FrancophonIA/ELRC3.0 huggingface dataset:
English: In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Slovenian: Pri bolnikih, okuženih s HIV, ki imajo v času uvedbe kombinirane protiretrovirusne terapije (KPRT) hudo imunsko pomanjkljivost, se lahko pojavi vnetna reakcija na asimptomatske ali rezidualne oportunistične patogene ter povzroči resna klinična stanja ali poslabšanje simptomov.
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).
Slovenian: V ključnih študijah (MOTIVATE 1 in MOTIVATE 2) je od presejanja do izhodišča (obdobje od 4 do 6 tednov) pri 7,6 % bolnikov prišlo do spremembe tropizma od CCR5-tropizma v CXCR4-tropizem ali dualni/mešani tropizem.
English: For combination with etravirine + PI, see below.
Slovenian: Za kombinacije z etravirinom in zaviralci proteaz glejte spodaj.
English: How to take CELSENTRI
Slovenian: Kako jemati zdravilo CELSENTRI
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
Slovenian: Ocena z zdravljenjem povezanih neželenih učinkov temelji na podatkih dobljenih v dveh študijah faze 2b/3 pri že zdravljenih odraslih bolnikih (MOTIVATE 1 in MOTIVATE 2) in eni študiji pri še nezdravljenih odraslih bolnikih (MERIT), okuženih s CCR5-tropnim virusom HIV-1 (glejte poglavji 4.4 in 5.1).
English: CELSENTRI 25 mg film-coated tablets EU/1/07/418/011
Slovenian: CELSENTRI 25 mg filmsko obložene tablete EU/1/07/418/011
English: Since maraviroc is moderately protein bound, dialysis may be beneficial in removal of this medicine.
Slovenian: Maravirok je zmerno vezan na beljakovine, zato lahko pri njegovem odstranjevanju koristi dializa.
English: Screening Viral Load >100,000 copies/mL Baseline CD4+ Cell Count ≤200 cells/mm3 Number (Percentage) of patients with GSS score1:
Slovenian: Presejalno virusno breme > 100.000 kopij/ml Izhodiščno število celic CD4+ ≤ 200 celic/mm Število (odstotek) bolnikov s seštevkom GSS1:
English: Do not use CELSENTRI after the expiry date which is stated on the bottle and carton label.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in nalepki škatle.
English: If you get any of the following symptoms while you're taking CELSENTRI :  swelling of the face, lips or tongue  difficulty breathing  widespread skin rash  fever (high temperature)  blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.
Slovenian:  oteklost obraza, ustnic ali jezika,  težko dihanje,  razširjen kožni izpuščaj,  zvišana telesna temperatura (vročina),  mehurji in lupljenje kože, zlasti okrog ust, nosu, oči in spolovil.
English: The exposure at this dose level corresponded to 39-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Slovenian: Izpostavljenost pri tej odmerni ravni ustreza 39-kratni ocenjeni prosti klinični AUC pri odmerku 300 mg dvakrat na dan.
English: The mean CD4+ cell count (percent) increase from baseline to Week 48 was 247 cells/mm3 (5%).
Slovenian: (odstotka) celic CD4+ od izhodišča do 48. tedna je bilo 247 celic/mm3 (5 %).
English: The clinical efficacy of maraviroc (in combination with other antiretroviral medicinal products) on plasma HIV RNA levels and CD4+ cell counts have been investigated in two pivotal randomized, double blind, multicentre studies (MOTIVATE 1 and MOTIVATE 2, n=1076) in patients infected with CCR5 tropic HIV-1 as determined by the Monogram Trofile Assay.
Slovenian: Klinično učinkovitost delovanja maraviroka (v kombinaciji z drugimi protiretrovirusnimi zdravili) na raven HIV RNA v plazmi in število celic CD4+ so raziskali v dveh ključnih randomiziranih dvojno slepih multicentričnih študijah (MOTIVATE 1 in MOTIVATE 2, n = 1076 ) pri bolnikih, okuženih s CCR5-tropnim HIV-1 (ugotovljeno z Monogramovim preskusom Trofile).
English: • kidney problems.
Slovenian: • težave z ledvicami.
English: Mean change from baseline (log copies/mL) Percentage of patients with HIV-1 RNA <400 copies/mL
Slovenian: Povprečna sprememba od izhodišča (log kopij/ml) Odstotek bolnikov s HIV-1 RNA < 400 kopij/ml
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).
Slovenian: Poleg tega so v študijah predhodno zdravljenih, s HIV okuženih bolnikov, ob maraviroku zabeležili več neželenih učinkov na jetra, niso pa se v celoti povečali nenormalni izvidi testov jetrne funkcije 3. oz. 4. stopnje po ACTG (glejte poglavje 4.8).
English: Table 6: Efficacy Outcomes at week 48 (pooled studies MOTIVATE 1 and MOTIVATE 2) Outcomes
Slovenian: Preglednica 6: Izidi učinkovitosti po 48 tednih (kumulativno za študiji MOTIVATE 1 in MOTIVATE 2)
English: The difference in maraviroc exposure between CYP3A5 extensive and poor metabolisers was reduced when maraviroc was administered together with a strong CYP3A inhibitor: extensive CYP3A5 metabolisers (n=12) had a 17% lower maraviroc AUC compared with poor CYP3A5 metabolisers (n=11) when dosed with maraviroc 150 mg once daily in the presence of darunavir/cobicistat (800/150 mg).
Slovenian: Razlika v izpostavljenosti maraviroku med izdatnimi in slabimi metabolizatorji s CYP3A5 se je zmanjšala, če je bil maravirok uporabljen skupaj z močnim zaviralcem CYP3A: izdatni metabolizatorji s CYP3A5 (n = 12) so imeli 17 % manjšo AUC maraviroka v primerjavi z slabimi metabolizatorji s CYP3A5 (n = 11), če je bil odmerek 150 mg maraviroka enkrat na dan uporabljen v prisotnosti kombinacije darunavir/kobicistat (800/150 mg).
English: ANTICONVULSANTS Carbamezepine, Phenobarbital, Phenytoin
Slovenian: ANTIEPILEPTIKI Karbamezepin, fenobarbital, fenitoin
English: CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adults, adolescents and children of 2 years of age, and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable (see sections 4.2 and 5.1).
Slovenian: Zdravilo CELSENTRI je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za uporabo pri odraslih, mladostnikih in otrocih, starih 2 leti ali več in s telesno maso vsaj 10 kg, okuženih le z ugotovljivim CCR5-tropnim HIV-1, ki so že bili zdravljeni (glejte poglavji 4.2 in 5.1).
English: Subjects with virologic failure generally appeared to have low compliance to both maraviroc and the background antiretroviral elements of their regimens.
Slovenian: Preiskovanci z virološkim neodzivom so bili na splošno po vsem sodeč slabo kompliantni tako z maravirokom kot z osnovnimi protiretrovirusnimi učinkovinami svojih terapevtskih shem.
English: Based on the extent of inhibition by lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir in the absence of etravirine, an increased exposure is expected.
Slovenian: Glede na obseg zavrtja z lopinavirjem/ritonavirjem, sakvinavirjem/ritonavirjem ali atazanavirjem/ritonavirjem brez etravirina je mogoče pričakovati večjo izpostavljenost.
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)
Slovenian: CELSENTRI 300 mg filmsko obložene tablete EU/1/07/418/006 (180 tablet) EU/1/07/418/007 (30 tablet) EU/1/07/418/008 (60 tablet) EU/1/07/418/009 (90 tablet) EU/1/07/418/010 (2 x 90 tablet - dvojno pakiranje)
English: Maraviroc AUC12: ↑ 2.86 (2.33-3.51) Maraviroc Cmax: ↑ 2.15 (1.71-2.69) Maraviroc C12: ↑ 4.23 (3.47-5.16)
Slovenian: Maravirok AUC12: ↑ 2,86 (2,33-3,51) Maravirok Cmax: ↑ 2,15 (1,71-2,69) Maravirok C12: ↑ 4,23 (3,47-5,16)
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.
Slovenian: CELSENTRI 150 mg in 300 mg filmsko obložene tablete so na voljo v plastenkah, ki vsebujejo 180 tablet, ali v pretisnih omotih, ki vsebujejo 30, 60 ali 90 tablet ter v dvojnem pakiranju s 180 (2 pakiranji po 90) filmsko obloženimi tabletami.
English: Hence, in the selection of a treatment regimen, it should be assumed that viruses forming part of the previously undetected CXCR4 -using population (i.e. minor viral population) harbours the same resistance pattern as the CCR5-tropic population.
Slovenian: Zato je treba pri izbiri terapije predpostaviti, da je vzorec odpornosti med virusi, ki so del predhodno neodkrite populacije uporabnikov CXCR4 (tj. manjšinske populacije virusov), enak kot v CCR5-tropni populaciji.
English: Study A4001031 is an open-label, multicenter trial in paediatric patients (aged 2 years to less than 18 years) infected with CCR5-tropic HIV-1, determined by the enhanced-sensitivity Trofile assay.
Slovenian: Študija A4001031 je bilo odprto, multicentrično preskušanje pri pediatričnih bolnikih (starih od 2 leti do manj kot 18 let), okuženih s CCR5-tropnim virusom HIV-1, kot je bilo določeno s preskusom Trofile z večjo senzitivnostjo.
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)
Slovenian: CELSENTRI 150 mg filmsko obložene tablete EU/1/07/418/001 (180 tablet) EU/1/07/418/002 (30 tablet) EU/1/07/418/003 (60 tablet) EU/1/07/418/004 (90 tablet) EU/1/07/418/005 (2 x 90 tablet - dvojno pakiranje)
English: Therefore, CELSENTRI should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Zato je treba zdravilo CELSENTRI pri bolnikih z okvaro jeter uporabljati previdno (glejte poglavji 4.4 in 5.2).
English: a Refer to Table 1 for maraviroc paediatric dosing recommendations when co-administered with antiretroviral therapy and other medicinal products.
Slovenian: a Glejte preglednico 1 za priporočila o odmerjanju maraviroka pri pediatričnih bolnikih v primeru sočasne uporabe s protiretrovirusnim zdravljenjem in drugimi zdravili.
English: Co-administration of maraviroc with medicinal products that induce CYP3A4 may decrease maraviroc concentrations and reduce its therapeutic effects.
Slovenian: Sočasna uporaba maraviroka z zdravili, ki inducirajo CYP3A4, lahko zmanjša koncentracijo maraviroka in njegove terapevtske učinke.
English: Name and address of the manufacturer responsible for batch release Tablets
Slovenian: Ime in naslov izdelovalcev, odgovornih za sproščanje serij
English: The primary objective assessed the incidence of Grade 3 and 4 ALT abnormalities (>5x upper limit of normal (ULN) if baseline ALT ≤ ULN; or >3.5x baseline if baseline ALT > ULN) at Week 48.
Slovenian: Primarni cilj je bila ocena pojavnosti nepravilnosti ALT 3. in 4. stopnje (> 5-kratna zgornja normalna meja (ZNM), če je bila izhodiščna vrednost ALT ≤ ZNM, ali > 3,5-kratna izhodiščna vrednost, če je bila izhodiščna vrednost ALT > ZNM) v 48. tednu.
English: Virologic escape from maraviroc can occur via 2 routes: the emergence of pre-existing virus which can use CXCR4 as its entry co-receptor (CXCR4-using virus) or the selection of virus that continues to use exclusively drug-bound CCR5 (CCR5-tropic virus).
Slovenian: Virološki pobeg maraviroku se lahko zgodi na 2 načina: s pojavnostjo že obstoječega virusa, ki lahko kot vstopni soreceptor uporabi CXCR4 (virus uporabnik CXCR4), ali s selekcijo virusa, ki še naprej uporablja izključno CCR5 z vezanim zdravilom (CCR5-tropni virus).
English: Limited data are available for coadministration with nelfinavir.
Slovenian: Podatki o sočasni uporabi z nelfinavirjem so omejeni.
English: Etravirine and lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir
Slovenian: Etravirin in lopinavir/ritonavir, sakvinavir/ritonavir ali atazanavir/ritonavir
English: What CELSENTRI looks like and contents of the pack
Slovenian: Izgled zdravila CELSENTRI in vsebina pakiranja
English: Mooswaldallee 1 79090 Freiburg Germany
Slovenian: 79090 Freiburg
English: Serious side effects - get medical help immediately Serious allergic or skin reactions
Slovenian: Resni neželeni učinki - nemudoma poiščite zdravniško pomoč
English: A. MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI ODGOVORNI ZA SPROŠČANJE SERIJ
English: Treatment-Experienced Paediatric Patients
Slovenian: Predhodno zdravljeni pediatrični bolniki
English: LIPID LOWERING MEDICINAL PRODUCTS Statins
Slovenian: ZDRAVILA ZA ZNIŽEVANJE RAVNI LIPIDOV Statini
English: Concomitant use of CELSENTRI and rifampicin + efavirenz is not recommended.
Slovenian: Sočasna uporaba zdravila CELSENTRI ter rifampicina in efavirenza ni priporočljiva.
English: When combining rifabutin with protease inhibitors that are potent inhibitors of CYP3A4 a net inhibitory effect on maraviroc is expected.
Slovenian: Med kombinirano uporabo rifabutina z zaviralci proteaz, ki so močni zaviralci CYP3A4, je mogoče pričakovati neto zaviralen učinek na maravirok.
English: Hepatobiliary disorders Aspartate aminotransferase
Slovenian: Bolezni jeter, žolčnika in žolčevodov Aspartat-aminotransferaza
English: People taking combination therapy for HIV may get other side effects.
Slovenian: Osebam, ki imajo kombinirano zdravljenje okužbe z virusom HIV, se lahko pojavijo še drugi neželeni učinki.
English: The viral tropism cannot be safely predicted by treatment history and assessment of stored samples.
Slovenian: Tropizma virusa ni mogoče varno predvideti na podlagi anamneze o zdravljenju ali na podlagi ocene shranjenih vzorcev.
English: The effects of moderate hepatic impairment may be underestimated due to limited data in patients with decreased metabolic capacity and higher renal clearance in these subjects.
Slovenian: Učinek zmerne okvare jeter je zaradi omejenih podatkov pri bolnikih z zmanjšano presnovno zmogljivostjo in zaradi večjega ledvičnega očistka pri takšnih osebah morda podcenjen, zato je treba rezultate tolmačiti previdno.
English: CELSENTRI 75 mg film-coated tablets EU/1/07/418/012
Slovenian: CELSENTRI 75 mg filmsko obložene tablete EU/1/07/418/012
English: The Monogram Trofile assay was used in the clinical studies of maraviroc.
Slovenian: V kliničnih študijah maraviroka so uporabljali Monogramov preskus Trofile.
English: • stomach pain or tenderness
Slovenian: • bolečine v želodcu ali občutljivost,
English: • antifungal medicines (ketoconazole, itraconazole, fluconazole)
Slovenian: • zdravila za zdravljenje glivičnih okužb (ketokonazol, itrakonazol, flukonazol),
English: The maravirocresistant viruses remained CCR5-tropic and there was no conversion from a CCR5-tropic virus to a CXCR4-using virus.
Slovenian: Proti maraviroku odporni virusi so ostali CCR5-tropni in sprememba iz CCR5-tropnega virusa v virus uporabnik CXCR4 se ni pojavila.
English: Screening HIV-1 RNA (copies /mL):
Slovenian: Presejalna HIV-1 RNA (kopij/ml):
English: CELSENTRI with products that are CYP3A inducers (without a potent CYP3A inhibitor)
Slovenian: CELSENTRI z zdravili, ki so induktorji CYP3A (brez močnega zaviralca CYP3A)
English: • anticonvulsant medicines (carbamazepine, phenytoin, phenobarbital).
Slovenian: • antiepileptična zdravila (karbamazepin, fenitoin, fenobarbital).
English: Intensive pharmacokinetics of maraviroc were evaluated in 50 treatment-experienced, CCR5tropic, HIV-1 infected paediatric patients aged 2 to 18 years (weight 10.0 to 57.6 kg) in the dosefinding stage of clinical trial A4001031.
Slovenian: Intenzivno so farmakokinetiko maraviroka ocenili pri 50 predhodno že zdravljenih pediatričnih bolnikih (starih od 2 do 18 let in s telesno maso od 10,0 do 57,6 kg), okuženih s CCR5-tropnim virusom HIV-1, v fazi določanja odmerka v kliničnem preskušanju A4001031.
English: Table 1 Recommended dosing regimen in children aged 2 years and above and weighing at least 10 kg
Slovenian: Preglednica 1: Priporočena shema odmerjanja pri otrocih, starih 2 leti ali več in s telesno maso vsaj 10 kg
English: CELSENTRI 25 mg and 75 mg film-coated tablets are supplied in bottles of 120 tablets.
Slovenian: CELSENTRI 25 mg in 75 mg filmsko obložene tablete so na voljo v plastenkah po 120 tablet.
English: For combination with efavirenz + PI, see separate recommendations below.
Slovenian: Za kombinacijo z efavirenzem in zaviralci proteaz glejte priporočilo navedeno ločeno spodaj.
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
Slovenian: rak žolčevoda, difuzni velikocelični limfom B, Hodgkinova bolezen, metastaze v kosteh, metastaze v jetrih, metastaze v peritoneju, rak nazofarinksa, karcinom požiralnika redki
English: <750/mm3
Slovenian: Absolutno število nevtrofilcev < 750/mm3
English: Limited data are available for coadministration with indinavir.
Slovenian: Podatki o sočasni uporabi z indinavirjem so omejeni.
English: * Based on drug-drug interactions (refer to section 4.5)
Slovenian: *Na podlagi medsebojnih delovanj zdravil (glejte poglavje 4.5).
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.
Slovenian: Povprečno povečanje števila celic CD4+ od izhodišča pri bolnikih, pri katerih je bilo zdravljenje neuspešno zaradi spremembe tropizma v dualni/mešani tropizem ali CXCR4, je bilo v skupini, ki je dobivala maravirok 300 mg dvakrat na dan in optimizirano osnovno terapijo (OOT), večje (+ 56 celic/mm3) kot med bolniki, pri katerih sta bila neuspešna placebo + OOT (+13,8 celic/mm3), ne glede na tropizem.
English: Subjects received 150 mg of maraviroc at different dose frequencies (healthy volunteers - every 12 hours; mild renal impairment - every 24 hours; moderate renal impairment - every 48 hours).
Slovenian: Preiskovanci so dobivali 150 mg maraviroka različno pogosto (zdravi prostovoljci na 12 ur, bolniki s blago okvaro ledvic na 24 ur in z zmerno okvaro ledvic na 48 ur).
English: The pharmacokinetics of maraviroc has not been studied in subjects with severe hepatic impairment (see sections 4.2 and 4.4).
Slovenian: Farmakokinetika maraviroka ni raziskana pri osebah s hudo okvaro jeter (glejte poglavji 4.2 in 4.4).
English: Alternative treatment options should be considered.
Slovenian: V poštev pridejo druge možnosti zdravljenja.
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.
Slovenian: Po 48 tednih (z analizo, ki je manjkajoče, zamenjavo ali prenehanje enačila z neuspehom) je HIV-1 RNA manj kot 48 kopij/ml doseglo 48 % preiskovancev, ki so prejemali maravirok in OOT; 65 % preiskovancev je doseglo HIV-1 RNA v plazmi manj kot 400 kopij/ml.
English: The OBT was selected on the basis of the subject's prior treatment history and baseline genotypic and phenotypic viral resistance measurements.
Slovenian: Optimizirana osnovna terapija je bila izbrana glede na anamnezo o preiskovančevi terapiji ter meritve izhodiščne genotipske in fenotipske odpornosti virusov.
English: The adverse reactions are listed by system organ class (SOC) and frequency.
Slovenian: Neželeni učinki so navedeni po organskih sistemih in pogostnosti.
English: Medicines containing St. John's Wort (Hypericum perforatum) are likely to prevent CELSENTRI
Slovenian: Zdravila, ki vsebujejo šentjanževko (Hypericum perforatum), verjetno preprečijo pravilno delovanje zdravila CELSENTRI.
English: 230 ml oral solution
Slovenian: 230 ml peroralna raztopina
English: Indinavir is a potent CYP3A4 inhibitor.
Slovenian: Indinavir je močan zaviralec CYP3A4.
English: Patients with very low CD4+ count at baseline (i.e. <50 cells/µL) had a less favourable outcome.
Slovenian: Izid je bil manj ugoden pri bolnikih z izhodiščno zelo majhnim številom CD4+ (tj. < 50 celic/µl).
English: Close the bottle tightly with the cap, leaving the adaptor in place.
Slovenian: Plastenko tesno zaprite s pokrovčkom; nastavek pustite nameščen.
English: Only a limited number of people with serious heart or circulatory problems have taken CELSENTRI.
Slovenian: Zdravilo CELSENTRI je namreč jemalo le malo bolnikov, ki so imeli resne težave s srcem ali obtočili.
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%).
Slovenian: Geometrična sredina AUCinf (KV %) za maravirok je bila: zdravi prostovoljci (normalno delovanje ledvic) 1348,4 ng·h/ml (61 %), huda okvara ledvic 4367,7 ng·h/ml (52 %), končna odpoved ledvic (odmerjanje po dializi) 2677,4 ng·h/ml (40 %) in končna odpoved ledvic (odmerjanje pred dializo) 2805,5 ng·h/ml (45 %).
English: Maraviroc AUC: ↓ 0.37
Slovenian: Maravirok AUC: ↓ 0,37
English: High density polyethylene (HDPE) bottle, with a child resistant closure, containing 230 mL maraviroc 20 mg/mL solution.
Slovenian: Plastenke iz polietilena velike gostote (HDPE) z zaporko, varno za otroke, ki vsebujejo 230 ml raztopine maraviroka 20 mg/ml.
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).
Slovenian: Poleg tega je študija je primerjala farmakokinetiko več odmerkov maraviroka v kombinaciji s sakvinavirjem/ritonavirjem 1000/100 mg dvakrat na dan (močan zaviralec CYP3A4) 7 dni pri bolnikih z blago (očistek kreatinina > 50 in  80 ml/min, n = 6) in zmerno okvaro ledvic (očistek kreatinina  30 in  50 ml/min, n = 6) ter pri zdravih prostovoljcih (n = 6).
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.
Slovenian: Študije razvoja zarodkov in plodov so bile opravljene pri podganah in kuncih v odmerkih do 39- oz. 34-kratnega ocenjenega prostega kliničnega AUC pri odmerku 300 mg dvakrat na dan.
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.
Slovenian: Študije pred- in ponatalnega razvoja so bile opravljene pri podganah v odmerkih do 27-kratne ocenjene proste klinične AUC pri odmerku 300 mg dvakrat na dan.
English: CELSENTRI with products that are not potent CYP3A inhibitors or potent CYP3A inducers
Slovenian: CELSENTRI z zdravili, ki niso močni zaviralci ali močni induktorji CYP3A
English: 30 to less than 40 kg at least 40 kg
Slovenian: Odmerek zdravila CELSENTRI pri otrocih glede na telesno maso od 10 do manj kot 20 kg od 20 do manj kot 30 kg od 30 do manj kot 40 kg vsaj 40 kg
English: The pack contains an oral applicator and a bottle adapter.
Slovenian: Pakiranje vsebuje aplikator za peroralno odmerjanje in nastavek za plastenko.