FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: Marketing Authorisation Holder Nordic Group B.V.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Nordic Group B.V.
English: NAME OF THE MEDICINAL PRODUCT Teysuno 20 mg/5.8 mg/15.8 mg hard capsules
Croatian: NAZIV LIJEKA Teysuno 20 mg/5,8 mg/15,8 mg tvrde kapsule
English: Nordic Pharma
Croatian: Ireland Nordic Pharma Ireland
English: • Lacrimal disorder includes adverse reactions of increased lacrimation, dry eye, and acquired dacryostenosis;
Croatian: • poremećaj suznog aparata uključuje nuspojave pojačanog suzenja, suhog oka i dakriostenoze;
English: - 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.
Croatian: 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).
English: - Heart: irregular or fast heart beat, chest pain, accumulation of excess fluid around the heart,
Croatian: - Srce: nepravilan ili ubrzani rad srca, bol u prsima, nakupljanje viška tekućine oko srca, srčani udar, zatajenje srca - Krvne žile: upala vena, navale vrućine
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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,
Croatian: 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.
English: Yellow iron oxide (E172)
Croatian: Tinta za označivanje željezov oksid, crveni (E172) željezov oksid, žuti (E172)
English: Dose suspension/adjustment should be implemented with the occurrence of Grade 2 or higher diarrhoea if symptoms persist despite adequate treatment.
Croatian: Ako nastupi proljev stupnja 2 ili višeg, a simptomi ustraju usprkos adekvatnom liječenju, treba implementirati odgodu/prilagodbu doze.
English: Location of primary lesion, n (%) Stomach
Croatian: Lokacija primarne lezije, n (%) želudac gastro-ezofagealni spoj oboje
English: For minimum criteria for resumption of Teysuno treatment, see Table 6.
Croatian: Minimalni kriteriji za nastavak liječenja lijekom Teysuno nakon prekida zbog toksičnosti navedeni su u Tablici 6.
English: doses, steady-state conditions are reached for tegafur, gimeracil, and oteracil at the latest by Day 8.
Croatian: Nakon primjene doza od 30 mg/m2, postignuti su uvjeti stanja dinamičke ravnoteže za tegafur, gimeracil i oteracil najdulje do 8. dana.
English: Patients should be tested for HBV infection before initiating treatment with Teysuno.
Croatian: Prije početka liječenja lijekom Teysuno bolesnike treba testirati na infekciju virusom hepatitisa B (HBV).
English: 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.
Croatian: 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.
English: Common side effects (may affect 1 to 10 in 100 people) include:
Croatian: Česte nuspojave (mogu se javiti u 1 do 10 na 100 osoba) uključuju:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/669/003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/669/003
English: - 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
Croatian: - 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
English: Very common side effects (may affect more than 1 in 10 people) include:
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) uključuju:
English: Resumption criteria for Teysuno treatment
Croatian: Kriteriji za prilagodbu doze lijeka Teysuno
English: 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.
Croatian: 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.
English: Calculated creatinine clearance ≥30 ml/mina Neutrophils ≥1.5 x 109/l
Croatian: Izračunati klirens kreatinina ≥ 30 ml/mina
English: Haematologic
Croatian: Nehematološki
English: 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
Croatian: 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
English: Iliac artery thrombosis, hypovolaemic shock, arterial limb thrombosis, thrombosis, flushing, pelvic venous thrombosis, thrombophlebitis, phlebitis, phlebitis superficial, orthostatic hypotension, haematoma, hyperaemia, hot flush
Croatian: venska tromboza, hipertenzija hipovolemijski šok, arterijska tromboza udova, tromboza, crvenilo, venska zdjelična tromboza, tromboflebitis, flebitis, površinski flebitis, ortostatska hipotenzija, hematomi, hiperemija, navale vrućine
English: The hard capsules have a white body and white cap imprinted "TC442" in grey.
Croatian: Tvrde kapsule se sastoje od bijelog tijela i bijele kapice s oznakom „TC442“ u sivoj boji.
English: 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).
Croatian: Tijekom liječenja lijekom Teysuno ne smijete uzimati brivudin (antivirusni lijek za liječenje herpes zostera ili vodenih kozica).
English: Dose limiting toxicities include diarrhoea and dehydration.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Toksičnosti koje ograničavaju dozu uključuju proljev i dehidraciju.
English: Uncommon side effects (may affect 1 to 10 in 1,000 people) include:
Croatian: Manje česte nuspojave (mogu se javiti u 1 do 10 na 1000 osoba) uključuju:
English: Glyceryl monooleate
Croatian: karnauba vosak šelak, izbijeljeni glicerilmonooleat
English: Red iron oxide (E172) Titanium dioxide (E171) Sodium lauryl sulphate
Croatian: Ovojnica kapsule želatina željezov oksid, crveni (E172) titanijev dioksid (E171) natrijev laurilsulfat talk
English: 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.
Croatian: 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.
English: 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
Croatian: 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
English: - 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
Croatian: - 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,
English: Titanium dioxide (E171) Sodium lauryl sulphate Talc
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) natrijev laurilsulfat talk
English: Nordic Group B.V. Siriusdreef 41
Croatian: Nordic Group B.V.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (as salt).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tvrda kapsula sadrži 15 mg tegafura, 4,35 mg gimeracila i 11,8 mg oteracila (u obliku soli).
English: Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil, and 11.8 mg oteracil (as monopotassium).
Croatian: Svaka tvrda kapsula sadrži 15 mg tegafura, 4,35 mg gimeracila i 11,8 mg oteracila (u obliku kalijeve soli).
English: Gastrointestinal perforation, oesophagitis, gastrointestinal infection, ileus, gastrointestinal obstruction, ascites, lip oedema, oesophageal spasm, gastric ulcer, gastroesophageal reflux disease, reflux gastritis, retroperitoneal fibrosis, gastrointestinal disorder, anal haemorrhage, haemorrhoids, salivary hypersecretion, retching, salivary gland disorder, cheilitis, aerophagia, eructation, glossodynia, oral pain, teeth brittle
Croatian: Gastrointestinalni poremećaji proljev, povraćanje, mučnina, zatvor gastrointestinalno krvarenje, stomatitis, gastrointestinalna upala, flatulencija, abdominalna bol, disfagija, abdominalna nelagoda, dispepsija, suha usta gastrointestinalna perforacija, ezofagitis, gastrointestinalna infekcija, ileus, gastrointestinalna opstrukcija, ascites, edem usana, spazam jednjaka, čir na želucu, gastroezofagealna refluksna bolest, refluksni gastritis, retroperitonealna fibroza, gastrointestinalni poremećaj, analno krvarenje, hemoroidi, hipersekrecija sline, dizanje želuca, poremećaj žlijezda slinovnica, upala usana, aerofagija, podrigivanje, glosodinija, oralna bol, lomljivost zubi akutni pankreatitis
English: Teysuno 20 mg/5.8 mg/15.8 mg hard capsules tegafur/gimeracil/oteracil
Croatian: Teysuno 20 mg/5,8 mg/15,8 mg tvrde kapsule tegafur/gimeracil/oteracil
English: Teysuno 15 mg/4.35 mg/11.8 mg hard capsules tegafur/gimeracil/oteracil
Croatian: Teysuno 15 mg/4,35 mg/11,8 mg tvrde kapsule tegafur/gimeracil/oteracil
English: The capsule has an opaque white body and opaque brown cap imprinted “TC448” in grey.
Croatian: Kapsula se sastoji od neprozirnog bijelog tijela i neprozirne smeđe kapice s oznakom „TC448“ u sivoj boji.
English: Endpoint Population
Croatian: Ishod Populacija
English: Adrenal haemorrhage
Croatian: Trombociti Hemoglobin
English: b incl corneal epithelium defect, corneal erosion, corneal lesion, corneal opacity, corneal perforation, keratitis, punctate keratitis, ulcerative keratitis, limbal stem cell deficiency, visual acuity reduced, visual impairment, vision blurred.
Croatian: b uklj. oštećenje epitela rožnice, erozija rožnice, lezija rožnice, zamućenje rožnice, perforacija rožnice, keratitis, točkasti keratitis, ulcerozni keratitis, nedostatak limbalnih matičnih stanica, smanjena oštrina vida, oštećenje vida, zamagljen vid.
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Severe renal impairment
Croatian: Supresija koštane srži
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil and 15.8 mg oteracil (as salt).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tvrda kapsula sadrži 20 mg tegafura, 5,8 mg gimeracila i 15,8 mg oteracila (u obliku soli).
English: The capsule has an opaque white body and opaque white cap imprinted “TC442” in grey.
Croatian: Kapsula se sastoji od neprozirnog bijelog tijela i neprozirne bijele kapice s oznakom „TC442“ u sivoj boji.
English: Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil, and 15.8 mg oteracil (as monopotassium).
Croatian: Svaka tvrda kapsula sadrži 20 mg tegafura, 5,8 mg gimeracila i 15,8 mg oteracila (u obliku kalijeve soli).
English: Discontinue treatment a According to the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 3.0. b For Grade 2 nausea and/or vomiting, the anti-emetic therapy should be optimized prior to a suspension of Teysuno.
Croatian: Adverse Events (CTCAE)) evaluacijskog programa liječenja karcinoma Nacionalnog Instituta za rak (US National Cancer Institute), verzija 3.0.
English: Hyperbilirubinaemia, alanine aminotransferase increased, aspartate aminotransferase increased
Croatian: Hepatobilijarni poremećaji hiperbilirubinemija, povećanje alaninaminotransferaze, povećanje aspartataminotransferaze abnormalni testovi funkcije jetre, povećanje gamaglutamiltransferaze akutno zatajenje jetre
English: either 42 capsules or 84 capsules.
Croatian: 84 kapsule ili 126 kapsula.
English: Pulmonary embolism, respiratory tract haemorrhage, exertional dyspnoea, pharyngolaryngeal pain, rhinorrhoea, pharyngeal erythema, rhinitis allergic, dysphonia, productive cough, nasal congestion
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja, epistaksa, štucanje, kašalj plućna embolija, krvarenje respiratornog trakta, dispneja u naporu, faringolaringealna bol, rinoreja, faringealni eritem, alergijski rinitis, disfonija, produktivni kašalj, nazalna kongestija intersticijska bolest pluća
English: Hyperglycaemia, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, hypophosphatameia, hypermagnesaemia, gout, hypoproteinaemia, hyperglobulinaemia, hyperlipidaemia, oral intake reduced
Croatian: Poremećaji metabolizma i prehrane anoreksija dehidracija, hipokalijemija, hiponatrijemija, hipokalcemija, hipomagnezijemija, hipoalbuminemija, hiperkalijemija hiperglikemija, porast alkalne fosfataze u krvi, porast laktat dehidrogenaze u krvi, hipofosfatemija, hipermagnezijemija, giht, hipoproteinemija, hiperglobulinemija, hiperlipidemija, smanjen oralni unos
English: 5-FU + Cisplatin
Croatian: 5-FU
English: Exfoliative rash, skin exfoliation, necrolytic migratory erythema, blood blister, dermatitis allergic, skin reaction, dermatitis acneiform, erythema, increased tendency to bruise, purpura, hyperhidrosis, night sweats, nail atrophy, pigmentation disorder, skin discoloration, hypertrichosis
Croatian: Poremećaji kože i potkožnog tkiva sindrom šakestopala, osip, hiperpigmentacija kože, suha koža, svrbež, alopecija eksfolijatvini osip, eksfolijacija kože, nekrolitički migracijski eritem, krvavi mjehurići, alergijski dermatitis, kožna reakcija, akneformni dermatitis, eritem, povećana sklonost modricama, purpura, hiperhidroza, noćno znojenje, atrofija noktiju, poremećaj pigmentacije, diskoloracija kože, hipertrihoza toksična epidermalna nekroliza, StevensJohnsonov sindrom, reakcije fotoosjetljivosti, poremećaji noktiju
English: Multi-organ failure, performance status decreased, pain, oedema, chest pain, chest discomfort, generalized oedema, face oedema, local swelling, localized oedema, weight increased, early satiety, feeling cold, injection site reaction, malaise
Croatian: Opći poremećaji i reakcije na mjestu primjene umor, astenija upala sluznice, pireksija, gubitak na težini, periferni edem, zimica multiorgansko zatajenje, redukcija općeg statusa, bol, edem, bol u prsima, nelagoda u prsima, generalizirani edem, edem lica, lokalno oticanje, lokalizirani edem, povećanje težine, prerana sitost, osjećaj hladnoće, reakcija na mjestu primjene, malaksalost
English: Table 3: Teysuno dose reduction schedule for treatment-related toxicities in general, except for haematologic and renal toxicities
Croatian: Prilagodbe doza lijeka Teysuno zbog nuspojava općenito, osim zbog hematološke i bubrežne toksičnosti Tablica 3: Raspored smanjenja doze lijeka Teysuno zbog toksičnosti uslijed primjene lijeka općenito, osim zbog hematološke i bubrežne toksičnosti
English: Patients with anorexia, asthenia, nausea, vomiting, diarrhoea, stomatitis, and gastrointestinal obstruction should be monitored closely for signs of dehydration.
Croatian: Treba pomno pratiti moguću pojavu znakova dehidracije u bolesnika s anoreksijom, astenijom, mučninom, povraćanjem, proljevom, stomatitisom i gastrointestinalnom opstrukcijom.
English: Tumour haemorrhage, cancer pain
Croatian: krvarenje iz tumora, bol uzrokovana tumorom
English: - Gut and mouth: fluid in the abdomen, gastroesophageal reflux disease, increased salivary secretion, excessive burping and belching, lip inflammation, gastrointestinal disorder, oral pain, abnormal contractions of muscles of the oesophagus, blockage in the stomach and intestine, stomach ulcer, retroperitoneal fibrosis, teeth that crack or break easily, swallowing difficulty, disorder of the salivary gland, haemorrhoids
Croatian: - Pluća i nosnu šupljinu: curenje iz nosa, poremećaj glasa, začepljenje nosa, crvenilo grla, peludna groznica - Usta i crijeva: tekućina u trbuhu, gastroezofagealna refluksna bolest, pojačano izlučivanje sline, prekomjerno podrigivanje, upala usnica, poremećaj probavnog trakta, bol u ustima, abnormalne kontrakcije mišića jednjaka, zastoj u želucu i crijevima, čir na želucu, retroperitonealna fibroza, zubi koji lako pucaju i lome se, poteškoće gutanja, poremećaj rada žlijezda slinovnica, hemoroidi - Kožu: gubitak boje kože, ljuštenje kože, pojačana dlakavost, smanjivanje noktiju, pojačano znojenje
English: Your doctor may reduce the dose if you have side effects that are too severe.
Croatian: Ako imate nuspojave koje su preteške, liječnik Vam može smanjiti dozu.
English: NAME OF THE MEDICINAL PRODUCT Teysuno 15 mg/4.35 mg/11.8 mg capsules tegafur/gimeracil/oteracil
Croatian: Teysuno l5 mg/4,35 mg/11,8 mg kapsule tegafur/gimeracil/oteracil
English: There must be at least a 4-week waiting period between end of treatment with brivudine and start of Teysuno therapy.
Croatian: Između završetka liječenja brivudinom i početka liječenja lijekom Teysuno moraju proći najmanje 4 tjedna.
English: No data are available on the concomitant use of folinic acid with Teysuno in combination with cisplatin.
Croatian: Nema dostupnih podataka o istodobnoj primjeni folinatne kiseline s lijekom Teysuno u kombinaciji s cisplatinom.
English: No data are available on the concomitant use of nitromidazoles with Teysuno in combination with cisplatin.
Croatian: Nema dostupnih podataka o istodobnoj primjeni nitroimidazola s lijekom Teysuno u kombinaciji s cisplatinom.
English: CrCl must be calculated at the beginning of every cycle before the start of treatment with Teysuno on Day 1.
Croatian: Neutrofili ≥ 1,5 x 109/l Hemoglobin ≥ 6,2 mmol/l CrCl treba izračunati na početku svakog ciklusa na prvi dan ciklusa prije početka liječenja lijekom Teysuno.
English: Slovenská republika NORDIC Pharma, s.r.o.
Croatian: Slovenija NORDIC Pharma, s.r.o.