natgillin/translations-raw huggingface dataset:
Tipiracil hydrochloride is not metabolised in either human liver S9 or cryopreserved hepatocytes.
Tipiracilijev klorid se ne presnavlja niti v S9 frakciji humanih jeter niti v krioprezerviranih humanih hepatocitih.
• redness, swelling, pain on the palms of your hands and soles of your feet (hand-foot syndrome)
• pordelost, otekanje in bolečina v dlaneh in podplatih (sindrom roka - noga)
In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP isoforms (see section 5.2).
Vrednotenje in vitro je pokazalo, da trifluridin, tipiracilijev klorid in FTY nimajo inducirajočega učinka na humane izoforme CYP (glejte poglavje 5.2).
In vitro studies indicated that trifluridine is a substrate for the nucleoside transporters CNT1, ENT1 and ENT2.
In vitro študije so pokazale, da je trifluridin substrat koncentracijskega nukleozidnega prenašalca CNT1 (CNT - Concentrative Nucleoside Transporters) in ravnotežnih nukleozidnih prenašalcev ENT1 in ENT2 (ENT - Equilibrative Nucleoside Transporters).
Lonsurf had no clinically relevant effect on QT/QTc prolongation compared with placebo in an open label study in patients with advanced solid tumours.
Zdravilo Lonsurf v odprti študiji pri bolnikih z napredovalimi solidnimi tumorji v primerjavi s placebom ni imelo klinično pomembnih učinkov na podaljšanje intervala QT/QTc.
Each tablet contains 20 mg trifluridine and 8.19 mg tipiracil.
Ena tableta vsebuje 20 mg trifluridina in 8,19 mg tipiracila.
In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP1A2, CYP2B6 or CYP3A4/5.
Vrednotenje in vitro je pokazalo, da trifluridin, tipiracilijev klorid in FTY nimajo inducirajočega učinka na humane CYP1A2, CYP2B6 ali CYPA4/5.
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.
Ta se v celicah nato presnovi v substrat deoksiribonukleinske kisline (DNA), ki se vgradi neposredno v DNA ter tako moti njeno funkcijo in preprečuje celično proliferacijo.
Transport of tipiracil hydrochloride by OCT2 and MATE1 might be affected when Lonsurf is administered concomitantly with inhibitors of OCT2 and MATE1.
Sočasna uporaba zdravila Lonsurf z zaviralci OCT2 in MATE1 lahko vpliva na prenos tipiracilijevega klorida z OCT2 in MATE1.
• raised itchy rash, red skin, blisters, skin sloughing off, hives, acne
• izbočen srbeč izpuščaj, rdeča koža, mehurji, odstopanje kože, koprivnica, akne
Therefore, women of child-bearing potential must use highly effective contraceptive measures while taking Lonsurf and for 6 months after stopping treatment.
Ženske v rodni dobi morajo zato med zdravljenjem in do 6 mesecev po zaključku zdravljenja uporabljati zelo učinkovite metode kontracepcije.
• bone pain, muscle pain, muscle weakness or spasms, pain in tendons, nerves or ligaments
• bolečina v kosteh, mišicah, mišična šibkost ali krči v mišicah, bolečina v kitah, živcih ali ligamentih
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.
Po peroralnem jemanju zdravila Lonsurf s [14C]-trifluridinom se absorbira vsaj 57 % trifluridina in le 3 % odmerka se izloči z blatom.
• sweating more than normal, sensitivity to light, nail problems
• čezmerno potenje, občutljivost na svetlobo, težave z nohti
• runny or bloody nose, sinus problems
• izcedek ali krvavitev iz nosu, težave s sinusi
If you are not sure, talk to your doctor before taking Lonsurf.
Če ste negotovi, se pred jemanjem zdravila Lonsurf posvetujte z zdravnikom.
Level 3 dose reduction: From 25 mg/m2 to 20 mg/m2 20 mg/m
3. raven zmanjšanja odmerka: s 25 mg/m2 na 20 mg/m2 20 mg/m2
Hazard ratio for progression or death, 0.48 (95% CI, 0.41-0.57) P<0.0001 by log-rank test
Razmerje ogroženosti za napredovanje bolezni ali smrt, 0,48 (95-% CI, 0,41 - 0,57) p < 0,0001 test log-rank
There have been reports of interstitial lung disease in patients receiving Lonsurf post approval.
Po odobritvi so pri bolnikih, zdravljenih z zdravilom Lonsurf, poročali o primerih intersticijske bolezni pljuč.
• reduced white blood cells called granulocytes or monocytes - can increase your risk for infection
• znižanje vrednosti belih krvnih celic, imenovanih granulociti ali monociti - kar lahko poveča tveganje za okužbe
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.
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.
The protein binding of trifluridine in human plasma was over 96% and trifluridine bound mainly to human serum albumin.
Vezava trifluridina na beljakovine v plazmi je bila več kot 96-%.
Each tablet contains 15 mg trifluridine and 6.14 mg tipiracil
Ena tableta vsebuje 15 mg trifluridina in 6,14 mg tipiracila.
After single oral administration of Lonsurf with [14C]-trifluridine, the total cumulative excretion of radioactivity was 60% of the administered dose.
Po enkratnem peroralnem odmerku zdravila Lonsurf s [14C]-trifluridina je bilo skupno kumulativno izločene radioaktivnosti 60 % danega odmerka.
• Mild renal impairment (CrCl 60 to 89 mL/min) or moderate renal impairment (CrCl 30 to
• Blaga ledvična okvara (očistek kreatinina od 60 do 89 ml/min) ali zmerna ledvična okvara
Dosing adjustments may be required based on individual safety and tolerability.
Glede na varnost in prenašanje zdravila pri posameznih bolnikih bo morda treba odmerjanje prilagoditi.
Lonsurf plus BSC (N=337)
Lonsurf in BSC (N = 337)
Hazard ratio [95% CI] P-valuec
Razmerje ogroženosti [95-% CI] Vrednost Pc
Hazard ratio for death, 0.69 (95% CI, 0.56-0.85) P=0.0003 (1-sided) ; p =0.0006 (2-sided)
Razmerje ogroženosti za smrt, 0,69 (95% CI, 0,56-0,85) p=0,0003 (enostranska) ; p =0,0006 (dvostranska)
• Thrombocytopenia (very common).
• trombocitopenija (zelo pogosti).
Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.75, 95% CI [0.59 to 0.94]).
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]).
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.
Enainšestdeset odstotkov (61 %, N = 485) vseh randomiziranih bolnikov je prejemalo fluoropirimidin kot del zadnjega režima zdravljenja pred randomizacijo.
Your doctor will do blood tests before each cycle of Lonsurf.
Pred vsakim ciklom zdravljenja z zdravilom Lonsurf bo vaš zdravnik naročil preiskave krvi.
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).
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).
Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.69, 95% CI [0.45 to 1.05]).
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]).
• swelling or pain in your joints or big toes
• oteklina ali bolečina v sklepih ali velikih prstih na nogah
Progression-free Survival Probability (%)
Verjetnost preživetja brez napredovnaja bolezni (%)
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).
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).
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).
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).
Embolism Hypertension Hypotension Flushing
Žilne bolezni embolija hipertenzija hipotenzija vročinski oblivi
Hazard ratio for death, 0.68 (95% CI, 0.58-0.81) P<0.0001
Razmerje ogroženosti za smrt, 0,68 (95-% CI, 0,58 - 0,81) P < 0,0001
Tabulated list of adverse drug reactions
Tabelarični seznam neželenih učinkov
Trifluridine was mainly eliminated by metabolism via TPase to form an inactive metabolite, FTY.
Triflurifin se večinoma izloča s presnovo s TPazo, ki ga pretvori v neaktiven presnovek 5-trifluorometil uracil (FTY).
Metastatic gastric cancer
Metastatski rak želodca
No adjustment of the starting dose is recommended in patients with mild or moderate renal impairment (see sections 4.4 and 5.2).
Pri bolnikih z blago ali zmerno ledvično okvaro ni priporočil glede prilagajanja začetnega odmerka (glejte poglavji 4.4 in 5.2).
The signs include difficulty in breathing, shortness of breath, with cough or fever.
Znaki vključujejo težko dihanje, zasoplost s kašljem ali zvišano telesno temperaturo.
• cough, feeling short of breath, infection of the sinuses, throat, airway or lungs, chest infections
• kašelj, zasoplost, vnetje sinusov, žrela, dihalnih poti ali pljuč, okužbe v prsnem košu
• inflammation or infection of bile ducts, increase in the diameter of the bile duct
• vnetje ali okužba žolčevodov, povečanje premera žolčevodov
c. Hand-foot skin reaction.
c kožna reakcija na dlaneh in stopalih
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.
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.
• feeling dizzy, headache
• omotica, glavobol
Common: may affect up to 1 in 10 people:
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
• gastrointestinal problems.
• prebavne težave.
Musculoskeletal pain Muscular weakness Muscle spasms Pain in extremity
Bolezni mišičnoskeletnega sistema in vezivnega tkiva otekanje sklepov artralgija bolečina v kosteh mialgija mišično-skeletna bolečina mišična oslabelost mišični krči bolečina v okončinah
• reduced white blood cells called leucocytes - can increase your risk for infection
• znižanje vrednosti belih krvnih celic, imenovanih levkociti - kar lahko poveča tveganje za okužbe.
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).
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).
• more noticeable heart-beat, chest pain
• bolj izrazit srčni utrip, bolečina v prsnem košu
KRAS status was wild (49%) or mutant (51%) at study entry.
Ob vključitvi v klinično študijo je imelo 49 % bolnikov divji tip gena KRAS, 51 % bolnikov pa mutirani gen KRAS.
It is not known whether Lonsurf changes your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni znano, ali zdravilo Lonsurf spremeni vašo sposobnost upravljanja vozil in strojev.
• feeling of numbness or pins and needles in hands or feet
• občutek otrplosti ali mravljinčenja v dlaneh ali stopalih
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.
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.
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.
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.
6.6 Special precautions for disposal and other handling Hands should be washed after handling the tablets.
Po rokovanju s tabletami si je treba umiti roke.
Pancytopenia Granulocytopenia Monocytopenia Erythropenia Leukocytosis Monocytosis
Bolezni krvi in limfatičnega sistema nevtropenija levkopenija anemija trombocitopenija febrilna nevtropenija limfopenija pancitopenija granulocitopenija monocitopenija eritropenija levkocitoza monocitoza
Do not drive or use any tools or machines if you experience symptoms that affect your ability to concentrate and react.
Če občutite simptome, ki vplivajo na vašo zbranost in odzivnost, ne vozite in ne upravljajte z orodji ali s stroji.
Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy (see section 4.8).
Pred začetkom zdravljenja in med njim je priporočljivo spremljanje proteinurije z urinskimi testnimi lističi (glejte poglavje 4.8).
LIST OF EXCIPIENTS Contains lactose monohydrate, see leaflet for further information.
SEZNAM POMOŽNIH SNOVI Zdravilo vsebuje laktozo monohidrat.
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.
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 %.
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.
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.
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.
(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.
• 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.
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.
What Lonsurf contains Lonsurf 15 mg/6.14 mg tablet
Kaj vsebuje zdravilo Lonsurf Lonsurf 15 mg/6,14 mg tableta
Table 5 - Adverse drug reactions reported in clinical trials in patients treated with Lonsurf System Organ Class (MedDRA)a
Preglednica 5 - Neželeni učinki, o katerih so poročali v kliničnem preskušanjih pri bolnikih zdravljenih z zdravilom Lonsurf
You and your partner should use effective methods of contraception while taking this medicine.
Med jemanjem tega zdravila in še 6 mesecev po zaključenem zdravljenju morate vi in vaš partner uporabljati učinkovito kontracepcijsko metodo.
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).
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 %).
Decreased appetite Hypoalbuminaemia Dehydration Hyperglycaemia
Presnovne in prehranske motnje zmanjšan apetit hipoalbuminemija dehidracija hiperglikemija hiperkaliemija hipokaliemija hipofosfatemija hipernatriemia hiponatriemija hipoglikemija protin
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.
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 %.
Dose modifications (delay and/or reduction) should be applied as necessary (see section 4.2).
Če je potrebno, prilagodite odmerke (zakasnite in/ali zmanjšajte odmerek).
How much to take
Koliko tablet zdravila vzeti
Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Lonsurf 15 mg/6,14 mg filmsko obložene tablete Lonsurf 20 mg/8,19 mg filmsko obložene tablete trifluridin/tipiracil
Neurotoxicity Dysaesthesia Hyperaesthesia Hypoaesthesia Syncope
Bolezni živčevja disgevzija periferna nevropatija nevrotoksičnost disestezija hiperestezija hipoestezija sinkopa parestezije pekoč občutek letargija omotica glavobol
The effect was also maintained in regorafenib-naive patients (hazard ratio: 0.69, 95% CI [0.57 to 0.83]).
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]).
• reduced number of white blood cells called lymphocytes - can increase your risk for infection
• znižanje vrednosti belih krvnih celic, imenovanih limfociti - kar lahko poveča tveganje za okužbe
NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg tablets trifluridine/tipiracil
IME ZDRAVILA Lonsurf 15 mg/6,14 mg tablete trifluridin/tipiracil
• inflammation and infection in your gut
• vnetje in okužba črevesja
Visual acuity reduced Vision blurred Diplopia
Očesne bolezni zmanjšana ostrina vida zamegljen vid diplopija katarakta suho oko
No adjustment of the starting dose is required on the basis of patient's race (see sections 5.1 and 5.2).
Začetnega odmerka ni treba prilagajati glede na etnično skupino (glejte poglavji 5.1 in 5.2).
If you experience any side effects, talk to your doctor or pharmacist.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
How to store Lonsurf
Shranjevanje zdravila Lonsurf
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.
Če je to klinično indicirano, je potrebna uporaba antiemetikov, antidiaroikov ter drugih ukrepov, kot je nadomeščanje tekočin in elektrolitov.
NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg tablets trifluridine/tipiracil
IME ZDRAVILA Lonsurf 20 mg/8,19 mg tablete trifluridin/tipiracil
This is because zidovudine may not work as well if you are taking Lonsurf.
Če jemljete zdravilo Lonsurf, zidovudin namreč lahko ne deluje dovolj dobro.
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.
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.
Feeling of body temperature change Xerosis
• zvišana telesna temperatura
Tipiracil hydrochloride was the major component and 6-hydroxymethyluracil was the major metabolite consistently in human plasma, urine, and faeces.
Glavna sestavina v humani plazmi, urinu in blatu je bil v vseh primerih tipiracilijev klorid, glavni presnovek pa 6-hidroksimetiluracil.
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.
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 %).
• 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.
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.
INFORMATION IN BRAILLE Lonsurf 15 mg/6.14 mg
Lonsurf 15 mg/6.14 mg
• inflammation or infection in your bladder
• vnetje ali okužba mehurja
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.
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.