se pkt.5.3).
English: Tipranavir/ritonavir concentrations were consistent with historical data.
Danish: Tipranavir/ritonavir-koncentrationen var i overensstemmelse med historiske data.
English: ViiV Healthcare sprl/bvba Belgique/Belgien Tél/Tel: + 32 (0) 10 85 65 00
Danish: Luxembourg/Luxemburg ViiV Healthcare sprl/bvba Belgique/Belgien Tél/Tel: + 32 (0) 10 85 65 00
English: After 48 weeks of treatment, maraviroc did not reach non-inferiority to efavirenz for the endpoint of HIV-1 RNA < 50 copies/mL (65.3 vs. 69.3 % respectively, lower confidence bound -11.9%).
Danish: Efter 48 ugers behandling blev der ikke vist noninferioritet til efavirenz for endepunkt hiv 1-RNA < 50 kopier/ml (hhv. 65,3 % mod 69,3 %, nedre konfidensgrænse -11,9 %).
English: The adverse reaction profile in paediatric patients is based on 48 Week safety data from study A4001031 in which 103 HIV-1 infected, treatment-experienced patients aged 2 to <18 years received maraviroc twice-daily with optimised background therapy (OBT).
Danish: Bivirkningsprofilen hos pædiatriske patienter er baseret på 48 ugers sikkerhedsdata fra studiet A4001031, hvori 103 hiv 1-inficerede, behandlingserfarne patienter i alderen 2 til < 18 år fik maraviroc to gange dagligt med optimeret baggrundsbehandling (OB).
English: Subjects with a functional CYP3A5 (CYP3A5*1 allele) have been shown to have a reduced exposure to maraviroc compared to subjects with defect CYP3A5 activity (e.g., CYP3A5*3, CYP3A5*6, and CYP3A5*7).
Danish: Det er påvist, at individer med en funktionel CYP3A5 (CYP3A5*1 allel) har en reduceret eksponering for maraviroc sammenlignet med personer med defekt CYP3A5aktivitet (fx CYP3A5*3, CYP3A5*6 og CYP3A5*7).
English: Screening HIV-1 RNA (copies /mL):
Danish: Screening hiv 1-RNA (kopier/ml):
English: CELSENTRI must be taken in combination with other medicines which are also used to treat the HIV infection.
Danish: Celsentri skal tages i kombination med anden medicin, der også anvendes mod hiv-infektion.
English: When maraviroc was administered in studies with healthy volunteers at doses higher than the recommended dose, cases of symptomatic postural hypotension were seen at a greater frequency than with placebo.
Danish: I studier med raske frivillige forsøgspersoner, der blev behandlet med maraviroc i doser, der var højere end den anbefalede dosis, var der en højere frekvens af symptomatisk ortostatisk hypotension end ved placebo.
English: • antifungal medicines (ketoconazole, itraconazole, fluconazole)
Danish: • medicin mod svampeinfektioner (ketoconazol, itraconazol, fluconazol)
English: If indicated, elimination of unabsorbed active maraviroc should be achieved by emesis or gastric lavage.
Danish: Hvis nødvendigt bør ikke-absorberet aktivt maraviroc elimineres ved opkastning eller ventrikelskylning.
English: Co-administration of a 300 mg tablet with a high fat breakfast reduced maraviroc Cmax and AUC by 33% and co-administration of 75 mg of oral solution with a high fat breakfast reduced maraviroc AUC by 73% in adult healthy volunteers.
Danish: Samtidig anvendelse af 300 mg-tabletten og et morgenmåltid med højt fedtindhold reducerede maravirocs Cmax og AUC med 33 %, og samtidig administration af 75 mg oral opløsning med et morgenmåltid med højt fedtindhold reducerede AUC med 73 % hos voksne raske frivillige forsøgspersoner.
English: 1Based on GeneSeq resistance assay.
Danish: 1Baseret på GeneSeq resistensanalyse.
English: The viral tropism cannot be predicted by treatment history or assessment of stored samples.
Danish: Viral tropisme kan ikke forudsiges af behandlingsanamnesen eller vurderes på opbevarede blodprøver.
English: The recommended dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice per day depending on other medicines that you are taking at the same time.
Danish: Den anbefalede dosis er 150 mg, 300 mg eller 600 mg 2 gange daglig afhængigt af, hvilken medicin du tager samtidig.
English: Darunavir/ritonavir concentrations were consistent with historical data.
Danish: Darunavir og ritonavir koncentrationen var forenelig med historiske data.
English: Some people taking CELSENTRI have developed severe and life-threatening skin reactions and allergic reactions.
Danish: Alvorlige allergiske reaktioner eller hudreaktioner Nogle personer, der tager Celsentri, udvikler alvorlige og livstruende hudreaktioner og allergiske reaktioner.
English: The pack includes an oral applicator and a bottle-adapter, which should be fitted in the bottle before use.
Danish: Pakningen indeholder en oral doseringssprøjte og en sprøjteadapter, som skal isættes flasken inden brug.
English: Population analysis of the Phase 1/2a and Phase 3 studies (16-65 years of age) has been conducted and no effect of age have been observed (see section 4.2).
Danish: Der er udført populationsanalyser af fase 1/2a- og fase 3-studierne (16-65 år), og der er ikke fundet nogen påvirkning, som kan tilskrives alder (se pkt.4.2).
English: Contents of the pack and other information What CELSENTRI contains
Danish: Pakningsstørrelser og yderligere oplysninger Celsentri indeholder
English: Maraviroc dosing was based on body surface area and doses were adjusted based on whether the subject was receiving potent CYP3A inhibitors and/or inducers.
Danish: Maraviroc-dosering var baseret på legemsoverfladeareal, og doserne blev justeret på baggrund af, om forsøgspersonerne fik potente CYP3A-hæmmere og/eller -induktorer.
English: In treatment-naïve patients, the incidence of grade 3 and 4 laboratory abnormalities using ACTG criteria was similar among the maraviroc and efavirenz treatment groups.
Danish: Hos behandlingsnaive patienter var forekomsten af laboratorieanormaliteter (grad 3 og 4), bestemt udfra ACTG-kriterier, ens mellem maraviroc- og efavirenz-grupperne.
English: Comparison to exposure in historical controls suggests that CELSENTRI 300 mg twice daily and nevirapine can be co-administered without dose adjustment.
Danish: Sammenligning af eksponering i historiske kontroller tyder på, at Celsentri 300 mg 2 gange daglig og nevirapin kan anvendes samtidigt uden dosisjustering.
English: Elvitegravir as a single agent is indicated only in combination with certain ritonavir boosted PIs.
Danish: Elvitegravir som monokomponentlægemiddel er kun indiceret i kombination med visse ritonavirboostede PI'er.
English: The oral applicator is provided for accurate measurement of the prescribed dose of oral solution.
Danish: Den orale doseringssprøjte medfølger for præcis opmåling af den ordinerede dosis oral opløsning.
English: There are currently no data regarding the reuse of CELSENTRI in patients that currently have only CCR5-tropic HIV-1 detectable, but have a history of failure on CELSENTRI (or other CCR5 antagonists) with a CXCR4 or dual/mixed tropic virus.
Danish: På nuværende tidspunkt er der ikke dokumentation vedrørende genanvendelse af Celsentri til patienter, der i øjeblikket er smittet kun med hiv 1-virus med CCR5-tropisme, men i anamnesen har haft manglende effekt af Celsentri (eller andre CCR5-antagonister) med en CXCR4 eller dual/mixed tropisme.
English: Concomitant use of CELSENTRI and fosamprenavir/ritonavir is not recommended.
Danish: Samtidig administration af Celsentri og fosamprenavir/ritonavir kan ikke tilrådes.
English: efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir,
Danish: darunavir, efavirenz, etravirin, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir,
English: In vitro studies have shown that maraviroc does not inhibit OATP1B1, MRP2 or any of the major P450 enzymes at clinically relevant concentrations (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4).
Danish: In vitro studier har vist, at maraviroc ved klinisk relevante koncentrationer ikke hæmmer OATP1B1, MRP2 eller nogen af de vigtige P450-enzymer (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4).
English: No significant interaction seen/expected.
Danish: Der er ikke set/forventet nogen signifikant interaktion.
English: The dose limiting adverse reaction was postural hypotension.
Danish: Den dosisbegrænsende bivirkning var ortostatisk hypotension.
English: Mean change from baseline (log copies/mL) Percentage of patients with HIV-1 RNA <400 copies/mL
Danish: Middel ændring fra baseline (log kopier/ml) Procentdel af patienter med hiv 1-RNA < 400 kopier/ml
English: Based on the extent of inhibition by atazanavir/ritonavir or darunavir/ritonavir in the absence of efavirenz, an increased exposure is expected.
Danish: På baggrund af hæmningsgraden af atazanavir/ritonavir eller darunavir/ritonavir i fravær af efavirenz, forventes en øget eksponering.
English: In vivo Treatment-Experienced Adult Patients
Danish: In vivo Behandlingserfarne Voksne Patienter
English: CELSENTRI film-coated tablets are blue coloured with “MVC 25”, “MVC 75”, “MVC 150” or “MVC 300”.
Danish: Udseende og pakningsstørrelser Celsentri filmovertrukne tabletter er blå og mærket ”MVC 25”, ”MVC 75”, MVC 150” eller ”MVC
English: Treatment-Experienced Paediatric Patients
Danish: Behandlingserfarne Pædiatriske Patienter
English: The viral tropism cannot be safely predicted by treatment history and assessment of stored samples.
Danish: Viral tropisme kan ikke med sikkerhed forudsiges af behandlingsanamnesen eller vurderes på opbevarede blodprøver.
English: The average concentration (Cavg) of maraviroc over 24 hours was 445.1 ng/mL, 338.3 ng/mL, and 223.7 ng/mL for subjects with normal renal function, mild renal impairment, and moderate renal impairment, respectively.
Danish: Den gennemsnitlige maraviroc-koncentration (Cavg) over 24 timer var 445,1 ng/ml; 338,3 ng/ml og 223,7 ng/ml for hhv. patienter med normal, let nedsat og moderat nedsat nyrefunktion.
English: Placebo + OBT N = 209
Danish: Placebo+OB N=209
English: Patients with cardiovascular co-morbidities could be at increased risk of cardiovascular adverse reactions triggered by postural hypotension.
Danish: Patienter med kardiovaskulær comorbiditet kan have øget risiko for kardiovaskulære bivirkninger udløst af ortostatisk hypotension.
English: Geometric mean ratios for Cmax and AUClast were 11% and 25% higher respectively for subjects with mild hepatic impairment, and 32% and 46% higher respectively for subjects with moderate hepatic impairment compared to subjects with normal hepatic function.
Danish: Det gennemsnitlige geometriske forhold for Cmax og AUClast var henholdsvis 11 % og 25 % højere for forsøgspersoner med mild nedsat leverfunktion, og henholdsvis 32 % og 46 % højere for forsøgspersoner med moderat nedsat leverfunktion sammenlignet med forsøgspersoner med normal leverfunktion.
English: In adult patients with a creatinine clearance of <80 mL/min, who are also receiving potent CYP3A4 inhibitors, the dose interval of maraviroc should be adjusted to 150 mg once daily (see sections 4.4 and 4.5).
Danish: Hos voksne patienter med kreatininclearance < 80 ml/min, som også får potente CYP3A4-hæmmere, skal doseringen af maraviroc justeres til 150 mg 1 gang daglig (se pkt.
English: In treatment-naïve patients such events occurred at a similarly low rate with maraviroc and control (efavirenz).
Danish: Hos behandlingsnaive patienter blev der set samme lave forekomst i maravirocgruppen og kontrolgruppen (efavirenz).
English: This risk is due to potential increases in maraviroc maximum concentrations when maraviroc is co-administered with potent CYP3A inhibitors or boosted PIs in these patients.
Danish: Denne risiko skyldes en potentiel stigning i maraviroc-maksimumkoncentrationen, når maraviroc gives sammen med potente CYP3A-hæmmere eller boostede proteasehæmmere hos disse patienter.
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 straks til lægen.
English: Effects on active substance levels Geometric mean change if not stated otherwise
Danish: Geometrisk gennemsnitsændring hvis ikke andet er angivet
English: When used with other antiretroviral medicinal products in cell culture, the combination of maraviroc was not antagonistic with a range of NRTIs, NNRTIs, PIs or the HIV fusion inhibitor enfuvirtide.
Danish: I cellekultur var kombinationen af maraviroc og andre antiretrovirale lægemidler ikke antagonistisk med en række NRTI, NNRTI, proteasehæmmere eller hiv-fusionshæmmeren enfuvirtid.
English: Background resistance to other classes of antiretrovirals have been shown to be similar in previously undetected CXCR4-tropic virus of the minor viral population, as that found in CCR5-tropic virus.
Danish: Baggrundsresistens over for andre klasser af antiretrovirale lægemidler har vist sig at være den samme hos tidligere ikke påvist CXCR4-tropisme virus hos den lave viralpopulation, som det, der blev fundet i CCR5-tropisme virus.
English: Pegylated interferon has not been studied, no interaction is expected.
Danish: Pegyleret interferon er ikke undersøgt.
English: The maravirocresistant viruses remained CCR5-tropic and there was no conversion from a CCR5-tropic virus to a CXCR4-using virus.
Danish: Maraviroc-resistent virus forbliver CCR5-tropisme, og der er ingen konversion fra CCR5-tropisme virus til CXCR4-using virus.
English: Each film-coated tablet contains 25 mg, 75 mg, 150 mg or 300 mg of maraviroc.
Danish: Hver filmovertrukken tablet indeholder enten 25 mg, 75 mg, 150 mg eller 300 mg maraviroc.
English: Maraviroc-resistant viruses that emerged in vitro remained sensitive to the fusion inhibitor enfuvirtide and the PI, saquinavir.
Danish: Maraviroc-resistente virus, der opstår in vitro forbliver følsomme over for fusionshæmmeren enfuvirtid og PIen, saquinavir.
English: Intensive pharmacokinetics of maraviroc were evaluated in 50 treatment-experienced, CCR5tropic, HIV-1 infected paediatric patients aged 2 to 18 years (weight 10.0 to 57.6 kg) in the dosefinding stage of clinical trial A4001031.
Danish: Intensiv farmakokinetik for maraviroc blev evalueret hos 50 behandlingserfarne, hiv 1-inficerede pædiatriske patienter i alderen 2 til 18 år (vægt fra 10,0 til 57,6 kg) med CCR5-tropisme i dosisbestemmelsesfasen af det kliniske studie A4001031.
English: There are limited data in patients with hepatitis B and/or C virus co-infection (see section 5.1).
Danish: Der er begrænsede data fra patienter med samtidig hepatitis B- og/eller C-virusinfektion (se pkt.
English: The safety and efficacy of maraviroc have not been specifically studied in patients with significant underlying liver disorders.
Danish: Maravirocs sikkerhed og virkning hos patienter med alvorlig underliggende leversygdom er ikke undersøgt specifikt.
English: The recommended dose of CELSENTRI is 150 mg (with potent CYP3A inhibitor with or without a potent CYP3A inducer), 300 mg (without potent CYP3A inhibitors or inducers) or 600 mg twice daily (with potent CYP3A inducer without a potent CYP3A inhibitor) depending on interactions with concomitant antiretroviral therapy and other medicinal products (see section 4.5).
Danish: Den anbefalede dosis er 150 mg (med potent CYP3A-hæmmer med eller uden en potent CYP3Ainduktor), 300 mg (uden potente CYP3A-hæmmere eller -induktorer) eller 600 mg Celsentri 2 gange daglig (med potent CYP3A-induktor uden en potent CYP3A-hæmmer) afhængig af interaktion med samtidig antiretroviralbehandling og anden medicin (se pkt.
English: Tell your doctor or pharmacist if you (or your child) begin taking a new medicine while taking CELSENTRI.
Danish: Fortæl lægen eller apotekspersonalet, hvis du (eller dit barn) begynder at tage ny medicin under behandling med Celsentri.
English: High density polyethylene (HDPE) bottle, with a child resistant closure, containing 230 mL maraviroc 20 mg/mL solution.
Danish: High density polyethylenflaske (HDPE) med børnesikret lukning indeholdende 230 ml maraviroc 20 mg/ml opløsning.
English: Study A4001031 is an open-label, multicenter trial in paediatric patients (aged 2 years to less than 18 years) infected with CCR5-tropic HIV-1, determined by the enhanced-sensitivity Trofile assay.
Danish: Studiet A4001031 er et åbent multicenterstudie med pædiatriske patienter (i alderen 2 år til under 18 år), der er inficeret med CCR5-tropisme hiv 1, bestemt ved Trofile-assay for øget følsomhed.
English: The OBT was selected on the basis of the subject's prior treatment history and baseline genotypic and phenotypic viral resistance measurements.
Danish: OB var valgt ud fra patienternes tidligere behandlingsanamnese og genotypisk og fænotypisk viral resistensbestemmelse ved baseline.
English: Depression, insomnia common
Danish: Depression, søvnløshed
English: How to take CELSENTRI
Danish: Sådan skal du tage Celsentri
English: Pancytopenia, granulocytopenia rare
Danish: Pancytopeni, granulocytopeni
English: Maraviroc is a member of a therapeutic class called CCR5 antagonists.
Danish: Maraviroc tilhører en terapeutisk gruppe, som kaldes CCR5-antagonister.
English: • yellowing of skin or eyes
Danish: • gulfarvning af huden eller det hvide i øjnene
English: If you accidentally take or give too much CELSENTRI:
Danish: Hvis du har taget eller givet for meget Celsentri Hvis du ved et uheld har taget eller givet for meget Celsentri:
English: GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Danish: Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
English: Fluconazole is considered to be a moderate CYP3A4 inhibitor.
Danish: Fluconazol anses for at være en moderat CYP3A4-hæmmer.
English: Based on the extent of inhibition by lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir in the absence of etravirine, an increased exposure is expected.
Danish: På baggrund af hæmningsgraden af lopinavir/ritonavir, saquinavir/ritonavir eller atazanavir/ritonavir i fravær af efavirenz, forventes en øget eksponering.
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: Ved initiering af antiretroviral kombinationsbehandling (CART) hos hiv-inficerede patienter med svær immuninsufficiens kan der opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: Patients were randomised in a 2:2:1 ratio to maraviroc 300 mg (dose equivalence) once daily, twice daily or placebo in combination with an optimized background consisting of 3 to 6 antiretroviral medicinal products (excluding low-dose ritonavir).
Danish: Patienterne blev randomiseret i forholdet 2:2:1, således at de enten fik maraviroc 300 mg (dosisækvivalens) 1 gang daglig, Celsentri 300 mg 2 gange daglig eller placebo i kombination med en optimal baggrundsbehandling (OB), der omfattede 3 til 6 antiretrovirale lægemidler (undtagen lavdosis ritonavir).
English: CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adults, adolescents and children of 2 years of age, and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable (see sections 4.2 and 5.1).
Danish: Celsentri er, i kombination med andre antiretrovirale lægemidler, indiceret til behandlingserfarne, voksne, unge og børn på 2 år og derover, som vejer mindst 10 kg og er smittet kun med hiv 1-virus med verificeret CCR5-tropisme (se pkt.
English: • kidney problems.
Danish: • nyreproblemer.
English: The difference in maraviroc exposure between CYP3A5 extensive and poor metabolisers was reduced when maraviroc was administered together with a strong CYP3A inhibitor: extensive CYP3A5 metabolisers (n=12) had a 17% lower maraviroc AUC compared with poor CYP3A5 metabolisers (n=11) when dosed with maraviroc 150 mg once daily in the presence of darunavir/cobicistat (800/150 mg).
Danish: Forskellen i eksponering for maraviroc mellem ekstensive og dårlige metabolisatorer af CYP3A5 blev reduceret, når maraviroc blev anvendt sammen med en stærk CYP3A-hæmmer: ekstensive CYP3A5-metabolisatorer (n = 12) havde en 17 % lavere AUC for maraviroc sammenlignet med dårlige CYP3A5-metabolisatorer (n = 11), når maraviroc 150 mg blev givet én gang dagligt sammen med darunavir/cobicistat (800/150 mg).
English: Before taking this medicine, make sure that your doctor knows if you (or your child) have or in the past had any of the following:
Danish: Inden behandling med dette lægemiddel skal du fortælle det til lægen, hvis du (eller dit barn) har eller tidligere har haft nogle af følgende lidelser:
English: The clinical efficacy of maraviroc (in combination with other antiretroviral medicinal products) on plasma HIV RNA levels and CD4+ cell counts have been investigated in two pivotal randomized, double blind, multicentre studies (MOTIVATE 1 and MOTIVATE 2, n=1076) in patients infected with CCR5 tropic HIV-1 as determined by the Monogram Trofile Assay.
Danish: Den kliniske effekt af maraviroc (i kombination med andre antiretrovirale lægemidler) på plasma-hivRNA-koncentrationer og CD4+-celletal er undersøgt i to pivotale, randomiserede, dobbeltblindede, multicenterstudier (MOTIVATE 1 og MOTIVATE 2, n=1.076) hos patienter inficeret med CCR5tropisme hiv 1-virus, bestemt ved Monogram Trofile-assay.
English: Adolescents and children from 2 years of age and weighing at least 10 kg
Danish: Unge og børn fra 2 år, som vejer mindst 10 kg
English: CELSENTRI 25 mg film-coated tablets EU/1/07/418/011
Danish: Celsentri 25 mg filmovertrukne tabletter EU/1/07/418/011
English: Lot: {number}
Danish: Lot:
English: • an increase in a substance known as CPK (seen in blood test results) which is a sign that muscles are inflamed or damaged.
Danish: • øget indhold i blodet af et stof, der kaldes CPK (som kan ses i blodprøver), hvilket er et tegn på,
English: An increased risk of postural hypotension may occur in patients with severe renal insufficiency who are treated with potent CYP3A inhibitors or boosted protease inhibitors (PIs) and maraviroc.
Danish: Der er øget risiko for ortostatisk hypotension hos patienter med alvorligt nedsat nyrefunktion, der behandles med potente CYP3A-hæmmere eller boostede proteasehæmmere og maraviroc.
English: In a retrospective analysis of the MOTIVATE studies with a more sensitive assay for screening of tropism (Trofile ES), the response rates (<50 copies/mL at week 48) in patients with only CCR5tropic virus detected at baseline was 48.2% in those treated with maraviroc + OBT (n=328), and 16.3% in those treated with placebo + OBT (n=178).
Danish: I en retrospektiv analyse af MOTIVATE-studierne med en mere følsom analyse til screening for tropisme (Trofile ES) var responsraten (< 50 kopier/ml ved uge 48) 48,2 % hos patienter med kun CCR5-tropisk virus påvist ved baseline og behandlet med maraviroc + OB (n=328) og 16,3 % hos patienter behandlet med placebo+OB (n=178).
English: Table 1 Recommended dosing regimen in children aged 2 years and above and weighing at least 10 kg
Danish: Tabel 1 Anbefalet doseringsregime til børn på 2 år og derover, som vejer mindst 10 kg
English: Population PK analysis in phase 3 studies suggests dose reduction of maraviroc when co-administered with indinavir gives appropriate maraviroc exposure.
Danish: Farmakokinetiske populationsanalyser fra fase 3-studier tyder på dosisreduktion af maraviroc, da det giver passende maraviroceksponering, hvis det gives samtidig med indinavir.