natgillin/translations-raw huggingface dataset:
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).
Pri uporabi zdravila Teysuno ob obroku se je zmanjšala izpostavljenost za oteracil in gimeracil, in sicer z izrazitejšim učinkom pri oteracilu kot pri gimeracilu (glejte poglavje 5.2).
As with other fluoropyrimidines, Teysuno administration caused embryolethality and teratogenicity in animals (see section 5.3).
Tako kot pri drugih fluoropirimidinih je tudi uporaba zdravila Teysuno povzročila smrtnost zarodkov in teratogenost pri živalih (glejte poglavje 5.3).
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:
Med redke (pojavijo se lahko pri 1 do 10 od 10.000 bolnikov) in zelo redke neželene učinke (pojavijo se pri manj kot 1 od 10.000 bolnikov) so vključeni:
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.
Primerjava varnosti, izvedena med 71 bolniki, starimi 70 let ali več (starejši), in 450 bolniki, starimi manj kot 70 let, ki so bili zdravljeni z zdravilom Teysuno v kombinaciji s cisplatinom, v študiji FLAGS je pokazala, da so pogostnost vseh neželenih učinkov stopnje 3 ali višje stopnje (62 % proti 52 %), pogostnost vseh resnih neželenih učinkov (30 % proti 19 %) in količnik predčasnega umika tako zdravila Teysuno kot cisplatina zaradi neželenih učinkov (21 % proti 12 %) višji pri bolnikih, starih 70 let ali več.
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 ovrednotenje je ob uporabi človeških jetrnih mikrosomov pokazalo, da niti tegafur niti gimeracil niti oteracil niso izkazali pomembnih zaviralnih učinkov na aktivnost encimov za citokrom P450, testirane izooblike (npr. CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 in CYP3A4).
A minimum washout period of 7 days is recommended between administration of Teysuno and other fluoropyrimidines.
Minimalna doba izpiranja, ki se priporoča med uporabo zdravila Teysuno in uporabo drugih fluoropirimidinov, je 7 dni.
Teysuno dose modifications for toxicity when used in combination with cisplatin can be made in two ways.
Odmerek zdravila Teysuno zaradi toksičnosti se lahko, če se to zdravilo uporablja v kombinaciji s cisplatinom, spreminja na dva načina.
Creatinine clearance (CrCl) must be determined for every cycle before the start of treatment on Day 1.
Spremembe odmerkov zaradi ledvične toksičnosti Očistek kreatinina (CrCl) je treba določiti za vsak cikel na 1. dan pred začetkom zdravljenja.
If any of the side effects get serious, stop taking Teysuno and tell your doctor immediately.
Če kateri koli neželeni učinek postane resen, prenehajte jemati zdravilo Teysuno in se takoj posvetujte s svojim zdravnikom.
Although studies of Teysuno in combination with cisplatin that were conducted in Japan utilised doses and dosing schedules that differed from this regimen, the safety profile from these studies was similar, with the most common toxicities being haematologic, gastrointestinal, fatigue, and anorexia.
Čeprav so bili odmerki in sheme odmerjanja, ki so se uporabljali v študijah zdravila Teysuno v kombinaciji s cisplatinom, opravljenih na Japonskem, drugačni od te sheme, je bil varnostni profil pri teh študijah podoben, saj so med najpogostejše toksične učinke spadali hematološka in gastrointestinalna toksičnost ter utrujenost in anoreksija.
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).
Med presnovki se je 9,5-9,7 % prejetega tegafurja izločilo z urinom kot 5-FU in približno 70-77 % kot FBAL, kar ustreza približno 83-91 % prejetega odmerka zdravila Teysuno (skupno tegafur + 5-FU + FBAL).
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).
je treba prilagoditi odmerek zdravila Teysuno in/ali cisplatin v skladu s Preglednico 4 in ustreznimi podpornimi ukrepi (glejte poglavje 4.2).
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.
Po enkratnem odmerku zdravila Teysuno se je približno 3,8-4,2 % prejetega tegafurja, 65-72 % prejetega gimeracila in 3,5-3,9 % prejetega oteracila v nespremenjeni obliki izločilo z urinom.
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 se jemljejo peroralno in z vodo ter najmanj 1 uro pred obrokom ali 1 uro po obroku (glejte poglavje 5.2).
The term peripheral neuropathy includes the following reported adverse reactions: peripheral sensory neuropathy, paraesthesia, hypoaesthesia, peripheral neuropathy, polyneuropathy, neurotoxicity, and dysaesthesia.
Izraz periferna nevropatija vključuje naslednje neželene učinke, o katerih so poročali: periferno senzorično nevropatijo, parestezijo, hipestezijo, periferno nevropatijo, polinevropatijo, nevrotoksičnost in disestezijo.
Coumarin-derivative anticoagulant
Kumarinski antikoagulant
If you forget to take Teysuno
Če ste pozabili vzeti zdravilo Teysuno
- 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.
- Majhno število trombocitov, kar poveča možnost krvavitve: o Če krvavite na koži, v ustih (zaradi umivanja zob), nosu, na respiratornem traktu, v želodcu, črevesju itd., prenehajte jemati zdravilo Teysuno in se takoj posvetujte s svojim zdravnikom.
Standard dosea: 25 mg/m2
Standardni odmereka: 25 mg/m2
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).
Če se zdravilo Teysuno uporablja v kombinaciji s cisplatinom, se priporoča standardni odmerek 25 mg/m2 (izraženo z vsebnostjo tegafurja) dvakrat dnevno, zjutraj in zvečer, in sicer 21 zaporednih dni, ki jim sledi 7 dni premora (1 cikel zdravljenja).
Dose modifications should be applied for the precipitating adverse reaction as necessary (see section 4.2).
Po potrebi je treba spremeniti odmerke zaradi sprožitvenih neželenih učinkov (glejte poglavje 4.2).
It is not known whether Teysuno or its metabolites are excreted in human milk.
Ni znano, ali se Teysuno/presnovki izločajo v materino mleko.
Following oral administration, tegafur is gradually converted to 5-FU in vivo, mainly by CYP2A6 enzyme activity in the liver.
Tegafur se po peroralni uporabi postopno pretvori v 5-FU in vivo, v glavnem z delovanjem encima CYP2A6 v jetrih.
Second dose reductiona: to 15 mg/m2 BSA ≥ 2.17 m2
Drugi zmanjšani odmereka: na 15 mg/m2 BSA ≥ 2,17 m2
Ethnicity
Narodnost
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.
Gre za fiksno kombinacijo odmerkov treh zdravilnih učinkovin: tegafurja, ki se po absorpciji pretvori v antikancerogeno snov 5-FU; gimeracila, inhibitorja dihidropirimidin dehidrogenaze (DPD), ki preprečuje razgradnjo snovi 5-FU v telesu, in oteracila, inhibitorja orotat fosforiboziltransferaze (OPRT), ki zmanjšuje aktivnost snovi 5-FU pri normalni gastrointestinalni sluznici.
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.
Primerjava 218 bolnikov z blago izhodiščno ledvično okvaro (CrCl 51-80 ml/min) in 297 bolnikov z normalno izhodiščno ledvično funkcijo (CrCl > 80 ml/min), zdravljenih z zdravilom Teysuno v kombinaciji s cisplatinom, v študiji FLAGS je pokazala, da med bolniki z blago ledvično okvaro in bolniki z normalno ledvično funkcijo ni bilo klinično pomembnih razlik glede varnosti.
There are no clinical data on the distribution of radiolabeled components of Teysuno.
Kliničnih podatkov o porazdelitvi radioaktivno označenih sestavin zdravila Teysuno ni.
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.
Na podlagi študije faze I je bila oblikovana trenutna shema odmerjanja, in sicer z ovrednotenjem kohort za zdravilo Teysuno in cisplatin v odmerkih 30 mg/m2 in 60 mg/m2 (opaženi toksični učinki, ki omejujejo odmerek (DLT), so bili utrujenost, driska in dehidracija); 25 mg/m2 in 60 mg/m2, ter 25 mg/m2 in 75 mg/m2.
a Expressed as tegafur content.
a Izraženo z vsebnostjo tegafurja.
Administration of Teysuno under fed conditions resulted in decreased AUC0-inf for oteracil of approximately 71% and gimeracil of approximately 25% relative to fasting administration.
Pri uporabi zdravila Teysuno na poln želodec se je AUC0-inf za oteracil zmanjšal za približno 71 % in za gimeracil za približno 25 % v primerjavi z uporabo na tešče.
Therefore, Teysuno should not be administered to children or adolescents under 18 years of age.
Zdravila Teysuno se ne sme uporabljati pri otrocih ali mladostnikih, starih pod 18 let.
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.
Zdi se, da zdravilo Teysuno ne vpliva na plodnost samcev ali samic pri podganah, toda pri uporabi zdravila po spočetju so opazili vrsto zunanjih, visceralnih in skeletnih nenormalnosti plodov pri podganah in kuncih.
Teysuno was not carcinogenic in either the rat or the mouse.
Zdravilo Teysuno niti pri podganah niti pri miših ni delovalo kancerogeno.
There are no side effects caused by stopping treatment with Teysuno.
Neželenih učinkov po prekinitvi zdravljenja z zdravilom Teysuno ni.
If you stop taking Teysuno
Če ste prenehali jemati zdravilo Teysuno
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.
Uporaba kumarinskega antikoagulanta v kliničnih študijah je bila povezana s povečano vrednostjo INR in gastrointestinalno krvavitvijo, nagnjenostjo h krvavitvam, hematurijo in anemijo pri bolnikih, ki so prejemali zdravilo Teysuno.
Overall Survival Intent-to-treat Full analysis set Progression-free Survival Full analysis set CI = confidence interval; Full analysis set = all randomised, treated patients analysed as allocated (primary analysis population)
IZ = interval zaupanja; Celotna skupina bolnikov = vsi naključno izbrani in zdravljeni bolniki, analizirani glede na razporeditev (populacija primarne analize)
Avoid fatty and strong-smelling food.
Izogibajte se hrani, ki je bogata z maščobami in ima izrazit vonj.
Gimeracil increases 5-fluorouracil (5-FU) exposure by inhibiting DPD, the primary enzyme for metabolizing 5-FU.
Gimeracil poveča izpostavljenost za 5-fluorouracil (5-FU), tako da zavira DPD, primarni encim, odgovoren za presnovo 5-FU.
Teysuno is prescribed by doctors for the treatment of adults with advanced stomach (gastric) cancer and is taken with cisplatin, another anti-cancer medicine.
Zdravilo Teysuno predpiše zdravnik za zdravljenje odraslih oseb z napredovalim rakom želodca, jemlje pa se s cisplatinom, še enim zdravilom proti raku.
5-AZU and CA do not inhibit OPRT enzyme activity.
5-AZU in CA ne zavirata aktivnosti encima OPRT.
However, nitromidazoles may reduce clearance of 5-FU and thus increase plasma levels of 5-FU.
Nitroimidazoli lahko zmanjšajo očistek 5-FU in zato povišajo ravni 5-FU v plazmi.
15 mg capsulea (brown/white)
15 mg kapsulaa (rjava/bela)
Dose modifications for Teysuno for adverse reactions in general except for haematologic and renal toxicities
Spremembe odmerkov zdravila Teysuno zaradi neželenih učinkov na splošno, razen hematološke in ledvične toksičnosti
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 ovrednotenje je ob uporabi primarnih kultur človeških hepatocitov pokazalo, da so imeli tegafur (0,7-70 µM), gimeracil (0,2-25 µM) in oteracil (0,04-4 µM) majhen pospeševalni učinek na presnovne aktivnosti encimov CYP1A2, CYP2B6 ali CYP3A4/5, ali pa ga sploh niso imeli.
Teysuno should only be prescribed by a qualified physician experienced in treating cancer patients with anti-neoplastic medicinal products.
Zdravilo Teysuno sme predpisati samo zdravnik, ki je usposobljen in že ima izkušnje z zdravljenjem rakavih bolnikov z antineoplastičnimi zdravili.
Teysuno belongs to the fluoropyrimidine class of medicines known as “antineoplastic agents” which stop the growth of cancer cells.
Zdravilo Teysuno sodi v skupino fluoropirimidinov, znanih kot "antineoplastična zdravila", ki zaustavijo rast rakavih celic.
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.
V tej študiji so 7 bolnikov z zmerno ledvično okvaro zdravili z 20 mg/m2 zdravila Teysuno dvakrat na dan, 7 bolnikov s hudo ledvično okvaro pa z 20 mg/m2 zdravila Teysuno enkrat na dan.
During and up to 6 months after treatment with Teysuno, you must use contraceptive measures.
Med zdravljenjem z zdravilom Teysuno in do 6 mesecev po zdravljenju morate uporabljati učinkovito kontracepcijo.
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).
Pri moških je bil navidezni končni razpolovni čas izločanja (T1/2) snovi 5-FU, ugotovljen po uporabi zdravila Teysuno (vsebuje tegafur, predzdravilo snovi 5-FU), daljši (približno 1,6-1,9 ure) kot tisti, o katerem so predhodno poročali po intravenski uporabi snovi 5-FU (10-20 minut).
There was no effect of gimeracil on renal clearance of tegafur, FBAL, and 5-FU following administration of Teysuno as compared to their clearance following administration of tegafur alone.
Pri gimeracilu niso opazili nobenega vpliva na ledvični očistek za tegafur, FBAL in 5-FU po uporabi zdravila Teysuno v primerjavi z očistkom po samostojni uporabi tegafurja.
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.
Pri bolnikih z rakom želodca povezava med občutljivostjo za 5-FU in vrednostjo MSI ni jasna, povezava med zdravilom Teysuno in vrednostjo MSI pri raku želodca pa je neznana.
Teysuno is contraindicated in pregnancy (see section 4.3).
Zdravilo Teysuno je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
No data is available regarding Teysuno administration in patients with end stage renal disease requiring dialysis (see section 4.3).
Podatkov o uporabi zdravila Teysuno pri bolnikih ledvično boleznijo v končnem stadiju, ki zahteva dializo, ni (glejte poglavje 4.3).
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.
Glede na rezultate in vitro študij del oteracila po neencimski poti razpade v 5-azauracil (5-AZU) v želodčni tekočini, nato pa se pretvori v cianurično kislino (CA) v prebavnem traktu.
No pharmacokinetc studies have been conducted with Teysuno in paediatric patients.
Farmakokinetičnih študij z zdravilom Teysuno pri pediatrični populaciji niso opravili.
In addition, hyperpigmentation in the skin and eyes and corneal opacity in dogs and cataracts in rats were observed following repeat dosing.
Poleg tega so po ponovnem odmerjanju opazili hiperpigmentacijo kože in oči, zamotnitev roženice pri psih in katarakte pri podganah.
Teysuno can be continued after stopping cisplatin.
Zdravljenje z zdravilom Teysuno se po ukinitvi cisplatina lahko nadaljuje.
ECOG Performance Status, n (%)
Indeks zmogljivosti ECOG, n (%)
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.
Čeprav ni na voljo nobenih intravenskih podatkov za zdravilo Teysuno pri ljudeh, je mogoče na grobo oceniti volumen porazdelitve na podlagi navideznega volumna porazdelitve in podatkov o izločanju z urinom, namreč kot 16 l/m2 za tegafur, 17 l/m2 za gimeracil in 23 l/m2 za oteracil.
Before starting treatment, you must tell your doctor or pharmacist if you are pregnant, if you think you are pregnant, or if you intend to become pregnant.
Če ste noseči ali mislite, da ste noseči, ali nameravate zanositi, morate pred začetkom zdravljenja o tem obvestiti svojega zdravnika ali farmacevta.
Teysuno will be given with another anti-cancer medicine called cisplatin.
Zdravilo Teysuno se predpiše s še enim zdravilom proti raku, ki se imenuje cisplatin.
- 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)
- akutna odpoved jeter - okužba trebušne slinavke - razpadanje mišic - izguba voha - alergija na sonce - razširjena koagulacija in krvavitev - bolezen, ki vpliva na belo možganovino - resno obolenje s pojavom mehurjev na koži, ustih in spolovilih - ponovitev (reaktivacija) okužbe z virusom hepatitisa B, če ste za okužbo z virusom hepatitisa B
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.
Presnovki folinata/folinske kisline oblikujejo trikomponentno zmes s timidilatno sintazo in fluorodeoksiuridin monofosfatom (FdUMP), kar lahko poveča citotoksičnost snovi 5-FU.
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 zavira presnovo snovi 5-FU, tako da reverzibilno in selektivno zavira DPD, primarni encim, odgovoren za presnovo 5-FU, s čimer je mogoče doseči večjo koncentracijo snovi 5-FU v plazmi ob uporabi manjšega odmerka tegafurja.
Table 3: Teysuno dose reduction schedule for treatment-related toxicities in general, except for haematologic and renal toxicities
Preglednica 3: Načrt za zmanjšanje odmerka zdravila Teysuno zaradi toksičnosti, povezane z zdravljenjem, na splošno, razen hematološke in ledvične toksičnosti
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).
Zdravljenje z zdravilom Teysuno se ne priporoča pri bolnikih s hudo ledvično okvaro zaradi morebitno večje incidence neželenih dogodkov bolezni krvi in limfatičnega sistema ter možnosti nepričakovano večje izpostavljenosti 5-FU, kar je posledica nihanja pri delovanju ledvic teh bolnikov, razen če je jasno, da so koristi večje od tveganja (glejte poglavja 4.2, 4.8 in 5.2).
- Nerve disorder: you may feel numbness, tingling, pain, abnormal sensation, weak muscle, shaking, or movement difficulties.
- Bolezni živčevja: občutite lahko otrplost, ščemenje, bolečino, nenormalne občutke, mišično oslabelost, tresenje ali imate gibalne težave.
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.
Opisali so klinično pomembno medsebojno delovanje med brivudinom in fluoropirimidini (npr. kapecitabinom, 5-fluorouracilom in tegafurjem), ki je rezultat brivudinovega zaviranja dihidropirimidin-dehidrogenaze.
If the patient becomes pregnant while receiving Teysuno, treatment should be discontinued and the potential risk to the foetus must be explained.
Če bolnica zanosi med prejemanjem zdravila Teysuno, je treba zdravljenje prekiniti, bolnico pa opozoriti na potencialna tveganja za zarodek.
• 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).
• Zmerna ledvična okvara (CrCl 30 do 50 ml/min) Priporočeni standardni odmerek za bolnike z zmerno ledvično okvaro je 20 mg/m2 dvakrat dnevno (izraženo z vsebnostjo tegafurja) (glej poglavji 4.8 in 5.2).
What Teysuno looks like and contents of the pack
Izgled zdravila Teysuno in vsebina pakiranja
Age, years
Starost v letih
None
brez
Cisplatin dose modification at the start of the cycle of treatment
Sprememba odmerka cisplatina na začetku cikla zdravljenja
Manufacturer Nordic Pharma Tolweg 15
Izdelovalec Nordic Pharma Tolweg 15
Therefore, the CYP2A6 polymorphism differences between Asian and Western populations do not appear to be the key determinant for differences in the MTD between populations.
Razlike med azijskimi in zahodnimi populacijami, ki so posledica polimorfizma encima CYP2A6, niso glavni dejavnik za različne vrednosti MTD (največji tolerančni odmerek) med populacijami.
Fluoropyrimidines may increase phenytoin plasma concentration when administered concomitantly with phenytoin causing phenytoin toxicity.
Fluoropirimidini lahko, če se uporabljajo sočasno s fenitoinom, povečajo koncentracijo fenitoina v plazmi, kar povzroči fenitoinsko toksičnost.
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.
Tako po enkratnem odmerku (50 mg) kot po večkratnem odmerjanju (30 mg/m2 dvakrat dnevno) zdravila Teysuno pri moških so največje koncentracije uracila, ki prikazujejo zaviranje encima DPD, opazili približno 4 ure po odmerku.