FrancophonIA/ELRC3.0 huggingface dataset:
English: This effect may be expected to be more pronounced for orally administered methylprednisolone.
Croatian: Očekuje se da će ovaj učinak biti izraženiji pri peroralnoj primjeni metilprednizolona.
English: †Difference and confidence interval (CI) were calculated using the method proposed by Miettinen and Nurminen and adjusted for Gender.
Croatian: Razlika i interval pouzdanosti (CI) izračunati pomoću metode po Miettinenu i Nurminenu i prilagođene prema spolu.
English: - This medicine has been prescribed for the child only.
Croatian: - Ovaj je lijek propisan samo djetetu.
English: WHEN: Take one EMEND 80 mg capsule each morning on the next two days.
Croatian: KADA: Uzmite jednu EMEND 80 mg kapsulu svakog jutra sljedeća dva dana.
English: Aprepitant does not seem to interact with the P-glycoprotein transporter, as suggested by the lack of interaction of aprepitant with digoxin.
Croatian: Čini se da aprepitant ne ulazi u interakciju s transporterom P-glikoproteinom, na što ukazuje nedostatak interakcije aprepitanta s digoksinom.
English: Start of Therapy
Croatian: Početak liječenja
English: These may not work properly when taken with this medicine.
Croatian: Ta sredstva mogu slabije djelovati kad se uzimaju zajedno s ovim lijekom.
English: The doctor may have to check the condition of the child's liver during treatment.
Croatian: Liječnik će zbog toga možda morati tijekom liječenja provjeravati u kakvom je stanju djetetova jetra.
English: The terminal half-life ranged from approximately 9 to 13 hours.
Croatian: Terminalno poluvrijeme varira od približno 9 do 13 sati.
English: 1-day regimen of fosaprepitant 150 mg in adults
Croatian: Jednodnevni režim liječenja fosaprepitantom u dozi od 150 mg u odraslih
English: In the event of overdose, EMEND should be discontinued and general supportive treatment and monitoring should be provided.
Croatian: U slučaju predoziranja treba prekinuti primjenu lijeka EMEND i primijeniti opće potporno liječenje te nadzirati bolesnika.
English: - increased amount of liver enzymes in your blood.
Croatian: - štucanje, - povišene vrijednosti jetrenih enzima u krvi.
English: EMEND is administered orally 1 hour prior to chemotherapy on Days 1, 2 and 3.
Croatian: EMEND se primjenjuje peroralno 1 sat prije kemoterapije 1. 2. i 3. dana.
English: Although a 32 mg intravenous dose of ondansetron was used in clinical trials, this is no longer the recommended dose.
Croatian: Iako se u kliničkim ispitivanjima primjenjivala intravenska doza ondanzetrona od 32 mg, ta se doza više ne preporučuje.
English: For adolescents aged 12-17 years, EMEND is available as capsules containing 80 mg, or 125 mg of aprepitant.
Croatian: Za adolescente u dobi od 12 do 17 godina, EMEND je dostupan u obliku kapsula koje sadrže 80 mg ili 125 mg aprepitanta.
English: Based on interaction studies with tolbutamide and oral contraceptives, total exposure of concomitantly administered active substances metabolised by CYP2C9 or CYP3A4 may be reduced up to 15-30 %.
Croatian: Na temelju ispitivanja interakcije s tolbutamidom i peroralnim kontraceptivima, ukupna izloženost istodobno primijenjenih drugih djelatnih tvari koje se metaboliziraju putem CYP2C9 ili CYP3A4 može se smanjiti za do 15-30%.
English: There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh class C).
Croatian: Nema kliničkih niti farmakokinetičkih podataka o bolesnicima s teškim oštećenjem funkcije jetre (ChildPugh stadij C).
English: No significant nausea (maximum VAS < 25 mm on a scale of 0-100 mm) Overall (0-120 hours)
Croatian: Izostanak značajne mučnine (<25 mm na vizualnoj analognoj ljestvici 0-100 mm) Ukupno (0-120 sati)
English: Therefore, no dose adjustment is recommended.
Croatian: Stoga se ne preporučuje prilagodba doze.
English: It should be taken into account that some people may feel dizzy and sleepy after taking EMEND.
Croatian: Treba imati na umu da neke osobe mogu osjetiti omaglicu i pospanost nakon uzimanja lijeka EMEND.
English: Given the short duration of the 3-day regimen and the time-dependent limited changes in exposure, dose reduction of the immunosuppressant is not recommended during the 3 days of co-administration with EMEND.
Croatian: S obzirom na kratko trajanje trodnevnog režima i ograničene vremenski ovisne promjene izloženosti, ne preporučuje se smanjivati dozu imunosupresiva tijekom trodnevne istodobne primjene s lijekom EMEND.
English: The following regimens are recommended in adults for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy:
Croatian: Preporučuju se sljedeći režimi liječenja u odraslih radi prevencije mučnine i povraćanja povezanih s emetogenom kemoterapijom raka:
English: The antiemetic activity of aprepitant was evaluated during the 0 to 48 hour period following the end of surgery.
Croatian: Antiemetičko djelovanje aprepitanta ocijenjeno je u razdoblju od 0 do 48 sati nakon završetka operacije.
English: For further information on interaction potential of aprepitant at higher and multiple doses, please refer to the Summary of Product Characteristics for EMEND 80 mg hard capsules and EMEND 125 mg hard capsules.
Croatian: Za dodatne informacije o mogućim interakcijama aprepitanta u većim i višekratnim dozama molimo pročitajte Sažetak opisa svojstava lijeka za EMEND 80 mg tvrde kapsule i EMEND 125 mg tvrde kapsule.
English: EMEND 165 mg is given on Day 1 only, approximately one hour before the start of chemotherapy, as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist.
Croatian: EMEND 165 mg se primjenjuje samo 1. dan liječenja, otprilike jedan sat prije početka kemoterapije, u sklopu režima liječenja koji uključuje kortikosteroid i antagonist 5-HT3.
English: Your doctor may therefore have to monitor the condition of your liver.
Croatian: Vaš liječnik će zbog toga možda morati nadgledati stanje
English: • Discard any remaining suspension and waste material.
Croatian: • Bacite svu preostalu suspenziju i otpadni materijal.
English: Before reconstitution:
Croatian: Prije pripreme za primjenu:
English: Aprepitant was given orally with 50 mL of water 1 to 3 hours before anaesthesia.
Croatian: Aprepitant se davao peroralno s 50 ml vode 1 do 3 sata prije anestezije.
English: Take the EMEND capsule on the first day of your chemotherapy cycle, together with other medicines, to prevent nausea and vomiting.
Croatian: Uzmite EMEND kapsulu 1. dana kemoterapije, zajedno s drugim lijekovima kako biste spriječili mučninu i povraćanje.
English: The safety and efficacy of EMEND powder for oral suspension in infants below 6 months of age or weighing less than 6 kg has not been established.
Croatian: Sigurnost i djelotvornost EMEND praška za oralnu suspenziju u dojenčadi mlađe od 6 mjeseci ili tjelesne težine manje od 6 kg nije ustanovljena.
English: The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in Figure 1.
Croatian: Procijenjeno vrijeme do prvog povraćanja u analizi udruženih podataka prikazano je pomoću Kaplan-Meierove krivulje na Slici 1.
English: Although no adverse effects were noted in reproduction studies when adult female animals were exposed 3.5-to 4-fold above the therapeutic exposure in humans at 40 mg, the potential effects on reproduction of alterations in neurokinin regulation are unknown.
Croatian: Premda nisu zamijećeni štetni učinci na reprodukciju kod izloženosti odraslih ženki životinja razinama 3,5 do 4 puta većim od terapijske izloženosti u ljudi pri dozi od 40 mg, potencijalni učinci promjena u regulaciji neurokinina na reprodukciju nisu poznati.
English: The efficacy of the 125 mg powder for oral suspension has not been established in children 12 years of age and older.
Croatian: Djelotvornost 125 mg praška za oralnu suspenziju u djece u dobi od 12 i više godina nije ustanovljena.
English: The antiemetic activity of EMEND was evaluated over a 5-day (120 hour) period following the initiation of chemotherapy on Day 1.
Croatian: Antiemetičko djelovanje lijeka EMEND bilo je procijenjeno tijekom petodnevnog (120 sati) razdoblja nakon početka kemoterapije 1. dana.
English: The plasma AUC of midazolam was increased by 1.5-fold.
Croatian: AUC midazolama u plazmi porastao je 1,5 puta.
English: In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
Croatian: U kliničkim ispitivanjima interakcija lijekova, aprepitant nije imao klinički važne učinke na farmakokinetiku ondanzetrona, granizetrona niti hidrodolazetrona (aktivnog metabolita dolazetrona).
English: 5-HT3 antagonists
Croatian: Antagonisti 5-HT3
English: It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with this medicine.
Croatian: Nije poznato izlučuje li se EMEND u majčino mlijeko; stoga se ne preporučuje dojiti tijekom liječenja ovim lijekom.
English: Take one EMEND 80 mg capsule each morning.
Croatian: Uzmite jednu EMEND 80 mg kapsulu svakog jutra.
English: This tells you how to prepare a dose of EMEND as an oral suspension.
Croatian: Tamo ćete saznati kako pripremiti dozu EMEND oralne suspenzije.
English: This effect may become apparent only after the end of a 3-day treatment with EMEND.
Croatian: Ovaj učinak može postati vidljiv tek na kraju trodnevnog režima liječenja lijekom EMEND.
English: An analysis of efficacy in subpopulations in Cycle 1 demonstrated that, regardless of age category, gender, use of dexamethasone for antiemetic prophylaxis, and emetogenicity of chemotherapy, the aprepitant regimen provided better control than the control regimen with respect to the complete response endpoints.
Croatian: Analiza djelotvornosti u podpopulacijama u 1. ciklusu pokazala je da je, bez obzira na dobnu kategoriju, spol, primjenu deksametazona zbog antiemetičke profilakse i emetogenost kemoterapije, režim liječenja s aprepitantom osigurao bolju kontrolu nego kontrolni režim u pogledu ishoda potpunog odgovora.
English: Ondansetron 4 mg intravenously (N=526)
Croatian: Ondanzetron 4 mg intravenski (N= 526)
English: Adverse reactions were reported in approximately 4 % of adults treated with 40 mg aprepitant compared with approximately 6 % of patients treated with 4 mg ondansetron intravenously.
Croatian: Nuspojave su prijavljene u približno 4% odraslih liječenih s 40 mg aprepitanta u usporedbi s približno 6% bolesnika liječenih s 4 mg ondanzetrona intravenski.
English: If the child could not take the whole dose, call the child's healthcare provider.
Croatian: Ako dijete nije moglo uzeti cijelu dozu, obratite se djetetovom liječniku.
English: As nausea and vomiting may occur in the days following your chemotherapy, it is important that you take EMEND for 2 consecutive days as prescribed by your doctor.
Croatian: Budući da mučnina i povraćanje mogu nastupiti u danima nakon kemoterapije, važno je da uzmete EMEND 2 dana zaredom, kako Vam je propisao Vaš liječnik.
English: It can also be stored refrigerated (between 2°C and 8°C) for up to 72 hours.
Croatian: Također se može čuvati u hladnjaku (između 2°C i 8°C) do 72 sata.
English: Fill the oral dispenser with the prescribed dose from the mixing cup according to the table below.
Croatian: Napunite oralni dozator propisanom dozom iz čaše za miješanje u skladu s tablicom niže.
English: Your doctor has prescribed EMEND, an anti-emetic, to help prevent nausea and vomiting associated with chemotherapy.
Croatian: Liječnik Vam je propisao EMEND, antiemetik, za sprječavanje mučnine i povraćanja izazvanih kemoterapijom.
English: Always give this medicine together with other medicines, to prevent nausea and vomiting.
Croatian: Uvijek dajte ovaj lijek zajedno s drugim lijekovima kako biste spriječili mučninu i povraćanje.
English: Tell your doctor if you are taking these medicines since your treatment must be modified before you start taking EMEND.
Croatian: Recite liječniku ako uzimate ove lijekove jer će morati prilagoditi terapiju prije nego počnete uzimati EMEND.
English: For additional information on the co-administration with corticosteroids, see section 4.5.
Croatian: Za dodatne informacije o istodobnoj primjeni s kortikosteroidima, vidjeti dio 4.5.
English: 3 mg/kg orally Maximum dose 125 mg
Croatian: 3 mg/kg peroralno Maksimalna doza 125 mg
English: Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant.
Croatian: Fosaprepitant, prolijek aprepitanta, nakon intravenske primjene brzo prelazi u aprepitant.
English: The safety and efficacy of the 80 mg and 125 mg capsules have not been demonstrated in children less than 12 years of age.
Croatian: Sigurnost i djelotvornost kapsula od 80 mg i 125 mg nije dokazana u djece mlađe od 12 godina.
English: Data are lacking regarding effects on CYP2C8 and CYP2C19.
Croatian: Nema podataka o učinku na CYP2C8 i CYP2C19.
English: The plasma clearance of aprepitant is dose-dependent, decreasing with increased dose and ranged from approximately 60 to 72 mL/min in the therapeutic dose range.
Croatian: Klirens aprepitanta iz plazme ovisi o dozi te opada s njezinim povećanjem, a raspon mu je od otprilike 60 do 72 ml/min unutar terapijskoga raspona doza.
English: No dose adjustment for EMEND is necessary based on gender.
Croatian: Nije potrebno prilagođavati dozu lijeka EMEND s obzirom na spol.
English: If you feel dizzy or sleepy, you should avoid driving or using machines after taking this medicine (see ‘Possible side effects').
Croatian: Ako osjetite omaglicu ili pospanost nakon uzimanja ovog lijeka, trebate izbjegavati upravljanje vozilima i rad sa strojevima (vidjeti "Moguće nuspojave").
English: The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of EMEND.
Croatian: Djelotvornost hormonskih kontraceptiva može biti smanjena tijekom primjene i u razdoblju od 28 dana nakon primjene lijeka EMEND.
English: EMEND 125 mg/80 mg is given as part of combination therapy (see section 4.2).
Croatian: EMEND 125 mg/80 mg primjenjuje se kao dio kombiniranog liječenja (vidjeti dio 4.2).
English: In controlled clinical studies in adults receiving general anaesthesia, 564 patients were administered 40 mg aprepitant orally and 538 patients were administered 4 mg ondansetron intravenously.
Croatian: U kontroliranim kliničkim ispitivanjima u odraslih koji su primali opću anesteziju, 564 bolesnika su peroralno primila aprepitant u dozi od 40 mg a 538 bolesnika je intravenski primilo ondanzetron u dozi od 4 mg.
English: Fosaprepitant 150 mg, a lyophilised prodrug of aprepitant for intravenous administration, is also available as a single dose and may be used as an alternative to oral EMEND 165 mg.
Croatian: Fosaprepitant 150 mg, liofilizirani prolijek aprepitanta za intravensku primjenu dostupan je kao jednokratna doza i može se koristiti kao alternativa peroralnom lijeku EMEND 165 mg.
English: Discard any remaining suspension and waste material.
Croatian: Bacite svu preostalu suspenziju i otpadni materijal.
English: EMEND works by blocking signals to that area and is used to prevent nausea and vomiting after surgery in adults.
Croatian: EMEND djeluje tako da blokira signale koji odlaze u taj dio mozga i koristi se za sprječavanje mučnine i povraćanja u odraslih nakon kirurškog zahvata.
English: - birth control medicines which can include birth control pills, skin patches, implants, and certain Intrauterine devices (IUDs) that release hormones may not work adequately when taken together with EMEND.
Croatian: - sredstva za kontrolu začeća, uključujući kontracepcijske tablete, hormonske flastere za kožu, implantate i neke intrauterine uloške koji oslobađaju hormone, mogu slabije djelovati kad se uzimaju zajedno s lijekom EMEND.
English: Intravenous 2 mg midazolam was given 1 hour after oral administration of a single dose of EMEND 125 mg.
Croatian: Midazolam u dozi od 2 mg primijenjen je intravenski 1 sat nakon peroralne primjene jednokratne doze lijeka EMEND 125 mg.
English: In vitro studies using human liver microsomes indicate that aprepitant is metabolised primarily by CYP3A4 and potentially with minor contribution by CYP1A2 and CYP2C19.
Croatian: In vitro ispitivanja na mikrosomima ljudske jetre ukazuju da se aprepitant prvenstveno metabolizira putem izoenzima CYP3A4, uz tek manji mogući doprinos izoenzima CYP1A2 i CYP2C19.
English: One sachet, two oral dispensers, one cap and one mixing cup.
Croatian: Jedna vrećica, dva oralna dozatora, jedan poklopac i jedna čaša za miješanje.
English: Aprepitant is also an inducer of CYP2C9.
Croatian: Aprepitant također inducira CYP2C9.
English: Method of administration The hard capsule should be swallowed whole.
Croatian: Tvrdu kapsulu treba progutati cijelu.
English: The content of each single-use sachet is to be suspended in 4.6 mL of water giving a final concentration of 25 mg per mL.
Croatian: Sadržaj jedne vrećice za jednokratnu primjenu suspendira se u 4,6 ml vode, što daje konačnu koncentraciju od 25 mg po ml.
English: Common side effects (may affect up to 1 in 10 people) are: - increased amount of liver enzymes in your blood.
Croatian: Česte nuspojave (mogu se javiti u do 1 do 10 osoba) su: - povišene vrijednosti jetrenih enzima u krvi.
English: Parents and caregivers: Always give this medicine to the child exactly as the doctor, pharmacist or nurse has told you.
Croatian: Roditelji i skrbnici: Uvijek djetetu dajte ovaj lijek točno onako kako su Vam rekli liječnik, ljekarnik ili medicinska sestra.
English: As nausea and vomiting may occur in the days following your chemotherapy, it is important that you take EMEND for 3 consecutive days as prescribed by your doctor.
Croatian: Budući da mučnina i povraćanje mogu nastupiti u danima nakon kemoterapije, važno je da uzmete EMEND 3 dana zaredom, kako Vam je propisao liječnik.
English: - Use 5 mL oral dispenser if dose is more than 1 mL.
Croatian: - Upotrijebite oralni dozator od 5 ml ukoliko je doza veća od 1 ml.
English: 1 hard capsule 6 x 1 hard capsule
Croatian: 1 tvrda kapsula 6 x 1 tvrda kapsula
English: CYP3A4 interactions
Croatian: Interakcije na razini CYP3A4
English: Figure 2 Time to first vomiting episode from start of chemotherapy administration - paediatric patients in the overall phase-Cycle 1 (Intent to treat population)
Croatian: Slika 2 Vrijeme do prve epizode povraćanja nakon početka primjene kemoterapije - pedijatrijski bolesnici u cijelom razdoblju - 1. ciklus (populacija planirana za liječenje)
English: The mixture will be cloudy pink to light pink.
Croatian: Mješavina treba biti mutno ružičasta do svijetloružičasta.
English: EMEND increased the AUC of midazolam 25 % on Day 4 and decreased the AUC of midazolam 19 % on Day 8 and 4 % on Day 15.
Croatian: EMEND je povećao AUC midazolama za 25% 4. dan, a smanjio ga za 19% 8. dan te za 4% 15. dan liječenja.
English: Both clearance and absolute bioavailability decrease with increasing dose.
Croatian: S povećanjem doze smanjuju se i klirens i apsolutna bioraspoloživost lijeka.
English: An additional study was completed with intravenous administration of midazolam and EMEND.
Croatian: Dovršeno je i dodatno ispitivanje istodobne primjene intravenski primijenjenog midazolama i lijeka EMEND.
English: In a randomised, double-blind, active comparator-controlled clinical study that included 302 children and adolescents (aged 6 months to 17 years) receiving moderately or highly emetogenic chemotherapy, the aprepitant regimen was compared to a control regimen for the prevention of CINV.
Croatian: U randomiziranom, dvostruko slijepom kliničkom ispitivanju kontroliranom aktivnim komparatorom koje je uključilo 302 djece i adolescenata (u dobi od 6 mjeseci do 17 godina) koji su primali umjereno ili jako emetogenu kemoterapiju, režim liječenja aprepitantom bio je uspoređen s kontrolnim režimom liječenja za sprječavanje CINV-a.
English: During treatment, the single 40 mg dose of aprepitant recommended for PONV results in a weak inhibition of CYP3A4.
Croatian: Tijekom liječenja, jednokratna doza od 40 mg aprepitanta preporučena za sprječavanje PONV-a uzrokuje slabu inhibiciju CYP3A4.
English: Side effects for which the frequency is not known: - Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction).
Croatian: Nuspojave čija učestalost nije poznata: - Stevens-Johnsonov sindrom/toksična epidermalna nekroliza (rijetka teška kožna reakcija).
English: No vomiting
Croatian: Bez povraćanja
English: EMEND can affect other medicines both during and after treatment with EMEND.
Croatian: EMEND može utjecati na djelovanje drugih lijekova i u vrijeme i nakon liječenja.
English: If you forget to take EMEND If you have missed a dose, contact your doctor for advice.
Croatian: Ako ste zaboravili uzeti EMEND Ako ste propustili uzeti dozu lijeka, obratite se za savjet svom liječniku.
English: Some less common ADRs in the adult population were not observed in the paediatric studies.
Croatian: Neke manje česte nuspojave zamijećene u odraslih nisu zamijećene u pedijatrijskim ispitivanjima.
English: 2 mg/kg orally Maximum dose 80 mg
Croatian: 2 mg/kg peroralno Maksimalna doza 80 mg
English: In particular, although no adverse effects were noted in reproduction studies at human exposure levels, the animal exposures are not sufficient to make an adequate risk assessment in man.
Croatian: Konkretno, premda pri ovim razinama nisu zamijećeni štetni učinci u ispitivanjima djelovanja na reprodukciju, razine izloženosti kod životinja nisu dovoljne za odgovarajuću procjenu rizika za ljude.
English: Excipients with known effect Each sachet contains approximately 125 mg of sucrose and 468.7 mg lactose (as anhydrous).
Croatian: Pomoćne tvari s poznatim učinkom Jedna vrećica sadrži približno 125 mg saharoze i 468,7 mg laktoze (bezvodne).
English: This combination (i.e. EMEND, ondansetron and dexamethasone) decreased the AUC of oral midazolam 16 % on Day 6, 9 % on Day 8, 7 % on Day 15 and 17 % on Day 22.
Croatian: Ova je kombinacija (tj. EMEND, ondanzetron i deksametazon) smanjila AUC peroralnog midazolama za 16% 6. dan, 9% 8. dan, 7% 15. dan te 17% 22. dan liječenja.
English: *Reported in patients taking a higher dose of aprepitant.
Croatian: *Prijavljeno u bolesnika koji su uzimali više doze aprepitanta
English: - with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems).
Croatian: - istodobno s lijekovima koji sadrže pimozid (za liječenje psihičkih bolesti), terfenadin i astemizol (za liječenje peludnih i drugih alergija), cisaprid (za liječenje probavnih problema).
English: What EMEND contains - The active substance is aprepitant.
Croatian: Što EMEND sadrži - Djelatna tvar je aprepitant.
English: The effects of EMEND or other medicines might be influenced if you or the child take EMEND together with other medicines including those listed below.
Croatian: Učinak lijeka EMEND ili drugih lijekova može se promijeniti ako Vi ili dijete uzimate EMEND zajedno s drugim lijekovima, uključujući sljedeće lijekove.
English: There were no margins to clinically relevant exposure of aprepitant.
Croatian: Nije bilo margine za klinički važnu izloženost aprepitantu.
English: In the same 2 clinical studies, 851 adult patients continued into the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy.
Croatian: U ista je 2 klinička ispitivanja 851 odrasli bolesnik nastavio višeciklusnu kemoterapiju do najviše pet dodatnih ciklusa.
English: 12 mg orally none none
Croatian: 12 mg peroralno ništa ništa
English: EMEND powder for oral suspension is given as part of combination therapy (see section 4.2).
Croatian: EMEND prašak za oralnu suspenziju daje se kao dio kombinirane terapije (vidjeti dio 4.2).
English: In healthy young adults, the increase in AUC0- was 26 % greater than dose proportional between 80 mg and 125 mg single doses administered in the fed state.
Croatian: U mladih i zdravih odraslih osoba povećanje AUC0-∞ bilo je 26% veće od proporcionalnog dozi u rasponu jednokratnih doza od 80 mg i 125 mg primijenjenih nakon obroka.