FrancophonIA/ELRC3.0 huggingface dataset:
English: Efient must not be used in patients who have a condition that causes excessive bleeding, who have had a stroke or transient ischaemic attack (a temporary reduction in the blood supply to part of the brain), or with severe liver problems.
Slovenian: Zdravila Efient ne smejo uporabljati bolniki z obolenjem, ki povzroča prekomerno krvavitev, bolniki, ki so doživeli kap ali tranzitorno ishemično atako (prehodno zmanjšan dotok krvi v delu možganov) ali imajo hude težave z jetri.
English: Efient is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention.
Slovenian: Zdravilo Efient se jemlje sočasno z aspirinom za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročijo krvni strdki in zatrditev arterij) pri bolnikih z akutnim koronarnim sindromom, ki so imeli perkutano koronarno intervencijo.
English: This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day.
Slovenian: Temu sledi 10-miligramski odmerek enkrat na dan, razen pri bolnikih, ki tehtajo manj kot 60 kg, ki morajo vzeti 5 mg enkrat na dan. Bolniki, ki jemljejo zdravilo Efient, morajo prav tako jemati aspirin, in sicer v odmerku, ki jim ga je predpisal zdravnik.
English: For the full list of all side effects reported with Efient, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Efient, glejte navodilo za uporabo.
English: The CHMP decided that Efient's benefits are greater than its risks, when given together with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Efient ob sočasni uporabi z aspirinom za preprečevanje aterotrombotičnih dogodkov pri bolnikih z akutnim koronarnim sindromom, ki so imeli primarno ali odloženo perkutano intervencijo, večje od z njim povezanih tveganj.
English: How has Efient been studied?
Slovenian: Kako je bilo zdravilo Efient raziskano?
English: The active substance in Efient, prasugrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina zdravila Efient, prasugrel, je zaviralec agregacije trombocitov.
English: When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Slovenian: Strjevanje krvi je posledica zlepljanja (agregacije) posebnih celic v krvi, imenovanih trombociti.
English: What is Efient used for?
Slovenian: Za kaj se zdravilo Efient uporablja?
English: What is Efient?
Slovenian: Kaj je zdravilo Efient?
English: How is Efient used?
Slovenian: Kako se zdravilo Efient uporablja?
English: How does Efient work?
Slovenian: Kako zdravilo Efient deluje?
English: Prasugrel stops the platelets aggregating by blocking a substance called ADP from binding to a receptor on their surface.
Slovenian: Prasugrel z zaviranjem vezave snovi, imenovane ADP (adenozin difosfat), na receptor na površini trombocitov prepreči njihovo agregacijo.
English: These changes were reversible.
Slovenian: Te spremembe so bile reverzibilne.
English: The cycles are repeated.
Slovenian: Cikli se ponavljajo.
English: Wear loose clothing to protect the skin.
Slovenian: Nosite ohlapna oblačila, da zaščitite kožo.
English: Even if you do not feel hungry, continue to eat as much as you can to maintain good nutrition.
Slovenian: Čeprav niste lačni, jejte kolikor morete, da ohranite ustrezno hranilno vrednost.
English: Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
Slovenian: Vaš zdravnik vam bo povedal, kakšen odmerek morate vzeti, kdaj ga morate vzeti in koliko časa ga morate jemati.
English: Calculate BSA to 2 decimal places.
Slovenian: Izračunajte BSA na 2 decimalni mesti.
English: Rare / Very rare
Slovenian: Redki/zelo redki
English: Microsatellite instability (MSI)
Slovenian: Mikrosatelitska nestabilnost (MSI)
English: This treatment cycle is repeated every 4 weeks.
Slovenian: Ta cikel zdravljenja se ponovi vsake 4 tedne.
English: Brush your teeth and blow your nose gently.
Slovenian: Nežno si umivajte zobe in lahkotno se useknite.
English: This 28 day period is one treatment cycle.
Slovenian: To 28-dnevno obdobje pomeni en cikel zdravljenja.
English: 3741 LM Baarn The Netherlands
Slovenian: 3741 LM Baarn Nizozemska
English: All studies were performed in cancer patients.
Slovenian: Vse študije so izvedli z bolniki z rakom.
English: The dose should be modified as recommended in section 4.2.
Slovenian: Odmerek je treba prilagoditi, kot je priporočeno v poglavju 4.2.
English: Genetic counseling should be considered.
Slovenian: Priporoča se genetsko svetovanje.
English: At the time of primary analysis, the median follow-up for overall survival in the full analysis set was 18.3 months.
Slovenian: Ob izvedbi primarne analize je mediana spremljanja glede celokupnega preživetja pri celotni skupini bolnikov znašala 18,3 meseca.
English: Patient characteristics are provided in Table 8.
Slovenian: Značilnosti bolnikov so navedene v Preglednici 8.
English: Teysuno must be taken twice daily (morning and evening).
Slovenian: Zdravilo Teysuno morate jemati dvakrat dnevno (zjutraj in zvečer).
English: No dose advice for this subpopulation can be provided.
Slovenian: Za odmerjanje v tej subpopulaciji ni mogoče dati navodil.
English: Each dose reduction results in approximately 20-25% reduction of dose.
Slovenian: Pri vsakem zmanjšanem odmerku se odmerek zmanjša za približno 20-25 %.
English: Black or African American Asian
Slovenian: Črnci ali Afroameričani Azijci
English: Treatment should not be resumed until dehydration and its underlying causes are corrected or adequately controlled.
Slovenian: Zdravljenje se ne sme ponovno uvesti, dokler dehidracija in njeni izvirni vzroki niso korigirani ali ustrezno nadzorovani.
English: During a 4-week cycle of treatment
Slovenian: Med 4-tedenskim ciklom zdravljenja
English: Dose modifications for toxicity should be made according to Tables 1, 3, 4, and 5.
Slovenian: Spremembe odmerkov zaradi toksičnosti morajo potekati skladno s Preglednicami 1, 3, 4 in 5.
English: Number of capsules for each dose (2 doses/day)
Slovenian: Število kapsul za vsak odmerek (2 odmerka/dan)
English: • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Slovenian: • Znano pomanjkanje dihidropirimidin dehidrogenaze (DPD).
English: Patients with renal impairment (see sections 4.2, 4.3, 4.4, and 5.2)
Slovenian: Bolniki z ledvično okvaro (glejte poglavja 4.2, 4.3, 4.4 in 5.2)
English: There were no clinically relevant differences in safety between males (N=382) and females (N=139) in the FLAGS study.
Slovenian: V študiji FLAGS ni bilo klinično pomembnih razlik glede varnosti med moškimi (N = 382) in ženskami (N = 139).
English: In addition, there is post-marketing experience in over 866,000 Asian (mainly Japanese) patients.
Slovenian: Poleg tega se upoštevajo izkušnje z zdravilom po začetku trženja pri več kot 866.000 azijskih (večinoma japonskih) bolnikih.
English: • At the request of the EMA
Slovenian: • na zahtevo Evropske agencije za zdravila;
English: 126 capsules
Slovenian: 126 kapsul
English: Teysuno capsules are usually taken for 21 days followed by a 7 day rest period (when no capsules are taken).
Slovenian: Teysuno kapsule se običajno jemljejo 21 dni, ki jim sledi 7-dnevni odmor (takrat se kapsule ne jemljejo).
English: Adjustments during treatment
Slovenian: Prilagoditve med zdravljenjem
English: Refer to “Dose modifications for special populations / Renal impairment for guidance.”
Slovenian: Za smernice si oglejte “Spremembe odmerkov za posebne populacije/Ledvična okvara”.
English: American Indian or Alaska Native Other
Slovenian: Ameriški Indijanci ali domorodci Aljaske
English: CYP2A6 inhibitors
Slovenian: Inhibitorji CYP2A6
English: Table 8: Demographics and baseline characteristics of patients in the FLAGS study
Slovenian: Preglednica 8: Demografske in izhodiščne značilnosti bolnikov v študiji FLAGS
English: - Weakness and fatigue, which could be side effects caused by other medicines.
Slovenian: - Oslabelost in utrujenost, ki sta lahko neželena učinka, povzročena z drugimi zdravili.
English: Millmount Healthcare Limited Block7, City North Business Campus, Stamullen Co. Meath, K32 YD60 Ireland
Slovenian: Millmount Healthcare Limited Block7, City North Business Campus, Stamullen Co. Meath, K32 YD60 Irska
English: In this study, antitumor activity was measured by best overall tumour response.
Slovenian: V tej študiji se je protitumorska učinkovitost merila z najboljšim skupnim odzivom tumorja.
English: Elderly (see section 4.2)
Slovenian: Starejši (glejte poglavje 4.2)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 March 2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 14. marec 2011 Datum zadnjega podaljšanja: 19. november 2015
English: Each term is presented in its most common category only and within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Vsak izraz je prikazan samo v kategoriji, ki je zanj najbolj značilna; znotraj vsake skupine pogostnosti pa so neželeni učinki navedeni po padajoči resnosti.
English: See also section “Do not take Teysuno”.
Slovenian: Glejte tudi poglavje “Ne jemljite zdravila Teysuno ”.
English: The majority (70.4%) of patients had Stable Disease as a best response (based on Investigator's assessment using RECIST criteria) and 29.6% patients had Progressive Disease as their best overall response.
Slovenian: Pri večini (70,4 %) bolnikov je bil najboljši odziv stabilna bolezen (glede na oceno raziskovalca z merili RECIST), pri 29,6 % bolnikov pa je bil najboljši skupni odziv napredujoča bolezen.
English: Table 7: Adverse reactions reported by decreasing seriousness in each frequency grouping
Slovenian: Preglednica 7: Neželeni učinki, navedeni po padajoči resnosti znotraj vsake skupine pogostnosti
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC53.
Slovenian: Farmakoterapevtska skupina: antineoplastična zdravila, antimetaboliti, oznaka ATC: L01BC53.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
English: 6.6 Special precautions for disposal and other handling Hands should be washed after handling capsules.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Po uporabi kapsul si je treba umiti roke.
English: If Grade 2 (or higher) dehydration occurs, treatment should be immediately suspended and the dehydration corrected.
Slovenian: Če nastopi dehidracija stopnje 2 (ali višje stopnje), je treba takoj ukiniti zdravljenje in popraviti dehidracijo.
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
Slovenian: PRILOGA II A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Trde kapsule.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Nordic Group B.V., Siriusdreef 41, 2132 WT Hoofddorp, The Netherlands 12.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Nordic Group B.V., Siriusdreef 41, 2132 WT Hoofddorp, Nizozemska
English: Once the Teysuno dose has been reduced, it should not be increased again.
Slovenian: Po tem, ko se odmerek zdravila Teysuno zmanjša, se odmerek ne sme več povečati.
English: This CYP2A6*4 allele is uncommon in the Caucasian population.
Slovenian: Alel CYP2A6*4 je v kavkaški populaciji neobičajen.
English: Teysuno should only be given on Days 1 to 21 of each cycle, i.e., treatment should not be given on Days 22 to 28 of a cycle.
Slovenian: Zdravilo Teysuno se lahko jemlje samo od 1. do 21. dneva v posameznem ciklu, to pomeni, da se zdravljenje ne sme izvajati od 22. do 28. dneva v ciklu.
English: Dehydration and any associated electrolyte disturbances should be prevented or corrected at onset.
Slovenian: Dehidracijo in kakor koli povezane elektrolitske motnje je treba preprečiti ali popraviti takoj na začetku.
English: - Loss of apetite (anorexia) can lead to weight loss and dehydration o You may become dehydrated if you do not eat and/or drink enough water.
Slovenian: Izguba apetita (anoreksija) lahko povzroči zmanjšanje telesne mase in dehidracijo o Če ne jeste in/ali ne pijete dovolj vode, lahko postanete dehidrirani.
English: Dehydration should be managed aggressively with rehydration and other appropriate measures.
Slovenian: Na dehidracijo se je treba odzvati aktivno, in sicer z rehidracijo in drugimi ustreznimi ukrepi.
English: o To prevent bleeding, avoid hard work or strenuous sports so as to prevent injuries and bruises.
Slovenian: o Če želite preprečiti krvavitev, se izogibajte težkemu delu ali napornim športom, tako da boste preprečili poškodbe in modrice.
English: Patients should be provided with outpatient prescriptions for anti-emetic and anti-diarrhoeal medicinal products.
Slovenian: Bolniki morajo prejeti recepte za antiemetična in antidiaroična zdravila.
English: Do not take the missed dose at all and do not take a double dose to make up for a forgotten dose.
Slovenian: Ne zaužijte izpuščenega odmerka in ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: If both medicinal products are considered to be causing the toxicity or it is not possible to distinguish them, then dose reduction should be performed for both according to the recommended dose reduction schedule.
Slovenian: Če se ugotovi, da obe zdravili povzročata toksičnost, ali če ju ni mogoče razločevati, potem se odmerek zmanjša za obe zdravili v skladu s priporočenim načrtom za zmanjšanje odmerka.
English: This leaflet was last revisedin
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: Table 9: Overall survival and progression-free survival in FLAGS
Slovenian: Preglednica 9: Celokupno preživetje in preživetje brez napredovanja bolezni v študiji FLAGS
English: DPD inducers
Slovenian: Induktorji DPD
English: If phenytoin toxicity develops, appropriate measures should be taken.
Slovenian: Če nastopi fenitoinska toksičnost, je treba sprejeti ustrezne ukrepe.
English: Treatment days missed in a cycle where medicinal product was held due to toxicity should not be replaced.
Slovenian: Izgubljeni dnevi v ciklu zdravljenja, na katere je bilo zdravilo zadržano zaradi toksičnosti, se ne nadomestijo.
English: Instead, continue your regular dosing schedule and check with your doctor.
Slovenian: Nadaljujte z rednim urnikom jemanja in se posvetujte s svojim zdravnikom.
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.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da izpostavljenost za 5-FU prav tako narašča z leti, toda obseg povečanja je bil v okviru individualne variabilnosti.
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.
Slovenian: o Med obroki pijte veliko tekočine, da nadomestite izgubljeno tekočino in da preprečite dehidracijo, znižanje volumna krvi in neravnovesje soli ali kemičnih snovi v krvi.
English: o To prevent infection, keep away from crowded places, gargle upon returning home, and wash your hands before meals and before and after using the bathroom.
Slovenian: o Če želite preprečiti okužbo, se izogibajte množicam, ob prihodu domov grgrajte tekočino, pred obroki ter pred in po uporabi stranišča pa si umivajte roke.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA < PC:
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC:
English: Total daily dose in mga
Slovenian: Skupni dnevni odmerek v mga
English: Also, you need to be particularly careful if you are taking any of the following: - other fluoropyrimidine based medicines such as the anti-fungal flucytosine.
Slovenian: Posebej pazljivi morate biti, če jemljete: - druga zdravila na osnovi fluoropirimidinov, kot je antimikotik flucitozin.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: → 15a and/or
Slovenian: → 15a in/ali
English: Oteracil AUC0-12 in the Asian group was approximately half that of the Caucasian group, however, this difference was not statistically significant due to its large individual variability.
Slovenian: Vrednost AUC0-12 za oteracil v azijski skupini je približno ustrezala polovici primerljive vrednosti v kavkaški skupini, vendar ta razlika zaradi velike individualne variabilnosti ni bila statistično značilna.
English: 20 mg capsulea (white)
Slovenian: 20 mg kapsulaa (bela)
English: • History of severe and unexpected reactions to fluoropyrimidine therapy.
Slovenian: • Hude ali nepričakovane reakcije na zdravljenje s fluoropirimidinom v preteklosti.
English: These changes with age were related to changes in renal function as measured by creatinine clearance (see section 5.2).
Slovenian: Te spremembe, ki nastopijo z leti, so bile povezane s spremembami v ledvični funkciji, izmerjenimi z vrednostjo očistka kreatinina (glejte poglavje 5.2).
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.
Slovenian: Posledično obstaja veliko tveganje za razvojno toksičnost pri kliničnih odmerkih, predvsem zaradi tegafurja (5-FU), v manjši meri pa zaradi oteracila.
English: Toxicity due to Teysuno administration should be managed with symptomatic treatment and/or treatment interruption or dose reduction.
Slovenian: Toksičnost zaradi uporabe zdravila Teysuno se obvladuje s simptomatskim zdravljenjem in/ali prekinitvijo zdravljenja ali zmanjšanjem odmerka.
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.
Slovenian: S sočasno uporabo inhibitorja protonske črpalke (PPI) se je zmanjšal vpliv hrane na farmakokinetični profil za oteracil, toda ne dovolj, da bi se vpliv hrane v celoti nevtraliziral.
English: Exposure of 5-FU was not statistically significantly different between the two groups.
Slovenian: Pri izpostavljenosti za 5-FU niso opazili statistično značilnih razlik med skupinama.
English: Gastro-oesophageal junction Both
Slovenian: Gastroezofagealna junkcija Oboje
English: The overall safety profile of Teysuno in combination with cisplatin is based primarily on clinical study data from 593 patients with advanced gastric cancer treated with this regimen.
Slovenian: Celotni varnostni profil zdravila Teysuno v kombinaciji s cisplatinom temelji predvsem na podatkih iz kliničnih študij o 593 bolnikih z napredovalim rakom želodca ob upoštevanju te sheme.
English: The highest single dose of Teysuno taken was 1400 mg; this patient developed leukopenia (Grade 3).
Slovenian: Največji enkratni odmerek zdravila Teysuno je bil 1400 mg; pri tem bolniku se je pojavila levkopenija (stopnja 3).
English: In addition, 5-fluorouridine-triphosphate (FUTP) is incorporated into RNA causing disruption of RNA functions.
Slovenian: Poleg tega je 5-fluorouridin-trifosfat (FUTP) vgrajen v RNA, kar povzroča motnje delovanja RNA.
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.
Slovenian: Incidenca neželenih učinkov bolezni krvi in limfatičnega sistema, ki so jih opazili v vseh ciklih pri bolnikih z zmerno in hudo ledvično okvaro, je bila 28,6- oziroma 44,4-odstotna.
English: Patients with low platelet counts are at increased risk for bleeding and should be monitored carefully.
Slovenian: Pri bolnikih z majhnim številom trombocitov je nevarnost krvavitve povečana, zato jih je treba skrbno spremljati.
English: 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.
Slovenian: Študija o vplivu zdravila Teysuno na repolarizacijo srca, izvedena pri bolnikih z napredovalim rakom, ustreza opredelitvi negativne študije v skladu s smernicami Mednarodne konference o usklajevanju (ICH).
English: Metastatic disease, n (%) ≥2 metastatic sites
Slovenian: Metastatska bolezen, n (%) 2 ali več metastatskih mest
English: Dose modifications for special populations
Slovenian: Spremembe odmerkov za posebne populacije
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Teysuno za vse podskupine pediatrične populacije z adenokarcinomom želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Based on non-clinical data, allopurinol may decrease anti-tumour activity due to suppression of phosphorylation of 5-FU.
Slovenian: Na osnovi nekliničnih podatkov lahko alopurinol zmanjša protitumorsko delovanje zaradi zaviranja fosforilacije 5-FU.
English: The most common treatment-related ocular disorders among patients in studies in Europe/United States of America (EU/USA) treated with Teysuno in combination with cisplatin were lacrimal disorders (8.8%), including increased lacrimation, dry eye, and acquired dacryostenosis (see section 4.8).
Slovenian: Najpogostejše očesne motnje, povezane z zdravljenjem, pri bolnikih, ki so bili vključeni v študije v Evropi/Združenih državah Amerike (EU/ZDA) in zdravljeni z zdravilom Teysuno v kombinaciji s cisplatinom, so bile lakrimalne motnje (8,8 %), vključno s povečanim solzenjem, suhimi očmi in pridobljeno dakriostenozo (glejte poglavje 4.8).
English: 42 capsules
Slovenian: 42 kapsul
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.
Slovenian: Ob stalno manjši aktivnosti encima CYP2A6 pri azijskih bolnikih je bila vrednost AUC0-12 za tegafur višja, čas t1/2 pa daljši v azijski skupini v primerjavi s kavkaško skupino.
English: The 5-FU pharmacokinetic profile was similar in the presence and absence of oteracil.
Slovenian: Farmakokinetični profil za 5-FU je bil v prisotnosti in odsotnosti oteracila podoben.
English: To detect early changes in renal function during treatment, renal parameters should be closely monitored (e.g., serum creatinine, CrCl).
Slovenian: Zaradi zgodnjega zaznavanja sprememb v ledvični funkciji med zdravljenjem je treba pozorno spremljati ledvične parametre (npr. kreatinin v serumu, CrCl).