natgillin/translations-raw huggingface dataset:
The effect of maraviroc on digoxin at the dose of 600 mg BID has not been studied. 
Vpliv maraviroka na digoksin v odmerku 600 mg 2-krat na dan ni raziskan.
 problems with your heart or circulatory system. 
• težave s srcem ali obtočili.
The Long Term Safety/Selected Endpoints (LTS/SE) included death, AIDS-defining events, hepatic failure, Myocardial infarction/cardiac ischaemia, malignancies, rhabdomyolysis and other serious infectious events with maraviroc treatment. 
Dolgoročna varnost/opazovani dogodki (LTS/SE - The Long Term safety/Selected Endpoints) so vključevali smrtne izide, dogodke značilne za AIDS, odpoved jeter, miokardni infarkt/srčno ishemijo, maligne bolezni, rabdomializo in druge hude okužbe pri uporabi maraviroka.
Population PK analysis in phase 3 studies suggests dose reduction of maraviroc when co-administered with indinavir gives appropriate maraviroc exposure. 
Analiza populacijske farmakokinetike v študijah 3. faze kaže, da zmanjšanje odmerka maraviroka med sočasno uporabo z indinavirjem omogoči ustrezno izpostavljenost maraviroku.
Delayed type hypersensitivity reactions, typically occurring within 2-6 weeks after start of therapy and including rash, fever, eosinophilia and liver reactions have been reported (see also section 4.4). 
Poročali so o pozni obliki preobčutljivostnih reakcij, ki so se praviloma pojavile v 2-6 tednih po začetku zdravljenja in so obsegale izpuščaj, zvišano telesno temperaturo, eozinofilijo in jetrne reakcije (glejte tudi poglavje 4.4).
Renal clearance accounts for approximately 23% of total clearance of maraviroc when maraviroc is administered without CYP3A4 inhibitors. 
Na račun ledvičnega očistka gre približno 23 % celotnega očistka maraviroka, kadar je le-ta uporabljen brez zaviralcev CYP3A4.
Metabolism and nutrition disorders Anorexia common 
Presnovne in prehranske motnje anoreksija pogosti
Significant reductions in amprenavir Cmin observed may result in virological failure in patients 
Opaženo bistveno zmanjšanje Cmin amprenavirja lahko pri bolnikih povzroči virološki neodziv.
If you have any further questions on the use of this medicine, ask your doctor or your pharmacist. 
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali farmacevtom.
However, a significant treatment benefit for maraviroc compared to placebo + OBT was still demonstrated (see Table 7). 
Kljub temu je bila dokazana bistvena terapevtska korist zdravila CELSENTRI v primerjavi s placebom + OOT (glejte preglednico 7).
In patients failing therapy with CCR5-tropic virus only, maraviroc might be considered still active if the MPI value is ≥95% (PhenoSense Entry assay). 
Pri neuspešno zdravljenih bolnikih, ki so imeli samo CCR5-tropni virus, lahko maravirok smatramo kot še vedno učinkovit, če je MPI ≥95% (meritev z metodo PhenoSense Entry).
Tropism 
Tropizem
Based on the in vitro and clinical data, the potential for maraviroc to affect the pharmacokinetics of co-administered medicinal products is low. 
Na podlagi podatkov in vitro in kliničnih podatkov ima maravirok majhen potencial za vpliv na farmakokinetiko sočasno uporabljenih zdravil.
Maraviroc is primarily metabolized and eliminated by the liver. 
Maravirok se presnovi in eliminira predvsem v jetrih.
Repeated dose toxicity studies in rats identified the liver as the primary target organ for toxicity (increases in transaminases, bile duct hyperplasia, and necrosis). 
Študije toksičnosti pri ponavljajočih se odmerkih pri podganah so pokazale, da so jetra primarni tarčni organ za toksičnost (zvišanje transaminaz, hiperplazija žolčevodov in nekroza).
Overall, the mechanisms of resistance to maraviroc observed in this treatment-experienced paediatric population were similar to those observed in adult populations. 
V celoti so bili mehanizmi odpornosti proti maraviroku v tej, predhodno že zdravljeni pediatrični populaciji podobni kot so jih opažali pri odraslih.
• diarrhoea, feeling sick, stomach ache, wind (flatulence), 
• driska, občutek slabosti, bolečine v želodcu, vetrovi (flatulenca),
The recommended dose of CELSENTRI is either 150 mg (7.5 ml), 300 mg (15 ml) or 600 mg (30 ml) twice daily, depending on other medicines that you are taking at the same time. 
Priporočeni odmerek zdravila CELSENTRI je ali 150 mg (7,5 ml), 300 mg (15 ml) ali 600 mg (30 ml) dvakrat na dan, odvisno od drugih zdravil, ki jih jemljete sočasno.
Failure with CXCR4-using virus 
Neuspeh z virusom uporabnikom CXCR4
Subjects were required to have HIV-1 RNA greater than 1,000 copies per mL at Screening. 
Preiskovanci so morali imeti ob presejanju HIV-1 RNA več kot 1.000 kopij/ml.
Baseline CD4+ (cells/µL): 
Izhodiščno število CD4+ (celic/µl):
Patients were randomised in a 2:2:1 ratio to maraviroc 300 mg (dose equivalence) once daily, twice daily or placebo in combination with an optimized background consisting of 3 to 6 antiretroviral medicinal products (excluding low-dose ritonavir). 
Bolniki so bili v razmerju 2:2:1 randomizirani na maravirok 300 mg (enakovrednost odmerka) enkrat na dan, dvakrat na dan ali placebo v kombinaciji z optimizirano osnovno terapijo (OOT), ki je obsegala od 3 do 6 protiretrovirusnih zdravil (izključujoč nizkoodmerni ritonavir).
The pack includes an oral applicator and a bottle-adapter, which should be fitted in the bottle before use. 
Pakiranju je priložen aplikator za peroralno odmerjanje in nastavek za plastenko, ki ga je treba pred uporabo namestiti v plastenko.
Maraviroc did not impair mating or fertility of male or female rats, and did not affect sperm of treated male rats up to 1000 mg/kg. 
Maravirok ni neugodno vplival na parjenje in plodnost podganjih samcev in samic ter pri samcih v odmerkih do 1000 mg/kg ni prizadel semena.
However, maraviroc does not significantly affect the pharmacokinetics of digoxin in vivo. 
Vendar pa maravirok in vivo ne vpliva pomembno na farmakokinetiko digoksina.
In addition, cholangiocarcinomas (2/60 males at 900 mg/kg) and cholangioma (1/60 females at 500 mg/kg) were reported in the rat study at a systemic exposure at least 15-times the expected free human exposure. 
Dodatno so v študiji pri podganah poročali o holangiokarcinomih (2/60 samcev pri 900 mg/kg) ter holangioadenomih (1/60 samic pri 500 mg/kg,) in sicer pri sistemski izpostavljenosti, ki je bila vsaj 15-krat tolikšna kot pričakovana prosta izpostavljenost pri človeku.
Therefore, maraviroc tablets and oral solution can be taken with or without food at the recommended doses in adults, adolescents and children aged 2 years and older and weighing at least 10 kg (see section 4.2). 
Zato je mogoče tablete in peroralno raztopino maraviroka v priporočenih odmerkih jemati s hrano ali brez nje; to velja za odrasle, mladostnike in otroke, stare 2 leti ali več in s telesno maso vsaj 10 kg (glejte poglavje 4.2).
One additional subject had CCR5 tropic-virus with reduced susceptibility to maraviroc at virologic failure, although this was not retained at the end of treatment. 
Dodaten preiskovanec je imel ob virološkem neodzivu CCR5-tropni virus z zmanjšano občutljivostjo za maravirok, ki pa se ni ohranil do konca zdravljenja.
Concentration response curves for the maraviroc-resistant viruses were characterized phenotypically by curves that did not reach 100% inhibition in assays using serial dilutions of maraviroc (<100% maximal percentage inhibition (MPI)). 
Krivulje odziva na koncentracijo za viruse, odporne proti maraviroku, so bile fenotipsko določene s krivuljami, ki v preskusih z zaporednimi razredčenji maraviroka niso dosegle 100 % zavrtja (<100% maksimalni delež zaviranja (MPI)).
Maraviroc should also be used with caution in patients with severe renal insufficiency and in patients who have risk factors for, or have a history of postural hypotension. 
Maravirok je treba previdno uporabljati tudi pri bolnikih s hudo insuficeno ledvic in tistih z dejavniki tveganja za posturalno hipotenzijo ali z njeno anamnezo.
There were no food restrictions in the adult studies (using tablet formulations) or in the paediatric study (using both tablet and oral solution formulations). 
Ne v študijah pri odraslih (z uporabo tablet) ne v študijah pri pediatričnih bolnikih (z uporabo tablet in peroralne raztopine) ni bilo prehranskih omejitev.
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. 
Pri osebah, ki so prejemale maravirok v tej opazovalni fazi, je bila incidenca teh opazovanih dogodkov v skladu z incidenco, opaženo v prejšnjih obdobjih opazovanja v študijah.
If you accidentally take or give too much CELSENTRI: 
Če pomotoma vzamete ali date večji odmerek zdravila CELSENTRI:
Maraviroc was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation, chromosome aberrations in human lymphocytes and mouse bone marrow micronucleus. 
Maravirok se ni izkazal za mutagenega ali genotoksičnega v skupini preizkusov in vitro in in vivo, vključno s preizkusom reverznih mutacij pri bakterijah, kromosomskih aberacij v človeških limfocitih in mikrojeder v mišjem kostnem mozgu.
These findings are considered of low human relevance. 
Ti podatki niso posebej relevantni za človeka.
Use of maraviroc was not associated with a significant decrease in HIV 1 RNA compared with placebo in these subjects and no adverse effect on CD4+ cell count was noted. 
Uporaba maraviroka pri teh preiskovancih ni bila povezana z bistvenim zmanjšanjem HIV1 RNA v primerjavi s placebom; neželenega učinka na število celic CD4+ niso ugotovili.
Patients with cardiovascular co-morbidities could be at increased risk of cardiovascular adverse reactions triggered by postural hypotension. 
Bolniki s sočasnimi kardiovaskularnimi boleznimi imajo lahko večje tveganje za kardiovaskularne neželene učinke, ki jih izzove posturalna hipotenzija.
Film-coat: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132). 
Filmska obloga: polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec, sojin lecitin, indigotin (E132).
Median peak maraviroc plasma concentrations are attained at 2 hours (range 0.5-4 hours) following single oral doses of 300 mg commercial tablet administered to healthy volunteers. 
Mediana največja koncentracija maraviroka v plazmi je dosežena po 2 urah (razpon od 0,5 do 4 ure) po posamičnem peroralnem zaužitju komercialno dostopne 300 mg tablete pri zdravih prostovoljcih.
• if you (or your child, if they are the patient) are allergic to maraviroc or to peanut or soya or to any of the other ingredients of CELSENTRI (listed in section 6 ). 
• če ste vi (ali vaš otrok) alergični na maravirok ali arašide ali sojo oziroma katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
The pharmacokinetics of oral maraviroc are not dose proportional over the dose range. 
Farmakokinetika peroralnega maraviroka v odmernem območju ni sorazmerna odmerku.
• an increase in a substance known as CPK (seen in blood test results) which is a sign that muscles are inflamed or damaged. 
• povečana količina snovi, imenovane kreatin fosfokinaza (CPK - creatine phosphokinase, pokaže se na preiskavah krvi), ki je lahko znak vnetja ali poškodbe mišic.
Thus, CELSENTRI dose should be modified in line with the recommendation for co-administration with respective PI/ritonavir combination (see ‘Protease Inhibitors'). 
Odmerek zdravila CELSENTRI je treba prilagoditi skladno s priporočili za sočasno zdravljenje s kominacijo zaviralec proteaz (PI)/ritonavir (glejte zaviralci proteaz (PI)).
In mice, no statistically significant increase in the incidence of tumours was reported at systemic exposures from 7 to 39-times the human exposure (unbound AUC 0-24h measurement) at a dose of 300 mg twice daily. 
Pri miših maravirok ni statistično pomembno povečal incidence nobene vrste tumorja pri sistemskih izpostavljenostih v območju od 7- do 39-kratne izpostavljenosti pri človeku (na podlagi merjenja nevezane AUC 0-24h) ob odmerku 300 mg dvakrat na dan.
• antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin) 
• antibiotike (klaritromicin, telitromicin, rifampicin, rifabutin),
Table 7: Proportion of patients achieving <50 copies/mL at Week 48 by subgroup (pooled Studies MOTIVATE 1 and MOTIVATE 2) 
Preglednica 7: Delež bolnikov, ki so po 48 tednih dosegli < 50 kopij/ml po podskupinah (kumulativno za študiji MOTIVATE 1 in MOTIVATE 2)
Primary pharmacological activity (CCR5 receptor affinity) was limited in the species studied (see section 5.3). 
Pri raziskanih vrstah je bila primarna farmakološka aktivnost (afiniteta za CCR5 receptor) omejena (glejte poglavje 5.3).
The bottle contains 230 ml of maraviroc solution (20 mg/ml). 
Plastenka vsebuje 230 ml raztopine maraviroka (20 mg/ml).
In vitro and in vivo studies showed that maraviroc has a potential to increase QTc interval at supratherapeutic doses with no evidence of arrhythmia. 
Študije in vitro ter in vivo so pokazale, da ima maravirok v supraterapevtskih odmerkih potencial za podaljšanje intervala QT brez znakov aritmije.
Hypersensitivity reactions including severe and potentially life threatening events have been reported in patients taking maraviroc, in most cases concomitantly with other medicinal products associated with these reactions. 
Pri bolnikih, ki so jemali maravirok, so bile opisane preobčutljivostne reakcije, vključno s hudimi in potencialno smrtno nevarnimi; večinoma so se pojavile sočasno z drugimi zdravili, ki so prav tako povezana s takšnimi reakcijami.
Discontinuation of maraviroc should be strongly considered in any patient with signs or symptoms of acute hepatitis, in particular if drug-related hypersensitivity is suspected or with increased liver transaminases combined with rash or other systemic symptoms of potential hypersensitivity (e.g. pruritic rash, eosinophilia or elevated IgE). 
Prekinitev uporabe maraviroka pride močno v poštev pri bolnikih z znaki ali simptomi akutnega hepatitisa, zlasti če obstaja sum na preobčutljivost za zdravilo ali so jetrne transaminaze zvišane v kombinaciji z izpuščajem ali drugimi sistemskimi simptomi možne preobčutljivosti (npr. srbeč izpuščaj, eozinofilija ali zvišanje IgE).
The results did not indicate any relevant efficacy or safety concern related to either fed or fasted dosing conditions. 
Rezultati ne kažejo pomembnih težav glede učinkovitosti ali varnosti ne v primeru jemanja na poln ne v primeru jemanja na prazen želodec.
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. 
Izpostavljenosti, ugotovljene pri bolnikih s hudo okvaro ledvic in končno odpovedjo ledvic, so bile v razponu, zabeleženem v študijah enkratnega 300-mg odmerka maraviroka pri zdravih prostovoljcih z normalnim delovanjem ledvic.
In vitro studies have shown that maraviroc does not inhibit OATP1B1, MRP2 or any of the major P450 enzymes at clinically relevant concentrations (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4). 
Študije In vitro so pokazale, da maravirok v klinično pomembnih koncentracijah ne zavira OATP1B1, MRP2 ali nobenega od pomembnih encimov P450 (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4).
Not studied, no interaction expected. 
Ni raziskano, medsebojno delovanje ni pričakovano.
Changes in viral tropism occur over time in HIV-1 infected patients. 
Pri bolnikih z okužbo s HIV-1 sčasoma pride do sprememb v tropizmu virusa.
The recommended dose of CELSENTRI is 150 mg (with potent CYP3A inhibitor with or without a potent CYP3A inducer), 300 mg (without potent CYP3A inhibitors or inducers) or 600 mg twice daily (with potent CYP3A inducer without a potent CYP3A inhibitor) depending on interactions with concomitant antiretroviral therapy and other medicinal products (see section 4.5). 
Priporočeni odmerek zdravila CELSENTRI je 150 mg (z močnim zaviralcem CYP3A, z ali brez močnega induktorja CYP3A), 300 mg (brez močnih zaviralcev ali induktorjev CYP3A) ali 600 mg dvakrat na dan (z močnim induktorjem CYP3A, brez močnega zaviralca CYP3A), odvisno od interakcij s sočasnim protiretrovirusnim zdravljenjem ali z drugimi zdravili (glejte poglavje 4.5).
ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands. 
Imetnik dovoljenja za promet z zdravilom ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Nizozemska.
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. 
Maravirok ni klinično pomembno vplival na farmakokinetiko midazolama, peroralnih kontraceptivov etinilestradiola in levonorgestrela, ali na razmerje med 6β-hidroksikortizolom in kortizolom v urinu, kar kaže na odsotnost zaviranja ali indukcije CYP3A4 in vivo.
Discard 60 days after first opening. 
Zavrzite 60 dni po prvem odprtju.
Maraviroc belongs to a group of medicines called CCR5 antagonists. 
Maravirok sodi v skupino zdravil, imenovanih antagonisti CCR5.
There is no data on the effects of maraviroc on human fertility. 
O vplivu maraviroka na plodnost pri ljudeh ni podatkov.
It is unknown whether maraviroc is excreted in human milk. 
Ni znano, ali se maravirok pri človeku izloča v materino mleko.
One subject in each treatment arm met the primary endpoint by Week 48 (at Week 8 for placebo and Week 36 for the maraviroc arm). 
Primarni opazovani dogodek je do 48. tedna v vsaki terapevtski skupini dosegel po en preiskovanec (v 8. tednu v skupini s placebom in v 36. tednu v skupini z maravirokom).
In treatment-naïve patients, the incidence of grade 3 and 4 laboratory abnormalities using ACTG criteria was similar among the maraviroc and efavirenz treatment groups. 
Pri še nezdravljenih bolnikih je bila incidenca laboratorijskih nenormalnosti 3. in 4. stopnje po merilih ACTG v terapevtski skupini z maravirokom in v terapevtski skupini z efavirenzem podobna.
In addition, co-administration of maraviroc with lamivudine/zidovudine showed no effect of maraviroc on lamivudine (primarily renally cleared) or zidovudine (non-P450 metabolism and renal clearance) pharmacokinetics. 
Poleg tega sočasna uporaba maraviroka z lamivudinom/zidovudinom ni pokazala, da bi maravirok vplival na farmakokinetiko lamivudina (ki se izloči predvsem skozi ledvice) ali zidovudina (presnova, ki ne poteka s P450, in izločanje skozi ledvice).
The remainder was excreted as metabolites. 
Preostanek se je izločil v obliki presnovkov.
Symptoms may include:  muscle weakness  weakness beginning in the hands and feet and moving up towards the trunk of the body  palpitations or tremor  hyperactivity (excessive restlessness and movement). 
 šibkost mišic,  oslabelost, ki se začne v dlaneh in stopalih in se pomika proti trupu,  razbijanje srca (palpitacije) ali tresenje (tremor),  hiperaktivnost (pretiran nemir in gibanje).
Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovino, arašide ali sojo ali katero koli pomožno snov, navedeno v poglavju 6.1.
The initial dose of maraviroc was scaled from adult doses using a body surface area (BSA) of 1.73 m2 to children and adolescent BSA (m2)-based bands. 
Začetni odmerek maraviroka je bil preračunan iz odmerka za odrasle na podlagi telesne površine 1,73 m na pasove (m2) telesne površine za otroke in mladostnike.
Refer to the Package Leaflets of these other medicines for guidance on how to take them. 
Glede napotkov za uporabo teh drugih zdravil glejte njihova navodila za uporabo.
• itraconazole, voriconazole, clarithromycin and telithromycin, 
• itrakonazol, vorikonazol, klaritromicin in telitromicin,
Maraviroc is a member of a therapeutic class called CCR5 antagonists. 
Maravirok sodi v terapevtsko skupino, imenovano antagonisti CCR5.
Co-administration of a 300 mg tablet with a high fat breakfast reduced maraviroc Cmax and AUC by 33% and co-administration of 75 mg of oral solution with a high fat breakfast reduced maraviroc AUC by 73% in adult healthy volunteers. 
Zaužitje 300 mg tablete hkrati z zajtrkom z visoko vsebnostjo maščob je pri zdravih odraslih prostovoljcih znižalo Cmax in AUC maraviroka za 33 %, zaužitje 75 mg peroralne raztopine z zajtrkom z visoko vsebnostjo maščob pa je zmanjšalo AUC maraviroka za 73 %.
Each film-coated tablet contains 25 mg, 75 mg, 150 mg or 300 mg of maraviroc. 
Ena filmsko obložena tableta vsebuje 25 mg, 75 mg, 150 mg ali 300 mg maraviroka.
The Cavg of maraviroc from 24-48 hours for subjects with moderate renal impairment was low (Cavg: 32.8 ng/mL). 
Cpovp maraviroka od 24 do 48 ur je bila pri bolnikih z zmerno okvaro ledvic majhna (Cpovp: 32,8 ng/ml).
Percentage of patients with HIV-1 RNA <50 copies/mL 
Odstotek bolnikov s HIV-1 RNA < 50 kopij/ml
In addition, dosing was based on whether subjects were receiving potent CYP3A inhibitors (38/50), potent CYP3A inducers (2/50) or other concomitant medicinal products that are not potent CYP3A inhibitors or potent CYP3A inducers (10/50) as part of OBT. 
Poleg tega je bilo pri odmerjanju upoštevano, ali preiskovanec kot del OOT prejema močne zaviralce CYP3A (38/50), močne induktorje CYP3A (2/50) ali druga sočasna zdravila, ki niso močni zaviralci ali močni induktorji CYP3A (10/50).
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) 
Preglednica 4: Nenormalnosti 3. in 4. stopnje (merila ACTG), ki so imele incidenco ≥ 1 %, na podlagi največje spremembe vrednosti laboratorijskih preiskav, ne glede na izhodiščne vrednosti; študiji MOTIVATE 1 in MOTIVATE 2 (kumulativna analiza, do 48 tednov)
The adverse reaction profile in paediatric patients is based on 48 Week safety data from study A4001031 in which 103 HIV-1 infected, treatment-experienced patients aged 2 to <18 years received maraviroc twice-daily with optimised background therapy (OBT). 
Značilnosti neželenih učinkov pri pediatričnih bolnikih temeljijo na 48-tedenskih podatkih o varnosti iz študije A4001031 v kateri so 103 s HIV-1 okužene in predhodno že zdravljene bolnike, stare od 2 do vključno 18 let, zdravili z maravirokom dvakrat na dan ob optimizirani osnovni terapiji (OOT).
Before taking CELSENTRI it has to be confirmed that only CCR5-tropic HIV-1 is detectable (i.e. CXCR4 or dual/mixed tropic virus not detected) using an adequately validated and sensitive detection method on a newly drawn blood sample. 
Pred uporabo zdravila CELSENTRI je treba potrditi, da je prisoten le CCR5-tropni HIV-1 (tj. da ni ugotovljen CXCR4- ali dualno/mešano-tropni virus); za potrditev je treba uporabiti ustrezno validirano in občutljivo metodo odkrivanja ter svež vzorec krvi.
The Monogram Trofile assay was used in the clinical studies of CELSENTRI (see sections 4.4 and 5.1). 
V kliničnih študijah zdravila CELSENTRI so uporabljali Monogramov preskus Trofile (glejte poglavji 4.4 in 5.1).
Ribavirin has not been studied, no interaction is expected. 
Ribavirin ni raziskan; medsebojno delovanje ni pričakovano.
This risk is due to potential increases in maraviroc maximum concentrations when maraviroc is co-administered with potent CYP3A inhibitors or boosted PIs in these patients. 
To tveganje je posledica možnega povečanja največje koncentracije maraviroka, če je maravirok pri teh bolnikih uporabljen hkrati z močnimi zaviralci CYP3A ali okrepljenimi zaviralci proteaz.
Tell your doctor or pharmacist if you (or your child) begin taking a new medicine while taking CELSENTRI. 
Zdravniku ali farmacevtu morate povedati, če boste vi (ali vaš otrok) začeli jemati novo zdravilo, medtem ko jemljete zdravilo CELSENTRI.
Table 4 shows the incidence ≥1% of Grade 3-4 Abnormalities (ACTG Criteria) based on the maximum shift in laboratory test values without regard to baseline values. 
Preglednica 4 prikazuje nenormalnosti 3. in 4. stopnje (merila ACTG), ki so imele incidenco ≥ 1 %, na podlagi največje spremembe vrednosti laboratorijskih preiskav, ne glede na izhodiščne vrednosti.