FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited numbers of patients from ethnicities other than Caucasian were included in the pivotal clinical studies, therefore very limited data are available in these patient populations.
Danish: Der er et begrænset antal patienter af anden etnisk oprindelse end hvide inkluderet i de pivotale studier, hvorfor kun begrænsede data er tilgængelige i disse patientpopulationer.
English: The clinical status of the patient and the adverse reaction profile of maraviroc should be borne in mind when considering the patient's ability to drive, cycle or operate machinery.
Danish: Patientens kliniske status og bivirkningsprofilen for maraviroc bør tages i betragtning ved overvejelse af patientens evne til at føre motorkøretøj, cykle eller betjene maskiner.
English: In patients with CCR5-tropic virus at time of treatment failure with maraviroc, 22 out of 58 patients had virus with reduced sensitivity to maraviroc.
Danish: Hos patienter med CCR5-tropismevirus på tidspunktet for behandlingssvigt med maraviroc havde 22 ud af 58 patienter virus med reduceret følsomhed over for maraviroc.
English: The solution is colourless with strawberry flavouring.
Danish: Opløsningen er farveløs med jordbærsmag.
English: The effect of maraviroc on human pregnancy is unknown.
Danish: Virkningen af maraviroc på human graviditet er ikke kendt.
English: • rash (see also ‘Serious allergic or skin reactions' earlier in section 4)
Danish: • udslæt (se også "Alvorlige allergiske reaktioner eller hudreaktioner" tidligere i punkt 4)
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) , or not known (cannot be estimated from the available data).
Danish: Frekvenserne er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Always take or give this medicine exactly as your doctor has told you.
Danish: Tag eller giv altid lægemidlet nøjagtigt efter lægens anvisning.
English: Elvitegravir per se is not expected to affect maraviroc exposure to a clinically relevant degree and the observed effect is attributed to ritonavir.
Danish: Elvitegravir som sådan forventes ikke at påvirke maraviroc eksponering i klinisk relevant udstrækning, og den observerede effekt skyldes ritonavir.
English:  tuberculosis (TB) or serious fungal infections.
Danish:  tuberkulose (TB) eller alvorlige svampeinfektioner.
English: In the Week 48 analysis (N=103), non-CCR5 tropic-virus was detected in 5/23 (22%) subjects at virologic failure.
Danish: I uge 48-analysen (N=103) blev der påvist non-CCR5-tropismevirus hos 5/23 (22 %) forsøgspersoner ved virologisk svigt.
English: Hence, the relevance of these mutations to maraviroc susceptibility in other viruses is not known.
Danish: Relevansen af disse mutationer over for maraviroc-følsomhed i andre virus er ikke kendt.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, can have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Danish: Patienter med leverdysfunktion i anamnesen, herunder kronisk aktiv hepatitis, kan have en øget frekvens af leverfunktionsanormaliteter under antiretroviral kombinationsbehandling og bør monitoreres i henhold til gældende standardpraksis.
English: Other possible side effects of combination therapy for HIV
Danish: Andre mulige bivirkninger ved kombinationsbehandling af hiv
English: The pharmacokinetics of maraviroc is dependent on CYP3A5 activity and expression level, which can be modulated by genetic variation.
Danish: Maravirocs farmakokinetik er afhængig af CYP3A5-aktivitet og ekspressionsniveau, som kan blive moduleret ved genetisk variation.
English: Limit
Danish: Grænse
English: For combination with etravirine + PI, see below.
Danish: For kombination med etravirin + proteasehæmmere, se nedenfor.
English: Studies in animals showed reproductive toxicity at high exposures.
Danish: Dyrestudier viser reproduktionstoksicitet ved høj eksponering.
English: The absolute bioavailability of a 100 mg dose is 23% and is predicted to be 33% at 300 mg. Maraviroc is a substrate for the efflux transporter Pglycoprotein.
Danish: Den absolutte biotilgængelighed af en dosis på 100 mg er 23 % og estimeres til 33 % for 300 mg. Maraviroc er et substrat for efflux-transporteren P-glycoprotein.
English: These reactions included rash, fever, and sometimes organ dysfunction and hepatic failure.
Danish: Reaktionerne omfatter udslæt, feber og nogle gange organdysfunktion og leversvigt.
English: Insert the applicator (C) firmly into the adapter.
Danish: Indsæt doseringssprøjten (C) fast ned i adapteren.
English: Studies in humans and in vitro studies using human liver microsomes and expressed enzymes have demonstrated that maraviroc is principally metabolized by the cytochrome P450 system to metabolites that are essentially inactive against HIV-1.
Danish: Studier med mennesker og in vitro-studier, hvor der anvendes humane levermikrosomer og udtrykte enzymer viste, at maraviroc fortrinsvis metaboliseres af cytochrom P450-systemet til metabolitter, der er essentielt inaktive over for hiv 1.
English: It is unknown whether maraviroc is excreted in human milk.
Danish: Det er ukendt, om maraviroc udskilles i human mælk.
English: In rats, there were no adverse effects on male or female fertility (see section 5.3).
Danish: Hos rotter var der ikke nogen bivirkninger på den mandlige- eller kvindelige fertilitet (se pkt.5.3).
English: Primary pharmacological activity (CCR5 receptor affinity) was present in the monkey (100% receptor occupancy) and limited in the mouse, rat, rabbit and dog.
Danish: Primær farmakologisk aktivitet (CCR5-receptoraffinitet) er tilstede hos aber (100 % receptorokkupation) og begrænset hos mus, rotter, kaniner og hunde.
English: There are limited data from the use of maraviroc in pregnant women.
Danish: Der er begrænset dokumentation fra anvendelse af maraviroc til gravide kvinder.
English: Dialysis had a minimal effect on exposure in subjects with ESRD.
Danish: Dialyse havde minimal virkning på koncentrationen hos patienter med ESRD.
English: A randomised, double-blinded study (MERIT), explored maraviroc versus efavirenz, both in combination with zidovudine/lamivudine (n=721, 1:1).
Danish: Et randomiseret, dobbeltblindet studie (MERIT) undersøgte maraviroc over for efavirenz, begge i kombination med zidovudin/lamivudin (n=721, 1:1).
English: • headache, problems sleeping, depression
Danish: • hovedpine, problemer med at sove, depression
English: • low blood pressure, including dizziness when you stand up or sit up quickly, or if you are taking any medicines to lower blood pressure.
Danish: • lavt blodtryk, herunder svimmelhed, når du står op eller rejser dig op hurtigt, eller hvis du tager medicin for at nedsætte blodtrykket.
English: The pharmacokinetics of oral maraviroc are not dose proportional over the dose range.
Danish: Farmakokinetikken af oral maraviroc er ikke dosisproportional over dosisintervallet.
English: Maraviroc inhibits P-glycoprotein in vitro (IC50 is 183 μM).
Danish: Maraviroc hæmmer P-glycoprotein in vitro (IC50 er 183 µM ).
English: • if you (or your child, if they are the patient) are allergic to maraviroc or to any of the other ingredients of CELSENTRI (listed in section 6 ).
Danish: • hvis du (eller dit barn, hvis barnet er patienten) er allergisk over for maraviroc eller et af de øvrige indholdsstoffer i Celsentri (angivet i punkt 6).
English: Alanine aminotransferase
Danish: Alaninaminotransferase
English: • drowsiness and confusion
Danish: • døsighed eller forvirring
English: Remove the applicator from the adapter.
Danish: Fjern doseringssprøjten fra adapteren.
English: Limited data are available in adult patients with hepatic impairment and no data are available to recommend a specific dose for paediatric patients.
Danish: Der er begrænset dokumentation hos voksne patienter med nedsat leverfunktion, og der findes ingen tilgængelige data til anbefaling af en specifik dosis til pædiatriske patienter.
English: Etravirine is only approved for use with boosted protease inhibitors.
Danish: Etravirin er kun godkendt til brug sammen med boostede proteasehæmmere.
English: Limited data are available for coadministration with indinavir.
Danish: Der findes begrænset dokumentation for samtidig administration med indinavir.
English: Patients who were eligible for these studies had prior exposure to at least 3 antiretroviral medicinal product classes [≥1 NRTIs, ≥1 NNRTIs, ≥2 PIs, and/or enfurvirtide] or documented resistance to at least one member of each class.
Danish: De patienter, der kunne indgå i studiet, skulle være behandlet med mindst 3 antiretrovirale lægemiddelklasser [≥ 1 NRTIer, ≥ 1 NNRTIer, ≥ 2 PIer, og/eller enfurvirtid] eller dokumenteret resistens over for mindst én i hver klasse.
English: The initial dose of maraviroc was scaled from adult doses using a body surface area (BSA) of 1.73 m2 to children and adolescent BSA (m2)-based bands.
Danish: Den initiale dosis maraviroc blev udmålt ud fra voksendoser under anvendelse af et legemsoverfladeområde (BSA) på 1,73 m2 til børn og unge i BSA (m2)-baserede grupper.
English: However, a significant treatment benefit for maraviroc compared to placebo + OBT was still demonstrated (see Table 7).
Danish: Der blev dog påvist en signifikant behandlingsfordel for maraviroc sammenlignet med placebo+OB (se tabel 7).
English: The Monogram Trofile assay was used in the clinical studies of maraviroc.
Danish: Monogram Trofile-assay blev benyttet i de kliniske studier med maraviroc.
English: 230 ml oral solution
Danish: 230 ml oral opløsning
English: The impact of potent CYP3A inhibitors and/or inducers on maraviroc pharmacokinetic parameters in paediatric patients was similar to that observed in adults.
Danish: Indvirkningen af potente CYP3A-hæmmere og/eller -induktorer på maravirocs farmakokinetiske parametre hos pædiatriske patienter var den samme, som er observeret hos voksne.
English: Use the oral applicator supplied with the pack to measure your dose accurately.
Danish: Brug den orale doseringssprøjte, der følger med pakningen, til at afmåle din dosis præcist.
English: If you belong to this age group, discuss with your doctor if you can use CELSENTRI.
Danish: Tal med lægen, hvis du tilhører denne aldersgruppe, for at høre, om du kan tage Celsentri.
English: Use of maraviroc was not associated with a significant decrease in HIV 1 RNA compared with placebo in these subjects and no adverse effect on CD4+ cell count was noted.
Danish: Anvendelse af maraviroc var ikke forbundet med et signifikant fald i hiv 1 RNA sammenlignet med placebo hos disse forsøgspersoner, og der blev ikke set nogen negativ virkning på CD4+-celletal.
English: If a child is unable to reliably swallow CELSENTRI tablets, the oral solution (20 mg per mL) should be prescribed (refer to Summary of Product Characteristics for CELSENTRI oral solution).
Danish: Hvis et barn ikke er i stand til på pålidelig vis at synke Celsentri-tabletterne, skal den orale opløsning (20 mg pr. ml) ordineres (se produktresumé for Celsentri oral opløsning).
English: The adverse reactions are listed by system organ class (SOC) and frequency.
Danish: Bivirkningerne er opført efter systemorganklasse og frekvens.
English: HIV-1 clinical isolates resistant to NRTIs, NNRTIs, PIs and enfuvirtide were all susceptible to maraviroc in cell culture.
Danish: Hiv 1-kliniske isolater, der er resistente over for NRTIer, NNRTIer, PIer og enfuvirtid var alle følsomme over for maraviroc i cellekulturer.
English: One additional subject had CCR5 tropic-virus with reduced susceptibility to maraviroc at virologic failure, although this was not retained at the end of treatment.
Danish: En yderligere forsøgsperson havde CCR5-tropismevirus med reduceret følsomhed over for maraviroc ved virologisk svigt, selvom dette ikke blev opretholdt ved afslutning af behandlingen.
English: Cases of syncope caused by postural hypotension have been reported.
Danish: Der er blevet rapporteret tilfælde af synkope forårsaget af ortostatisk hypotension.
English: Your doctor will decide the correct dose of CELSENTRI, based on weight and on other medicines being taken at the same time.
Danish: Lægen vil bestemme den korrekte dosis Celsentri baseret på vægt og anden medicin, der tages samtidig.
English:  low blood pressure, including dizziness when you stand up or sit up quickly, or if you are taking any medicines to lower blood pressure.
Danish:  lavt blodtryk, herunder svimmelhed, når du rejser dig op eller rejser dig op hurtigt, eller hvis du tager medicin for at nedsætte blodtrykket.
English: In the pivotal studies (MOTIVATE 1 and MOTIVATE 2), 7.6% of patients had a change in tropism result from CCR5-tropic to CXCR4-tropic or dual/mixed-tropic between screening and baseline (a period of 4-6 weeks).
Danish: I de pivotale studier (MOTIVATE 1 og MOTIVATE 2) fik 7,6 % af patienterne ændring i tropismeresultatet fra CCR5-tropisme til CXCR4-tropisme eller dual/mixed-tropisme mellem screening og baseline (en periode på 4-6 uger).
English: For details please refer to the pharmacology section of the CELSENTRI European Public Assessment Report (EPAR) on the European Medicines Agency (EMA) website.
Danish: For yderligere information henvises til farmakologiafsnittet i den europæiske offentlige vurderingsrapport (EPAR) for Celsentri på det Europæiske Lægemiddelagenturs (EMA) hjemmeside.
English: • itraconazole, voriconazole, clarithromycin and telithromycin,
Danish: • itraconazol, voriconazol, clarithromycin og telithromycin,
English: Renal clearance accounts for approximately 23% of total clearance of maraviroc when maraviroc is administered without CYP3A4 inhibitors.
Danish: Renal clearance udgør ca. 23 % af den samlede clearance for maraviroc, når maraviroc anvendes uden CYP3A4-hæmmere.
English: Remove the bottle cap (A).
Danish: Tag flaskens låg (A) af.
English: All subjects in the Phase 1 study achieved the Cavg concentrations that have been shown to be associated with near maximal virologic efficacy with maraviroc (75 ng/mL) in the Phase 3 study in treatment-naïve adult patients (MERIT).
Danish: Samtlige forsøgspersoner i fase 1-studiet opnåede de Cavg-koncentrationer, der er påvist at være forbundet med nær-maksimal virologisk effektivitet med maraviroc (75 ng/ml) i fase 3-studiet hos behandlingsnaive voksne patienter (MERIT).
English: Examples of agents/regimens with such potent CYP3A4-inhibiting activity are:
Danish: Eksempler på lægemidler/regimer med potent CYP3A4-hæmmende aktivitet er:
English: Table 5: Demographic and baseline characteristics of patients (pooled studies MOTIVATE 1 and MOTIVATE 2)
Danish: Tabel 5: Demografiske og baseline karakteristika hos patienter (puljede data fra studierne MOTIVATE 1 og MOTIVATE 2)
English: Some people taking medicines for HIV infection develop other conditions, which can be serious.
Danish: Nogle personer, der tager medicin mod hiv-infektion, udvikler andre tilstande, som kan være alvorlige.
English: 2 What you need to know before you take CELSENTRI Do not take CELSENTRI:
Danish: 2 Det skal du vide, før du begynder at tage Celsentri Tag ikke Celsentri:
English: It may not be excluded that maraviroc can increase the exposure to the P-glycoprotein substrate dabigatran etexilate.
Danish: Det kan ikke udelukkes, at maraviroc kan øge eksponeringen af Pglykoprotein-substratet dabigatranetexilat.
English: For combination with efavirenz + PI, see separate recommendations below.
Danish: For kombination med efavirenz + proteasehæmmere, se separate anbefalinger nedenfor.
English: There is no data on the effects of maraviroc on human fertility.
Danish: Der foreligger ingen data af maravirocs påvirkning af menneskets fertilitet.
English: A mass balance/excretion study was conducted using a single 300 mg dose of 14C-labeled maraviroc.
Danish: Der er udført et massebalance/ekskretionsstudie med en enkeltdosis på 300 mg 14C-mærket maraviroc.
English: Approximately 20% of the radiolabel was recovered in the urine and 76% was recovered in the faeces over 168 hours.
Danish: Over 168 timer blev ca. 20 % af det radioaktivt mærkede stof genfundet i urinen, og 76 % blev genfundet i fæces.
English: 70 subjects (Child-Pugh Class A, n=64; Child-Pugh Class B, n=6) were randomized to the maraviroc group and 67 subjects (Child-Pugh Class A, n=59; Child-Pugh Class B, n=8) were randomized to the placebo group.
Danish: 70 forsøgspersoner (Child-Pugh klasse A, n=64; Child-Pugh klasse B, n=6) blev randomiseret til maraviroc-gruppen, og 67 forsøgspersoner (Child-Pugh klasse A, n=59; Child-Pugh klasse B, n=8) blev randomiseret til placebogruppen.
English: Discontinue maraviroc and other suspect agents immediately if signs or symptoms of severe skin or hypersensitivity reactions develop.
Danish: Seponer omgående maraviroc og andre mistænkte lægemidler, hvis der udvikles tegn eller symptomer på alvorlige hud- eller overfølsomhedsreaktioner.
English: Patients should be informed that dizziness has been reported during treatment with maraviroc.
Danish: Patienterne skal informeres om, at der er rapporteret svimmelhed under behandling med maraviroc.
English: Mutations were found to accumulate in the gp120 envelope glycoprotein (the viral protein that binds to the CCR5 co-receptor).
Danish: Mutationer ser ud til at akkumulere i gp120-kappe-glycoprotein (viralt protein som bindes til CCR5 co-receptor).
English: Cross-resistance in vitro
Danish: Krydsresistens in vitro
English: This will allow your doctor to prescribe the right dose of CELSENTRI.
Danish: På den måde kan lægen udskrive den korrekte dosis af Celsentri.
English: In patients failing therapy with CCR5-tropic virus only, maraviroc might be considered still active if the MPI value is ≥95% (PhenoSense Entry assay).
Danish: Hos de patienter, der kun havde behandlingssvigt med CCR5-tropismevirus, kan maraviroc måske stadig betragtes som aktiv, hvis MPI er ≥ 95 % (PhenoSense Entry assay).
English: Maraviroc 300 mg twice daily + OBT was superior to placebo + OBT across all subgroups of patients analysed (see Table 7).
Danish: Maraviroc 300 mg 2 gange daglig + OB var bedre end placebo+OB i alle undergrupper af patientanalyser (se tabel 7).
English: An analysis of tropism following failure of maraviroc therapy with CXCR4using virus in patients with CCR5 virus at baseline, demonstrated that the virus population reverted back to CCR5 tropism in 33 of 36 patients with more than 35 days of follow-up.
Danish: En analyse af tropisme efter behandlingssvigt med maraviroc med CXCR4-using virus hos patienter med CCR5-virus ved baseline viste, at viruspopulationen vendte tilbage til CCR5tropisme hos 33 af de 36 patienter, der have en opfølgningsperiode på mere en 35 dage.
English: Dose of CELSENTRI in children based on weight 10 to less than 20 kg
Danish: Dosis af celsentri til børn, baseret på vægt 10 til mindre end 20 kg
English: Limited data are available for coadministration with nelfinavir.
Danish: Der findes begrænset dokumentation for samtidig administration med nelfinavir.
English: In vitro studies also indicate that polymorphic enzymes CYP2C9, CYP2D6 and CYP2C19 do not contribute significantly to the metabolism of maraviroc.
Danish: In vitro-studier tyder også på, at polymorfiske enzymer som CYP2C9, CYP2D6 og CYP2C19 ikke signifikant medvirker til maravirocs metabolisme.
English: Therefore, dosing frequencies of longer than 24 hours in subjects with renal impairment may result in inadequate exposures between 24-48 hours.
Danish: Derfor kan doseringsintervaller længere end 24 timer hos patienter med nedsat nyrefunktion medføre for lave koncentrationer mellem 24 og 48 timer efter dosering.
English: There are no data available to recommend a specific dose in paediatric patients with renal impairment.
Danish: Der findes ingen tilgængelige data til anbefaling af en specifik dosis til pædiatriske patienter med nedsat nyrefunktion.
English: The serum adjusted EC90 value in 43 primary HIV-1 clinical isolates was 0.57 (0.06 - 10.7) ng/mL without significant changes between different subtypes tested.
Danish: Den serum-justerede EC90-værdi hos 43 primære hiv 1-kliniske isolater var 0,57 (0,0610,7) ng/ml uden signifikante ændringer mellem forskellige undersøgte undertyper.
English: The mean CD4+ cell count (percent) increase from baseline to Week 48 was 247 cells/mm3 (5%).
Danish: Middelstigningen i CD4+-celletallet (procent) fra baseline til uge 48 var 247 celler/mm3 (5 %).
English: Delayed type hypersensitivity reactions, typically occurring within 2-6 weeks after start of therapy and including rash, fever, eosinophilia and liver reactions have been reported (see also section 4.4).
Danish: Der er rapporteret forsinkede overfølsomhedsreaktioner, typisk inden for 2-6 uger efter behandlingsstart, herunder udslæt, feber, eosinofili og leverreaktioner (se også pkt.
English: Study A4001029 was an exploratory study in patients infected with dual/mixed or CXCR4 tropic HIV-1 with a similar design as the studies MOTIVATE 1 and MOTIVATE 2.
Danish: Studiet A4001029 er et eksplorativt studie med patienter inficeret med dual/mixed eller CXCR4tropisme hiv 1 med et lignende design som studierne MOTIVATE 1 og MOTIVATE 2.
English: Maraviroc selectively binds to the human chemokine receptor CCR5, preventing CCR5-tropic HIV-1 from entering cells.
Danish: Maraviroc bindes selektivt til human kemokin-receptor CCR5, idet den forhindrer CCR5-tropisme hiv 1 i at komme ind i cellerne.
English:  stiffness in the joints  aches and pains (especially in the hip, knee or shoulder)  difficulty moving.
Danish: • ømhed og smerter (særligt i hofter, knæ eller skuldre)
English: All subjects (n = 103) received maraviroc twice daily and OBT.
Danish: Alle forsøgspersoner (n = 103) fik maraviroc to gange dagligt og OB.
English: For example, if the dose is 15 ml, you need one and a half applicator -full of medicine.
Danish: 15 ml, skal du have halvanden doseringssprøjte - fuld af medicin.
English: Further details for concomitantly administered medicinal products are provided below (see Table
Danish: Yderligere oplysninger om samtidig anvendelse af andre lægemidler er anført nedenfor (se tabel 2).
English: However, maraviroc does not significantly affect the pharmacokinetics of digoxin in vivo.
Danish: Maraviroc påvirker dog ikke farmakokinetikken af digoxin signifikant in vivo.
English: Please also refer to the respective Summary of Product Characteristics of the other antiretroviral medicinal products used in the combination.
Danish: Der henvises desuden til produktresuméerne for de antiretrovirale lægemidler, der anvendes i kombinationen.
English: People taking combination therapy for HIV may get other side effects.
Danish: Personer, der tager kombinationsbehandling mod hiv, kan få andre bivirkninger.
English: These include:
Danish: Det omfatter:
English: In rabbit, 7 foetuses had external anomalies at maternally toxic doses and 1 foetus at the mid dose of 75 mg/kg.
Danish: Hos kaniner havde 7 fostre ydre misdannelser ved administration af dosis som var toksisk for moderdyret, og 1 foster havde misdannelse ved en middeldosis på 75 mg/kg.
English: Maraviroc was evaluated for carcinogenic potential by a 6 month transgenic mouse study and a 24 month study in rats.
Danish: Maraviroc er undersøgt for karcinogenicitet i dyrestudier af 6 måneders varighed med transgene mus og af 24 måneders varighed med rotter.
English: Baseline CD4+ (cells/µL):
Danish: Baseline CD4+ (celler/µl):
English: Blood and lymphatic system disorders Absolute neutrophil count
Danish: Blod og lymfesystemet Absolut neutrofiltal