natgillin/translations-raw huggingface dataset:
Such medicinal products, if used concomitantly with Lonsurf, may compete with the effector, trifluridine, for activation via thymidine kinases.
Omenjena zdravila lahko ob sočasni uporabi zdravila Lonsurf tekmujejo z efektorjem trifluridinom za aktivacijo prek timidin-kinaze.
• Trifluridine stops the growth of cancer cells.
• Trifluridin zavira rast rakavih celic.
• Wash your hands after handling this medicine.
• Po rokovanju s tabletami zdravila si umijte roke.
• increased liver enzymes
• zvišanje jetrnih encimov
• CTCAE* non-haematologic Grade 3 or Grade 4 adverse reaction; except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or diarrhoea responsive to antidiarrhoeal medicinal products
• Nehematološki neželeni učinek 3. ali 4. stopnje po CTCAE*; razen navzee in/ali bruhanja 3. stopnje, ki ju lahko nadzorujete z antiemetičnim zdravljenjem, ali diareje, ki se odziva na antidiaroike.
Your doctor will be looking out for these side effects in your test results.
Vaš zdravnik bo prek vaših izvidov preiskav spremljal te neželene učinke.
• increased lactate dehydrogenase level in your blood
• zvišanje vrednosti laktatne dehidrogenaze v krvi
There are no data available on the effects of Lonsurf on human fertility.
Podatkov o vplivu zdravila Lonsurf na plodnost pri ljudeh ni na voljo.
Talk to your doctor about whether to switch to a different HIV medicine.
Posvetujte se z zdravnikom, ali je potrebna menjava zdravila za zdravljenje okužbe z virusom HIV.
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.
Neželeni učinki, o katerih so poročali pri 533 zdravljenih bolnikih z metastatskim kolorektalnim rakomv preskušanju III. faze (RECOURSE), nadzorovanem s placebom, in 335 zdravljenih bolnikih z metastatskim rakom želodca v preskušanju III. faze (TAGS), nadzorovanem s placebom, so navedeni v Preglednici 5.
Number of deaths, N (%) Median OS (months)a [95% CI]b
Število smrti, N (%) Mediana OS (meseci)a [95-% CI]b
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvi PSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
The increases in the corpus luteum count and implanting embryo count observed in female rats at high doses were not considered adverse (see section 4.6).
Povečanje števila rumenih telesc in števila vsajenih embrijev, ki so ga opazili pri podganjih samicah pri velikih odmerkih, ni bilo ocenjeno kot škodljivo (glejte poglavje 4.6).
Do not breast-feed if you are taking Lonsurf as it is not known whether Lonsurf passes into the mother's milk.
Med zdravljenjem z zdravilom Lonsurf ne smete dojiti, saj ni znano, ali zdravilo Lonsurf prehaja v materino mleko.
Marketing Authorisation Holder Les Laboratoires Servier 50 rue Carnot
Imetnik dovoljenja za promet z zdravilom Les Laboratoires Servier 50, rue Carnot
Fatigue, dizziness or malaise may occur during treatment (see section 4.8).
Med zdravljenjem se lahko pojavijo utrujenost, omotica ali splošno slabo počutje (glejte poglavje 4.8).
Interruption criteria
Kriterij za prekinitev zdravljenja
• The active substances are trifluridine and tipiracil.
• Zdravilni učinkovini sta trifluridin in tipiracil.
There is no relevant use of Lonsurf in the paediatric population for the indications of metastatic colorectal cancer and metastatic gastric cancer.
Zdravilo Lonsurf ni namenjeno za uporabo pri pediatrični populaciji za indikaciji metastatskega kolorektalnega raka in metastatskega raka želodca.
A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 twice daily.
Dovoljena so največ 3 zmanjšanja odmerka na najmanjši odmerek 20 mg/m2 dvakrat dnevno.
The signs include unusual bruising or bleeding (see section 2).
Znaki vključujejo neobičajne modrice ali krvavitve (glejte poglavje 2);
Lonsurf is a type of cancer chemotherapy which belongs to the group of medicines called "cytostatic antimetabolite medicines".
Zdravilo Lonsurf je vrsta kemoterapije za zdravljenje raka, ki spada v skupino zdravil, ki se imenujejo citostatiki (antimetaboliti).
It is unknown whether Lonsurf or its metabolites are excreted in human milk.
Ni znano, ali se zdravilo Lonsurf ali njegovi presnovki izločajo v materino mleko.
The absorbed trifluridine was metabolised, and excreted into urine as FTY and trifluridine glucuronide isomers.
Absorbirani trifluridin se presnovi in izloči v urin kot FTY in izomere glukuronidov trifluridina.
All patients received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Vsi bolniki so prej prejemali kemoterapijo na osnovi fluoropirimidina, oksaliplatina in irinotekana.
• high blood sugar (hyperglycaemia), increased salt, urea, creatinine and potassium in your blood
• visok krvni sladkor (hiperglikemija), zvišanje vrednosti soli, sečnine, kreatinina in kalija v krvi
• abnormal increase or decrease in heart rate
• nenormalno povečanje ali zmanjšanje srčne frekvence
Based on the population PK analysis, liver function parameters including alkaline phosphatase (ALP, 36-2322 U/L), aspartate aminotransferase (AST, 11-197 U/L), alanine aminotransferase (ALT, 5-182 U/L) , and total bilirubin (0.17-3.20 mg/dL) were not significant covariates for PK parameters of either trifluridine or tipiracil hydrochloride.
Na podlagi populacijske farmakokinetične analize parametri spremljanja delovanja jeter, vključno z alkalno fosfatazo (AF, 36 - 2322 U/l), aspartat-aminotransferazo (AST, 11 - 197 U/l), alanin-aminotransferazo (ALT, 5 - 182 U/l) in celotnim bilirubinom (0,17 - 3,20 mg/dl), niso bili hkratne spremenljivke farmakokinetičnih parametrov niti trifluridina niti tipiracilijevega klorida.
Given that the majority were reported in the context of bone marrow suppression, the patient's condition should be monitored closely, and appropriate measures, such as antimicrobial agents and granulocyte-colony stimulating factor (G-CSF), should be administered as clinically indicated.
O večini so poročali v povezavi s supresijo kostnega mozga, zato morate stanje bolnika pozorno spremljati in uporabiti ustrezne ukrepe, ko so protimikrobna zdravila in granulocitne kolonije stimulirajoči faktor (G-CSF), če je to klinično indicirano.
No peri/post-natal developmental toxicity studies have been performed.
Študij toksičnosti na perinatalni in postnatalni razvoj niso izvedli.
50a a At a total daily dose of 50 mg, patients should take 1 x 20 mg/8.19 mg tablet in the morning and 2 x 15 mg/6.14 mg tablets in the evening.
50a a Pri celotnem dnevnem odmerku 50 mg mora bolnik vzeti eno 20 mg/8,19 mg tableto zjutraj in dve 15 mg/6,14 mg tableti zvečer.
The cytotoxic activity of trifluridine/tipiracil hydrochloride against several human tumour xenografts correlated highly with the amount of trifluridine incorporated into DNA, suggesting this as the primary mechanism of action.
Citotoksična učinkovitost trifluridina/tipiracilijevega klorida proti različnim humanim tumorskim ksenotransplantatom je močno sovpadala s količino trifluridina, vgrajenega v DNA, kar nakazuje, da je to primarni mehanizem delovanja.
Plasma protein binding of tipiracil hydrochloride was below 8%.
Vezava tipiracilijevega klorida na beljakovine v plazmi je bila manj kot 8-%.
The signs include shortness of breath and pain in the chest or in the legs.
Znaki vključujejo zasoplost in bolečino v prsih ali nogah;
Trifluridine is a substrate of TPase, but is not metabolised by cytochrome P450 (CYP).
Trifluridin je substrat TPaze, a se ne presnavlja s citokromom P450 (CYP).
In the Phase III clinical trials, treatment-related infections occurred more frequently in Lonsurf-treated patients (5.8%) compared to those receiving placebo (1.8%).
V kliničnih preskušanjih III. faze so se okužbe, povezane z zdravljenjem, pojavljale pogosteje v skupini, zdravljeni z zdravilom Lonsurf (5,8 %), kot pri skupini, ki je prejemala placebo (1,8 %).
Based on findings in animals, trifluridine may cause foetal harm when administered to pregnant women.
Na osnovi izkušenj pri živalih lahko trifluridin škoduje plodu, če ga jemlje nosečnica.
• Severe gastrointestinal problems: abdominal pain (common), ascites (uncommon), colitis (uncommon), acute pancreatitis (uncommon), ileus (uncommon) and subileus (uncommon).
• hude prebavne težave: bolečina v trebuhu (pogosti), ascites (občasni), kolitis (občasni), akutni pankreatitis (občasni), ileus (občasni) in subileus (občasni).
Table 3 - Recommended dose modifications for Lonsurf in case of haematological and non-haematological adverse reactions
Preglednica 3 - Priporočene spremembe odmerkov zdravila Lonsurf v primeru hematoloških in nehematoloških neželenih učinkov Neželeni učinek
Nearly all (99.8%) patients received prior fluoropyrimidine, 100% received prior platinum therapy and 90.5% received prior taxane therapy.
Skoraj vsi bolniki (99,8 %) so prej prejemali fluoropirimidine, 100 % jih je prej prejemalo zdravljenje na osnovi platine in 90,5 % jih je prej prejemalo zdravljenje na osnovi taksanov.
Table 2 - Dose interruption and resumption criteria for haematological toxicities related to myelosuppression
Preglednica 2 - Kriteriji za prekinitev zdravljenja in ponovno uvedbo odmerka zaradi hematološke toksičnosti, povezane z mielosupresijo
The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (RECOURSE) in patients with previously treated metastatic colorectal cancer.
Klinično učinkovitost in varnost zdravila Lonsurf so ovrednotili v mednarodni, randomizirani, dvojno slepi, s placebom nadzorovani študiji III. faze (RECOURSE) pri bolnikih z metastatskim kolorektalnim rakom, ki so bili predhodno že zdravljeni.
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA citotoksično zdravilo
• low levels of phosphates, sodium, potassium or calcium in your blood
• nizke vrednosti fosfatov, natrija, kalija ali kalcija v krvi
Very common: may affect more than 1 in 10 people:
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
Each film-coated tablet contains 90.735 mg of lactose monohydrate.
Ena filmsko obložena tableta vsebuje 90,735 mg laktoze monohidrata.
Approximately half (55.4%) of patients received prior irinotecan, 33.3% received prior ramucirumab, and 16.6% received prior HER2-targeted therapy.
Približno polovica bolnikov (55,4 %) je prej prejemalo irinotekan, 33,3 % jih je prej prejemalo ramucirumab in 16,6 % bolnikov je prej prejemalo tarčno zdravljenje proti HER2.
Treatment must not be started if the absolute neutrophil count is < 1.5 ×109/L, if the platelet counts are < 75× 109/L, or if the patient has an unresolved Grade 3 or 4 non-haematological clinically relevant toxicity from prior therapies.
Zdravljenja ne smete začeti, če je absolutno število nevtrofilcev  1,5 x 109/l, če je število trombocitov  75 x 109/l ali če se je pri bolniku zaradi predhodnih zdravljenj pojavila klinično pomembna nehematološka toksičnost 3. ali 4. stopnje, ki še traja.
The most frequently observed adverse drug reactions (≥ 30%) in patients receiving Lonsurf are neutropenia (53% [34% ≥ Grade 3]), nausea (34% [1% ≥ Grade 3]), fatigue (32% [4% ≥ Grade 3]), anaemia (32% [12% ≥ Grade 3]).
Najpogosteje opaženi neželeni učinki (≥ 30 %) pri bolnikih, zdravljenih z zdravilom Lonsurf, so nevtropenija (53 % [34 % ≥ 3. stopnjo]), navzea (34 % [1 % ≥ 3. stopnjo], utrujenost (32 % [4 % ≥ 3. stopnjo], anemija (32 % [12 % ≥ 3. stopnjo]).
The ORR (complete response + partial response) was not significantly higher in patients treated with Lonsurf (4.5% vs 2.1 %, p-value = 0.2833) but the DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Lonsurf (44.1% vs 14.5%, p < 0.0001).
ORR (popoln odziv + delni odziv) ni bil bistveno večji pri bolnikih, zdravljenih z zdravilom Lonsurf (4,5 % v primerjavi z 2,1 %, p-vrednost = 0,2833), vendar je bil DCR (popoln odziv ali delni odziv ali stabilna bolezen) značilno višji pri bolnikih, zdravljenih z zdravilom Lonsurf (44,1 % v primerjavi s 14,5 %, p < 0,0001).
• CTCAE* Grade 4 neutropenia (< 0.5 x 109/L) or thrombocytopenia (< 25 × 109/L) that results in more than 1 week's delay in start of next cycle
• Nevtropenija (< 0,5 x 109/l) ali trombocitopenija (< 25 x 109/l) 4. stopnje po CTCAE*, ki ima za posledico vsaj 1-tedensko zakasnitev začetka naslednjega cikla zdravljenja.
There is no known antidote for an overdose of Lonsurf.
Specifični antidot za preveliko odmerjanje zdravila Lonsurf ni znan.
Complete blood cell counts must be obtained prior to initiation of therapy and as needed to monitor toxicity, but at a minimum, prior to each treatment cycle.
Pred uvedbo zdravljenja in po potrebi za spremljanje toksičnosti zdravila, najmanj pred vsakim ciklom zdravljenja, je treba pregledati celotno krvno sliko.
0.0003 (1-sided), 0.0006 (2-sided)
0,0003 (enostranska), 0,0006 (obojestranska)
The European Medicines Agency has waived the obligation to submit the results of studies with Lonsurf in all subsets of the paediatric population in refractory metastatic colorectal cancer and in refractory metastatic gastric cancer (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Lonsurf za eno ali več podskupin pediatrične populacije pri zdravljenju neodzivnega metastatskega kolorektalnega raka in neodzivnega metastatskega raka želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The recommended starting dose of Lonsurf in adults is 35 mg/m2/dose administered orally twice daily on Days 1 to 5 and Days 8 to 12 of each 28-day cycle as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4).
Priporočeni začetni odmerek zdravila Lonsurf pri odraslih je 35 mg/m2/odmerek peroralno dvakrat dnevno na 1. do 5. dan in 8. do 12. dan vsakega 28-dnevnega cikla zdravljenja, dokler je mogoče opaziti klinično korist oziroma dokler se ne pojavijo nesprejemljivi toksični učinki (glejte poglavje
Lonsurf should be prescribed by physicians experienced in the administration of anticancer therapy.
Zdravilo Lonsurf mora predpisati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
Recommended dose adjustments
Priporočene prilagoditve odmerka
In addition, a higher exposure of trifluridine and tipiracil was observed in patients with moderate renal impairment, compared with patients with normal renal function or patients with mild renal impairment (see section 5.2).
Dodatno so opazili tudi večjo izpostavljenost trifluridinu in tipiracilu pri bolnikih z zmerno ledvično okvaro v primerjavi z bolniki z normalnim ledvičnim delovanjem ali z blago ledvično okvaro (glejte poglavje 5.2).
You can help by reporting any side effects you may experience.
Tudi sami lahko k temu prispevate tako, da poročate o katerem koli neželenem učinku zdravila, ki bi se utegnil pojaviti pri vas.
• pain or inflammation in upper or lower part of digestive tract
• bolečina ali vnetje v zgornjem ali spodnjem delu prebavnega trakta
Study treatment was administered orally twice daily after morning and evening meals for 5 days a week with 2 days rest for 2 weeks, followed by 14 days rest, repeated every 4 weeks.
Preučevano zdravilo so bolniki s ponovitvijo vsake štiri tedne jemali peroralno dvakrat na dan po jutranjem in večernem obroku 5 dni na teden z 2-dnevnim premorom 2 tedna, ki jima je sledilo 14 dni brez zdravljenja.
If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Lonsurf.
Če karkoli od zgoraj naštetega velja za vas (oz. niste prepričani, ali se nanaša na vas), se pred jemanjem zdravila Lonsurf posvetujte z zdravnikom ali farmacevtom.
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 filmsko obloženih tablet EU/1/16/1096/002 40 filmsko obloženih tablet EU/1/16/1096/003 60 filmsko obloženih tablet
Tablets per dose (2x daily)
Število tablet na odmerek (2-krat dnevno)
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).
Zdravilo Lonsurf uporabljamo za zdravljenje odraslih z rakom kolona ali rektuma - t.i. kolorektalnim rakom in rakom želodca (vključno z rakom prehoda med požiralnikom in želodcem).
Men with a partner of child-bearing potential must use effective contraception during treatment and for up to 6 months after discontinuation of treatment.
Moški, katerih partnerice so v rodni dobi, morajo uporabljati učinkovito metodo kontracepcije med zdravljenjem in do 6 mesecev po zaključku zdravljenja.
• feeling of being cold
• občutek mraza
• accumulation of fluid in the lungs
• nabiranje tekočine v pljučih
• Interstitial lung disease has been reported in patients receiving the medicine.
• pri bolnikih, ki so prejemali zdravilo, so poročali o intersticijski bolezni pljuč.
What Lonsurf looks like and contents of the pack
Izgled zdravila Lonsurf in vsebina pakiranja
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.
Razpolovni čas izločanja (t1/2) in razmerje akumulacije trifluridina in tipiracilijevega klorida sta bila pri bolnikih z zmerno, blago jetrno okvaro in normalnim jetrnim delovanjem podobna.
a Kaplan-Meier estimates b Methodology of Brookmeyer and Crowley c Stratified log-rank test (strata: KRAS status, time since diagnosis of first metastasis, region)
a ocena po metodi Kaplan-Meier b metodologija Brookmeyer in Crowley c stratificirani test log-rank (stratificiran glede na: status gena KRAS, čas od prve diagnoze metastatske bolezni, regija)
As for the other exposure parameters of trifluridine and tipiracil hydrochloride, those appeared to be dose proportional.
Drugi parametri izpostavljenosti trifluridinu in tipiracilijevemu kloridu naj bi bili sorazmerni z odmerkom.
Estimated (CrCl) was a significant covariate for CL/F in both final models of trifluridine and tipiracil hydrochloride.
Ocenjeni očistek kreatinina je bil pomembna hkratna spremenljivka peroralnega očistka (CL/F) pri obeh končnih modelih trifluridina in tipiracilijevega klorida.
• mouth pain or problems
• bolečina ali težave v ustih
No adjustment of the starting dose is required in patients ≥ 65 years old (see sections 4.8, 5.1 and 5.2).
Prilagoditev začetnega odmerka pri bolnikih ≥ 65 let ni potrebna (glejte poglavja 4.8, 5.1 in 5.2).
Each film-coated tablet contains 120.980 mg of lactose monohydrate.
Ena filmsko obložena tableta vsebuje 120,980 mg laktoze monohidrata.
However, there was no accumulation for tipiracil hydrochloride, and no further accumulation of trifluridine with successive cycles (Day 12 of Cycles 2 and 3) of administration of Lonsurf.
Akumulacije tipiracilijevega klorida in nadaljnje akumulacije trifluridina z nadaljnjimi cikli (12. dan 2. in 3. cikla) zdravljenja z zdravilom Lonsurf ni bilo.
This is because Lonsurf can affect the way some other medicines work.
Zdravilo Lonsurf namreč lahko vpliva na delovanje nekaterih zdravil.
Lonsurf comes in two strengths.
Zdravilo Lonsurf je na voljo v dveh jakostih.
Serious infections have been reported following treatment with Lonsurf (see section 4.8).
Med zdravljenjem z zdravilom Lonsurf so poročali o resnih okužbah (glejte poglavje 4.8).
The signs include chills, fever, sweating or other sign of bacterial or fungal infection (see section 2).
Znaki vključujejo mrazenje, zvišano telesno temperaturo, potenje ali druge znake bakterijske ali glivične okužbe (glejte poglavje 2);
a Kaplan-Meier estimates b Methodology of Brookmeyer and Crowley c Stratified log-rank test (strata: region, ECOG status at baseline, prior ramucirumab treatment)
a ocena po metodi Kaplan-Meier b metodologija Brookmeyer in Crowley c stratificirani test log-rank (stratificiran glede na: regijo, izhodiščno stanje ECOG, pred zdravljenjem z ramucirumabom)
• Dose reductions are permitted to a minimum dose of 20 mg/m2/dose twice daily.
• Zmanjšanja odmerka so dovoljena do najnižjega odmerka 20 mg/m2/odmerek dvakrat dnevno.
• Week 2 - take the dose 2 times a day for 5 days - then have 2 days off - no medicine
• 2. teden - Odmerek jemljite 5 dni 2-krat na dan. - Nato imate 2 dni premora - brez zdravila.
Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease (see section 5.1).
Zdravilo Lonsurf je indicirano v monoterapiji za zdravljenje odraslih bolnikov z metastatskim rakom želodca vključno z adenokarcinomom gastro-ezofagealnega prehoda, ki so bili predhodno že zdravljeni z najmanj dvema sistemskima režimoma zdravljenja za napredovalo bolezen (glejte poglavje 5.1).
The following side effects may happen with this medicine:
Pri jemanju tega zdravila se lahko pojavijo naslednji neželeni učinki:
The OS and PFS benefit was observed consistently, in all relevant pre-specified subgroups, including race, geographic region, age (< 65; ≥ 65), sex, ECOG PS, KRAS status, time since diagnosis of first metastasis, number of metastatic sites, and primary tumour site.
Podaljšanje OS in PFS so dosledno pokazali v vseh ustreznih predhodno določenih podskupinah vključno glede na etnično pripadnost, geografsko regijo, starost (< 65; ≥ 65), spol, PS po ECOG, status KRAS, čas od prve diagnoze metastatske bolezni, število mest metastaz in mesto primarnega tumorja.
• Week 1 - take the dose 2 times a day for 5 days - then have 2 days off - no medicine
• 1. teden - Odmerek jemljite 5 dni 2-krat na dan. - Nato imate 2 dni premora - brez zdravila.
• inflammation or increased acid in your stomach or gullet, reflux
• vnetje ali povečano izločanje kisline v želodcu ali požiralniku, refluks
In nonclinical studies, trifluridine/tipiracil hydrochloride demonstrated antitumour activity against both 5-fluorouracil (5-FU) sensitive and resistant colorectal cancer cell lines.
V predkliničnih študijah je kombinacija trifluridin/tipiracilijev klorid pokazala protitumorno delovanje pri celičnih linijah kolorektalnega raka, tako pri občutljivih kot rezistentnih na 5-fluorouracil (5-FU).
Patients continued therapy until disease progression or unacceptable toxicity (see section 4.2).
Bolniki so z zdravljenjem nadaljevali do napredovanja bolezni ali nesprejemljivih toksičnih učinkov (glejte poglavje 4.2).
The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (TAGS) in patients with previously treated metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction), who had been previously treated with at least two prior systemic treatment regimens for advanced disease, including fluoropyrimidine-, platinum-, and either taxane- or irinotecan-based chemotherapy, plus if appropriate human epidermal growth factor receptor 2 (HER2) -targeted therapy.
Klinično učinkovitost in varnost zdravila Lonsurf so ovrednotili v mednarodni, randomizirani, dvojno slepi, s placebom nadzorovani študiji III. faze (TAGS) pri bolnikih s predhodno zdravljenim metastatskim rakom želodca (vključujoč adenokarcinomom gastroezofagealnega prehoda), ki so bili predhodno zdravljeni z vsaj dvema sistemskima oblikama zdravljenja za napredovalo bolezen vključujoč kemoterapijo na osnovi fluoropirimidinov, platine in bodisi taksanov ali irinotekana ter z dodanim tarčnim zdravljenjem proti receptorjem humanega epidermalnega rastnega dejavnika 2 (HER2), če je bilo potrebno.