natgillin/translations-raw huggingface dataset:
Neoplasms benign, malignant and unspecified (incl. 
Dobroćudne, zloćudne i nespecifične novotvorine (uklj. ciste i polipe)
Dose reduction 1 (mg/m2) 
Smanjenje doze 1 (mg/m2)
Comparison of safety between 71 patients ≥70 years old (elderly) and 450 patients <70 years old treated with Teysuno in combination with cisplatin in the FLAGS study demonstrated that the incidence of all Grade 3 or higher adverse reactions (62% vs 52%), all serious adverse reactions (30% vs 19%), and the rate of premature withdrawal due to adverse reactions from both Teysuno and cisplatin (21% vs 12%) appeared to be higher among patients ≥70 years old. 
< 70 godina liječenih lijekom Teysuno u kombinaciji s cisplatinom u FLAGS studiji je pokazala da je incidencija svih nuspojava stupnja 3 ili višeg (62 % prema 52 %), svih ozbiljnih nuspojava (30 % prema 19 %) kao i udio preranog povlačenja iz studije zbog nuspojava, oba lijeka: lijeka Teysuno i cisplatina (21 % prema 12 %) bila viša kod bolesnika u dobi
INFORMATION IN BRAILLE Teysuno 20 mg/5.8 mg/15.8 mg 17. 
PODACI NA BRAILLEOVOM PISMU Teysuno 20 mg/5,8 mg/15,8 mg
Mean 5-FU maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) values were approximately 3-fold higher after Teysuno administration than after administration of tegafur alone, despite a 16-fold lower Teysuno dose (50 mg of tegafur) compared to tegafur alone (800 mg), and are attributed to inhibition of DPD by gimeracil. 
Srednja maksimalna koncentracija 5-FU-a u plazmi (Cmax) i površina ispod krivulje koncentracija-vrijeme (AUC) bile su otprilike 3 puta veće nakon primjene lijeka Teysuno nego nakon primjene samog tegafura, usprkos 16 puta nižoj dozi lijeka Teysuno (50 mg tegafura) u usporedbi s samim tegafurom (800 mg), a pripisuju se inhibiciji DPD gimeracilom.
Teysuno doses 
Doze lijeka Teysuno
Median [95% CI]. 
N Medijan[95%CI], mjeseci
Warnings and precautionsTalk to your doctor before taking teysuno if you have: blood disorders kidney disease stomach and/or bowel problems such as pain, diarrhoea, vomiting and dehydration eye disorders, such as “dry eye” or increased tearing a current or previous infection of the liver with the hepatitis B virus, since your doctor may want to monitor you more closely 
- probleme sa želucem i/ili crijevima kao što je bol, proljev, povraćanje i dehidracija - poremećaje oka kao što je 'suho oko' ili pojačano suzenje - trenutna ili prethodna infekcija jetre virusom hepatitisa B, jer će Vas liječnik možda željeti pažljivije pratiti
N 
a
INFORMATION IN BRAILLE Teysuno 15 mg/4.35 mg/11.8 mg 17. 
PODACI NA BRAILLEOVOM PISMU Teysuno 15 mg/4,35 mg/11,8 mg
Name and address of the manufacturer responsible for batch release 
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJELIJEKA
In a Phase I Teysuno monotherapy study that investigated the pharmacokinetics of components and metabolites in patients with normal and impaired renal function, patients with mild renal impairment (CrCl 51 to 80 ml/min) receiving the same monotherapy dose of 30 mg/m2 twice daily (the maximum tolerated dose for monotherapy) as patients with normal renal function (CrCl >80 ml/min) had an increase in mean 5-FU AUC0-inf relative to that of the normal patients. 
U studiji faze I monoterapije lijekom Teysuno koja je ispitivala farmakokinetiku sastojaka i metabolite u bolesnika s normalnom i oštećenom bubrežnom funkcijom, bolesnici s blagim oštećenjem bubrega (CrCl 51 do 80 ml/min) koji su uzimali istu monoterapijsku dozu od 30 mg/m2 dva puta na dan (maksimalna doza podnošenja u monoterapiji) kao i bolesnici s normalnom funkcijom bubrega (CrCl > 80 ml/min) imali su povećanu artimetičku sredinu AUC0-inf 5-FU-a u odnosu na bolesnike s normalnom funkcijom bubrega.
Ink: red iron oxide (E172), yellow iron oxide (E172), Indigo carmine (E132), carnauba wax, bleached shellac, glyceryl monooleate 
Tinta: crveni željezov oksid (E172), žuti željezov oksid (E172), Indigo carmine (E132), karnauba vosak, izbijeljeni šelak, glicerilmonooleat
Therefore, concurrent administration with Teysuno should be avoided. 
Stoga treba izbjegavati njegovu istodobnu primjenu sa lijekom Teysuno.
Patients receiving oral coumarin-derivative anticoagulant therapy must have their anticoagulant response (International Normalized Ratio for prothrombin time [INR] or prothrombin time [PT]) monitored closely and the anticoagulant dose adjusted accordingly (see section 4.5). 
International Normalized Ratio) ili protrombinsko vrijeme [PV]) kod bolesnika koji uzimaju oralnu antikoagulantnu terapiju derivatima kumarina i sukladno tomu prilagoditi dozu antikoagulansa (vidjeti dio 4.5).
Non-clinical studies demonstrated that Teysuno did not appear to affect male or female fertility in the rat (see section 5.3). 
Pretkliničke studije nisu pokazale utjecaj lijeka Teysuno na plodnost u mužjaka ili ženki štakora (vidjeti dio 5.3).
Standard anti-diarrhoeal therapy (e.g., loperamide) and intravenous fluids/electrolytes should be initiated early when diarrhoea develops. 
Kad se razvije proljev treba rano započeti sa standardnom terapijom proljeva (npr. loperamid) i intravenskom primjenom tekućine/elektrolita.
No adjustment of the standard dose is recommended for patients with hepatic impairment (see section 5.2). 
Ne preporučuje se prilagodba standardne doze u bolesnika s oštećenjem jetre (vidjeti dio 5.2).
Treatment with brivudine can be started 24 hours after the last dose of Teysuno (see section 4.3 and 4.5). 
Između završetka liječenja brivudinom i početka liječenja lijekom Teysuno moraju proći najmanje 4 tjedna, dok se liječenje brivudinom može započeti 24 sata nakon primjene posljednje doze lijeka Teysuno (vidjeti dijelove 4.3 i 4.5).
The median Tmax for 5-FU was 2.0 hours and the mean AUC0-inf and Cmax was 842 ± 252 ng.hr/ml and 174 ± 58 ng/ml. 
Medijan Tmax za 5-FU je iznosio 2,0 sata, a aritmetička sredina AUC0-inf i Cmax iznosila je 842 ± 252 ng.sati/ml i 174 ± 58 ng/ml.
Toxicity gradesa 
Stupanj toksičnostia
Table 6: Minimum criteria to resume Teysuno treatment following its suspension due to a toxicity Non-haematologic 
Kriteriji za ponovni početak liječenja lijekom Teysuno Tablica 6: Minimalni kriteriji za nastavak liječenja lijekom Teysuno nakon odgode zbog toksičnosti
As renal function decreased, there was an increase in 5-FU steady state exposure. 
Kako se smanjivala bubrežna funkcija, povećavala se dinamička ravnoteža izloženosti 5-FU-u.
There was no effect of gimeracil on renal clearance of tegafur, FBAL, and 5-FU following administration of Teysuno as compared to their clearance following administration of tegafur alone. 
Nakon primjene lijeka Teysuno nije bilo učinka gimeracila na bubrežni klirens tegafura, FBAL-a i 5-FU-a u usporedbi s njihovim klirensom nakon primjene tegafura samog.
NAME OF THE MEDICINAL PRODUCT Teysuno 15 mg/4.35 mg/11.8 mg hard capsules 
NAZIV LIJEKA Teysuno 15 mg/4,35 mg/11,8 mg tvrde kapsule
IU 
ᴑ
the median Tmax for Teysuno components tegafur, gimeracil, and oteracil was 0.5, 1.0, and 2.0 hours, respectively, and the mean ± standard deviation (SD) AUC0-inf and Cmax was 14595 ± 4340 ng.hr/ml and 1762 ± 279 ng/ml for tegafur, 1884 ± 640 ng.hr/ml and 452 ± 102 ng/ml for gimeracil, 556 ± 281 ng.hr/ml and 112 ± 52 ng/ml for oteracil. 
Tmax za sastojke lijeka Teysuno, tegafur, gimeracil i oteracil je iznosio 0,5; 1,0 i 2,0 sata, a aritmetička sredina ± standardna devijacija (SD) AUC0-inf i Cmax iznosila je 14 595 ± 4340 ng.sati/ml i 1762 ± 279 ng/ml za tegafur, 1884 ± 640 ng.sati/ml i 452 ± 102 ng/ml za gimeracil, 556 ± 281 ng.sati/ml i 112 ± 52 ng/ml za oteracil.
Dose reduction 2 (mg/m2) 
Smanjenje doze 2 (mg/m2)
4.7 Effects on ability to drive and use machines Teysuno has a moderate influence on the ability to drive and use machines as fatigue, dizziness, blurred vision, and nausea are common adverse reactions of Teysuno in combination with cisplatin. 
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Teysuno umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog umora, omaglice, zamagljenog vida i mučnine kao najčešćih nuspojava lijeka Teysuno u kombinaciji s cisplatinom.
The patient's BSA must be recalculated and the Teysuno dose adjusted accordingly if a patient's weight increases or decreases by ≥10% from the one used for the previous calculation of BSA and the change is clearly not related to fluid retention. 
Ako se tjelesna masa poveća ili smanji za ≥ 10% u odnosu na prethodni izračun BSA, mora se ponovno izračunati površina tijela bolesnika i prema njoj prilagoditi doza lijeka Teysuno, osim ako ta promjena nije jasno posljedica zadržavanje tekućine.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/669/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/669/001
In a dose escalation study comparing the tolerability of 5_FU in Teysuno and tegafur + gimeracil (no oteracil), the 25 mg/m2 dose level could not be attained in the absence of oteracil due to the occurrence of dose limiting toxicities (Grade 3 diarrhoea in 2 patients, and cardio-respiratory arrest in 1 patient) in the tegafur+gimeracil arm. 
U studiji povećanja doze koja je uspoređivala podnošljivost 5-FU-a u lijeku Teysuno i tegafur + gimeracil (bez oteracila) u grupi koja je primala tegafur + gimeracil, nije se mogla postići doza od 25 mg/m2 u odsutnosti oteracila zbog pojave toksičnosti koja ograničava dozu (proljev stupnja 3 u 2 bolesnika i kardio-respiratorni zastoj u jednog bolesnika).
Table 8: Demographics and baseline characteristics of patients in the FLAGS study 
Tablica 8: Demografske i osnovne karakteristike bolesnika u FLAGS studiji Teysuno + cisplatin 75 mg/m2
NAME OF THE MARKETING AUTHORISATION HOLDER Nordic Group B.V. 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Nordic Group B.V.
Capsule contents: lactose monohydrate, magnesium stearate Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171), sodium lauryl sulphate, talc 
Sadržaj kapsule: laktoza hidrat, magnezijev stearat Ovojnica kapsule: želatina, crveni željezov oksid (E172), titanijev dioksid (E171), natrijev laurilsulfat, talk
Mean AUC0-inf and Cmax for 5-FU were approximately 3-fold greater following administration of Teysuno (50 mg expressed as tegafur content) than following administration of tegafur alone (800 mg), while AUC0-inf and Cmax values for the 5-FU metabolite α-fluoro-β-alanine (FBAL) were approximately 15- to 22-fold lower following administration of Teysuno than following administration of tegafur. 
Aritmetička sredina AUC0-inf i Cmax za 5-FU bila je otprilike 3 puta veća nakon primjene lijeka Teysuno (50 mg izraženo kao sadržaj tegafura) u odnosu na aritmetičku sredinu nakon primjene tegafura samog (800 mg), dok su AUC0-inf i Cmax vrijednosti za metabolit 5-FU-a, α-fluoro-β-alanin (FBAL) otprilike 1522 puta niže nakon primjene lijeka Teysuno nego nakon primjene tegafura.
Marketing Authorisation Holder Nordic Group B.V. 
Nositelj odobrenja za stavljanje lijeka u promet Nordic Group B.V.
NAME OF THE MEDICINAL PRODUCT Teysuno 20 mg/5.8 mg/15.8 mg hard capsules 
NAZIV LIJEKA Teysuno 20 mg/5,8 mg/15,8 mg tvrde kapsule
Nordic Pharma 
Ireland Nordic Pharma Ireland
• Lacrimal disorder includes adverse reactions of increased lacrimation, dry eye, and acquired dacryostenosis; 
• poremećaj suznog aparata uključuje nuspojave pojačanog suzenja, suhog oka i dakriostenoze;
- are taking other fluoropyrimidine anti-cancer medicine such as fluorouracil and capecitabine, or have had severe and unexpected reactions to fluoropyrimidines - have known genetic deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) - are pregnant or breast-feeding - have severe blood disorders - have kidney disease requiring dialysis - are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy. 
Nemojte uzimati Teysuno: - ako ste alergični na tegafur, gimeracil, oteracil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) - ako uzimate drugi fluoropirimidinski lijek protiv raka kao što je fluorouracil i kapecitabin ili ste imali teške i neočekivane reakcije na fluoropirimidine - ako je poznato da imate genetski nedostatak enzima dihidropirimidin dehidrogenaze (DPD) - ako ste trudni ili dojite - ako imate teške poremećaje krvi - ako imate bolest bubrega koja zahtijeva dijalizu - ako se liječite ili ste u posljednja 4 tjedna liječeni brivudinom u sklopu liječenja herpes zostera (vodene kozice ili herpes zoster).
- Heart: irregular or fast heart beat, chest pain, accumulation of excess fluid around the heart, 
- Srce: nepravilan ili ubrzani rad srca, bol u prsima, nakupljanje viška tekućine oko srca, srčani udar, zatajenje srca - Krvne žile: upala vena, navale vrućine
The median Tmax for 5-FU was 2.0 hours and the mean AUC(0-12h) and Cmax was 870 ± 405 ng.hr/ml and 165 ± 62 ng/ml, respectively. 
Medijan Tmax za 5-FU je iznosio 2,0 sata a aritmetička sredina AUC (0-12 sati) i Cmax iznosila je 870 ± 405 ng.hr/ml i 165 ± 62 ng/ml.
Patients with moderate renal impairment (CrCl 30 to 50 ml/min) who received a reduced dose of 20 mg/m2 twice daily showed no significant increase in mean 5-FU AUC0-inf relative to that of the normal group. 
Kod bolesnika s umjerenim oštećenjem bubrega (CrCl 30 do 50 ml/min) koji su uzimali smanjenu dozu od 20 mg/m2 dva puta na dan nije pokazan značajni porast aritmetičke sredine AUC0-inf 5-FU-a u odnosu na isto u skupini bolesnika s normalnom funkcijom bubrega.
Following a reduced dose of Teysuno 20 mg/m2 administered once daily to the severe renal impairment group (CrCl < 30 ml/min), the single-dose AUC0-inf and multiple-dose AUC0-τ values for 5-FU were approximately 2-fold higher in the severe renal impairment group compared to those observed in the normal renal function group receiving 30 mg/m2 twice daily. 
Nakon smanjenja doze lijeka Teysuno na 20 mg/m2 primijenjene jednom dnevno u skupini bolesnika s teškim oštećenjem bubrega (CrCl< 30 ml/min), vrijednosti AUC0-inf 5-FU-a jednostruke doze i AUC0-t 5FU-a višestruke doze bile su otprilike dvostruko više u skupini bolesnika s teškim oštećenjem bubrega u usporedbi sa vrijednostima opaženima u skupini bolesnika s normalnom bubrežnom funkcijom koja je primala Teysuno u dozi od 30 mg/m2 dva puta na dan.
There were no significant differences in AUCs of 5-FU, tegafur, gimeracil, or oteracil after either single or multiple dose administration of Teysuno 30 mg/m2 twice daily in patients with mild, 
Nije bilo značajnih razlika u AUC 5-FU-a, tegafura, gimeracila ili oteracila bilo nakon jednostruke ili višestruke primjene doze lijeka Teysuno od 30 mg/m2 dva puta na dan u bolesnika sa blagim, umjerenim ili teškim oštećenjem jetre u usporedbi sa onima sa normalnom funkcijom jetre.
Yellow iron oxide (E172) 
Tinta za označivanje željezov oksid, crveni (E172) željezov oksid, žuti (E172)
Dose suspension/adjustment should be implemented with the occurrence of Grade 2 or higher diarrhoea if symptoms persist despite adequate treatment. 
Ako nastupi proljev stupnja 2 ili višeg, a simptomi ustraju usprkos adekvatnom liječenju, treba implementirati odgodu/prilagodbu doze.
Location of primary lesion, n (%) Stomach 
Lokacija primarne lezije, n (%) želudac gastro-ezofagealni spoj oboje
For minimum criteria for resumption of Teysuno treatment, see Table 6. 
Minimalni kriteriji za nastavak liječenja lijekom Teysuno nakon prekida zbog toksičnosti navedeni su u Tablici 6.
doses, steady-state conditions are reached for tegafur, gimeracil, and oteracil at the latest by Day 8. 
Nakon primjene doza od 30 mg/m2, postignuti su uvjeti stanja dinamičke ravnoteže za tegafur, gimeracil i oteracil najdulje do 8. dana.
Patients should be tested for HBV infection before initiating treatment with Teysuno. 
Prije početka liječenja lijekom Teysuno bolesnike treba testirati na infekciju virusom hepatitisa B (HBV).
After multiple dose administration (30 mg/m2, expressed as tegafur content, twice daily for 14 days; N=10), the median Tmax of tegafur, gimeracil, and oteracil was 0.8, 1.0, and 2.0 hours, respectively, and the corresponding mean ± SD AUC(0-12h) and Cmax was 19967 ± 6027 ng.hr/ml and 2970 ± 852 ng/ml for tegafur, 1483 ± 527 ng.hr/ml and 305 ± 116 ng/ml for gimeracil, and 692 ± 529 ng.hr/ml and 122 ± 82 ng/ml for oteracil. 
dana; N=10), medijan Tmax za tegafur, gimeracil i oteracil je iznosio 0,8; 1,0 i 2,0 sati i odgovarajuća aritmetička sredina ± SD AUC (0-12 sati) i Cmax iznosila je 19 967 ± 6027 ng.sati/ml i 2970 ± 852 ng/ml za tegafur, 1483 ± 527 ng.sati/ml i 305 ± 116 ng/ml za gimeracil i 692 ± 529 ng.sati/ml i 122 ± 82 ng/ml za oteracil.
Common side effects (may affect 1 to 10 in 100 people) include: 
Česte nuspojave (mogu se javiti u 1 do 10 na 100 osoba) uključuju:
MARKETING AUTHORISATION NUMBER(S) EU/1/11/669/003 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/669/003
- Skin: loss of skin colour, peeling skin, excessive body hair, nail shrinkage, excessive sweating, - General: general condition worsening, weight increase, redness and swelling at the injection site, cancer pain and bleeding, multiple organ failure - Changes in blood tests: high blood sugar, high blood lipids, changes in blood clotting time, high blood cell counts, low or high protein level - Other: frequent urination, blood in urine, neck pain, back pain, breast pain, muscle tightness or cramps, joint swelling, limb discomfort, muscle weakness, arthritis inflammation and pain 
- Općenito: pogoršanje općeg stanja, povećanje težine, crvenilo i oticanje na mjestu, injekcije, bol od tumora i krvarenje, zatajenje više organa - Promjene u nalazima krvi: visoki šećer u krvi, visoki lipidi u krvi, promjene u zgrušavanju krvi, visoki broj krvnih stanica, niske ili visoke razine proteina - Ostalo: često mokrenje, krv u urinu, bol u vratu, bol u leđima, bol u dojkama, napetost i grčevi u mišićima, oticanje zglobova, nelagoda u udovima, mišićna slabost, upalni artritis i bol
Very common side effects (may affect more than 1 in 10 people) include: 
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) uključuju:
Resumption criteria for Teysuno treatment 
Kriteriji za prilagodbu doze lijeka Teysuno
4.7 Effects on ability to drive and use machines Teysuno has moderate influence on the ability to drive and use machines as fatigue, dizziness, blurred vision, and nausea are common adverse reactions of Teysuno in combination with cisplatin. 
Teysuno umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog umora, omaglice, zamagljenog vida i mučnine kao najčešćih nuspojava lijeka Teysuno u kombinaciji s cisplatinom.
Calculated creatinine clearance ≥30 ml/mina Neutrophils ≥1.5 x 109/l 
Izračunati klirens kreatinina ≥ 30 ml/mina
Haematologic 
Nehematološki
Cerebrovascular accident, cerebellar infarction, cerebrovascular disorder, convulsion, ischaemic stroke, syncope, hemiparesis, aphasia, ataxia, metabolic encephalopathy, loss of consciousness, acoustic neuritis, memory impairment, balance disorder, somnolence, tremor, ageusia, parosmia, burning sensation, formication 
Poremećaji živčanog sustava periferna neutropatija vrtoglavica, glavobolja, promjena okusa cerebrovaskularni događaj , infarkt malog mozga, cerebrovaskularni poremećaj, konvulzije, ishemijski inzult, sinkopa, hemipareza, afazija, ataksija, metabolička encefalopatija, gubitak svijesti, akustični neuritis, oštećenje memorije, poremećaj ravnoteže, pospanost, tremor, ageuzija, parosmija, osjećaj pečenja, formikacija leukoencefalopatija, anosmija
Iliac artery thrombosis, hypovolaemic shock, arterial limb thrombosis, thrombosis, flushing, pelvic venous thrombosis, thrombophlebitis, phlebitis, phlebitis superficial, orthostatic hypotension, haematoma, hyperaemia, hot flush 
venska tromboza, hipertenzija hipovolemijski šok, arterijska tromboza udova, tromboza, crvenilo, venska zdjelična tromboza, tromboflebitis, flebitis, površinski flebitis, ortostatska hipotenzija, hematomi, hiperemija, navale vrućine
The hard capsules have a white body and white cap imprinted "TC442" in grey. 
Tvrde kapsule se sastoje od bijelog tijela i bijele kapice s oznakom „TC442“ u sivoj boji.
You must not take brivudine (an anti-viral medicine for the treatment of shingles or chickenpox) at the same time as Teysuno treatment (including during any rest periods when you are not taking any Teysuno capsules). 
Tijekom liječenja lijekom Teysuno ne smijete uzimati brivudin (antivirusni lijek za liječenje herpes zostera ili vodenih kozica).
Dose limiting toxicities include diarrhoea and dehydration. 
4.4 Posebna upozorenja i mjere opreza pri uporabi Toksičnosti koje ograničavaju dozu uključuju proljev i dehidraciju.
Uncommon side effects (may affect 1 to 10 in 1,000 people) include: 
Manje česte nuspojave (mogu se javiti u 1 do 10 na 1000 osoba) uključuju:
Glyceryl monooleate 
karnauba vosak šelak, izbijeljeni glicerilmonooleat
Red iron oxide (E172) Titanium dioxide (E171) Sodium lauryl sulphate 
Ovojnica kapsule želatina željezov oksid, crveni (E172) titanijev dioksid (E171) natrijev laurilsulfat talk
The use of coumarin-derivative anticoagulant in clinical trials has been associated with elevated INR and gastrointestinal bleeding, bleeding tendency, haematuria, and anaemia in patients receiving Teysuno therapy. 
U kliničkim ispitivanjima kod bolesnika koji su uzimali Teysuno, uporaba antikoagulansa - derivata kumarina bila je povezana s povećanim INR-om i gastrointestinalnim krvarenjem, sklonošću krvarenju, hematurijom i anemijom.
Neutropenic sepsis, septic shock, sepsis, infection, pneumonia, bacteremia, respiratory tract infection, upper respiratory tract infection, pyelonephritis acute, urinary tract infection, pharyngitis, nasopharyngitis, rhinitis, tooth infection, candidiasis, oral herpes, paronychia, furuncle 
Infekcije i infestacije neutropenijska sepsa, septički šok, sepsa, infekcija, pneumonija, bakterijemija, infekcija respiratornog trakta, infekcija gornjeg respiratornog trakta, akutni pijelonefritis, infekcija urinarnog trakta, faringitis, nazofaringitis, rinitis, infekcija zubi, kandidijaza, oralni herpes, paronihija, furunkul reaktivacija hepatitisa B
- Nerve: headache, dizziness, sleeplessness, changes in taste - Eye: eye problems, increased or decreased tearing discomfort, vision problems, serious illness with blistering of the eyes, wearing away of the surface “skin” of the eye (corneal erosion) - Ear: hearing problems - Blood vessels: high or low blood pressure, blood clots in the leg and lung 
- Živčane: glavobolja, omaglica, nesanica, promjene okusa - Oko: problemi s očima, povećano ili smanjeno suzenje, problemi s vidom, ozbiljna bolest sa stvaranjem mjehurića na očima uz gubitak površine „sluznice“ oka (erozija rožnice) - Uho: problemi sa sluhom - Krvne žile: visok ili nizak krvni tlak, krvni ugrušci u nogama i plućima - Pluća i nosnu šupljinu: nedostatak zraka, kašalj - Crijeva i usta: suha usta, ranice u ustima, grlu i jednjaku, štucavica, bol u trbuhu, probavne tegobe,
Titanium dioxide (E171) Sodium lauryl sulphate Talc 
Ovojnica kapsule želatina titanijev dioksid (E171) natrijev laurilsulfat talk
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (as salt). 
NAVOĐENJE DJELATNE(IH) TVARI Svaka tvrda kapsula sadrži 15 mg tegafura, 4,35 mg gimeracila i 11,8 mg oteracila (u obliku soli).
Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil, and 11.8 mg oteracil (as monopotassium). 
Svaka tvrda kapsula sadrži 15 mg tegafura, 4,35 mg gimeracila i 11,8 mg oteracila (u obliku kalijeve soli).