natgillin/translations-raw huggingface dataset:
This subgroup had a high degree of bad prognostic markers, i.e. extensive resistance and high baseline viral loads. 
Ova podskupina bolesnika imala je više prognostički negativnih pokazatelja tj. jako izraženu rezistenciju i veliki početni rezervoar virusa.
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. 
CELSENTRI 150 mg i 300 mg filmom obložene tablete dostupne su u bocama od 180 tableta ili u blisterima od 30, 60, 90 filmom obloženih tableta i višestrukom pakiranju koji sadrži 180 (2 pakiranja od 90) filmom obloženih tableta.
The bottle contains 230 ml of maraviroc solution (20 mg/ml). 
Boca sadrži 230 ml otopine maraviroka (20 mg/ml).
In rats, administration of maraviroc at a systemic exposure 21-times the expected human exposure produced thyroid adenomas associated with adaptive liver changes. 
Kod štakora je sistemska ekspozicija dozi 21 puta većoj od ekspozicije očekivane kod ljudi dovela do nastanka adenoma štitnjače povezanih s adaptivnim promjenama u jetri.
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). 
U pivotalnim ispitivanjima (MOTIVATE 1 i MOTIVATE 2) kod 7,6 % bolesnika primijećena je promjena tropizma virusa iz CCR5-tropnog u CXCR4-tropni ili dvostruko/miješano-tropni u razdoblju od prvog pregleda do početka ispitivanja (razdoblje od 4-6 tjedana).
The CYP3A5 allelic frequency depends on ethnicity: the majority of Caucasians (~90%) are poor metabolisers of CYP3A5 substrates (i.e., subjects with no copy of functional CYP3A5 alleles) while approximately 40% of African-Americans and 70% of Sub-Saharan Africans are extensive metabolisers (i.e., subjects with two copies of functional CYP3A5 alleles). 
Učestalost alela CYP3A5 ovisi o etničkom podrijetlu: većina bijelaca (~90%) slabi su metabolizatori supstrata CYP3A5 (ispitanici bez kopija fukcionalnih alela CYP3A5), dok približno 40% Afroamerikanaca i 70% ispitanika podrijetlom iz supsaharske Afrike (ispitanici s dvije kopije fukcionalnih alela CYP3A5) opsežno metabolizira te supstrate.
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. 
Preporučena doza lijeka CELSENTRI je 150 mg (7,5 ml), 300 mg (15 ml) ili 600 mg (30 ml) dva puta na dan, ovisno o ostalim lijekovima koje istodobno primjenjujete
Table 3: Adverse reactions observed in clinical trials or post-marketing System Organ Class 
Tablica 3: Nuspojave zabilježene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet Organski sustav
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 treba primjenjivati samo onda kada je utvrđen jedino CCR5-tropni HIV-1 (tj. kada nisu detektabilni CXCR4 ili dvostruko/miješani tropni virus), korištenjem primjereno validirane i osjetljive metode detekcije (vidjeti dijelove 4.1, 4.2 i 5.1).
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). 
Ispitivanja in vitro pokazala su da maravirok u klinički relevantnim koncentracijama ne inhibira OATP1B1, MRP2 ni glavne enzime P450 (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i CYP3A4).
Patients with cardiovascular co-morbidities could be at increased risk of cardiovascular adverse reactions triggered by postural hypotension. 
U bolesnika s popratnim kardiovaskularnim bolestima može postojati povećan rizik od kardiovaskularnih nuspojava izazvanih posturalnom hipotenzijom.
In paediatric patients with a successful tropism test, dual mixed/CXCR4-tropic virus was detected in around 40% of screening samples (8/27, 30% in 2-6 year-olds, 31/81, 38% in 6-12 year-olds and 41/90, 46% in 12-18 year-olds), underscoring the importance of tropism testing also in the paediatric population. 
Među pedijatrijskim bolesnicima kod kojih je uspješno utvrđen tropizam, dvostruko miješani/CXCR4-tropni virus pronađen je u približno 40% uzoraka prikupljenih pri probiru (8/27 [30%] bolesnika u dobi od 2 do 6 godina, 31/81 [38%] bolesnika u dobi od 6 do 12 godina te 41/90 [46%] bolesnika u dobi od 12 do 18 godina), što naglašava važnost određivanja tropizma i u pedijatrijskoj populaciji.
• dark urine 
• tamnu mokraću
Lipase 
Lipaza
Each film-coated tablet contains 25 mg, 75 mg, 150 mg or 300 mg of maraviroc. 
Jedna filmom obložena tableta sadrži 25 mg, 75 mg, 150 mg ili 300 mg maraviroka.
Keep taking CELSENTRI until your doctor tells you to stop. 
Ako Vi ili Vaše dijete prestanete uzimati CELSENTRI Nastavite uzimati CELSENTRI dok Vam liječnik ne kaže da prestanete.
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). 
Bolesnici su randomizirani u omjeru 2:2:1 na maravirok 300 mg (ekvivalentna doza) jednom dnevno, dvaput dnevno ili placebo u kombinaciji s optimiziranom popratnom terapijom (OBT) koja je uključivala 3-6 antiretrovirusnih lijekova (ne uključujući ritonavir u niskim dozama).
Pancytopenia, granulocytopenia rare 
Pancitopenija, granulocitopenija rijetko
ViiV Healthcare (logo) 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET ViiV Healthcare (logo)
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). 
Preporučena doza lijeka CELSENTRI je 150 mg (u kombinaciji sa snažnim inhibitorom CYP3A, uz snažan induktor CYP3A ili bez njega), 300 mg (bez snažnih inhibitora ili induktora CYP3A) ili 600 mg dva puta na dan (u kombinaciji sa snažnim induktorom CYP3A, ali bez snažnog inhibitora CYP3A), ovisno o interakcijama s istodobno primijenjenim antiretrovirusnim i ostalim lijekovima (vidjeti dio 4.5).
Patients who were eligible for these studies had prior exposure to at least 3 antiretroviral medicinal product classes [≥1 NRTIs, ≥1 NNRTIs, ≥2 PIs, and/or enfurvirtide] or documented resistance to at least one member of each class. 
Da bi zadovoljili kriterije za uključivanje u ove studije bolesnici su trebali biti prethodno liječeni lijekovima iz najmanje tri skupine antiretrovirusnih lijekova 1 NRTI, 1 NNRTI, 2 IP-a i/ili enfurvirtid ili su imali dokazanu rezistenciju na najmanje jedan lijek iz svake skupine.
Maraviroc dosing was based on body surface area and doses were adjusted based on whether the subject was receiving potent CYP3A inhibitors and/or inducers. 
Doza maraviroka temeljila se na tjelesnoj površini, a prilagođavala se ovisno o tome je li ispitanik primao snažne inhibitore i/ili induktore CYP3A.
Repeated dose toxicity studies in rats identified the liver as the primary target organ for toxicity (increases in transaminases, bile duct hyperplasia, and necrosis). 
Ispitivanja toksičnosti opetovanih doza kod štakora pokazale su da je jetra organ izložen najvećem riziku (povišenje transaminaza, hiperplazija žučnih vodova i nekroza).
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. 
Incidencija tih odabranih ishoda u ispitanika liječenih maravirokom u sklopu spomenute opservacijske faze bila je u skladu s incidencijom primijećenom u ranijim vremenskim točkama tijekom ispitivanja.
The Monogram Trofile assay was used in the clinical studies of CELSENTRI (see sections 4.4 and 5.1). 
U kliničkim ispitivanjima za CELSENTRI korištena je Monogram Trofile metoda (vidjeti dijelove 4.4 i 5.1).
Tipranavir/ritonavir concentrations were consistent with historical data. 
Koncentracije tipranavira/ritonavira bile su u skladu s podacima od ranije.
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 nije pokazao klinički značajan učinak na farmakokinetiku midazolama, oralnih kontraceptiva etinilestradiola i levonorgestrela, ili na omjer 6βhidroksikortizol / kortizol u mokraći, što govori u prilog nepostojanja inhibicije odnosno indukcije CYP3A4 in vivo.
Concomitant use of CELSENTRI and fosamprenavir/ritonavir is not recommended. 
Ne preporučuje se istodobna primjena lijeka CELSENTRI i fosamprenavira/ritonavira.
CD4+ cell count Mean change from baseline (cells/µL) 1 p-values < 0.0001 2 For all efficacy endpoints the confidence intervals were 95%, except for HIV-1 RNA Change from baseline, which was 97.5% 
Broj CD4+ stanica srednja promjena u odnosu na početne vrijednosti (stanica/µl) 1p-vrijednosti  0,0001 2Za sve mjere ishoda djelotvornosti, intervali pouzdanosti bili su 95% osim za promjenu HIV-1 RNA u odnosu na početnu vrijednost, gdje je iznosila 97,5%.
Maraviroc-resistant viruses that emerged in vitro remained sensitive to the fusion inhibitor enfuvirtide and the PI, saquinavir. 
Virusi s in vitro uočenom rezistencijom na maravirok ostali su osjetljivi na inhibitor fuzije enfuvirtid i IP sakvinavir.
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. 
Primarni cilj bio je procjena incidencije odstupanja ALT-a stupnja 3 i 4 (>5x od gornje granice normale (GGN) ako je početni ALT ≤ GGN; ili >3,5x početna vrijednost ako je početni ALT > GGN)
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. 
Prije početka uzimanja lijeka CELSENTRI potrebno je potvrditi da je prisutan samo CCR5-tropni HIV-1 (tj. da nisu prisutni CXCR4 ili dvostruko/miješani tropni virusi), korištenjem primjereno validirane i osjetljive metode detekcije na svježe uzetom uzorku krvi.
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. 
Geometrijske srednje vrijednosti Cmax i AUClast bile su 11%, odnosno 25% više kod ispitanika s blagim oštećenjem jetre te 32%, odnosno 46% više kod bolesnika s umjerenim oštećenjem jetre u usporedbi s ispitanicima koji su imali normalnu funkciju jetre.
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) 
Tablica 4: Patološka odstupanja 3-4 stupnja (prema ACTG kriterijima) čija je incidencija bila 1%, a koja se odnose na maksimalna odstupanja od normalnih laboratorijskih vrijednosti bez obzira na početne vrijednosti u ispitivanjima MOTIVATE 1 i MOTIVATE 2 (skupna analiza, do 48 tjedana)
Cardiovascular safety 
Sigurnost za kardiovaskularni sustav
• diarrhoea, feeling sick, stomach ache, wind (flatulence), 
• proljev, mučnina, bol u trbuhu, vjetrovi (flatulencija)
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). 
Rezistencija virusa na maravirok može se razviti na dva načina: porastom broja kopija već postojećeg virusa koji može koristiti CXCR4 kao ko-receptor za ulaz (virus koji koristi CXCR4) ili selekcijom virusa koji i dalje koristi samo CCR5 receptor vezan za lijek (CCR5-tropni virus).
CELSENTRI 25 mg and 75 mg film-coated tablets are supplied in bottles of 120 tablets. 
CELSENTRI 25 mg i 75 mg filmom obložene tablete dostupne su u bocama od 120 tableta.
People taking combination therapy for HIV may get other side effects. 
U osoba koje uzimaju kombiniranu terapiju za HIV možda će se javiti neke druge nuspojave.
Table 5: Demographic and baseline characteristics of patients (pooled studies MOTIVATE 1 and MOTIVATE 2) 
Tablica 5: Demografske značajke bolesnika i nalazi s početka ispitivanja (objedinjena ispitivanja MOTIVATE 1 i MOTIVATE 2)
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. 
Klinička djelotvornost maraviroka (u kombinaciji s drugim antiretrovirusnim lijekovima) na razinu HIV RNA u plazmi i broj CD4+ stanica ispitivani su u dva pivotalna randomizirana, dvostruko slijepa, multicentrična ispitivanja (MOTIVATE 1 i MOTIVATE 2, n=1076), koja su se provodila kod bolesnika zaraženih CCR5-tropnim HIV-1 utvrđenim Monogram Trofile testom.
• The active ingredient in CELSENTRI is maraviroc. 
• Djelatna tvar u lijeku CELSENTRI je maravirok.
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 ne pokazuje antivirusnu aktivnost in vitro protiv virusa koji mogu koristiti CXCR4 kao koreceptor ulaska (dvostruko-tropni ili CXCR4-tropni virusi, zajedničkim imenom nazvani „virusi koji koriste CXCR4“).
Table 7: Proportion of patients achieving <50 copies/mL at Week 48 by subgroup (pooled Studies MOTIVATE 1 and MOTIVATE 2) 
Tablica 7: Udio bolesnika u pojedinim podskupinama u kojih je u 48. tjednu postignuto 50 kopija/ml (zajednički podaci ispitivanja MOTIVATE 1 i MOTIVATE 2)
>5.0x ULN 
5,0 x GGN
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. 
Stoga pri odabiru načina liječenja, treba pretpostaviti da na početku neotkrivena populacija virusa koja koristi CXCR4 (tj. minorna populacija virusa) ima isti način razvoja rezistencije kao CCR5-tropni virusi.
The pharmacokinetics of oral maraviroc are not dose proportional over the dose range. 
Farmakokinetika peroralno primijenjenog maraviroka nije proporcionalna primijenjenim dozama unutar raspona doziranja.
Skin and subcutaneous tissue disorders 
Poremećaji kože i potkožnog tkiva*
Hyperbilirubinaemia, gammaglutamyltransferase increased uncommon 
Hiperbilirubinemija, porast gamaglutamiltransferaze manje često
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). 
Profil nuspojava u pedijatrijskih bolesnika temelji se na 48-tjednim podacima o sigurnosti iz ispitivanja A4001031, u kojem su 103 prethodno liječena bolesnika u dobi od 2 do < 18 godina zaražena virusom HIV-1 primala maravirok dva puta na dan u kombinaciji s optimiziranom osnovnom terapijom.
Based on the in vitro and clinical data, the potential for maraviroc to affect the pharmacokinetics of co-administered medicinal products is low. 
Prema in vitro i kliničkim podacima, maravirok ima slab potencijal da utječe na farmakokinetiku istodobno primijenjenih lijekova.
Based on the extent of inhibition by atazanavir/ritonavir or darunavir/ritonavir in the absence of efavirenz, an increased exposure is expected. 
Temeljem stupnja inhibicije atazanavira/ritonavira ili darunavira/ritonavira u odsutnosti efavirenza, očekuje se povišenje koncentracije.
Table 1 Recommended dosing regimen in children aged 2 years and above and weighing at least 10 kg 
Tablica 1 Preporučen režim doziranja za djecu u dobi od 2 ili više godina i tjelesne težine od najmanje 10 kg
Renal clearance accounts for approximately 23% of total clearance of maraviroc when maraviroc is administered without CYP3A4 inhibitors. 
Renalni klirens maraviroka iznosi približno 23% od ukupnog klirensa maraviroka u slučaju kad nema istodobne primjene CYP3A4 inhibitora.
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). 
U odraslih bolesnika s klirensom kreatinina < 80 ml/min koji istodobno primaju snažne inhibitore CYP3A4, interval doziranja maraviroka treba prilagoditi na 150 mg jedanput na dan (vidjeti dijelove 4.4 i 4.5).
How to store CELSENTRI 
Kako čuvati CELSENTRI
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). 
Razlika u izloženosti maraviroku između opsežnih i slabih metabolizatora CYP3A5 bila je manja kada se maravirok primjenjivao zajedno sa snažnim inhibitorom CYP3A: opsežni metabolizatori CYP3A5 (n=12) imali su 17% niži AUC maraviroka nego slabi metabolizatori CYP3A5 (n=11) kod primjene maraviroka u dozi od 150 mg jedanput na dan u prisutnosti darunavira/kobicistata (800/150 mg).
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. 
Kod bolesnika inficiranih HIV-om s teškom imunodeficijencijom tijekom početka kombinirane antiretrovirusne terapije (CART) može se javiti upalni odgovor na asimptomatske i zaostale oportunističke infekcije.
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. 
Kod odraslih zdravih ispitanika uzimanje tablete od 300 mg istodobno s doručkom s visokim sadržajem masnoća dovodi do smanjenja Cmax i AUC za 33%, dok primjena 75 mg oralne otopine istodobno s doručkom s visokim sadržajem masnoća smanjuje AUC maraviroka za 73%.
Limited data are available for coadministration with indinavir. 
Podaci o istodobnoj primjeni s indinavirom su ograničeni.
 stiffness in the joints  aches and pains (especially in the hip, knee or shoulder)  difficulty moving. 
• bolovi (posebice u kuku, koljenu ili ramenu)
Co-administration of maraviroc with medicinal products that induce CYP3A4 may decrease maraviroc concentrations and reduce its therapeutic effects. 
Istodobna primjena maraviroka s lijekovima koji induciraju CYP3A4 može sniziti koncentraciju maraviroka i umanjiti njegov terapijski učinak.
The pharmacokinetics in other races has not been evaluated. 
Kod pripadnika ostalih rasa farmakokinetika nije ispitivana.
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). 
CELSENTRI je u kombinaciji s drugim antiretrovirusnim lijekovima indiciran u liječenju prethodno liječenih odraslih osoba, adolescenata i djece u dobi od 2 ili više godina i tjelesne težine od najmanje 10 kg kod kojih je kao uzročnik bolesti utvrđen samo CCR5-tropni HIV-1 (vidjeti dijelove 4.2 i 5.1).
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) 
CELSENTRI 300 mg filmom obložene tablete EU/1/07/418/006 (180 tableta) EU/1/07/418/007 (30 tableta) EU/1/07/418/008 (60 tableta) EU/1/07/418/009 (90 tableta) EU/1/07/418/010 (2 x 90 tableta - višestruko pakiranje)
>2.0x ULN 
2,0 x GGN
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. 
U uvjetima imunološke reaktivacije prijavljeni su i autoimuni poremećaji (kao što je Gravesova bolest i autoimuni hepatitis); međutim, prijavljeno vrijeme do nastupa bolesti je varijabilnije pa se ti događaji mogu javiti i mjesecima nakon započinjanja liječenja.
Etravirine and lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir 
Etravirin i lopinavir/ritonavir, sakvinavir/ritonavir ili atazanavir/ritonavir
The effect of maraviroc on digoxin at the dose of 600 mg BID has not been studied. 
Nije ispitivan učinak maraviroka na digoksin pri dozi od 600 mg 2x dnevno.
Co-administration of maraviroc with St. John's Wort is expected to substantially decrease maraviroc concentrations and may result in suboptimal levels and lead to loss of virologic response and possible resistance to maraviroc. 
Istodobna primjena maraviroka i gospine trave mogla bi dovesti do značajnog sniženja koncentracija maraviroka, što bi moglo rezultirati subterapijskim koncentracijama i dovesti do gubitka osjetljivosti virusa i moguće rezistencije na maravirok.
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) 
CELSENTRI 150 mg filmom obložene tablete EU/1/07/418/001 (180 tableta) EU/1/07/418/002 (30 tableta) EU/1/07/418/003 (60 tableta) EU/1/07/418/004 (90 tableta) EU/1/07/418/005 (2 x 90 tableta - višestruko pakiranje)
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 
Procjena nuspojava vezanih za uzimanje lijeka temelji se na skupnim podacima iz dvaju ispitivanja faze 2b/3 na prethodno liječenim odraslim bolesnicima (MOTIVATE 1 i MOTIVATE 2) te jednog ispitivanja na prethodno neliječenim bolesnicima (MERIT) zaraženima CCR5-tropnim virusom HIV-1 (vidjeti dijelove 4.4 i 5.1).
Efavirenz and atazanavir/ritonavir or darunavir/ritonavir 
Efavirenz i atazanavir/ritonavir ili darunavir/ritonavir
Based on the extent of inhibition by lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir in the absence of etravirine, an increased exposure is expected. 
Temeljem stupnja inhibicije od strane lopinavira/ritonavira, sakvinavira/ritonavira ili atazanavira/ritonavira u odsutnosti etravirina, očekuje se povišenje koncentracije.
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. 
Ispitivanje A4001031 bilo je otvoreno, multicentrično ispitivanje provedeno u pedijatrijskih bolesnika (u dobi od 2 do manje od 18 godina) zaraženih CCR5-tropnim virusom HIV-1, što je utvrđeno testom Trofile pojačane osjetljivosti.