FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatobiliary disorders reported in treatment-naïve patients were uncommon and balanced between treatment groups (see section 4.8).
Danish: Hos behandlingsnaive patienter var hepatobiliære lidelser ikke almindelige og ligeligt fordelt mellem de forskellige behandlingsgrupper (se pkt.
English: Store the oral solution below 30°C.
Danish: Den orale opløsning skal opbevares ved temperaturer under 30 °C.
English: Placebo + OBT
Danish: Placebo+OB
English: CELSENTRI contains a medicine called maraviroc.
Danish: Celsentri indeholder et aktivt stof, der kaldes maraviroc.
English: • The active ingredient in CELSENTRI is maraviroc.
Danish: • Aktivt stof: maraviroc.
English: Failure with CCR5-tropic virus
Danish: Behandlingssvigt med CCR5-tropismevirus
English: Table 4: Incidence ≥1% of grade 3-4 abnormalities (ACTG criteria) based on maximum shift in laboratory test values without regard to baseline studies MOTIVATE 1 and MOTIVATE 2 (pooled analysis, up to 48 weeks)
Danish: Tabel 4: Hyppigheden ≥ 1 % af grad 3-4 anormaliteter (ACTG-kriterier) baseret på den maksimale grænse i laboratorieværdier uden hensyn til baseline studier MOTIVATE 1 og MOTIVATE 2 (puljede analyser op til 48 uger)
English: The incidence of these selected endpoints for subjects on maraviroc in this observational phase was consistent with the incidence seen at earlier timepoints in the studies.
Danish: I observationsfasen var forekomsten af disse valgte endepunkter for patienter behandlet med maraviroc i overensstemmelse med den forekomst, der er set på tidligere tidspunkter i studierne.
English: ViiV Healthcare (logo)
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN ViiV Healthcare (logo)
English: No clinically significant interaction seen.
Danish: Der er ikke set nogen signifikant interaktion.
English: Etravirine and lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir
Danish: Etravirin og lopinavir/ritonavir, saquinavir/ritonavir eller atazanavir/ritonavir
English: Table 6: Efficacy Outcomes at week 48 (pooled studies MOTIVATE 1 and MOTIVATE 2) Outcomes
Danish: Tabel 6: Effektresultater ved 48 uger (puljede data fra studierne MOTIVATE 1 og MOTIVATE 2)
English: In rats, administration of maraviroc at a systemic exposure 21-times the expected human exposure produced thyroid adenomas associated with adaptive liver changes.
Danish: Ved administration af maraviroc hos rotter ses thyroideaadenom, der er forbundet med adaptive leverændringer ved en systemisk eksponering, der er 21 gange den forventede humane dosis.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver gruppe af bivirkninger med samme frekvens, er bivirkningerne opstillet efter, hvor alvorlige bivirkningerne er.
English: ViiV Healthcare sprl/bvba .
Danish: België/Belgique/Belgien ViiV Healthcare sprl/bvba.
English: Efavirenz and atazanavir/ritonavir or darunavir/ritonavir
Danish: Efavirenz og atazanavir/ritonavir eller darunavir/ritonavir
English: In addition, an increase in hepatic adverse reactions with maraviroc was observed during studies of treatment-experienced subjects with HIV infection, although there was no overall increase in ACTG Grade 3/4 liver function test abnormalities (see section 4.8).
Danish: Derudover er der i studier med behandlingserfarne forsøgspersoner med hiv-infektion set et øget antal leverpåvirkninger med maraviroc, men der var ikke en samlet stigning i ACTG-grad 3-4 anormalitet i leverfunktionsprøverne (se pkt.
English: Maraviroc is metabolised by cytochrome P450 CYP3A4 and CYP3A5.
Danish: Maraviroc metaboliseres af CYP3A4 og CYP3A5.
English: Turn the bottle upside down.
Danish: Vend flasken med bunden opad.
English: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands.
Danish: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Holland.
English: At baseline, mean plasma HIV-1 RNA was 4.3 log10 copies/mL (range 2.4 to 6.2 log10 copies per mL), mean CD4+ cell count was 551 cells/mm3 (range 1 to 1654 cells/mm3) and mean CD4+ % was 21% (range 0% to 42%).
Danish: Ved baseline var middel plasma hiv 1 RNA 4,3 log10 kopier/ml (interval 2,4 til 6,2 log10 kopier pr. ml), middel CD4+-celletal var 551 celler/mm3 (interval 1 til 1654 celler/mm3) og middel CD4+ % var 21 % (interval 0 % til 42 %).
English: When combining rifabutin with protease inhibitors that are potent inhibitors of CYP3A4 a net inhibitory effect on maraviroc is expected.
Danish: Når rifabutin kombineres med en proteasehæmmer, som er en potent hæmmer af CYP3A4, forventes en netto hæmmende virkning på maraviroc.
English: The Cavg of maraviroc from 24-48 hours for subjects with moderate renal impairment was low (Cavg: 32.8 ng/mL).
Danish: Hos patienter med moderat nedsat nyrefunktion var Cavg for maraviroc lav fra 24-48 timer (Cavg: 32,8 ng/ml).
English: Bile duct cancer, diffuse large B-cell lymphoma, Hodgkin's disease, metastases to bone, metastases to liver, metastases to peritoneum, nasopharyngeal cancer, oesophageal carcinoma rare
Danish: Cancer i galdegange, diffust storcellet B-celle lymfom, Hodgkins sygdom, knoglemetastaser, levermetastaser, metastaser i peritoneum, kræft i næsesvælget, øsofagal karcinom
English: Maraviroc has no antiviral activity in vitro against viruses which can use CXCR4 as their entry coreceptor (dual-tropic or CXCR4-tropic viruses, collectively termed ‘CXCR4-using' virus below).
Danish: In vitro har maraviroc ingen aktivitet mod virus, der bruger CXCR4 som deres indtrædende coreceptor (dual-tropisme eller CXCR4-tropisme, der tilsammen benævnes CXCR4-using virus, se nedenfor).
English: Pre- and post-natal developmental studies were performed in rats at doses up to 27-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Danish: Der er udført præ- og postnatale udviklingsstudier i rotter i doser op til 27 gange det estimerede frie kliniske AUC ved en dosis på 300 mg 2 gange daglig.
English: Hepatitis toxic, hepatic failure, hepatic cirrhosis, blood alkaline phosphatase increased rare
Danish: Toksisk hepatitis, leversvigt, levercirrose, forhøjet blod-phosphatase
English: CELSENTRI should be used with caution in adult patients with severe renal impairment (CLcr <30 mL/min) who are receiving potent CYP3A4 inhibitors (see sections 4.4 and 5.2).
Danish: Celsentri bør anvendes med forsigtighed hos voksne patienter med alvorligt nedsat nyrefunktion (kreatininclearance < 30 ml/min), som får potente CYP3A4-hæmmere (se pkt.
English: • anticonvulsant medicines (carbamazepine, phenytoin, phenobarbital).
Danish: • krampestillende medicin (carbamazepin, phenytoin, phenobarbital).
English: The pharmacokinetics of maraviroc in paediatric patients below 2 years of age have not been established (see section 4.2).
Danish: Maravirocs farmakokinetik er ikke undersøgt hos børn under 2 år (se pkt.
English: These include:  symptoms of infections and inflammation  joint pain, stiffness and bone problems.
Danish:  symptomer på infektioner og betændelse  ledsmerter, stivhed og knogleproblemer.
English: Cobicistat is a potent CYP3A inhibitor.
Danish: Cobicistat er en potent CYP3Ahæmmer.
English: CELSENTRI 150 mg film-coated tablets EU/1/07/418/001 (180 tablets) EU/1/07/418/002 (30 tablets) EU/1/07/418/003 (60 tablets) EU/1/07/418/004 (90 tablets) EU/1/07/418/005 (2 x 90 tablets - multipack)
Danish: Celsentri 150 mg filmovertrukne tabletter EU/1/07/418/001 (180 tabletter) EU/1/07/418/002 (30 tabletter) EU/1/07/418/003 (60 tabletter) EU/1/07/418/004 (90 tabletter) EU/1/07/418/005 (2 x 90 tabletter - multipakning)
English: Maraviroc had no clinically relevant effect on the pharmacokinetics of midazolam, the oral contraceptives ethinylestradiol and levonorgestrel, or urinary 6β-hydroxycortisol/cortisol ratio, suggesting no inhibition or induction of CYP3A4 in vivo.
Danish: Maraviroc havde ingen klinisk relevant effekt på midazolams farmakokinetik, de orale antikonceptiva ethinylestradiol og levonorgestrel, eller på urin 6-hydroxycortisol/cortisol-forholdet.
English: CELSENTRI 75 mg film-coated tablets EU/1/07/418/012
Danish: Celsentri 75 mg filmovertrukne tabletter EU/1/07/418/012
English: • increase in liver enzymes (seen in blood test results), which can be a sign of liver problems (see also ‘Liver problems' earlier in section 4).
Danish: • forhøjede leverenzymer (kan ses i blodprøver), som kan være tegn på leverproblemer (se også
English: The exposure at this dose level corresponded to 39-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Danish: Denne dosiseksponering svarer til 39 gange det estimerede frie kliniske AUC med en dosis på 300 mg 2 gange daglig.
English: The C max (CV%) was 335.6 ng/mL (87%) in healthy volunteers (normal renal function); 801.2 ng/mL (56%) in severe renal impairment; 576.7 ng/mL (51%) in ESRD (dosing after dialysis) and 478.5 ng/mL (38%) in ESRD (dosing before dialysis).
Danish: Cmax (CV%) var 335,6 ng/ml (87 %) hos raske frivillige forsøgspersoner (normal nyrefunktion); 801,2 ng/ml (56 %) ved alvorligt nedsat nyrefunktion; 576,7 ng/ml (51 %) ved ESRD (dosering efter dialyse) og 478,5 ng/ml (38 %) ved ESRD (dosering før dialyse).
English: Mooswaldallee 1 79090 Freiburg Germany
Danish: 79090 Freiburg
English: CELSENTRI 25 mg and 75 mg film-coated tablets are supplied in bottles of 120 tablets.
Danish: Celsentri 25 mg og 75 mg filmovertrukne tabletter findes i en beholder med 120 tabletter.
English: If this happens, lie down until you (or your child) feel better.
Danish: Hvis dette sker, skal du ligge ned, indtil du (eller dit barn) føler dig bedre tilpas.
English: At 48 weeks, using a missing, switch or discontinuation equals failure analysis, 48% of subjects treated with maraviroc and OBT achieved plasma HIV-1 RNA less than 48 copies/mL and 65% of subjects achieved plasma HIV-1 RNA less than 400 copies per mL.
Danish: Ved uge 48, hvor manglende data på follow-up, et skift eller seponering betragtes som svigt, opnåede 48 % af forsøgspersonerne, der blev behandlet med maraviroc og OB plasma hiv 1-RNA mindre end 48 kopier/ml og 65 % af forsøgspersonerne opnåede plasma hiv 1 RNA mindre end 400 kopier pr. ml.
English: Store below 30 °C.
Danish: Opbevares ved temperaturer under 30 ºC.
English: CELSENTRI 300 mg film-coated tablets EU/1/07/418/006 (180 tablets) EU/1/07/418/007 (30 tablets) EU/1/07/418/008 (60 tablets) EU/1/07/418/009 (90 tablets) EU/1/07/418/010 (2 x 90 tablets - multipack)
Danish: Celsentri 300 mg filmovertrukne tabletter EU/1/07/418/006 (180 tabletter) EU/1/07/418/007 (30 tabletter) EU/1/07/418/008 (60 tabletter) EU/1/07/418/009 (90 tabletter) EU/1/07/418/010 (2 x 90 tabletter - multipakning)
English: CELSENTRI 20 mg/ml oral solution maraviroc
Danish: Celsentri 20 mg/ml oral opløsning maraviroc
English: Exposures observed in subjects with severe renal impairment and ESRD were within the range observed in single maraviroc 300 mg dose studies in healthy volunteers with normal renal function.
Danish: Koncentrationerne, der blev set hos patienter med alvorligt nedsat nyrefunktion og ESRD, lå inden for intervallet set ved en enkelt 300 mg dosis maraviroc til raske frivillige forsøgspersoner med normal nyrefunktion.
English: Ketoconazole concentrations not measured, no effect is expected.
Danish: Ketoconazol koncentrationer er ikke målt.
English: Use of weight (kg)-based doses in treatment-experienced HIV-1-infected children and adolescents results in maraviroc exposures similar to those observed in treatment-experienced adults receiving recommended doses with concomitant medications.
Danish: Anvendelse af vægt-(kg)-baserede doser hos behandlingserfarne hiv 1-inficerede børn og unge resulterer i eksponering for maraviroc, der er magen til den, der observeres hos behandlingserfarne voksne, der får anbefalede doser sammen med anden medicin.
English: Physicians should ensure that appropriate dose adjustment of maraviroc is made when maraviroc is co-administered with potent CYP3A4 inhibitors and/or inducers since maraviroc concentrations and its therapeutic effects may be affected (see sections 4.2 and 4.5).
Danish: Lægen skal sikre den nødvendige dosisjustering af maraviroc, når det anvendes sammen med potente CYP3A4-hæmmere og/eller -induktorer, da maravirockoncentrationer og den terapeutiske effekt kan påvirkes (se pkt.
English: Prior to deciding the dose of CELSENTRI by weight, please refer to Table 2 in section 4.5 to carefully determine the corresponding adult dose.
Danish: 4.5 inden fastlæggelse af dosis af Celsentri efter vægt, så den tilsvarende voksendosis kan fastlægges præcist.
English: * Based on drug-drug Interactions (refer to section 4.5)
Danish: * Baseret på lægemiddelinteraktioner (se pkt.
English: 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer
English: In a Phase 1 study conducted in healthy subjects, Blacks with a CYP3A5 genotype conferring extensive maraviroc metabolism (2 CYP3A5*1 alleles; n=12) had a 37% and 26% lower AUC when dosed with maraviroc 300 mg twice daily compared with Black (n=11) and Caucasian (n=12) subjects with CYP3A5 genotype conferring poor maraviroc metabolism (no CYP3A5*1 allele), respectively.
Danish: I et fase 1-studie med raske forsøgspersoner havde sorte med en CYP3A5-genotype, der medfører ekstensiv metabolisme af maraviroc (2 CYP3A5*1-alleler; n = 12), hhv. 37 % og 26 % lavere AUC, når de fik maraviroc 300 mg to gange dagligt, sammenlignet med sorte (n = 11) og kaukasiske (n = 12) forsøgspersoner med en CYP3A5-genotype, der bibringer dårlig metabolisering af maraviroc (ingen CYP3A5*1-allel).
English: Ribavirin has not been studied, no interaction is expected.
Danish: Ribavirin er ikke undersøgt.
English: • other medicines to treat HIV or hepatitis C infection (such as atazanavir, cobicistat, darunavir,
Danish: • anden medicin til at behandle hiv- eller hepatitis C-infektion (f.eks. atazanavir, cobicistat,
English: Hyperbilirubinaemia, gammaglutamyltransferase increased uncommon
Danish: Hyperbilirubinæmi, stigning i gammaglutamyltransferase
English: Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, jordnødder (peanuts), soja eller over for et eller flere af hjælpestofferne anført i pkt.
English: Signs to look out for include:
Danish: Symptomer, som du skal holde øje med, omfatter:
English: A study compared the pharmacokinetics of a single 300 mg dose of maraviroc in patients with mild (Child-Pugh Class A, n=8), and moderate (Child-Pugh Class B, n=8) hepatic impairment compared to healthy subjects (n=8).
Danish: Et studie sammenlignede farmakokinetikken af en enkeltdosis på 300 mg maraviroc hos patienter med mild (Child-Pugh klasse A, n=8) og moderat (Child-Pugh klasse B, n=8) nedsat leverfunktion og hos raske forsøgspersoner (n=8).
English: HERBAL PRODUCTS St. John's Wort (Hypericum Perforatum)
Danish: NATURLÆGEMIDLER Perikon (Hypericum perforatum)
English: Children from 2 years of age and weighing at least 10kg The recommended dose of CELSENTRI should be based on body weight (kg) and should not exceed the recommended adult dose.
Danish: Den anbefalede dosis Celsentri skal baseres på legemsvægt (kg) og må ikke overstige den anbefalede dosis for voksne.
English: CELSENTRI 150 mg and 300 mg film-coated tablets are supplied in bottles of 180 tablets or in blister packs of 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) filmcoated tablets.
Danish: Celsentri 150 mg og 300 mg filmovertrukne tabletter findes i en beholder med 180 tabletter og i blisterpakninger med 30, 60, 90 filmovertrukne tabletter samt i en multipakning med 180 (2 pakninger med 90) filmovertrukne tabletter.
English: If uncertainty still exists, contact a pharmacist for advice.
Danish: Kontakt apotekspersonalet for rådgivning, hvis der stadig er tvivl.
English: The mean increase in CD4+ cell count from baseline in patients who failed with a change in tropism result to dual/mixed tropic or CXCR4, in the maraviroc 300 mg twice daily + OBT (+56 cells/mm3) group was greater than that seen in patients failing placebo + OBT (+13.8 cells/mm3) regardless of tropism.
Danish: Den gennemsnitlige stigning i CD4+-celletal ved baseline hos patienter, som havde manglende effekt af behandlingen og med en ændring i tropismeresultat til dual/mixed tropisme eller CXCR4 var højere i gruppen, der fik maraviroc 300 mg 2 gange daglig + (OB) (+56 celler/mm3) end hos de patienter, der havde behandlingssvigt med placebo+OB (+13,8 celler/mm3) uanset tropisme.
English: In addition, the study compared the pharmacokinetics of multiple dose maraviroc in combination with saquinavir/ritonavir 1000/100 mg BID (a potent CYP3A4 inhibitor) for 7 days in subjects with mild renal impairment (CLcr >50 and ≤80 mL/min, n=6) and moderate renal impairment (CLcr ≥30 and ≤50 mL/min, n=6) to healthy volunteers (n=6).
Danish: Desuden sammenlignede studiet farmakokinetikken efter flere doser maraviroc i kombination med saquinavir/ritonavir 1.000/100 mg 2 gange daglig (en potent CYP3A4-hæmmer) i 7 dage hos patienter med let nedsat nyrefunktion (kreatininclearance > 50 og ≤ 80 ml/min, n=6) og moderat nedsat nyrefunktion (kreatininclearance ≥ 30 og ≤ 50 ml/min, n=6) med raske frivillige forsøgspersoner (n=6).
English: CELSENTRI 300 mg twice daily should be administered with caution when co-administered with fluconazole.
Danish: Celsentri 300 mg 2 gange daglig bør anvendes med forsigtighed, når det anvendes samtidigt med fluconazol.
English: Hepatic failure with allergic features very rare
Danish: Leversvigt med allergilignende karakteristika
English: Use of weight (kg)-based doses in treatment-experienced HIV-1-infected paediatrics results in maraviroc exposures similar to those observed in treatmentexperienced adults receiving recommended doses with concomitant medications.
Danish: Anvendelse af vægt-(kg)-baserede doser hos behandlingserfarne hiv 1-inficerede pædiatriske patienter resulterer i eksponering for maraviroc, der er magen til den, der observeres hos behandlingserfarne voksne, der får anbefalede doser sammen med anden medicin.
English: Embryofoetal development studies were conducted in rats and rabbits at doses up to 39- and 34fold the estimated free clinical AUC for a 300 mg twice daily dose.
Danish: Der er udført dyrestudier for embryoets/fostrets udvikling med rotter og kaniner i doser op til 39 og 34 gange det estimerede frie kliniske AUC med en dosis på 300 mg 2 gange daglig.
English: Not studied, but these are potent CYP3A4 inducers and would be expected to decrease maraviroc concentrations.
Danish: Ikke undersøgt, men dette er potente CYP3A4-induktorer og forventes at reducere koncentrationen af maraviroc.
English: A study compared the pharmacokinetics of a single 300 mg dose of maraviroc in subjects with severe renal impairment (CLcr < 30 mL/min, n=6) and end stage renal disease (ESRD) to healthy volunteers (n=6).
Danish: Et studie sammenlignede farmakokinetikken af en enkelt 300 mg dosis maraviroc hos patienter med alvorligt nedsat nyrefunktion (kreatininclearance < 30 ml/min, n=6) og nyresygdom i slutstadiet (ESRD) med raske frivillige forsøgspersoner (n=6).
English: Phenotypic resistance
Danish: Fænotypisk resistens
English: Discard 60 days after first opening.
Danish: Bortskaffes 60 dage efter anbrud.
English: CELSENTRI with products that are not potent CYP3A inhibitors or potent CYP3A inducers
Danish: Celsentri sammen med produkter, der ikke er potente CYP3A-hæmmere eller potente CYP3A-induktorer
English: Indinavir is a potent CYP3A4 inhibitor.
Danish: Indinavir er en potent CYP3A4-hæmmer.
English: Co-administration of maraviroc with medicinal products that inhibit CYP3A4 may increase maraviroc plasma concentrations.
Danish: Samtidig anvendelse af maraviroc og lægemidler, der hæmmer CYP3A4, kan øge maravirocs plasmakoncentration.
English: Pneumonia, oesophageal candidiasis uncommon
Danish: Pneumoni, øsofagal candidiasis
English: Turn the bottle the correct way up.
Danish: Vend flasken korrekt igen.
English: • diarrhoea, feeling sick, stomach ache, wind (flatulence),
Danish: • diarré, kvalme, mavesmerter, luft i maven
English: AUCt: ↔ 1.00
Danish: Digoxin AUCt: ↔ 1,00
English: Assessment of treatment related adverse reactions is based on pooled data from two Phase 2b/3 studies in treatment-experienced adult patients (MOTIVATE 1 and MOTIVATE 2) and one study in treatment-naïve adult patients (MERIT) infected with CCR5-tropic HIV-1 (see sections 4.4 and
Danish: Vurderingen af de behandlingsrelaterede bivirkninger bygger på puljede data fra to fase 2b/3-studier med behandlingserfarne voksne patienter (MOTIVATE 1 og MOTIVATE 2) samt et studie med behandlingsnaive patienter (MERIT).
English: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 120 film-coated tablets.
Danish: High density polyethylenbeholder (HDPE) med børnesikret polypropylenlåg og med en aluminiumsfolie/polyethylen varmeinduceret forsegling, der indeholder 120 filmovertrukne tabletter.
English: Dose adjustment of maraviroc is recommended when maraviroc is co-administered with potent CYP3A4 inhibitors and/or inducers.
Danish: Det er nødvendigt at justere dosis af maraviroc, når maraviroc anvendes samtidigt med potente CYP3A4-hæmmere og/eller -induktorer.
English: Name and address of the manufacturer responsible for batch release Tablets
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
English: GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Danish: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
English: The geometric mean AUCinf (CV%) for maraviroc was as follows: healthy volunteers (normal renal function) 1348.4 ng·h/mL (61%); severe renal impairment 4367.7 ng·h/mL (52%); ESRD (dosing after dialysis) 2677.4 ng·h/mL (40%); and ESRD (dosing before dialysis) 2805.5 ng·h/mL (45%).
Danish: Der sås følgende geometriske gennemsnit AUCinf (CV%) for maraviroc: raske frivillige forsøgspersoner (normal nyrefunktion): 1.348,4 ng ∙ time/ml (61 %); alvorligt nedsat nyrefunktion: 4.367,7 ng ∙ time/ml (52 %); ESRD (dosering efter dialyse): 2.677,4 ng ∙ time/ml (40 %) og ESRD (dosering før dialyse): 2.805,5 ng ∙ time/ml (45 %).
English: Polyvinyl chloride (PVC) blisters with child-resistant (CR) aluminium/polyethylene terephthalate (PET) lidding foil in a carton containing 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets.
Danish: Polyvinylchlorid (PVC) blister med børnesikret aluminium/polyethylenterephtalat (PET) lågfolie i en karton, der indeholder 30, 60, 90 filmovertrukne tabletter og en multipakning med 180 (2 pakninger med 90) filmovertrukne tabletter.
English: Etravirine and darunavir/ritonavir (maraviroc 150 mg BID)
Danish: Etravirin og darunavir/ritonavir (maraviroc 150 mg 2 gange daglig)
English: Co-administration of maraviroc with medicinal products that induce CYP3A4 may decrease maraviroc concentrations and reduce its therapeutic effects.
Danish: Samtidig anvendelse af maraviroc og lægemidler, der inducerer CYP3A4, kan nedsætte maravirocs koncentration samt nedsætte den terapeutiske effekt af maraviroc.
English: Maraviroc should only be used when only CCR5-tropic HIV-1 is detectable (i.e. CXCR4 or dual/mixed tropic virus not detected) as determined by an adequately validated and sensitive detection method (see sections 4.1, 4.2 and 5.1).
Danish: Maraviroc bør kun anvendes hos patienter smittet kun med hiv 1-virus med verificeret CCR5-tropisme (dvs. CXCR4 eller dual/mixed tropisme må ikke være verificeret), der er bestemt ved hjælp af en egnet, valideret detektionsmetode (se pkt.
English: LIPID LOWERING MEDICINAL PRODUCTS Statins
Danish: LIPIDSÆNKENDE STOFFER Statiner
English: There is limited experience in patients with reduced hepatic function, therefore maraviroc should be used with caution in this population (see sections 4.2 and 5.2).
Danish: På grund af begrænset erfaring hos patienter med nedsat leverfunktion skal maraviroc anvendes med forsigtighed til denne patientpopulation (se pkt.