FrancophonIA/ELRC3.0 huggingface dataset:
English: • infection of the urinary system
Croatian: • infekcije u mokraćnom sustavu
English: Compared to healthy volunteers, patients with mild hepatic impairment had approximately 111% (95% CI: 45% to 283%) higher plasma eltrombopag AUC(0-) values and patients with moderate hepatic impairment had approximately 183% (95% CI: 90% to 459%) higher plasma eltrombopag AUC(0-) values.
Croatian: U usporedbi sa zdravim dobrovoljcima, bolesnici s blagim oštećenjem jetre imali su približno 111% (95% CI: 45% do 283%) više vrijednosti AUC(0-) eltrombopaga u plazmi, dok su bolesnici s umjerenim oštećenjem jetre imali 183% (95% CI: 90% do 459%) više vrijednosti AUC(0-) eltrombopaga u plazmi.
English: Five of the 6 patients treated with eltrombopag experienced the thrombotic complication at a platelet count >200,000/µl and within 30 days of the last dose of eltrombopag.
Croatian: Pet od 6 bolesnika liječenih eltrombopagom je imalo trombotičke komplikacije pri broju trombocita >200 000/µl i unutar 30 dana od posljednje doze eltrombopaga.
English: Sustained response was seen in 50% of the initial responders during 20 out of 24 weeks in the PETIT 2 study and 15 out of 24 weeks in the PETIT Study.
Croatian: Održani odgovor je uočen kod 50% bolesnika s odgovorom na početku tijekom 20 od 24 tjedna u ispitivanju PETIT 2 i tijekom 15 od 24 tjedna u ispitivanju PETIT.
English: It is not known whether eltrombopag/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se eltrombopag ili njegovi metaboliti u majčino mlijeko.
English: Eltrombopag was detected in the plasma of all F1 rat pups for the entire 22 hour sampling period following administration of medicinal product to the F0 dams, suggesting that rat pup exposure to eltrombopag was likely via lactation.
Croatian: Eltrombopag je detektiran u plazmi svih F1 mladunaca štakora, tijekom sva 22 sata uzimanja uzoraka nakon primjene lijeka u F0 grupi, što upućuje na to da je izloženost mladunaca eltrombopagu nastupila putem mlijeka (laktacijom).
English: Use lowest dose of eltrombopag and/or concomitant ITP treatment to maintain platelet counts that avoid or reduce bleeding.
Croatian: Primijeniti najnižu dozu eltrombopaga i/ili popratnog ITP liječenja za održavanje broja trombocita na razini kojom se može izbjeći ili smanjiti krvarenje.
English: QTc interval prolongation has been reported in clinical studies of patients with ITP and thrombocytopenic patients with HCV.
Croatian: Produljenje QTc intervala je zabilježeno u kliničkim ispitivanjima bolesnika s ITP-om i trombocitopeničnih bolesnika s HCV-om.
English: When switching between the tablet and powder for oral suspension formulations, platelet counts should be monitored weekly for 2 weeks.
Croatian: Kada bolesnik prelazi s formulacije tablete na formulaciju praška za oralnu suspenziju, potrebno je pratiti broj trombocita svaki tjedan tijekom 2 tjedna.
English: Eltrombopag can be administered in addition to other ITP medicinal products.
Croatian: Eltrombopag se može primijeniti uz druge lijekove za liječenje ITP-a.
English: The proportion of eltrombopag-treated patients with any bleeding (Grades 1-4) and clinically significant bleeding (Grades 2-4) was reduced from baseline by approximately 50% from Day 15 to the end of treatment throughout the 6-month treatment period.
Croatian: Udio bolesnika liječenih eltrombopagom s bilo kojim oblikom krvarenja (stupanj 1-4) i klinički značajnim krvarenjem (stupanj 2-4) smanjen je u odnosu na početnu vrijednost za otprilike 50% od 15. dana do kraja ispitivanja, tijekom svih 6 mjeseci liječenja.
English: The administration of eltrombopag tablet or powder for oral suspension formulations with a highcalcium meal (e.g. a meal that included dairy products) significantly reduced plasma eltrombopag AUC0-∞ and Cmax.
Croatian: Primjena eltrombopag tablete ili praška za oralnu suspenziju uz obrok s visokim udjelom kalcija (npr. obrok koji je uključivao mliječne proizvode) značajno je smanjio plazmatski AUC0-∞ i Cmax eltrombopaga.
English: • digestive system problems including being sick (vomiting), change in appetite (increased or decreased), stomach pain/discomfort, swollen stomach, passing wind, change in stool colour
Croatian: • tegobe s probavnim sustavom uključujući mučninu (povraćanje), promjenu apetita (povećani ili smanjeni), bol/nelagodu u trbuhu, nadutost trbuha, vjetrove, promjenu boje stolice
English: 30 sachets.
Croatian: 30 vrećica.
English: If new cytogenetic abnormalities are detected, it must be evaluated whether continuation of eltrombopag is appropriate (see sections 4.4 and 4.8).
Croatian: Ako se uoče nove citogenetske abnormalnosti, mora se ocijeniti je li primjeren nastavak liječenja eltrombopagom (vidjeti dijelove 4.4 i 4.8).
English: b p-value a a Logistic regression model adjusted for randomisation stratification variables b 21 out of 63 (33%) patients treated with eltrombopag who were taking an ITP medicinal product at baseline permanently discontinued all baseline ITP medicinal products.
Croatian: b p-vrijednost a a Model logističke regresije prilagođen za varijable randomizirane u stratuse b 21 od 63 (33%) bolesnika liječenih eltrombopagom koji su uzimali druge lijekove za liječenje ITP na početku ispitivanja, trajno je prekinulo sve prethodno liječenje za ITP.
English: TRA115450 (PETIT2): The primary endpoint was a sustained response, defined as the proportion of patients receiving eltrombopag, compared to placebo, achieving platelet counts ≥50,000/µl for at least 6 out of 8 weeks (in the absence of rescue therapy), between weeks 5 to 12 during the double-blind randomised period.
Croatian: TRA115450 (PETIT2): Mjera primarnog ishoda bila je održani odgovor, definiran kao udio bolesnika koji su primali eltrombopag, u usporedbi s placebom, i koji su postigli broj trombocita ≥50 000/µl tijekom najmanje 6 od 8 tjedana (bez simptomatske terapije), između 5. i 12. tjedna tijekom dvostruko slijepog randomiziranog razdoblja.
English: • Pull back on the plunger to the 20 ml mark on the syringe.
Croatian: • Povucite klip natrag do oznake za 20 ml na štrcaljki.
English: Immune (primary) thrombocytopenia (ITP) studies
Croatian: Ispitivanja imunosne (primarne) trombocitopenije (ITP)
English: The sachets are co-packaged in a kit with a 40 ml HDPE mixing bottle, and 30 single-use 20 ml oral dosing syringes (polypropylene/silicon rubber) with 1 ml graduations.
Croatian: Vrećice su pakirane zajedno u kompletu s HDPE bočicom za miješanje od 40 ml i 30 dozirnih štrcaljki za usta od 20 ml za jednokratnu uporabu (polipropilen/silikonska guma) s oznakama od 1 ml.
English: Very common side effects that may show up in blood tests: • decreased number of red blood cells (anaemia)
Croatian: Vrlo česte nuspojave koje se mogu vidjeti u krvnim pretragama: • smanjeni broj crvenih krvnih stanica (anemija)
English: Revolade is indicated for the treatment of patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
Croatian: Revolade je indiciran za liječenje bolesnika u dobi od 1 godine i starijih s primarnom imunosnom trombocitopenijom (ITP) u trajanju od 6 mjeseci ili duže od dijagnoze i koji su refrakterni na druge vidove liječenja (npr. kortikosteroide, imunoglobuline) (vidjeti dijelove 4.2 i 5.1).
English: Retinal haemorrhages, mostly Grade 1 or 2, have been reported in HCV patients receiving interferon, ribavirin and eltrombopag (2% of the eltrombopag group and 2% of the placebo group.
Croatian: Retinalna krvarenja, većinom 1. i 2. stupnja zabilježena su u bolesnika s HCV-om koji su primali interferon, ribavirin i eltrombopag (2% u skupini koja je primala eltrombopag i 2% u placebo skupini).
English: Eltrombopag should only be administered to such patients after careful consideration of the expected benefits in comparison with the risks.
Croatian: Takvim bolesnicima eltrombopag se može propisati samo nakon pažljivog razmatranja očekivanih koristi u odnosu na rizike.
English: If the use of eltrombopag is deemed necessary for ITP patients with hepatic impairment the starting dose must be 25 mg once daily.
Croatian: Ako se primjena eltrombopaga smatra neophodnom za bolesnike s ITP-om s oštećenjem jetre, početna doza mora biti 25 mg jednom dnevno.
English: If bilirubin is elevated fractionation should be performed.
Croatian: Ako je bilirubin povišen, potrebno je provesti određivanje frakcija bilirubina.
English: Patients with bleeding (WHO Grades 1-4) at any time during 6 months, n (%)
Croatian: Bolesnici s krvarenjem (WHO stupanj 1-4) u bilo koje vrijeme tijekom 6 mjeseci, n (%)
English: There is a theoretical concern that TPO-R agonists may stimulate the progression of existing haematological malignancies such as MDS.
Croatian: Postoji teorijska zabrinutost da bi agonisti trombopoetinskih receptora (TPO-R) mogli stimulirati progresiju postojećih hematoloških zloćudnih bolesti poput MDS-a.
English: Use lowest dose of eltrombopag as necessary to avoid dose reductions of peginterferon.
Croatian: Primijeniti najnižu dozu eltrombopaga koja je potrebna da bi se izbjeglo smanjivanje doze peginterferona.
English: • skin problems including small red or purple spots caused by bleeding into the skin (petechiae)
Croatian: • kožni problemi uključujući male crvene ili ljubičaste točkice uzrokovane krvarenjem u kožu
English: SAA is a disease in which the bone marrow is damaged, causing a deficiency of the red blood cells (anaemia), white blood cells (leukopenia) and platelets (thrombocytopenia).
Croatian: Teška aplastična anemija je bolest kod koje je koštana srž oštećena, što uzrokuje nedostatak crvenih krvnih stanica (anemija), bijelih krvnih stanica (leukopenija) i krvnih pločica (trombocitopenija).
English: • Pull back on the plunger to the 10 ml mark on the syringe.
Croatian: • Povucite klip natrag do oznake za 10 ml na štrcaljki.
English: Median platelet counts at baseline were 16,000/l for both treatment groups and in the eltrombopag group were maintained above 50,000/µl at all on-therapy visits starting at Day 15; in contrast, median platelet counts in the placebo group remained <30,000/µl throughout the study.
Croatian: Medijan početnog broja trombocita je iznosio 16 000/l za obje ispitivane skupine, i u skupini liječenoj eltrombopagom njihov je broj održavan iznad 50 000/µl na svim kontrolnim pregledima tijekom liječenja počevši od 15. dana; nasuprot tome medijan broja trombocita u placebo skupini ostao je <30 000/µl tijekom cijelog ispitivanja.
English: Hepatic decompensation in patients with chronic hepatitis C: Monitoring is required in patients with low albumin levels (≤35 g/l) or with MELD score ≥10 at baseline.
Croatian: Dekompenzacija jetre u bolesnika s kroničnim hepatitisom C: potrebno je pratiti bolesnike s niskim početnim razinama albumina (≤35 g/l) ili MELD indeksom ≥10.
English: The influence of gender on eltrombopag pharmacokinetics was evaluated using population pharmacokinetics analysis in 635 patients with HCV (260 females).
Croatian: Utjecaj spola na farmakokinetiku eltrombopaga procijenjen je koristeći analizu populacijske farmakokinetike na 635 bolesnika s HCV-om (260 žena).
English: Clean the mixing equipment.
Croatian: 15. Očistite opremu za miješanje.
English: Platelet counts should be monitored when combining eltrombopag with other medicinal products for the treatment of ITP in order to avoid platelet counts outside of the recommended range (see section 4.2).
Croatian: Potrebno je praćenje broja trombocita kada se eltrombopag kombinira s drugim lijekovima za liječenje ITP-a, da bi se izbjegao poremećaj broja trombocita izvan preporučenog raspona (vidjeti dio 4.2).
English: Don't breast-feed while you are taking Revolade.
Croatian: Ne dojite dok uzimate Revolade.
English: 75 mg a AUC(0-) and Cmax based on population PK post-hoc estimates.
Croatian: 75 mg a AUC(0-) i Cmax bazirani na post-hoc procjenama farmakokinetike u populaciji.
English: • Revolade is used to treat a bleeding disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and above who have already taken other medicines (corticosteroids or immunoglobulins), which have not worked.
Croatian: • Revolade se može koristiti u liječenju poremećaja zgrušavanja krvi tj. krvarenja koje zovemo imunosna (primarna) trombocitopenija (ITP) u bolesnika (u dobi od 1 godine i stariji) koji su već uzimali druge lijekove (kortikosteroide ili imunoglobuline), a bez odgovarajućeg učinka.
English: If these side effects become severe, please tell your doctor, pharmacist or nurse.
Croatian: Ako ove nuspojave postanu ozbiljne, recite svom liječniku, ljekarniku ili medicinskoj sestri.
English: The influence of Asian ethnicity (such as Chinese, Japanese, Taiwanese, Korean, and Thai) on the pharmacokinetics of eltrombopag was evaluated using a population pharmacokinetic analysis in 635 patients with HCV (145 Asians and 69 South Asians).
Croatian: Utjecaj pripadnosti azijskoj etničkoj skupini (poput Kineza, Japanaca, Tajvanaca, Korejaca i Tajlanđana) na farmakokinetiku eltrombopaga je procijenjen koristeći analizu populacijske farmakokinetike u 635 bolesnika s HCV-om (145 iz Azije i 69 iz južne Azije).
English: The standard eltrombopag dose adjustment, either decrease or increase, would be 25 mg once daily.
Croatian: Uobičajeni način prilagođavanja doze eltrombopaga, bilo da se radi o sniženju ili povišenju doze, trebao bi biti za 25 mg dnevno.
English: Administration of eltrombopag concomitantly with antacids and other products containing polyvalent cations such as dairy products and mineral supplements significantly reduces eltrombopag exposure (see section 4.2).
Croatian: Istodobna primjena eltrombopaga s antacidima i ostalim proizvodima koji sadrže polivalentne katione poput mliječnih proizvoda ili preparata minerala, značajno smanjuju izloženost eltrombopagu (vidjeti dio 4.2).
English: No dose adjustment is required for thrombocytopenic patients with chronic HCV and mild hepatic impairment (Child-Pugh score ≤6).
Croatian: Nije potrebna prilagodba doze u bolesnika s trombocitopenijom i kroničnim HCV-om i blagim oštećenjem jetre (≤6 bodova po Child-Pugh ljestvici).
English: Patients receiving ITP therapy at baseline (n) Patients who attempted to reduce or discontinue baseline therapy, n (%)
Croatian: Bolesnici koji su primali terapiju za ITP na početku ispitivanja (n) Bolesnici kojima je pokušano smanjenje ili prekid ishodišnog liječenja, n (%)
English: People who have low platelet counts as well as advanced chronic (long-term) liver disease are more at risk of side effects, including life-threatening liver damage and blood clots.
Croatian: Osobe koje imaju niske razine trombocita kao i uznapredovalu kroničnu (dugotrajnu) bolest jetre izložene su većem riziku od nuspojava, što uključuje i po život opasno oštećenje jetre i krvne ugruške.
English: There are limited data on the use of eltrombopag in ITP patients aged 65 years and older and no clinical experience in ITP patients aged over 85 years.
Croatian: Podaci o primjeni eltrombopaga u bolesnika s ITP-om u dobi od 65 godina i starijih su ograničeni i nema kliničkog iskustva s primjenom eltrombopaga u bolesnika s ITP-om starijih od 85 godina.
English: Frequency Adverse reaction Infections and infestations Very common
Croatian: Infekcije i infestacije vrlo često nazofaringitis
English: Haematological response was defined as meeting one or more of the following criteria: 1) platelet count increases to 20,000/µl above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks; 2) haemoglobin increase by >1.5g/dl, or a reduction in ≥4 units of red blood cell (RBC) transfusions for 8 consecutive weeks; 3) absolute neutrophil count (ANC) increase of 100% or an ANC increase >0.5 x 10
Croatian: Hematološki odgovor bio je definiran kao ispunjavanje jednog ili više od sljedećih kriterija: 1) povećanje broja trombocita do 20 000/μl iznad početne vrijednosti ili stabilni brojevi trombocita uz neovisnost o transfuziji u trajanju od najmanje 8 tjedana; 2) povišenje hemoglobina za >1,5 g/dl, ili smanjenje u ≥4 jedinice transfuzije eritrocita tijekom 8 uzastopnih tjedana; 3) povišenje apsolutnog broja neutrofila (ABN) od 100% ili povišenje ABN-a od >0,5 x 10
English: • Turn the mixing bottle upside-down together with the syringe.
Croatian: • Okrenite bočicu za miješanje naopako zajedno sa štrcaljkom.
English: Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician.
Croatian: Bolesnici bi trebali periodički biti klinički evaluirani i nadležni liječnik bi trebao, ovisno o nalazima, donijeti odluku o nastavku liječenja za svakog bolesnika ponaosob.
English: Eltrombopag was studied in a single-arm, single-centre open-label study in 43 patients with severe aplastic anaemia with refractory thrombocytopenia following at least one prior immunosuppressive therapy (IST) and who had a platelet count ≤30,000/µl.
Croatian: Eltrombopag se proučavao u otvorenom ispitivanju s jednom skupinom koje se provodilo u jednom centru, u 43 bolesnika s teškom aplastičnom anemijom s refrakternom trombocitopenijom nakon najmanje jedne prethodne imunosupresivne terapije (IST), koji su imali broj trombocita ≤30 000/μl.
English: Bone marrow reticulin formation and risk of bone marrow fibrosis
Croatian: Retikulinska formacija koštane srži i rizik od fibroze koštane srži
English: The sudden blocking of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.
Croatian: Iznenadno začepljenje krvne žile krvnim ugruškom je manje česta nuspojava koja se može javiti u do 1 na 100 osoba.
English: The objective of treatment with eltrombopag should not be to normalise platelet counts.
Croatian: Cilj liječenja eltrombopagom ne bi trebao biti normalizacija broja trombocita.
English: Treatment with eltrombopag should be reinitiated in accordance with dosing and administration recommendations (see section 4.2).
Croatian: Potrebno je ponovno započeti liječenje eltrombopagom u skladu s preporukama o doziranju i načinu primjene (vidjeti dio 4.2).
English: Carcinogenicity and mutagenicity
Croatian: Karcinogenost i mutagenost
English: Plasma eltrombopag Cmax and AUC(0-) estimates for patients with HCV enrolled in the phase III studies are presented for each dose studied in Table 9.
Croatian: Procjene Cmax i AUC(0-) eltrombopaga u plazmi za bolesnike s HCV-om uključene u fazu III ispitivanja za svaku ispitivanu dozu prikazane su u tablici 9.
English: • decreased levels of white blood cells
Croatian: • smanjena razina bijelih krvnih stanica
English: At baseline, more than 70% of ITP patients in each treatment group reported any bleeding (WHO Grades 1-4) and more than 20% reported clinically significant bleeding (WHO Grades 2-4), respectively.
Croatian: Na početku ispitivanja više od 70% bolesnika s ITP-om u svakoj ispitivanoj skupini prijavilo je bilo koji oblik krvarenja (WHO stupanj 1-4), a više od 20% je prijavilo klinički značajno krvarenje (WHO stupanj 2-4).
English: Stop eltrombopag; increase the frequency of platelet monitoring to twice weekly.
Croatian: Prekinuti primjenu eltrombopaga, povećati učestalost praćenja trombocita na dva puta tjedno.
English: Revolade can make you dizzy and have other side effects that make you less alert.
Croatian: Od lijeka Revolade možete osjećati omaglicu te imati druge nuspojave koje Vam mogu smanjiti pozornost.
English: The effectiveness and safety of Revolade have not been established for the treatment of thrombocytopenia due to MDS.
Croatian: Učinkovitost i sigurnost Revoladea nisu utvrđene za liječenje trombocitopenije koja je posljedica MDS-a.
English: In both RAISE and TRA100773B the response to eltrombopag relative to placebo was similar irrespective of ITP medicinal product use, splenectomy status and baseline platelet count (≤15,000/µl, >15,000/µl) at randomisation.
Croatian: U oba ispitivanja - RAISE i TRA100773B, odgovor na eltrombopag u odnosu na placebo je bio sličan, bez obzira na primjenu drugih lijekova za liječenje ITP-a, splenektomiranost bolesnika ili početni broj trombocita (≤15 000/µl, >15 000/µl) na početku randomizacije.
English: If the patient develops new or worsening morphological abnormalities or cytopenia(s), treatment with eltrombopag should be discontinued and a bone marrow biopsy considered, including staining for fibrosis.
Croatian: Ukoliko bolesnik razvije pogoršanje ili nove morfološke abnormalnosti ili citopeniju, liječenje eltrombopagom treba prekinuti i razmotriti biopsiju koštane srži, uključujući bojanje kojim se otkriva fibroza.
English: The safety of eltrombopag in severe aplastic anaemia was assessed in a single-arm, open-label study (N=43) in which 11 patients (26%) were treated for >6 months and 7 patients (21%) were treated for >1 year.
Croatian: Sigurnost eltrombopaga kod teške aplastične anemije ocijenjena je u otvorenom ispitivanju s jednom skupinom (N=43) u kojem se 11 bolesnika (26%) liječilo >6 mjeseci, a 7 bolesnika (21%) liječilo se >1 godine.
English: In a small number of ITP patients, eltrombopag treatment was discontinued due to bone marrow reticulin (see section 4.4).
Croatian: Kod malog broja bolesnika s ITP-om liječenje eltrombopagom je prekinuto zbog umnožavanja retikulina u koštanoj srži (vidjeti dio 4.4).
English: • skin discolouration
Croatian: • diskoloracija kože
English: Plasma eltrombopag AUC(0-) and Cmax estimates for ITP patients are presented (Table 8).
Croatian: Prikazani su AUC(0-) eltrombopaga u plazmi i procjene Cmax za bolesnike s ITP-om (tablica 8).
English: • sleep disorders, abnormal drowsiness, depression, anxiety
Croatian: • poremećaji spavanja, neuobičajena omamljenost, depresija, tjeskoba
English: Forty-two to 60% of the eltrombopag-treated patients in the RAISE study were receiving 75 mg from Day 29 to the end of treatment.
Croatian: Četrdeset dva do 60% bolesnika liječenih eltrombopagom u RAISE studiji primalo je dozu lijeka od 75 mg, od 29. dana do kraja ispitivanog perioda liječenja.
English: Very common side effects that may show up in the blood tests • abnormal changes to the cells in your bone marrow
Croatian: Vrlo česte nuspojave koje se mogu vidjeti u krvnim pretragama • abnormalne promjene stanica u Vašoj koštanoj srži
English: Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C infection.
Croatian: Sigurnost i djelotvornost primjene eltrombopaga nisu utvrđene za primjenu lijeka u kombinaciji s izravno djelujućim antivirusnim lijekovima koji su odobreni za liječenje kronične infekcije hepatitisom C.
English: Caution should be exercised in these patients (see section 4.4).
Croatian: Potreban je oprez pri primjeni lijeka kod tih bolesnika (vidjeti dio 4.4).
English: How to take Revolade
Croatian: Kako uzimati Revolade
English: • swelling in the hands or feet
Croatian: • trnci ili utrnulost u rukama ili nogama
English: In vitro studies suggest that CYP1A2 and CYP2C8 are responsible for oxidative metabolism of eltrombopag.
Croatian: In vitro ispitivanja upućuju na to da su CYP1A2 i CYP2C8 odgovorni za oksidativni metabolizam eltrombopaga.
English: Make sure the plunger is pushed all the way into the syringe.
Croatian: Provjerite da je klip gurnut u štrcaljku do kraja.
English: The TPO-R is predominantly expressed on the surface of cells of the myeloid lineage.
Croatian: TPO-R su prvenstveno prisutni na površini stanica mijeloidne loze.
English: These tests will be repeated at intervals while you are taking it.
Croatian: Ove će se pretrage ponavljati redovito tijekom uzimanja ovog lijeka.
English: These may affect up to 1 in 10 people.
Croatian: Mogu se javiti u do 1 na 10 osoba.
English: If the abnormalities are confirmed, serum liver tests should be monitored until the abnormalities resolve, stabilise, or return to baseline levels.
Croatian: Ako se abnormalne vrijednosti jetrenih enzima potvrde ponovnim testiranjem, jetrene enzime treba pratiti do nestanka tih abnormalnih vrijednosti, stabilizacije ili vraćanja na početne vrijednosti.