natgillin/translations-raw huggingface dataset:
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). 
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).
Store below 30 °C. 
Shranjujte pri temperaturi do 30°C.
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. 
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.
If you belong to this age group, discuss with your doctor if you can use CELSENTRI. 
Če sodite v to starostno skupino, se glede uporabe zdravila CELSENTRI posvetujte z zdravnikom.
Based on the extent of inhibition by atazanavir/ritonavir or darunavir/ritonavir in the absence of efavirenz, an increased exposure is expected. 
Glede na obseg zavrtja z atazanavirjem/ritonavirjem ali darunavirjem/ritonavirjem brez efavirenza je mogoče pričakovati večjo izpostavljenost.
Maraviroc is metabolised by cytochrome P450 CYP3A4 and CYP3A5. 
Maravirok se presnavlja s citokromoma P450 CYP3A4 in CYP3A5.
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). 
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
Darunavir/ritonavir concentrations were consistent with historical data. 
Koncentracija darunavirja/ritonavirja se je ujemala s podatki iz preteklosti.
In rats, administration of maraviroc at a systemic exposure 21-times the expected human exposure produced thyroid adenomas associated with adaptive liver changes. 
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.
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). 
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).
• dark urine 
• temen urin,
Rifabutin + PI 
Rifabutin + zaviralci proteaz
ORAL CONTRACEPTIVES 
PERORALNI KONTRACEPTIVI Etinilestradiol
Depression, insomnia common 
Psihiatrične motnje depresija, nespečnost pogosti
Clear, colourless, oral solution. 
Bistra, brezbarvna peroralna raztopina.
If indicated, elimination of unabsorbed active maraviroc should be achieved by emesis or gastric lavage. 
Če je indicirano, lahko za odstranitev neabsorbiranega maraviroka uporabimo bruhanje ali izpiranje želodca.
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. 
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.
HIV-1 RNA <50 copies/mL Maraviroc 300 mg twice daily + OBT N=426 
HIV-1 RNA < 50 kopij/ml Maravirok 300 mg dvakrat na dan + OOT n = 426
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. 
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.
CELSENTRI should always be taken by mouth. 
Zdravilo CELSENTRI morate vedno zaužiti peroralno.
There are no data regarding the switch from a medicinal product of a different antiretroviral class to CELSENTRI in virologically suppressed patients. 
Za virološko suprimirane bolnike ni podatkov o prehodu z zdravil iz druge protiretrovirusne skupine na zdravilo CELSENTRI.
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. 
Če ste noseči, če menite, da bi lahko bili noseči ali načrtujete zanositev:
CELSENTRI 300 mg twice daily should be administered with caution when co-administered with fluconazole. 
Zdravilo CELSENTRI 300 mg dvakrat na dan je treba uporabljati previdno, če je uporabljen sočasno s flukonazolom.
Comparison to exposure in historical controls suggests that CELSENTRI 300 mg twice daily and nevirapine can be co-administered without dose adjustment. 
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.
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). 
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).
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. 
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.
Treatment-Experienced Adult Patients 
Predhodno zdravljeni odrasli bolniki
Elvitegravir per se is not expected to affect maraviroc exposure to a clinically relevant degree and the observed effect is attributed to ritonavir. 
Ni pričakovati, da bi elvitegravir kot tak klinično pomembno vplival na izpostavljenost maraviroku.
CELSENTRI oral solution is supplied in a carton containing a high density polyethylene bottle, with a child resistant cap. 
Peroralna raztopina CELSENTRI je na voljo v škatlah, ki vsebujejo plastenko iz polietilena velike gostote, na kateri je za otroke varna zaporka.
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. 
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.
The solution is colourless with strawberry flavouring. 
Raztopina je brezbarvna in jagodnega okusa.
CELSENTRI 20 mg/ml oral solution maraviroc 
CELSENTRI 20 mg/ml peroralna raztopina maravirok
Refer to section 4.5 for corresponding adult dosage. 
Za ustrezno odmerjanje za odrasle bolnike glejte poglavje 4.5.
Itraconazole, is a potent CYP3A4 inhibitor and would be expected to increase the exposure of maraviroc. 
Itrakonazol je močan zaviralec CYP3A4 in pričakovati je mogoče povečanje izpostavljenosti maraviroku.
CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets 
CELSENTRI 25 mg filmsko obložene tablete CELSENTRI 75 mg filmsko obložene tablete CELSENTRI 150 mg filmsko obložene tablete CELSENTRI 300 mg filmsko obložene tablete
If uncertainty still exists, contact a pharmacist for advice. 
Če ste še vedno negotovi, se posvetujte s farmacevtom.
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). 
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 %).
The viral tropism cannot be predicted by treatment history or assessment of stored samples. 
Tropizma virusa ni mogoče predvideti na podlagi anamneze o terapiji ali na podlagi shranjenih vzorcev.
Not studied, but these are potent CYP3A4 inducers and would be expected to decrease maraviroc concentrations. 
Ni raziskano, vendar so močni induktorji CYP3A4, zato je mogoče pričakovati znižanje koncentracije maraviroka.
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). 
Na osnovi izsledkov klinične študije pri bolnikih, ki še niso bili zdravljeni, maraviroka pri tej populaciji ni priporočeno uporabljati (glejte poglavje 5.1).
Write the date the oral solution should be discarded on the carton in the space provided. 
Datum, ko morate peroralno raztopino zavreči, vpišite v predvideni prostor na škatli.
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). 
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%.
Etravirine and darunavir/ritonavir (maraviroc 150 mg BID) 
Etravirin in darunavir/ritonavir (maravirok 150 mg dvakrat na dan)
Co-administration of maraviroc with medicinal products that inhibit CYP3A4 may increase maraviroc plasma concentrations. 
Sočasna uporaba maraviroka z zdravili, ki zavirajo CYP3A4, lahko poveča koncentracijo maraviroka v plazmi.
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). 
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).
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 
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
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. 
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.
Concomitant use of maraviroc and St. John's Wort or products containing St. John's Wort is not recommended. 
Sočasna uporaba maraviroka in šentjanževke ali pripravkov, ki vsebujejo šentjanževko, ni priporočljiva.
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). 
Maravirok in vitro ne deluje proti virusom, ki lahko kot soreceptor za vstop uporabijo CXCR4 (duotropni ali CXCR4-tropni virusi; v nadaljevanju: "uporabniki CXCR4").
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). 
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).
The incidence of AIDS-defining infections was similar between maraviroc and placebo arms in the pivotal studies. 
V ključnih študijah je bila incidenca okužb, značilnih za aids, podobna med kraki z maravirokom ter s placebom.
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. 
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.
High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 120 film-coated tablets. 
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.
ANTIARRHYTHMICS Digoxin 0.25 mg Single Dose (maraviroc 300 mg BID) 
ANTIARITMIKI Digoksin 0,25 mg enkraten odmerek (maravirok 300 mg dvakrat na dan)
Multipack: 180 (2 packs of 90) film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA Dvojno pakiranje: 180 (2 pakiranji po 90) filmsko obloženih tablet
Always take or give this medicine exactly as your doctor has told you. 
Pri jemanju ali dajanju tega zdravila natančno upoštevajte navodila zdravnika.
Hepatobiliary disorders reported in treatment-naïve patients were uncommon and balanced between treatment groups (see section 4.8). 
Bolezni jeter, žolčnika in žolčevodov, zabeležene pri še nezdravljenih bolnikih, so bile občasne in po terapevtskih skupinah uravnotežene (glejte poglavje 4.8).
Nelfinavir is a potent CYP3A4 inhibitor and would be expected to increase maraviroc concentrations. 
Nelfinavir je močan zaviralec CYP3A4 in pričakovati je mogoče zvišanje koncentracije maraviroka.
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. 
Obvestite zdravnika ali farmacevta, če vi (ali vaš otrok) jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
In treatment-naïve patients such events occurred at a similarly low rate with maraviroc and control (efavirenz). 
Med še nezdravljenimi bolniki je bil delež takšnih dogodkov z maravirokom podobno majhen kot s primerjalnim zdravilom (efavirenz).
Therefore CELSENTRI is not recommended for children younger than 2 years, or weighing less than 10 kg. 
Zato zdravilo CELSENTRI ni priporočljivo za otroke, mlajše od 2 let ali s telesno maso manj kot 10 kg.
The most frequently reported adverse reactions occurring in the Phase 2b/3 studies were nausea, 
Najpogosteje opisani neželeni učinki v študijah faze 2b/3 so bili navzea, driska, utrujenost in glavobol.
The discard date of the oral solution should be written on the carton in the space provided. 
Datum, ko je treba peroralno raztopino zavreči, zapišite v temu namenjeni prostor na škatli.
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. 
Pri razmisleku o bolnikovi sposobnosti vožnje, kolesarjenja ali upravljanja strojev je treba upoštevati bolnikovo klinično stanje in značilnosti neželenih učinkov maraviroka.
Uncommon side effects These may affect up to 1 in 100 people: 
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
• 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). 
• zvišanje vrednosti jetrnih encimov (pokaže se na preiskavah krvi), ki je lahko znak težav z jetri
Cobicistat is a potent CYP3A inhibitor. 
Kobicistat je močan zaviralec CYP3A.
The use of CELSENTRI has not been tested in children under the age of 2 or weighing less than 10 kg . 
Uporaba zdravila CELSENTRI ni bila raziskana pri otrocih, mlajših od 2 let ali s telesno maso manj kot 10 kg.
Cases of hepatotoxicity and hepatic failure with allergic features have been reported in association with maraviroc. 
V povezavi z maravirokom so bili opisani primeri hepatotoksičnosti in jetrne odpovedi z alergijskimi značilnostmi.
Elvitegravir as a single agent is indicated only in combination with certain ritonavir boosted PIs. 
Kot posamezna zdravilna učinkovina je elvitegravir indiciran samo v kombinaciji z zaviralci proteaz, okrepljenimi z ritonavirjem.
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). 
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).
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 
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
Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate 
Jedro tablete: mikrokristalna celuloza, brezvodni kalcijev hidrogenfosfat, natrijev karboksimetilškrob, magnezijev stearat.
These may affect 1 to 10 in 100 people: 
Pogosti neželeni učinki (pojavijo se lahko pri 1 do 10 od 100 bolnikov):
High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 180 film-coated tablets. 
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.
90 film-coated tablets. 
90 filmsko obloženih tablet
Phenotypic resistance 
Fenotipska odpornost
Examples of agents/regimens with such potent CYP3A4-inhibiting activity are: 
Primeri zdravilnih učinkovin z močnim zaviralnim učinkom na CYP3A4:
Maraviroc 300 mg twice daily + OBT N =421* 
Maravirok 300 mg dvakrat na dan + OOT n = 421*
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 
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
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%). 
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
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. 
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).
Rare side effects These may affect up to 1 in 1,000 people: 
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
Excipient with known effect: each 300 mg film-coated tablet contains 1.68 mg of soya lecithin. 
Pomožne snovi z znanim učinkom: ena 300 mg filmsko obložena tableta vsebuje 1,68 mg sojinega lecitina.
Fluconazole is considered to be a moderate CYP3A4 inhibitor. 
Flukonazol velja za zmeren zaviralec CYP3A4.
>5.0x ULN 
> 5,0 x ZNM 4,8
 stiffness in the joints  aches and pains (especially in the hip, knee or shoulder)  difficulty moving. 
• bolečine (zlasti v kolku, kolenu ali rami),
Use the oral applicator supplied with the pack to measure your dose accurately. 
Za točno odmerjanje odmerka uporabite aplikator za peroralno odmerjanje, ki je priložen v pakiranju.
Maraviroc 300 mg twice daily + OBT N=426 
Maravirok 300 mg dvakrat na dan + OOT n = 426
If you notice any of these symptoms: Tell your doctor. 
Če se vam pojavijo ti simptomi, nemudoma obvestite zdravnika.
These include:  symptoms of infections and inflammation  joint pain, stiffness and bone problems. 
 simptomi okužb in vnetja,  bolečine v sklepih, togost sklepov in težave s kostmi.
Ketoconazole concentrations not measured, no effect is expected. 
Koncentracija ketokonazola ni bila merjena, učinki niso pričakovani.
Maraviroc is the major circulating component (approximately 42% radioactivity) following a single oral dose of 300 mg. 
Po posamičnem peroralnem odmerku 300 mg je maravirok glavna komponenta v obtoku (približno 42 % radioaktivnosti).
Hepatic disease 
Bolezni jeter
Poly (vinyl alcohol) Titanium dioxide (E171) Macrogol 3350 
Filmska obloga polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec sojin lecitin indigotin (E132)
Dialysis had a minimal effect on exposure in subjects with ESRD. 
Dializa je pri bolnikih s končno odpovedjo ledvic minimalno vplivala na izpostavljenost.
More patients treated with maraviroc discontinued due to lack of efficacy (43 vs.15) and among patients with lack of efficacy, the proportion acquiring NRTI resistance (mainly lamivudine) was higher in the maraviroc arm. 
Med bolniki z nezadostno učinkovitostjo je bil delež s pridobljeno odpornostjo za nukleozidne zaviralce reverzne transkriptaze (predvsem za lamivudin) večji v kraku z maravirokom.
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). 
Pri odraslih bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min), ki jemljejo močne zaviralce CYP3A4, je treba zdravilo CELSENTRI uporabljati previdno (glejte poglavji 4.4 in 5.2).
Anti-HCV Ribavirin 
Zdravila proti hepatitisu C Ribavirin
CELSENTRI 300 mg film-coated tablets 
CELSENTRI 300 mg filmsko obložene tablete
ANTIBIOTICS Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (maraviroc 300 mg BID) 
ANTIBIOTIKI Sulfametoksazol/ trimetoprim 800 mg/160 mg dvakrat na dan (maravirok 300 mg dvakrat na dan)
CELSENTRI 75 mg film-coated tablets 
CELSENTRI 75 mg filmsko obložene tablete