FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Neutropenic sepsis Upper respiratory tract infection Conjunctivitis
Danish: Neutropenisk sepsis Øvre luftvejsinfektion Konjunktivit
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.
Danish: • 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.
English: Tipiracil hydrochloride is not metabolised in either human liver S9 or cryopreserved hepatocytes.
Danish: Tipiracilhydrochlorid metaboliseres ikke, hverken i en human lever S9-fraktion eller i kryopræserverede hepatocytter.
English: Embolism Hypertension Hypotension Flushing
Danish: Emboli Hypertension Hypotension Ansigtsrødme
English: How to take Lonsurf
Danish: Sådan skal du tage Lonsurf
English: 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.
Danish: C]-trifluridin blev mindst 57 % af den administrerede trifluridin absorberet, og kun 3 % af dosis blev udskilt i fæces.
English: Transport of tipiracil hydrochloride by OCT2 and MATE1 might be affected when Lonsurf is administered concomitantly with inhibitors of OCT2 and MATE1.
Danish: OCT2- og MATE1-medieret transport af tipiracilhydrochlorid kan være påvirket, når Lonsurf administreres samtidig med hæmmere af OCT2 og MATE1.
English: • athlete's foot - fungal infection of feet, yeast infections
Danish: • fodsvamp - svampeinfektion i fødderne, infektioner forårsaget af gærsvampe
English: INFORMATION IN BRAILLE Lonsurf 15 mg/6.14 mg
Danish: INFORMATION I BRAILLESKRIFT Lonsurf 15 mg/6,14 mg
English: If you experience any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: <0.0001 (1-sided and 2-sided)
Danish: < 0,0001 (1-sidet og 2-sidet)
English: < 0.0001 (1-sided and 2-sided)
Danish: <0,0001 (1-sidet og 2-sidet)
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).
Danish: 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.
English: • Dose reductions are permitted to a minimum dose of 20 mg/m2/dose twice daily.
Danish: • Dosisreduktion er tilladt til en minimumdosis på 20 mg/m 2/dosis to gange dagligt • Øg ikke dosis, efter den er reduceret
English: 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).
Danish: effektmål var samlet overlevelse (OS), og støttende effektmål var progressionsfri overlevelse (PFS), samlet responsrate (ORR), sygdomskontrolrate (DCR), tid til forværring af Eastern Cooperative
English: Level 3 dose reduction: From 25 mg/m2 to 20 mg/m2 20 mg/m
Danish: Niveau 3-dosisreduktion: Fra 25 mg/m til 20 mg/m20 mg/m a
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).
Danish: 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.
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).
Danish: 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).
English: Colorectal cancer
Danish: Kolorektal cancer
English: Table 7 - Efficacy results from the Phase III (TAGS) clinical trial in patients with metastatic gastric cancer
Danish: Tabel 7 - Effektresultater fra det kliniske fase III-studie (TAGS) hos patienter med metastatisk gastrisk cancer
English: Abdominal pain Constipation Stomatitis Oral disorder
Danish: Abdominalsmerter Obstipation Stomatitis Oral lidelse
English: 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).
Danish: Kinetikken for trifluridin og tipiracilhydrochlorid er ikke undersøgt hos patienter med svært nedsat nyrefunktion eller terminal nyresygdom (se pkt.
English: 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).
Danish: Administration af en enkelt dosis Lonsurf (35 mg/m trifluridin 37 gange og Cmax 22 gange med mindre variabilitet sammenlignet med trifluridin alene
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Lonsurf indeholder lactose og bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Gastrectomy
Danish: Gastrektomi
English: • weight loss
Danish: Nedsat vægt
English: • more noticeable heart-beat, chest pain
Danish: • mere mærkbare hjerteslag, brystsmerter
English: Febrile neutropenia Lymphopenia
Danish: Febril neutropeni Lymfopeni
English: 1a
Danish: 1a a
English: In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP isoforms (see section 5.2).
Danish: In vitro evaluering indikerede, at trifluridin, tipiracilhydrochlorid og FTY ikke har induktiv effekt på humane CYP-isozymer (se pkt.
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).
Danish: 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).
English: 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.
Danish: 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
English: Lonsurf has minor influence on the ability to drive and use machines.
Danish: 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.
English: Each tablet contains 15 mg trifluridine and 6.14 mg tipiracil
Danish: Hver tablet indeholder 15 mg trifluridin og 6,14 mg tipiracil
English: 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.
Danish: 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.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Lonsurf 15 mg/6.14 mg film-coated tablets
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Lonsurf 15 mg/6,14 mg filmovertrukne tabletter
English: 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.
Danish: 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.
English: • swelling or pain in your joints or big toes
Danish: • hævelse eller smerter i dine led eller storetæer
English: Musculoskeletal pain Muscular weakness Muscle spasms Pain in extremity
Danish: Muskuloskeletale smerter Muskelsvaghed Muskelspasmer Ekstremitetssmerter
English: • mouth pain or problems
Danish: • mundsmerter eller andre problemer fra munden
English: In vitro studies indicated that trifluridine, tipiracil hydrochloride and 5-[trifluoromethyl] uracil (FTY) did not inhibit the activity of human cytochrome P450 (CYP) isoforms.
Danish: In vitro studier indikerede, at trifluridin, tipiracilhydrochlorid og 5-[trifluormethyl] uracil (FTY) ikke hæmmer aktiviteten af humane CYP-isozymer.
English: Metastatic colorectal cancer
Danish: Metastatisk kolorektal cancer
English: • runny or bloody nose, sinus problems
Danish: • løbende næse eller næseblod, problemer med bihulerne
English: • reduced number of white blood cells called lymphocytes - can increase your risk for infection
Danish: • nedsat antal af de hvide blodlegemer, som kaldes lymfocytter - kan øge din risiko for infektion
English: • redness, itching of the eye, eye infections, watery eyes
Danish: • røde øjne, kløe i øjet, øjeninfektioner, vandige øjne
English: • bone pain, muscle pain, muscle weakness or spasms, pain in tendons, nerves or ligaments
Danish: • knoglesmerter, muskelsmerter, muskelsvaghed eller muskelkramper, smerter i sener, nerver eller ledbånd
English: Blood lactate dehydrogenase increased
Danish: Forhøjet blod-laktatdehydrogenase
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1096/004 20 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1096/004 20 filmovertrukne tabletter
English: - Printing ink: shellac, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine aluminium lake (E132), carnauba wax and talc.
Danish: - Prægeblæk: Shellac, jernoxid rød (E172), jernoxid gul (E172), titandioxid (E171), indigocarmin (E132), carnaubavoks og talcum.
English: Hazard ratio for progression or death, 0.48 (95% CI, 0.41-0.57) P<0.0001 by log-rank test
Danish: Hazard ratio for progression eller død, 0,48 (95% CI, 0,41-0,57) P<0,0001 ved log-rank test
English: • Severe gastrointestinal problems: abdominal pain (common), ascites (uncommon), colitis (uncommon), acute pancreatitis (uncommon), ileus (uncommon) and subileus (uncommon).
Danish: • 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).
English: Gastric cancer
Danish: Gastrisk cancer
English: Lactose monohydrate Starch, Pregelatinised (Maize) Stearic acid
Danish: Pregelatineret stivelse (majs) Stearinsyre
English: Each tablet contains 20 mg trifluridine and 8.19 mg tipiracil.
Danish: Hver tablet indeholder 20 mg trifluridin og 8,19 mg tipiracil.
English: Hazard ratio for death, 0.69 (95% CI, 0.56-0.85) P=0.0003 (1-sided) ; p =0.0006 (2-sided)
Danish: Hazard ratio for død, 0,69 (95 % CI, 0,56-0,85) p=0,0003 (1-sidet); p=0,0006 (2-sidet)
English: Interruption criteria
Danish: Kriterie for doseringsafbrydelse
English: • reduced white blood cells called leucocytes - can increase your risk for infection
Danish: • nedsat antal af de hvide blodlegemer, der kaldes leukocytter - kan øge din risiko for infektion
English: Gastrooesophageal reflux disease Proctalgia
Danish: Gastroøsofageal reflukssygdom Proktalgi
English: Hazard ratio for progression or death, 0.57 (95% CI, 0.47-0.70) P<0.0001 (1-sided and 2-sided)
Danish: Hazard ratio for progression eller død, 0,57 (95 % CI, 0,47-0,70) p<0,0001 (1-sidet og 2-sidet)
English: Hazard ratio for death, 0.68 (95% CI, 0.58-0.81) P<0.0001
Danish: Hazard ratio for død, 0,68 (95% CI, 0,58-0,81) P<0,0001
English: Palmar-plantar erythrodysaesthesia syndromec
Danish: Palmoplantar erytrodysæstesisyndrom c
English: • cough, feeling short of breath, infection of the sinuses, throat, airway or lungs, chest infections
Danish: • hoste, kortåndethed, infektion i bihuler, hals, luftveje eller lunger, brystinfektioner
English: 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.
Danish: Trifluridins og tipiracilhydrochlorids halveringstider (t½) og akkumulationsratioer var sammenlignelige hos patienter med moderat eller let nedsat leverfunktion og normal leverfunktion.
English: Skin exfoliation Urticaria
Danish: Hudeksfoliering Urticaria
English: Number of deaths, N (%) Median OS (months)a [95% CI]b
Danish: Samlet overlevelse Antal døde, N (%) Median OS (måneder)
English: • inflammation or infection in your bladder
Danish: • inflammation eller betændelse i blæren
English: Impaired gastric emptying Abdominal distension Anal inflammation Mouth ulceration Dyspepsia
Danish: Nedsat gastrisk tømning Abdominal udspiling Anal inflammation Mundsår
English: Metastatic gastric cancer
Danish: Metastatisk gastrisk cancer
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.
Danish: En OS-analyse af studiet blev gennemført som planlagt ved 76 % (N = 384) af hændelserne og demonstrerede en klinisk relevant og statistisk signifikant forbedring af OS ved Lonsurf plus BSC sammenlignet med placebo og BSC med en hazard ratio (HR) på 0,69 (95 % CI: 0,56; 0,85; 1- og 2-sidede p-værdier var henholdsvis 0,0003 og 0,0006) svarende til en reduktion på 31 % i risikoen for død i Lonsurf-gruppen.
English: Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.75, 95% CI [0.59 to 0.94]).
Danish: OS-fordelen ved Lonsurf blev opretholdt hos disse patienter (hazard ratio: 0,75, 95 % CI [0,59 til 0,94]).
English: After single oral administration of Lonsurf with [14C]-trifluridine, the total cumulative excretion of radioactivity was 60% of the administered dose.
Danish: C]-trifluridin var den samlede kumulative udskillelse af radioaktivitet 60 % af den administrerede dosis.
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.
Danish: Tabletten er en blegrød, bikonveks, rund, filmovertrukket tablet med en diameter på 7,6 mm og en tykkelse på 3,2 mm, præget med ”20” på den ene side og ”102” og ”20 mg” på den anden side med gråt blæk.
English: Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.69, 95% CI [0.45 to 1.05]).
Danish: OS-fordelen ved Lonsurf blev opretholdt hos disse patienter (hazard ratio: 0,69, 95 % CI [0,45 til 1,05]).
English: • feeling of numbness or pins and needles in hands or feet
Danish: • følelsesløshed eller prikkende og stikkende fornemmelse i hænder eller fødder
English: What Lonsurf contains Lonsurf 15 mg/6.14 mg tablet
Danish: Lonsurf indeholder: Lonsurf 15 mg/6,14 mg tablet
English: No adjustment of the starting dose is required on the basis of patient's race (see sections 5.1 and 5.2).
Danish: Det er ikke nødvendigt at justere startdosis på baggrund i patientens race (se pkt.
English: - Film coat: hypromellose, macrogol (8000), titanium dioxide (E171), and magnesium stearate.
Danish: - Filmovertræk: Hypromellose, macrogol (8000), titandioxid (E171) og magnesiumstearat.
English: • reduced white blood cells called granulocytes or monocytes - can increase your risk for infection
Danish: • nedsat antal af de hvide blodlegemer, som kaldes granulocytter og monocytter - kan øge risiko for infektion
English: • swelling in your hands or legs or feet
Danish: • hævede hænder, ben eller fødder
English: • decreased appetite
Danish: • appetitløshed
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.
Danish: En opdateret OS-analyse blev udført ved 89 % (N = 712) af hændelserne og bekræftede den klinisk relevante og statistisk signifikante overlevelsesfordel ved Lonsurf plus BSC sammenlignet med placebo plus BSC (hazard ratio: 0,69; 95 % CI [0,59 til 0,81]; p < 0,0001) med en median OS på 7,2 måneder versus 5,2 måneder og en 1-årig overlevelsesrate på henholdsvis 27,1 % og 16,6 %.
English: • sweating more than normal, sensitivity to light, nail problems
Danish: • svedtendens, lysfølsomhed, negleproblemer
English: < 50 × 109/L
Danish: < 75 x 10
English: • inflammation and infection in your gut
Danish: • inflammation og betændelse i tarmen
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.
Danish: En OS-analyse af studiet blev gennemført som planlagt ved 72 % (N = 574) af hændelserne, og demonstrerede en klinisk relevant og statistisk signifikant overlevelsesfordel ved Lonsurf plus BSC sammenlignet med placebo plus BSC (hazard ratio: 0,68; 95 % konfidensinterval [CI] [0,58 til 0,81]; p < 0,0001) med en median OS på henholdsvis 7,1 måneder versus 5,3 måneder og en 1-årig overlevelsesrate på henholdsvis 26,6 % og 17,6%.
English: Hyperbilirubinaemia Hepatotoxicity Biliary dilatation
Danish: Levertoksicitet Biliær dilatation
English: Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Danish: Lonsurf 15 mg/6,14 mg filmovertrukne tabletter Lonsurf 20 mg/8,19 mg filmovertrukne tabletter trifluridin/tipiracil
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.
Danish: I et dosis-responsstudie (15 til 35 mg/m to gange dagligt) var der tendens til, at AUC fra tid 0 til 10 timer (AUC0-10) for trifluridin steg mere end forventet ud fra stigningen i dosis.
English: • a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding and work by clumping and clotting blood vessel injuries
Danish: • nedsat antal blodplader (trombocytopeni), som er vigtige for at stoppe blødning.
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).
Danish: Behandlingsrelateret proteinuri forekom oftere hos patienter behandlet med Lonsurf (1,8 %) end hos patienter i placebogruppen (0.9 %).
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.
Danish: 2) hos patienter med avancerede solide tumorer var den tilsyneladende enkelt dosis Lonsurf (35 mg/m fordelingsvolumen (Vd/F) for trifluridin og tipiracilhydrochlorid henholdsvis 21 l og 333 l.
English: - Film coating: hypromellose, macrogol (8000), titanium dioxide (E171), iron oxide red (E172) and magnesium stearate.
Danish: - Filmovertræk: Hypromellose, macrogol (8000), titandioxid (E171), jernoxid rød (E172) og magnesiumstearat.
English: No adjustment of the starting dose is required in patients ≥ 65 years old (see sections 4.8, 5.1 and 5.2).
Danish: Det er ikke nødvendigt at justere startdosis hos patienter ≥ 65 år (se pkt.
English: Mucosal inflammation Malaise
Danish: Mucosainflammation Utilpashed
English: Lonsurf 15 mg/6.14 mg film-coated tablets
Danish: Lonsurf 15 mg/6,14 mg filmovertrukne tabletter
English: • inflammation, swelling or bleeding in your bowel
Danish: • inflammation, hævelse eller blødning i indvoldene
English: Figure 2 - Kaplan-Meier curves of progression-free survival in patients with metastatic colorectal cancer
Danish: Figur 2 - Kaplan-Meier kurve for progressionsfri overlevelse hos patienter med metastatisk kolorektal cancer
English: * Common terminology criteria for adverse events Table 4 - Dose reductions according to body surface area (BSA)
Danish: Tabel 4 - Dosisreduktioner ud fra kroppens overfladeareal (BSA)
English: Visual acuity reduced Vision blurred Diplopia
Danish: Nedsat synsskarphed Synsforstyrrelser Diplopi
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.
Danish: 2) hos patienter med fremskredne solide tumorer var den Efter en enkelt dosis af Lonsurf (35 mg/m orale clearance (CL/F) af trifluridin og tipiracilhydrochlorid henholdsvis 10,5 l /time og 109 l/time.
English: Do not drive or use any tools or machines if you experience symptoms that affect your ability to concentrate and react.
Danish: Hvis du får bivirkninger, der påvirker din evne til at koncentrere dig og reagere, må du ikke køre bil eller betjene værktøj eller maskiner.
English: The signs include feeling short of breath, tiredness or looking pale (see section 2).
Danish: Symptomerne inkluderer kortåndethed, træthed eller bleghed (se punkt
English: Each film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride).
Danish: Hver filmovertrukket tablet indeholder 15 mg trifluridin og 6,14 mg tipiracil (som hydrochlorid).
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Neutropeni Leukopeni