FrancophonIA/ELRC3.0 huggingface dataset:
English: Some patients have presented with disseminated rather than localised disease.
Croatian: Neki su bolesnici imali kliničku sliku više diseminirane nego lokalizirane bolesti.
English: If you take more XELJANZ than you should
Croatian: Ako uzmete više lijeka XELJANZ nego što ste trebali
English: Some medicines should not be taken with XELJANZ.
Croatian: Neki se lijekovi ne smiju uzimati s lijekom XELJANZ.
English: Patients were required to have active plaque psoriasis at the screening visit.
Croatian: Bolesnici su morali bolovati od aktivne plak psorijaze na posjetu probira.
English: XELJANZ can reduce your body's ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection - if you have or have a history of tuberculosis or have been in close contact with someone with tuberculosis.
Croatian: XELJANZ može umanjiti sposobnost Vašeg organizma da odgovori na infekcije te može pogoršati postojeću infekciju ili povećati vjerovatnost za razvoj nove infekcije - ako trenutno ili u povijesti bolesti imate tuberkulozu ili ste bili u bliskom kontaktu s osobom koja boluje od tuberkuloze.
English: Tofacitinib tablets may be crushed and taken with water.
Croatian: Tablete tofacitiniba mogu se zdrobiti i popiti s vodom.
English: No data are available on the secondary transmission of infection by live vaccines to patients receiving tofacitinib.
Croatian: Nisu dostupni podaci o sekundarnom prijenosu infekcije živim cjepivima u bolesnika koji primaju tofacitinib.
English: Tofacitinib was discontinued and the patient recovered after treatment with standard doses of antiviral medication.
Croatian: Liječenje tofacitinibom je prekinuto i bolesnik se oporavio nakon liječenja standardnim dozama antivirusnih lijekova.
English: The between-subject variability (percentage coefficient of variation) in AUC of tofacitinib is estimated to be approximately 27%.
Croatian: Procjenjuje se da je varijabilnost između bolesnika (postotci koeficijenta varijacije) u AUC-u tofacitiniba približno 27%.
English: Events of gastrointestinal perforation have been reported in clinical trials although the role of JAK inhibition in these events is not known.
Croatian: Slučajevi gastrointestinalne perforacije prijavljeni su u kliničkim ispitivanjima, iako uloga JAK inhibicije u tim događajima nije poznata.
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Croatian: Potrebno je uzeti u obzir aditivni učinak istodobno primijenjenih lijekova koji sadrže sorbitol (ili fruktozu) i unos sorbitola (ili fruktoze) prehranom.
English: Nominal p<0.0001 for active treatment versus placebo at month 3.
Croatian: Nominalni p < 0,0001 za aktivno liječenje u odnosu na placebo u 3. mjesecu.
English: Following initiation, routine monitoring of liver tests and prompt investigation of the causes of any observed liver enzyme elevations are recommended to identify potential cases of drug-induced liver injury.
Croatian: Nakon početka terapije, preporučuje se rutinsko praćenje jetrene funkcije i hitna ispitivanja uzroka svakog zamijećenog povišenja jetrenih enzima, kako bi se identificirali potencijalni slučajevi oštećenja jetre uzrokovanog lijekom.
English: Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Croatian: Pon., Uto., Sri., Čet., Pet., Sub., Ned.
English: Changes in CRP observed with tofacitinib treatment do not reverse fully within 2 weeks after discontinuation, indicating a longer duration of pharmacodynamic activity compared to the half-life.
Croatian: Promjene CRP-a uočene kod liječenja tofacitinibom ne povlače se u potpunosti unutar 2 tjedna nakon prekida liječenja, što ukazuje na dulje trajanje farmakodinamičke aktivnosti u usporedbi s poluvijekom.
English: The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, or disease status.
Croatian: Učinak liječenja bio je sličan u bolesnika, neovisno o statusu reumatoidnog faktora, dobi, spolu, rasi ili statusu bolesti.
English: Physical function response and health-related outcomes
Croatian: Odgovor s obzirom na fizičku funkciju i zdravstvene ishode
English: Patients with severe renal impairment should remain on a reduced dose even after haemodialysis (see section 5.2).
Croatian: Bolesnici s teškim oštećenjem bubrega moraju ostati na sniženoj dozi čak i nakon hemodijalize (vidjeti dio 5.2).
English: The tablets are provided in blisters containing 14 tablets.
Croatian: Tablete dolaze u blisterima koji sadrže 14 tableta.
English: The efficacy results based on the endoscopic readings at the study sites were consistent with the results based on the central endoscopy readings.
Croatian: Rezultati djelotvornosti dobiveni na temelju očitanja endoskopskih nalaza u ispitivačkim centrima bili su dosljedni rezultatima dobivenim na temelju centralno očitanih endoskopskih nalaza.
English: Physical function and health-related quality of life Improvement in physical functioning was measured by the HAQ-DI.
Croatian: Fizička funkcija i kvaliteta života povezana sa zdravljem Poboljšanje fizičkih funkcija izmjereno je upitnikom HAQ-DI.
English: Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Croatian: Globalno postignuta statistička značajnost pri p ≤ 0,05 po unaprijed određenom step-down postupku testiranja.
English: Note: Reference group is administration of tofacitinib alone.
Croatian: Napomena: Referentna skupina je primjena samo tofacitiniba.
English: At month 12 in OCTAVE Open, 52% (25/48) and 45% (37/83) of these patients achieved remission, respectively.
Croatian: U 12. mjesecu ispitivanja OCTAVE Open, 52 % (25/48), odnosno 45 % (37/83) ovih bolesnika postiglo je remisiju.
English: Enrolled patients had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or a TNF inhibitor.
Croatian: Bolesnici uključeni u ispitivanje bili su prethodno neuspješno liječeni najmanje 1 konvencionalnom terapijom, uključujući kortikosteroide, imunomodulatore i/ili inhibitor TNF-a.
English: • Your doctor may decide to stop XELJANZ if XELJANZ does not work for you within 16 weeks.
Croatian: • Možda će liječnik odlučiti prekinuti Vaše liječenje lijekom XELJANZ ako XELJANZ ne bude djelovao unutar 16 tjedana.
English: What you need to know before you take XELJANZ
Croatian: Što morate znati prije nego počnete uzimati XELJANZ
English: • Inherited coagulation disorder
Croatian: • Nasljedni poremećaj koagulacije
English: If you forget to take XELJANZ
Croatian: Ako ste zaboravili uzeti XELJANZ
English: Tofacitinib is well-absorbed, with an oral bioavailability of 74%.
Croatian: Tofacitinib se dobro apsorbira uz oralnu bioraspoloživost od 74%.
English: There are limited data in patients aged 75 years and older.
Croatian: Podaci su ograničeni u bolesnika u dobi od 75 godina i starijih.
English: RA and PsA patients have an increased risk for cardiovascular disorders.
Croatian: Bolesnici s RA i PsA-om imaju povećan rizik od kardiovaskularnih poremećaja.
English: Tofacitinib had no effects on male fertility, sperm motility or sperm concentration.
Croatian: Tofacitinib nije imao učinaka na mušku plodnost, pokretljivost ili koncentraciju sperme.
English: Benign testicular interstitial (Leydig) cell tumours were observed in rats: benign Leydig cell tumours in rats are not associated with a risk of Leydig cell tumours in humans.
Croatian: Benigni tumori intersticijskih stanica testisa (Leydigovih stanica) uočeni su kod štakora; benigni tumori Leydigovih stanica u štakora nisu povezani s rizikom od tumora Leydigovih stanica u ljudi.
English: The possibility exists for tofacitinib to affect host defences against malignancies.
Croatian: Postoji mogućnost da tofacitinib utječe na obrambeni sustav domaćina protiv malignih bolesti.
English: Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection.
Croatian: Bolesnici s reumatoidnim artritisom koji uzimaju kortikosteroide mogu biti skloniji infekciji.
English: If you take more 11 mg prolonged-release tablets than you should, immediately tell your doctor or pharmacist.
Croatian: Ako uzmete više tableta s produljenim oslobađanjem od 11 mg nego što ste trebali, odmah obavijestite svog liječnika ili ljekarnika.
English: CYP Inducer Rifampicin
Croatian: Induktor CYP enzima Rifampicin
English: There was no evidence of a relationship between serious or opportunistic infections or herpes zoster and lymphocyte subset counts (see section 4.2 for absolute lymphocyte count monitoring).
Croatian: Nije bilo dokaza odnosa između ozbiljnih ili oportunističkih infekcija ili herpes zostera i broja limfocita u podskupinama (vidjeti dio 4.2 za nadzor apsolutnog broja limfocita).
English: Treatment groups (randomisation ratio)
Croatian: Ispitivane skupine (omjer randomizacije)
English: Your doctor should perform blood tests before you start taking XELJANZ, and after 4 to 8 weeks of treatment and then every 3 months, to determine if you have a low white blood cell (neutrophil or lymphocyte) count, or a low red blood cell count (anaemia).
Croatian: Vaš liječnik treba napraviti krvne pretrage prije nego počnete liječenje lijekom XELJANZ, nakon 4 do 8 tjedana liječenja i potom svaka 3 mjeseca kako bi se odredilo imate li nizak broj bijelih krvnih stanica (neutrofila ili limfocita) ili nizak broj crvenih krvnih stanica (anemiju).
English: Once daily Do not swallow the desiccant.
Croatian: Primjena jednom dnevno Nemojte progutati sredstvo za sušenje.
English: The carcinogenic potential of tofacitinib was assessed in 6-month rasH2 transgenic mouse carcinogenicity and 2-year rat carcinogenicity studies.
Croatian: Kancerogeni potencijal tofacitiniba ocijenjen je u šestomjesečnoj studiji na rasH2 transgeničnim miševima te u dvogodišnjoj studiji kancerogenosti na štakorima.
English: Tofacitinib is given orally with or without food.
Croatian: Tofacitinib se uzima peroralno, s hranom ili bez nje.
English: Drug hypersensitivity* Angioedema* Urticaria*
Croatian: Preosjetljivost na lijek*, Angioedem*, Urtikarija*
English: Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with tofacitinib.
Croatian: Bolesnike treba pomno nadzirati na razvoj znakova i simptoma infekcije tijekom i nakon liječenja tofacitinibom.
English: The risk of opportunistic infections is higher in Asian geographic regions (see section 4.8).
Croatian: Rizik od oportunističkih infekcija je veći na azijskom zemljopisnom području (vidjeti dio 4.8).
English: The enzymatic activity of CYP enzymes is reduced in RA patients due to chronic inflammation.
Croatian: Enzimska aktivnost CYP enzima smanjena je u bolesnika s RA zbog kronične upale.
English: Remission a
Croatian: Remisija a
English: The most common serious adverse reactions were serious infections (see section 4.4).
Croatian: Najčešće ozbiljne nuspojave bile su ozbiljne infekcije (vidjeti dio 4.4).
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMPa.
English: Changes in lipid parameters from baseline through the end of the study (6-24 months) in the controlled clinical studies in RA are summarised below:
Croatian: Promjene u lipidnim parametrima od početka do kraja ispitivanja (6 - 24 mjeseca) u kontroliranim kliničkim ispitivanjima RA sažete su u nastavku:
English: The decision to use live vaccines prior to tofacitinib treatment should take into account the pre-existing immunosuppression in a given patient.
Croatian: Kod odluke o primjeni živih cjepiva prije liječenja tofacitinibom treba uzeti u obzir postojeću imunosupresiju u pojedinog bolesnika.
English: Table 8: Proportion (%) of patients with an ACR response ORAL Solo: DMARD inadequate responders
Croatian: Tablica 8: Udio (%) bolesnika s ACR odgovorom ORAL Solo: Bolesnici s neodgovarajućim odgovorom na DMARD
English: Asian patients
Croatian: Bolesnici azijatskog podrijetla
English: A patient who develops a new infection during treatment with tofacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
Croatian: Bolesnik koji razvije novu infekciju tijekom liječenja tofacitinibom mora proći promptno i cjelovito dijagnostičko testiranje prikladno za imunokompromitiranog bolesnika i započeti odgovarajuću antimikrobnu terapiju te je bolesnika potrebno pomno nadzirati.
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0) 1 52 11 400
Croatian: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400
English: - The active substance is tofacitinib.
Croatian: - Djelatna tvar je tofacitinib.
English: If needed, your doctor may interrupt your XELJANZ treatment to reduce the risk of infection (white blood cell counts) or anaemia (red blood cell counts).
Croatian: Ako je potrebno, Vaš liječnik može prekinuti Vaše liječenje lijekom XELJANZ kako bi se smanjio rizik od infekcije (nizak broj bijelih krvnih stanica) ili anemije (nizak broj crvenih krvnih stanica).
English: Elevations in lipid parameters (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) were first assessed at 1 month following initiation of tofacitinib in the controlled double-blind clinical trials of RA.
Croatian: Povišenja u lipidnim parametrima (ukupni kolesterol, LDL kolesterol, HDL kolesterol, trigliceridi) prvo su ocjenjivana nakon mjesec dana od početka liječenja tofacitinibom u kontroliranim, dvostruko slijepim kliničkim ispitivanjima RA.
English: The metabolism of tofacitinib is primarily mediated by CYP3A4 with minor contribution from CYP2C19.
Croatian: Metabolizam tofacitiniba prvenstveno je posredovan enzimom CYP3A4 uz manji doprinos CYP2C19.
English: Leukopenia Lymphopenia Neutropenia
Croatian: Leukopenija Limfopenija Neutropenija
English: Caution should be exercised when considering initiation of tofacitinib treatment in patients with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST), particularly when initiated in combination with potentially hepatotoxic medicinal products such as MTX.
Croatian: Potreban je oprez prilikom razmatranja početka terapije tofacitinibom u bolesnika s povišenom alanin aminotransferazom (ALT) ili aspartat aminotransferazom (AST), osobito kad se terapija započinje u kombinaciji s potencijalno hepatotoksičnim lijekovima poput MTX-a.
English: In non-clinical studies, effects were observed on the immune and haematopoietic systems that were attributed to the pharmacological properties (JAK inhibition) of tofacitinib.
Croatian: U nekliničkim ispitivanjima uočeni su učinci na imunološki i hematopoetski sustav koji su bili pripisani farmakološkim svojstvima tofacitiniba (inhibicija JAK-a).
English: In those patients experiencing liver enzyme elevation, modification of treatment regimen, such as reduction in the dose of concomitant DMARD, interruption of tofacitinib, or reduction in tofacitinib dose, resulted in decrease or normalisation of liver enzymes.
Croatian: U onih bolesnika koji su iskusili porast jetrenih enzima, promjena režima liječenja poput sniženja doze istodobno primijenjenog DMARD-a, prekid primjene tofacitiniba ili sniženje doze tofacitiniba rezultirao je sniženjem ili normalizacijom vrijednosti jetrenih enzima.
English: All these lymphocyte subset changes returned toward baseline after temporary discontinuation of treatment.
Croatian: Sve te promjene na poskupinama limfocita vratile su se prema početnim vrijednostima nakon privremenog prekida liječenja.
English: Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving tofacitinib.
Croatian: Ozbiljne i ponekad smrtonosne infekcije zbog bakterijskih, mikobakterijskih, invazivnih gljivičnih, virusnih ili drugih oportunističkih patogena prijavljene su u bolesnika koji primaju tofacitinib.
English: If you are not sure regarding any of the information provided above, please contact your doctor.
Croatian: Ako niste sigurni odnose li se gore navedene informacije na Vas, obratite se svom liječniku.
English: Changes in total serum IgG, IgM, and IgA levels over 6-month tofacitinib dosing in patients with RA were small, not dose-dependent and similar to those seen on placebo, indicating a lack of systemic humoral suppression.
Croatian: Promjene u ukupnim serumskim razinama IgG, IgM i IgA tijekom 6-mjesečnog doziranja tofacitiniba u bolesnika s RA bile su male, nisu bile ovisne o dozi i bile su slične onima nađenim uz placebo, ukazujući na nedostatak sistemske humoralne supresije.
English: Vaccination with live vaccines should occur at least 2 weeks but preferably 4 weeks prior to initiation of tofacitinib or in accordance with current vaccination guidelines regarding immunomodulatory medicinal products.
Croatian: Cijepljenje živim cjepivima treba provesti najmanje 2 tjedna, a poželjno 4 tjedna prije početka liječenja tofacitinibom ili prema trenutnim smjernicama za cijepljenje obzirom na primjenu imunomodulatornih lijekova.
English: The PK profile of tofacitinib is characterised by rapid absorption (peak plasma concentrations are reached within 0.5-1 hour), rapid elimination (half-life of ~3 hours) and dose-proportional increases in systemic exposure.
Croatian: Farmakokinetički profil tofacitiniba karakteriziran je brzom apsorpcijom (vršne koncentracije u plazmi dostižu se unutar 0,5 do 1 sat), brzom eliminacijom (poluvijek od približno 3 sata) i porastom sistemske izloženosti proporcionalnom dozi.
English: • For patients, who have previously taken biologic medicines to treat ulcerative colitis (such as those that block the activity of tumour necrosis factor in the body) and these medicines did not work, the doctor may decide to continue giving 10 mg twice a day.
Croatian: • U slučaju bolesnika koji su prethodno uzimali biološke lijekove za liječenje ulceroznog kolitisa (poput onih koji sprječavaju aktivnost čimbenika nekroze tumora u tijelu), a ti im lijekovi nisu djelovali, liječnik može odlučiti da trebaju nastaviti s primjenom 10 mg dva puta dnevno.
English: Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection.
Croatian: Rizik od infekcije može biti veći uz porast stupnjeva limfopenije, a kod procjene rizika od infekcije pojedinog bolesnika treba uzeti u obzir i broj limfocita.
English: Each prolonged-release tablet contains 152.23 mg of sorbitol.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 152,23 mg sorbitola.
English: Study PsA-II (OPAL BEYOND) evaluated 394 patients who had discontinued a TNF inhibitor due to lack of efficacy or intolerance; 36.0% had a previous inadequate response to > 1 biological DMARD.
Croatian: Ispitivanje PsA-II (OPAL BEYOND) ocjenjivalo je 394 bolesnika koji su prestali primati inhibitor TNF-a zbog izostanka djelotvornosti ili zbog nepodnošenja; 36,0% bolesnika imalo je prethodno neodgovarajući odgovor na > 1 biološki DMARD.
English: No dose adjustment is required in patients aged 65 years and older.
Croatian: Nije potrebna prilagodba doze u bolesnika u dobi od 65 godina i starijih.
English: Common ≥1/100 to <1/10
Croatian: Često ≥ 1/100 i < 1/10
English: After treatment with tofacitinib in RA patients, rapid decreases in serum C-reactive protein (CRP) were observed and maintained throughout dosing.
Croatian: Nakon liječenja tofacitinibom u bolesnika s RA, uočena su brza smanjenja u vrijednosti serumskog C-reaktivnog proteina (CRP) koja su se održala kroz doziranje.
English: Take your next tablet at the usual time and continue as before.
Croatian: Sljedeću tabletu uzmite u uobičajeno vrijeme, a sve daljnje doze nastavite uzimati prema uobičajenom rasporedu.
English: Cases of opportunistic infections have been reported (see section 4.4).
Croatian: Prijavljeni su slučajevi oportunističkih infekcija (vidjeti dio 4.4).
English: Events of interstitial lung disease (some of which had a fatal outcome) have been reported in patients treated with tofacitinib in RA clinical trials and in the post-marketing setting although the role of Janus kinase (JAK) inhibition in these events is not known.
Croatian: Slučajevi intersticijske bolesti pluća (neki od njih s fatalnim ishodom) prijavljeni su u bolesnika liječenih tofacitinibom u kliničkim ispitivanjima RA-a i u postmarketinškom praćenju, premda uloga inhibicije Janus kinaze (JAK) u ovim slučajevima nije poznata.
English: Patients with latent TB, who test positive, should be treated with standard antimycobacterial therapy before administering tofacitinib.
Croatian: Bolesnike s latentnom tuberkulozom, čiji je test pozitivan, treba liječiti standardnom antimikobakterijskom terapijom prije primjene tofacitiniba.
English: Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers.
Croatian: Istodobna primjena tofacitiniba nije imala utjecaj na farmakokinetiku oralnih kontraceptiva, levonorgestrela i etinilestradiola u zdravih ženskih dobrovoljaca.
English: Lab value (g/dL)
Croatian: Laboratorijska vrijednost (g/dl)
English: Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5).
Croatian: Tofacitinib se može davati kao monoterapija kada se MTX ne podnosi ili kada liječenje MTX-om nije prikladno (vidjeti dijelove 4.4 i 4.5).
English: If therapy is interrupted, restarting treatment with tofacitinib can be considered.
Croatian: Ako dođe do privremenog prekida terapije, može se razmotriti ponovno liječenje tofacitinibom.
English: • who have resided or travelled in areas of endemic TB.
Croatian: • prebivali ili putovali u područja s endemskom tuberkulozom.
English: If taken with XELJANZ, they could alter the level of XELJANZ in your body, and the dose of XELJANZ may require adjustment.
Croatian: Ako se uzmu zajedno s lijekom XELJANZ, može doći do promjene razine lijeka XELJANZ u Vašem tijelu, zbog čega može biti potrebna prilagodba doze.
English: Excipient with known effect Each film-coated tablet contains 118.88 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna filmom obložena tableta sadrži 118,88 mg laktoze.
English: The most common infections resulting in discontinuation of therapy were herpes zoster and pneumonia.
Croatian: Najčešće infekcije koje su rezultirale prekidom liječenja bile su herpes zoster i pneumonija.
English: Health-related quality of life was assessed by the Short Form Health Survey (SF-36).
Croatian: Short Form Health Survey, SF-36).
English: Each pack contains 56, 112, or 182 tablets and each bottle contains 60 or 180 tablets.
Croatian: Jedno pakiranje sadrži 56, 112 ili 182 tablete, a jedna boca sadrži 60 ili 180 tableta.
English: Since tofacitinib is metabolised by CYP3A4, interaction with medicinal products that inhibit or induce CYP3A4 is likely.
Croatian: S obzirom da se tofacitinib metabolizira putem enzima CYP3A4, vjerojatna je interakcija s lijekovima koji inhibiraju ili induciraju CYP3A4.
English: • with recurrent infections,
Croatian: • s rekurentnim infekcijama,
English: Less than or equal to 2 g/dL decrease and greater than or equal to 9.0 g/dL
Croatian: Pad manji od ili jednak 2 g/dl i vrijednost veća od ili jednaka 9,0 g/dl
English: Excipient with known effect Each film-coated tablet contains 59.44 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna filmom obložena tableta sadrži 59,44 mg laktoze.