FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of Teysuno in hepatitis B virus carriers, HBc antigen negative and HBc antibody positive patients, or HBs antigen negative and HBs antibody positive patients may result in reactivation of hepatitis B.
Croatian: Primjena lijeka Teysuno u prenosioca virusa hepatitisa B, HBc antigen negativnih i HBc antitijelo pozitivnih bolesnika, ili HBs antigen negativnih i HBs antitijelo pozitivnih bolesnika može rezultirati reaktivacijom hepatitisa B.
English: Table 7: Adverse reactions reported by decreasing seriousness in each frequency grouping
Croatian: Tablica 7: Nuspojave prikazane u padajućem nizu prema ozbiljnosti unutar svake grupe učestalosti
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with this medicinal product.
Croatian: Žene u reproduktivnoj dobi/Kontracepcija u muškaraca i žena Ženama u reproduktivnoj dobi treba savjetovati izbjegavanje trudnoće tijekom liječenja ovim lijekom.
English: In addition, 5-fluorouridine-triphosphate (FUTP) is incorporated into RNA causing disruption of RNA functions.
Croatian: Dodatno, 5-fluorouridintrifosfat (FUTP) se ugrađuje u RNA uzrokujući poremećaj funkcija RNA.
English: 5-AZU and CA do not inhibit OPRT enzyme activity.
Croatian: 5-AZU i CA ne inhibiraju enzimsku aktivnost OPRT-a.
English: Adjustments during treatment
Croatian: Prilagodbe doza tijekom liječenja
English: Cisplatin will be stopped after 6 treatment cycles.
Croatian: Primjena cisplatina će biti prekinuta nakon 6 ciklusa liječenja.
English: o Take plenty of liquids between meals to replace lost fluids and prevent dehydration, low blood volume, and imbalance of salts or chemicals in the blood.
Croatian: ᴑ Uzimajte mnogo tekućine između obroka da nadoknadite gubitak tekućine i spriječite dehidraciju, nizak volumen krvi i disbalans soli ili minerala u krvi.
English: Concomitant administration of a proton pump inhibitor (PPI) reduced the effect of food on the pharmacokinetic profile of oteracil, but not by a sufficient margin to completely negate the food effect.
Croatian: Proton pump inhibitor, PPI) smanjila je učinak hrane na farmakokinetički profil oteracila, ali ne dovoljno da bi potpuno poništila utjecaj hrane.
English: Post-marketing surveillance experience in gastric cancer patients
Croatian: Iskustvo postmarketinškog praćenja u bolesnika s karcinomom želuca
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Nordic Group B.V., Siriusdreef 41, 2132 WT Hoofddorp, The Netherlands 12.
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Nordic Group B.V., Siriusdreef 41, 2132 WT Hoofddorp, Nizozemska
English: 5-FU + Cisplatin 100 mg/m2 (N=508)
Croatian: + cisplatin 100 mg/m2 (N=508)
English: Based on non-clinical data, allopurinol may decrease anti-tumour activity due to suppression of phosphorylation of 5-FU.
Croatian: Na osnovu nekliničkih podataka, alopurinol može smanjiti antitumorsku aktivnost zbog sprječavanja fosforilacije 5-FU-a.
English: 42 capsules
Croatian: 42 kapsule
English: If deterioration of glomerular filtration rate is observed, Teysuno and/or cisplatin dose should be adjusted according to Table 4, and appropriate supportive measures taken (see section 4.2).
Croatian: Ako je uočeno pogoršanje brzine glomerularne filtracije, treba prilagoditi dozu lijeka Teysuno i/ili cisplatina u skladu s Tablicom 4 i poduzeti odgovarajuće suportivne mjere (vidjeti dio 4.2).
English: Most ocular reactions will resolve or improve with suspension of medicinal product and proper treatment (instillation of artificial tears, antibiotic eye drops, implantation of glass or silicone tubes in lacrimal punctas or canaliculi, and/or use of spectacles rather than contact lenses).
Croatian: Najveći broj očnih reakcija rješava se ili poboljšava privremenom obustavom primjene lijeka i pravilnim liječenjem (ukapavanjem umjetnih suza, antibiotskim očnim kapima, implantacijom staklenih ili silikonskih cjevčica u suzne kanale i/ili uporabom naočala radije nego kontaktnih leća).
English: The frequencies of medically relevant rare and very rare adverse reactions are estimated from post-marketing surveillance of 866,000 patients in Asia (mostly Japanese) treated with Teysuno-based therapy.
Croatian: Učestalosti medicinski relevantnih rijetkih i vrlo rijetkih nuspojava procijenjene su iz postmarketinškog praćenja 866 000 bolesnika iz Azije (uglavnom Japanaca) liječenih terapijom na bazi lijeka Teysuno.
English: Coumarin-derivative anticoagulant
Croatian: Antikoagulansi derivati kumarina
English: Consistent with the lower CYP2A6 activity in the Asian patients, tegafur AUC0-12 was higher and T1/2 was longer in the Asian group compared to the Caucasian group.
Croatian: U skladu s nižom CYP2A6 aktivnošću u azijskih bolesnika, AUC0-12 tegafura je bila viša i T1/2 duži u grupi Azijata u usporedbi s bijelcima.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of Teysuno or its metabolites in milk (for details see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazali su izlučivanje lijeka Teysuno ili njegovih metabolita u mlijeko (za detalje vidjeti dio 5.3).
English: It should be taken with water at least 1 hour before or 1 hour after a meal (see section 4.2).
Croatian: Treba ga uzimati s vodom najmanje 1 sat prije ili 1 sat nakon obroka (vidjeti dio 4.2).
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II. A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D.
English: Patients taking Teysuno should be informed of the risks and instructed to contact their physician immediately if moderate or severe toxicity occurs.
Croatian: Bolesnike treba obavijestiti o rizicima uzimanja lijeka Teysuno te ih uputiti da odmah obavijeste nadležnog liječnika ako dođe do umjerene ili teške toksičnosti.
English: Start cisplatin treatment at a 50% dose reduction from the previous cycle
Croatian: Početak liječenja cisplatinom s 50% smanjenom dozom u odnosu na prethodni ciklus
English: The gimeracil component did not affect the pharmacokinetic profile of tegafur.
Croatian: Sastojak gimeracil nije utjecao na farmakokinetički profil tegafura.
English: ECOG Performance Status, n (%)
Croatian: ECOG status izvedbe, n (%)
English: Table 1: Standard dose and dose reductions allowed for Teysuno and/or for cisplatin
Croatian: Tablica 1: Standardana doza i dopušteno smanjenje doze lijekova Teysuno i/ili cisplatina
English: Suspend treatment until Grade 0 or 1
Croatian: Odgoditi liječenje do postizanja toksičnosti stupnja 0 ili 1
English: It is not known whether Teysuno or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se Teysuno ili njegovi metaboliti u majčino mlijeko u ljudi.
English: Therefore, Teysuno cannot be used as a substitute for other oral 5-FU products.
Croatian: Zato se Teysuno ne može koristiti kao zamjena za ostale oralne 5-FU-ne lijekove.
English: 15 mg capsulea (brown/white)
Croatian: 15 mg kapsulea (smeđe/bijele)
English: c At the discretion of the treating physician, patients may continue with treatment without reduction or interruption for adverse reactions (irrespective of grade) considered unlikely to become serious or lifethreatening (e.g., alopecia, changes in sexual function, and dry skin).
Croatian: c Prema nahođenju nadležnog liječnika, bolesnici mogu nastaviti liječenje bez smanjenja doze ili prekida liječenja zbog nuspojava (neovisno o stupnju) za koje je malo vjerojatno da će postati teške ili ugrožavati život (npr. alopecija, promjene seksualne funkcije i suha koža).
English: A minimum washout period of 7 days is recommended between administration of Teysuno and other fluoropyrimidines.
Croatian: Preporučuje se minimalni period ispiranja ('washout') od 7 dana između primjene lijeka Teysuno i primjene ostalih fluoropirimidina.
English: Although CYP2A6 variants are associated with pharmacokinetic variability of tegafur, the AUC of gimeracil, which is affected by renal function, is the key determinant in the pharmacokinetic variability of 5-FU.
Croatian: Iako su varijante CYP2A6 povezane s farmakokinetičkom varijabilnošću tegafura, AUC gimeracila, na koji utječe funkcija bubrega, je ključni odlučujući faktor varijabilnosti farmakokinetike 5FU-a.
English: Renal function, as reflected by creatinine clearance, was the primary factor that influenced gimeracil exposure and 5-FU exposure.
Croatian: Bubrežna funkcija, kao što je vidljivo po klirensu kreatinina, bila je primarni faktor koji je utjecao na izloženost gimeracilu i 5-FU-u.
English: Gimeracil and uracil AUC0-12 values were comparable between the two groups, suggesting that DPD inhibition was similar for the Asian and Caucasian groups.
Croatian: Vrijednosti AUC0-12 gimeracila i uracila bile su usporedive među skupinama pokazujući da je DPD inhibicija slična za grupu Azijata i bijelaca.
English: Patients with low white blood cell counts should be monitored carefully for infection and risk of other complications of neutropaenia and treated as medically indicated (e.g., with antibiotics, granulocyte-colony stimulating factor [G-CSF]).
Croatian: Treba pažljivo motriti bolesnike s malim brojem bijelih krvnih stanica zbog infekcije i rizika od ostalih komplikacija neutropenije te ih liječiti sukladno indikaciji (npr. antibioticima, faktorom stimulacije granulocitnih kolonija [G-CSF]).
English: Caution is advised as folinic acid is known to enhance the activity of 5-FU.
Croatian: Preporučuje se oprez jer je poznato da folinatna kiselina povećava aktivnost 5-FU-a.
English: Third occurrence
Croatian: Treća pojava
English: Dehydration and any associated electrolyte disturbances should be prevented or corrected at onset.
Croatian: Dehidraciju kao i bilo koji prateći poremećaj elektrolita treba spriječiti ili ispraviti na početku.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Teysuno in all subsets of the paediatric population in gastric adenocarcinoma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Teysuno u svim podskupinama pedijatrijske populacije za adenokarcinom želuca (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Maintain treatment at same dose level
Croatian: Održavanje liječenja na istoj razini doze nema
English: Do not replace the dose that has been vomited.
Croatian: Ne nadoknađujte dozu koju ste povratili.
English: These changes with age were related to changes in renal function as measured by creatinine clearance (see section 5.2).
Croatian: Ove promjene s dobi bile su povezane s promjenama bubrežne funkcije mjerene klirensom kreatinina (vidjeti dio 5.2).
English: In addition, hyperpigmentation in the skin and eyes and corneal opacity in dogs and cataracts in rats were observed following repeat dosing.
Croatian: Dodatno je uočena hiperpigmentacija kože i očiju i zamućenje rožnice u pasa te katarakta u štakora nakon ponovljene doze lijeka.
English: No dose limiting toxicities were observed in the first cycle of treatment.
Croatian: Nisu uočene toksičnosti koje ograničavaju dozu u prvom ciklusu liječenja.
English: No consistent relationship was seen between absolute QTcF interval values or change from Baseline values and maximum plasma concentration of Teysuno components.
Croatian: Nije uočena konzistentna veza između apsolutnih vrijednosti OTcF intervala ili promjene početne vrijednosti i maksimalne koncentracije sastojaka lijeka Teysuno u plazmi.
English: There is therefore a high risk for developmental toxicity at clinical doses, primarily due to tegafur (5-FU) and to oteracil to a lesser extent.
Croatian: Zato postoji visoki rizik za nastanak toksičnosti u kliničkim dozama, prvenstveno zbog tegafura (5-FU), a nešto manje i oteracila.
English: Millmount Healthcare Limited Block7, City North Business Campus, Stamullen Co. Meath, K32 YD60 Ireland
Croatian: Millmount Healthcare Limited Block7, City North Business Campus, Stamullen Co.
English: Standard dosea: 25 mg/m2
Croatian: Standardna dozaa: 25 mg/m2
English: However, due to possible additive pharmacodynamic effects (myelotoxicity), caution is advised as coadministration may increase the risk and severity of haematologic toxicity of Teysuno.
Croatian: Zbog mogućih aditivnih farmakodinamičkih učinaka (mijelotoksičnost), preporučuje se oprez jer istodobna primjena može povećati rizik i težinu hematološke toksičnosti lijeka Teysuno.
English: Treatment with Teysuno produced various skin effects in rat (keratosis of footpad and tail) and dog (skin crusts and erosions).
Croatian: Liječenje lijekom Teysuno proizvodi različite učinke na koži štakora (keratoza na jastučićima stopala, i repu) i pasa (ljuštenje kože i erozije).
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: • Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Following oral administration, tegafur is gradually converted to 5-FU in vivo, mainly by CYP2A6 enzyme activity in the liver.
Croatian: Nakon oralne primjene tegafur se postupno konvertira u 5-FU in vivo, uglavnom uz pomoć enzimske aktivnosti CYP2A6 u jetri.
English: Teysuno was not carcinogenic in either the rat or the mouse.
Croatian: Teysuno se nije pokazao kancerogenim ni u štakora ni u miševa.
English: There are no clinical data on the distribution of radiolabeled components of Teysuno.
Croatian: Nema kliničkih podataka o distribuciji radiooznačenih sastojaka lijeka Teysuno.
English: Caution is advised as co-administration of Teysuno and coumarin anticoagulation therapy may increase the risk of bleeding (see section 4.4).
Croatian: Preporučuje se oprez jer istodobna primjena lijeka Teysuno i kumarinske antikoagulantne terapije može povećati rizik od krvarenja (vidjeti dio 4.4).
English: As with other fluoropyrimidines, Teysuno administration caused embryolethality and teratogenicity in animals (see section 5.3).
Croatian: Kao i kod drugih fluoropirimidina, primjena lijeka Teysuno uzrokuje embrioletalnost i teratogenost u životinja (vidjeti dio 5.3).
English: - This medicine does not require any special storage conditions.
Croatian: Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vas je liječnik upozorio da ne podnosite neke šećere, obavijestite ga prije nego uzmete ovaj lijek.
English: A Phase I study investigated the pharmacokinetics of Teysuno monotherapy in Asian (Chinese/Malay) and Caucasian (US) patients.
Croatian: U studiji faze I ispitivana je farmakokinetika lijeka Teysuno u monoterapiji na Azijatima (Kinezi/Malezijci) i bijelcima (bolesnici iz SAD-a).
English: 5-FU is activated within cells by phosphorylation to its active metabolite, 5-fluoro-deoxyuridine-monophosphate (FdUMP).
Croatian: 5-FU se aktivira unutar stanica fosforilacijom, u aktivni metabolit, 5-fluoro-deoksiuridin-monofosfat (FdUMP).
English: The safety profile of Teysuno in a post-marketing safety surveillance study in Japan of 4,177 patients treated with Teysuno for advanced gastric cancer was generally similar to that seen with this regimen and in the Japanese registration studies (i.e., major toxicities were leukocytopaenia, anorexia, and nausea/vomiting).
Croatian: Profil sigurnosti primjene lijeka Teysuno u postmarketinškom ispitivanju praćenja sigurnosti provedenom u Japanu na 4177 bolesnika s uznapredovalim karcinomom želuca liječenih lijekom Teysuno, bio je uglavnom sličan onome opaženom s ovim režimom te onom opaženom u japanskim registracijskim ispitivanjima (tj. glavne toksičnosti su bile leukocitopenija, anoreksija i mučnina/povraćanje).
English: Although no intravenous data are available for Teysuno in humans, the volume of distribution could be roughly estimated from the apparent volume of distribution and urinary excretion data as 16 l/m2, 17 l/m2, and 23 l/m2 for tegafur, gimeracil and oteracil, respectively.
Croatian: Iako nisu dostupni intravenski podaci za Teysuno u ljudi, volumen distribucije može se grubo procijeniti iz podataka prividnog volumena distribucije i izlučivanja urinom kao 16 l/m2, 17 l/m2 i 23 l/m2 za tegafur, gimeracil i oteracil.
English: If a treatment delay is indicated for either Teysuno or cisplatin, then administration of both medicinal products should be delayed until the requirements for restarting both are met unless one of the medicinal products has been permanently discontinued.
Croatian: Ako je odgoda liječenja indicirana bilo za Teysuno bilo za cisplatin, treba odgoditi primjenu oba lijeka do postizanja uvjeta za ponovni početak liječenja s oba lijeka, osim ako liječenje jednim od navedenih lijekova nije trajno ukinuto.
English: If a DPD inducer were to be concomitantly administered with Teysuno, the exposure of 5-FU might not reach the efficacious level.
Croatian: Ako se induktori DPD-a primjenjuju istodobno s lijekom Teysuno, izloženost 5-FU-u možda neće moći dostići djelotvornu razinu.
English: Teysuno is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).
Croatian: Teysuno je indiciran u odraslih za liječenje uznapredovalog karcinoma želuca kada se primjenjuje u kombinaciji s cisplatinom (vidjeti dio 5.1).
English: If you stop taking Teysuno
Croatian: Ako prestanete uzimati Teysuno
English: They are provided in blisters containing 14 capsules each.
Croatian: Dolaze u blisterima koji od kojih svaki sadrži 14 kapsula.
English: Carriers of HBV who require treatment with Teysuno should be closely monitored for signs and symptoms of active HBV infection throughout therapy, and follow-up monitoring for hepatic function tests or viral markers are recommended.
Croatian: Prenosiocima HBV-a, koji zahtijevaju liječenje lijekom Teysuno, treba pažljivo pratiti znakove i simptome aktivne infekcije HBV-om tijekom terapije te se preporuča naknadno praćenje testova funkcije jetre ili virusnih markera.
English: To detect early changes in renal function during treatment, renal parameters should be closely monitored (e.g., serum creatinine, CrCl).
Croatian: Za utvrđivanje ranih promjena bubrežne funkcije tijekom liječenja, treba pomno pratiti parametre funkcije bubrega (npr. serumski kreatinin, klirens kreatinina).
English: This CYP2A6*4 allele is uncommon in the Caucasian population.
Croatian: Alel CYP2A6*4 je rijedak u populaciji bijelaca.
English: Co-administration of other fluoropyrimidines such as capecitabine, 5-FU, tegafur, or flucytosine can lead to additive toxicities, and is contraindicated.
Croatian: Istodobna primjena ostalih fluoropirimidina kao što su kapecitabin, 5-FU, tegafur ili flucitozin može dovesti do dodatne toksičnosti i kontraindicirana je.
English: After administration of a single dose of 50 mg Teysuno (expressed as tegafur content) in man (approximately 30 mg/m2 based on body surface area of 1.56 to 2.10 m2 for a typical patient; N=14),
Croatian: Nakon primjene jednostruke doze od 50 mg lijeka Teysuno (izraženo kao sadržaj tegafura) u muškarca (otprilike 30 mg/m2 bazirano na površini tijela od 1,56 do 2,10 m2 za tipičnog bolesnika; N=14), medijan
English: The recommended standard dose of Teysuno when administered in combination with cisplatin is 25 mg/m2 (expressed as tegafur content) twice daily, morning and evening, for 21 consecutive days followed by 7 days rest (1 treatment cycle).
Croatian: Preporučena standardna doza lijeka Teysuno kada se primjenjuje u kombinaciji s cisplatinom iznosi 25 mg/m2 (izraženo kao sadržaj tegafura) dva puta na dan, ujutro i navečer, tijekom 21 dana uzastopno, nakon čega slijedi 7 dana odmora (1 ciklus liječenja).
English: Studies in Japanese patients have suggested an effect of CYP2A6*4 polymorphism on Teysuno pharmacokinetics.
Croatian: Ispitivanja na japanskim bolesnicima ukazuju na utjecaj polimorfizma CYP2A6*4 na farmakokinetiku lijeka Teysuno.
English: FdUMP and reduced folate are bound to thymidylate synthase leading to formation of a ternary complex which inhibits DNA synthesis.
Croatian: FdUMP i reducirani folat se vežu na timidilat sintetazu što vodi do nastanka ternarnog kompleksa koji inhibira sintezu DNA.
English: The incidence of blood and lymphatic systems disorders adverse reactions observed across all cycles in the moderate and severe renal impairment patients were 28.6% and 44.4%, respectively.
Croatian: Incidencija nuspojava poremećaja krvi i limfnog sustava uočenih kroz sve cikluse u bolesnika sa umjerenim ili teškim oštećenjem bubrega iznosile su 28,6 % i 44,4 %.
English: A population pharmacokinetics analysis demonstrated that 5-FU exposure also tended to increase with age, but the extent of the increase was within the range of individual variability.
Croatian: Populacijske farmakokinetičke analize su pokazale da je izloženost 5-FU-u također težila porastu s dobi bolesnika, ali je porast bio unutar raspona individualne varijabilnosti.
English: Teysuno capsules should be swallowed with water at least 1 hour before or 1 hour after a meal.
Croatian: Teysuno kapsule treba progutati s vodom najkasnije 1 sat prije ili 1 sat nakon obroka.
English: • End stage renal disease patients requiring dialysis.
Croatian: • Zadnji stadij bolesti bubrega u bolesnika koji trebaju dijalizu.
English: Summary of safety profile
Croatian: Sažetak profila sigurnosti primjene lijeka
English: During a 4-week cycle of treatment
Croatian: • Tijekom 4-tjednog ciklusa liječenja
English: If you have taken brivudine you must wait for at least 4 weeks after stopping brivudine before starting to take Teysuno.
Croatian: Ako ste uzimali brivudin, morate pričekati najmanje 4 tjedna od završetka liječenja brivudinom do početka liječenja lijekom Teysuno.
English: o If you feel tired and have fever together with loss of appetite, contact your doctor immediately.
Croatian: ᴑ Ako osjećate umor i imate vrućicu zajedno s gubitkom apetita, odmah obavijestite liječnika.
English: System Organ Classa
Croatian: Klasifikacija organskih sustavaa
English: However, it is to be noted that the exposure to 5-FU can be variable and unexpectedly higher in patients with severe renal impairment due to the impact of fluctuations in renal function in these patients.
Croatian: Međutim treba napomenuti da izloženost 5-FU-u može biti promjenjiva i neočekivano viša u bolesnika s teškim oštećenjem bubrega zbog fluktuacije funkcije bubrega u tih bolesnika.
English: Each hard capsule contains 70.2 mg lactose monohydrate.
Croatian: Svaka tvrda kapsula sadrži 70,2 mg laktoze hidrata.
English: Treatment with Teysuno in combination with cisplatin may be associated with a transient decline of glomerular filtration rate caused primarily by pre-renal factors (e.g., dehydration, electrolyte imbalance, etc).
Croatian: Liječenje lijekom Teysuno u kombinaciji s cisplatinom može biti praćeno privremenim smanjenjem brzine glomerularne filtracije prvenstveno uzrokovanim prerenalnim čimbenicima (npr. dehidracija, disbalans elektrolita, itd.).
English: Median (Range) ≥65, n (%)
Croatian: Dob, godine medijan (raspon) ≥ 65, n (%)
English: During and up to 6 months after treatment with Teysuno, you must use contraceptive measures.
Croatian: Tijekom liječenja i do 6 mjeseci nakon prestanka terapije lijekom Teysuno morate provoditi učinkovite mjere kontracepcije.