natgillin/translations-raw huggingface dataset:
After single dose administration, there was a statistically significant decrease in 5-FU and gimeracil Cmax for the severe hepatic impairment group relative to that of the normal group, but this difference was not observed after multiple dose administration.
Nakon primjene jednostruke doze zabilježeno je značajno smanjenje Cmax 5-FU-a i gimeracila u skupini bolesnika s teškim oštećenjem jetre u odnosu na Cmax 5-FU-a i gimeracila u skupini bolesnika s normalnom funkcijom jetre, ali ta razlika nije uočena nakon primjene višestruke doze lijeka.
The association between 5-FU sensitivity and MSI in patients with gastric cancer is unclear and the association between Teysuno and MSI in gastric cancer is unknown.
Povezanost između osjetljivosti na 5-FU i MSI u bolesnika s karcinomom želuca nije jasna te povezanost između lijeka Teysuno i MSI u bolesnika s karcinomom želuca nije poznata.
Suspend treatment until resumption criterion is met (see Table 6) and then resume dosing at one reduced dose level.
Odgoditi liječenje do postizanja kriterija za ponovni početak liječenja (vidjeti Tablicu 6) i tada nastaviti primjenu dozom smanjenom za jednu razinu.
Teysuno can be continued after stopping cisplatin.
Liječenje samo lijekom Teysuno može se nastaviti nakon ukidanja cisplatina.
No data is available regarding Teysuno administration in patients with end stage renal disease requiring dialysis (see section 4.3).
Nisu dostupni podatci u svezi primjene lijeka Teysuno kod bolesnika u završnom stadiju bolesti bubrega koji trebaju dijalizu (vidjeti dio 4.3).
Cardiac failure, acute myocardial infarction, pericardial effusion, atrial fibrillation, angina pectoris, cardiac fibrillation, tachycardia, palpitations
Srčani poremećaji zatajenje srca, akutni infarkt miokarda, perikardijalni izljev, fibrilacija atrija, angina pektoris, srčana fibrilacija, tahikardija, palpitacije
Teysuno was clastogenic in vitro using Chinese hamster lung cells and was weakly clastogenic in vivo in mouse bone marrow.
Teysuno se pokazao klastogenim u in vitro ispitivanjima na stanicama pluća kineskog hrčka i slabo klastogenim u in vivo ispitivanjima na koštanoj srži miša.
The frequencies of very common, common, and uncommon adverse reactions are from 593 patients treated with Teysuno in combination with cisplatin in clinical trials.
Učestalosti vrlo čestih, čestih i manje čestih nuspojava potječu od 593 bolesnika liječenih lijekom Teysuno u kombinaciji s cisplatinom tijekom kliničkih studija.
If you have any doubts talk to your doctor.
Ako imate bilo kakvih nejasnoća, razgovarajte sa svojim liječnikom.
Teysuno contains
Što Teysuno sadrži
• Moderate renal impairment (CrCl 30 to 50 ml/min) The recommended standard dose in patients with moderate renal impairment is 20 mg/m2 twice daily (expressed as tegafur content) (see sections 4.8 and 5.2).
• umjereno oštećenje bubrega (CrCl 30 do 50 ml/min) Preporučena standardna doza u bolesnika s umjerenim oštećenjem bubrega iznosi 20 mg/m2 dva puta na dan (izraženo kao sadržaj tegafura) (vidjeti dijelove 4.8 i 5.2).
- Eye: itchy and red eyes, allergic reactions in eyes, drooping upper eyelid - Ear: vertigo, ear clogging, ear discomfort
- Oko: svrbež i crvenilo oka, alergijske reakcije u očima, spušteni gornji kapak - Uho: vrtoglavica, začepljenje uha, nelagoda u uhu
Patients should be provided with outpatient prescriptions for anti-emetic and anti-diarrhoeal medicinal products.
Bolesnike treba opskrbiti receptima za antiemetike i lijekove protiv proljeva, za primjenu u izvanbolničkim uvjetima.
Contusion, medication error a Adverse reactions in the Investigations system organ class (SOC) have been reallocated to clinically appropriate SOCs related to their target organ.
Ozljede, otrovanje i proceduralne komplikacije kontuzije, medikacijske pogreške aNuspojave u klasi organskih sustava „Pretrage“ su preraspodijeljene u klinički odgovarajuće klase organskih sustava koji se odnose na ciljani organ.
However, metabolites of folinate/folinic acid will form a ternary structure with thymidylate synthase and fluorodeoxyuridine monophosphate (FdUMP), potentially increasing the cytotoxicity of 5-FU.
Metaboliti folinata/folinatne kiseline tvore trojnu strukturu sa timidilat sintetazom i fluorodeoksiuridin monofosfatom (FdUMP) što potencijalno povećava citotoksičnost 5-FU-a.
Platelet count ≥100 x 109/l
Broj trombocita ≥100 x 109/l
Black or African American Asian
Rasa, n (%) bijela crna ili afrička američka azijska američki Indijanci ili domoroci s Aljaske ostali
Suspend cisplatin treatment until resumption criterion (≥30 ml/min) is met and then start treatment at a 50% dose reduction from the previous cycle a Treatment for patients with CrCl <30 ml/min is not recommended unless the benefits of Teysuno treatment clearly outweigh the risks.
Odgoditi liječenje cisplatinom do postizanja kriterija za ponovni početak liječenja (≥30 ml/min) te početak liječenja s 50% smanjenom dozom u odnosu na prethodni ciklus a Ne preporučuje se liječenje bolesnika sa CrCl < 30 ml/min osim ako korist liječenja lijekom Teysuno jasno premašuje rizike.
Levels of tegafur, gimeracil, oteracil and 5-FU were quantifiable through 10 hours postdose.
Razine tegafura, gimeracila, oteracila i 5-FU-a bile su mjerljive kroz 10 sati nakon primjene.
- acute liver failure - pancreas infection - muscle breakdown - loss of sense of smell - sun allergy - widespread blood clotting and bleeding - disease affecting the white matter of the brain - serious illness with blistering of the skin, mouth and genitals recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection)
- akutno zatajenje jetre - infekcija gušterače - slabost mišića - gubitak osjeta mirisa - alergija na sunce - rasprostranjeno zgrušavanje krvi i krvarenje - bolest koja zahvaća bijelu moždanu tvar - ozbiljna bolest sa mjehurićima na koži, ustima i genitalijama - povratak (reaktivacija) infekcije virusom hepatitisa B, ako ste već imali hepatitis B u prošlosti
o If you become dehydrated you may have symptoms such as dry mouth, weakness, dry skin, dizziness, cramping o Try to eat frequent small meals.
ᴑ Ako dehidrirate možete imati simptome kao što su suha usta, slabost, suha koža, omaglica, grčenje.
The activity of a coumarin-derivative anticoagulant was enhanced by Teysuno.
Aktivnost antikoagulansa derivata kumarina povećava se primjenom lijeka Teysuno.
Table 4: Teysuno and cisplatin dose modification according to creatinine clearance values at the start of a cycle of treatment
Tablica 4. Prilagodba doze lijekova Teysuno i cisplatina u skladu s vrijednostima klirens kreatinina na početku ciklusa liječenja Klirens kreatinina
<0.5 x 109/l
IU <0,5 x 109/l < 25 x 109/l
However, nitromidazoles may reduce clearance of 5-FU and thus increase plasma levels of 5-FU.
Nitroimidazoli mogu smanjiti klirens 5-FU-a i tako povećati njegove razine u plazmi.
- Nerve disorder: you may feel numbness, tingling, pain, abnormal sensation, weak muscle, shaking, or movement difficulties.
- Poremećaj živaca: možete osjećati utrnulost, trnce, bol, promjene osjeta, mišićnu slabost, drhtanje ili poteškoće u kretanju.
In this study, 7 patients with moderate renal impairment were treated with 20 mg/m2 Teysuno twice daily, while 7 patients with severe renal impairment received Teysuno 20 mg/m2 once daily.
U toj studiji je 7 bolesnika s umjerenim oštećenjem bubrega primalo 20 mg/m2 lijeka Teysuno dva puta dnevno, dok je 7 bolesnika s teškim oštećenjem bubrega primalo 20 mg/m2 lijeka Teysuno jedanput na dan.
Other fluoropyrimidines
Ostali fluoropirimidini
Manufacturer Nordic Pharma Tolweg 15
Proizvođač Nordic Pharma Tolweg 15
• Eye disorder includes adverse reactions of eye pruritus, ocular hyperaemia, eye irritation, eye disorder, and foreign body sensation in eyes.
• poremećaj oka uključuje nuspojave pruritusa, očne hiperemije, iritacije oka, poremećaja oka i osjećaja stranog tijela u očima.
Therefore, the daily exposure to 5-FU would be expected to be comparable in these groups, since the daily exposure in patients in the severe renal impairment group is based on the administration of Teysuno once a day, while the daily exposure to 5-FU in the patients with normal renal function is based on the administration of Teysuno twice daily.
Za očekivati je usporedivost dnevne izloženosti 5FU-u u tim skupinama jer je dnevna izloženost u skupini s teškim oštećenjem bubrega bazirana na primjeni lijeka Teysuno jednom dnevno, dok je dnevna izloženost 5-FU-u u bolesnika s normalnom funkcijom bubrega bazirana na primjeni lijeka Teysuno dva puta na dan.
The increase in 5-FU exposure in patients with mild renal impairment in this study together with the results of simulation in the population pharmacokinetic analysis suggest that a Teysuno dose of 25 mg/m2 twice daily in patients with mild renal impairment could achieve 5-FU plasma concentrations similar to those obtained in patients with normal renal function receiving 30 mg/m2 twice daily as monotherapy and also those with moderate renal impairment receiving 20 mg/m2 twice daily.
Porast izloženosti 5-FU-u u bolesnika s blagim oštećenjem bubrega u ovoj studiji zajedno s rezultatima simulacije u populacijskoj farmakokinetičkoj analizi, upućuje da doza lijeka Teysuno od 25 mg/m2 dva puta na dan u bolesnika s blagim oštećenjem bubrega može postići koncentraciju 5-FU-a u plazmi sličnu onoj postignutoj u bolesnika s normalnom bubrežnom funkcijom koji su uzimali 30 mg/m2 dva puta na dan kao monoterapiju kao i onoj postignutoj u bolesnika s umjerenim oštećenjem bubrežne funkcije koji su uzimali 20 mg/m2 dva puta na dan.
Ocular toxicity
Očna toksičnost
o To help manage nausea and vomiting: ▪ Lie down or take deep breaths when feeling nauseous ▪ Avoid tight clothing - Low red blood cell count leading to anaemia o You may have symptoms such as cold hands and feet, looking pale, light-headedness, fatigue, breathlessness.
ᴑ Da olakšate kontrolu mučnine i povraćanja: ▪ lezite ili duboko dišite kad osjećate mučninu ▪ izbjegavajte usku odjeću - Smanjenje broja crvenih krvnih stanica što dovodi do anemije ᴑ Možete imati simptome kao što su hladne ruke i stopala, možete izgledati blijedo, biti blago omamljeni, umorni, imati nedostatak daha.
Treatment should be discontinued if progressive disease or intolerable toxicity is observed.
Ako je došlo do progresije bolesti ili ako je uočena netolerabilna toksičnost, liječenje treba prekinuti.
Standard dose (mg/m2)
Standardna doza (mg/m2)
Cisplatin dose modification at the start of the cycle of treatment
Prilagodba doze cisplatina na početku ciklusa liječenja
How to store Teysuno
Kako čuvati Teysuno
Gender, n (%)
Spol, n (%) muški ženski
Following a single dose of Teysuno, approximately 3.8% to 4.2% of administered tegafur, 65% to 72% of administered gimeracil, and 3.5% to 3.9% of administered oteracil were excreted unchanged in the urine.
Nakon primjene jednokratne doze lijeka Teysuno izlučilo se nepromijenjeno putem urina otprilike 3,8 % do 4,2 % primijenjenog tegafura , 65 % do 72 % primijenjenog gimeracila i 3,5 % do 3,9 % primijenjenog oteracila.
Patients treated with Teysuno in combination with cisplatin should be closely monitored and laboratory tests, including haematology, liver function, renal function, and serum electrolytes, should be performed frequently.
Bolesnike na terapiji lijekom Teysuno u kombinaciji s cisplatinom treba pomno nadzirati te provoditi česte laboratorijske pretrage što uključuje hematološke pretrage, kontrolu funkcije jetre, bubrega i elektrolita u serumu.
At the initiation of subsequent cycles of treatment
• Na početku sljedećeg ciklusa liječenja
Teysuno dose modification at the start of the cycle of treatment
Prilagodba doze lijeka Teysuno na početku ciklusa liječenja
Most adverse reactions are reversible and can be managed by symptomatic therapy, dose interruptions and dose reductions.
Najveći broj nuspojava je reverzibilan i kontrolira se simptomatskim liječenjem, prestankom liječenja ili smanjenjem doze.
However, polyglutamated methotrexate inhibits thymidylate synthase and dihydrofolate reductase, potentially increasing cytotoxicity of 5-FU.
Poliglutaminski metotreksat inhibira timidilat sintetazu i dihidrofolat reduktazu što potencijalno povećava citotoksičnost 5-FU-a.
A study of the effect of Teysuno on cardiac repolarisation conducted in advanced cancer patients met the definition for a negative study according to International Conference on Harmonisation (ICH) guidelines.
Ispitivanje učinka lijeka Teysuno na repolarizaciju srca provedeno u bolesnika s uznapredovalim rakom ispunilo je definiciju za negativnu studiju prema ICH smjernicama (engl.
• Vision disorder includes adverse reactions of blurred vision, diplopia, photopsia, reduced visual acuity, and blindness;
• poremećaj vida uključuje nuspojave zamagljenog vida, diplopije, fotopsije, smanjene oštrine vida i sljepoće;
Breast-feeding must be discontinued while receiving treatment with Teysuno.
Mora se prekinuti dojenje tijekom liječenja lijekom Teysuno.
Caution is advised as co-administration may increase the toxicity of Teysuno.
Preporučuje se oprez jer istodobna primjena može povećati toksičnost lijeka Teysuno.
Using plasma uracil concentrations to assess DPD activity in clinical studies, no marked changes in plasma uracil concentrations were observed after administration of a single 800 mg dose of tegafur while plasma uracil concentrations increased markedly after administration of a single 50 mg dose of Teysuno (reflecting DPD inhibition by gimeracil).
U kliničkim studijama korištenjem koncentracije uracila u plazmi za procjenu aktivnosti DPD-a, nisu uočene značajne promjene u koncentracijama uracila u plazmi nakon primjene jednostruke doze od 800 mg tegafura, dok su koncentracije uracila u plazmi značajno porasle nakon primjene jednostruke doze od 50 mg lijeka Teysuno (odražavajući inhibiciju DPD-a gimeracilom).
Based on the results of in vitro studies, a part of oteracil is non-enzymatically degraded to 5-azauracil (5-AZU) by gastric fluid, and is then converted to cyanuric acid (CA) in the digestive tract.
Bazirano na rezultatima in vitro studija, dio oteracila se neenzimatski razgrađuje želučanim sokovima u 5-azauracil (5AZU), a potom konvertira u probavnom traktu u cijanurnu kiselinu (CA).
Grade 1 Any occurrence
Stupanj 1
- Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXP.
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i blisteru iza oznake „Rok valjanosti“.
Manifestations of acute overdose reported include nausea, vomiting, diarrhoea, mucositis, gastrointestinal irritation, bleeding, bone marrow depression, and respiratory failure.
Zabilježene manifestacije akutnog predoziranja uključuju mučninu, povraćanje, proljev, mukozitis, gastrointestinalne iritacije, krvarenje, depresiju koštane srži i zatajenje disanja.
No pharmacokinetc studies have been conducted with Teysuno in paediatric patients.
Nisu provedene farmakokinetičke studije s lijekom Teysuno u pedijatrijskoj populaciji.
Refer to the cisplatin SmPC for eye disorders observed with cisplatin therapy.
Vidjeti sažetak opisa svojstava lijeka za cisplatin za poremećaje očiju uočene tijekom liječenja cisplatinom.
Gimeracil inhibits the metabolism of 5-FU by reversibly and selectively inhibiting DPD, the primary metabolic enzyme for 5-FU, so that higher plasma concentrations of 5-FU are achieved with the administration of a lower dose of tegafur.
Gimeracil inhibira metabolizam 5-FU-a reverzibilnom i selektivnom inhibicijom DPD-a, primarnog metaboličkog enzima za 5-FU-a, čime se postiže viša koncentracija 5-FU-a u plazmi primjenom niže doze tegafura.
No data are available on the effect of Teysuno in combination with cisplatin on human fertility.
Nema dostupnih podataka o učinku lijeka Teysuno u kombinaciji s cisplatinom na ljudsku plodnost.
- inhibitors of the enzyme CYP2A6 which activates Teysuno such as tranylcypromine and methoxsalen - folinic acid (often used in chemotherapy with methotrexate) - blood-thinning medicines: coumarin-derivative anticoagulants such as warfarin - medicines for the treatment of seizures or tremors such as phenytoin - medicines that treat gout such as allopurinol
Teysuno se ne može zamijeniti drugim oralnim fluorpirimidinom. - inhibitore enzima CYP2A6 koji aktiviraju Teysuno kao što su tranilcipromin i metoksalen - folinatnu kiselinu (često korištenu u kemoterapiji sa metotreksatom) - lijekove za razrjeđivanje krvi: antikoagulanse, derivate kumarina kao što je varfarin - lijekove za liječenje napadaja ili tremora kao što je fenitoin - lijekove za liječenje gihta kao što je alopurinol
• Severe renal impairment (CrCl below 30 ml/min) Although roughly similar daily exposure to 5-FU would be expected in patients with severe renal impairment at a dose of 20 mg/m2 once daily compared to 30 mg/m2 twice daily in patients with normal renal function (see section 5.2), administration of Teysuno is not recommended due to possibly higher incidence of adverse events of the blood and lymphatic system disorders unless the benefits clearly outweigh the risks (see sections 4.4 and 4.8).
Iako bi se očekivala otprilike slična dnevna izloženost 5-FU-u u bolesnika s teškim oštećenjem bubrega kod doze od 20 mg/m2 jednom dnevno, u usporedbi s 30 mg/m2 dva puta dnevno u bolesnika s normalnom funkcijom bubrega (vidjeti dio 5.2), primjena lijeka Teysuno se ne preporučuje zbog moguće veće incidencije štetnih događaja u smislu poremećaja krvi i limfnog sustava, osim ako korist liječenja lijekom Teysuno jasno premašuje rizike (vidjeti dijelove 4.4 i
Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Prije nego se počne liječenje, u bolesnika s pozitivnim serološkim testom na hepatitis B (uključujući one s aktivnom bolešću) te bolesnika s pozitivnim testom na infekciju HBV-om tijekom liječenja, treba konzultirati stručnjake za liječenje bolesti jetre i hepatitisa B.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
• Periodička izvješća o neškodljivosti lijeka (PSUR-evi) Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
Suspend treatment until resumption criterion (≥30 ml/min) is met and then start treatment at one reduced dose level
Odgoditi liječenje do postizanja kriterija za ponovni početak liječenja (≥ 30 ml/min) te početak liječenja dozom smanjenom za jednu razinu
Teysuno is contraindicated during breast-feeding (see section 4.3).
Teysuno je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
Doses omitted for toxicity are not replaced; and, if a patient vomits after taking a dose, this dose should not be replaced.
Doze propuštene zbog toksičnosti se ne nadoknađuju kao ni doza koju bolesnik povrati nakon uzimanja.
- Do not use Teysuno after the expiry date which is stated on the outer carton and blister after EXP.
- Teysuno se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i blisteru iza oznake „Rok valjanosti“.
Table 5: Haematologic toxicities for which Teysuno treatment should be suspended Units
Prilagodbe doze zbog hematološke toksičnosti Tablica 5: Hematološka toksičnost zbog koje treba odgoditi liječenje lijekom Teysuno Jedinice Neutrofili
However, co-administration may decrease clearance and, thus increase plasma levels of 5-FU.
Istodobna primjena može smanjiti klirens i tako povećati razine 5-FU-a u plazmi.
Dose modifications should be applied for the precipitating adverse reaction as necessary (see section 4.2).
U slučaju nuspojave uslijed precipitacije treba prilagoditi dozu prema potrebi (vidjeti dio 4.2).
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.