FrancophonIA/ELRC3.0 huggingface dataset:
English: The viral tropism cannot be safely predicted by treatment history and assessment of stored samples.
Croatian: Tropizam virusa nije moguće sa sigurnošću odrediti temeljem podataka o prethodnom liječenju niti analizom ranije pohranjenih uzoraka krvi.
English: Etravirine and darunavir/ritonavir (maraviroc 150 mg BID)
Croatian: Etravirin i darunavir/ritonavir (maravirok 150 mg 2x dnevno)
English: In the remaining 36 patients, there was no evidence of virus with reduced sensitivity as identified by exploratory virology analyses on a representative group.
Croatian: Kod preostalih 36 bolesnika, metodama eksperimentalne virologije kod reprezentativne skupine bolesnika, nije ustanovljena prisutnost virusa smanjene osjetljivosti.
English: Use of weight (kg)-based doses in treatment-experienced HIV-1-infected paediatrics results in maraviroc exposures similar to those observed in treatmentexperienced adults receiving recommended doses with concomitant medications.
Croatian: Primjena doza određenih na temelju tjelesne težine (kg) u prethodno liječenih pedijatrijskih bolesnika zaraženih virusom HIV-1 dovodi do razina izloženosti maraviroku sličnih onima opaženima u prethodno liječenih odraslih bolesnika koji su primali preporučene doze uz druge istodobno primijenjene lijekove.
English: OBT: Optimised Background Therapy * Percentages based on total patients evaluated for each laboratory parameter
Croatian: *Postoci temeljeni na ukupnom broju bolesnika kod kojih je određivan svaki od laboratorijskih parametara.
English: The mean increase in CD4+ cell count from baseline in patients who failed with a change in tropism result to dual/mixed tropic or CXCR4, in the maraviroc 300 mg twice daily + OBT (+56 cells/mm3) group was greater than that seen in patients failing placebo + OBT (+13.8 cells/mm3) regardless of tropism.
Croatian: U bolesnika u kojih liječenje nije bilo uspješno, i u kojih je utvrđena promjena tropizma virusa u dvostruko/miješani tropni ili CXCR4, a koji su dobivali maravirok 300 mg dva puta dnevno + OBT (+56 stanica/mm3), srednja vrijednost porasta broja CD4+ stanica u odnosu na početni bila je viša nego u skupini bolesnika neuspješno liječenih kombinacijom placebo + OBT (+13,8 st/mm3), bez obzira na tropizam virusa.
English: Fluconazole is considered to be a moderate CYP3A4 inhibitor.
Croatian: Flukonazol se smatra umjerenim CYP3A4 inhibitorom.
English: Other medicines and CELSENTRI Tell your doctor or pharmacist if you (or your child) are taking, any other medicines, have recently taken, or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako Vi (ili Vaše dijete) uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • anticonvulsant medicines (carbamazepine, phenytoin, phenobarbital).
Croatian: • antikonvulzive (karbamazepin, fenitoin, fenobarbital)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label - maraviroc 20 mg/ml oral solution
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na boci - marvirok 20 mg/ml oralna otopina
English: Maraviroc C12: ↑ 4.74
Croatian: Maravirok C12:  4,74
English: Treatment-Experienced Paediatric Patients
Croatian: Prethodno liječeni pedijatrijski bolesnici
English: Pharmacokinetic Enhancers Cobicistat
Croatian: ANTIMIKROBNI LIJEKOVI Antiretrovirusni lijekovi Farmakokinetički pojačivači Kobicistat
English: The discard date of the oral solution should be written on the carton in the space provided.
Croatian: Datum kada treba baciti oralnu otopinu treba upisati na za to predviđeno mjesto na kutiji.
English: Comparison to exposure in historical controls suggests that CELSENTRI 300 mg twice daily and nevirapine can be co-administered without dose adjustment.
Croatian: Usporedba s podacima iz ranije provedenih liječenja upućuje da CELSENTRI 300 mg 2x dnevno i nevirapin mogu biti istodobno primijenjeni bez prilagođavanja doze.
English: CELSENTRI with products that are CYP3A inducers (without a potent CYP3A inhibitor)
Croatian: CELSENTRI u kombinaciji s lijekovima koji su induktori CYP3A (bez snažnog inhibitora CYP3A)
English: AUCt: ↔ 1.00
Croatian: Digoksin: AUCt:  1,00
English: This analysis indicated that CXCR4-using virus emerged from a pre-existing CXCR4-using reservoir not detected at baseline, rather than from mutation of CCR5-tropic virus present at baseline.
Croatian: Analiza je pokazala da virusi koji koriste CXCR4 vjerojatnije potječu iz već ranije postojećeg rezervoara virusa koji koriste CXCR4, a koji nije otkriven na početku ispitivanja, nego od mutacija CCR5-tropnih virusa prisutnih na početku ispitivanja.
English: Therefore, unless your doctor tells you (or your child) to stop treatment, it is important to keep taking CELSENTRI correctly, as described above.
Croatian: Zbog toga je važno da Vi (ili Vaše dijete) nastavite pravilno uzimati CELSENTRI kako je ranije opisano, osim ako Vam liječnik ne savjetuje da prekinete liječenje.
English: CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets
Croatian: CELSENTRI 25 mg filmom obložene tablete CELSENTRI 75 mg filmom obložene tablete CELSENTRI 150 mg filmom obložene tablete CELSENTRI 300 mg filmom obložene tablete
English: CELSENTRI with products that are not potent CYP3A inhibitors or potent CYP3A inducers
Croatian: CELSENTRI u kombinaciji s lijekovima koji nisu snažni inhibitori CYP3A ni snažni induktori CYP3A
English: Multipack: 180 (2 packs of 90) film-coated tablets
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ Višestruko pakiranje: 180 (2 pakiranja od 90) filmom obloženih tableta
English: Therefore CELSENTRI is not recommended for children younger than 2 years, or weighing less than 10 kg.
Croatian: Zbog toga se ne preporučuje primjena lijeka CELSENTRI kod djece mlađe od 2 godine ili tjelesne težine manje od 10 kg.
English: Maraviroc concentrations not measured, no interaction expected.
Croatian: Koncentracije maraviroka nisu određivane, ne očekuju se interakcije.
English: CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets maraviroc
Croatian: CELSENTRI 25 mg filmom obložene tablete CELSENTRI 75 mg filmom obložene tablete CELSENTRI 150 mg filmom obložene tablete CELSENTRI 300 mg filmom obložene tablete maravirok
English: Pfizer Manufacturing Deutschland GmbH
Croatian: Pfizer Manufacturing Deutschland GmbH Betriebsstātte Freiburg Mooswaldallee 1
English: Limited data are available for coadministration with nelfinavir.
Croatian: Podaci o primjeni s nelfinavirom su ograničeni.
English: Screening HIV-1 RNA (copies /mL):
Croatian: HIV-1 RNA na probiru (kopija/ml):
English: AUC12: ↔ 0.98
Croatian: Zidovudin AUC12:  0,98
English: Embryofoetal development studies were conducted in rats and rabbits at doses up to 39- and 34fold the estimated free clinical AUC for a 300 mg twice daily dose.
Croatian: Ispitivanja embriofetalnog razvoja provedena su u štakora i kunića primjenom doza koje su bile do 39, odnosno 34 puta više od procijenjenog AUC slobodne frakcije nakon kliničke primjene doze od 300 mg dva puta na dan.
English: Co-administration of maraviroc with medicinal products that inhibit CYP3A4 may increase maraviroc plasma concentrations.
Croatian: Istodobna primjena maraviroka s lijekovima koji inhibiraju CYP3A4 može dovesti do povišenja koncentracije maraviroka u plazmi.
English: The Monogram Trofile assay was used in the clinical studies of maraviroc.
Croatian: U kliničkim ispitivanjima maraviroka korištena je Monogram Trofile metoda.
English: Pre- and post-natal developmental studies were performed in rats at doses up to 27-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Croatian: Pre- i postnatalne studije razvoja provedene su na štakorima s dozama do 27 puta većim od predviđenih za AUC slobodne frakcije kod ljudi za kliničku dozu od 300 mg dva puta na dan.
English: If indicated, elimination of unabsorbed active maraviroc should be achieved by emesis or gastric lavage.
Croatian: Ako je to indicirano, neresorbirani maravirok se može iz tijela ukloniti izazivanjem povraćanja ili ispiranjem želuca.
English: At baseline, mean plasma HIV-1 RNA was 4.3 log10 copies/mL (range 2.4 to 6.2 log10
Croatian: Srednja plazmatska vrijednost HIV-1 RNK na početku ispitivanja iznosila je 4,3 log10 kopija/ml (raspon: 2,4 - 6,2 log10 kopija/ml), srednja vrijednost broja
English: Nelfinavir is a potent CYP3A4 inhibitor and would be expected to increase maraviroc concentrations.
Croatian: Nelfinavir je snažan inhibitor CYP3A4 i moglo bi se očekivati povišenje koncentracija maraviroka.
English: Maraviroc AUC12: ↑ 5.00
Croatian: Maravirok AUC12:  5,00
English: Ribavirin has not been studied, no interaction is expected.
Croatian: Nisu provedena ispitivanja ribavirina, ali se interakcije ne očekuju.
English: Number of active ARVs in OBT1:
Croatian: Broj aktivnih ARV (antiretrovirusnih lijekova) u OBT
English: HIV-1 RNA <50 copies/mL Maraviroc 300 mg twice daily + OBT N=426
Croatian: HIV-1 RNA 50 kopija/ml Maravirok 300 mg 2 x dnevno + OBT N=426
English: ANTIARRHYTHMICS Digoxin 0.25 mg Single Dose (maraviroc 300 mg BID)
Croatian: ANTIARITMICI Digoksin 0,25 mg jednokratna doza (maravirok 300 mg 2x dnevno)
English: Use the oral applicator supplied with the pack to measure your dose accurately.
Croatian: Da biste točno odmjerili dozu, upotrijebite aplikator za usta priložen u pakiranju.
English: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 120 film-coated tablets.
Croatian: Boce od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu, zatvorene zalijepljenom zaštitnom aluminijskom folijom/polietilenom, koje sadrže 120 filmom obloženih tableta.
English: Lamivudine Cmax: ↔ 1.16
Croatian: Lamivudin Cmax:  1,16
English: 75 mg twice daily
Croatian: 75 mg dva puta na dan
English: CELSENTRI with products that are potent CYP3A inhibitors (with or without a CYP3A inducer)
Croatian: CELSENTRI u kombinaciji s lijekovima koji su snažni inhibitori CYP3A (uz induktor CYP3A ili bez njega)
English: Screening Viral Load >100,000 copies/mL Baseline CD4+ Cell Count ≤200 cells/mm3 Number (Percentage) of patients with GSS score1:
Croatian: Početni broj CD4+ stanica 200 stanica/mm3 Broj (postotak) bolesnika s GSS skorom1:
English: Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
Croatian: Jezgra tablete celuloza, mikrokristalična kalcijev hidrogenfosfat, bezvodni natrijev škroboglikolat magnezijev stearat
English: Excipient with known effect: each 300 mg film-coated tablet contains 1.68 mg of soya lecithin.
Croatian: Pomoćna tvar s poznatim učinkom: jedna filmom obložena tableta od 300 mg sadrži 1,68 mg sojinog lecitina.
English: Maraviroc AUC12: ↔ 1.11
Croatian: Maravirok AUC12:  1,11
English: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 180 film-coated tablets.
Croatian: Boce od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu, zatvorene zalijepljenom zaštitnom aluminijskom folijom/polietilenom, koje sadrže 180 filmom obloženih tableta.
English: Etravirine AUC12: ↔ 1.00
Croatian: Etravirin AUC12  1,00
English: Race (White/Black/Other) Mean Baseline HIV-1 RNA (log10 copies/mL) Median Baseline CD4+ Cell Count (cells/mm3) (range, cells/mm3)
Croatian: Rasa (bijela/crna/ostale) Srednja početna vrijednost HIV-1 RNA (log10 kopija/ml)
English: Not studied, but both are potent CYP3A4 inhibitors and would be expected to increase maraviroc concentrations.
Croatian: Ne postoje ispitivanja, ali su oba snažni inhibitori CYP3A4 i očekuje se povećanje koncentracije maraviroka.
English: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) Lamivudine 150 mg BID (maraviroc 300 mg BID)
Croatian: Nukleozidni/nukleotidni inhibitori reverzne transkriptaze (NRTI) Lamivudin 150 mg 2x dnevno (maravirok 300 mg 2x dnevno)
English: At 48 weeks, using a missing, switch or discontinuation equals failure analysis, 48% of subjects treated with maraviroc and OBT achieved plasma HIV-1 RNA less than 48 copies/mL and 65% of subjects achieved plasma HIV-1 RNA less than 400 copies per mL.
Croatian: 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.
English: The most frequently reported adverse reactions occurring in the Phase 2b/3 studies were nausea,
Croatian: Najčešće prijavljene nuspojave zabilježene tijekom ispitivanja faze2b/3 bile su mučnina, proljev, umor i glavobolja.
English: Abdominal pain, flatulence, nausea common
Croatian: Poremećaji probavnog sustava Bol u trbuhu, flatulencija, mučnina često
English: Contents of the pack and other information What CELSENTRI contains
Croatian: Sadržaj pakiranja i druge informacije
English: The mean CD4+ cell count (percent) increase from baseline to Week 48 was 247 cells/mm3 (5%).
Croatian: Srednja vrijednost porasta broja (postotka) CD4+ stanica od početka ispitivanja do 48. tjedna iznosila je 247 stanica/mm
English: Darunavir Cmax: ↔ 0.96 Darunavir C12: ↓ 0.77
Croatian: Darunavir AUC12  0,86 Darunavir Cmax  0,96 Darunavir C12  0,77
English: 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.
Croatian: Taj je rizik rezultat potencijalnog porasta maksimalnih koncentracija maraviroka u slučaju istodobne primjene maraviroka i snažnih inhibitora CYP3A ili inhibitora proteaze (IP) pojačanog djelovanja.
English: Hepatitis toxic, hepatic failure, hepatic cirrhosis, blood alkaline phosphatase increased rare
Croatian: Toksični hepatitis, zatajenje jetre, ciroza jetre, porast alkalne fosfataze rijetko Zatajenje jetre s alergijskim značajkama vrlo rijetko
English: 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).
Croatian: 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).
English: Myositis, blood creatine phosphokinase increased uncommon
Croatian: Miozitis, porast kreatinin fosfokinaze u krvi manje često Atrofija mišića rijetko
English: Itraconazole, is a potent CYP3A4 inhibitor and would be expected to increase the exposure of maraviroc.
Croatian: Itrakonazol je snažan CYP3A4 inhibitor i očekuje se povećanje koncentracije maraviroka.
English: Dose adjustment of maraviroc is recommended when maraviroc is co-administered with potent CYP3A4 inhibitors and/or inducers.
Croatian: Preporučuje se prilagoditi dozu maraviroka kod istodobne primjene sa snažnim inhibitorima i/ili induktorima CYP3A4.
English: Maraviroc 300 mg twice daily + OBT N =421*
Croatian: Maravirok 300 mg 2 x dnevno + OBT N=421*
English: Phenotypic resistance
Croatian: Fenotipska rezistencija
English: ANTIBIOTICS Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (maraviroc 300 mg BID)
Croatian: ANTIBIOTICI Sulfametoksazol/trimetop rim 800 mg/160 mg 2x dnevno (maravirok 300 mg 2x dnevno)
English: Etravirine C12: ↔ 1.08
Croatian: Etravirin C12:  1,08
English: 90 film-coated tablets.
Croatian: 90 filmom obloženih tableta
English: 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
Croatian: 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
English: 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
Croatian: 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
English: 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.
Croatian: 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.
English: NNRTI + PI Efavirenz 600 mg QD + lopinavir/ritonavir 400mg/100 mg BID (maraviroc 300 mg BID)
Croatian: NNRTI + IP Efavirenz 600 mg 1x dnevno + lopinavir/ritonavir 400 mg/100 mg 2x dnevno (maravirok 300 mg 2x dnevno)
English: 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).
Croatian: 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).
English: CELSENTRI 300 mg film-coated tablets
Croatian: CELSENTRI 300 mg filmom obložene tablete
English: • liver problems, including chronic hepatitis B or C. Only a limited number of people with liver problems have taken CELSENTRI.
Croatian: • jetrene tegobe, uključujući kronični hepatitis B ili C.
English: The incidence of AIDS-defining infections was similar between maraviroc and placebo arms in the pivotal studies.
Croatian: 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.
English: 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.
Croatian: 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.
English: Other developmental parameters of these offspring, including fertility and reproductive performance, were not affected by the maternal administration of maraviroc.
Croatian: Maternalna primjena maraviroka nije utjecala na druge razvojne parametre kod potomstva, uključujući plodnost i reproduktivnu sposobnost.
English: Citric acid (anhydrous) Sodium citrate dihydrate Sucralose
Croatian: 6.1 Popis pomoćnih tvari citratna kiselina (bezvodna) natrijev citrat dihidrat sukraloza natrijev benzoat aroma jagode pročišćena voda
English: 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).
Croatian: 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).
English: Further details for concomitantly administered medicinal products are provided below (see Table
Croatian: Dodatne pojedinosti o istodobno primijenjenim lijekovima navedene su u Tablici 2.
English: What CELSENTRI is and what it is used for What you need to know before you take CELSENTRI How to take CELSENTRI
Croatian: Što morate znati prije nego počnete uzimati CELSENTRI
English: 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).
Croatian: 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).
English: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz 600 mg QD (maraviroc 100 mg BID)
Croatian: Nenukleozidni inhibitori reverzne transkriptaze (NNRTI) Efavirenz 600 mg 1x dnevno (maravirok 100 mg 2x dnevno)
English: CELSENTRI 75 mg film-coated tablets
Croatian: CELSENTRI 75 mg filmom obložene tablete
English: 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.
Croatian: 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.
English: The use of CELSENTRI has not been tested in children under the age of 2 or weighing less than 10 kg .
Croatian: Primjena lijeka CELSENTRI nije se ispitivala u djece mlađe od 2 godine ni one čija je tjelesna težina manja od 10 kg.
English: Postural hypotension
Croatian: HIPOLIPEMICI Statini
English: • feeling sick or being sick
Croatian: • osjećaj lupanja srca ili nevoljno drhtanje
English:  old, hidden infections flaring up again as the body fights them  the immune system attacking healthy body tissue (autoimmune disorders).
Croatian: • starim, prikrivenim infekcijama koje se ponovno razbuktaju kad se tijelo počne boriti protiv njih
English: 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).
Croatian: 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).
English: Nevirapine 200 mg BID (maraviroc 300 mg Single Dose)
Croatian: Nevirapin 200 mg 2x dnevno (maravirok 300 mg pojedinačna doza)
English: Not studied, but these are potent CYP3A4 inducers and would be expected to decrease maraviroc concentrations.
Croatian: Nisu provedena ispitivanja, no ti su lijekovi snažni induktori CYP3A4, pa se očekuje da će sniziti koncentraciju maraviroka.
English: PHARMACEUTICAL FORM AND CONTENTS
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ Sadržaj boce:
English: If you get any of the following symptoms while you're taking CELSENTRI :  swelling of the face, lips or tongue  difficulty breathing  widespread skin rash  fever (high temperature)  blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.
Croatian: • mjehuriće na koži i ljuštenje kože, osobito oko usta, nosa, očiju i genitalija
English: Levonorgestrel 150 mcg QD (maraviroc 100 mg BID)
Croatian: Levonorgestrel 150 mcg 1x dnevno (maravirok 100 mg 2x dnevno)
English: Combination with two inducers has not been studied.
Croatian: Rifampicin + efavirenz Kombinacija s dva induktora nije ispitivana.
English: Sulphamethoxazole/trimethoprim concentrations not measured, no effect expected.
Croatian: Koncentracije sulfametoksazol/trimetoprima nisu određivane, učinak nije očekivan.
English: Ketoconazole concentrations not measured, no effect is expected.
Croatian: Koncentracije ketokonazola nisu određivane, učinak nije očekivan.