natgillin/translations-raw huggingface dataset:
Thus trifluridine and tipiracil hydrochloride are not expected to cause or be subject to a significant medicinal product interaction mediated by CYP.
Zato ni pričakovati, da bi bila trifluridin in tipiracilijev klorid vključena v pomembno medsebojno delovanje z drugimi zdravili prek CYP.
• blood clots, e.g. in the brain or legs
• krvni strdki, npr. v možganih ali nogah
Of the 533 patients in the RECOURSE study who received Lonsurf, 306 (57%) patients had normal renal function (CrCl ≥ 90 mL/min), 178 (33%) patients had mild renal impairment (CrCl 60 to 89 mL/min), and 47 (9%) had moderate renal impairment (CrCl 30 to 59 mL/min), with data missing for 2 patients.
Od 533 bolnikov, ki so prejemali zdravilo Lonsurf v študiji RECOURSE, jih je 306 (57 %) imelo normalno delovanje ledvic (očistek kreatinina ≥ 90 ml/min), 178 (33 %) bolnikov je imelo blago ledvično okvaro (očistek kreatinina od 60 do 89 ml/min) in 47 (9 %) bolnikov je imelo zmerno ledvično okvaro (očistek kreatinina od 30 do 59 ml/min).
In a dedicated study the PK of trifluridine and tipiracil hydrochloride were evaluated in cancer patients with mild or moderate hepatic impairment (National Cancer Institute [NCI] Criteria Group B and C, respectively) and in patients with normal hepatic function.
V namenski študiji so vrednotili farmakokinetiko trifluridina in tipiracilijevega klorida pri bolnikih z blago ali zmerno jetrno okvaro (B oziroma C skupina kriterijev Nacionalnega Inštituta za raka [NCINational Cancer Institute]) in pri bolnikih z normalnim jetrnim delovanjem.
If you take more Lonsurf than you should, talk to a doctor or go to a hospital straight away.
Če ste vzeli večji odmerek zdravila Lonsurf, kot bi smeli Če ste vzeli večji odmerek zdravila Lonsurf, kot bi smeli, se takoj posvetujte z zdravnikom ali pojdite v bolnišnico.
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.
Po večkratnem odmerjanju zdravila Lonsurf v priporočenem režimu in odmerku je bil srednji razpolovni čas izločanja (t1/2) trifluridina na 1. dan 1. cikla 1,4 ure, na 12. dan 1. cikla pa 2,1 ure.
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 vrednost t1/2 tipiracilijevega klorida je bila na 1. dan 1. cikla 2,1 ure, na 12. dan 1. cikla pa 2,4 ure.
In vitro evaluation of trifluridine and tipiracil hydrochloride was conducted using human uptake and efflux transporters (trifluridine with MDR1, OATP1B1, OATP1B3 and BCRP; tipiracil hydrochloride with OAT1, OAT3, OCT2, MATE1, MDR1 and BCRP).
Vrednotenje trifluridina in tipiracilijevega klorida in vitro so izvajali z uporabo humanih privzemnih in izločevalnih prenašalcev (trifluridin z MDR1, OATP1B1, OATP1B3 in BCRP, tipiracilijev klorid z OAT1, OAT3, OCT2, MATE1, MDR1 in BCRP).
Dose in mg (2x daily)
Odmerek v mg (2-krat dnevno)
• a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding and work by clumping and clotting blood vessel injuries
• zmanjšano število trombocitov v krvi (trombocitopenija), ki so pomembni pri ustavljanju krvavitev z zlepljanjem in s strjevanjem ob poškodbah krvnih kapilar;
If doses were missed or held, the patient must not make up for missed doses.
Če bolnik pozabi vzeti odmerek ali ne dobi odmerka zdravila, ne sme vzeti več odmerkov hkrati, da nadomesti izpuščene odmerke.
• Febrile neutropenia
• Febrilna nevtropenija.
40 film-coated tablets
40 filmsko obloženih tablet
• sore throat, hoarse voice, problems with your voice
• vneto žrelo, hripav glas, težave z glasom
Results of animal studies did not indicate an effect of trifluridine and tipiracil hydrochloride on male and female fertility in rats.
Rezultati študij pri živalih ne kažejo, da bi trifluridin in tipiracilijev klorid vplivala na plodnost pri podganjih samcih in samicah.
Lonsurf is not recommended for use in patients with severe renal impairment or end-stage renal disease (creatinine clearance [CrCl] < 30 mL/min or requiring dialysis, respectively), as Lonsurf has not been studied in these patients (see section 5.2).
Zdravilo Lonsurf ni primerno za uporabo pri bolnikih s hudo ledvično okvaro (očistek kreatinina [CrCl - Creatinine Clearance] < 30 ml/min) ali končno stopnjo ledvične okvare (potrebna dializa), ker zdravila Lonsurf pri teh bolnikih še niso preskušali (glejte poglavje 5.2).
• athlete's foot - fungal infection of feet, yeast infections
• atletsko stopalo - glivična okužba stopal, okužba s kvasovkami
(febrile neutropenia) and blood infection (septic shock) may occur
Kot posledica nevtropenije se lahko pojavita zvišana telesna temperatura (febrilna nevtropenija) in okužbe krvi (septični šok);
Results of animal studies did not indicate an effect of Lonsurf on male or female fertility (see section 5.3).
Izsledki študij na živalih niso pokazali vpliva na plodnost pri moških in ženskah (glejte poglavje 5.3)
Studies in animals have shown excretion of trifluridine, tipiracil hydrochloride and/or their metabolites in milk (see section 5.3).
Študije na živalih so pokazale, da se trifluridin, tipiracilijev klorid in/ali njuni presnovki izločajo v materino mleko (glejte poglavje 5.3).
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).
Enkratni odmerek zdravila Lonsurf (35 mg/m2/odmerek) je povečal srednji AUC0-zadnji trifluridina za 37-krat in Cmax za 22-krat z zmanjšano variabilnostjo v primerjavi s samim trifluridinom (35 mg/m2/odmerek).
• pain or discomfort in your arms or legs
• bolečina ali nelagodje v rokah in nogah
Breast-feeding should be discontinued during treatment with Lonsurf.
Med zdravljenjem z zdravilom Lonsurf je treba prenehati z dojenjem.
Based on a population PK analysis, the exposure of Lonsurf in patients with mild renal impairment (CrCl = 60 to 89 mL/min) was similar to those in patients with normal renal function (CrCl ≥ 90 mL/min).
Na podlagi populacijske farmakokinetične analize je bila izpostavljenost zdravilu Lonsurf pri bolnikih z blago ledvično okvaro (očistek kreatinina = od 60 do 89 ml/min) podobna kot pri bolnikih z normalnim ledvičnim delovanjem (očistek kreatinina ≥ 90 ml/min).
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%).
Pri bolnikih starih 65 let ali več, zdravljenih z zdravilom Lonsurf, je bila glede na bolnike, mlajše od 65 let, večja pojavnost naslednjih neželenih učinkov: - metastatski kolorektalni rak (RECOURSE): nevtropenija 3. in 4. stopnje (48 % v primerjavi s 30 %), anemija 3. stopnje (26 % v primerjavi z 12 %), levkopenija 3. in 4. stopnje (26 % v primerjavi z 18 %) in trombocitopenija 3. in 4. stopnje (9 % v primerjavi z 2 %); - metastaski rak želodca (TAGS): zmanjšanje števila nevtrofilcev 3. in 4. stopnje (17,0 % v primerjavi s 6,6 %), zmanjšan apetit (37,3 % v primerjavi s 31,9 %), astenija (22,2 % v primerjavi s 17,0 %) in stomatitis (7,2 % v primerjavi s 2,2 %).
The most serious observed adverse drug reactions in patients receiving Lonsurf are bone marrow suppression and gastrointestinal toxicity (see section 4.4).
Najbolj resna neželena učinka, ki so ju opazili pri bolnikih, zdravljenih z zdravilom Lonsurf, sta supresija kostnega mozga in toksičnost za prebavila (glejte poglavje 4.4).
However, trifluridine is rapidly degraded by TPase and readily metabolised by a first-pass effect following oral administration, hence the inclusion of the TPase inhibitor, tipiracil hydrochloride.
TPaza hitro razgradi trifluridin in njegova presnova po peroralni uporabi je hitra zaradi učinka prvega prehoda, zato je v zdravilo vključen zaviralec TPaze, tipiracilijev klorid.
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).
Dodatni opazovani dogodki učinkovitosti so bili preživetje brez napredovanja bolezni (PFS), celotni delež odziva (ORR), stopnja nadzora nad boleznijo (DCR), čas do poslabšanja stanja zmogljivosti ≥2 po ECOG in kakovost življenja (QoL - Quality of Life).
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).
Študije in vitro so pokazale, da trifluridin, tipiracilijev klorid in FTY (neaktiven presnovek trifluridina) ne zavirajo testiranih izoform CYP (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 in CYP3A4/5).
A higher exposure of Lonsurf was observed in moderate renal impairment (CrCl = 30 to 59 mL/min).
Povečano izpostavljenost zdravilu Lonsurf so opazili pri bolnikih z zmerno ledvično okvaro (očistek kreatinina = od 30 do 59 ml/min).
Thus it is unlikely to cause an interaction with other medicinal products, at recommended doses, due to inhibition of OCT2 and MATE1.
Zato je malo verjetno, da bi bil v priporočenih odmerkih zaradi zaviranja OCT2 in MATE1 vključen v medsebojno delovanje z drugimi zdravili.
No. at Risk: Lonsurf Placebo
Št. ogroženih: Lonsurf placebo
Women should avoid becoming pregnant while taking Lonsurf and for up to 6 months after ending treatment.
Ženske se morajo med jemanjem zdravila Lonsurf in do 6 mesecev po zaključku zdravljenja izogibati zanositvi.
Within each frequency group, adverse drug reactions are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Based on the population PK analysis, there is no clinically relevant effect of age, gender or race on the PK of trifluridine or tipiracil hydrochloride.
Na podlagi populacijske farmakokinetične analize starost, spol ali etnična pripadnost nimajo klinično pomembnih vplivov na farmakokinetiko trifluridina ali tipiracilijevega klorida.
Talk to your doctor or pharmacist before taking Lonsurf if:
Pred začetkom jemanja zdravila Lonsurf se posvetujte z zdravnikom ali farmacevtom, če:
Lonsurf contains lactose.
Zdravilo Lonsurf vsebuje laktozo.
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.
Srednje relativno razmerje AUC pri bolnikih z blago (n = 38) ledvično okvaro v primerjavi z bolniki z normalnim ledvičnim delovanjem (n = 84) je bilo 1,31 za trifluridin in 1,34 za tipiracilijev klorid, pri bolnikih z zmerno (n = 16) ledvično okvaro pa 1,43 za trifluridin in 1,65 za tipiracilijev klorid.
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 zdravljenja z zdravilom Lonsurf glede podaljšanja preživetja se je ohranila tudi po prilagoditvi na vse pomembne prognostične dejavnike, in sicer na čas od prve diagnoze metastatske bolezni, PS po ECOG in število mest metastaz (razmerje ogroženosti: 0,69; 95-% CI [od 0,58 do
Lonsurf caused an increase in the incidence of myelosuppression including anaemia, neutropenia, leukopenia, and thrombocytopenia.
Zdravilo Lonsurf je povečalo pojavnost mielosupresije vključno z anemijo, nevtropenijo, levkopenijo in trombocitopenijo.
• swelling of mucous membranes - this could be inside the nose, mouth, throat, eyes, vagina, lungs or gut
• otekanje sluznic - lahko v nosu, ustih, žrelu, očeh, nožnici, pljučih ali črevesju
Lonsurf has been shown to cause embryo-foetal lethality and embryo-foetal toxicity in pregnant rats when given at dose levels lower than the clinical exposure.
Zdravilo Lonsurf je pri brejih podganjih samicah pri odmerkih, ki so bili manjši od klinične izpostavljenosti, povzročilo embriofetalno smrtnost in toksičnost.
Repeat-dose toxicity
Toksičnost pri ponavljajočih se odmerkih
Table 1 - Starting dose calculation according to body surface area (BSA)
Preglednica 1 - Izračun začetnega odmerka na osnovi telesne površine (BSA)
How to take Lonsurf
Kako jemati zdravilo Lonsurf
This 4 week period is called a ‘cycle.'
Ti 4 tedni se imenujejo cikel zdravljenja, ki sledi naslednji posebni shemi odmerjanja:
Do not take Lonsurf :
Ne jemljite zdravila Lonsurf
<0.0001 (1-sided and 2-sided)
<0,0001 (enostranska in obojestranska)
In the pharmacokinetic (PK) analyses of the multiple dose administration of Lonsurf (35 mg/m2/dose, twice daily for 5 days a week with 2 days rest for 2 weeks followed by a 14-day rest, repeated every 4 weeks), trifluridine area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) was approximately 3-fold higher and maximum concentration (Cmax) was approximately 2-fold higher after multiple dose administration (Day 12 of Cycle 1) of Lonsurf than after single-dose (Day 1 of Cycle 1).
V farmakokinetični analizi dajanja večkratnih odmerkov zdravila Lonsurf (35 mg/m2/odmerek, dvakrat dnevno 5 dni v tednu z 2-dnevnim premorom 2 tedna, ki jima je sledilo 14 dni brez zdravljenja, kar so ponovili vsake 4 tedne), je bila površina pod krivuljo koncentracija-čas od časa 0 do zadnje merljive koncentracije (AUC0-zadnji) trifluridina približno 3-krat večja kot po enkratnem odmerku (1. dan 1. cikla).
• bad breath, tooth decay, tooth or gum problems, bleeding gums, gum infections
• slab zadah, zobna gniloba, težave z zobmi ali dlesnimi, krvavitev iz dlesni, okužbe dlesni
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,
Zdravilo Lonsurf sestavljata antineoplastični timidinski nukleozidni analog, trifluridin, in zaviralec timidin-fosforilaze (TPaze), tipiracilijev klorid, v molarnem razmerju 1:0,5 (masno razmerje 1:0,471).
Lonsurf contains lactose
Zdravilo Lonsurf vsebuje laktozo
The signs include intense stomach or abdominal pain that can be associated with vomiting, blocked or partly blocked bowel, fever or swelling of the abdomen.
Znaki vključujejo možno bolečino v želodcu ali prebavilih, ki je lahko povezana z bruhanjem, zaporo ali delno zaporo črevesja, zvišano telesno temperaturo ali otekanjem trebušne votline;
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 študije so pokazale, da trifluridin, tipiracilijev klorid in 5-trifluorometil uracil (FTY) ne zavirajo aktivnosti humanih izoform citokroma P450 (CYP).
No correlation was seen for trifluridine nor tipiracil hydrochloride between PK parameters and AST or/and total blood bilirubin.
Niti pri trifluridinu niti pri tipiracilijevemu kloridu niso opazili korelacije med farmakokinetičnimi parametri in AST ali/in skupnim bilirubinom v krvi.
Table 6 - Efficacy results from the Phase III (RECOURSE) clinical trial in patients with metastatic colorectal cancer
Preglednica 6 - Rezultati učinkovitosti iz klinične študije III. faze (RECOURSE) pri bolnikih z metastatskim kolorektalnim rakom
• passing out (syncope)
• omedlevica (sinkopa)
Tipiracil hydrochloride was an inhibitor of OCT2 and MATE1 in vitro, but at concentrations substantially higher than human plasma Cmax at steady state.
Tipiracilijev klorid je in vitro zaviral prenašalca OCT2 in MATE1, a v znatno višjih koncentracijah kot je plazemska Cmax v stanju dinamičnega ravnovesja pri človeku.
Metastatic colorectal cancer
Metastatski kolorektalni rak
The median OS was 5.7 months (95% CI: 4.8, 6.2) for the Lonsurf group versus 3.6 months (95% CI: 3.1, 4.1) for the placebo group; with 1-year survival rates of 21.2% and 13.0%, respectively.
Mediana OS je bila 5,7 meseca (95-% CI: 4,8; 6,2) v skupini, zdravljeni z zdravilom Lonsurf, v primerjavi s 3,6 meseca (95-% CI: 3,1; 4,1) v placebo skupini; z 1letno stopnjo preživetja 21,2 % v primerjavi s 13,0 %.
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.
Ko so zdravilo Lonsurf v enkratnem odmerku 35 mg/m2 dali 14 bolnikom s solidnimi tumorji po standardnem obroku, bogatem z maščobami in s kalorijami, se površina pod krivuljo koncentracija-čas (AUC) trifluridina ni spremenila, za približno 40 % pa so se v primerjavi s tistimi, ki so zdravilo vzeli na tešče, zmanjšali Cmax trifluridina ter Cmax in AUC tipiracilijevega klorida.
Level 2 dose reduction: From 30 mg/m2 to 25 mg/m2 25 mg/m2
2. raven zmanjšanja odmerka: s 30 mg/m2 na 25 mg/m2 25 mg/m2
The signs include feeling short of breath, tiredness or looking pale (see section 2).
Znaki vključujejo občutek zasoplosti, utrujenosti ali bledo kožo (glejte poglavje 2);
Lonsurf caused an increase in the incidence of gastrointestinal toxicities including nausea, vomiting and diarrhoea.
Zdravilo Lonsurf lahko poveča pojavnost toksičnih učinkov na prebavila vključno z navzeo, bruhanjem in diarejo.
• If you forget a dose, talk to your doctor or pharmacist.
• Če ste pozabili vzeti odmerek, se posvetujte z zdravnikom ali farmacevtom.
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).
Farmakokinetike trifluridina in tipiracilijevega klorida pri bolnikih s hudo ledvično okvaro ali končno stopnjo ledvične bolezni niso preučevali (glejte poglavje 4.4).
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.
Podaljšanje OS in PFS se je dosledno pokazalo v vseh randomiziranih slojih in v vseh predhodno določenih podskupinah glede na spol, starost (< 65 let; ≥ 65 let), etnično pripadnost, PS po ECOG, predhodno zdravljenje z ramucirumabom, predhodno zdravljenje z irinotekanom, število predhodnih linij zdravljenja (2; 3; ≥ 4), predhodno gastrektomijo, mesto primarnega tumorja (želodec, gastroezofagealni prehod) in status HER2.
• you have kidney problems
• imate težave z ledvicami,
Tipiracil hydrochloride was not metabolised in human liver S9 or in cryopreserved human hepatocytes.
Tipiracilijev klorid se v S9 frakciji humanih jeter ali v krioprezerviranih humanih hepatocitih ni presnavljal.
Neither trifluridine nor tipiracil hydrochloride was an inhibitor of or substrate for human uptake and efflux transporters based on in vitro studies, except for OCT2 and MATE1.
Na osnovi študij in vitro niti trifluridin niti tipiracilijev klorid nista inhibitorja ali substrata privzemnih in izločevalnih prenašalcev pri človeku, z izjemo OCT2 in MATE1.
The primary efficacy endpoint was overall survival (OS), and supportive efficacy endpoints were progression-free survival (PFS), overall response rate (ORR) and disease control rate (DCR).
Sekundarni opazovani dogodki učinkovitosti so bili preživetje brez napredovanja bolezni (PFS - Progression Free Survival), celotni delež odziva (ORROverall Response Rate) in stopnja nadzora nad boleznijo (DCR - Disease Control Rate).
Placebo plus BSC (N=266)
Placebo in BSC (N = 266)
Placebo plus BSC (N=170)
Placebo in BSC (N = 170)
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.
Po enkratnem peroralnem dajanju zdravila Lonsurf s [14C]-tipiracilijevim kloridom je bila zaznana radioaktivnost 77 % odmerka, ki sta jo sestavljala v 27 % izločanje z urinom in v 50 % izločanje z blatom.
Lactose monohydrate Starch, Pregelatinised (Maize) Stearic acid
Jedro tablete laktoza monohidrat predgelirani koruzni škrob stearinska kislina
In total, 800 patients were randomised 2:1 to receive Lonsurf (N = 534) plus best supportive care (BSC) or matching placebo (N = 266) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Skupaj je bilo 800 bolnikov randomiziranih 2:1 v skupino, ki je prejemala zdravilo Lonsurf (N = 534) in najboljšo podporno oskrbo (BSC - Best Supportive Care) ali ustrezen placebo (N = 266) in BSC. Odmerjanje zdravila Lonsurf je bilo osnovano na telesni površini (BSA) z začetnim odmerkom 35 mg/m2/odmerek.
• inflammation, swelling or bleeding in your bowel
• vnetje, otekanje ali krvavitev v črevesju
In total, 507 patients were randomised 2:1 to receive Lonsurf (N = 337) plus best supportive care (BSC) or placebo (N = 170) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Skupaj je bilo 507 bolnikov randomiziranih 2:1 v skupino, ki je prejemala zdravilo Lonsurf (N = 337) in najboljšo podporno oskrbo (BSC) ali placebo (N = 170) in BSC. Odmerjanje zdravila Lonsurf je bilo osnovano na telesni površini (BSA) z začetnim odmerkom 35 mg/m2/odmerek.
Table 7 - Efficacy results from the Phase III (TAGS) clinical trial in patients with metastatic gastric cancer
Preglednica 7 - Rezultati učinkovitosti iz kliničnega preskušanja III. faze (TAGS) pri bolnikih z metastatskim rakom želodca
• Moderate or severe hepatic impairment
• Zmerna in huda jetrna okvara
Iron oxide red (E172) Iron oxide yellow (E172) Titanium dioxide (E171) Indigo carmine aluminium lake (E132) Carnauba wax
Črnilo šelak rdeči železov oksid (E172) rumeni železov oksid (E172) titanov dioksid (E171) indigotin (E132) karnauba vosek smukec
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.
Med 507 randomiziranimi bolniki je bila mediana starost 63 let, 73 % je bilo moških, 70 % je bilo belcev, 16 % je bilo Azijcev in < 1 % je bilo črncev/Afroameričanov.
This is because it may harm your unborn baby.
Med zdravljenjem s tem zdravilom ne smete zanositi, ker lahko škoduje vašemu nerojenemu otroku.
After oral administration of Lonsurf with [14C]-tipiracil hydrochloride, at least 27% of the administered tipiracil hydrochloride was absorbed and 50% of the total radioactivity dose measured into faeces, suggestive of moderate gastrointestinal absorption of tipiracil hydrochloride.
Po peroralnem jemanju zdravila Lonsurf s [14C]-tipiracilijevim kloridom se absorbira vsaj 27 % tipiracilijevega klorida in le 50 % celotne radioaktivnosti danega odmerka so izmerili v blatu, kar kaže na zmeren obseg gastrointestinalne absorpcije tipiracilijevega klorida.
• painful tongue, polyps inside your mouth, mouth ulcers, retching
• boleč jezik, polipi v ustih, razjede v ustih, siljenje na bruhanje
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.
Mediana časa do poslabšanja stanja zmogljivosti po ECOG na ≥ 2 je bila 4,3 meseca za skupino, zdravljeno z zdravilom Lonsurf, v primerjavi z 2,3 meseca za placebo skupino, pri čemer je bilo razmerje ogroženosti 0,69 (95-% CI: od 0,562 do 0,854), p-vrednost = 0,0005.
Lonsurf plus BSC (N=534)
Lonsurf in BSC (N = 534)