natgillin/translations-raw huggingface dataset:
Effects on active substance levels Geometric mean change if not stated otherwise
Promjena geometrijske sredine, ako nije drugačije navedeno
HIV-1 variants with reduced susceptibility to maraviroc have been selected in vitro, following serial passage of two CCR5-tropic viruses (0 laboratory strains, 2 clinical isolates).
In vitro su razvijeni HIV-1 oblici sa smanjenom osjetljivošću na maravirok i to nakon serijske pasaže dva CCR5-tropna virusa (0 laboratorijski sojevi, 2 klinička izolata).
• antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin)
• antibiotike (klaritromicin, telitromicin, rifampicin, rifabutin)
* Based on drug-drug Interactions (refer to section 4.5)
*Na temelju interakcija između lijekova (vidjeti dio 4.5)
After intravenous administration (30 mg), the half-life of maraviroc was 13.2 h, 22% of the dose was excreted unchanged in the urine and the values of total clearance and renal clearance were 44.0 L/h and 10.17 L/h respectively.
Nakon intravenske primjene (30 mg) vrijeme poluživota maraviroka iznosilo je 13,2 h, 22% doze izlučeno je u obliku nepromijenjenog lijeka u urinu, a vrijednosti ukupnog klirensa i bubrežnog klirensa iznosile su 44,0 l/h, odnosno 10,17 l/h.
Limited data exist with the use of maraviroc in patients with severe cardiovascular disease, therefore special caution should be exercised when treating these patients with maraviroc.
Podaci o primjeni maraviroka kod bolesnika s teškim bolestima kardiovaskularnog sustava su ograničeni, zbog toga je potreban poseban oprez kad se maravirok primjenjuje u liječenju ovih bolesnika.
Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar, kikiriki, soju ili neku od pomoćnih tvari navedenih u dijelu 6.1.
The adverse reactions are listed by system organ class (SOC) and frequency.
Nuspojave su navedene prema organskim sustavima (SOC) i učestalosti.
Some people taking CELSENTRI have developed severe and life-threatening skin reactions and allergic reactions.
U nekih osoba koje su uzimale CELSENTRI javile su se teške i po život opasne kožne reakcije i alergijske reakcije.
Population PK analysis in phase 3 studies suggests dose reduction of maraviroc when co-administered with indinavir gives appropriate maraviroc exposure.
Populacijska PK analiza u ispitivanju faze 3 ukazuje da smanjivanje doze maraviroka pri istodobnoj primjeni s indinavirom, osigurava primjerenu koncentraciju maraviroka.
The Cavg of maraviroc from 24-48 hours for subjects with moderate renal impairment was low (Cavg: 32.8 ng/mL).
Cavg maraviroka od 24 do 48 sati u bolesnika s umjerenim bubrežnim oštećenjem bila je niska (Cavg : 32,8 ng/ml).
A relatively small number of individuals receiving maraviroc-containing therapy have failed with phenotypic resistance (i.e. the ability to use drug-bound CCR5 with MPI <95%).
Relativno malen broj osoba liječenih terapijom koja je sadržavala maravirok doživjelo je terapijski neuspjeh zbog fenotipske rezistencije (tj. sposobnosti virusa da koristi CCR5 receptor vezan za lijek uz MPI <95%).
Demographic and Baseline Characteristics
Demografske značajke i početna obilježja
In patients failing therapy with CCR5-tropic virus only, maraviroc might be considered still active if the MPI value is ≥95% (PhenoSense Entry assay).
U bolesnika sa samo CCR5-tropnim virusom u kojih je zabilježen terapijski neuspjeh, maravirok se može smatrati i dalje aktivnim ako je MPI ≥95% (PhenoSense Entry test).
Store below 30 °C.
Čuvati na temperaturi ispod 30ºC.
Discard 60 days after first opening.
Baciti 60 dana nakon prvog otvaranja.
The absorption of maraviroc is variable with multiple peaks.
Apsorpcija maraviroka je varijabilna s nekoliko vršnih vrijednosti.
DRUG ABUSE Methadone
ZLOUPORABA LIJEKOVA Metadon
Maraviroc AUCtau: ↑ 5.00
Maravirok AUCtau:  5,00
Tropism
Tropizam
Failure with CXCR4-using virus
Neuspjeh kod virusa koji koriste CXCR4
A mass balance/excretion study was conducted using a single 300 mg dose of 14C-labeled maraviroc.
Ispitivanje masene bilance/eliminacije provedeno je primjenom jednokratne doze od 300 mg maraviroka obilježenog 14C-radioaktivnim izotopom.
Wait for the next dose at its regular time.
Pričekajte i sljedeću dozu uzmite/dajte u za to predviđeno vrijeme.
Cross-resistance in vitro
Križna rezistencija in vitro
The pack also includes a thermoplastic elastomeric press in bottle adapter, and a 10 ml oral applicator comprised of a polypropylene barrel (with mL graduations) and a polyethylene plunger.
Pakiranje uključuje i termoplastičan elastomerni nastavak koji se utisne u grlo boce te aplikator za usta volumena 10 ml, koji se sastoji od polipropilenskog tijela (s oznakama za ml) i polietilenskog klipa.
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Iako se pretpostavlja da nastaje zbog više uzroka (primjena kortikosteroida, konzumacija alkohola, teška imunosupresija, povišeni indeks tjelesne mase), osteonekroza je najčešće uočena kod bolesnika s uznapredovalom bolešću uzrokovanom HIV-om i/ili onih kod kojih je kroz dulje razdoblje primjenjivana kombinirana antiretrovirusna terapija (CART).
There are currently no data regarding the reuse of CELSENTRI in patients that currently have only CCR5-tropic HIV-1 detectable, but have a history of failure on CELSENTRI (or other CCR5 antagonists) with a CXCR4 or dual/mixed tropic virus.
Za sada još nema podataka koji se odnose na ponovnu primjenu lijeka CELSENTRI kod bolesnika koji trenutno imaju detektabilan samo CCR5-tropni HIV-1, a koji u anamnezi imaju podatak o neuspjehu liječenja lijekom CELSENTRI (ili drugim CCR5 antagonistima) infekcije s CXCR4 ili dvojno/miješano tropnim virusom.
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 je uočena pojava kolangiokarcinoma (2/60 mužjaka pri dozi od 900 mg/kg) i kolangioma (1/60 ženki pri dozi od 500 mg/kg) u ispitivanju na štakorima kod kojih je sistemska ekspozicija bila najmanje 15 puta viša od očekivane ekspozicije slobodnom lijeku kod ljudi.
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.
U bolesnika koji su uzimali maravirok prijavljene su reakcije preosjetljivosti, uključujući teške i potencijalno po život opasne događaje, najčešće pri istodobnoj primjeni s drugim lijekovima povezanima s tim reakcijama.
Push the plastic adapter (B) into the neck of the bottle so it is fully inserted.
Utisnite plastični nastavak (B) u grlo boce cijelom dužinom.
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.
Osim toga, doziranje se temeljilo i na tome jesu li ispitanici u sklopu OBT-a primali snažne inhibitore CYP3A (38/50), snažne induktore CYP3A (2/50) ili druge istodobno primijenjene lijekove koji nisu snažni inhibitori CYP3A ni snažni induktori CYP3A (10/50).
To date, no signature mutation(s) have been identified.
Zasad nisu pronađene karakteristične mutacije.
Subjects with virologic failure generally appeared to have low compliance to both maraviroc and the background antiretroviral elements of their regimens.
Čini se da su se ispitanici s virološkim neuspjehom općenito slabo pridržavali i liječenja maravirokom i primjene osnovnih antiretrovirusnih lijekova u svom režimu.
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.
Ekspozicije zabilježene u ispitanika s teškim bubrežnim oštećenjem i ESRD kretale su se unutar raspona zabilježenog u ispitivanjima pri primjeni jednokratne doze maraviroka od 300 mg u zdravih dobrovoljaca s normalnom bubrežnom funkcijom.
If a patient is hypersensitive to peanut or soya, CELSENTRI should not be used.
Bolesnicima preosjetljivima na kikiriki ili soju ne smije se davati CELSENTRI.
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.
Kod miševa nije primijećen statistički značajan porast incidencije pojavljivanja tumora tijekom sistemske ekspozicije 7 do 39 puta veće od ekspozicije kod ljudi (mjerenje AUC 0-24 sata slobodne frakcije) uz dozu od 300 mg dva puta dnevno.
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.
K tome, niti istodobna primjena maraviroka s lamivudinom/zidovudinom nije pokazala utjecaj maraviroka na farmakokinetiku lamivudina (primarno se uklanja putem bubrega) ni zidovudina (ne metabolizira se preko P450 i uklanja se bubrezima).
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.
Više bolesnika koji su dobivali maravirok prekinulo je liječenje zbog izostanka djelotvornosti (43 prema 15), a među bolesnicima kod kojih nije bilo djelotvornosti više je onih koji su stekli otpornost prema NRTI (uglavnom lamivudin) iz skupine koja je dobivala maravirok.
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).
Ispitanici su dobivali 150 mg maraviroka različitom učestalošću doziranja (zdravi dobrovoljci - svakih 12 sati; ispitanici s blagim bubrežnim oštećenjem - svaka 24 sata; ispitanici s umjerenim bubrežnim oštećenjem - svakih 48 sati).
When maraviroc was administered in studies with healthy volunteers at doses higher than the recommended dose, cases of symptomatic postural hypotension were seen at a greater frequency than with placebo.
Kad je maravirok primjenjivan u dozama višim od preporučenih, tijekom studija na zdravim ispitanicima, učestalost simptomatske posturalne hipotenzije bila je veća nego pri primjeni placeba.
In treatment-naïve patients such events occurred at a similarly low rate with maraviroc and control (efavirenz).
U prethodno neliječenih bolesnika takvi su se događaji javljali s usporedivo niskom stopom kako u skupini liječenoj maravirokom, tako i u kontrolnoj skupini (efavirenz).
The maravirocresistant viruses remained CCR5-tropic and there was no conversion from a CCR5-tropic virus to a CXCR4-using virus.
Virusi rezistentni na maravirok ostali su CCR5-tropni i nije bilo prijelaza s CCR5-tropnog virusa u virus koji koristi CXCR4.
Depression, insomnia common
Depresija, nesanica često
When combining rifabutin with protease inhibitors that are potent inhibitors of CYP3A4 a net inhibitory effect on maraviroc is expected.
Pri kombiniranju rifabutina s inhibitorima proteaza koji su snažni inhibitori CYP3A4 očekuje se čisti inhibitorni učinak na maravirok.
• antifungal medicines (ketoconazole, itraconazole, fluconazole)
• antimikotike (ketokonazol, itrakonazol, flukonazol)
HIV-1 clinical isolates resistant to NRTIs, NNRTIs, PIs and enfuvirtide were all susceptible to maraviroc in cell culture.
Klinički izolati HIV-1 rezistentni na NRTI, NNRTI, IP i enfuvirtid u kulturi stanica su bili osjetljivi na maravirok.
ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands.
ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Nizozemska.
Prolongation of the QT interval was seen in dogs and monkeys at plasma concentrations 6 and 12 times, respectively, those expected in humans at the maximum recommended dose of 300 mg twice daily.
Kod pasa i majmuna je uočeno produljenje QT intervala kod koncentracija u plazmi koje su 6 odnosno 12 puta više od onih očekivanih kod ljudi pri primjeni maksimalne preporučene doze od 300 mg dvaput dnevno.
There may be a risk of suboptimal levels with risk of loss of virologic response and resistance development.
Postoji rizik subterapijskih koncentracija s posljedičnim gubitkom osjetljivosti virusa i razvojem rezistencije.
The recommended dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice per day depending on other medicines that you are taking at the same time.
Preporučena doza lijeka CELSENTRI je 150 mg, 300 mg ili 600 mg dva puta na dan, ovisno o ostalim lijekovima koje istodobno primjenjujete.
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.
Početna doza maraviroka određivala se umanjivanjem doze za odrasle, utvrđene na temelju tjelesne površine od 1,73 m2, prema odgovarajućim kategorijama tjelesne površine za djecu i adolescente (m2).
The oral applicator is provided for accurate measurement of the prescribed dose of oral solution.
Aplikator za usta služi za točno odmjeravanje propisane doze oralne otopine.
There is limited experience in patients with reduced hepatic function, therefore maraviroc should be used with caution in this population (see sections 4.2 and 5.2).
Iskustva su ograničena kod bolesnika sa smanjenom funkcijom jetre zbog čega se maravirok treba oprezno primjenjivati u toj populaciji bolesnika (vidjeti dijelove 4.2 i 5.2).
Table 3: Adverse reactions observed in clinical trials or post-marketing
Tablica 3: Nuspojave zabilježene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet
It is unknown whether maraviroc is excreted in human milk.
Nije poznato izlučuje li se maravirok u majčino mlijeko.
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)