natgillin/translations-raw huggingface dataset:
Patients 65 years of age or older who received Lonsurf had a higher incidence of the following events compared to patients younger than 65 years: - metastatic colorectal cancer (RECOURSE): Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anaemia (26% vs 12%), Grade 3 or 4 leukopenia (26% vs 18%) and Grade 3 or 4 thrombocytopenia (9% vs 2%), - metastatic gastric cancer (TAGS): Grade 3 or 4 neutrophil count decrease (17.0% vs 6.6%), decreased appetite (37.3% vs 31.9%), asthenia (22.2% vs 17.0%) and stomatitis (7.2% vs 2.2%).
U usporedbi s bolesnicima mlađim od 65 godina, bolesnici stari 65 godina ili stariji koji su uzimali Lonsurf imali su veću incidenciju sljedećih nuspojava: - metastatski kolorektalni karcinom (ispitivanje RECOURSE): neutropenija 3. ili 4. stupnja (48% naspram 30%), anemija 3. stupnja (26% naspram 12%), leukopenija 3. ili 4. stupnja (26% naspram 18%) i trombocitopenija 3. ili 4. stupnja (9% naspram 2%), - metastatski karcinom želuca (ispitivanje TAGS): smanjenje broja neutrofila 3. ili 4. stupnja (17,0% naspram 6,6%), smanjenje apetita (37,3% naspram 31,9%), astenija (22,2% naspram 17,0%) i stomatitis (7,2% naspram 2,2%).
The Lonsurf survival benefit was maintained after adjusting for all significant prognostic factors, namely, time since diagnosis of first metastasis, ECOG PS and number of metastatic sites (hazard ratio: 0.69; 95% CI [0.58 to 0.81]).
Korist u smislu preživljenja uz primjenu Lonsurfa je održana i nakon prilagodbe za sve prognostički značajne čimbenike, i to vrijeme od dijagnoze prve metastaze, ECOG PS i broj metastatskih sijela (omjer hazarda 0,69; 95% CI [0,58 do 0,81]).
The signs include shortness of breath and pain in the chest or in the legs.
Znaci uključuju nedostatak zraka i bolove u prsištu ili nogama.
Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
Lonsurf je indiciran kao monoterapija za liječenje odraslih bolesnika s metastatskim kolorektalnim karcinomom (KRK) koji su prethodno liječeni, ili se ne smatraju kandidatima za liječenje dostupnim terapijama, uključujući kemoterapije koje se zasnivaju na fluoropirimidinu, oksaliplatinu i irinotekanu,
• cough, feeling short of breath, infection of the sinuses, throat, airway or lungs, chest infections
• kašalj, osjećaj nedostatka zraka, infekcija sinusa, grla, dišnih putova ili pluća, infekcije prsnog koša
• If you forget a dose, talk to your doctor or pharmacist.
• Ako ste zaboravili uzeti dozu, obratite se svom liječniku ili ljekarniku.
There was a slightly higher incidence of overall haematological and myelosuppression-related adverse reactions for patients who received prior radiotherapy compared to patients without prior radiotherapy in RECOURSE (54.6% versus 49.2%, respectively), of note febrile neutropenia was higher in Lonsurf-treated patients who received prior radiotherapy vs. those that did not.
U kliničkom ispitivanju RECOURSE zabilježeno je blago povećana incidencija hematoloških i mijelosupresivnih nuspojava u bolesnika koji su prethodno liječeni radioterapijom u usporedbi s bolesnicima koji nisu prethodno liječeni radioterapijom (54,6% u usporedbi s 49,2%), a incidencija značajnih febrilnih neutropenija veća je u bolesnika koji su uzimali Lonsurf nakon radioterapije u usporedbi s onima koji nisu bili podvrgnuti radioterapiji.
Patients with nausea, vomiting, diarrhoea and other gastrointestinal toxicities should be carefully monitored, and anti-emetic, anti-diarrhoeal and other measures, such as fluid/electrolyte replacement therapy, should be administered as clinically indicated.
Bolesnici s mučninom, povraćanjem, proljevom i ostalim gastrointestinalnim toksičnim reakcijama trebaju se pažljivo pratiti te se trebaju poduzeti potrebne mjere u slučaju kliničke indikacije kao što su primjena antiemetika, antidijaroika i drugih mjera kao što su nadoknada tekućine/elektrolita.
All patients received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Svi bolesnici su ranije primili kemoterapiju na bazi fluoropirimidina, oksaliplatine i irinotekana.
Lactose monohydrate Starch, Pregelatinised (Maize) Stearic acid
Škrob, prethodno geliran (kukuruzni) Stearatna kiselina
The OS and PFS benefit was observed consistently, in all randomization strata and across most pre specified subgroups, including sex, age (< 65; ≥ 65 years), ethnic origin, ECOG PS, prior ramucirumab treatment, prior irinotecan treatment, number of prior regimens (2; 3; ≥ 4), previous gastrectomy, primary tumour site (gastric; gastroesophageal junction) and HER2 status.
Korist u smislu OS i PFS je konzistentno zabilježena u svim slojevima randomizacije i u većini prethodno specificiranih podskupina, uključujući spol, starost (< 65; ≥ 65), rasu, ECOG PS, prethodno liječenje ramucirumabom, prethodno liječenje irinotekanom, broj prethodnih ciklusa liječenja (2; 3; ≥ 4), prethodnu gastrektomiju, mjesto primarnog tumora (želudac; gastroezofagealna spojnica) i HER2 status.
The primary efficacy endpoint was overall survival (OS), and supportive efficacy endpoints were progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), time to deterioration of ECOG performance status ≥2 and Quality of Life (QoL).
Primarna mjera ishoda za djelotvornost bilo je ukupno preživljenje (eng. overall survival, OS), a dodatne mjere ishoda za djelotvornost su bili preživljenje bez progresije (eng. progression-free survival, PFS), ukupna stopa odgovora (eng. overall response rate, ORR), stopa kontrole bolesti (eng. disease control rate, DCR), vrijeme do pogoršanja ECOG izvedbenog statusa ≥2 i kvaliteta života (eng. Quality of Life, QoL).
Lonsurf caused an increase in the incidence of myelosuppression including anaemia, neutropenia, leukopenia, and thrombocytopenia.
Lonsurf je uzrokovao povećanu incidenciju mijelosupresije uključujući anemiju, neutropeniju, leukopeniju i trombocitopeniju.
Half-life time (t1/2) and the accumulation ratio of trifluridine and tipiracil hydrochloride were similar between the moderate, mild and normal hepatic function patients.
Poluvijek života (t1/2) i udio akumulacije trifluridina i tipiracilklorida su bili slični kod bolesnika s normalnom funkcijom jetre i kod bolesnika s blagim i umjerenim oštećenjem jetrene funkcije.
Table 7 - Efficacy results from the Phase III (TAGS) clinical trial in patients with metastatic gastric cancer
Table 7 - Rezultati djelotvornosti iz kliničkog ispitivanja faze III (TAGS) u bolesnika s metastatskim karcinomom želuca
In vitro studies indicated that trifluridine, tipiracil hydrochloride and 5-[trifluoromethyl] uracil (FTY) did not inhibit the activity of human cytochrome P450 (CYP) isoforms.
In vitro ispitivanja ukazuju da trifluridin, tipiracilklorid i 5-[trifluorometil] uracil (FTY) ne inhibiraju aktivnost ljudskih izoformi citokroma P450 (CYP).
Palmar-plantar erythrodysaesthesia syndromec
Sindrom palmarno-plantarne eritrodisestezijec Osip
Following the multiple-dose administration of Lonsurf at the recommended dose and regimen, the mean elimination half-life (t1/2) for trifluridine on Day 1 of Cycle 1 and on Day 12 of Cycle 1 were 1.4 hours and 2.1 hours, respectively.
Nakon višekratno primjenjenih doza Lonsurfa u preporučenoj dozi i režimu, srednja vrijednost poluvremena eliminacije (t1/2) trifluridina na 1. dan, 1. ciklusa je bila 1,4 sata, a na 12. dan, 1. ciklusa 2,1 sat.
In vitro studies indicated that trifluridine, tipiracil hydrochloride and FTY (inactive metabolite of trifluridine) did not inhibit the CYP isoforms tested (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5).
In vitro ispitivanja upućuju da ni trifluridin, ni tipiracilklorid niti FTY (neaktivni metabolit trifluridin) ne inhibiraju testirane izoforme CYP (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 i CYP3A4/5).
• sore throat, hoarse voice, problems with your voice
• grlobolja, promuklost glasa, poteškoće s glasom
Colorectal cancer
Kolorektalni karcinom
Each film-coated tablet contains 120.980 mg of lactose monohydrate.
Svaka filmom obložena tableta sadrži 120,980 mg laktoze hidrata.
Lonsurf is used to treat adults with colon or rectal cancer - sometimes called ‘colorectal' cancer and stomach cancer (including cancer of the junction between the oesophagus and the stomach).
Lonsurf se primjenjuje u odraslih bolesnika za liječenje raka debelog ili završnog dijela debelog crijeva (koji se ponekad naziva kolorektalni karcinom) i raka želuca (uključujući rak u spoju između jednjaka i želuca).
Tipiracil hydrochloride is not metabolised in either human liver S9 or cryopreserved hepatocytes.
Tipiracilklorid se ne metabolizira niti u ljudskoj jetri S9 niti smrznutim hepatocitima.
The adverse drug reactions observed from the 533 treated patients with metastatic colorectal cancer in the placebo-controlled Phase III (RECOURSE) clinical trial and the 335 treated patients with metastatic gastric cancer in the placebo-controlled Phase III (TAGS) clinical trial, are shown in Table 5.
Nuspojave prijavljene u 533 liječena bolesnika s metastatskim kolorektalnim karcinomom u placebom kontroliranom kliničkom ispitivanju faze III (RECOURSE) i 335 liječenih bolesnika s metastatskim karcinomom želuca u placebom kontroliranom kliničkom ispitivanju faze III (TAGS) prikazani su u Tablici 5. Razvrstane su prema klasifikaciji organskih sustava (SOC, od engl.
Lonsurf is comprised of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride, at a molar ratio 1:0.5 (weight ratio,
Lonsurf je sastavljen od trifluridina, nukleozidnog analoga koji se zasniva na timidinu a ima antineoplastični učinak, i tipiracilklorida, inhibitora timidin fosforilaze (TPaze), u molarnom omjeru 1:0,5 (maseni omjer 1:0,471).
EU/1/16/1096/001 20 film-coated tablets EU/1/16/1096/002 40 film-coated tablets EU/1/16/1096/003 60 film-coated tablets
EU/1/16/1096/001 20 filmom obloženih tableta EU/1/16/1096/002 40 filmom obloženih tableta EU/1/16/1096/003 60 filmom obloženih tableta
Lonsurf had no clinically relevant effect on QT/QTc prolongation compared with placebo in an open label study in patients with advanced solid tumours.
Lonsurf nije imao klinički relevantan učinak na produljenje QT/QTc intervala u usporedbi s placebom.
Following uptake into cancer cells, trifluridine, is phosphorylated by thymidine kinase, further metabolised in cells to a deoxyribonucleic acid DNA substrate, and incorporated directly into DNA, thereby interfering with DNA function to prevent cell proliferation.
Trifluridin se, nakon ulaska u tumorsku stanicu, fosforilira timidin kinazom, nadalje se metabolizira u stanicama u substrat za sintezu deoksiribonukleinske kiseline (DNA) i ugrađuje se izravno u DNA te na taj način interferira s ulogom DNA kako bi spriječio staničnu proliferaciju.
Photosensitivity reaction Erythema
Reakcije fotoosjetljivosti
Do not use this medicine after the expiry date which is stated on the outer carton or blister tray after “EXP.” The expiry date refers to the last day of that month.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake “EXP.”
Tipiracil hydrochloride was not metabolised in human liver S9 or in cryopreserved human hepatocytes.
Tipiracilklorid se nije metabolizirao u ljudskoj jetri S9 niti u zamrznutim ljudskim hepatocitima.
Single-dose administration of Lonsurf (35 mg/m2/dose) increased the mean AUC0-last of trifluridine by 37-fold and Cmax by 22-fold with reduced variability compared to trifluridine alone (35 mg/m2/dose).
Primjena jedne doze Lonsurfa (35 mg/m2/dozi) povećava srednju vrijednost AUC0-zadnje trifluridina za 37 puta i Cmax za 22 puta sa smanjenom varijabilnošću u usporedbi sa samim trifluridinom (35 mg/m2/dozi).
• a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding and work by clumping and clotting blood vessel injuries
• smanjenje broja trombocita u krvi (trombocitopenija) koji su važni u zaustavljanju krvarenja i koji djeluju tako da se skupljaju i stvaraju ugrušak kod oštećenih krvnih žila.
How to store Lonsurf
Kako čuvati Lonsurf
• redness, itching of the eye, eye infections, watery eyes
• crvenilo, svrbež oka, infekcije oka, suzne oči
Anxiety Insomnia
Anksioznost Nesanica
• Lonsurf 20 mg/8.19 mg is a pale red, biconvex, round, film-coated tablet, printed with “20” on one side and “102” and “20 mg” on the other side in grey ink.
• Lonsurf 20 mg/8,19 mg je blijedo crvena, bikonveksna, okrugla filmom obložena tableta, s oznakom “20” na jednoj strani, i “102” i “20 mg” na drugoj, u sivoj tinti.
Table 6 - Efficacy results from the Phase III (RECOURSE) clinical trial in patients with metastatic colorectal cancer
Tablica 6: Rezultati djelotvornosti iz kliničkog ispitivanja faze III (RECOURSE) u bolesnika s metastatskim kolorektalnim karcinomom
INFORMATION IN BRAILLE Lonsurf 20 mg/8.19 mg
16. PODACI NA BRAILLEOVOM PISMU Lonsurf 20 mg/8,19 mg
Therefore, women of child-bearing potential must use highly effective contraceptive measures while taking Lonsurf and for 6 months after stopping treatment.
Shodno tome, žene u generativnoj dobi moraju koristiti visokoučinkovite metode kontracepcije tijekom liječenja lijekom Lonsurf te šest mjeseci nakon prekida liječenja.
Your doctor will do blood tests before each cycle of Lonsurf.
• Prije svakog ciklusa liječenja lijekom Lonsurf, Vaš liječnik će napraviti krvne pretrage.
Results of animal studies did not indicate an effect of trifluridine and tipiracil hydrochloride on male and female fertility in rats.
Rezultati ispitivanja u životinja nisu ukazala utjecaj trifluridina ni tipiracilklorida na plodnost niti u mužjaka niti u ženki štakora.
Level 2 dose reduction: From 30 mg/m2 to 25 mg/m2 25 mg/m2
Stupanj 2 smanjenja doze: Sa 30 mg/m2 na 25 mg/m2 25 mg/m2
The PK of trifluridine and tipiracil hydrochloride have not been studied in patients with severe renal impairment or end-stage renal disease (see section 4.4).
Farmakokinetika trifluridina i tipiracilklorida nije bila ispitivana u bolesnika s ozbiljno oštećenom funkcijom bubrega niti s krajnjim stadijem bubrežne bolesti (vidjeti dio 4.4).
There have been reports of interstitial lung disease in patients receiving Lonsurf post approval.
Zabilježeni su slučajevi intersticijske bolesti pluća u bolesnika koji su uzimali Lonsurf nakon što je lijek stavljen na tržište.
Iron oxide red (E172) Iron oxide yellow (E172) Titanium dioxide (E171) Indigo carmine aluminium lake (E132) Carnauba wax
Željezov oksid crveni (E172) Željezov oksid žuti (E172) Titanijev dioksid (E171) Boja indigo carmine aluminium lake (E132) Karnauba vosak
When Lonsurf at a single dose of 35 mg/m2 was administered to 14 patients with solid tumours after a standardised high-fat, high-calorie meal, trifluridine area under the concentration-time curve (AUC) did not change, but trifluridine Cmax, tipiracil hydrochloride Cmax and AUC decreased by approximately 40% compared to those in a fasting state.
Kada je primijenjena jedna doza Lonsurfa od 35 mg/m2/dozi u 14 bolesnika sa solidnim tumorima nakon standardiziranog punomasnog, visokokaloričnog obroka, površina ispod krivulje koncentracijavrijeme (AUC) za trifluridin se nije promijenila, ali su Cmax trifluridina i Cmax tipiracilklorida kao i AUC smanjene za oko 40% u usporedbi s vrijednostima na tašte.
Neutropenic sepsis Upper respiratory tract infection Conjunctivitis
Neutropenična sepsa Infekcije gornjih dišnih puteva Konjunktivitis
After oral administration of Lonsurf with [14C]-trifluridine, at least 57% of the administered trifluridine was absorbed and only 3% of the dose was excreted into faeces.
Nakon peroralne primjene Lonsurfa s [14C]-trifluridinom, najmanje 57% primjenjenog trifluridina je bilo apsorbirano i samo je 3% doze izlučeno fecesom.
Tipiracil hydrochloride was a substrate for OCT2 and MATE1, therefore, the concentration might be increased when Lonsurf is administered concomitantly with inhibitors of OCT2 or MATE1.
Tipiracilklorid je supstrat za OCT2 i MATE1, i zbog toga može doći do povećanja koncentracije ako se Lonsurf primjenjuje istodobno s inhibitorima OCT2 ili MATE1.
No adjustment of the starting dose is required on the basis of patient's race (see sections 5.1 and 5.2).
Nije potrebno prilagoditi početnu dozu s obzirom na rasu bolesnika (vidjeti dijelove 5.1 i 5.2).
• redness, swelling, pain on the palms of your hands and soles of your feet (hand-foot syndrome)
• crvenilo, oteklina, bol u dlanovima šaka i tabanima stopala (sindrom šaka-stopalo)
A higher exposure of Lonsurf was observed in moderate renal impairment (CrCl = 30 to 59 mL/min).
Veća izloženost Lonsurfu je primijećena kod umjereno oštećene funkcije bubrega (CrCl 30 - 59 mL/min).
Interruption criteria
Kriterij za privremeni prekid primjene
Metastatic colorectal cancer
Metastatski kolorektalni karcinom
Transport of tipiracil hydrochloride by OCT2 and MATE1 might be affected when Lonsurf is administered concomitantly with inhibitors of OCT2 and MATE1.
Prijenos tipiracilklorida putem OCT2 i MATE1 može biti pod negativnim utjecajem ukoliko se Lonsurf primjenjuje istodobno s inhibitorima OCT2 i MATE1.
The median time to deterioration of ECOG performance status to ≥2 was 4.3 months for the Lonsurf group versus 2.3 months for the placebo group with HR of 0.69 (95% CI: 0.562, 0.854), p-value = 0.0005.
Medijan vremena do pogoršanja ECOG izvedbenog statusa na ≥2 bio je 4,3 mjeseca za skupinu koja je primala Lonsurf u odnosu na 2,3 mjeseca za placebo skupinu s omjerom hazarda od 0,69 (95% CI: 0,562; 0,854), p vrijednost = 0,0005.
See Section 4.8 for how to report adverse reactions.
Za postupak prijavljivanja nuspojava vidjeti dio 4.8.
The target organs identified were the lymphatic and haematopoietic systems and the gastrointestinal tract.
Ciljno su se pratili limfatički i hematopoetski sustav te gastrointestinalni sustav.
The mean relative ratio of AUC in patients with mild (n=38) and moderate (n=16) renal impairment compared to patients with normal renal function (n=84) were 1.31 and 1.43 for trifluridine, respectively, and 1.34 and 1.65 for tipiracil hydrochloride, respectively.
Srednja vrijednost relativnog omjera AUC-a za trifluridin u bolesnika s blago (n=38) oštećenom funkcijom bubrega je bila 1,31 i umjereno (n=16) oštećenom funkcijom bubrega je iznosila 1,43 u usporedbi s bolesnicima s normalnom bubrežnom funkcijom (n=84); dok je srednji relativni omjer AUC za tipiracilklorid iznosio 1,34 i 1,65 u usporedbi istih skupina bolesnika.
Hepatic enzyme increased
Povišeni jetreni enzimi
After single oral administration of Lonsurf with [14C]-trifluridine, the total cumulative excretion of radioactivity was 60% of the administered dose.
Nakon peroralne primjene jedne doze Lonsurfa s [14C]-trifluridinom, ukupno kumulativno izlučivanje radioaktivnosti je iznosilo 60% primjenjene doze.
Of the 507 randomised patients, the median age was 63 years, 73% were male, 70% were White, 16% were Asian, and <1% were Black/African American, and all patients had baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
U 507 randomiziranih bolesnika medijan dobi bio je 63 godine, 73% su bili muškarci, 70% bijelci, 16% Azijati, <1% crnci/Afroamerikanci, te su svi bolesnici imali početni ECOG PS (engl.
• protein in your urine
• nalaz proteina u mokraći
INFORMATION IN BRAILLE Lonsurf 15 mg/6.14 mg
16. PODACI NA BRAILLEOVOM PISMU Lonsurf 15 mg/6,14 mg
The mean t1/2 values for tipiracil hydrochloride on Day 1 of Cycle 1 and on Day 12 of Cycle 1 were 2.1 hours and 2.4 hours, respectively.
Srednja vrijednost poluvremena eliminacije (t1/2) tipiracilklorida na 1. dan, 1. ciklusa je bila 2,1 sata, a na 12. dan, 1. ciklusa 2,4 sat.
After single oral administration of Lonsurf with [14C]-tipiracil hydrochloride, recovered radioactivity was 77% of the dose, which consisted of 27% urinary excretion and 50% faecal excretion.
Nakon peroralne primjene jedne doze Lonsurfa s [14C]-tipiracilkloridom, eliminirana radioaktivnost je iznosila 77% doze, pri čemu je 27% izlučeno urinom, a 50% fecesom.
Lonsurf should be prescribed by physicians experienced in the administration of anticancer therapy.
Lonsurf mora propisati liječnik s iskustvom u primjeni antineoplastičnih lijekova.
Level 3 dose reduction: From 25 mg/m2 to 20 mg/m2 20 mg/m
Stupanj 3 smanjenja doze: Sa 25 mg/m2 na 20 mg/m2 20 mg/m2
• raised itchy rash, red skin, blisters, skin sloughing off, hives, acne
• uzdignuti osip koji svrbi, crvenilo kože, mjehurići, ljuštenje kože, koprivnjača, akne
In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP isoforms (see section 5.2).
In vitro ispitivanja ukazuju da trifluridin, tipiracilklorid i FTY nemaju indukcijski učinak na ljudske CYP izoforme (vidjeti dio 5.2).
Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.69, 95% CI [0.45 to 1.05]).
U toj skupini bolesnika, korist u smislu OS uz primjenu Lonsurfa je bila održana (omjer hazarda 0,69; 95% CI [0,45 do 1,05]).
NAME OF THE MARKETING AUTHORISATION HOLDER Les Laboratoires Servier
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Les Laboratoires Servier
Papaellinas Ltd. Τηλ: +357 22741741
Τηλ: +357 22741741
Nearly all (99.8%) patients received prior fluoropyrimidine, 100% received prior platinum therapy and 90.5% received prior taxane therapy.
Medijan prijašnjeg broja linija liječenja metastatskog karcinoma je bio 3. Skoro svi bolesnici (99,8%) su ranije primili kemoterapiju na bazi fluoropirimidina, 100% ih je primilo kemoterapiju na bazi platine, a 90,5% je ranije primilo kemoterapiju na bazi taksana.
<0.0001 (1-sided and 2-sided)
<0.0001 (1-strano i 2-strano)
• Thrombocytopenia (very common).
• Trombocitopenija (vrlo često).
Embolism Hypertension Hypotension Flushing
Embolija Hipertenzija Hipotenzija
Contribution of tipiracil hydrochloride
Doprinos tipiracilklorida
Tinea pedis
Herpes zoster Tinea Pedis
Of the 800 randomised patients, the median age was 63 years, 61% were male, 58% were Caucasian/White, 35% were Asian/Oriental, and 1% were Black/African American, and all patients had baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
U 800 randomiziranih bolesnika medijan dobi bio je 63 godine, 61% su bili muškarci, 58% bijelci, 35% Azijati, 1% crnci/Afroamerikanci, te su svi bolesnici imali početni ECOG PS (engl.
- Film coat: hypromellose, macrogol (8000), titanium dioxide (E171), and magnesium stearate.
- Film ovojnica: hipromeloza, makrogol (8000), titanijev dioksid (E171), i magnezijev stearat.
In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP1A2, CYP2B6 or CYP3A4/5.
In vitro ispitivanja upućuju da ni trifluridin, ni tipiracilklorid niti FTY nemaju induktivno djelovanja na ljudske CYP1A2, CYP2B6 i CYP3A4/5.
• Mild renal impairment (CrCl 60 to 89 mL/min) or moderate renal impairment (CrCl 30 to
• Blago oštećenje bubrega (CrCl 60 - 89 ml/min) ili umjereno oštećenje bubrega (CrCl 30 - 59
CLINICAL PARTICULARS
U kliničkim ispitivanjima
• bad breath, tooth decay, tooth or gum problems, bleeding gums, gum infections
• loš dah, karijes zuba, poteškoće sa zubima ili desnima, krvarenje desni, infekcije desni
• feeling generally out of sorts (malaise)
• opće loše osjećanje (malaksalost)
• reduced white blood cells called granulocytes or monocytes - can increase your risk for infection
• smanjeni broj bijelih krvnih stanica koje se nazivaju granulociti ili monociti - može povećati rizik za infekcije
Each tablet contains 15 mg trifluridine and 6.14 mg tipiracil
Svaka tableta sadrži 15 mg trifluridina i 6,14 mg tipiracila
Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.75, 95% CI [0.59 to 0.94]).
U toj skupini bolesnika, korist u smislu OS uz primjenu Lonsurfa je bila održana (omjer hazarda 0,75; 95% CI [0,59 do 0,94]).