natgillin/translations-raw huggingface dataset:
Not studied, but both are potent CYP3A4 inhibitors and would be expected to increase maraviroc concentrations.
Ne postoje ispitivanja, ali su oba snažni inhibitori CYP3A4 i očekuje se povećanje koncentracije maraviroka.
Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) Lamivudine 150 mg BID (maraviroc 300 mg BID)
Nukleozidni/nukleotidni inhibitori reverzne transkriptaze (NRTI) Lamivudin 150 mg 2x dnevno (maravirok 300 mg 2x dnevno)
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.
Prema analizi u kojoj su se bolesnici za koje su nedostajali podaci, oni koji su prešli na drugo liječenje i oni koji su prekinuli liječenje uvrštavali u kategoriju neuspješnog liječenja, u 48. tjednu je plazmatsku razinu HIV-1 RNK manju od 48 kopija/ml ostvarilo 48% ispitanika liječenih maravirokom i OBT-om, dok je 65% ispitanika postiglo razinu HIV-1 RNK manju od 400 kopija/ml.
The most frequently reported adverse reactions occurring in the Phase 2b/3 studies were nausea,
Najčešće prijavljene nuspojave zabilježene tijekom ispitivanja faze2b/3 bile su mučnina, proljev, umor i glavobolja.
Abdominal pain, flatulence, nausea common
Poremećaji probavnog sustava Bol u trbuhu, flatulencija, mučnina često
Contents of the pack and other information What CELSENTRI contains
Sadržaj pakiranja i druge informacije
The mean CD4+ cell count (percent) increase from baseline to Week 48 was 247 cells/mm3 (5%).
Srednja vrijednost porasta broja (postotka) CD4+ stanica od početka ispitivanja do 48. tjedna iznosila je 247 stanica/mm
Darunavir Cmax: ↔ 0.96 Darunavir C12: ↓ 0.77
Darunavir AUC12  0,86 Darunavir Cmax  0,96 Darunavir C12  0,77
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.
Taj je rizik rezultat potencijalnog porasta maksimalnih koncentracija maraviroka u slučaju istodobne primjene maraviroka i snažnih inhibitora CYP3A ili inhibitora proteaze (IP) pojačanog djelovanja.
Hepatitis toxic, hepatic failure, hepatic cirrhosis, blood alkaline phosphatase increased rare
Toksični hepatitis, zatajenje jetre, ciroza jetre, porast alkalne fosfataze rijetko Zatajenje jetre s alergijskim značajkama vrlo rijetko
Dose adjustment is necessary in patients with renal impairment receiving maraviroc with potent CYP3A4 inhibitors (see sections 4.2 and 4.4 and 4.5).
Potrebna je prilagodba doze kod bolesnika s oštećenjem bubrega koji dobivaju maravirok zajedno sa snažnim inhibitorima CYP3A4 (vidjeti dijelove 4.2, 4.4 i 4.5).
Myositis, blood creatine phosphokinase increased uncommon
Miozitis, porast kreatinin fosfokinaze u krvi manje često Atrofija mišića rijetko
Itraconazole, is a potent CYP3A4 inhibitor and would be expected to increase the exposure of maraviroc.
Itrakonazol je snažan CYP3A4 inhibitor i očekuje se povećanje koncentracije maraviroka.
Dose adjustment of maraviroc is recommended when maraviroc is co-administered with potent CYP3A4 inhibitors and/or inducers.
Preporučuje se prilagoditi dozu maraviroka kod istodobne primjene sa snažnim inhibitorima i/ili induktorima CYP3A4.
Maraviroc 300 mg twice daily + OBT N =421*
Maravirok 300 mg 2 x dnevno + OBT N=421*
Phenotypic resistance
Fenotipska rezistencija
ANTIBIOTICS Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (maraviroc 300 mg BID)
ANTIBIOTICI Sulfametoksazol/trimetop rim 800 mg/160 mg 2x dnevno (maravirok 300 mg 2x dnevno)
Etravirine C12: ↔ 1.08
Etravirin C12:  1,08
90 film-coated tablets.
90 filmom obloženih tableta
Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 150 mg film-coated tablets
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Naljepnica na vanjskom omotu višestrukog pakiranja od 180 (2 pakiranja od 90 filmom obloženih tableta) omotanih u prozirnu foliju - uključujući plavi okvir - 150 mg filmom obložene tablete
Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 300 mg film-coated tablets
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Naljepnica na vanjskom omotu višestrukog pakiranja od 180 (2 pakiranja od 90 filmom obloženih tableta) omotanih u prozirnu foliju - uključujući plavi okvir - 300 mg filmom obložene tablete
At the time of failure with CXCR4-using virus, the resistance pattern to other antiretrovirals appears similar to that of the CCR5-tropic population at baseline, based on available data.
Temeljem raspoloživih podataka, kod neuspjeha u liječenju kod virusa koji koriste CXCR4, uzorak rezistencije na ostale antiretrovirusne lijekove čini se sličnim onom populacije CCR5-tropnih virusa na početku liječenja.
NNRTI + PI Efavirenz 600 mg QD + lopinavir/ritonavir 400mg/100 mg BID (maraviroc 300 mg BID)
NNRTI + IP Efavirenz 600 mg 1x dnevno + lopinavir/ritonavir 400 mg/100 mg 2x dnevno (maravirok 300 mg 2x dnevno)
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).
Zbog toga se u odraslih, adolescenata i djece u dobi od 2 ili više godina i tjelesne težine od najmanje 10 kg preporučene doze maravirok tableta i oralne otopine mogu uzimati bez jela ili uz jelo (vidjeti dio 4.2).
CELSENTRI 300 mg film-coated tablets
CELSENTRI 300 mg filmom obložene tablete
• liver problems, including chronic hepatitis B or C. Only a limited number of people with liver problems have taken CELSENTRI.
• jetrene tegobe, uključujući kronični hepatitis B ili C.
The incidence of AIDS-defining infections was similar between maraviroc and placebo arms in the pivotal studies.
Incidencija infekcija koje ukazuju na AIDS, utvrđena tijekom pivotalnih studija bila je slična i u skupinama bolesnika koji su uzimali maravirok i u skupinama u kojima je primjenjivan placebo.
However, no clinically significant QT prolongation compared to placebo + OBT was seen in the Phase 3 clinical studies using the recommended dose of maraviroc or in a specific pharmacokinetic study to evaluate the potential of maraviroc to prolong the QT interval.
Međutim, u kliničkim ispitivanjima faze 3, u kojima je primjenjivana preporučena doza maraviroka kao i u specifičnim farmakokinetičkim ispitivanjima u kojima je ispitivan eventualni potencijal maraviroka da uzrokuje produljenje QT intervala, nije uočena klinički značajna razlika u odnosu na bolesnike koji su dobivali placebo + OBT.
Other developmental parameters of these offspring, including fertility and reproductive performance, were not affected by the maternal administration of maraviroc.
Maternalna primjena maraviroka nije utjecala na druge razvojne parametre kod potomstva, uključujući plodnost i reproduktivnu sposobnost.
Citric acid (anhydrous) Sodium citrate dihydrate Sucralose
6.1 Popis pomoćnih tvari citratna kiselina (bezvodna) natrijev citrat dihidrat sukraloza natrijev benzoat aroma jagode pročišćena voda
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with efavirenz and a PI (except tipranavir/ritonavir where the dose should be 600 mg twice daily).
Dozu lijeka CELSENTRI treba smanjiti na 150 mg 2x dnevno, pri istodobnoj primjeni s efavirenzom u prisustvu IP (osim tipranavira/ritonavira gdje doza treba biti 600 mg dva puta dnevno).
Further details for concomitantly administered medicinal products are provided below (see Table
Dodatne pojedinosti o istodobno primijenjenim lijekovima navedene su u Tablici 2.
What CELSENTRI is and what it is used for What you need to know before you take CELSENTRI How to take CELSENTRI
Što morate znati prije nego počnete uzimati CELSENTRI
Therefore, no dose adjustment is necessary in patients with renal impairment receiving maraviroc without a potent CYP3A4 inhibitor (see sections 4.2, 4.4 and 4.5).
Stoga u bolesnika s oštećenjem bubrega koji dobivaju maravirok bez prisustva snažnog inhibitora CYP3A4 prilagodba doze nije potrebna (vidjeti dijelove 4.2, 4.4 i 4.5).
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz 600 mg QD (maraviroc 100 mg BID)
Nenukleozidni inhibitori reverzne transkriptaze (NNRTI) Efavirenz 600 mg 1x dnevno (maravirok 100 mg 2x dnevno)
CELSENTRI 75 mg film-coated tablets
CELSENTRI 75 mg filmom obložene tablete
CXCR4-using virus was detected at failure in approximately 60% of subjects who failed treatment on maraviroc, as compared to 6% of subjects who experienced treatment failure in the placebo + OBT arm. To investigate the likely origin of the on-treatment CXCR4-using virus, a detailed clonal analysis was conducted on virus from 20 representative subjects (16 subjects from the maraviroc arms and 4 subjects from the placebo + OBT arm) in whom CXCR4-using virus was detected at treatment failure.
Da bi se utvrdilo vjerojatno podrijetlo virusa koji koristi CXCR4, provedena je detaljna klonalna analiza virusa od 20 reprezentativnih ispitanika (16 ispitanika iz skupine koji su dobivali maravirok i 4 ispitanika iz skupine koji su dobivali placebo + OBT) kod kojih je virus koji koristi CXCR4 utvrđen kod neuspjeha liječenja.
The use of CELSENTRI has not been tested in children under the age of 2 or weighing less than 10 kg .
Primjena lijeka CELSENTRI nije se ispitivala u djece mlađe od 2 godine ni one čija je tjelesna težina manja od 10 kg.
Postural hypotension
HIPOLIPEMICI Statini
• feeling sick or being sick
• osjećaj lupanja srca ili nevoljno drhtanje
 old, hidden infections flaring up again as the body fights them  the immune system attacking healthy body tissue (autoimmune disorders).
• starim, prikrivenim infekcijama koje se ponovno razbuktaju kad se tijelo počne boriti protiv njih
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with rifabutin and a PI (except tipranavir/ritonavir where the dose should be 300 mg twice daily).
Dozu lijeka CELSENTRI treba smanjiti na 150 mg 2x dnevno pri istodobnoj primjeni rifabutina u prisustvu IP (osim tipranavira/ritonavira kada doza treba biti 300 mg 2x dnevno).
Nevirapine 200 mg BID (maraviroc 300 mg Single Dose)
Nevirapin 200 mg 2x dnevno (maravirok 300 mg pojedinačna doza)
Not studied, but these are potent CYP3A4 inducers and would be expected to decrease maraviroc concentrations.
Nisu provedena ispitivanja, no ti su lijekovi snažni induktori CYP3A4, pa se očekuje da će sniziti koncentraciju maraviroka.
PHARMACEUTICAL FORM AND CONTENTS
4. FARMACEUTSKI OBLIK I SADRŽAJ Sadržaj boce:
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.
• mjehuriće na koži i ljuštenje kože, osobito oko usta, nosa, očiju i genitalija
Levonorgestrel 150 mcg QD (maraviroc 100 mg BID)
Levonorgestrel 150 mcg 1x dnevno (maravirok 100 mg 2x dnevno)
Combination with two inducers has not been studied.
Rifampicin + efavirenz Kombinacija s dva induktora nije ispitivana.
Sulphamethoxazole/trimethoprim concentrations not measured, no effect expected.
Koncentracije sulfametoksazol/trimetoprima nisu određivane, učinak nije očekivan.
Ketoconazole concentrations not measured, no effect is expected.
Koncentracije ketokonazola nisu određivane, učinak nije očekivan.
The hepatic safety of maraviroc in combination with other antiretroviral agents in CCR5-tropic HIV-1-infected subjects with HIV RNA <50 copies/mL, co-infected with Hepatitis C and/or Hepatitis B Virus was evaluated in a multicentre, randomized, double blinded, placebo-controlled study.
U multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju, ispitivana je sigurnost za jetru kod primjene maraviroka u kombinaciji s drugim antiretrovirusnim lijekovima u ispitanika zaraženih CCR5-tropnim virusom HIV-1 kod kojih je HIV RNK <50 kopija/ml, a koji su istodobno zaraženi virusom hepatitisa B i/ili hepatitisa C.
Efavirenz 600 mg QD + saquinavir/ritonavir 1000 mg/100 mg BID (maraviroc 100 mg BID)
Efavirenz 600 mg 1x dnevno + sakvinavir/ritonavir 1000 mg/ 100 mg 2x dnevno (maravirok 100 mg 2x dnevno)
The clinical status of the patient and the adverse reaction profile of maraviroc should be borne in mind when considering the patient's ability to drive, cycle or operate machinery.
Kada se razmatra bolesnikova sposobnost upravljanja vozilom, vožnje bicikla ili rada sa strojevima, treba uzeti u obzir njegov klinički status i profil nuspojava maraviroka.
Subjects with a functional CYP3A5 (CYP3A5*1 allele) have been shown to have a reduced exposure to maraviroc compared to subjects with defect CYP3A5 activity (e.g., CYP3A5*3, CYP3A5*6, and CYP3A5*7).
Pokazalo se da je izloženost maraviroku u ispitanika s funkcionalnim enzimom CYP3A5 (alel CYP3A5*1) manja nego u ispitanika sa smanjenom aktivnošću CYP3A5 (npr.
CELSENTRI 25 mg film-coated tablets
CELSENTRI 25 mg filmom obložene tablete
Study A4001029 was an exploratory study in patients infected with dual/mixed or CXCR4 tropic HIV-1 with a similar design as the studies MOTIVATE 1 and MOTIVATE 2.
Ispitivanje A4001029 bilo je eksploratorno ispitivanje u bolesnika zaraženih dvostruko/miješanim ili CXCR4 tropnim HIV-1, dizajna sličnog ispitivanjima MOTIVATE 1 i MOTIVATE 2. U tih ispitanika primjena maraviroka nije bila povezana sa značajnim smanjenjem vrijednosti HIV-1 RNK u odnosu na placebo i nije primijećen negativan učinak na broj CD4+ stanica.
CELSENTRI 150 mg film-coated tablets
CELSENTRI 150 mg filmom obložene tablete
Metabolism and nutrition disorders Anorexia common
Poremećaji metabolizma i prehrane
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with ketoconazole.
Dozu lijeka CELSENTRI treba smanjiti na 150 mg 2x dnevno kada se primjenjuje istodobno s ketokonazolom.
CELSENTRI dose should be increased to 600 mg twice daily when coadministered with carbamazepine, phenobarbital or phenytoin in the absence of a potent CYP3A4 inhibitor.
Dozu lijeka CELSENTRI treba povećati na 600 mg 2x dnevno kada se primjenjuje istodobno s karbamazepinom, fenobarbitalom ili fenitoinom, a bez snažnog inhibitora CYP3A4.
Atazanavir concentrations not measured, no effect is expected.
Koncentracije atazanavira nisu određivane, učinak nije očekivan.
boceprevir, telaprevir)
nelfinavir, ritonavir, sakvinavir, boceprevir, telaprevir)
Excipient with known effect: each 75 mg film-coated tablet contains 0.42 mg of soya lecithin.
Pomoćna tvar s poznatim učinkom: jedna filmom obložena tableta od 75 mg sadrži 0,42 mg sojinog lecitina.
Tipranavir/ritonavir 500 mg/200 mg BID (maraviroc 150 mg BID)
Tipranavir/ritonavir 500 mg/200 mg 2x dnevno (maravirok 150 mg 2x dnevno)
2x carton for blister pack containing 300 mg maraviroc film-coated tablets - without Blue Box
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 2x kutija za blister pakiranja koja sadrži filmom obložene tablete od 300 mg maraviroka - bez plavog okvira
CELSENTRI dose should be increased to 600 mg twice daily when co-administered with rifampicin in the absence of a potent CYP3A4 inhibitor.
Dozu lijeka CELSENTRI treba povećati na 600 mg 2x dnevno kad se primjenjuje istodobno s rifampicinom bez prisustva snažnih CYP3A4 inhibitora.
Blue, biconvex, oval film-coated tablets, approximate dimensions 8.56 mm x 15.5 mm and debossed with “MVC 150”.
Plave, bikonveksne, ovalne filmom obložene tablete približnih dimenzija 8,56 mm x 15,5 mm, sutisnutom oznakom „MVC 150“.
Maraviroc 300 mg twice daily + OBT N=426
Maravirok 300 mg 2x dnevno +OBT N = 426
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with clarithromycin and telithromycin.
Dozu lijeka CELSENTRI treba smanjiti na 150 mg 2x dnevno kad se primjenjuje istodobno s klaritromicinom ili telitromicinom.
Each film-coated tablet contains 75 mg of maraviroc.
Jedna filmom obložena tableta sadrži 75 mg maraviroka.
Each film-coated tablet contains 300 mg of maraviroc.
Jedna filmom obložena tableta sadrži 300 mg maraviroka.
2x carton for blister pack containing 150 mg maraviroc film-coated tablets - without Blue Box
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 2x kutija za blister pakiranja koja sadrži filmom obložene tablete od 150 mg maraviroka - bez plavog okvira
Efavirenz concentrations not measured, no effect is expected.
Koncentracije efavirenza nisu određivane, učinak nije očekivan.
Blue, biconvex, oval film-coated tablets, approximate dimensions 6.74 mm x 12.2 mm and debossed with “MVC 75”.
Plave, bikonveksne, ovalne filmom obložene tablete približnih dimenzija 6,74 mm x 12,2 mm, s utisnutom oznakom „MVC 75“.
Maraviroc Cmax: ↑ 1.25
Maravirok Cmax:  1,25
Midazolam 7.5 mg Single Dose (maraviroc 300 mg BID)
Midazolam 7,5 mg jednokratna doza (maravirok 300 mg 2x dnevno)
Protease Inhibitors (PIs) Atazanavir 400 mg QD (maraviroc 300 mg BID)
Inhibitori proteaze (IP) Atazanavir 400 mg 1x dnevno (maravirok 300 mg 2x dnevno)
CELSENTRI 20 mg/ml oral solution
NAZIV LIJEKA CELSENTRI 20 mg/ml oralna otopina
Anti-HCV Ribavirin
Lijekovi za hepatitis C Ribavirin
Blue, biconvex, oval film-coated tablets, approximate dimensions 10.5 mm x 19.0 mm and debossed with “MVC 300”.
Plave, bikonveksne, ovalne filmom obložene tablete približnih dimenzija 10,5 mm x 19,0 mm, s utisnutom oznakom „MVC 300“.
Maraviroc concentrations not measured, no effect is expected.
Koncentracije maraviroka nisu određivane, učinak nije očekivan.
Maraviroc Cmax: ↑ 4.78
Maravirok Cmax:  4,78
Maraviroc AUC12: ↑ 2.53
Maravirok AUC12:  2,53
Discontinue maraviroc and other suspect agents immediately if signs or symptoms of severe skin or hypersensitivity reactions develop.
Ako se pojave znakovi ili simptomi teških kožnih reakcija ili reakcija preosjetljivosti, odmah prekinite primjenu maraviroka i drugih suspektnih lijekova.
Maraviroc AUC12: ↓ 0.55
Maravirok AUC12:  0,55
Gastrointestinal disorders Amylase
Poremećaji probavnog sustava Amilaza
Atazanavir/ritonavir concentrations not measured, no effect is expected.
Koncentracije atazanavira/ritonavira nisu određivane, učinak nije očekivan.
ANTIFUNGALS Ketoconazole 400 mg QD (maraviroc 100 mg BID)
ANTIMIKOTICI Ketokonazol 400 mg 1x dnevno (maravirok 100 mg 2x dnevno)
Serious side effects - get medical help immediately Serious allergic or skin reactions
Ozbiljne nuspojave - odmah potražite liječničku pomoć
• skin rash or itching
• kožni osip ili svrbež
Excipient with known effect: each 150 mg film-coated tablet contains 0.84 mg of soya lecithin.
Pomoćna tvar s poznatim učinkom: jedna filmom obložena tableta od 150 mg sadrži 0,84 mg sojinog lecitina.
50 mg twice daily
50 mg dva puta na dan
Excipient with known effect: each 25 mg film-coated tablet contains 0.14 mg of soya lecithin.
Pomoćna tvar s poznatim učinkom: jedna filmom obložena tableta od 25 mg sadrži 0,14 mg sojinog lecitina.
Tenofovir concentrations not measured, no effect is expected.
Koncentracije tenofovira nisu određivane, učinak nije očekivan.
Each film-coated tablet contains 25 mg of maraviroc.
Jedna filmom obložena tableta sadrži 25 mg maraviroka.
Tenofovir 300 mg QD (maraviroc 300 mg BID)
Tenofovir 300 mg 1x dnevno (maravirok 300 mg 2x dnevno)
120 film-coated tablets
60 filmom obloženih tableta
300 mg twice daily
300 mg dva puta na dan
Antiretrovirals
ANTIKONVULZIVI
celsentri 20 mg/ml
16. PODACI NA BRAILLEOVOM PISMU celsentri 20 mg/ml
Maraviroc Cmax: ↑ 2.29
Maravirok Cmax:  2,29
Atazanavir/ritonavir 300 mg/100 mg QD (maraviroc 300 mg BID)
Atazanavir/ritonavir 300 mg/100 mg 1x dnevno (maravirok 300 mg 2x dnevno)
100 mg twice daily
100 mg dva puta na dan
Maraviroc Cmax: ↑ 2.67
Maravirok Cmax:  2,67
Darunavir/ritonavir 600 mg/100 mg BID (maraviroc 150 mg BID)
Darunavir/ritonavir 600 mg/100 mg 2x dnevno (maravirok 150 mg 2x dnevno)
Zidovudine Cmax: ↔ 0.92
Zidovudin Cmax:  0,92
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.
Brojni in vitro i in vivo testovi (uključujući reverznu mutaciju bakterija, kromosomske aberacije u limfocitima čovjeka i mikronukleus koštane srži miša) nisu pokazali postojanje mutagenosti kao niti genotoksičnosti maraviroka.
Maraviroc Cmax: ↑ 2.26
Maravirok Cmax:  2,26
Maraviroc Cmax: ↔ 0.86
Maravirok Cmax:  0,86
CELSENTRI 300 mg twice daily should be administered with caution when co-administered with fluconazole.
Doza lijeka CELSENTRI je 300 mg 2x dnevno kod istodobne primjene s flukonazolom uz pojačani oprez.
Zidovudine AUC12: ↔ 0.98
Levonorgestrel AUC12:  0,98
Rifampicin 600 mg QD (maraviroc 100 mg BID)
Rifampicin 600 mg 1x dnevno (maravirok 100 mg 2x dnevno)
Each film-coated tablet contains 150 mg of maraviroc.
Jedna filmom obložena tableta sadrži 150 mg maraviroka.
Blue, biconvex, oval film-coated tablets, approximate dimensions 4.6 mm x 8.0 mm and debossed with “MVC 25”.
Plave, bikonveksne, ovalne filmom obložene tablete približnih dimenzija 4,6 mm x 8,0 mm, s utisnutom oznakom „MVC 25“.
CELSENTRI 300 mg twice daily and sulphamethoxazole/ trimethoprim can be co-administered without dose adjustment.
CELSENTRI 300 mg 2x dnevno i sulfametoksazol/trimetoprim mogu se istodobno primijeniti bez prilagođavanja doze.
Maraviroc Cmax: ↑ 2.09
Maravirok Cmax:  2,09
Maraviroc Cmax: ↔ 1.19
Maravirok Cmax:  1,19
Maraviroc AUC12 ↔ 1.02
Maravirok AUC12:  1,02
Studies in Treatment-Experienced Paediatric Patients Infected with CCR5-tropic Virus
Ispitivanja u prethodno liječenih pedijatrijskih bolesnika zaraženih CCR5-tropnim virusom
Each ml of oral solution contains 20 mg maraviroc.
2. NAVOĐENJE DJELATNE(IH) TVARI Jedan ml oralne otopine sadrži 20 mg maraviroka.
Raltegravir 400 mg BID (maraviroc 300 mg BID)
Raltegravir 400 mg 2x dnevno (maravirok 300 mg 2x dnevno)
Laboratory abnormalities
Laboratorijska patološka odstupanja
Lopinavir/ritonavir concentrations not measured, no effect is expected.
Koncentracije lopinavira/ritonavira nisu određivane, učinak nije očekivan.
CELSENTRI 75 mg film-coated tablets maraviroc
NAZIV LIJEKA CELSENTRI 75 mg filmom obložene tablete maravirok
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with etravirine and a PI.
Doza lijeka CELSENTRI se mora smanjiti na 150 mg dva puta na dan kad se primjenjuje istodobno s etravirinom, u prisutnosti IP.
Maraviroc Cmax: ↑ 1.97
Maravirok Cmax:  1,97
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with itraconazole.
Dozu lijeka CELSENTRI treba smanjiti na 150 mg 2x dnevno kod istodobne primjene s itrakonazolom.
Ethinylestradiol 30 mcg QD (maraviroc 100 mg BID)
Etinilestradiol 30 mcg 1x dnevno (maravirok 100 mg 2x dnevno)
CELSENTRI 300 mg twice daily and raltegravir can be co-administered without dose adjustment.
CELSENTRI 300 mg dva puta na dan i raltegravir mogu se primjenjivati istodobno bez prilagođavanja doze.
Etravirine 200 mg BID (maraviroc 300 mg BID)
Etravirin 200 mg 2x dnevno (maravirok 300 mg 2x dnevno)
celsentri 75 mg
16. PODACI NA BRAILLEOVOM PISMU celsentri 75 mg
AUC: ↔ 1.18 Midazolam.
AUC:  1,18
Studies in Treatment-Experienced Adult Patients Infected with Non-CCR5-tropic Virus
Ispitivanja u prethodno liječenih odraslih bolesnika zaraženih virusima koji nisu CCR5-tropni
Studies in Treatment-Experienced Adult Patients Infected with CCR5-tropic Virus
Ispitivanja u prethodno liječenih odraslih bolesnika zaraženih CCR5-tropnim virusom
Lopinavir/ritonavir 400 mg/100 mg BID (maraviroc 300 mg BID)
Lopinavir/ritonavir 400 mg/100 mg 2x dnevno (maravirok 300 mg 2x dnevno)
The adverse reactions and laboratory abnormalities presented below are not exposure adjusted.
Prilikom procjene nuspojava i patoloških laboratorijskih nalaza navedenih u tablicama nisu u obzir uzimane doze lijeka kojima su bolesnici bili izloženi.
Efavirenz, saquinavir/ritonavir concentrations not measured, no effect expected.
Koncentracije efavirenza, sakvinavira/ritonavira nisu određivane, učinak nije očekivan.