FrancophonIA/ELRC3.0 huggingface dataset:
English: The median peak dabigatran exposure in the investigated healthy subjects was in the range of a twice daily administration of 150 mg dabigatran etexilate in patients.
Croatian: Medijan vršne izloženosti dabigatranu u zdravih ispitanika bio je u rasponu primjene 150 mg dabigatraneteksilata dvaput dnevno u bolesnika.
English: In a subgroup of 6 phase I subjects, idarucizumab was administered a second time, two months after the first administration.
Croatian: U podskupini od 6 ispitanika u ispitivanjima faze I, idarucizumab je primijenjen drugi put, dva mjeseca nakon prve primjene.
English: Restricted to hospital use only.
Croatian: Samo za bolničku primjenu.
English: The highest single dose of Praxbind studied in healthy subjects was 8 g. No safety signals have been identified in this group.
Croatian: Najviša jednokratna doza Praxbinda ispitana u zdravih dobrovoljaca bila je 8 g.
English: In patients with hereditary fructose intolerance there is a risk for serious adverse reactions, which must be weighed against the benefit of an emergency treatment with Praxbind.
Croatian: U bolesnika s nasljednom nepodnošljivošću fruktoze postoji rizik od ozbiljnih nuspojava koji se mora odvagnuti u odnosu na korist od hitnog liječenja Praxbindom.
English: An impact of hepatic impairment, assessed by hepatic injury as determined by elevated liver function tests, on the pharmacokinetics of idarucizumab has not been observed.
Croatian: Nije opaženo da oštećenje jetre, procijenjeno prema oštećenju jetre utvrđenom po povišenim vrijednostima na testovima jetrene funkcije, utječe na farmakokinetiku idarucizumaba.
English: Reversal was only evaluable for those patients showing prolonged coagulation times prior to idarucizumab treatment.
Croatian: Poništenje učinka moglo se procijeniti samo u onih bolesnika koji su prije liječenja idarucizumabom imali produljeno vrijeme koagulacije.
English: OTHER - Printing on inside of lid
Croatian: DRUGO - ispis na unutarnjoj strani poklopca
English: What Praxbind is used for
Croatian: Za što se Praxbind koristi
English: In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests have occurred up to 24 hours after administration of idarucizumab (see section 5.1).
Croatian: Ponovna pojava plazmatskih koncentracija nevezanog dabigatrana i istodobno produljenje vrijednosti koagulacijskih testova pojavili su se u podskupini bolesnika do 24 sati nakon primjene idarucizumaba (vidjeti dio 5.1).
English: Dabigatran prolongs the clotting time of coagulation markers such as diluted Thrombin Time (dTT), Thrombin Time (TT), activated Partial Thromboplastin Time (aPTT) and Ecarin Clotting Time (ECT), which provide an approximate indication of the anticoagulation intensity.
Croatian: Dabigatran produžuje vrijeme zgrušavanja koagulacijskih markera poput razrijeđenog trombinskog vremena (dTT), trombinskog vremena (TT), aktiviranog parcijalnog tromboplastinskog vremena (aPTT) i ekarinskog vremena zgrušavanja (ECT), što pruža približan uvid u intenzitet antikoagulacije.
English: Therefore, in patients with hereditary fructose intolerance the risk of treatment with Praxbind must be weighed against the potential benefit of such an emergency treatment.
Croatian: Stoga se u bolesnika s nasljednom nepodnošljivošću fruktoze mora odvagnuti rizik od liječenja Praxbindom naspram potencijalne koristi od ovakvog hitnog liječenja.
English: No dose adjustment is required in patients with hepatic injury (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem jetre (vidjeti dio 5.2).
English: Idarucizumab treatment normalised both thrombin lag time ratio and time to peak ratio to baseline levels as determined 0.5 to 12 hours after the end of the idarucizumab infusion.
Croatian: Liječenje idarucizumabom normaliziralo je i omjer vremena kašnjenja početka stvaranja trombina te omjer vremena i vršne vrijednosti u odnosu na početne vrijednosti kao što se utvrdilo 0,5 i 12 sati nakon završetka infuzije idarucizumaba.
English: 24 hours after the idarucizumab infusion, re-administration of dabigatran etexilate resulted in expected anticoagulant activity.
Croatian: Ponovna primjena dabigatraneteksilata 24 sata nakon infuzije idarucizumaba rezultirala je očekivanom antikoagulantnom aktivnošću.
English: Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.
Croatian: Izostanak antitrombotske terapije izlaže bolesnike riziku od tromboze u njihovoj osnovnoj bolesti ili stanju.
English: Praxbind is used to rapidly trap dabigatran in order to inactivate its effect.
Croatian: Praxbind se primjenjuje za brzo hvatanje dabigatrana kako bi se poništio njegov učinak.
English: Praxbind causes transient proteinuria as a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously (see section 5.2).
Croatian: Praxbind uzrokuje prolaznu proteinuriju kao fiziološku reakciju na pretjerani priljev (engl. overflow) proteina bubrezima nakon bolusa/kratkotrajne intravenske primjene 5 g idarucizumaba (vidjeti dio 5.2).
English: How to store Praxbind
Croatian: Kako čuvati Praxbind
English: The risk of using Praxbind in patients with known hypersensitivity (e.g. anaphylactoid reaction) to idarucizumab or to any of the excipients needs to be weighed cautiously against the potential benefit of such an emergency treatment.
Croatian: U bolesnika s poznatom preosjetljivošću (npr. anafilaktoidnom reakcijom) na idarucizumab ili neku od pomoćnih tvari, potrebno je oprezno odvagnuti rizik primjene Praxbinda naspram potencijalne koristi ovakvog hitnog liječenja.
English: What Praxbind is
Croatian: Što je Praxbind
English: No impact on the pharmacokinetics or the reversal effect of idarucizumab or hypersensitivity reactions were observed.
Croatian: Utjecaj na farmakokinetiku ili poništenje učinka idarucizumaba ili reakcije preosjetljivosti nisu zapažene.
English: The transient proteinuria is a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously.
Croatian: Prolazna proteinurija je fiziološka reakcija na pretjerani priljev (engl. overflow) proteina bubrezima nakon bolusa/kratkotrajne intravenske primjene 5 g idarucizumaba.
English: The idarucizumab-dabigatran complex is characterised by a rapid on-rate and extremely slow off-rate resulting in a very stable complex.
Croatian: Kompleks idarucizumaba i dabigatrana karakteriziran je brzim vezivanjem i izuzetno sporim otpuštanjem, što rezultira vrlo stabilnim kompleksom.
English: Dosage and adminstration:
Croatian: Doziranje i primjena:
English: Until now, no side effects have been indentified.
Croatian: Dosad još nisu utvrđene nuspojave.
English: None of the patients re-dosed with idarucizumab tested positive for anti-idarucizumab antibodies.
Croatian: Niti jedan od tih bolesnika koji su ponovno primili dozu idarucizumaba nije imao pozitivan nalaz antitijela na idarucizumab.
English: - The other ingredients are sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20 and water for injection.
Croatian: - Drugi sastojci su natrijev acetat trihidrat, acetatna kiselina, sorbitol, polisorbat 20 i voda za injekcije.
English: There are no data for the use of Praxbind in pregnant women.
Croatian: Nema podataka o primjeni Praxbinda u trudnica.
English: The pharmacodynamics of idarucizumab after administration of dabigatran etexilate were investigated in 141 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g as intravenous infusion are presented.
Croatian: Farmakodinamika idarucizumaba nakon primjene dabigatraneteksilata ispitana je u 141 dobrovoljca u ispitivanjima faze I, od kojih su predstavljeni podaci za reprezentativnu podskupinu od 6 zdravih ispitanika u dobi od 45 do 64 godina koji su primili dozu od 5 g u obliku intravenske infuzije.
English: No dose adjustment is required in renally impaired patients.
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem bubrega.
English: The pharmacokinetics of idarucizumab were investigated in 224 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g as intravenous infusion are presented.
Croatian: Farmakokinetika idarucizumaba ispitivana je u 224 osoba u fazi I, od kojih su prikazani podaci za reprezentativnu podskupinu od 6 zdravih ispitanika u dobi od 45 do 64 godina, a koji su primili dozu od 5 g u obliku intravenske infuzije.
English: • Intravenous administration as two consecutive infusions over 5 to 10 min each or as bolus injections
Croatian: • Intravenska primjena u obliku dvije uzastopne infuzije tijekom 5 do 10 minuta svaka ili u obliku bolus injekcija.
English: After administration of Praxbind, other antithrombotic therapy (e.g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved.
Croatian: Nakon primjene Praxbinda, u svakom trenutku se može početi s drugom antitrombotskom terapijom (npr. heparinom niske molekulske mase), ako je bolesnik klinički stabilan te je postignuta odgovarajuća hemostaza.
English: Renal impairment did not impact the reversal effect of idarucizumab (see section 5.2).
Croatian: Oštećenje bubrega nije utjecalo na antagonistički učinak idarucizumaba (vidjeti dio 5.2).
English: Praxbind (2x2.5 g/50 mL) is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
Croatian: Praxbind (2 x 2,5 g/50 ml) se primjenjuje intravenski u obliku dvije konsekutivne infuzije tijekom 5 do 10 minuta svaka ili u obliku bolus injekcije.
English: Pradaxa (dabigatran etexilate) treatment can be re-initiated 24 hours after administration of Praxbind, if the patient is clinically stable and adequate haemostasis has been achieved.
Croatian: Liječenje Pradaxom (dabigatraneteksilatom) može se ponovo započeti 24 sata nakon primjene Praxbinda, ako je bolesnik klinički stabilan te je postignuta odgovarajuća hemostaza.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena formalna ispitivanja interakcija Praxbinda i drugih lijekova.
English: Clear to slightly opalescent, colourless to slightly yellow solution.
Croatian: Bistra do blago zamućena, bezbojna do blago žuta otopina.
English: The primary endpoint was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, based on central laboratory determination of dilute thrombin time (dTT) or ecarin clotting time (ECT).
Croatian: Primarna mjera ishoda je bila maksimalni postotak poništenja antikoagulacijskog učinka dabigatrana unutar 4 sata nakon primjene idarucizumaba na temelju razrijeđenog trombinskog vremena (dTT) ili ekarinskog vremena zgrušavanja određenih u središnjem laboratoriju.
English: Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) (see section 5.1).
Croatian: Relevatni parametri koagulacije su aktivirano parcijalno tromboplastinsko vrijeme (aPTT), razrijeđeno trombinsko vrijeme (dTT) ili ekarinsko vrijeme zgrušavanja (ECT) (vidjeti dio 5.1).
English: PHARMACEUTICAL FORM AND CONTENTS solution for injection/infusion 2 vials of 50 mL each
Croatian: OBLIK I SADRŽAJ otopina za injekciju/infuziju 2 bočice od 50 ml svaka
English: Your doctor will continue treating you with medicines used to prevent the formation of blood clots as soon as your medical condition allows.
Croatian: Čim Vaše medicinsko stanje dopusti, liječnik će Vas nastaviti liječiti lijekovima koji se koriste za sprječavanje stvaranja krvnih ugrušaka.
English: • The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL)
Croatian: • Preporučena doza Praxbinda je 5 g (2 x 2,5 g/50 ml).
English: Praxbind binds specifically to dabigatran and reverses its anticoagulant effect.
Croatian: Praxbind se specifično veže za dabigatran i poništava njegov antikoagulacijski učinak.
English: LIST OF EXCIPIENTS Excipients: Sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20, water for injection.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev acetat trihidrat, acetatna kiselina, sorbitol, polisorbat 20, voda za injekcije.
English: The recommended dose is 5 g (2 vials of 50 mL).
Croatian: Preporučena doza je 5 g (2 bočice od 50 ml).
English: PHARMACEUTICAL FORM AND CONTENTS 2 vials of 50 mL solution for injection/infusion each
Croatian: OBLIK I SADRŽAJ 2 bočice od 50 ml otopine za injekciju/infuziju svaka
English: After treatment with idarucizumab proteinuria has been observed.
Croatian: Nakon liječenja idarucizumabom uočena je proteinurija.
English: Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises their anticoagulant effect.
Croatian: Idarucizumab se potentno i specifično veže za dabigatran i njegove metabolite te neutralizira njihov antikoagulacijski učinak.
English: In one subject, treatment-emergent anti-idarucizumab antibodies were detected after the second administration.
Croatian: U jednog ispitanika nakon druge primjene otkrivena su antitijela na idarucizumab nastala tijekom liječenja.
English: Figure 4 - Plasma-levels of unbound dabigatran in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Croatian: Slika 4 - plazmatske razine nevezanog dabigatrana u reprezentativnoj skupini zdravih ispitanika (primjena idarucizumaba ili placeba pri 0 h)
English: The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL).
Croatian: Preporučena doza Praxbinda je 5 g (2 x 2,5 g/50 ml).
English: They will take this into account before treating you with Praxbind.
Croatian: Oni će to uzeti u obzir prije no što Vas liječe Praxbindom.
English: It is unknown whether idarucizumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se idarucizumab u majčino mlijeko u ljudi.
English: Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT).
Croatian: Relevatni parametri koagulacije su aktivirano parcijalno tromboplastinsko vrijeme (aPTT), razrijeđeno trombinsko vrijeme (dTT) ili ekarinsko vrijeme zgrušavanja (ECT).
English: None.
Croatian: Ne postoje.
English: Parenteral medicinal products such as Praxbind should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Lijekove za parenteralnu primjenu poput Praxbinda potrebno je prije primjene vizualno pregledati na prisutnost čestičnih tvari i promjene boje.
English: Each vial contains 2.5 g idarucizumab in 50 mL.
Croatian: Jedna bočica sadrži 2,5 g idarucizumaba u 50 ml.
English: Figure 5 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Croatian: Slika 5 - poništenje produljenja vremena zgrušavanja induciranog dabigatranom utvrđenog testom dTT u reprezentativnoj skupini zdravih ispitanika (primjena idarucizumaba ili placeba pri 0 h)
English: Figure 3 - Reversal of dabigatran-induced clotting time prolongation determined by aPTT in patients from the RE-VERSE AD study (N=486)
Croatian: Slika 3 - poništenje produljenja vremena zgrušavanja induciranog dabigatranom utvrđenog testom aPTT u bolesnika iz ispitivanja RE-VERSE AD (N=486)
English: NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion
Croatian: NAZIV LIJEKA Praxbind 2,5 g/50 ml otopina za injekciju/infuziju
English: No local irritation of the blood vessel was observed after i.v.
Croatian: Nije zapažena lokalna iritacija krvne žile nakon intravenske ili paravenske primjene idarucizumaba.
English: Package leaflet: Information for the patient and user Praxbind 2.5 g/50 mL solution for injection/infusion idarucizumab
Croatian: Uputa o lijeku: Informacije za bolesnika Praxbind 2,5 g/50 ml otopina za injekciju/infuziju idarucizumab
English: Figure 1 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in patients from the RE-VERSE AD study (N=487)
Croatian: Slika 1 - poništenje produljenja vremena zgrušavanja induciranog dabigatranom utvrđenog testom dTT u bolesnika iz ispitivanja RE-VERSE AD (N=487)
English: Subjects with a creatinine clearance below 44 mL/min have not been studied in Phase I. Depending on the degree of renal impairment the total clearance was reduced compared to healthy subjects, leading to an increased exposure of idarucizumab.
Croatian: Ovisno o stupnju oštećenja bubrega ukupni klirens se smanjio u usporedbi sa zdravim ispitanicima, što je dovelo do povećane izloženosti idarucizumabu.
English: Preclinical pharmacodynamics
Croatian: Pretklinička farmakodinamika
English: Figure 6 - Reversal of dabigatran-induced clotting time prolongation determined by ECT in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Croatian: Slika 6 - poništenje produljenja vremena zgrušavanja induciranog dabigatranom utvrđenog testom ECT u reprezentativnoj skupini zdravih ispitanika (primjena idarucizumaba ili placeba pri 0 h)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 50 mL contains 2.5 g idarucizumab.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 50 ml sadrži 2,5 g idarucizumaba.
English: Idarucizumab alone has shown no procoagulant effect measured as ETP.
Croatian: Idarucizumab u obliku monoterapije nije pokazao prokoagulantni učinak mjeren kao ETP, što ukazuje da idarucizumab nema protrombotski učinak.
English: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
Croatian: Poništenje terapije dabigatranom izlaže bolesnike riziku od tromboze u njihovoj osnovnoj bolesti ili stanju.
English: All pigs survived at idarucizumab doses of approximately 2.5 and 5 g. Without idarucizumab, the mortality in the anticoagulated group was 100 %.
Croatian: Sve svinje su preživjele pri dozama idarucizumaba od približno 2,5 i 5 g.
English: NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion Idarucizumab
Croatian: Praxbind 2,5 g/50 ml otopine za injekciju/infuziju idarucizumab
English: Figure 2 - Reversal of dabigatran-induced clotting time prolongation determined by ECT in patients from the RE-VERSE AD study (N=487)
Croatian: Slika 2 - poništenje produljenja vremena zgrušavanja induciranog dabigatranom utvrđenog ekarinskim vremenom zgrušavanja u bolesnika iz ispitivanja RE-VERSE AD (N=487)
English: Idarucizumab is a specific reversal agent for dabigatran.
Croatian: Idarucizumab je specifičan antagonist dabigatrana.
English: Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect.
Croatian: Idarucizumab se specifično veže za dabigatran i poništava njegov antikoagulacijski učinak.
English: Nine patients were re-dosed with idarucizumab.
Croatian: Devet bolesnika ponovno je primilo dozu idarucizumaba.
English: -1 Porcine circovirus type 2 ORF2 subunit antigen: ≥ 1,436 AU* per 0.2 ml * Antigenic units as determined in the in vitro potency test (antigenic mass assay).
Croatian: --1 Porcin cirkovirus tip 2 ORF2 subjedinica antigena ≥ 1,436 AU* za 0,2 ml * Jedinice antigena određene in vitro testom potencije ( test mase antigena ).
English: Content Package size
Croatian: Način primjene Pakovanje Sadržaj Veličina pakovanja
English: The subgroups in these studies were too small to draw reliable conclusions.
Croatian: Podskupine u tim ispitivanjima bile su premale da bi se izvukli pouzdani zaključci.
English: Then take the next capsule at the usual time.
Croatian: Zatim uzmite sljedeću kapsulu u uobičajeno vrijeme.
English: • Take the capsule once in the morning and once in the evening.
Croatian: • Uzmite jednu kapsulu ujutro i jednu navečer.
English: Effect on other transport proteins
Croatian: Učinak na druge transportne proteine
English: • Take the capsules at about the same time each day.
Croatian: • Uzimajte kapsule svakoga dana približno u isto vrijeme.
English: Body Weight and Gender
Croatian: Tjelesna težina i spol
English: They may be taken with or without food.
Croatian: Mogu se uzimati s hranom ili bez nje.
English: Fifty percent of objective tumour responses were achieved during the first 8 weeks of treatment.
Croatian: Pedeset posto objektivnih tumorskih odgovora postignuto je tijekom prvih 8 tjedana liječenja.
English: Correct electrolytes as necessary.
Croatian: Korigirajte elektrolite po potrebi.
English: Treatment of children and adolescents with this medicine is not recommended.
Croatian: Liječenje djece i adolescenata ovim lijekom se ne preporučuje.
English: XALKORI with food and drink
Croatian: XALKORI s hranom i pićem
English: It is important to take XALKORI every day, as long as your doctor prescribes it to you.
Croatian: Važno je da XALKORI uzimate svakodnevno, onoliko dugo koliko Vam ga liječnik propisuje.
English: Monitor heart rate and blood pressure regularly.
Croatian: Redovito provjeravajte srčanu frekvenciju i krvni tlak.
English: Date of latest renewal: 29 July 2016
Croatian: Datum posljednje obnove odobrenja: 29. srpnja 2016.
English: • Decreased appetite.
Croatian: • smanjeni apetit.
English: This medicinal product should not be used during pregnancy unless the clinical condition of the mother requires treatment.
Croatian: Ovaj lijek se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje.
English: If you are not able to take the medicine as your doctor prescribed, or you feel you do not need it anymore, contact your doctor right away.
Croatian: Ako ne možete uzimati ovaj lijek onako kako Vam je propisao liječnik, ili smatrate da ga više ne trebate uzimati, odmah se javite liječniku.
English: Tell your doctor about the missed dose at your next visit.
Croatian: Obavijestite svog liječnika o propuštenoj dozi na sljedećoj kontroli.
English: The full effect of crizotinib on reduction of heart rate may not develop until several weeks after start of treatment.
Croatian: Potpuni učinak krizotiniba na smanjenje brzine otkucaja srca možda se neće razviti do nekoliko tjedana nakon početka liječenja.
English: No adverse drug reactions were reported with an absolute difference of ≥15%.
Croatian: Nisu prijavljene nuspojave na lijek s apsolutnom razlikom od ≥15%.
English: If the combination is needed, then close clinical monitoring should be exercised.
Croatian: Ako je takva kombinacija neophodna, potreban je pažljiv klinički nadzor.
English: • Reduction in the number of red blood cells (anaemia).
Croatian: • smanjenje broja crvenih krvnih stanica (anemija).
English: These cases generally occurred within 3 months after the initiation of treatment.
Croatian: Ti su slučajevi općenito nastupili unutar 3 mjeseca nakon započinjanja liječenja.
English: OS is based on a median follow up of approximately 63 months.
Croatian: OS se temelji na medijanu praćenja od približno 63 mjeseca. a.
English: Do not take a double dose (two capsules at the same time) to make up for a forgotten capsule.
Croatian: Nemojte uzeti dvostruku dozu (dvije kapsule odjednom) kako biste nadoknadili zaboravljenu kapsulu.
English: • If you have ever had any other lung problems.
Croatian: • ako ste ikada imali nekih drugih tegoba s plućima.
English: The indication does not cover children and adolescents.
Croatian: Indikacija za liječenje ne obuhvaća djecu i adolescente.
English: If you take more XALKORI than you should
Croatian: Ako uzmete više lijeka XALKORI nego što ste trebali
English: • Decreased levels of testosterone, a male sex hormone.
Croatian: • smanjene razine testosterona, muškog spolnog hormona.
English: What XALKORI is and what it is used for
Croatian: Što je XALKORI i za što se koristi
English: Dysgeusia was also very commonly reported in these studies, and was primarily Grade 1 in severity.
Croatian: U ovim je ispitivanjima vrlo često prijavljena i disgeuzija, a bila je prvenstveno stupnja težine 1.