natgillin/translations-raw huggingface dataset:
• Uge 2 - tag dosis 2 gange daglig i 5 dage - derefter 2 dage uden medicin 
• Week 2 - take the dose 2 times a day for 5 days - then have 2 days off - no medicine
Ud af de 533 patientser i RECOURSE-studiet, som fik Lonsurf, havde 306 (57 %) patienter normal nyrefunktion (CrCl ≥ 90 ml/min), 178 (33 %) patienter havde let nedsat nyrefunktion (CrCl 60 til 89 ml/min), og 47 (9 %) havde moderat nedsat nyrefunktion (CrCl 30 til 59 ml/min). 
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.
Det skal du vide, før du begynder at tage Lonsurf 
What you need to know before you take Lonsurf
Median OS var 5,7 måneder (95 % CI: 4,8; 6,2) for Lonsurf-gruppen versus 3,6 måneder (95 % CI: 3,1; 4,1) for placebo-gruppen, med 1-årige overlevelsesrater på henholdsvis 21,2 % og 13,0 %. 
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.
Angina pectoris Arytmi 
Angina pectoris Arrhythmia Palpitations
• inflammation eller øget mængde syre i maven eller spiserøret, halsbrand 
• inflammation or increased acid in your stomach or gullet, reflux
I alt blev 507 patienter randomiseret 2:1 til at få Lonsurf (N = 337) plus den bedste understøttende behandling (BSC) eller placebo (N = 170) plus BSC. Lonsurf-dosis blev administreret på basis af BSA med en startdosis på 35 mg/m2/dosis. 
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.
Patienter med moderat nedsat nyrefunktion bør overvåges oftere for hæmatologisk toksicitet. 
Patients with renal impairment should be monitored closely when being treated with Lonsurf; patients with moderate renal impairment should be more frequently monitored for haematological toxicities.
Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ} 
This leaflet was last revised in
Baseret på en farmakokinetisk populationsanalyse var eksponeringen af Lonsurf hos patienter med let nedsat nyrefunktion (CrCl = 60 til 89 ml/min) den samme som hos patienter med normal nyrefunktion (CrCl ≥ 90 ml/min). 
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).
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Knoglemarvssuppression 
4.4 Special warnings and precautions for use
Lonsurf anbefales ikke til patienter med svært nedsat nyrefunktion (kreatininclearance [CrCl] < 30 ml/min) eller terminal nyresygdom (som kræver dialyse), da Lonsurf ikke er undersøgt hos denne patientgruppe (se pkt. 
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).
• dårlig ånde, huller i tænderne, problemer i tænder eller gummer, blødende gummer, infektioner i gummerne 
• bad breath, tooth decay, tooth or gum problems, bleeding gums, gum infections
C]-tipiracilhydrochlorid blev mindst 27 % af det administrerede tipiracilhydrochlorid absorberet, og 50 % af den totale radioaktive dosis blev målt i fæces, hvilket indikerer moderat gastrointestinal absorption af tipiracilhydrochlorid. 
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.
In vitro studier indikerede, at trifluridin, tipiracilhydrochlorid og FTY (inaktiv metabolit af trifluridin) ikke hæmmer de testede CYP-isoformer (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4/5). 
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).
• rødme, hævelse og smerte i dine håndflader og fodsåler (hånd-fod syndrom) 
• redness, swelling, pain on the palms of your hands and soles of your feet (hand-foot syndrome)
• smerte eller betændelse i øvre eller nedre del af fordøjelseskanalen 
• pain or inflammation in upper or lower part of digestive tract
• unormal stigning eller fald i hjertefrekvensen (pulsen) 
• abnormal increase or decrease in heart rate
Anbefalede dosisjusteringer 
Recommended dose modifications
De identificerede målorganer var lymfesystemet og det hæmatopoietiske system samt mavetarm-kanalen. 
The target organs identified were the lymphatic and haematopoietic systems and the gastrointestinal tract.
Symptomerne omfatter vejrtrækningsbesvær og kortåndethed med hoste eller feber. 
The signs include difficulty in breathing, shortness of breath, with cough or fever.
Trifluridins og tipiracilhydrochlorids farmakokinetik blev evalueret i et specifikt studie hos cancerpatienter med let eller moderat nedsat leverfunktion (National Cancer Institute [NCI] Criteria gruppe B og C) og patienter med normal leverfunktion. 
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.
Efter gentagne doser af Lonsurf i det anbefalede doseringsregime var den gennemsnitlige halveringstid (t1/2) af trifluridin på henholdsvis dag 1 og dag 12 i cyklus 1 1,4 timer og 2,1 timer. 
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.
Efter godkendelse har der været rapporter om interstitiel lungesygdom hos patienter i behandling med Lonsurf. 
There have been reports of interstitial lung disease in patients receiving Lonsurf post approval.
• ophobning af væske i lungerne 
• accumulation of fluid in the lungs
Når en enkelt dosis af Lonsurf på 35 mg/m blev administreret til 14 patienter med solide tumorer efter et standardiseret fedtholdigt og kalorierigt måltid, ændrede trifluridin-AUC sig ikke, men trifluridinCmax og tipiracilhydrochlorid-Cmax og AUC faldt med cirka 40 % sammenlignet med ved faste. 
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.
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Les Laboratoires Servier Industrie 
Name and address of the manufacturer responsible for batch release
Med hensyn til de øvrige eksponeringsparametre for trifluridin og dosisintervallet 20 til 35 mg/m tipiracilhydrochlorid syntes de at være dosisproportionale. 
As for the other exposure parameters of trifluridine and tipiracil hydrochloride, those appeared to be dose proportional.
Hæmoragisk enterocolitis Gastrointestinal blødning Akut pankreatitis Ascites 
Enterocolitis haemorrhagic Gastrointestinal haemorrhage Pancreatitis acute Ascites
Resultater af dyrestudier indikerede ikke en effekt af Lonsurf på hanlig eller hunlig fertilitet (se pkt. 
Results of animal studies did not indicate an effect of Lonsurf on male or female fertility (see section 5.3).
Der blev ikke set korrelation mellem hverken trifluridins eller tipiracilhydrochloids farmakokinetiske parametre og ASAT og/eller total-bilirubin. 
No correlation was seen for trifluridine nor tipiracil hydrochloride between PK parameters and AST or/and total blood bilirubin.
Hazard ratio [95 % CI] 
Hazard ratio [95% CI] P-valuec
Effekten blev også opretholdt hos regorafenib-naive patienter (hazard ratio: 0,69, 95 % CI [0,57 til 0,83]). 
The effect was also maintained in regorafenib-naive patients (hazard ratio: 0.69, 95% CI [0.57 to 0.83]).
Hver filmovertrukket tablet indeholder 90,735 mg lactosemonohydrat. 
Each film-coated tablet contains 90.735 mg of lactose monohydrate.
Stratificeret log-rank test (strata: region, ECOG-status ved baseline, tidligere behandling med ramucirumab) 
a Kaplan-Meier estimates b Methodology of Brookmeyer and Crowley c Stratified log-rank test (strata: region, ECOG status at baseline, prior ramucirumab treatment)
In vitro evaluering viste, at trifluridin, tipiracilhydrochlorid og FTY ikke havde induktiv effekt på human CYP1A2, CYP2B6 eller CYP3A4/5. 
In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP1A2, CYP2B6 or CYP3A4/5.
Niveau 2-dosisreduktion: Fra 30 mg/m til 25 mg/m25 mg/m a 
Level 2 dose reduction: From 30 mg/m2 to 25 mg/m2 25 mg/m2
Mediantiden til forværring af ECOG PS til ≥ 2 var 4,3 måneder for Lonsurf-gruppen versus 2,3 måneder for placebo-gruppen med HR på 0,69 (95 % CI: 0,562; 0,854), p-værdi = 0,0005. 
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.
• Let nedsat nyrefunktion (CrCl 60 til 89 ml/min) og moderat nedsat nyrefunktion (CrCl 30 til 
• Mild renal impairment (CrCl 60 to 89 mL/min) or moderate renal impairment (CrCl 30 to
Tipiracilhydrochlorid blev ikke metaboliseret i en human lever S9-fraktion eller i kryopræserverede humane hepatocytter. 
Tipiracil hydrochloride was not metabolised in human liver S9 or in cryopreserved human hepatocytes.
INFORMATION I BRAILLESKRIFT Lonsurf 20 mg/8,19 mg 
INFORMATION IN BRAILLE Lonsurf 20 mg/8.19 mg
I tillæg blev en højere eksponering for trifluridin og tipiracil observeret hos patienter med moderat nedsat nyrefunktion sammenlignet med patienter med normal eller let nedsat nyrefunktion (se pkt. 
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).
• smertefuld tunge, polypper i munden, mundsår, opkastning 
• painful tongue, polyps inside your mouth, mouth ulcers, retching
C]-tipiracilhydrochlorid var den genfundne radioaktivitet 77 % af dosis og bestod af 27 % urinudskillelse og 50 % fækal udskillelse. 
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.
Tipiracilhydrochlorid er substrat for OCT2 og MATE1, derfor kan koncentrationen blive øget, når Lonsurf administreres samtidig med hæmmere af OCT2 eller MATE1. 
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.
Hver filmovertrukket tablet indeholder 120,980 mg lactosemonohydrat. 
Each film-coated tablet contains 120.980 mg of lactose monohydrate.
Hos de 507 randomiserede patienter var medianalderen 63 år, 73 % var mænd, 70 % var hvide, 16 % var asiater og < 1 % var sorte/afroamerikanere, og alle patienter havde ECOG PS på 0 eller 1 ved baseline. 
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.
Tabel 6 - Effektresultater fra det kliniske fase III-studie (RECOURSE) hos patienter med metastatisk kolorektal cancer 
Table 6 - Efficacy results from the Phase III (RECOURSE) clinical trial in patients with metastatic colorectal cancer
Lungeemboli b 
Pulmonary embolismb
OS- og PFT-fordelen blev konsekvent observeret i alle randomiserede strata og på tværs af de fleste præspecificerede undergrupper, herunder køn, alder (< 65; ≥ 65 år), etnisk oprindelse, ECOG PS, tidligere behandling med ramucirumab, tidligere behandling med irinotecan, antal af tidligere regimer (2; 3; ≥ 4), tidligere gastrektomi, fokus for primær tumor (gastrisk, gastroøsofageal overgang) og HER2-status. 
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.
Neutropenisk sepsis Øvre luftvejsinfektion Konjunktivit 
Neutropenic sepsis Upper respiratory tract infection Conjunctivitis
• Lonsurf 20 mg/8,19 mg er en blegrød, bikonveks, rund, filmovertrukket tablet, præget med “20” på den ene side og “102” og “20 mg” på den anden side med gråt blæk. 
• 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.
Tipiracilhydrochlorid metaboliseres ikke, hverken i en human lever S9-fraktion eller i kryopræserverede hepatocytter. 
Tipiracil hydrochloride is not metabolised in either human liver S9 or cryopreserved hepatocytes.
Emboli Hypertension Hypotension Ansigtsrødme 
Embolism Hypertension Hypotension Flushing
Sådan skal du tage Lonsurf 
How to take Lonsurf
C]-trifluridin blev mindst 57 % af den administrerede trifluridin absorberet, og kun 3 % af dosis blev udskilt i fæces. 
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.
OCT2- og MATE1-medieret transport af tipiracilhydrochlorid kan være påvirket, når Lonsurf administreres samtidig med hæmmere af OCT2 og MATE1. 
Transport of tipiracil hydrochloride by OCT2 and MATE1 might be affected when Lonsurf is administered concomitantly with inhibitors of OCT2 and MATE1.
• fodsvamp - svampeinfektion i fødderne, infektioner forårsaget af gærsvampe 
• athlete's foot - fungal infection of feet, yeast infections
INFORMATION I BRAILLESKRIFT Lonsurf 15 mg/6,14 mg 
INFORMATION IN BRAILLE Lonsurf 15 mg/6.14 mg
Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. 
If you experience any side effects, talk to your doctor or pharmacist.
< 0,0001 (1-sidet og 2-sidet) 
<0.0001 (1-sided and 2-sided)
<0,0001 (1-sidet og 2-sidet) 
< 0.0001 (1-sided and 2-sided)
Administration anbefales ikke til patienter med moderat eller svært nedsat leverfunktion ved baseline (National Cancer Institute [NCI] Criteria gruppe C og D, defineret ved total-bilirubin > 1,5 × ULN), da der er observeret en højere forekomst af hyperbilirubinæmi grad 3 og 4 hos patienter med moderat nedsat leverfunktion ved baseline, selvom dette er baseret på meget begrænsede data (se pkt. 
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).
• Dosisreduktion er tilladt til en minimumdosis på 20 mg/m 2/dosis to gange dagligt • Øg ikke dosis, efter den er reduceret 
• Dose reductions are permitted to a minimum dose of 20 mg/m2/dose twice daily.
effektmål var samlet overlevelse (OS), og støttende effektmål var progressionsfri overlevelse (PFS), samlet responsrate (ORR), sygdomskontrolrate (DCR), tid til forværring af Eastern Cooperative 
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).
Niveau 3-dosisreduktion: Fra 25 mg/m til 20 mg/m20 mg/m a 
Level 3 dose reduction: From 25 mg/m2 to 20 mg/m2 20 mg/m
Lonsurf anbefales ikke til patienter med moderat eller svært nedsat leverfunktion ved baseline (National Cancer Institute [NCI] Criteria gruppe C og D, defineret ved total-bilirubin > 1,5 × ULN), da der er observeret en højere forekomst af hyperbilirubinæmi grad 3 og 4 hos patienter med moderat nedsat leverfunktion ved baseline, selvom dette er baseret på meget begrænsede data (se pkt. 
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).
PFS var signifikant bedre hos patienter, der fik Lonsurf plus BSC sammenlignet med placebo plus BSC (HR på 0,57; 95 % CI [0,47 til 0,70]; p < 0,0001 (se tabel 7, Figur 3 og Figur 4). 
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).
Kolorektal cancer 
Colorectal cancer
Tabel 7 - Effektresultater fra det kliniske fase III-studie (TAGS) hos patienter med metastatisk gastrisk cancer 
Table 7 - Efficacy results from the Phase III (TAGS) clinical trial in patients with metastatic gastric cancer
Abdominalsmerter Obstipation Stomatitis Oral lidelse 
Abdominal pain Constipation Stomatitis Oral disorder
Kinetikken for trifluridin og tipiracilhydrochlorid er ikke undersøgt hos patienter med svært nedsat nyrefunktion eller terminal nyresygdom (se pkt. 
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).
Administration af en enkelt dosis Lonsurf (35 mg/m trifluridin 37 gange og Cmax 22 gange med mindre variabilitet sammenlignet med trifluridin alene 
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).
Lonsurf indeholder lactose og bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption. 
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Gastrektomi 
Gastrectomy
Nedsat vægt 
• weight loss
• mere mærkbare hjerteslag, brystsmerter 
• more noticeable heart-beat, chest pain
Febril neutropeni Lymfopeni 
Febrile neutropenia Lymphopenia
In vitro evaluering indikerede, at trifluridin, tipiracilhydrochlorid og FTY ikke har induktiv effekt på humane CYP-isozymer (se pkt. 
In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP isoforms (see section 5.2).
PFS var signifikant bedre hos patienter, der fik Lonsurf plus BSC (hazard ratio: 0,48; 95 % CI [0,41 til 0,57]; p < 0,0001 (se tabel 6, figur 1 og figur 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).
I alt blev 800 patienter randomiseret 2:1 til at få Lonsurf (N = 534) plus den bedste understøttende behandling (best supportive care, BSC) eller matchende placebo (N = 266) plus BSC. Lonsurf-dosis 
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.
4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Lonsurf påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner. 
Lonsurf has minor influence on the ability to drive and use machines.
Hver tablet indeholder 15 mg trifluridin og 6,14 mg tipiracil 
Each tablet contains 15 mg trifluridine and 6.14 mg tipiracil
Baseret på in vitro studier var hverken trifluridin eller tipiracilhydrochlorid hæmmere af eller substrater for humane optagelses- og effluxtransportører, med undtagelse af OCT2 og MATE1. 
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.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Lonsurf 15 mg/6,14 mg filmovertrukne tabletter 
QUALITATIVE AND QUANTITATIVE COMPOSITION Lonsurf 15 mg/6.14 mg film-coated tablets
Tabletten er en hvid, bikonveks, rund, filmovertrukket tablet med en diameter på 7,1 mm og en tykkelse på 2,7 mm, præget med ”15” på den ene side og ”102” og ”15 mg” på den anden siden med gråt blæk. 
The tablet is a white, biconvex, round, film-coated tablet, with a diameter of 7.1 mm and a thickness of 2.7 mm, imprinted with ‘15' on one side, and ‘102' and '15 mg' on the other side, in grey ink.
• hævelse eller smerter i dine led eller storetæer 
• swelling or pain in your joints or big toes
Muskuloskeletale smerter Muskelsvaghed Muskelspasmer Ekstremitetssmerter 
Musculoskeletal pain Muscular weakness Muscle spasms Pain in extremity
• mundsmerter eller andre problemer fra munden 
• mouth pain or problems
In vitro studier indikerede, at trifluridin, tipiracilhydrochlorid og 5-[trifluormethyl] uracil (FTY) ikke hæmmer aktiviteten af humane CYP-isozymer. 
In vitro studies indicated that trifluridine, tipiracil hydrochloride and 5-[trifluoromethyl] uracil (FTY) did not inhibit the activity of human cytochrome P450 (CYP) isoforms.
Metastatisk kolorektal cancer 
Metastatic colorectal cancer
• løbende næse eller næseblod, problemer med bihulerne 
• runny or bloody nose, sinus problems
• nedsat antal af de hvide blodlegemer, som kaldes lymfocytter - kan øge din risiko for infektion 
• reduced number of white blood cells called lymphocytes - can increase your risk for infection
• røde øjne, kløe i øjet, øjeninfektioner, vandige øjne 
• redness, itching of the eye, eye infections, watery eyes
• knoglesmerter, muskelsmerter, muskelsvaghed eller muskelkramper, smerter i sener, nerver eller ledbånd 
• bone pain, muscle pain, muscle weakness or spasms, pain in tendons, nerves or ligaments
Forhøjet blod-laktatdehydrogenase 
Blood lactate dehydrogenase increased
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1096/004 20 filmovertrukne tabletter 
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1096/004 20 film-coated tablets
- Prægeblæk: Shellac, jernoxid rød (E172), jernoxid gul (E172), titandioxid (E171), indigocarmin (E132), carnaubavoks og talcum. 
- Printing ink: shellac, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine aluminium lake (E132), carnauba wax and talc.
Hazard ratio for progression eller død, 0,48 (95% CI, 0,41-0,57) P<0,0001 ved log-rank test 
Hazard ratio for progression or death, 0.48 (95% CI, 0.41-0.57) P<0.0001 by log-rank test
• Alvorlige problemer i mave-tarm-kanalen: Mavesmerter (almindelig), ansamling af væske i bughulen (ikke almindelig), tyktarmsbetændelse (ikke almindelig), akut betændelse i bugspytkirtlen (ikke almindelig), tarmslyng (ikke almindelig) og delvist hindret tarmpassage (ikke almindelig). 
• Severe gastrointestinal problems: abdominal pain (common), ascites (uncommon), colitis (uncommon), acute pancreatitis (uncommon), ileus (uncommon) and subileus (uncommon).
Gastrisk cancer 
Gastric cancer
Pregelatineret stivelse (majs) Stearinsyre 
Lactose monohydrate Starch, Pregelatinised (Maize) Stearic acid
Hver tablet indeholder 20 mg trifluridin og 8,19 mg tipiracil. 
Each tablet contains 20 mg trifluridine and 8.19 mg tipiracil.
Hazard ratio for død, 0,69 (95 % CI, 0,56-0,85) p=0,0003 (1-sidet); p=0,0006 (2-sidet) 
Hazard ratio for death, 0.69 (95% CI, 0.56-0.85) P=0.0003 (1-sided) ; p =0.0006 (2-sided)