natgillin/translations-raw huggingface dataset:
The safety and efficacy of Teysuno in children and adolescents under 18 years old have not been established.
Sigurnost i djelotvornost lijeka Teysuno u djece i adolescenata u dobi do 18 godina nisu ustanovljene.
The capsules should be taken by mouth with water at least 1 hour before or 1 hour after a meal (see section 5.2).
Kapsule treba uzimati kroz usta s vodom najmanje 1 sat prije ili 1 sat nakon obroka (vidjeti dio 5.2).
In case you are using blood thinning or anti-seizure medicines, stopping Teysuno might require that your doctor adjusts the dose of your medicines.
U slučaju da uzimate lijekove za razrjeđivanje krvi ili lijekove protiv napadaja, zbog prestanka uzimanja lijeka Teysuno Vaš liječnik će možda trebati prilagoditi njihovu dozu.
Frequent monitoring of phenytoin blood/plasma levels is advised when Teysuno and phenytoin are administered concomitantly.
Preporučuje se česti nadzor razina fenitoina u krvi/plazmi kod istodobne primjene lijeka Teysuno i fenitoina.
No adjustment of the standard dose is recommended in patients >70 years old (see section 4.8).
Ne preporučuje se prilagodba standardne doze u bolesnika ≥ 70 godina starosti (vidjeti dio 4.8).
Data from a multicentre, multinational (excluding Asia), randomised, controlled, open-label Phase III clinical study (FLAGS) support the use of Teysuno in combination with cisplatin for the treatment of patients with advanced gastric cancer.
Podaci multicentrične, multinacionalne (isključivši Aziju), randomizirane, kontrolirane, otvorene studije faze III (FLAGS) podupiru primjenu lijeka Teysuno u kombinaciji s cisplatinom za liječenje bolesnika s uznapredovalim rakom želuca.
In vitro evaluation using primary cultures of human hepatocytes indicated that tegafur (0.7-70 µM), gimeracil (0.2-25 µM) and oteracil (0.04-4 µM) had little or no inductive effect on CYP1A2, CYP2B6 or CYP3A4/5 metabolic activities.
In vitro evaluacija korištenjem primarnih kultura humanih hepatocita upućuje da tegafur (0,7 - 70 µM), gimeracil (0,2-25 µM) i oteracil (0,04-4 µM) imaju mali ili nikakav indukcijski učinak na metaboličku aktivnost CYP1A2, CYP2B ili CYP3A4/5.
Teysuno dose changes within a 21-day treatment cycle
Promjena doze lijekaTeysuno unutar 21-dnevnog ciklusa liječenja
Teysuno was not found to be mutagenic when tested in the in vitro Ames assay.
Nije se pokazao mutagen u in vitro Ames testu.
How to take Teysuno
Kako uzimati Teysuno
Detailed information this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
Capsule contents Lactose monohydrate Magnesium stearate
Sadržaj kapsule laktoza hidrat magnezijev stearat
Among 593 patients treated with Teysuno in combination with cisplatin, the most common severe adverse reactions (Grade 3 or higher with frequency of at least 10%) were neutropaenia, anaemia, and fatigue.
U 593 bolesnika liječenih lijekom Teysuno u kombinaciji s cisplatinom, najčešće zabilježene teške nuspojave (stupnja 3 ili višeg sa učestalošću namanje 10%) bile su neutropenija, anemija i umor.
Terms for treatment-related ocular toxicities have been combined as follows.
Pojmovi očne toksičnosti uzrokovane liječenjem, kombinirani su kako slijedi.
If indicated, the dose of phenytoin should be adjusted according to the phenytoin SmPC.
Ako je indicirano treba prilagoditi dozu fenitoina u skladu sa sažetkom opisa svojstava za fenitoin.
Gimeracil is primarily cleared by the kidney (see section 5.2); so, in patients with renal insufficiency gimeracil renal clearance is decreased and 5-FU exposure thus increased.
Gimeracil se prvenstveno odstranjuje bubrezima (vidjeti dio 5.2); tako se, u bolesnika s bubrežnom insuficijencijom renalni klirens gimeracila smanjuje čime se povećava izloženost 5-FU-u.
Treatment with Teysuno is not recommended in patients with severe renal impairment due to possibly higher incidence of adverse events of the blood and lymphatic system and the possibility of unexpectedly higher exposure to 5-FU as a result of fluctuations in renal function in these patients, unless the benefits clearly outweigh the risks (see sections 4.2, 4.8 and 5.2).
Ne preporuča se liječenje lijekom Teysuno u bolesnika s teškim oštećenjem bubrega zbog moguće veće učestalosti neželjenih događaja krvi i limfnog sustava te mogućnosti neočekivano veće izloženosti 5-FU-u koja je rezultat fluktuacija bubrežne funkcije u takvih bolesnika, osim ako korist liječenja lijekom Teysuno jasno premašuje rizike (vidjeti dijelove 4.2, 4.8 i 5.2).
Among the metabolites, 9.5% to 9.7% of the administered tegafur was excreted in the urine as 5-FU and approximately 70% to 77% as FBAL, accounting for approximately 83% to 91% of the administered Teysuno dose (total tegafur + 5-FU + FBAL).
Od metabolita, 9,5 % do 9,7 % primijenjenog tegafura izlučilo se u urinu kao 5-FU a otprilike 70 % do 77 % kao FBAL, računajući na otprilike 83 % do 91 % primijenjene doze lijeka Teysuno (ukupni tegafur + 5-FU + FBAL).
5-FU is metabolised by the liver enzyme DPD.
5-FU se metabolizira uz pomoć jetrenog enzima DPD.
If any of the side effects get serious, stop taking Teysuno and tell your doctor immediately.
Ako se bilo koja nuspojava pogorša, prestanite uzimati Teysuno i odmah obavijestite liječnika.
Each pack contains either 42 capsules, 84 capsules or 126 capsules.
Svako pakiranje sadrži 42 kapsule, 84 kapsule ili 126 kapsula
Tegafur is a prodrug of 5-FU with good oral bioavailability.
Tegafur je predlijek 5-FU-a sa dobrom oralnom bioraspoloživošću.
Administration of Teysuno with a meal reduced exposure to oteracil and gimeracil, with a more pronounced effect for oteracil than for gimeracil (see section 5.2).
Primjena lijeka Teysuno uz obrok smanjuje izloženost oteracilu i gimeracilu izražavajući veći učinak oteracila od gimeracila (vidjeti dio 5.2).
Confusional state, restlessness, personality disorder, hallucination, depression, anxiety, libido decreased, sexual inhibition
Psihijatrijski poremećaji nesanica stanje zbunjenosti, uznemirenost, poremećaj osobnosti, halucinacije, depresija, anksioznost, smanjeni libido, spolna inhibicija
Following both single dose (50 mg) and multiple dose (30 mg/m2 twice daily) administration of Teysuno in man, maximum uracil concentrations reflecting DPD inhibition were observed approximately 4 hours postdose.
Primjenom i jednostruke doze (50 mg) i višestruke doze (30 mg/m2 dva puta na dan) lijeka Teysuno u ljudi, maksimalne koncentracije uracila koje odražavaju inhibiciju DPD-a opažene su otprilike 4 sata nakon primjene.
Patients with diarrhoea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.
Bolesnike s proljevom treba pažljivo nadzirati i ukoliko su dehidrirali provesti nadoknadu tekućine i elektrolita.
The dose for one patient in the severe cohort was reduced to 13.2 mg/m2 once daily at the start of Cycle 12 due to an adverse reaction (Grade 2 diarrhoea) in Cycle 11.
Doza za jednog bolesnika u kohorti bolesnika s teškim oštećenjem bubrega smanjena je na 13,2 mg/m2 jednom dnevno na početku 12. ciklusa zbog nuspojava (proljev stupnja 2) u 11. ciklusu.
Creatinine clearance (CrCl) must be determined for every cycle before the start of treatment on Day 1.
Prilagodbe doze zbog bubrežne toksičnosti Mora se odrediti klirens kreatinina (CrCl) za svaki ciklus prije početka liječenja, na 1. dan ciklusa.
Grade 3 or higherc First occurrence
Stupanj 3 ili višic Prva pojava
A maximum of two consecutive dose reductions for each medicinal product, as described in Table 1, can be applied in case of toxicity.
U slučaju toksičnosti mogu se provesti najviše dva uzastopna smanjenja doze za svaki lijek, kao što je opisano u Tablici 1.
The term peripheral neuropathy includes the following reported adverse reactions: peripheral sensory neuropathy, paraesthesia, hypoaesthesia, peripheral neuropathy, polyneuropathy, neurotoxicity, and dysaesthesia.
Pojam periferna neuropatija uključuje sljedeće zabilježene nuspojave: periferna senzorna neuropatija, parestezija, hipoestezija, periferna neutropatija, polineuropatija, neurotoksičnost i disestezija.
A clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5Fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described.
U literaturi je opisana klinički značajna interakcija između brivudina i fluoropirimidina (npr. kapecitabina, 5-fluorouracila, tegafura), koja proizlazi iz inhibicije dihidropirimidin dehidrogenaze brivudinom.
In man, the apparent terminal elimination half-life (T1/2) of 5-FU observed after administration of Teysuno (containing tegafur, a 5-FU prodrug) was longer (approximately 1.6 - 1.9 hours) than that previously reported after intravenous administration of 5-FU (10 to 20 minutes).
Prividni poluvijek eliminacije u ljudi (T1/2) 5-FU-a uočen nakon primjene lijeka Teysuno (sadrži tegafur, prolijek 5-FU-a) je bio duži (otprilike 1,6-1,9 sati) nego što je prethodno objavljeno nakon intravenske primjene 5-FU-a (10 do 20 minuta).
- Low platelet count leading to an increased chance of bleeding o If you have bleeding of the skin, mouth (caused by brushing teeth), nose, respiratory tract, stomach, gut, etc., stop taking Teysuno and contact your doctor immediately.
- Smanjenje broja trombocita što dovodi do povećane mogućnosti krvarenja ᴑ Ako krvarite po koži, u ustima (uslijed pranja zubi), iz nosa, dišnog trakta, želuca, crijeva itd., prestanite uzimati Teysuno i odmah se javite liječniku.
Efforts should be made to ensure early detection of ocular reactions, including an early ophthalmologic consultation in the event of any persistent or vision-reducing ocular symptoms such as lacrimation or corneal symptoms.
Potrebno je osigurati ranu detekciju očnih reakcija što uključuje rane konzultacije s oftalmologom u slučaju bilo kakvih trajnih simptoma, ili simptoma smanjenja vida, kao što su suzenje ili simptomi na rožnici.
Teysuno contains the active substances tegafur gimeracil and oteracil.
Teysuno sadrži djelatne tvari tegafur gimeracil i oteracil.
Treatment-related toxicities can be expected to increase as 5-FU exposure increases (see section 5.2).
Zbog povećanja izloženosti 5-FU-u može se očekivati povećanje toksičnosti uzrokovane liječenjem (vidjeti dio 5.2).
Refer to the cisplatin SmPC for the effects of cisplatin on fertility, pregnancy and lactation.
Vidjeti sažetak opisa svojstava za cisplatin o njegovom učinku na plodnost, trudnoću i dojenje.
The single and multiple dose pharmacokinetics (PK) of Teysuno in combination with cisplatin were evaluated in three studies.
Pharmacokinetics) pojedinačne i višestruke doze lijeka Teysuno u kombinaciji s cisplatinom evaluirana je u tri studije.
A Phase I study established the current regimen by evaluating cohorts of Teysuno and cisplatin of 30 mg/m2 and 60 mg/m2 (dose-limiting toxicities [DLTs] seen were fatigue, and diarrhoea and dehydration); 25 mg/m2 and 60 mg/m2; and 25 mg/m2 and 75 mg/m2.
Studija faze I odredila je važeći režim evaluacijom kohorte lijeka Teysuno i cisplatina u dozama od 30 mg/m2 i 60 mg/m2 (uočene toksičnosti koje su ograničavale dozu [DLT od engl. dose-limiting toxicities] bile su umor, proljev i dehidracija); 25 mg/m2 i 60 mg/m2; i 25 mg/m2 i 75 mg/m2.
Repeat-dose toxicity studies in rats, dogs and monkeys produced changes typically associated with administration of an anti-cancer medicinal product eliciting cytotoxic effects on populations of rapidly dividing cells, such as anaemia, decrease in the immune and digestive system function, disruption of spermatogenesis, and atrophy in male and female reproductive organs.
Studije toksičnosti ponovljene doze u štakora, pasa i majmuna dovele su do tipičnih promjena povezanih s primjenom antitumorskih lijekova pokazujući citotoksični učinak na populaciju stanica koje se brzo dijele, kao što su anemija, smanjenje funkcije imunološkog i probavnog sustava, poremećaj spermatogeneze i atrofija muških i ženskih organa za reprodukciju.
Therefore, Teysuno should not be administered to children or adolescents under 18 years of age.
Zato Teysuno ne treba primjenjivati u djece i adolescenata do 18 godina starosti.
Treatment days missed in a cycle where medicinal product was held due to toxicity should not be replaced.
Dani ciklusa u kojima je izostalo liječenje zbog toksičnosti ne smiju se nadoknađivati.
After oral administration, oteracil was distributed at high concentrations in normal gastrointestinal tract tissues while considerably lower concentrations were seen in blood and tumour tissue in animal studies.
U ispitivanjima na životinjama, nakon oralne primjene, oteracil se u visokim koncentracijama raspodjeljuje u tkivima normalnog gastrointestinalnog trakta dok su u krvi i tumorskom tkivu vidljive znatno niže koncentracije.
Children and adolescents Teysuno is not recommended for children under 18 years of age.
Teysuno se ne preporuča djeci mlađoj od 18 godina.
None
nema
6.4 Special precautions for storage This medicinal product does not require any special storage conditions.
Posebne mjere pri čuvanju lijeka Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
Patients with low platelet counts are at increased risk for bleeding and should be monitored carefully.
U bolesnika s malim brojem trombocita postoji povećani rizik krvarenja te ih je potrebno posebno nadzirati.
In the Phase III FLAGS study, there was no apparent relationship between 5-FU AUC (Teysuno/cisplatin arm) and 5-FU concentration (5-FU/cisplatin arm) during Cycle 1 and efficacy outcomes of overall survival (OS) or progression-free survival (PFS).
U studiji faze III FLAGS nije bilo vidljive povezanosti između AUC 5-FU-a (Teysuno/cisplatin skupina) i koncentracije 5-FU-a (5-FU/cisplatin skupina) tijekom 1. ciklusa i ishoda učinkovitosti: ukupnog preživljenja ili preživljenja bez progresije bolesti.
The recommended dose of cisplatin with this regimen is 75 mg/m2 by intravenous infusion administered once every 4 weeks.
Preporučeni režim doziranja cisplatina je 75 mg/m2, jednom u 4 tjedna, intravenskom infuzijom.
Baseline or Grade 1
Početak ili stupanj 1
• Pregnancy and breast-feeding.
• Trudnoća i dojenje.
However, since no DPD inducers are currently known, the interaction between a DPD inducer and Teysuno can not be evaluated.
Kako induktori DPD-a nisu poznati, interakcija između induktora DPD-a i lijeka Teysuno ne može se evaluirati.
In the Phase III (FLAGS) study, tegafur AUC was significantly higher in patients with the CYP2A6*4 allele, however, no significant difference was found for 5-FU AUC and for the incidence of adverse reactions.
U (FLAGS) studiji faze III AUC tegafura je bila značajno viša u bolesnika s alelom CYP2A6*4, no nije pronađena značajna razlika u AUC 5-FU-a i učestalosti nuspojava.
The washout period described in the SmPC of other fluoropyrimidine medicinal products should be followed if Teysuno is to be administered subsequent to other fluoropyrimidine medicinal products.
Potrebno je slijediti period ispiranja opisan u sažetku opisa svojstava ostalih fluoropirimidinskih lijekova ako se Teysuno primjenjuje nakon njih.
a Treatment for patients with CrCl <30 ml/min is not recommended unless the benefits of Teysuno treatment clearly outweigh the risks.
Ne preporučuje se liječenje bolesnika sa CrCl < 30 ml/min osim ako korist liječenja lijekom Teysuno jasno premašuje rizike.
A population PK analysis of Teysuno components and metabolites assessed the influence of various factors, including gender, age, food, ethnicity (Caucasian vs Asian), renal function, and hepatic function in 315 patients.
Populacijska farmakokinetička analiza sastojaka lijeka Teysuno i metabolita provedena na 315 bolesnika, procjenjivala je utjecaj različitih faktora uključujući spol, dob, hranu, etničku pripadnost (bijelci prema Azijatima), bubrežnu funkciju i jetrenu funkciju.
The main metabolic pathway for tegafur is through conversion to 5-FU via CYP2A6 in the liver, whereas gimeracil was stable in human liver homogenate (S9 fraction) with adenosine 3'-phosphate 5'-phosphosulfphate lithium salt (PAPS; a co-factor for sulfotransferase) or nicotinamide adenine dinucleotide phosphate (NADPH).
Glavni put metabolizma tegafura je kroz konverziju u 5-FU pomoću CYP2A6 u jetri, dok je gimeracil stabilan u ljudskom homogenatu jetre (S9 frakcija) s litijevom soli adenozin 3'-fosfat-5'-fosfosulfata (PAPS; ko-faktor sulfotransferaze) ili nikotinamid adenin dinukleotid fosfatom (NADP).
• Co-administration of other fluoropyrimidines with Teysuno.
• Istodobna primjena drugih fluoropirimidina s lijekom Teysuno.
o If you experience nausea and vomit a dose of medication, make sure you tell your doctor.
ᴑ Ako imate mučninu i povratite dozu lijeka, obavijestite svog liječnika.
Teysuno does not appear to affect male or female fertility in the rat; however, administration at any time after conception resulted in a range of external, visceral, and skeletal foetal abnormalities in rat and rabbit.
Nije uočeno da Teysuno utječe na plodnost bilo mužjaka bilo ženki štakora, no primjena u bilo koje vrijeme nakon začeća rezultirala je vanjskim, organskim i koštanim abnormalnostima fetusa štakora i kunića.
Cisplatin should be discontinued after 6 cycles without withdrawal of Teysuno.
Nakon 6 ciklusa treba prekinuti primjenu cisplatina bez ukidanja lijeka Teysuno.
- Mental: seeing and hearing some things that are not there, personality change, unable to sit still, confusion, feeling of nervousness, depression, sexual dysfunction - Nerve:, voice disorder, inability to speak and understand words, memory problem, unsteady gait, balance problems, one sided body weakness, sleepiness, nerve inflammation, distorted sense of smell, brain dysfunction, fainting, loss of consciousness, stroke, seizures
- Mentalne: kada se vide i čuju neke stvari kojih nema, promjena osobnosti, nemogućnost mirnog sjedenja, zbunjenost, osjećaj nervoze, depresija, seksualna disfunkcija - Živčane: poremećaj glasa, nemogućnost izgovaranja i razumijevanja riječi, problemi s pamćenjem, nestabilan hod, problemi s ravnotežom, slabost jedne strane tijela, pospanost, upala živca, narušen osjećaj mirisa, disfunkcija mozga, klonulost, gubitak svijesti, moždani udar, napadaji
No adjustment of the standard dose is recommended for patients of Asian ethnicity (see section 5.2).
Ne preporučuje se prilagodba standardne doze u bolesnika azijske etničke skupine (vidjeti dio 5.2).
It is a fixed dose combination of three active substances, tegafur, which after absorption is converted into the anti-cancer substance 5-FU; gimeracil, a dihydropyrimidine dehydrogenase (DPD) inhibitor to prevent degradation of 5-FU by the body; and, oteracil, an orotate phosphoribosyltransferase (OPRT) inhibitor that decreases the activity of 5-FU in normal gastrointestinal mucosa.
On je kombinacija fiksnih doza tri djelatne tvari, tegafura, koji se nakon apsorpcije konvertira u anti-kancerogenu supstanciju 5-FU; gimeracila, inhibitora dihidropirimidin dehidrogenaze (DPD) za sprječavanje razgradnje 5-FU-a u tijelu; i oteracila, inhibitora orotat fosforiboziltransferaze (OPRT) koji smanjuje aktivnost 5-FU-a u normalnoj gastrointestinalnoj sluznici.
There are no side effects caused by stopping treatment with Teysuno.
Nema nuspojava uzrokovanih prestankom liječenja lijekom Teysuno.
In a Japanese Phase I study that utilized 5 dose groups with doses ranging from 25 to 200 mg/body, there was a dose-proportional increase in exposure for tegafur, gimeracil and oteracil.
U japanskoj studiji faze I koja je koristila 5 doznih skupina s rasponima doza od 25 do 200 mg/organizmu, uočen je dozi proporcionalan porast izloženosti tegafuru, gimeracilu i oteracilu.
A Phase I study was conducted to evaluate the PK of the components of Teysuno and their metabolites in cancer patients with impaired renal function compared to those with normal renal function.
Provedena je studija faze I za evaluaciju farmakokinetike sastojaka lijeka Teysuno i njegovih metabolita u bolesnika oboljelih od raka s oštećenom bubrežnom funkcijom u usporedbi s bolesnicima s normalnom bubrežnom funkcijom.
Teysuno dose modifications for toxicity when used in combination with cisplatin can be made in two ways.
Prilagodba doze zbog toksičnosti lijeka Teysuno u kombinaciji s cisplatinom, može se provesti na dva načina.
No dose modification
Nema prilagodbe doze
The plasma concentrations of uracil returned to baseline levels approximately 48 hours after dosing indicating reversibility of DPD inhibition by gimeracil.
Koncentracije uracila u plazmi vratile su se na osnovnu razinu otprilike 48 sati nakon primjene upućujući na reverzibilnost inhibicije DPD-a gimeracilom.
Comparison of 218 patients with mild renal impairment at baseline (CrCl 51 to 80 ml/min) to 297 patients with normal renal function at baseline (CrCl >80 ml/min) treated with Teysuno in combination with cisplatin in the FLAGS study indicated that there were no clinically significant differences in safety between patients with mild renal impairment and patients with normal renal function.
Usporedba 218 bolesnika s blagim oštećenjem bubrega na početku liječenja (CrCl 51 do 80 ml/min) s 297 bolesnika s normalnom bubrežnom funkcijom na početku liječenja (CrCl > 80 ml/min) liječenih lijekom Teysuno u kombinaciji s cisplatinom u FLAGS studiji, indicirala je da nema klinički značajnih razlika u sigurnosti primjene između bolesnika sa blagim oštećenjem bubrega i onih s normalnom funkcijom bubrega.
In vitro evaluation using human liver microsomes indicated that neither tegafur, gimeracil nor oteracil showed any relevant inhibitory effects on enzyme activities of the cytochrome P450 isoforms tested (i.e., CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4).
In vitro evaluacija korištenjem ljudskih jetrenih mikrosoma upućuje na to da niti tegafur, niti gimeracil niti oteracil ne pokazuju nikakve značajne inhibitorne učinke na ispitivanu enzimsku aktivnost izoforme citokroma P450 (tj. CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 i CYP3A4).
In this study, 521 patients were randomised to treatment with Teysuno (25 mg/m2 orally twice daily for 21 days followed by a 7-day rest period) and cisplatin (75 mg/m2 intravenous infusion once every 4 weeks); and 508 patients were randomised to treatment with 5-FU (1000 mg/m2/24 hours as a continuous intravenous infusion on Days 1 through 5 repeated every 4 weeks) and cisplatin (100 mg/m2 as an intravenous infusion on Day 1 repeated every 4 weeks).
U toj studiji, 521 bolesnik je randomiziran u skupinu liječenu lijekom Teysuno (25 mg/m2 oralno dva puta dnevno tijekom 21 dan, nakon čega slijedi odmor od 7 dana) i cisplatinom (75 mg/m2 intravenskom infuzijom jednom u svaka 4 tjedna), a 508 bolesnika je randomizirano u skupinu liječenu 5-FU-om (1000 mg/m2/24 sata kao kontinuirana intravenska infuzija od 1. do 5. dana, ponovljeno svaka 4 tjedna) i cisplatinom (100 mg/m2 kao intravenska infuzija 1. dan,
Each pack contains 42 capsules or 84 capsules.
Svako pakiranje sadrži ili 42 kapsule ili 84 kapsule
Rare side effects (may affect 1 to 10 in 10,000 people) and very rare side effects (may affect less than 1 in 10,000 people) include:
Rijetke nuspojave (mogu se javiti u 1 do 10 na 10 000 osoba) i vrlo rijetke nuspojave (mogu se javiti u manje od 1 na 10 000 osoba) uključuju:
Maximum plasma uracil concentration was observed at 4 hours, with a return to baseline levels within approximately 48 hours after dosing, indicating the reversibility of the DPD inhibition by gimeracil.
Maksimalna koncentracija uracila u plazmi opažena je nakon 4 sata, s povratom na početnu vrijednost unutar otprilike 48 sati nakon primjene, upućujući na reverzibilnost inhibicije DPD-a gimeracilom.
Other oral fluorpyrimidines
Ostali oralni fluoropirimidini
Advanced gastric cancer
Uznapredovali rak želuca