FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Zdravnik mora poskrbeti za ustrezno prilagoditev odmerka maraviroka, kadar je le-ta uporabljen sočasno z močnimi zaviralci in/ali induktorji CYP3A4; takšna sočasna uporaba namreč lahko vpliva na koncentracijo maraviroka in njegove terapevtske učinke (glejte poglavji 4.2 in 4.5).
English: Store below 30 °C.
Slovenian: Shranjujte pri temperaturi do 30°C.
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.
Slovenian: Izpostavljenost maraviroku, dosežena z uporabo odmerkov na podlagi (kg) telesne mase pri predhodno že zdravljenih otrocih in mladostnikih, okuženih s HIV-1, je podobna kot je dosežena pri predhodno že zdravljenih odraslih bolnikih, ki prejemajo priporočene odmerke sočasnih zdravil.
English: If you belong to this age group, discuss with your doctor if you can use CELSENTRI.
Slovenian: Če sodite v to starostno skupino, se glede uporabe zdravila CELSENTRI posvetujte z zdravnikom.
English: Based on the extent of inhibition by atazanavir/ritonavir or darunavir/ritonavir in the absence of efavirenz, an increased exposure is expected.
Slovenian: Glede na obseg zavrtja z atazanavirjem/ritonavirjem ali darunavirjem/ritonavirjem brez efavirenza je mogoče pričakovati večjo izpostavljenost.
English: Maraviroc is metabolised by cytochrome P450 CYP3A4 and CYP3A5.
Slovenian: Maravirok se presnavlja s citokromoma P450 CYP3A4 in CYP3A5.
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).
Slovenian: Pri odraslih bolnikih z očistkom kreatinina < 80 ml/min, ki hkrati jemljejo močne zaviralce CYP3A4, je potrebno interval odmerjanja maraviroka prilagoditi na 150 mg enkrat na dan (glejte poglavji 4.4 in
English: Darunavir/ritonavir concentrations were consistent with historical data.
Slovenian: Koncentracija darunavirja/ritonavirja se je ujemala s podatki iz preteklosti.
English: In rats, administration of maraviroc at a systemic exposure 21-times the expected human exposure produced thyroid adenomas associated with adaptive liver changes.
Slovenian: Pri podganah je uporaba maraviroka povzročila ščitnične adenome, povezane z adaptivnimi spremembami jeter, in sicer pri sistemski izpostavljenosti, ki je bila 21-krat tolikšna kot pričakovana izpostavljenost pri človeku.
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).
Slovenian: Študija je farmakokinetiko enega 300-mg odmerka maraviroka pri bolnikih z blago (razred A po Child-Pughu, n = 8) in zmerno (razred B po Child-Pughu, n = 8) okvaro jeter primerjala s farmakokinetiko pri zdravih preiskovancih (n = 8).
English: • dark urine
Slovenian: • temen urin,
English: Rifabutin + PI
Slovenian: Rifabutin + zaviralci proteaz
English: ORAL CONTRACEPTIVES
Slovenian: PERORALNI KONTRACEPTIVI Etinilestradiol
English: Depression, insomnia common
Slovenian: Psihiatrične motnje depresija, nespečnost pogosti
English: Clear, colourless, oral solution.
Slovenian: Bistra, brezbarvna peroralna raztopina.
English: If indicated, elimination of unabsorbed active maraviroc should be achieved by emesis or gastric lavage.
Slovenian: Če je indicirano, lahko za odstranitev neabsorbiranega maraviroka uporabimo bruhanje ali izpiranje želodca.
English: This analysis indicated that CXCR4-using virus emerged from a pre-existing CXCR4-using reservoir not detected at baseline, rather than from mutation of CCR5-tropic virus present at baseline.
Slovenian: Analiza je pokazala, da je virus uporabnik CXCR4 vzniknil iz predobstoječega, izhodiščno neodkritega rezervoarja uporabnikov CXCR4 in ni nastal zaradi mutacije izhodiščno prisotnega CCR5-tropnega virusa.
English: HIV-1 RNA <50 copies/mL Maraviroc 300 mg twice daily + OBT N=426
Slovenian: HIV-1 RNA < 50 kopij/ml Maravirok 300 mg dvakrat na dan + OOT n = 426
English: However, no clinically significant QT prolongation compared to placebo + OBT was seen in the Phase 3 clinical studies using the recommended dose of maraviroc or in a specific pharmacokinetic study to evaluate the potential of maraviroc to prolong the QT interval.
Slovenian: Vendar pa v kliničnih študijah 3. faze, v katerih so uporabljali priporočeni odmerek maraviroka, in v specifični farmakokinetični študiji za oceno potenciala maraviroka za podaljšanje intervala QT, niso ugotovili klinično pomembnega podaljšanja QT v primerjavi s placebom + OOT.
English: CELSENTRI should always be taken by mouth.
Slovenian: Zdravilo CELSENTRI morate vedno zaužiti peroralno.
English: GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Slovenian: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
English: There are no data regarding the switch from a medicinal product of a different antiretroviral class to CELSENTRI in virologically suppressed patients.
Slovenian: Za virološko suprimirane bolnike ni podatkov o prehodu z zdravil iz druge protiretrovirusne skupine na zdravilo CELSENTRI.
English: If you are pregnant, if you become pregnant, or if you are planning to have a baby: Talk to your doctor about the risks and benefits of taking CELSENTRI.
Slovenian: Če ste noseči, če menite, da bi lahko bili noseči ali načrtujete zanositev:
English: CELSENTRI 300 mg twice daily should be administered with caution when co-administered with fluconazole.
Slovenian: Zdravilo CELSENTRI 300 mg dvakrat na dan je treba uporabljati previdno, če je uporabljen sočasno s flukonazolom.
English: Comparison to exposure in historical controls suggests that CELSENTRI 300 mg twice daily and nevirapine can be co-administered without dose adjustment.
Slovenian: Primerjava izpostavljenosti pri kontrolnih osebah iz preteklosti kaže, da je mogoče zdravilo CELSENTRI 300 mg dvakrat na dan uporabljati sočasno z nevirapinom brez prilagoditve odmerka.
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).
Slovenian: Ena študija je primerjala farmakokinetiko enega 300-mg odmerka maraviroka pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min, n = 6) in bolnikih s končno odpovedjo ledvic s farmakokinetiko pri zdravih prostovoljcih (n = 6).
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.
Slovenian: Pretisni omoti, varni za otroke, iz polivinilklorida (PVC) s prekrivno folijo iz aluminija/polietilen tereftalata (PET) v škatlah, ki vsebujejo 30, 60, 90 filmsko obloženih tablet in dvojno pakiranje s 180 (2 pakiranji po 90) filmsko obloženimi tabletami.
English: Treatment-Experienced Adult Patients
Slovenian: Predhodno zdravljeni odrasli bolniki
English: Elvitegravir per se is not expected to affect maraviroc exposure to a clinically relevant degree and the observed effect is attributed to ritonavir.
Slovenian: Ni pričakovati, da bi elvitegravir kot tak klinično pomembno vplival na izpostavljenost maraviroku.
English: Maraviroc C12: ↑ 4.74
Slovenian: Maravirok C12: ↑ 4,74
English: CELSENTRI oral solution is supplied in a carton containing a high density polyethylene bottle, with a child resistant cap.
Slovenian: Peroralna raztopina CELSENTRI je na voljo v škatlah, ki vsebujejo plastenko iz polietilena velike gostote, na kateri je za otroke varna zaporka.
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.
Slovenian: Maravirok, uporabljen v celični kulturi z drugimi protiretrovirusnimi zdravili, ni bil antagonističen s celo vrsto nukleozidnih zaviralcev reverzne transkriptaze, nenukleozidnimi zaviralci reverzne transkriptaze, zaviralci proteaz ali zaviralcem fuzije HIV enfuvirtidom.
English: The solution is colourless with strawberry flavouring.
Slovenian: Raztopina je brezbarvna in jagodnega okusa.
English: CELSENTRI 20 mg/ml oral solution maraviroc
Slovenian: CELSENTRI 20 mg/ml peroralna raztopina maravirok
English: Maraviroc AUC12: ↑ 5.00
Slovenian: Maravirok AUC12: ↑ 5,00
English: Refer to section 4.5 for corresponding adult dosage.
Slovenian: Za ustrezno odmerjanje za odrasle bolnike glejte poglavje 4.5.
English: Itraconazole, is a potent CYP3A4 inhibitor and would be expected to increase the exposure of maraviroc.
Slovenian: Itrakonazol je močan zaviralec CYP3A4 in pričakovati je mogoče povečanje izpostavljenosti maraviroku.
English: CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets
Slovenian: CELSENTRI 25 mg filmsko obložene tablete CELSENTRI 75 mg filmsko obložene tablete CELSENTRI 150 mg filmsko obložene tablete CELSENTRI 300 mg filmsko obložene tablete
English: If uncertainty still exists, contact a pharmacist for advice.
Slovenian: Če ste še vedno negotovi, se posvetujte s farmacevtom.
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).
Slovenian: Cmax (KV %) je bila pri zdravih prostovoljcih (normalno delovanje ledvic) 335,6 ng/ml (87 %), pri bolnikih s hudo okvaro ledvic 801,2 ng/ml (56 %), pri bolnikih s končno odpovedjo ledvic (uporaba po dializi) 576,7 ng/ml (51 %) in s končno odpovedjo ledvic (uporaba pred dializo) 478,5 ng/ml (38 %).
English: The viral tropism cannot be predicted by treatment history or assessment of stored samples.
Slovenian: Tropizma virusa ni mogoče predvideti na podlagi anamneze o terapiji ali na podlagi shranjenih vzorcev.
English: Not studied, but these are potent CYP3A4 inducers and would be expected to decrease maraviroc concentrations.
Slovenian: Ni raziskano, vendar so močni induktorji CYP3A4, zato je mogoče pričakovati znižanje koncentracije maraviroka.
English: Maraviroc is not recommended to be used in treatment-naïve patients based on the results of a clinical study in this population (see section 5.1).
Slovenian: Na osnovi izsledkov klinične študije pri bolnikih, ki še niso bili zdravljeni, maraviroka pri tej populaciji ni priporočeno uporabljati (glejte poglavje 5.1).
English: Write the date the oral solution should be discarded on the carton in the space provided.
Slovenian: Datum, ko morate peroralno raztopino zavreči, vpišite v predvideni prostor na škatli.
English: Lamivudine AUC12: ↔ 1.13
Slovenian: Lamivudin AUC12: ↔ 1,13
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).
Slovenian: V retrospektivni analizi študij MOTIVATE z občutljivejšim preskusom presejalnega testa tropizma (Trofile ES), je bil delež odziva 48,2 % pri bolnikih ( < 50 kopij/ml po 48 tednih), pri katerih so ob začetku raziskave ugotovili samo CCR5-tropni virus in so jih zdravili z maravirokom + OOT (n=328), pri bolnikih, ki so prejemali placebo + OOT (n=178), pa je bil delež odziva 16,3%.
English: Etravirine and darunavir/ritonavir (maraviroc 150 mg BID)
Slovenian: Etravirin in darunavir/ritonavir (maravirok 150 mg dvakrat na dan)
English: Co-administration of maraviroc with medicinal products that inhibit CYP3A4 may increase maraviroc plasma concentrations.
Slovenian: Sočasna uporaba maraviroka z zdravili, ki zavirajo CYP3A4, lahko poveča koncentracijo maraviroka v plazmi.
English: Paediatric patients (children younger than 2 years of age or weighing less than 10 kg) The safety and efficacy of CELSENTRI in children younger than 2 years of age or weighing less than 10 kg has not been established (see section 5.2).
Slovenian: Varnost in učinkovitost zdravila CELSENTRI pri otrocih, mlajših od 2 let oziroma s telesno maso manj kot 10 kg, še nista bili dokazani (glejte poglavje 5.2).
English: CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets maraviroc
Slovenian: CELSENTRI 25 mg filmsko obložene tablete CELSENTRI 75 mg filmsko obložene tablete CELSENTRI 150 mg filmsko obložene tablete CELSENTRI 300 mg filmsko obložene tablete maravirok
English: Elvitegravir Cmax: ↔ 1.01 (0.89-1.15) Elvitegravir C24: ↔ 1.09 (0.95-1.26)
Slovenian: Elvitegravir AUC24: ↔ 1,07 (0,96-1,18) Elvitegravir Cmax: ↔ 1,01 (0,89-1,15) Elvitegravir C24: ↔ 1,09 (0,95-1,26)
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.
Slovenian: Povprečna 24-urna koncentracija (Cpovp) maraviroka je bila pri osebah z normalnim delovanjem ledvic 445,1 ng/ml, pri bolnikih z blago okvaro ledvic 338,3 ng/ml in z zmerno okvaro ledvic 223,7 ng/ml.
English: Concomitant use of maraviroc and St. John's Wort or products containing St. John's Wort is not recommended.
Slovenian: Sočasna uporaba maraviroka in šentjanževke ali pripravkov, ki vsebujejo šentjanževko, ni priporočljiva.
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).
Slovenian: Maravirok in vitro ne deluje proti virusom, ki lahko kot soreceptor za vstop uporabijo CXCR4 (duotropni ali CXCR4-tropni virusi; v nadaljevanju: "uporabniki CXCR4").
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).
Slovenian: Maravirok naj bi uporabljali le, če je z ustrezno validirano in občutljivo metodo (glejte poglavja 4.1, 4.2 in 5.1) ugotovljen CCR5-tropni HIV-1 (tj. ni odkrit CXCR4- ali dualno/mešano-tropni virus).
English: The incidence of AIDS-defining infections was similar between maraviroc and placebo arms in the pivotal studies.
Slovenian: V ključnih študijah je bila incidenca okužb, značilnih za aids, podobna med kraki z maravirokom ter s placebom.
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.
Slovenian: Pri preiskovancih z blago okvaro jeter je bilo razmerje geometrijskih sredin za Cmax 11 % večje in za AUClast 25 % večje, pri preiskovancih z zmerno okvaro jeter pa za Cmax 32 % večje in za AUClast 46 % večje kot pri preiskovancih z normalnim delovanjem jeter.
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.
Slovenian: Plastenke iz polietilena velike gostote (HDPE) s polipropilensko, za otroke varno zaporko, zaprte z aluminijsko folijo/polietilenom s toplotno indukcijo; plastenke vsebujejo 120 filmsko obloženih tablet.
English: ANTIARRHYTHMICS Digoxin 0.25 mg Single Dose (maraviroc 300 mg BID)
Slovenian: ANTIARITMIKI Digoksin 0,25 mg enkraten odmerek (maravirok 300 mg dvakrat na dan)
English: Multipack: 180 (2 packs of 90) film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Dvojno pakiranje: 180 (2 pakiranji po 90) filmsko obloženih tablet
English: Always take or give this medicine exactly as your doctor has told you.
Slovenian: Pri jemanju ali dajanju tega zdravila natančno upoštevajte navodila zdravnika.
English: Hepatobiliary disorders reported in treatment-naïve patients were uncommon and balanced between treatment groups (see section 4.8).
Slovenian: Bolezni jeter, žolčnika in žolčevodov, zabeležene pri še nezdravljenih bolnikih, so bile občasne in po terapevtskih skupinah uravnotežene (glejte poglavje 4.8).
English: Nelfinavir is a potent CYP3A4 inhibitor and would be expected to increase maraviroc concentrations.
Slovenian: Nelfinavir je močan zaviralec CYP3A4 in pričakovati je mogoče zvišanje koncentracije maraviroka.
English: Other medicines and CELSENTRI Tell your doctor or pharmacist if you (or your child) are taking, any other medicines, have recently taken, or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če vi (ali vaš otrok) jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: In treatment-naïve patients such events occurred at a similarly low rate with maraviroc and control (efavirenz).
Slovenian: Med še nezdravljenimi bolniki je bil delež takšnih dogodkov z maravirokom podobno majhen kot s primerjalnim zdravilom (efavirenz).
English: Therefore CELSENTRI is not recommended for children younger than 2 years, or weighing less than 10 kg.
Slovenian: Zato zdravilo CELSENTRI ni priporočljivo za otroke, mlajše od 2 let ali s telesno maso manj kot 10 kg.
English: The most frequently reported adverse reactions occurring in the Phase 2b/3 studies were nausea,
Slovenian: Najpogosteje opisani neželeni učinki v študijah faze 2b/3 so bili navzea, driska, utrujenost in glavobol.
English: The discard date of the oral solution should be written on the carton in the space provided.
Slovenian: Datum, ko je treba peroralno raztopino zavreči, zapišite v temu namenjeni prostor na škatli.
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.
Slovenian: Pri razmisleku o bolnikovi sposobnosti vožnje, kolesarjenja ali upravljanja strojev je treba upoštevati bolnikovo klinično stanje in značilnosti neželenih učinkov maraviroka.
English: Uncommon side effects These may affect up to 1 in 100 people:
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: Pfizer Manufacturing Deutschland GmbH
Slovenian: Pfizer Manufacturing Deutschland GmbH Betriebsstātte Freiburg Mooswaldallee 1
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).
Slovenian: • zvišanje vrednosti jetrnih encimov (pokaže se na preiskavah krvi), ki je lahko znak težav z jetri
English: Cobicistat is a potent CYP3A inhibitor.
Slovenian: Kobicistat je močan zaviralec CYP3A.
English: The use of CELSENTRI has not been tested in children under the age of 2 or weighing less than 10 kg .
Slovenian: Uporaba zdravila CELSENTRI ni bila raziskana pri otrocih, mlajših od 2 let ali s telesno maso manj kot 10 kg.
English: Cases of hepatotoxicity and hepatic failure with allergic features have been reported in association with maraviroc.
Slovenian: V povezavi z maravirokom so bili opisani primeri hepatotoksičnosti in jetrne odpovedi z alergijskimi značilnostmi.
English: Elvitegravir as a single agent is indicated only in combination with certain ritonavir boosted PIs.
Slovenian: Kot posamezna zdravilna učinkovina je elvitegravir indiciran samo v kombinaciji z zaviralci proteaz, okrepljenimi z ritonavirjem.
English: Therefore, no dose adjustment is necessary in patients with renal impairment receiving maraviroc without a potent CYP3A4 inhibitor (see sections 4.2, 4.4 and 4.5).
Slovenian: Zato bolnikom z okvaro ledvic, ki dobivajo maravirok brez močnega zaviralca CYP3A4, odmerka ni treba prilagoditi (glejte poglavje 4.2, 4.4 in 4.5).
English: Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 300 mg film-coated tablets
Slovenian: Nalepka na zunanjem ovoju dvojnega pakiranja po 180 (2 škatli z 90 filmsko obloženimi tabletami), ki je ovito v prozorno folijo - vključno z blue box-om - 300 mg filmsko obložene tablete
English: Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
Slovenian: Jedro tablete: mikrokristalna celuloza, brezvodni kalcijev hidrogenfosfat, natrijev karboksimetilškrob, magnezijev stearat.
English: These may affect 1 to 10 in 100 people:
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri 1 do 10 od 100 bolnikov):
English: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 180 film-coated tablets.
Slovenian: Plastenke iz polietilena velike gostote (HDPE) s polipropilensko, za otroke varno zaporko, zaprte z aluminijsko folijo/polietilenom s toplotno indukcijo; plastenke vsebujejo 180 filmsko obloženih tablet.
English: 90 film-coated tablets.
Slovenian: 90 filmsko obloženih tablet
English: Phenotypic resistance
Slovenian: Fenotipska odpornost
English: Examples of agents/regimens with such potent CYP3A4-inhibiting activity are:
Slovenian: Primeri zdravilnih učinkovin z močnim zaviralnim učinkom na CYP3A4:
English: Maraviroc 300 mg twice daily + OBT N =421*
Slovenian: Maravirok 300 mg dvakrat na dan + OOT n = 421*
English: Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 150 mg film-coated tablets
Slovenian: Nalepka na zunanjem ovoju dvojnega pakiranja po 180 (2 škatli z 90 filmsko obloženimi tabletami), ki je ovito v prozorno folijo - vključno z blue box-om - 150 mg filmsko obložene tablete
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%).
Slovenian: Izhodiščno je bila povprečna HIV-1 RNA v plazmi 4,3 log10 kopij/ml (razpon: od 2,4 do 6,2 log10 kopij/ml), povprečno število celic CD4+ je bilo 551 celic/mm
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.
Slovenian: V študiji faze I pri zdravih preiskovancih so imeli črnci z genotipom CYP3A5, ki prinaša izdatno presnovo maraviroka (2 alela CYP3A5*1, n = 12), med uporabo 300 mg maraviroka dvakrat na dan 37 % oziroma 26 % manjšo AUC kot črnci (n = 11) in belci (n = 12) z genotipom CYP3A5, ki prinaša slabo presnovo maraviroka (brez alela CYP3A5*1).
English: Rare side effects These may affect up to 1 in 1,000 people:
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: Excipient with known effect: each 300 mg film-coated tablet contains 1.68 mg of soya lecithin.
Slovenian: Pomožne snovi z znanim učinkom: ena 300 mg filmsko obložena tableta vsebuje 1,68 mg sojinega lecitina.
English: Fluconazole is considered to be a moderate CYP3A4 inhibitor.
Slovenian: Flukonazol velja za zmeren zaviralec CYP3A4.
English: >5.0x ULN
Slovenian: > 5,0 x ZNM 4,8
English:  stiffness in the joints  aches and pains (especially in the hip, knee or shoulder)  difficulty moving.
Slovenian: • bolečine (zlasti v kolku, kolenu ali rami),