FrancophonIA/ELRC3.0 huggingface dataset:
English: • runny or bloody nose, sinus problems
Slovenian: • izcedek ali krvavitev iz nosu, težave s sinusi
English: If you are not sure, talk to your doctor before taking Lonsurf.
Slovenian: Če ste negotovi, se pred jemanjem zdravila Lonsurf posvetujte z zdravnikom.
English: Level 3 dose reduction: From 25 mg/m2 to 20 mg/m2 20 mg/m
Slovenian: 3. raven zmanjšanja odmerka: s 25 mg/m2 na 20 mg/m2 20 mg/m2
English: Hazard ratio for progression or death, 0.48 (95% CI, 0.41-0.57) P<0.0001 by log-rank test
Slovenian: Razmerje ogroženosti za napredovanje bolezni ali smrt, 0,48 (95-% CI, 0,41 - 0,57) p < 0,0001 test log-rank
English: There have been reports of interstitial lung disease in patients receiving Lonsurf post approval.
Slovenian: Po odobritvi so pri bolnikih, zdravljenih z zdravilom Lonsurf, poročali o primerih intersticijske bolezni pljuč.
English: • reduced white blood cells called granulocytes or monocytes - can increase your risk for infection
Slovenian: • znižanje vrednosti belih krvnih celic, imenovanih granulociti ali monociti - kar lahko poveča tveganje za okužbe
English: 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.
Slovenian: Med 800 randomiziranimi bolniki je bila mediana starost 63 let, 61 % je bilo moških, 58 % je bilo belcev, 35 % je bilo azijskega oz. orientalskega porekla in 1 % je bilo črne rase.
English: The protein binding of trifluridine in human plasma was over 96% and trifluridine bound mainly to human serum albumin.
Slovenian: Vezava trifluridina na beljakovine v plazmi je bila več kot 96-%.
English: Each tablet contains 15 mg trifluridine and 6.14 mg tipiracil
Slovenian: Ena tableta vsebuje 15 mg trifluridina in 6,14 mg tipiracila.
English: After single oral administration of Lonsurf with [14C]-trifluridine, the total cumulative excretion of radioactivity was 60% of the administered dose.
Slovenian: Po enkratnem peroralnem odmerku zdravila Lonsurf s [14C]-trifluridina je bilo skupno kumulativno izločene radioaktivnosti 60 % danega odmerka.
English: • Mild renal impairment (CrCl 60 to 89 mL/min) or moderate renal impairment (CrCl 30 to
Slovenian: • Blaga ledvična okvara (očistek kreatinina od 60 do 89 ml/min) ali zmerna ledvična okvara
English: Dosing adjustments may be required based on individual safety and tolerability.
Slovenian: Glede na varnost in prenašanje zdravila pri posameznih bolnikih bo morda treba odmerjanje prilagoditi.
English: Lonsurf plus BSC (N=337)
Slovenian: Lonsurf in BSC (N = 337)
English: Hazard ratio [95% CI] P-valuec
Slovenian: Razmerje ogroženosti [95-% CI] Vrednost Pc
English: Hazard ratio for death, 0.69 (95% CI, 0.56-0.85) P=0.0003 (1-sided) ; p =0.0006 (2-sided)
Slovenian: Razmerje ogroženosti za smrt, 0,69 (95% CI, 0,56-0,85) p=0,0003 (enostranska) ; p =0,0006 (dvostranska)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1096/001-006
Slovenian: EU/1/16/1096/001-006
English: • Thrombocytopenia (very common).
Slovenian: • trombocitopenija (zelo pogosti).
English: Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.75, 95% CI [0.59 to 0.94]).
Slovenian: Med temi bolniki je bila ohranjena korist zdravljenja z zdravilom Lonsurf glede podaljšanja OS (razmerje ogroženosti: 0,75, 95-% CI [od 0,59 do 0,94]).
English: Sixty one percent (61%, N = 485) of all randomised patients received a fluoropyrimidine as part of their last treatment regimen prior to randomisation, of which 455 (94%) were refractory to the fluoropyrimidine at that time.
Slovenian: Enainšestdeset odstotkov (61 %, N = 485) vseh randomiziranih bolnikov je prejemalo fluoropirimidin kot del zadnjega režima zdravljenja pred randomizacijo.
English: Your doctor will do blood tests before each cycle of Lonsurf.
Slovenian: Pred vsakim ciklom zdravljenja z zdravilom Lonsurf bo vaš zdravnik naročil preiskave krvi.
English: Administration is not recommended in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin > 1.5 x ULN) as, a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see sections 4.4 and 5.2).
Slovenian: Uporaba zdravila ni priporočljiva pri bolnikih z obstoječo zmerno ali hudo jetrno okvaro (C oziroma D skupina kriterijev Nacionalnega Inštituta za raka [NCI - National Cancer Institute], ki sta določeni s skupnim bilirubinom > 1,5-kratno zgornjo mejo normalnih vrednosti [ULN - Upper Limit of Normal]), ker so pri bolnikih z obstoječo zmerno jetrno okvaro opazili večjo pojavnost hiperbilirubinemije 3. ali 4. stopnje, čeprav na osnovi zelo malo podatkov (glejte poglavji 4.4 in 5.2).
English: Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.69, 95% CI [0.45 to 1.05]).
Slovenian: Med temi bolniki je bila ohranjena korist zdravljenja z zdravilom Lonsurf glede podaljšanja celokupnega preživetja (razmerje ogroženosti: 0,69, 95-% CI [od 0,45 do 1,05]).
English: • swelling or pain in your joints or big toes
Slovenian: • oteklina ali bolečina v sklepih ali velikih prstih na nogah
English: Progression-free Survival Probability (%)
Slovenian: Verjetnost preživetja brez napredovnaja bolezni (%)
English: Lonsurf is not recommended for use in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin > 1.5 x ULN), as a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see section 5.2).
Slovenian: Uporaba zdravila Lonsurf pri bolnikih z obstoječo zmerno ali hudo jetrno okvaro ni priporočljiva (C oziroma D skupina kriterijev Nacionalnega Inštituta za raka [NCI - National Cancer Institute], ki sta določeni s skupnim bilirubinom > 1,5 x ULN), ker so pri bolnikih z obstoječo zmerno jetrno okvaro opazili večjo pojavnost hiperbilirubinemije 3. ali 4. stopnje, čeprav na osnovi zelo malo podatkov (glejte poglavje 5.2).
English: PFS was significantly improved in patients receiving Lonsurf plus BSC (hazard ratio: 0.48; 95% CI [0.41 to 0.57]; p < 0.0001 (see Table 6, Figure 1 and Figure 2).
Slovenian: PFS se je značilno izboljšal pri bolnikih, ki so prejemali zdravilo Lonsurf in BSC (razmerje ogroženosti 0,48; 95-% CI [od 0,41 do 0,57]; p < 0,0001) (glejte Preglednico 6 ter Sliki 1 in 2).
English: Embolism Hypertension Hypotension Flushing
Slovenian: Žilne bolezni embolija hipertenzija hipotenzija vročinski oblivi
English: Hazard ratio for death, 0.68 (95% CI, 0.58-0.81) P<0.0001
Slovenian: Razmerje ogroženosti za smrt, 0,68 (95-% CI, 0,58 - 0,81) P < 0,0001
English: Tabulated list of adverse drug reactions
Slovenian: Tabelarični seznam neželenih učinkov
English: Trifluridine was mainly eliminated by metabolism via TPase to form an inactive metabolite, FTY.
Slovenian: Triflurifin se večinoma izloča s presnovo s TPazo, ki ga pretvori v neaktiven presnovek 5-trifluorometil uracil (FTY).
English: Metastatic gastric cancer
Slovenian: Metastatski rak želodca
English: No adjustment of the starting dose is recommended in patients with mild or moderate renal impairment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z blago ali zmerno ledvično okvaro ni priporočil glede prilagajanja začetnega odmerka (glejte poglavji 4.4 in 5.2).
English: The signs include difficulty in breathing, shortness of breath, with cough or fever.
Slovenian: Znaki vključujejo težko dihanje, zasoplost s kašljem ali zvišano telesno temperaturo.
English: • cough, feeling short of breath, infection of the sinuses, throat, airway or lungs, chest infections
Slovenian: • kašelj, zasoplost, vnetje sinusov, žrela, dihalnih poti ali pljuč, okužbe v prsnem košu
English: • inflammation or infection of bile ducts, increase in the diameter of the bile duct
Slovenian: • vnetje ali okužba žolčevodov, povečanje premera žolčevodov
English: c. Hand-foot skin reaction.
Slovenian: c kožna reakcija na dlaneh in stopalih
English: The tablet is a pale red, biconvex, round, film-coated tablet, with a diameter of 7.6 mm and a thickness of 3.2 mm, imprinted with ‘20' on one side, and ‘102' and ‘20 mg' on the other side, in grey ink.
Slovenian: Tableta je bledo rdeča, bikonveksna, okrogla filmsko obložena tableta s premerom 7,6 mm in debeline 3,2 mm, s sivo oznako "20" na eni ter "102" in "20 mg" na drugi strani.
English: • feeling dizzy, headache
Slovenian: • omotica, glavobol
English: Common: may affect up to 1 in 10 people:
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
English: • gastrointestinal problems.
Slovenian: • prebavne težave.
English: Musculoskeletal pain Muscular weakness Muscle spasms Pain in extremity
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva otekanje sklepov artralgija bolečina v kosteh mialgija mišično-skeletna bolečina mišična oslabelost mišični krči bolečina v okončinah
English: • reduced white blood cells called leucocytes - can increase your risk for infection
Slovenian: • znižanje vrednosti belih krvnih celic, imenovanih levkociti - kar lahko poveča tveganje za okužbe.
English: PFS was significantly improved in patients receiving Lonsurf plus BSC compared to placebo plus BSC (HR of 0.57; 95% CI [0.47 to 0.70]; p < 0.0001 (see Table 7, Figure 3 and Figure 4).
Slovenian: PFS je bil statistično značilno podaljšan pri bolnikih, ki so prejemali zdravilo Lonsurf in BSC, v primerjavi s placebom in BSC (razmerje ogroženosti: 0,57; 95-% CI [od 0,47 do 0,70]; p <0,0001) (glejte Preglednico 7, Sliko 3 in Sliko 4).
English: • more noticeable heart-beat, chest pain
Slovenian: • bolj izrazit srčni utrip, bolečina v prsnem košu
English: KRAS status was wild (49%) or mutant (51%) at study entry.
Slovenian: Ob vključitvi v klinično študijo je imelo 49 % bolnikov divji tip gena KRAS, 51 % bolnikov pa mutirani gen KRAS.
English: It is not known whether Lonsurf changes your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni znano, ali zdravilo Lonsurf spremeni vašo sposobnost upravljanja vozil in strojev.
English: • feeling of numbness or pins and needles in hands or feet
Slovenian: • občutek otrplosti ali mravljinčenja v dlaneh ali stopalih
English: An OS analysis of the study, carried out as planned at 76% (N = 384) of events, demonstrated that Lonsurf plus BSC resulted in a statistically significant improvement in OS compared to placebo plus BSC with an hazard ratio (HR) of 0.69 (95% CI: 0.56, 0.85; 1- and 2-sided p-values were 0.0003 and 0.0006, respectively) corresponding to a 31% reduction in the risk of death in the Lonsurf group.
Slovenian: Vnaprej načrtovana analiza OS študije, izvedena pri 76 % dogodkov (N = 384), je pokazala statistično značilno podaljšanje celokupnega preživetja pri zdravilu Lonsurf in BSC v primerjavi s placebom in BSC z razmerjem ogroženosti (HR - hazard ratio) 0,69 (95-% CI: 0,56; 0,85; 1- in 2-stranski pvrednosti sta bili 0,0003 oz. 0,0006), kar ustreza 31 % zmanjšanju tveganja za smrt v skupini, zdravljeni z zdravilom Lonsurf.
English: Whitening, breakage, and malocclusion were observed in teeth of rats treated with trifluridine/tipiracil hydrochloride, which are considered rodent specific and not relevant for human.
Slovenian: Pri podganah, ki so jim dajali trifluridin/tipiracilijev klorid, so opazili beljenje, lomljenje in nepravilno izraščanje zob; omenjene spremembe se smatrajo specifične za glodalce in niso pomembne za ljudi.
English: 6.6 Special precautions for disposal and other handling Hands should be washed after handling the tablets.
Slovenian: Po rokovanju s tabletami si je treba umiti roke.
English: Pancytopenia Granulocytopenia Monocytopenia Erythropenia Leukocytosis Monocytosis
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija levkopenija anemija trombocitopenija febrilna nevtropenija limfopenija pancitopenija granulocitopenija monocitopenija eritropenija levkocitoza monocitoza
English: Do not drive or use any tools or machines if you experience symptoms that affect your ability to concentrate and react.
Slovenian: Če občutite simptome, ki vplivajo na vašo zbranost in odzivnost, ne vozite in ne upravljajte z orodji ali s stroji.
English: Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy (see section 4.8).
Slovenian: Pred začetkom zdravljenja in med njim je priporočljivo spremljanje proteinurije z urinskimi testnimi lističi (glejte poglavje 4.8).
English: LIST OF EXCIPIENTS Contains lactose monohydrate, see leaflet for further information.
Slovenian: SEZNAM POMOŽNIH SNOVI Zdravilo vsebuje laktozo monohidrat.
English: An OS analysis of the study, carried out as planned at 72% (N = 574) of events, demonstrated a clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.68; 95% confidence interval [CI] [0.58 to 0.81]; p < 0.0001) and a median OS of 7.1 months vs 5.3 months, respectively; with 1-year survival rates of 26.6% and 17.6%, respectively.
Slovenian: Vnaprej načrtovana analiza OS, izvedena pri 72 % dogodkov (N = 574), je pokazala klinično pomembno ter statistično značilno podaljšanje preživetja pri zdravilu Lonsurf in BSC v primerjavi s placebom in BSC (razmerje ogroženosti 0,68; 95-% interval zaupanja [CI - Confidence Interval] [od 0,58 do 0,81]; p < 0,0001) z mediano OS 7,1 meseca v primerjavi s 5,3 meseca ter stopnjo preživetja po 1 letu 26,6 % v primerjavi s 17,6 %.
English: Lonsurf 20 mg/8.19 mg tablet
Slovenian: Lonsurf 20 mg/8,19 mg tableta
English: Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the apparent volume of distribution (Vd/F) for trifluridine and tipiracil hydrochloride was 21 L and 333 L, respectively.
Slovenian: Po enkratnem odmerku zdravila Lonsurf (35 mg/m2) pri bolnikih z napredovalimi solidnimi tumorji je bil navidezni volumen porazdelitve (Vd/F) trifluridina 21 l, tipiracilijevega klorida pa 333 l.
English: In a dose finding study (15 to 35 mg/m2 twice daily), the AUC from time 0 to 10 hours (AUC0-10) of trifluridine tended to increase more than expected based on the increase in dose; however, oral clearance (CL/F) and apparent volume of distribution (Vd/F) of trifluridine were generally constant at the dose range of 20 to 35mg/m2.
Slovenian: (AUC0-10) trifluridina praviloma povečal bolj kot pričakovano na podlagi povečanja odmerka, peroralni očistek (CL/F) in navidezni volumen porazdelitve (Vd/F) pa sta bila na splošno konstantna v razponu odmerkov od 20 do 35 mg/m2.
English: • 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.
Slovenian: Zdravilo Lonsurf 20 mg/8,19 mg je v obliki bledo rdečih, bikonveksnih, okroglih filmsko obloženih tablet s sivo oznako "20" na eni ter "102" in "20 mg" na drugi strani.
English: What Lonsurf contains Lonsurf 15 mg/6.14 mg tablet
Slovenian: Kaj vsebuje zdravilo Lonsurf Lonsurf 15 mg/6,14 mg tableta
English: Table 5 - Adverse drug reactions reported in clinical trials in patients treated with Lonsurf System Organ Class (MedDRA)a
Slovenian: Preglednica 5 - Neželeni učinki, o katerih so poročali v kliničnem preskušanjih pri bolnikih zdravljenih z zdravilom Lonsurf
English: You and your partner should use effective methods of contraception while taking this medicine.
Slovenian: Med jemanjem tega zdravila in še 6 mesecev po zaključenem zdravljenju morate vi in vaš partner uporabljati učinkovito kontracepcijsko metodo.
English: Treatment-related proteinuria occurred more frequently in Lonsurf-treated patients (1.8%) compared to those receiving placebo (0.9%), all of which were Grade 1 or 2 in severity (see section 4.4).
Slovenian: Proteinurije, povezane z zdravljenjem, so se pojavljale pogosteje v skupini, zdravljeni z zdravilom Lonsurf (1,8 %), kot pri skupini, ki je prejemala placebo (0,9 %).
English: Decreased appetite Hypoalbuminaemia Dehydration Hyperglycaemia
Slovenian: Presnovne in prehranske motnje zmanjšan apetit hipoalbuminemija dehidracija hiperglikemija hiperkaliemija hipokaliemija hipofosfatemija hipernatriemia hiponatriemija hipoglikemija protin
English: An updated OS analysis, carried out at 89% (N = 712) of events, confirmed the clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.69; 95% CI [0.59 to 0.81]; p < 0.0001) and a median OS of 7.2 months vs 5.2 months; with 1-year survival rates of 27.1% and 16.6%, respectively.
Slovenian: Dodatna analiza OS, izvedena pri 89 % dogodkov (N = 712), je potrdila klinično pomembno in statistično značilno podaljšanje preživetja pri zdravilu Lonsurf in BSC v primerjavi s placebom in BSC (razmerje ogroženosti 0,69; 95-% CI [od 0,59 do 0,81]; p < 0,0001) z mediano OS 7,2 meseca v primerjavi s 5,2 meseca ter stopnjo preživetja po 1 letu 27,1 % v primerjavi s 16,6 %.
English: Dose modifications (delay and/or reduction) should be applied as necessary (see section 4.2).
Slovenian: Če je potrebno, prilagodite odmerke (zakasnite in/ali zmanjšajte odmerek).
English: How much to take
Slovenian: Koliko tablet zdravila vzeti
English: Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Slovenian: Lonsurf 15 mg/6,14 mg filmsko obložene tablete Lonsurf 20 mg/8,19 mg filmsko obložene tablete trifluridin/tipiracil
English: Neurotoxicity Dysaesthesia Hyperaesthesia Hypoaesthesia Syncope
Slovenian: Bolezni živčevja disgevzija periferna nevropatija nevrotoksičnost disestezija hiperestezija hipoestezija sinkopa parestezije pekoč občutek letargija omotica glavobol
English: The effect was also maintained in regorafenib-naive patients (hazard ratio: 0.69, 95% CI [0.57 to 0.83]).
Slovenian: Korist je bila prav tako ohranjena pri bolnikih, ki se še niso zdravili z regorafenibom (razmerje ogroženosti: 0,69, 95 % CI [od 0,57 do 0,83]).
English: • reduced number of white blood cells called lymphocytes - can increase your risk for infection
Slovenian: • znižanje vrednosti belih krvnih celic, imenovanih limfociti - kar lahko poveča tveganje za okužbe
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg tablets trifluridine/tipiracil
Slovenian: IME ZDRAVILA Lonsurf 15 mg/6,14 mg tablete trifluridin/tipiracil
English: • inflammation and infection in your gut
Slovenian: • vnetje in okužba črevesja
English: Visual acuity reduced Vision blurred Diplopia
Slovenian: Očesne bolezni zmanjšana ostrina vida zamegljen vid diplopija katarakta suho oko
English: No adjustment of the starting dose is required on the basis of patient's race (see sections 5.1 and 5.2).
Slovenian: Začetnega odmerka ni treba prilagajati glede na etnično skupino (glejte poglavji 5.1 in 5.2).
English: If you experience any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: How to store Lonsurf
Slovenian: Shranjevanje zdravila Lonsurf
English: 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.
Slovenian: Če je to klinično indicirano, je potrebna uporaba antiemetikov, antidiaroikov ter drugih ukrepov, kot je nadomeščanje tekočin in elektrolitov.
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg tablets trifluridine/tipiracil
Slovenian: IME ZDRAVILA Lonsurf 20 mg/8,19 mg tablete trifluridin/tipiracil
English: This is because zidovudine may not work as well if you are taking Lonsurf.
Slovenian: Če jemljete zdravilo Lonsurf, zidovudin namreč lahko ne deluje dovolj dobro.
English: Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the oral clearance (CL/F) for trifluridine and tipiracil hydrochloride were 10.5 L/hr and 109 L/hr, respectively.
Slovenian: Po enkratnem odmerku zdravila Lonsurf (35 mg/m2) pri bolnikih z napredovalimi solidnimi tumorji je bil peroralni očistek (CL/F) trifluridina 10,5 l/h, tipiracilijevega klorida pa 109 l/h.
English: Feeling of body temperature change Xerosis
Slovenian: • zvišana telesna temperatura
English: Tipiracil hydrochloride was the major component and 6-hydroxymethyluracil was the major metabolite consistently in human plasma, urine, and faeces.
Slovenian: Glavna sestavina v humani plazmi, urinu in blatu je bil v vseh primerih tipiracilijev klorid, glavni presnovek pa 6-hidroksimetiluracil.
English: 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.
Slovenian: Pri bolnikih v preskušanju RECOURSE, ki so predhodno prejemali obsevalno zdravljenje, je bila pojavnost celokupnih hematoloških neželenih učinkov in neželenih učinkov, povezanih s supresijo kostnega mozga, rahlo večja kot pri bolnikih, ki niso bili obsevani (54,6 % v primerjavi z 49,2 %).
English: • Lonsurf 15 mg/6.14 mg is a white, biconvex, round, film-coated tablet, printed with “15” on one side and “102” and “15 mg” on the other side in grey ink.
Slovenian: Zdravilo Lonsurf 15 mg/6,14 mg je v obliki belih, bikonveksnih, okroglih filmsko obloženih tablet s sivo oznako "15" na eni ter "102" in "15 mg" na drugi strani.
English: INFORMATION IN BRAILLE Lonsurf 15 mg/6.14 mg
Slovenian: Lonsurf 15 mg/6.14 mg
English: • inflammation or infection in your bladder
Slovenian: • vnetje ali okužba mehurja
English: Following multiple doses of Lonsurf (35 mg/m2/dose twice daily) in patients with advanced solid tumours, the mean times to peak plasma concentrations (tmax) of trifluridine and tipiracil hydrochloride were around 2 hours and 3 hours, respectively.
Slovenian: Po večkratnih odmerkih zdravila Lonsurf (35 mg/m2/odmerek dvakrat na dan) pri bolnikih z napredovalimi solidnimi tumorji je bil srednji čas do največje plazemske koncentracije (tmax) trifluridina okoli 2 uri, tipiracilijevega klorida pa 3 ure.
English: Overall Survival Number of deaths, N (%) Median OS (months)a [95% CI]b Hazard ratio [95% CI] P-valuec
Slovenian: Preživetje brez napredovanja bolezni Število napredovanj bolezni ali smrti, N (%) Mediana PFS (meseci)a [95-% CI]b Razmerje ogroženosti [95-% CI] Vrednost pc
English: * Common terminology criteria for adverse events Table 4 - Dose reductions according to body surface area (BSA)
Slovenian: * enotna razvrstitev meril neželenih dogodkov (CTCAE - Common Terminology Criteria for Adverse Events)
English: Bone pain
Slovenian: Eλλάδα
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets
Slovenian: Lonsurf 15 mg/6,14 mg filmsko obložene tablete Lonsurf 20 mg/8,19 mg filmsko obložene tablete
English: Pleural effusion Rhinorrhoea Dysphonia Oropharyngeal pain Epistaxis
Slovenian: Jetrna okvara • Blaga jetrna okvara
English: 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.
Slovenian: Tipiracilijev klorid je substrat prenašalca za organske katione OCT2 (OCT2 - Organic Cation Transporter 2) in prenašalca za ekstruzijo več zdravil in toksinov (MATE1 - MultiDrug and Toxin Extrusion 2), zato se lahko njegova koncentracija ob sočasni uporabi zdravila Lonsurf in inhibitorjev OCT2 in MATE1 poveča.
English: Lonsurf 20 mg/8.19 mg film-coated tablets
Slovenian: Lonsurf 20 mg/8,19 mg filmsko obložene tablete
English: Special populations
Slovenian: Etnične skupine