FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Lijek Efient uzima se s aspirinom kako bi se spriječili aterotrombotski poremećaji (problemi uzrokovani krvnim ugrušcima i otvrdnućem arterija) u bolesnika s akutnim koronarnim sindromom koji su podvrgnuti perkutanoj koronarnoj intervenciji.
English: Prasugrel stops the platelets aggregating by blocking a substance called ADP from binding to a receptor on their surface.
Croatian: Prasugrel sprječava nakupljanje trombocita tako što inhibira tvar naziva ADP od vezivanja na posebne receptore na površini.
English: What is Efient used for?
Croatian: Za što se Efient koristi?
English: What benefit has Efient shown during the studies?
Croatian: Koje su koristi lijeka Efient utvrđene u ispitivanjima?
English: How is Efient used?
Croatian: Kako se Efient koristi?
English: The active substance in Efient, prasugrel, is an inhibitor of platelet aggregation.
Croatian: Djelatna tvar lijeka Efient, prasugrel, jest inhibitor nakupljanja trombcita.
English: For the full list of all side effects reported with Efient, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Efient potražite u uputi o lijeku.
English: Percutaneous coronary intervention is a procedure used to unblock the blood vessels supplying the heart.
Croatian: Perkutana koronarna intervencija postupak je kojim se ponovno uspostavlja nesmetana cirkulacija krvi u krvnim žilama koje srce opskrbljuju krvlju.
English: How has Efient been studied?
Croatian: Kako je Efient ispitivan?
English: When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Croatian: Krv se gruša zbog nakupljanja (povezivanja) posebnih stanica u krvi naziva trombociti.
English: How does Efient work?
Croatian: Kako djeluje Efient?
English: These changes were reversible.
Croatian: Ove su promjene bile reverzibilne.
English: Genetic counseling should be considered.
Croatian: Treba razmotriti genetičko savjetovanje.
English: Wear loose clothing to protect the skin.
Croatian: Nosite meku odjeću da zaštitite kožu.
English: Even if you do not feel hungry, continue to eat as much as you can to maintain good nutrition.
Croatian: Čak i ako ne osjećate glad, nastavite jesti što više možete da biste održali dobru uhranjenost.
English: The cycles are repeated.
Croatian: Ciklusi se ponavljaju.
English: You should check with your doctor if you are not sure.
Croatian: Provjerite sa svojim liječnikom ako niste sigurni.
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.
Croatian: Liječnik će Vam odrediti koju dozu trebate uzeti, kada ćete je uzeti i koliko dugo je trebate uzimati.
English: Brush your teeth and blow your nose gently.
Croatian: Lagano četkajte zube i blago pušite nos.
English: No dose advice for this subpopulation can be provided.
Croatian: Ne može se dati preporuka doziranja za tu subpopulaciju.
English: Rare / Very rare
Croatian: Rijetko/vrlo rijetko
English: Microsatellite instability (MSI)
Croatian: Mikrosatelitna nestabilnost (MSI)
English: Teysuno must be taken twice daily (morning and evening).
Croatian: Teysuno morate uzimati dva puta na dan (ujutro i navečer).
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitate cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: Studies in animals have shown reproductive toxicity.
Croatian: Ispitivanja na životinjama su pokazala reproduktivnu toksičnost.
English: This treatment cycle is repeated every 4 weeks.
Croatian: Ovaj se ciklus liječenja ponavlja svaka 4 tjedna.
English: Instead, continue your regular dosing schedule and check with your doctor.
Croatian: Umjesto toga, nastavite s redovnim rasporedom doziranja i provjerite s Vašim liječnikom.
English: Patient characteristics are provided in Table 8.
Croatian: Karakteristike bolesnika su prikazane u Tablici 8.
English: There were no clinically relevant differences in safety between males (N=382) and females (N=139) in the FLAGS study.
Croatian: Nije bilo klinički relevantnih razlika u sigurnosti primjene između muškaraca (N=382) i žena (N=139) u FLAGS studiji.
English: At the time of primary analysis, the median follow-up for overall survival in the full analysis set was 18.3 months.
Croatian: U vrijeme primarne analize, medijan praćenja za ukupno preživljenje u ukupnom setu analiza iznosio je 18,3 mjeseca.
English: Total daily dose in mga
Croatian: Ukupna dnevna doza u mga
English: Always take Teysuno exactly as your doctor has told you.
Croatian: Uvijek uzmite Teysuno točno onako kako Vam je rekao Vaš liječnik.
English: 3741 LM Baarn The Netherlands
Croatian: 3741 LM Baarn Nizozemska
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA < PC:
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC:
English: Each dose reduction results in approximately 20-25% reduction of dose.
Croatian: Svako smanjenje doze iznosi otprilike 20-25%.
English: Number of capsules for each dose (2 doses/day)
Croatian: Broj kapsula za svaku dozu (2 doze/dan)
English: What is teysuno and what is it used for
Croatian: Što je Teysuno i za što se koristi
English: - This medicine has been prescribed for you.
Croatian: - Ovaj lijek je propisan samo Vama.
English: This 28 day period is one treatment cycle.
Croatian: Ovaj 28-dnevni period predstavlja 1 ciklus liječenja.
English: Your doctor will discuss this with you and will explain the possible risks and benefits of the treatment.
Croatian: Liječnik će razgovarati s Vama i objasniti Vam moguće rizike i koristi liječenja.
English: Grade 2b,c Any occurrence
Croatian: Stupanj 2b,c Pojava bilo kojeg štetnog događaja
English: Table 9: Overall survival and progression-free survival in FLAGS
Croatian: Tablica 9: Ukupno preživljenje i preživljenje bez progresije u FLAGS studiji
English: DPD inducers
Croatian: DPD induktori
English: Exposure of 5-FU was not statistically significantly different between the two groups.
Croatian: Izloženost 5-FU-u nije bila statistički značajno različita između te dvije skupine.
English: Avoid fatty and strong-smelling food.
Croatian: Izbjegavajte masnu i hranu jakog mirisa.
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.
Croatian: - Gubitak apetita (anoreksija) što dovodi do gubitka tjelesne težine i dehidracije ᴑ Možete dehidrirati ako ne jedete i/ili ne pijete dovoljno vode.
English: See also section “Do not take Teysuno”.
Croatian: Pogledajte i dio „Nemojte uzimati Teysuno“.
English: Teysuno capsules are usually taken for 21 days followed by a 7 day rest period (when no capsules are taken).
Croatian: Teysuno kapsule se obično uzimaju tijekom 21 dana, nakon čega slijedi 7 dana odmora (kada se kapsule ne uzimaju).
English: Similar inhibition was seen following single and multiple dosing.
Croatian: Uočena je slična inhibicija i nakon jednostrukog i nakon višestrukog doziranja.
English: There is no known antidote available in case of overdose.
Croatian: Nema poznatih dostupnih antidota za slučaj predoziranja.
English: • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Croatian: • Poznati nedostatak dihidropirimidin dehidrogenaze (DPD).
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.
Croatian: Svaki je termin predstavljen samo u svojoj zajedničkoj kategoriji, a unutar svake grupe učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed in adult or paediatric patients.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja interakcija u odraslih niti pedijatrijskih bolesnika.
English: What Teysuno looks like and contents of the pack
Croatian: Kako Teysuno izgleda i sadržaj pakiranja
English: Eighteen additional PK studies were performed using the relevant regimen as monotherapy.
Croatian: Dodatno je provedeno 18 PK ispitivanja koristeći relevantni režim kao monoterapiju.
English: CYP2A6 inhibitors
Croatian: Inhibitori CYP2A6
English: Medical management of overdose should include customary therapeutic and supportive medical interventions aimed at correcting the presenting clinical manifestations and preventing their possible complications.
Croatian: Medicinsko zbrinjavanje kod predoziranja treba uključiti uobičajene terapijske i suportivne medicinske intervencije usmjerene na ispravljanje prisutnih kliničkih manifestacija i sprječavanje njihovih mogućih komplikacija.
English: Like all medicines, Teysuno can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Teysuno može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Only a small amount of oteracil is metabolised in the liver because of its low permeability.
Croatian: Samo se mala količina oteracila metabolizira u jetri zbog njene slabe permeabilnosti.
English: o To prevent bleeding, avoid hard work or strenuous sports so as to prevent injuries and bruises.
Croatian: ᴑ Za sprječavanje krvarenja, izbjegavajte težak rad ili naporan sport kako bi se spriječile ozljede i modrice.
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.
Croatian: Glavnina bolesnika (70,4 %) imala je stabilnu bolest kao najbolji odgovor (bazirano na ocjeni ispitivača korištenjem RECIST kriterija) a 29,6 % bolesnika imalo je progresiju bolesti kao najbolji ukupni odgovor.
English: Your dose of Teysuno will be determined by your doctor based on your height and weight.
Croatian: Dozu lijeka Teysuno će Vam odrediti liječnik ovisno o Vašoj visini i težini.
English: If you become pregnant during this time, you must tell your doctor.
Croatian: Ako zatrudnite tijekom tog vremena, o tome morate obavijestiti svog liječnika.
English: The dose should be modified as recommended in section 4.2.
Croatian: Potrebno je prilagoditi dozu kao što je preporučeno u dijelu 4.2).
English: If phenytoin toxicity develops, appropriate measures should be taken.
Croatian: Ako se razvije toksičnost fenitoina, potrebno je poduzeti odgovarajuće mjere.
English: 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.
Croatian: Prije početka liječenja morate obavijestiti Vašeg liječnika ili ljekarnika ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: How to store Teysuno - Keep out of the sight and reach of children.
Croatian: Kako čuvati Teysuno - Lijek čuvajte izvan pogleda i dohvata djece.
English: Different MedDRA preferred terms that were considered clinically similar have been grouped into a single term.
Croatian: Različiti MedDRA izrazi koji se smatraju klinički sličnima, grupirani su u pojedinačni termin.
English: Teysuno with food and drink Teysuno should be taken at least one hour before or one hour after a meal.
Croatian: Teysuno s hranom i pićem Teysuno treba uzimati najmanje jedan sat prije ili jedan sat nakon obroka.
English: Dehydration should be managed aggressively with rehydration and other appropriate measures.
Croatian: Dehidraciju treba agresivno kontrolirati rehidracijom i drugim odgovarajućim mjerama.
English: 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.
Croatian: Zato se razlike u polimorfizmu CYP2A6 između azijske i zapadne populacije ne smatraju ključnim odlučujućim faktorom za razlike u MTD-u između populacija.
English: Other medicines and Teysuno Tell your doctor if you are taking , have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Teysuno Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Folinate/folinic acid
Croatian: Folinat/folinatna kiselina
English: In addition, there is post-marketing experience in over 866,000 Asian (mainly Japanese) patients.
Croatian: Dodatno postoji postmarketinško iskustvo na preko 866 000 azijskih bolesnika (pretežno Japanaca).
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Posavjetujte se sa svojim liječnikom ili ljekarnikom prije nego uzmete bilo koji lijek.
English: In this study, antitumor activity was measured by best overall tumour response.
Croatian: U toj je studiji antitumorska aktivnost mjerena najboljim tumorskim odgovorima.
English: Fatal cases have been reported following capecitabine interaction.
Croatian: Prijavljeni su smrtni slučajevi nakon nastupa interakcije s kapecitabinom.
English: During a treatment cycle, dose adjustment should be performed for each individual medicinal product that is considered to be causally related to the toxicity, if such a distinction can be made.
Croatian: Tijekom ciklusa liječenja, prilagodbu doze treba provoditi za svaki pojedini lijek koji se smatra uzrokom toksičnosti, ako je takva distinkcija moguća.
English: • At the request of the EMA
Croatian: • na zahtjev Europske agencije za lijekove;
English: Nitroimidazoles, including metronidazole and misonidazole
Croatian: Nitroimidazoli uključujući metronidazol i misonidazol
English: Lactose (one type of sugar).
Croatian: Teysuno sadrži laktozu (jednu vrstu šećera).
English: The only Grade 3 or higher adverse reaction was reduced visual acuity.
Croatian: Jedina nuspojava stupnja 3 ili višeg bilo je smanjenje oštrine vida.
English: Do not take the missed dose at all and do not take a double dose to make up for a forgotten dose.
Croatian: Uopće ne uzimajte propuštenu dozu i nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Treatment should not be resumed until dehydration and its underlying causes are corrected or adequately controlled.
Croatian: Liječenje ne treba nastaviti sve dok se dehidracija i njeni uzroci ne isprave ili adekvatno kontroliraju.
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC53.
Croatian: Farmakoterapijska skupina: antineoplastične tvari, antimetaboliti, ATK oznaka: L01BC53.
English: PCTFE/PVC/Al opaque blisters containing 14 capsules each.
Croatian: PCTFE/PVC/Al neprozirni blisteri od kojih svaki sadrži 14 kapsula.
English: What Teysuno is and what it is used for What you need to know before you take Teysuno How to take Teysuno
Croatian: Što je Teysuno i za što se koristi Što morate znati prije nego počnete uzimati Teysuno Kako uzimati Teysuno
English: The 5-FU pharmacokinetic profile was similar in the presence and absence of oteracil.
Croatian: Farmakokinetički profil 5-FU-a je bio sličan u prisustvu i odsustvu oteracila.
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.
Croatian: ᴑ Za sprječavanje infekcije, držite se podalje od mjesta gdje je puno ljudi, ispirite grlo kad dođete kući i perite ruke prije jela kao i prije i nakon korištenja nužnika.
English: - Weakness and fatigue, which could be side effects caused by other medicines.
Croatian: - Slabost i umor, što mogu biti nuspojave izazvane drugim lijekovima.
English: 20 mg capsulea (white)
Croatian: 20 mg kapsulea (bijele)
English: Patients with rare hereditory problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabasorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim problemom nepodošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcije glukoze/galaktoze ne bi smjeli uzimati ovaj lijek.
English: There have been some case reports of foetal abnormalities.
Croatian: Bilo je nekih prikaza slučajeva abnormalnosti fetusa.
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.
Croatian: Također, trebate biti posebno pažljivi ako uzimate neki od sljedećih lijekova: - drugi lijek na bazi fluporopirimidina kao što je antimikotik flucitozin.
English: Dose modifications for toxicity should be made according to Tables 1, 3, 4, and 5.
Croatian: Prilagodbu doze zbog toksičnosti treba provesti u skladu s podacima u Tablicama 1, 3, 4 i 5.
English: The highest single dose of Teysuno taken was 1400 mg; this patient developed leukopenia (Grade 3).
Croatian: Najveća primijenjena pojedinačna doza lijeka Teysuno je bila 1400 mg; bolesnik je razvio leukopeniju (stupnja 3).
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.
Croatian: Ako se oba lijeka smatraju uzrokom toksičnosti ili ako nije moguće razlučiti koji od njih jest, treba smanjiti doze oba lijeka u skladu s preporučenim rasporedom smanjenja doze.
English: All studies were performed in cancer patients.
Croatian: Sva su ispitivanja provedena na bolesnicima oboljelim od raka.
English: If Grade 2 (or higher) dehydration occurs, treatment should be immediately suspended and the dehydration corrected.
Croatian: Ako dehidracija dosegne stupanj 2 (ili viši) liječenje treba odmah prekinuti i dehidraciju ispraviti.
English: The following headings are used to rank the adverse reactions by frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Croatian: Korištene su sljedeće odrednice u procjeni učestalosti nuspojava: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
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.
Croatian: AUC0-12 oteracila u skupini Azijata iznosila je otprilike polovinu AUC0-12 u skupini bijelaca, no ta razlika nije bila statistički značajna zbog velike individualne varijabilnosti.
English: • History of severe and unexpected reactions to fluoropyrimidine therapy.
Croatian: • Anamneza teških i neočekivanih reakcija na liječenje fluoropirimidinom.
English: 126 capsules
Croatian: 126 kapsula
English: While some symptoms are easily identified as side effects by the patients themselves, a blood test is required to identify some other symptoms.
Croatian: Dok neke znakove bolesti bolesnici i sami lako prepoznaju kao nuspojave, kako bi se utvrdili ostali simptomi potrebne su krvne pretrage.
English: Metastatic disease, n (%) ≥2 metastatic sites
Croatian: Metastatska bolest, n (%) ≥ 2 metastatska sijela
English: Contraceptive measures must be taken by both male and female patients during and up to 6 months after stopping treatment with Teysuno.
Croatian: Potrebno je poduzeti kontraceptivne mjere i u muških i u ženskih bolesnika tijekom i do 6 mjeseci nakon prestanka liječenja lijekom Teysuno.
English: You must not take Teysuno if you are pregnant or think you might be.
Croatian: Ne smijete uzimati Teysuno ako ste trudni ili mislite da biste mogli biti trudni.
English: 30 to 49 ml/min Start treatment at one reduced dose level
Croatian: 30 do 49 ml/min Početak liječenja dozom smanjenom za jednu razinu
English: Median [95% CI], months
Croatian: N Medijan [95%CI], mjeseci
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsules
Croatian: OBLIK I SADRŽAJ Tvrde kapsule
English: You must not breastfeed if you are taking Teysuno.
Croatian: Ne smijete dojiti ako uzimate Teysuno.
English: Once the Teysuno dose has been reduced, it should not be increased again.
Croatian: Jednom smanjenu dozu lijeka Teysuno, ne treba ponovno povećavati.
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.
Croatian: Cjelokupni profil sigurnosti lijeka Teysuno u kombinaciji s cisplatinom prvenstveno je baziran na podacima iz kliničkih studija provedenih na 593 bolesnika s uznapredovalim karcinomom želuca liječenih ovim režimom.
English: If you experience any of the side effects or if you notice any side effects not listed in this leaflet, please tell your doctor.
Croatian: Ako primijetite bilo koju nuspojavu ili ako primijetite bilo koju nuspojavu koja nije navedena u ovoj uputi, obavijestite svog liječnika.
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.
Croatian: Teysuno treba davati samo od 1. do 21. dana svakog ciklusa, tj. liječenje se ne provodi od 22. do 28.
English: Dose modifications for special populations
Croatian: Prilagodbe doze za posebne populacije
English: However, limited data available on CYP2A6*4/*4 genotype in Japanese patients treated with Teysuno suggest significantly decreased 5-FU levels in this subpopulation.
Croatian: Međutim, dostupni ograničeni podaci za CYP2A6*4/*4 genotip u japanskih bolesnika liječenih lijekom Teysuno, sugeriraju značajni pad razina 5-FU-a u toj subpopulaciji.
English: However, the increase in 5-FU exposure tended to be greater than proportional to the increasing tegafur dose.
Croatian: Međutim, povećanje izloženosti 5-FU-u bilo je veće od proporcionalnog povećanju doze tegafura.
English: For the primary endpoint of overall survival, Teysuno in combination with cisplatin was non-inferior to 5-FU in combination with cisplatin (see Table 9).
Croatian: Za primarni ishod ukupnog preživljenja, Teysuno u kombinaciji s cisplatinom nije bio inferioran u odnosu na 5-FU u kombinaciji s cisplatinom (vidjeti Tablicu 9).
English: Despite the lack of DLTs in the last cohort, the dose of cisplatin was not elevated beyond 75 mg/m2.
Croatian: u posljednjoj kohorti, doza cisplatina nije se povećavala iznad 75 mg/m2.
English: 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)
Croatian: Ukupno preživljenje Intent-to-treat Puni set analiza Preživljenje bez progresije Puni set analiza CI = interval pouzdanosti; Puni set analiza = svi randomizirani, liječeni bolesnici analizirani kako je naznačeno (primarno analizirana populacija)
English: 6.6 Special precautions for disposal and other handling Hands should be washed after handling capsules.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Nakon rukovanja kapsulama treba oprati ruke.
English: Treatment with brivudine can be started 24 hours after the last dose of Teysuno.
Croatian: Liječenje brivudinom može se započeti 24 sata nakon posljednje doze lijeka Teysuno.
English: Patients with renal impairment (see sections 4.2, 4.3, 4.4, and 5.2)
Croatian: Bolesnici s oštećenjem bubrega (vidjeti dijelove 4.2, 4.3, 4.4 i 5.2)
English: See Table 2 for the details of the number of Teysuno capsules to be administered for each dose level.
Croatian: U Tablici 2 detaljno je vidljiv broj Teysuno kapsula koje se primjenjuju za svaku razinu doze.