FrancophonIA/ELRC3.0 huggingface dataset:
English: Maraviroc is a member of a therapeutic class called CCR5 antagonists.
Croatian: Maravirok pripada terapijskoj skupini antagonista CCR5.
English: Therefore, CELSENTRI should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
Croatian: Stoga CELSENTRI treba primjenjivati uz oprez u bolesnika s oštećenjem jetre (vidjeti dijelove 4.4 i 5.2).
English: The geometric mean AUCinf (CV%) for maraviroc was as follows: healthy volunteers (normal renal function) 1348.4 ng·h/mL (61%); severe renal impairment 4367.7 ng·h/mL (52%); ESRD (dosing after dialysis) 2677.4 ng·h/mL (40%); and ESRD (dosing before dialysis) 2805.5 ng·h/mL (45%).
Croatian: Geometrijska srednja vrijednost AUCinf (CV%) za maravirok bila je kako slijedi: zdravi dobrovoljci (normalna bubrežna funkcija) 1348,4 ng·h/ml (61%); teško oštećenje bubrežne funkcije 4367,7 ng·h/ml (52%); ESRD (doziranje nakon dijalize) 2677,4 ng·h/ml (40%); te ESRD (doziranje prije dijalize) 2805,5 ng.h/ml (45%).
English: There are no data regarding the switch from a medicinal product of a different antiretroviral class to CELSENTRI in virologically suppressed patients.
Croatian: Nema podataka o prebacivanju virološki suprimiranih bolesnika liječenih lijekom neke druge antiretrovirusne skupine na CELSENTRI.
English: Background resistance to other classes of antiretrovirals have been shown to be similar in previously undetected CXCR4-tropic virus of the minor viral population, as that found in CCR5-tropic virus.
Croatian: Prethodna rezistencija na ostale skupine antiretrovirusnih lijekova pokazala se sličnom kod prethodno neutvrđenog CXCR4 tropnog virusa iz manje virusne populacije, kao i kod CCR5 tropnog virusa.
English: The OBT was selected on the basis of the subject's prior treatment history and baseline genotypic and phenotypic viral resistance measurements.
Croatian: OBT je određen temeljem iskustava iz ranijeg liječenja bolesnika kao i određivanjem početne genotipske i fenotipske rezistencije virusa.
English: An increased risk of postural hypotension may occur in patients with severe renal insufficiency who are treated with potent CYP3A inhibitors or boosted protease inhibitors (PIs) and maraviroc.
Croatian: U bolesnika s teškom bubrežnom insuficijencijom može doći do povećanog rizika posturalne hipotenzije ako se liječe snažnim inhibitorima izoenzima CYP3A ili inhibitorima proteaze (IP) pojačanog djelovanja i maravirokom.
English: Concentration response curves for the maraviroc-resistant viruses were characterized phenotypically by curves that did not reach 100% inhibition in assays using serial dilutions of maraviroc (<100% maximal percentage inhibition (MPI)).
Croatian: Krivulje koncentracija/odgovor kod virusa rezistentnih na maravirok fenotipski su određene izostankom 100%-tne inhibicije tijekom analiza serijskih razrjeđenja maraviroka (maksimalna postotna inhibicija [MPI] <100%).
English: Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label.
Croatian: CELSENTRI se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru ili naljepnici boce iza oznake EXP.
English: • itraconazole, voriconazole, clarithromycin and telithromycin,
Croatian: • itrakonazol, vorikonazol, klaritromicin i telitromicin
English: You (or your child) can still pass on HIV when taking this medicine, although the risk is lowered by effective treatment.
Croatian: HIV virus možete prenijeti čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije.
English: High density polyethylene (HDPE) bottle, with a child resistant closure, containing 230 mL maraviroc 20 mg/mL solution.
Croatian: Boca od polietilena visoke gustoće (HDPE) sa sigurnosnim zatvaračem za djecu, koja sadrži 230 ml otopine maraviroka od 20 mg/ml.
English: Examples of agents/regimens with such potent CYP3A4-inhibiting activity are:
Croatian: Primjeri lijekova/režima koji djeluju kao snažni inhibitori CYP3A4:
English: Close the bottle tightly with the cap, leaving the adaptor in place.
Croatian: Čvrsto zatvorite bocu zatvaračem, a nastavak za bocu ostavite u grlu boce.
English: The C max (CV%) was 335.6 ng/mL (87%) in healthy volunteers (normal renal function); 801.2 ng/mL (56%) in severe renal impairment; 576.7 ng/mL (51%) in ESRD (dosing after dialysis) and 478.5 ng/mL (38%) in ESRD (dosing before dialysis).
Croatian: Cmax (CV%) bila je 335,6 ng/ml (87%) u zdravih dobrovoljaca (normalna bubrežna funkcija); 801,2 ng/ml (56%) za teško oštećenje bubrežne funkcije; 576,7 ng/ml (51%) za ESRD (doziranje nakon dijalize) te 478,5 ng/ml (38%) za ESRD (doziranje prije dijalize).
English: Not studied, no interaction expected.
Croatian: Nije ispitivan, ne očekuju se interakcije.
English: Maraviroc Cmax: ↑ compared to historical controls Nevirapine concentrations not measured, no effect is expected.
Croatian: Maravirok AUC12:  u usporedbi s ranije provedenim liječenjem Maravirok Cmax:  u usporedbi s ranije provedenim liječenjem Koncentracije nevirapina nisu određivane, učinak nije očekivan.
English: Percentage of patients with HIV-1 RNA <50 copies/mL
Croatian: Postotak bolesnika s HIV-1 RNA  50 kopija/ml
English: CELSENTRI 75 mg film-coated tablets EU/1/07/418/012
Croatian: CELSENTRI 75 mg filmom obložene tablete EU/1/07/418/012
English: Medicinal product by therapeutic areas (dose of CELSENTRI used in study)
Croatian: Lijekovi prema terapijskim područjima (doza lijeka
English: In a retrospective analysis of the MOTIVATE studies with a more sensitive assay for screening of tropism (Trofile ES), the response rates (<50 copies/mL at week 48) in patients with only CCR5tropic virus detected at baseline was 48.2% in those treated with maraviroc + OBT (n=328), and 16.3% in those treated with placebo + OBT (n=178).
Croatian: U retrospektivnoj analizi ispitivanja MOTIVATE, u kojoj se koristio osjetljiviji test za probir na tropizam (Trofile ES), stopa odgovora (< 50 kopija/ml u 48. tjednu) bolesnika u kojih je na početku ispitivanja otkriven samo CCR5-tropni virus iznosila je 48,2% u bolesnika liječenih maravirokom i OBT-om (n=328) te 16,3% u onih liječenih kombinacijom placebo + OBT (n=178).
English: ANTICONVULSANTS Carbamezepine, Phenobarbital, Phenytoin
Croatian: Karbamazepin, fenobarbital, fenitoin
English: Medicines containing St. John's Wort (Hypericum perforatum) are likely to prevent CELSENTRI
Croatian: Lijekovi koji sadrže gospinu travu (Hypericum perforatum) vjerojatno će onemogućiti pravilno djelovanje lijeka CELSENTRI.
English: If you are pregnant, if you become pregnant, or if you are planning to have a baby: Talk to your doctor about the risks and benefits of taking CELSENTRI.
Croatian: Ako ste trudni, ako zatrudnite ili ako planirate imati dijete:
English: Maraviroc should also be used with caution in patients with severe renal insufficiency and in patients who have risk factors for, or have a history of postural hypotension.
Croatian: Maravirok treba primjenjivati uz oprez i u bolesnika s teškom bubrežnom insuficijencijom te u bolesnika koji imaju faktore rizika za posturalnu hipotenziju ili posturalnu hipotenziju u anamnezi.
English: CELSENTRI should be used with caution in adult patients with severe renal impairment (CLcr <30 mL/min) who are receiving potent CYP3A4 inhibitors (see sections 4.4 and 5.2).
Croatian: CELSENTRI treba primjenjivati uz oprez u odraslih bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) koji uzimaju snažne inhibitore CYP3A4 (vidjeti dijelove 4.4 i 5.2).
English: If you have any further questions on the use of this medicine, ask your doctor or your pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: EXP {MM/YYYY}
Croatian: ROK VALJANOSTI EXP {MM-GGGG}
English: Elvitegravir as a single agent is indicated only in combination with certain ritonavir boosted PIs.
Croatian: Elvitegravir je u monoterapiji indiciran samo u kombinaciji s određenim inhibitorima proteaze pojačanima ritonavirom.
English: In vitro studies indicate that CYP3A4 is the major enzyme responsible for maraviroc metabolism.
Croatian: In vitro ispitivanja su pokazala da je CYP3A4 ključni enzim u metaboliziranju maraviroka.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Croatian: Bolesnike treba savjetovati da se obrate liječniku ako primijete pojavu stalnih tupih i povremeno jačih bolova u zglobovima, ukočenost zglobova ili otežanu pokretljivost zglobova.
English: Write the date the oral solution should be discarded on the carton in the space provided.
Croatian: Upišite datum kada trebate baciti oralnu otopinu na za to predviđeno mjesto na kutiji.
English: Name and address of the manufacturer responsible for batch release Tablets
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: Bile duct cancer, diffuse large B-cell lymphoma, Hodgkin's disease, metastases to bone, metastases to liver, metastases to peritoneum, nasopharyngeal cancer, oesophageal carcinoma rare
Croatian: Karcinom žučnih vodova, difuzni limfom velikih B-stanica, Hodgkinova bolest, metastaze kostiju, metastaze jetre, peritonealne metastaze, nazofaringealni karcinom, ezofagealni karcinom rijetko
English: In addition, the study compared the pharmacokinetics of multiple dose maraviroc in combination with saquinavir/ritonavir 1000/100 mg BID (a potent CYP3A4 inhibitor) for 7 days in subjects with mild renal impairment (CLcr >50 and ≤80 mL/min, n=6) and moderate renal impairment (CLcr ≥30 and ≤50 mL/min, n=6) to healthy volunteers (n=6).
Croatian: Pored toga, ispitivanjem se uspoređivala farmakokinetika višekratnih doza maraviroka u kombinaciji sa sakvinavirom/ritonavirom (snažni inhibitori CYP3A4) 1000/100 mg dva puta na dan tijekom 7 dana u ispitanika s blagim bubrežnim oštećenjem (CLcr > 50 i ≤80 ml/min, n=6) i ispitanika s umjerenim bubrežnim oštećenjem (CLcr ≥ 30 i ≤50 ml/min, n=6) prema zdravim dobrovoljcima (n=6).
English: Intensive pharmacokinetics of maraviroc were evaluated in 50 treatment-experienced, CCR5tropic, HIV-1 infected paediatric patients aged 2 to 18 years (weight 10.0 to 57.6 kg) in the dosefinding stage of clinical trial A4001031.
Croatian: Intenzivno ocjenjivanje farmakokinetike maraviroka provodilo se u 50 prethodno liječenih pedijatrijskih bolesnika u dobi od 2 do 18 godina (tjelesne težine od 10,0 do 57,6 kg) zaraženih CCR5-tropnim virusom HIV-1 u razdoblju kliničkog ispitivanja A4001031 u kojem se utvrđivala doza.
English: Maraviroc AUC: ↓ 0.37
Croatian: Maravirok AUC:  0,37
English: ANTIVIRALS Anti-HBV Pegylated interferon
Croatian: ANTIVIROTICI Lijekovi za hepatitis B Pegilirani interferon
English: CELSENTRI must be taken in combination with other medicines to treat HIV.
Croatian: CELSENTRI morate primjenjivati u kombinaciji s drugim lijekovima za liječenje HIV-a.
English: The exposure at this dose level corresponded to 39-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Croatian: Ekspozicija ovim razinama doze odgovarala je 39 puta procijenjenoj AUC slobodne frakcije nakon kliničke primjene doze od 300 mg dva puta na dan.
English: The absolute bioavailability of a 100 mg dose is 23% and is predicted to be 33% at 300 mg. Maraviroc is a substrate for the efflux transporter Pglycoprotein.
Croatian: Apsolutna bioraspoloživost doze od 100 mg iznosi 23%, a pretpostavlja se da iznosi 33% za dozu od 300 mg.
English: • other medicines to treat HIV or hepatitis C infection (such as atazanavir, cobicistat, darunavir,
Croatian: • druge lijekove za liječenje HIV infekcije ili infekcije virusom hepatitisa C (kao što su atazanavir, kobicistat, darunavir, efavirenz, etravirin, fosamprenavir, indinavir, lopinavir,
English: Maraviroc AUC12: ↑ 2.86 (2.33-3.51) Maraviroc Cmax: ↑ 2.15 (1.71-2.69) Maraviroc C12: ↑ 4.23 (3.47-5.16)
Croatian: Maravirok AUC12: ↑ 2,86 (2,33-3,51) Maravirok Cmax: ↑ 2,15 (1,71-2,69) Maravirok C12: ↑ 4,23 (3,47-5,16)
English: CELSENTRI oral solution is supplied in a carton containing a high density polyethylene bottle, with a child resistant cap.
Croatian: CELSENTRI oralna otopina dolazi u kutiji koja sadrži bocu od polietilena visoke gustoće sa sigurnosnim zatvaračem za djecu.
English: No significant interaction seen/expected.
Croatian: Nisu primijećene/očekivane značajne interakcije.
English: The pharmacokinetics of maraviroc has not been studied in subjects with severe hepatic impairment (see sections 4.2 and 4.4).
Croatian: Farmakokinetika maraviroka nije ispitivana kod bolesnika s teškim oštećenjem jetre (vidjeti dijelove 4.2 i 4.4).
English: Treatment-Experienced Adult Patients
Croatian: Prethodno liječeni odrasli bolesnici
English: Gender
Croatian: Muški spol
English: Subjects were required to have HIV-1 RNA greater than 1,000 copies per mL at Screening.
Croatian: Ispitanicima je HIV-1 RNK pri probiru morao biti iznad 1000 kopija/ml.
English: In a Phase 1 study conducted in healthy subjects, Blacks with a CYP3A5 genotype conferring extensive maraviroc metabolism (2 CYP3A5*1 alleles; n=12) had a 37% and 26% lower AUC when dosed with maraviroc 300 mg twice daily compared with Black (n=11) and Caucasian (n=12) subjects with CYP3A5 genotype conferring poor maraviroc metabolism (no CYP3A5*1 allele), respectively.
Croatian: U ispitivanju faze 1 provedenom u zdravih ispitanika, crnci s genotipom CYP3A5 koji dovodi do opsežnog metabolizma maraviroka (2 alela CYP3A5*1; n=12) imali su 37% odnosno 26% niži AUC kod primjene maraviroka u dozi od 300 mg dvaput na dan nego crnci (n=11) i bijelci (n=12) s genotipom CYP3A5 koji dovodi do slabog metabolizma maraviroka (ispitanici bez alela CYP3A5*1).
English: Maraviroc AUC12: ↑ 2.86 (2.33-3.51) Maraviroc Cmax: ↑ 2.15 (1.71-2.69) Maraviroc C12: ↑ 4.23 (3.47-5.16) Elvitegravir AUC24: ↔ 1.07
Croatian: Maravirok AUC12: ↑ 2,86 (2,33-3,51) Maravirok Cmax: ↑ 2,15 (1,71-2,69) Maravirok C12: ↑ 4,23 (3,47-5,16) Elvitegravir AUC24: ↔ 1,07
English: Physicians should ensure that appropriate dose adjustment of maraviroc is made when maraviroc is co-administered with potent CYP3A4 inhibitors and/or inducers since maraviroc concentrations and its therapeutic effects may be affected (see sections 4.2 and 4.5).
Croatian: Liječnici trebaju voditi računa o odgovarajućem prilagođavanju doze kad se maravirok primjenjuje istodobno sa snažnim inhibitorima i/ili induktorima CYP3A4 jer može doći do promjene koncentracije i terapijskog učinka maraviroka (vidjeti dijelove 4.2 i 4.5).
English: In treatment-naïve patients, the incidence of grade 3 and 4 laboratory abnormalities using ACTG criteria was similar among the maraviroc and efavirenz treatment groups.
Croatian: U prethodno neliječenih bolesnika, incidencija laboratorijskih patoloških odstupanja 3-4 stupnja (prema ACTG kriterijima) bila je slična u skupini liječenoj maravirokom kao i u onoj liječenoj efavirenzom.
English: Poly (vinyl alcohol) Titanium dioxide (E171) Macrogol 3350
Croatian: Film ovojnica poli(vinilni alkohol) titanijev dioksid (E171) makrogol 3350 talk sojin lecitin
English: Patients with very low CD4+ count at baseline (i.e. <50 cells/µL) had a less favourable outcome.
Croatian: Ishod liječenja bolesnika s vrlo niskim brojem CD4+ na početku ispitivanja (tj. 50 stanica/µl) bio je lošiji.
English: Tell your doctor or pharmacist if you (or your child) begin taking a new medicine while taking CELSENTRI.
Croatian: Recite svom liječniku ili ljekarniku ako tijekom liječenja lijekom CELSENTRI Vi (ili Vaše dijete) počnete uzimati neki novi lijek.
English: Discontinuation of maraviroc should be strongly considered in any patient with signs or symptoms of acute hepatitis, in particular if drug-related hypersensitivity is suspected or with increased liver transaminases combined with rash or other systemic symptoms of potential hypersensitivity (e.g. pruritic rash, eosinophilia or elevated IgE).
Croatian: Kod svakog bolesnika kod kojeg se pojave znakovi ili simptomi akutnog hepatitisa, posebice ako se sumnja na reakciju preosjetljivosti na lijek, odnosno u slučaju povišenja jetrenih transaminaza u kombinaciji s kožnim osipom ili drugim sistemskim znakovima potencijalne preosjetljivosti (npr. osipa praćenog svrbežom, eozinofilije ili povišenog IgE), treba svakako razmotriti prekid primjene maraviroka.
English: Maraviroc is metabolised by cytochrome P450 CYP3A4 and CYP3A5.
Croatian: Maravirok metaboliziraju enzimi citokroma P450 CYP3A4 i CYP3A5.
English: Hepatobiliary disorders Aspartate aminotransferase
Croatian: Poremećaji jetre i žuči Aspartat aminotransferaza
English: Polyvinyl chloride (PVC) blisters with child-resistant (CR) aluminium/polyethylene terephthalate (PET) lidding foil in a carton containing 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets.
Croatian: Polivinilkloridni (PVC) blisteri sigurni za djecu prekriveni aluminijskom/polietilen tereftelat (PET) folijom u kutiji s 30, 60, 90 filmom obloženih tableta i višestruka pakiranja koja sadrže 180 (2 pakiranja od 90) filmom obloženih tableta.
English: Maraviroc was the major component present in urine (mean of 8% dose) and faeces (mean of 25% dose).
Croatian: Nepromijenjen lijek činio je najveći udio kako u urinu (srednja vrijednost 8% doze) tako i u fecesu (srednja vrijednost 25% doze).
English: CELSENTRI 20 mg/ml oral solution maraviroc
Croatian: CELSENTRI 20 mg/ml oralna otopina maravirok
English: a Refer to Table 1 for maraviroc paediatric dosing recommendations when co-administered with antiretroviral therapy and other medicinal products.
Croatian: aVidjeti Tablicu 1 za preporuke za doziranje maraviroka u pedijatrijskih bolesnika pri istodobnoj primjeni s antiretrovirusnim i drugim lijekovima.
English: In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Croatian: Kod HIV zaraženih bolesnika sa znakovima teške imunodeficijencije može, nakon započinjanja kombinirane antiretrovirusne terapije (CART), doći do pojave jake upalne reakcije na asimptomatske ili oportunističke patogene uzročnike uz ozbiljnu kliničku sliku odnosno pogoršanje znakova bolesti.
English: The average concentration (Cavg) of maraviroc over 24 hours was 445.1 ng/mL, 338.3 ng/mL, and 223.7 ng/mL for subjects with normal renal function, mild renal impairment, and moderate renal impairment, respectively.
Croatian: Prosječna koncentracija (Cavg) maraviroka tijekom 24 sata iznosila je 445,1 ng/ml (kod ispitanika s normalnom bubrežnom funkcijom), 338,3 ng/ml (kod blage bubrežne insuficijencije) te 223,7 ng/ml (kod umjerene bubrežne insuficijencije).
English: Indinavir is a potent CYP3A4 inhibitor.
Croatian: Indinavir je snažan CYP3A4 inhibitor.
English: Postural hypotension (see section 4.4) uncommon
Croatian: Posturalna hipotenzija (vidjeti dio 4.4)
English: Lamivudine AUC12: ↔ 1.13
Croatian: Lamivudin AUC12:  1,13
English: Store the oral solution below 30°C.
Croatian: Čuvajte oralnu otopinu na temperaturi ispod 30°C.
English: • The active substance in CELSENTRI oral solution is 20 mg of maraviroc in each ml of the solution.
Croatian: • Djelatna tvar u CELSENTRI oralnoj otopini je 20 mg maraviroka u jednom ml otopine.
English: It is not known how common this condition is.
Croatian: Nije poznato koliko je ovo stanje često, ali veća je vjerojatnost da će se razviti:
English: In addition, an increase in hepatic adverse reactions with maraviroc was observed during studies of treatment-experienced subjects with HIV infection, although there was no overall increase in ACTG Grade 3/4 liver function test abnormalities (see section 4.8).
Croatian: Prijavljeni su slučajevi hepatotoksičnosti i zatajenja jetre, uzrokovani alergijskom reakcijom na maravirok . Osim toga, uočen je povećan broj jetrenih nuspojava povezan s uzimanjem maraviroka tijekom ispitivanja na već liječenim bolesnicima s HIV infekcijom, iako treba napomenuti da nije bilo ukupnog povećanja oštećenja jetrenih funkcija stupnja 3/4 ACTG klasifikacije (vidjeti dio 4.8).
English: A study compared the pharmacokinetics of a single 300 mg dose of maraviroc in subjects with severe renal impairment (CLcr < 30 mL/min, n=6) and end stage renal disease (ESRD) to healthy volunteers (n=6).
Croatian: Provedeno je ispitivanje kojim se uspoređivala farmakokinetika jednokratne doze od 300 mg maraviroka u ispitanika s teškim bubrežnim oštećenjem (CLcr< 30 ml/min, n=6) i terminalnim stadijem bubrežne bolesti prema zdravim dobrovoljcima (n=6).
English: Remove and wash the applicator thoroughly in clean water once you have finished using it. Let it dry completely before you use it again.
Croatian: Pustite da se potpuno osuši prije ponovne upotrebe.
English: For combination with efavirenz + PI, see separate recommendations below.
Croatian: Za kombinaciju s efavirenzom + IP, vidjeti niže u tablici.
English: Many medicines have profound effects on maraviroc exposure due to drug-drug interactions.
Croatian: Zbog interakcija između lijekova, mnogi lijekovi značajno utječu na izloženost maraviroku.
English: copies per mL), mean CD4+ cell count was 551 cells/mm3 (range 1 to 1654 cells/mm3) and mean CD4+ % was 21% (range 0% to 42%).
Croatian: CD4+ stanica iznosila je 551 stanicu/mm3 (raspon: 1 - 1654 stanica/mm3), dok je srednji postotak CD4+ stanica iznosio 21% (raspon: 0 - 42%).
English: Use of weight (kg)-based doses in treatment-experienced HIV-1-infected children and adolescents results in maraviroc exposures similar to those observed in treatment-experienced adults receiving recommended doses with concomitant medications.
Croatian: Primjena doza određenih na temelju tjelesne težine (kg) u prethodno liječene djece i adolescenata 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: Turn the bottle the correct way up.
Croatian: 6. Postavite bocu uspravno.
English: Pegylated interferon has not been studied, no interaction is expected.
Croatian: Nisu provedena ispitivanja pegiliranog interferona, ali se interakcije ne očekuju.
English: 30 to less than 40 kg at least 40 kg
Croatian: Doza lijeka CELSENTRI za djecu na temelju tjelesne težine od 10 do manje od 20 kg od 20 do manje od 30 kg od 30 do manje od 40 kg najmanje 40 kg
English: Maraviroc 300 mg twice daily + OBT was superior to placebo + OBT across all subgroups of patients analysed (see Table 7).
Croatian: U svim analiziranim podskupinama bolesnika maravirok 300 mg dva puta na dan + OBT su pokazali bolje rezultate u odnosu na primjenu kombinacije placebo + OBT (vidjeti Tablicu 7).
English: Table 6: Efficacy Outcomes at week 48 (pooled studies MOTIVATE 1 and MOTIVATE 2) Outcomes
Croatian: Tablica 6: Ishodi djelotvornosti liječenja u 48. tjednu (zajednički podaci iz ispitivanja MOTIVATE 1 i MOTIVATE 2)
English: A study compared the pharmacokinetics of a single 300 mg dose of maraviroc in patients with mild (Child-Pugh Class A, n=8), and moderate (Child-Pugh Class B, n=8) hepatic impairment compared to healthy subjects (n=8).
Croatian: U jednom ispitivanju uspoređivana je farmakokinetika jednokratne doze maraviroka od 300 mg u bolesnika s blagim oštećenjem jetre (Child-Pugh stadija A, n=8), umjerenim oštećenjem jetre (Child-Pugh stadija B, n=8) i zdravih ispitanika (n=8).
English: Limited numbers of patients from ethnicities other than Caucasian were included in the pivotal clinical studies, therefore very limited data are available in these patient populations.
Croatian: Budući da je u ove pivotalne studije uključen mali broj pripadnika ostalih rasa izuzev bijelaca, podaci za ostale populacije bolesnika vrlo su ograničeni.
English: GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Croatian: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com