FrancophonIA/ELRC3.0 huggingface dataset:
English: In man, the apparent terminal elimination half-life (T1/2) of 5-FU observed after administration of Teysuno (containing tegafur, a 5-FU prodrug) was longer (approximately 1.6 - 1.9 hours) than that previously reported after intravenous administration of 5-FU (10 to 20 minutes).
Croatian: Prividni poluvijek eliminacije u ljudi (T1/2) 5-FU-a uočen nakon primjene lijeka Teysuno (sadrži tegafur, prolijek 5-FU-a) je bio duži (otprilike 1,6-1,9 sati) nego što je prethodno objavljeno nakon intravenske primjene 5-FU-a (10 do 20 minuta).
English: - Low platelet count leading to an increased chance of bleeding o If you have bleeding of the skin, mouth (caused by brushing teeth), nose, respiratory tract, stomach, gut, etc., stop taking Teysuno and contact your doctor immediately.
Croatian: - Smanjenje broja trombocita što dovodi do povećane mogućnosti krvarenja ᴑ Ako krvarite po koži, u ustima (uslijed pranja zubi), iz nosa, dišnog trakta, želuca, crijeva itd., prestanite uzimati Teysuno i odmah se javite liječniku.
English: Efforts should be made to ensure early detection of ocular reactions, including an early ophthalmologic consultation in the event of any persistent or vision-reducing ocular symptoms such as lacrimation or corneal symptoms.
Croatian: Potrebno je osigurati ranu detekciju očnih reakcija što uključuje rane konzultacije s oftalmologom u slučaju bilo kakvih trajnih simptoma, ili simptoma smanjenja vida, kao što su suzenje ili simptomi na rožnici.
English: Teysuno contains the active substances tegafur gimeracil and oteracil.
Croatian: Teysuno sadrži djelatne tvari tegafur gimeracil i oteracil.
English: Treatment-related toxicities can be expected to increase as 5-FU exposure increases (see section 5.2).
Croatian: Zbog povećanja izloženosti 5-FU-u može se očekivati povećanje toksičnosti uzrokovane liječenjem (vidjeti dio 5.2).
English: Refer to the cisplatin SmPC for the effects of cisplatin on fertility, pregnancy and lactation.
Croatian: Vidjeti sažetak opisa svojstava za cisplatin o njegovom učinku na plodnost, trudnoću i dojenje.
English: The single and multiple dose pharmacokinetics (PK) of Teysuno in combination with cisplatin were evaluated in three studies.
Croatian: Pharmacokinetics) pojedinačne i višestruke doze lijeka Teysuno u kombinaciji s cisplatinom evaluirana je u tri studije.
English: A Phase I study established the current regimen by evaluating cohorts of Teysuno and cisplatin of 30 mg/m2 and 60 mg/m2 (dose-limiting toxicities [DLTs] seen were fatigue, and diarrhoea and dehydration); 25 mg/m2 and 60 mg/m2; and 25 mg/m2 and 75 mg/m2.
Croatian: Studija faze I odredila je važeći režim evaluacijom kohorte lijeka Teysuno i cisplatina u dozama od 30 mg/m2 i 60 mg/m2 (uočene toksičnosti koje su ograničavale dozu [DLT od engl. dose-limiting toxicities] bile su umor, proljev i dehidracija); 25 mg/m2 i 60 mg/m2; i 25 mg/m2 i 75 mg/m2.
English: Repeat-dose toxicity studies in rats, dogs and monkeys produced changes typically associated with administration of an anti-cancer medicinal product eliciting cytotoxic effects on populations of rapidly dividing cells, such as anaemia, decrease in the immune and digestive system function, disruption of spermatogenesis, and atrophy in male and female reproductive organs.
Croatian: Studije toksičnosti ponovljene doze u štakora, pasa i majmuna dovele su do tipičnih promjena povezanih s primjenom antitumorskih lijekova pokazujući citotoksični učinak na populaciju stanica koje se brzo dijele, kao što su anemija, smanjenje funkcije imunološkog i probavnog sustava, poremećaj spermatogeneze i atrofija muških i ženskih organa za reprodukciju.
English: Therefore, Teysuno should not be administered to children or adolescents under 18 years of age.
Croatian: Zato Teysuno ne treba primjenjivati u djece i adolescenata do 18 godina starosti.
English: Treatment days missed in a cycle where medicinal product was held due to toxicity should not be replaced.
Croatian: Dani ciklusa u kojima je izostalo liječenje zbog toksičnosti ne smiju se nadoknađivati.
English: After oral administration, oteracil was distributed at high concentrations in normal gastrointestinal tract tissues while considerably lower concentrations were seen in blood and tumour tissue in animal studies.
Croatian: U ispitivanjima na životinjama, nakon oralne primjene, oteracil se u visokim koncentracijama raspodjeljuje u tkivima normalnog gastrointestinalnog trakta dok su u krvi i tumorskom tkivu vidljive znatno niže koncentracije.
English: Children and adolescents Teysuno is not recommended for children under 18 years of age.
Croatian: Teysuno se ne preporuča djeci mlađoj od 18 godina.
English: None
Croatian: nema
English: 6.4 Special precautions for storage This medicinal product does not require any special storage conditions.
Croatian: Posebne mjere pri čuvanju lijeka Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: Patients with low platelet counts are at increased risk for bleeding and should be monitored carefully.
Croatian: U bolesnika s malim brojem trombocita postoji povećani rizik krvarenja te ih je potrebno posebno nadzirati.
English: In the Phase III FLAGS study, there was no apparent relationship between 5-FU AUC (Teysuno/cisplatin arm) and 5-FU concentration (5-FU/cisplatin arm) during Cycle 1 and efficacy outcomes of overall survival (OS) or progression-free survival (PFS).
Croatian: U studiji faze III FLAGS nije bilo vidljive povezanosti između AUC 5-FU-a (Teysuno/cisplatin skupina) i koncentracije 5-FU-a (5-FU/cisplatin skupina) tijekom 1. ciklusa i ishoda učinkovitosti: ukupnog preživljenja ili preživljenja bez progresije bolesti.
English: The recommended dose of cisplatin with this regimen is 75 mg/m2 by intravenous infusion administered once every 4 weeks.
Croatian: Preporučeni režim doziranja cisplatina je 75 mg/m2, jednom u 4 tjedna, intravenskom infuzijom.
English: Baseline or Grade 1
Croatian: Početak ili stupanj 1
English: • Pregnancy and breast-feeding.
Croatian: • Trudnoća i dojenje.
English: However, since no DPD inducers are currently known, the interaction between a DPD inducer and Teysuno can not be evaluated.
Croatian: Kako induktori DPD-a nisu poznati, interakcija između induktora DPD-a i lijeka Teysuno ne može se evaluirati.
English: In the Phase III (FLAGS) study, tegafur AUC was significantly higher in patients with the CYP2A6*4 allele, however, no significant difference was found for 5-FU AUC and for the incidence of adverse reactions.
Croatian: U (FLAGS) studiji faze III AUC tegafura je bila značajno viša u bolesnika s alelom CYP2A6*4, no nije pronađena značajna razlika u AUC 5-FU-a i učestalosti nuspojava.
English: The washout period described in the SmPC of other fluoropyrimidine medicinal products should be followed if Teysuno is to be administered subsequent to other fluoropyrimidine medicinal products.
Croatian: Potrebno je slijediti period ispiranja opisan u sažetku opisa svojstava ostalih fluoropirimidinskih lijekova ako se Teysuno primjenjuje nakon njih.
English: a Treatment for patients with CrCl <30 ml/min is not recommended unless the benefits of Teysuno treatment clearly outweigh the risks.
Croatian: Ne preporučuje se liječenje bolesnika sa CrCl < 30 ml/min osim ako korist liječenja lijekom Teysuno jasno premašuje rizike.
English: A population PK analysis of Teysuno components and metabolites assessed the influence of various factors, including gender, age, food, ethnicity (Caucasian vs Asian), renal function, and hepatic function in 315 patients.
Croatian: Populacijska farmakokinetička analiza sastojaka lijeka Teysuno i metabolita provedena na 315 bolesnika, procjenjivala je utjecaj različitih faktora uključujući spol, dob, hranu, etničku pripadnost (bijelci prema Azijatima), bubrežnu funkciju i jetrenu funkciju.
English: The main metabolic pathway for tegafur is through conversion to 5-FU via CYP2A6 in the liver, whereas gimeracil was stable in human liver homogenate (S9 fraction) with adenosine 3'-phosphate 5'-phosphosulfphate lithium salt (PAPS; a co-factor for sulfotransferase) or nicotinamide adenine dinucleotide phosphate (NADPH).
Croatian: Glavni put metabolizma tegafura je kroz konverziju u 5-FU pomoću CYP2A6 u jetri, dok je gimeracil stabilan u ljudskom homogenatu jetre (S9 frakcija) s litijevom soli adenozin 3'-fosfat-5'-fosfosulfata (PAPS; ko-faktor sulfotransferaze) ili nikotinamid adenin dinukleotid fosfatom (NADP).
English: • Co-administration of other fluoropyrimidines with Teysuno.
Croatian: • Istodobna primjena drugih fluoropirimidina s lijekom Teysuno.
English: o If you experience nausea and vomit a dose of medication, make sure you tell your doctor.
Croatian: ᴑ Ako imate mučninu i povratite dozu lijeka, obavijestite svog liječnika.
English: Teysuno does not appear to affect male or female fertility in the rat; however, administration at any time after conception resulted in a range of external, visceral, and skeletal foetal abnormalities in rat and rabbit.
Croatian: Nije uočeno da Teysuno utječe na plodnost bilo mužjaka bilo ženki štakora, no primjena u bilo koje vrijeme nakon začeća rezultirala je vanjskim, organskim i koštanim abnormalnostima fetusa štakora i kunića.
English: Cisplatin should be discontinued after 6 cycles without withdrawal of Teysuno.
Croatian: Nakon 6 ciklusa treba prekinuti primjenu cisplatina bez ukidanja lijeka Teysuno.
English: - Mental: seeing and hearing some things that are not there, personality change, unable to sit still, confusion, feeling of nervousness, depression, sexual dysfunction - Nerve:, voice disorder, inability to speak and understand words, memory problem, unsteady gait, balance problems, one sided body weakness, sleepiness, nerve inflammation, distorted sense of smell, brain dysfunction, fainting, loss of consciousness, stroke, seizures
Croatian: - Mentalne: kada se vide i čuju neke stvari kojih nema, promjena osobnosti, nemogućnost mirnog sjedenja, zbunjenost, osjećaj nervoze, depresija, seksualna disfunkcija - Živčane: poremećaj glasa, nemogućnost izgovaranja i razumijevanja riječi, problemi s pamćenjem, nestabilan hod, problemi s ravnotežom, slabost jedne strane tijela, pospanost, upala živca, narušen osjećaj mirisa, disfunkcija mozga, klonulost, gubitak svijesti, moždani udar, napadaji
English: No adjustment of the standard dose is recommended for patients of Asian ethnicity (see section 5.2).
Croatian: Ne preporučuje se prilagodba standardne doze u bolesnika azijske etničke skupine (vidjeti dio 5.2).
English: It is a fixed dose combination of three active substances, tegafur, which after absorption is converted into the anti-cancer substance 5-FU; gimeracil, a dihydropyrimidine dehydrogenase (DPD) inhibitor to prevent degradation of 5-FU by the body; and, oteracil, an orotate phosphoribosyltransferase (OPRT) inhibitor that decreases the activity of 5-FU in normal gastrointestinal mucosa.
Croatian: On je kombinacija fiksnih doza tri djelatne tvari, tegafura, koji se nakon apsorpcije konvertira u anti-kancerogenu supstanciju 5-FU; gimeracila, inhibitora dihidropirimidin dehidrogenaze (DPD) za sprječavanje razgradnje 5-FU-a u tijelu; i oteracila, inhibitora orotat fosforiboziltransferaze (OPRT) koji smanjuje aktivnost 5-FU-a u normalnoj gastrointestinalnoj sluznici.
English: There are no side effects caused by stopping treatment with Teysuno.
Croatian: Nema nuspojava uzrokovanih prestankom liječenja lijekom Teysuno.
English: In a Japanese Phase I study that utilized 5 dose groups with doses ranging from 25 to 200 mg/body, there was a dose-proportional increase in exposure for tegafur, gimeracil and oteracil.
Croatian: U japanskoj studiji faze I koja je koristila 5 doznih skupina s rasponima doza od 25 do 200 mg/organizmu, uočen je dozi proporcionalan porast izloženosti tegafuru, gimeracilu i oteracilu.
English: A Phase I study was conducted to evaluate the PK of the components of Teysuno and their metabolites in cancer patients with impaired renal function compared to those with normal renal function.
Croatian: Provedena je studija faze I za evaluaciju farmakokinetike sastojaka lijeka Teysuno i njegovih metabolita u bolesnika oboljelih od raka s oštećenom bubrežnom funkcijom u usporedbi s bolesnicima s normalnom bubrežnom funkcijom.
English: Teysuno dose modifications for toxicity when used in combination with cisplatin can be made in two ways.
Croatian: Prilagodba doze zbog toksičnosti lijeka Teysuno u kombinaciji s cisplatinom, može se provesti na dva načina.
English: No dose modification
Croatian: Nema prilagodbe doze
English: The plasma concentrations of uracil returned to baseline levels approximately 48 hours after dosing indicating reversibility of DPD inhibition by gimeracil.
Croatian: Koncentracije uracila u plazmi vratile su se na osnovnu razinu otprilike 48 sati nakon primjene upućujući na reverzibilnost inhibicije DPD-a gimeracilom.
English: Comparison of 218 patients with mild renal impairment at baseline (CrCl 51 to 80 ml/min) to 297 patients with normal renal function at baseline (CrCl >80 ml/min) treated with Teysuno in combination with cisplatin in the FLAGS study indicated that there were no clinically significant differences in safety between patients with mild renal impairment and patients with normal renal function.
Croatian: Usporedba 218 bolesnika s blagim oštećenjem bubrega na početku liječenja (CrCl 51 do 80 ml/min) s 297 bolesnika s normalnom bubrežnom funkcijom na početku liječenja (CrCl > 80 ml/min) liječenih lijekom Teysuno u kombinaciji s cisplatinom u FLAGS studiji, indicirala je da nema klinički značajnih razlika u sigurnosti primjene između bolesnika sa blagim oštećenjem bubrega i onih s normalnom funkcijom bubrega.
English: In vitro evaluation using human liver microsomes indicated that neither tegafur, gimeracil nor oteracil showed any relevant inhibitory effects on enzyme activities of the cytochrome P450 isoforms tested (i.e., CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4).
Croatian: In vitro evaluacija korištenjem ljudskih jetrenih mikrosoma upućuje na to da niti tegafur, niti gimeracil niti oteracil ne pokazuju nikakve značajne inhibitorne učinke na ispitivanu enzimsku aktivnost izoforme citokroma P450 (tj. CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 i CYP3A4).
English: In this study, 521 patients were randomised to treatment with Teysuno (25 mg/m2 orally twice daily for 21 days followed by a 7-day rest period) and cisplatin (75 mg/m2 intravenous infusion once every 4 weeks); and 508 patients were randomised to treatment with 5-FU (1000 mg/m2/24 hours as a continuous intravenous infusion on Days 1 through 5 repeated every 4 weeks) and cisplatin (100 mg/m2 as an intravenous infusion on Day 1 repeated every 4 weeks).
Croatian: U toj studiji, 521 bolesnik je randomiziran u skupinu liječenu lijekom Teysuno (25 mg/m2 oralno dva puta dnevno tijekom 21 dan, nakon čega slijedi odmor od 7 dana) i cisplatinom (75 mg/m2 intravenskom infuzijom jednom u svaka 4 tjedna), a 508 bolesnika je randomizirano u skupinu liječenu 5-FU-om (1000 mg/m2/24 sata kao kontinuirana intravenska infuzija od 1. do 5. dana, ponovljeno svaka 4 tjedna) i cisplatinom (100 mg/m2 kao intravenska infuzija 1. dan,
English: Each pack contains 42 capsules or 84 capsules.
Croatian: Svako pakiranje sadrži ili 42 kapsule ili 84 kapsule
English: Rare side effects (may affect 1 to 10 in 10,000 people) and very rare side effects (may affect less than 1 in 10,000 people) include:
Croatian: Rijetke nuspojave (mogu se javiti u 1 do 10 na 10 000 osoba) i vrlo rijetke nuspojave (mogu se javiti u manje od 1 na 10 000 osoba) uključuju:
English: Maximum plasma uracil concentration was observed at 4 hours, with a return to baseline levels within approximately 48 hours after dosing, indicating the reversibility of the DPD inhibition by gimeracil.
Croatian: Maksimalna koncentracija uracila u plazmi opažena je nakon 4 sata, s povratom na početnu vrijednost unutar otprilike 48 sati nakon primjene, upućujući na reverzibilnost inhibicije DPD-a gimeracilom.
English: Other oral fluorpyrimidines
Croatian: Ostali oralni fluoropirimidini
English: Advanced gastric cancer
Croatian: Uznapredovali rak želuca
English: After single dose administration, there was a statistically significant decrease in 5-FU and gimeracil Cmax for the severe hepatic impairment group relative to that of the normal group, but this difference was not observed after multiple dose administration.
Croatian: Nakon primjene jednostruke doze zabilježeno je značajno smanjenje Cmax 5-FU-a i gimeracila u skupini bolesnika s teškim oštećenjem jetre u odnosu na Cmax 5-FU-a i gimeracila u skupini bolesnika s normalnom funkcijom jetre, ali ta razlika nije uočena nakon primjene višestruke doze lijeka.
English: The association between 5-FU sensitivity and MSI in patients with gastric cancer is unclear and the association between Teysuno and MSI in gastric cancer is unknown.
Croatian: Povezanost između osjetljivosti na 5-FU i MSI u bolesnika s karcinomom želuca nije jasna te povezanost između lijeka Teysuno i MSI u bolesnika s karcinomom želuca nije poznata.
English: Suspend treatment until resumption criterion is met (see Table 6) and then resume dosing at one reduced dose level.
Croatian: Odgoditi liječenje do postizanja kriterija za ponovni početak liječenja (vidjeti Tablicu 6) i tada nastaviti primjenu dozom smanjenom za jednu razinu.
English: Teysuno can be continued after stopping cisplatin.
Croatian: Liječenje samo lijekom Teysuno može se nastaviti nakon ukidanja cisplatina.
English: No data is available regarding Teysuno administration in patients with end stage renal disease requiring dialysis (see section 4.3).
Croatian: Nisu dostupni podatci u svezi primjene lijeka Teysuno kod bolesnika u završnom stadiju bolesti bubrega koji trebaju dijalizu (vidjeti dio 4.3).
English: Cardiac failure, acute myocardial infarction, pericardial effusion, atrial fibrillation, angina pectoris, cardiac fibrillation, tachycardia, palpitations
Croatian: Srčani poremećaji zatajenje srca, akutni infarkt miokarda, perikardijalni izljev, fibrilacija atrija, angina pektoris, srčana fibrilacija, tahikardija, palpitacije
English: Teysuno was clastogenic in vitro using Chinese hamster lung cells and was weakly clastogenic in vivo in mouse bone marrow.
Croatian: Teysuno se pokazao klastogenim u in vitro ispitivanjima na stanicama pluća kineskog hrčka i slabo klastogenim u in vivo ispitivanjima na koštanoj srži miša.
English: The frequencies of very common, common, and uncommon adverse reactions are from 593 patients treated with Teysuno in combination with cisplatin in clinical trials.
Croatian: Učestalosti vrlo čestih, čestih i manje čestih nuspojava potječu od 593 bolesnika liječenih lijekom Teysuno u kombinaciji s cisplatinom tijekom kliničkih studija.
English: If you have any doubts talk to your doctor.
Croatian: Ako imate bilo kakvih nejasnoća, razgovarajte sa svojim liječnikom.
English: Teysuno contains
Croatian: Što Teysuno sadrži
English: • Moderate renal impairment (CrCl 30 to 50 ml/min) The recommended standard dose in patients with moderate renal impairment is 20 mg/m2 twice daily (expressed as tegafur content) (see sections 4.8 and 5.2).
Croatian: • umjereno oštećenje bubrega (CrCl 30 do 50 ml/min) Preporučena standardna doza u bolesnika s umjerenim oštećenjem bubrega iznosi 20 mg/m2 dva puta na dan (izraženo kao sadržaj tegafura) (vidjeti dijelove 4.8 i 5.2).
English: - Eye: itchy and red eyes, allergic reactions in eyes, drooping upper eyelid - Ear: vertigo, ear clogging, ear discomfort
Croatian: - Oko: svrbež i crvenilo oka, alergijske reakcije u očima, spušteni gornji kapak - Uho: vrtoglavica, začepljenje uha, nelagoda u uhu
English: Patients should be provided with outpatient prescriptions for anti-emetic and anti-diarrhoeal medicinal products.
Croatian: Bolesnike treba opskrbiti receptima za antiemetike i lijekove protiv proljeva, za primjenu u izvanbolničkim uvjetima.
English: Contusion, medication error a Adverse reactions in the Investigations system organ class (SOC) have been reallocated to clinically appropriate SOCs related to their target organ.
Croatian: Ozljede, otrovanje i proceduralne komplikacije kontuzije, medikacijske pogreške aNuspojave u klasi organskih sustava „Pretrage“ su preraspodijeljene u klinički odgovarajuće klase organskih sustava koji se odnose na ciljani organ.
English: However, metabolites of folinate/folinic acid will form a ternary structure with thymidylate synthase and fluorodeoxyuridine monophosphate (FdUMP), potentially increasing the cytotoxicity of 5-FU.
Croatian: Metaboliti folinata/folinatne kiseline tvore trojnu strukturu sa timidilat sintetazom i fluorodeoksiuridin monofosfatom (FdUMP) što potencijalno povećava citotoksičnost 5-FU-a.
English: Platelet count ≥100 x 109/l
Croatian: Broj trombocita ≥100 x 109/l
English: Black or African American Asian
Croatian: Rasa, n (%) bijela crna ili afrička američka azijska američki Indijanci ili domoroci s Aljaske ostali
English: Suspend cisplatin treatment until resumption criterion (≥30 ml/min) is met and then start treatment at a 50% dose reduction from the previous cycle a Treatment for patients with CrCl <30 ml/min is not recommended unless the benefits of Teysuno treatment clearly outweigh the risks.
Croatian: Odgoditi liječenje cisplatinom do postizanja kriterija za ponovni početak liječenja (≥30 ml/min) te početak liječenja s 50% smanjenom dozom u odnosu na prethodni ciklus a Ne preporučuje se liječenje bolesnika sa CrCl < 30 ml/min osim ako korist liječenja lijekom Teysuno jasno premašuje rizike.
English: Levels of tegafur, gimeracil, oteracil and 5-FU were quantifiable through 10 hours postdose.
Croatian: Razine tegafura, gimeracila, oteracila i 5-FU-a bile su mjerljive kroz 10 sati nakon primjene.
English: - acute liver failure - pancreas infection - muscle breakdown - loss of sense of smell - sun allergy - widespread blood clotting and bleeding - disease affecting the white matter of the brain - serious illness with blistering of the skin, mouth and genitals recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection)
Croatian: - akutno zatajenje jetre - infekcija gušterače - slabost mišića - gubitak osjeta mirisa - alergija na sunce - rasprostranjeno zgrušavanje krvi i krvarenje - bolest koja zahvaća bijelu moždanu tvar - ozbiljna bolest sa mjehurićima na koži, ustima i genitalijama - povratak (reaktivacija) infekcije virusom hepatitisa B, ako ste već imali hepatitis B u prošlosti
English: o If you become dehydrated you may have symptoms such as dry mouth, weakness, dry skin, dizziness, cramping o Try to eat frequent small meals.
Croatian: ᴑ Ako dehidrirate možete imati simptome kao što su suha usta, slabost, suha koža, omaglica, grčenje.
English: The activity of a coumarin-derivative anticoagulant was enhanced by Teysuno.
Croatian: Aktivnost antikoagulansa derivata kumarina povećava se primjenom lijeka Teysuno.
English: Table 4: Teysuno and cisplatin dose modification according to creatinine clearance values at the start of a cycle of treatment
Croatian: Tablica 4. Prilagodba doze lijekova Teysuno i cisplatina u skladu s vrijednostima klirens kreatinina na početku ciklusa liječenja Klirens kreatinina
English: <0.5 x 109/l
Croatian: IU <0,5 x 109/l < 25 x 109/l
English: However, nitromidazoles may reduce clearance of 5-FU and thus increase plasma levels of 5-FU.
Croatian: Nitroimidazoli mogu smanjiti klirens 5-FU-a i tako povećati njegove razine u plazmi.
English: - Nerve disorder: you may feel numbness, tingling, pain, abnormal sensation, weak muscle, shaking, or movement difficulties.
Croatian: - Poremećaj živaca: možete osjećati utrnulost, trnce, bol, promjene osjeta, mišićnu slabost, drhtanje ili poteškoće u kretanju.
English: In this study, 7 patients with moderate renal impairment were treated with 20 mg/m2 Teysuno twice daily, while 7 patients with severe renal impairment received Teysuno 20 mg/m2 once daily.
Croatian: U toj studiji je 7 bolesnika s umjerenim oštećenjem bubrega primalo 20 mg/m2 lijeka Teysuno dva puta dnevno, dok je 7 bolesnika s teškim oštećenjem bubrega primalo 20 mg/m2 lijeka Teysuno jedanput na dan.
English: Other fluoropyrimidines
Croatian: Ostali fluoropirimidini
English: Manufacturer Nordic Pharma Tolweg 15
Croatian: Proizvođač Nordic Pharma Tolweg 15