FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study performed in patients with renal impairment, the most common adverse reactions reported over all cycles across all cohorts were diarrhoea (57.6%), nausea (42.4%), vomiting (36.4%), fatigue (33.3%) and anaemia (24.2%).
Croatian: U studiji provedenoj na bolesnicima s oštećenjem bubrega, najčešće zabilježene nuspojave tijekom svih ciklusa kroz sve kohorte bile su proljev (57,6 %), mučnina (42,4 %), povraćanje (36,4 %), umor (33,3 %) i anemija (24,2 %).
English: If you forget to take Teysuno
Croatian: Ako ste zaboravili uzeti Teysuno
English: Hyperhydration (forced diuresis) should be administered according to the cisplatin SmPC to reduce the risk of renal toxicity associated with cisplatin therapy.
Croatian: Treba primijeniti hiperhidraciju (prisilnu diurezu) u skladu sa sažetkom opisa svojstava lijeka za cisplatin kako bi se smanjio rizik renalne toksičnosti povezan s liječenjem cisplatinom.
English: Prophylactic treatment for diarrhoea should be administered as indicated.
Croatian: Treba primijeniti profilaktičko liječenje proljeva, kao što je indicirano.
English: No dose limiting toxicities were observed in Cycle 1 in patients with moderate or severe renal impairment.
Croatian: Nije uočena toksičnost koja ograničava dozu u 1. ciklusu u bolesnika s umjerenim ili teškim oštećenjem bubrega.
English: Teysuno will be given with another anti-cancer medicine called cisplatin.
Croatian: Teysuno se daje s drugim lijekom protiv raka koji se zove cisplatin.
English: Therefore, brivudine must not be administered concomitantly with Teysuno (see section 4.3 and 4.4).
Croatian: Stoga se brivudin ne smije primjenjivati istodobno s lijekom Teysuno (vidjeti dijelove 4.3 i 4.4).
English: Calculate BSA to 2 decimal places.
Croatian: Izračunajte BSA na 2 decimale. a izraženo kao sadržaj tegafura.
English: This analysis also demonstrated that the trend in changes in Teysuno pharmacokinetics observed with increasing age was related to change in renal function as measured by creatinine clearance.
Croatian: Ova analiza također pokazuje da je uočena tendencija promjene u farmakokinetici lijeka Teysuno s povećanjem životne dobi povezana s promjenom bubrežne funkcije mjerene klirensom kreatinina.
English: In the event of accidental administration of brivudine to patients being treated with Teysuno, effective measures should be taken to reduce the toxicity of Teysuno.
Croatian: Ako se brivudin slučajno primijeni u bolesnika koji se liječe lijekom Teysuno, potrebno je poduzeti učinkovite mjere za smanjenje toksičnosti lijeka Teysuno.
English: • Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction).
Croatian: • Nedavno ili istodobno liječenje brivudinom (za informacije o interakciji između lijekova vidjeti dijelove 4.4 i 4.5).
English: Other clinical studies with Teysuno in combination with cisplatin
Croatian: Ostale kliničke studije s lijekom Teysuno u kombinaciji s cisplatinom
English: Dehydration and diarrhoea may increase the risk of renal toxicity for cisplatin.
Croatian: Dehidracija i proljev mogu povećati rizik renalne toksičnosti izazvane cisplatinom.
English: If the patient becomes pregnant while receiving Teysuno, treatment should be discontinued and the potential risk to the foetus must be explained.
Croatian: Ako tijekom liječenja lijekom Teysuno dođe do trudnoće, liječenje treba prekinuti te treba ukazati na mogući rizik za fetus.
English: - Diarrhoea, nausea, vomiting, constipation o If you experience diarrhoea more than 4 times a day or in the middle of the night, or if you experience sore mouth accompanied by diarrhoea, stop taking Teysuno and contact your doctor immediately.
Croatian: - Proljev, mučninu, povraćanje, konstipaciju ᴑ Ako imate proljev više od 4 puta na dan ili usred noći ili ako imate ranice u ustima praćene proljevom, prestanite s uzimanjem lijeka Teysuno i odmah obavijestite svog liječnika.
English: Use caution when driving or operating a machine, as Teysuno may make you tired, nauseous or have blurred vision.
Croatian: Budite pažljivi prilikom upravljanja vozilima ili rada na strojevima, jer Teysuno može izazvati umor, mučninu ili zamagljen vid.
English: • Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil) or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na bilo koju djelatnu tvar (tegafur, gimeracil i oteracil) ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Teysuno dose adjustment for next dose / next cycle
Croatian: Prilagodba doze lijeka Teysuno za sljedeću dozu/ sljedeći ciklus
English: Fluoropyrimidines may increase phenytoin plasma concentration when administered concomitantly with phenytoin causing phenytoin toxicity.
Croatian: Fluoropirimidini mogu povećati koncentraciju fenitoina u plazmi kod istodobne primjene s fenitoinom uzrokujući fenitoinsku toksičnost.
English: o If you have fever of 38.5o C or higher, stop taking Teysuno and contact your doctor immediately.
Croatian: ᴑ Ako imate temperaturu 38.5 ºC ili višu, prestanite s uzimanjem lijeka Teysuno i odmah se javite liječniku.
English: Teysuno has not been studied in gastric cancer patients with MSI.
Croatian: Teysuno nije proučavan u bolesnika s karcinomom želuca s MSI.
English: As CYP2A6 is the major enzyme responsible for the conversion of tegafur to 5-FU, co-administration of a known CYP2A6 inhibitor and Teysuno should be avoided as effectiveness of Teysuno could be decreased (see section 5.2).
Croatian: Kako je CYP2A6 glavni enzim odgovoran za konverziju tegafura u 5-FU, treba izbjegavati istodobnu primjenu poznatog CYP2A6 inhibitora i lijeka Teysuno, jer može doći do smanjenja učinkovitosti lijeka Teysuno (vidjeti dio 5.2).
English: Oteracil, gimeracil, 5-FU, and tegafur were 8.4%, 32.2%, 18.4%, and 52.3% protein bound, respectively.
Croatian: Oteracil, gimeracil, 5-FU i tegafur se vezuju za proteine 8,4 %, 32,2 %, 18,4 % i 52,3 %.
English: What you need to know before you take Teysuno
Croatian: Što morate znati prije nego počnete uzimati Teysuno
English: Teysuno is contraindicated in pregnancy (see section 4.3).
Croatian: Teysuno je kontraindiciran u trudnoći (vidjeti dio 4.3).
English: Second dose reductiona: to 15 mg/m2 BSA ≥ 2.17 m2
Croatian: Drugo smanjenje dozea: na 15 mg/m2 BSA ≥ 2,17 m2
English: Teysuno should only be prescribed by a qualified physician experienced in treating cancer patients with anti-neoplastic medicinal products.
Croatian: Teysuno može propisivati samo kvalificiran liječnik s iskustvom u liječenju bolesnika oboljelih od karcinoma s antineoplastičnim lijekovima.
English: Brivudine must not be administered concomitantly with Teysuno.
Croatian: Brivudin se ne smije primjenjivati istodobno s lijekom Teysuno.
English: • Contraindications for cisplatin; refer to the cisplatin SmPC.
Croatian: • Kontraindikacije za cisplatin; vidjeti sažetak opisa svojstava lijeka za cisplatin.
English: The most common treatment-related ocular disorders among patients in studies in Europe/United States of America (EU/USA) treated with Teysuno in combination with cisplatin were lacrimal disorders (8.8%), including increased lacrimation, dry eye, and acquired dacryostenosis (see section 4.8).
Croatian: Najčešći poremećaji očiju, u bolesnika liječenih lijekom Teysuno u kombinaciji s cisplatinom koji su sudjelovali u ispitivanjima u Europi/Sjedinjenim Američkim Državama (EU/SAD), bili su poremećaji suzenja oka (8,8 %) uključujući pojačano suzenje, suho oko i stečenu dakriostenozu (vidjeti dio 4.8).
English: Each hard capsule contains 93.6 mg lactose monohydrate.
Croatian: Svaka tvrda kapsula sadrži 93,6 mg laktoze hidrata.
English: Following a single dose of Teysuno, T1/2 values ranged from 6.7 to 11.3 hours for tegafur, from 3.1 to 4.1 hours for gimeracil, and from 1.8 to 9.5 hours for oteracil.
Croatian: Nakon jednokratne doze lijeka Teysuno, vrijednosti T1/2 kretale su se u rasponu od 6,7 do 11,3 sata za tegafur, od 3,1 do 4,1 sat za gimeracil te od 1,8 do 9,5 sati za oteracil.
English: If cisplatin is discontinued before 6 cycles, Teysuno treatment alone can be resumed when the criteria for restarting it are met.
Croatian: Ako se njegova primjena prekine prije 6. ciklusa, liječenje samo lijekom Teysuno može se nastaviti kada se postignu kriteriji za ponovni početak primjene.
English: First dose reductiona: to 20 mg/m2 BSA ≥ 2.13 m2
Croatian: Prvo smanjenje dozea: na 20 mg/m2 BSA ≥ 2,13 m2
English: Teysuno is an oral fluoropyrimidine anti-cancer medicinal product.
Croatian: Teysuno je oralni fluoropirimidinski lijek za liječenje raka.
English: No clinical trials are available comparing Teysuno versus other oral 5-FU compounds.
Croatian: Nisu dostupna klinička ispitivanja koja uspoređuju Teysuno s ostalim oralnim 5-FU-nim spojevima.
English: There was a 15% decrease in AUC0-inf for 5-FU under fed versus fasting conditions, and tegafur exposure was not altered by food (thus demonstrating absence of a food effect).
Croatian: AUC0-inf za 5-FU je smanjen za 15 % kod uzimanja hrane u odnosu na vrijednosti bez uzimanja hrane, a izloženost tegafuru nije bila izmijenjena hranom (što pokazuje odsutnost učinka hrane).
English: • Severe bone marrow suppression (severe leukopaenia, neutropaenia, or thrombocytopaenia; see section 4.2, Table 5).
Croatian: • Teška supresija koštane srži (teška leukopenija, neutropenija ili trombocitopenija; vidjeti dio 4.2,
English: If you take more Teysuno than you should If you take more capsules than you should, contact your doctor immediately.
Croatian: Ako ste uzeli više kapsula nego što ste trebali, odmah obavijestite liječnika.
English: o If you vomit more than two times in 24 hours, stop taking Teysuno and contact your doctor immediately.
Croatian: ᴑ Ako povratite više od dva puta u 24 sata, prestanite s uzimanjem lijeka Teysuno i odmah obavijestite liječnika.
English: Central and peripheral neuropathy has been reported in patients treated with Teysuno in combination with cisplatin.
Croatian: Zabilježene su centralna i periferna neuropatija u bolesnika liječenih lijekom Teysuno u kombinaciji s cisplatinom.
English: Toxicity due to Teysuno administration should be managed with symptomatic treatment and/or treatment interruption or dose reduction.
Croatian: Toksičnost zbog primjene lijeka Teysuno treba kontrolirati simptomatskim liječenjem i/ili prestankom liječenja ili smanjenjem doze.
English: Adverse reactions of Grade 3 or higher such as increased blood creatinine, decreased creatinine clearance, toxic nephropathy, and acute renal failure have all been reported in patients receiving Teysuno in combination with cisplatin (see section 4.8).
Croatian: Nuspojave stupnja 3 ili višeg kao što su porast kreatinina u krvi, smanjenje klirensa kreatinina, toksična nefropatija i akutno zatajenje bubrega uočeni su u bolesnika koji su primali Teysuno u kombinaciji s cisplatinom (vidjeti dio 4.8).
English: No studies have been performed with Teysuno alone or in combination with cisplatin in paediatric patients.
Croatian: Nisu provedena ispitivanja s lijekom Teysuno samim ili u kombinaciji s cisplatinom u pedijatrijskih bolesnika.
English: o If you experience diarrhoea, avoid high-fibre, fatty and spicy foods.
Croatian: ᴑ Ako imate proljev, izbjegavajte visoko-vlaknastu, masnu i začinjenu hranu.
English: Glucose/galactose intolerance/malabsorption
Croatian: Nepodnošenje/malapsorpcija glukoze/galaktoze
English: Gimeracil increases 5-fluorouracil (5-FU) exposure by inhibiting DPD, the primary enzyme for metabolizing 5-FU.
Croatian: Gimeracil povećava izloženost 5-fluorouracilu (5-FU) inhibicijom DPD-a, primarnog enzima metabolizma 5-FU-a.
English: The standard and reduced Teysuno and cisplatin doses and calculations according to body surface area (BSA) for doses of Teysuno given in combination with cisplatin are provided in Table 1 and Table 2, respectively.
Croatian: Standardne i smanjene doze lijekova Teysuno i cisplatina i izračunavanje doza prema površini tijela (BSA, engl. body surface area) za Teysuno u kombinaciji s cisplatinom, prikazane su u Tablicama 1 i 2.
English: Refer to “Dose modifications for special populations / Renal impairment for guidance.”
Croatian: Za smjernice vidjeti „Prilagodbe doze za posebne populacije/oštećenje bubrega.“
English: The protein binding in human serum was not concentration-dependent over a range of 0.1 to 1.0 µg/ml for oteracil, gimeracil, and 5-FU and 1.2 to 11.8 µg/ml for tegafur.
Croatian: Vezanje za proteine u ljudskom serumu ne ovisi o koncentraciji u rasponu od 0,1 do 1,0 µg/ml za oteracil, gimeracil i 5-FU i 1,2 do 11,8 µg/ml za tegafur.
English: Although studies of Teysuno in combination with cisplatin that were conducted in Japan utilised doses and dosing schedules that differed from this regimen, the safety profile from these studies was similar, with the most common toxicities being haematologic, gastrointestinal, fatigue, and anorexia.
Croatian: Iako su ispitivanja lijeka Teysuno u kombinaciji s cisplatinom provedena u Japanu koristeći doze i raspored doziranja koji se razlikovao od ovog režima, profil sigurnosti primjene lijeka iz tih ispitivanja je bio sličan; najčešće toksičnosti bile su hematološka i gastrointestinalna te umor i anoreksija.
English: The oteracil component of Teysuno did not affect the pharmacokinetic profiles of 5-FU, tegafur, gimeracil, FBAL, or uracil.
Croatian: Oteracil kao sastojak lijeka Teysuno nije utjecao na farmakokinetičke profile 5-FU-a, tegafura, gimeracila, FBAL-a niti uracila.
English: Teysuno is prescribed by doctors for the treatment of adults with advanced stomach (gastric) cancer and is taken with cisplatin, another anti-cancer medicine.
Croatian: Teysuno propisuje liječnik za liječenje odraslih s uznapredovalim karcinomom želuca i uzima se s cisplatinom, drugim lijekom protiv raka.
English: Teysuno belongs to the fluoropyrimidine class of medicines known as “antineoplastic agents” which stop the growth of cancer cells.
Croatian: Teysuno pripada skupini fluoropirimidinskih lijekova poznatih kao 'antineoplastične tvari' koje zaustavljaju rast stanica raka.
English: Administration of Teysuno under fed conditions resulted in decreased AUC0-inf for oteracil of approximately 71% and gimeracil of approximately 25% relative to fasting administration.
Croatian: Primjena lijeka Teysuno s hranom rezultirala je smanjenjem AUC0-inf za oteracil za otprilike 71%, a za gimeracil za otprilike 25% u odnosu na primjenu natašte.
English: The combination of tegafur, gimeracil, and oteracil was set at 1:0.4:1 molar ratio as optimum in order to maintain 5-FU exposure and thus sustain anti-tumour activity while reducing toxicity associated with 5-FU alone.
Croatian: Kombinacija tegafura, gimeracila i oteracila u molarnim omjerima 1:0,4:1 je optimalna za održavanje izloženosti 5-FU-u i tako održava antitumorsku aktivnost istodobno smanjujući toksičnost povezanu s 5-FU-om.
English: The safety and efficacy of Teysuno in children and adolescents under 18 years old have not been established.
Croatian: Sigurnost i djelotvornost lijeka Teysuno u djece i adolescenata u dobi do 18 godina nisu ustanovljene.
English: The capsules should be taken by mouth with water at least 1 hour before or 1 hour after a meal (see section 5.2).
Croatian: Kapsule treba uzimati kroz usta s vodom najmanje 1 sat prije ili 1 sat nakon obroka (vidjeti dio 5.2).
English: In case you are using blood thinning or anti-seizure medicines, stopping Teysuno might require that your doctor adjusts the dose of your medicines.
Croatian: U slučaju da uzimate lijekove za razrjeđivanje krvi ili lijekove protiv napadaja, zbog prestanka uzimanja lijeka Teysuno Vaš liječnik će možda trebati prilagoditi njihovu dozu.
English: Frequent monitoring of phenytoin blood/plasma levels is advised when Teysuno and phenytoin are administered concomitantly.
Croatian: Preporučuje se česti nadzor razina fenitoina u krvi/plazmi kod istodobne primjene lijeka Teysuno i fenitoina.
English: No adjustment of the standard dose is recommended in patients >70 years old (see section 4.8).
Croatian: Ne preporučuje se prilagodba standardne doze u bolesnika ≥ 70 godina starosti (vidjeti dio 4.8).
English: Data from a multicentre, multinational (excluding Asia), randomised, controlled, open-label Phase III clinical study (FLAGS) support the use of Teysuno in combination with cisplatin for the treatment of patients with advanced gastric cancer.
Croatian: Podaci multicentrične, multinacionalne (isključivši Aziju), randomizirane, kontrolirane, otvorene studije faze III (FLAGS) podupiru primjenu lijeka Teysuno u kombinaciji s cisplatinom za liječenje bolesnika s uznapredovalim rakom želuca.
English: In vitro evaluation using primary cultures of human hepatocytes indicated that tegafur (0.7-70 µM), gimeracil (0.2-25 µM) and oteracil (0.04-4 µM) had little or no inductive effect on CYP1A2, CYP2B6 or CYP3A4/5 metabolic activities.
Croatian: In vitro evaluacija korištenjem primarnih kultura humanih hepatocita upućuje da tegafur (0,7 - 70 µM), gimeracil (0,2-25 µM) i oteracil (0,04-4 µM) imaju mali ili nikakav indukcijski učinak na metaboličku aktivnost CYP1A2, CYP2B ili CYP3A4/5.
English: Teysuno dose changes within a 21-day treatment cycle
Croatian: Promjena doze lijekaTeysuno unutar 21-dnevnog ciklusa liječenja
English: Teysuno was not found to be mutagenic when tested in the in vitro Ames assay.
Croatian: Nije se pokazao mutagen u in vitro Ames testu.
English: How to take Teysuno
Croatian: Kako uzimati Teysuno
English: Detailed information this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Capsule contents Lactose monohydrate Magnesium stearate
Croatian: Sadržaj kapsule laktoza hidrat magnezijev stearat
English: Among 593 patients treated with Teysuno in combination with cisplatin, the most common severe adverse reactions (Grade 3 or higher with frequency of at least 10%) were neutropaenia, anaemia, and fatigue.
Croatian: U 593 bolesnika liječenih lijekom Teysuno u kombinaciji s cisplatinom, najčešće zabilježene teške nuspojave (stupnja 3 ili višeg sa učestalošću namanje 10%) bile su neutropenija, anemija i umor.
English: Terms for treatment-related ocular toxicities have been combined as follows.
Croatian: Pojmovi očne toksičnosti uzrokovane liječenjem, kombinirani su kako slijedi.
English: If indicated, the dose of phenytoin should be adjusted according to the phenytoin SmPC.
Croatian: Ako je indicirano treba prilagoditi dozu fenitoina u skladu sa sažetkom opisa svojstava za fenitoin.
English: Gimeracil is primarily cleared by the kidney (see section 5.2); so, in patients with renal insufficiency gimeracil renal clearance is decreased and 5-FU exposure thus increased.
Croatian: Gimeracil se prvenstveno odstranjuje bubrezima (vidjeti dio 5.2); tako se, u bolesnika s bubrežnom insuficijencijom renalni klirens gimeracila smanjuje čime se povećava izloženost 5-FU-u.
English: Treatment with Teysuno is not recommended in patients with severe renal impairment due to possibly higher incidence of adverse events of the blood and lymphatic system and the possibility of unexpectedly higher exposure to 5-FU as a result of fluctuations in renal function in these patients, unless the benefits clearly outweigh the risks (see sections 4.2, 4.8 and 5.2).
Croatian: Ne preporuča se liječenje lijekom Teysuno u bolesnika s teškim oštećenjem bubrega zbog moguće veće učestalosti neželjenih događaja krvi i limfnog sustava te mogućnosti neočekivano veće izloženosti 5-FU-u koja je rezultat fluktuacija bubrežne funkcije u takvih bolesnika, osim ako korist liječenja lijekom Teysuno jasno premašuje rizike (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Among the metabolites, 9.5% to 9.7% of the administered tegafur was excreted in the urine as 5-FU and approximately 70% to 77% as FBAL, accounting for approximately 83% to 91% of the administered Teysuno dose (total tegafur + 5-FU + FBAL).
Croatian: Od metabolita, 9,5 % do 9,7 % primijenjenog tegafura izlučilo se u urinu kao 5-FU a otprilike 70 % do 77 % kao FBAL, računajući na otprilike 83 % do 91 % primijenjene doze lijeka Teysuno (ukupni tegafur + 5-FU + FBAL).
English: 5-FU is metabolised by the liver enzyme DPD.
Croatian: 5-FU se metabolizira uz pomoć jetrenog enzima DPD.
English: If any of the side effects get serious, stop taking Teysuno and tell your doctor immediately.
Croatian: Ako se bilo koja nuspojava pogorša, prestanite uzimati Teysuno i odmah obavijestite liječnika.
English: Each pack contains either 42 capsules, 84 capsules or 126 capsules.
Croatian: Svako pakiranje sadrži 42 kapsule, 84 kapsule ili 126 kapsula
English: Tegafur is a prodrug of 5-FU with good oral bioavailability.
Croatian: Tegafur je predlijek 5-FU-a sa dobrom oralnom bioraspoloživošću.
English: Administration of Teysuno with a meal reduced exposure to oteracil and gimeracil, with a more pronounced effect for oteracil than for gimeracil (see section 5.2).
Croatian: Primjena lijeka Teysuno uz obrok smanjuje izloženost oteracilu i gimeracilu izražavajući veći učinak oteracila od gimeracila (vidjeti dio 5.2).
English: Confusional state, restlessness, personality disorder, hallucination, depression, anxiety, libido decreased, sexual inhibition
Croatian: Psihijatrijski poremećaji nesanica stanje zbunjenosti, uznemirenost, poremećaj osobnosti, halucinacije, depresija, anksioznost, smanjeni libido, spolna inhibicija
English: Following both single dose (50 mg) and multiple dose (30 mg/m2 twice daily) administration of Teysuno in man, maximum uracil concentrations reflecting DPD inhibition were observed approximately 4 hours postdose.
Croatian: Primjenom i jednostruke doze (50 mg) i višestruke doze (30 mg/m2 dva puta na dan) lijeka Teysuno u ljudi, maksimalne koncentracije uracila koje odražavaju inhibiciju DPD-a opažene su otprilike 4 sata nakon primjene.
English: Patients with diarrhoea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.
Croatian: Bolesnike s proljevom treba pažljivo nadzirati i ukoliko su dehidrirali provesti nadoknadu tekućine i elektrolita.
English: The dose for one patient in the severe cohort was reduced to 13.2 mg/m2 once daily at the start of Cycle 12 due to an adverse reaction (Grade 2 diarrhoea) in Cycle 11.
Croatian: Doza za jednog bolesnika u kohorti bolesnika s teškim oštećenjem bubrega smanjena je na 13,2 mg/m2 jednom dnevno na početku 12. ciklusa zbog nuspojava (proljev stupnja 2) u 11. ciklusu.
English: Creatinine clearance (CrCl) must be determined for every cycle before the start of treatment on Day 1.
Croatian: Prilagodbe doze zbog bubrežne toksičnosti Mora se odrediti klirens kreatinina (CrCl) za svaki ciklus prije početka liječenja, na 1. dan ciklusa.
English: Grade 3 or higherc First occurrence
Croatian: Stupanj 3 ili višic Prva pojava
English: A maximum of two consecutive dose reductions for each medicinal product, as described in Table 1, can be applied in case of toxicity.
Croatian: U slučaju toksičnosti mogu se provesti najviše dva uzastopna smanjenja doze za svaki lijek, kao što je opisano u Tablici 1.
English: The term peripheral neuropathy includes the following reported adverse reactions: peripheral sensory neuropathy, paraesthesia, hypoaesthesia, peripheral neuropathy, polyneuropathy, neurotoxicity, and dysaesthesia.
Croatian: Pojam periferna neuropatija uključuje sljedeće zabilježene nuspojave: periferna senzorna neuropatija, parestezija, hipoestezija, periferna neutropatija, polineuropatija, neurotoksičnost i disestezija.
English: A clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5Fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described.
Croatian: U literaturi je opisana klinički značajna interakcija između brivudina i fluoropirimidina (npr. kapecitabina, 5-fluorouracila, tegafura), koja proizlazi iz inhibicije dihidropirimidin dehidrogenaze brivudinom.