FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro evaluation of trifluridine and tipiracil hydrochloride was conducted using human uptake and efflux transporters (trifluridine with MDR1, OATP1B1, OATP1B3 and BCRP; tipiracil hydrochloride with OAT1, OAT3, OCT2, MATE1, MDR1 and BCRP).
Danish: In vitro evaluering af trifluridin og tipiracilhydrochlorid blev udført under anvendelse af humane optagelses- og effluxtransportører (trifluridin med MDR1, OATP1B1, OATP1B3 og BCRP; tipiracilhydrochlorid med OAT1, OAT3, OCT2, MATE1, MDR1 og BCRP).
English: 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).
Danish: ORR (komplet respons + partielt respons) var ikke signifikant højere hos patienter, som blev behandlet med Lonsurf (4,5 % versus 2,1 %, p-værdi = 0,2833), men DCR (komplet respons, partielt respons eller stabil sygdom) var signifikant højere hos patienter, som blev behandlet med Lonsurf (44,1 % versus 14,5 %, p < 0,0001).
English: 40 film-coated tablets
Danish: 40 filmovertrukne tabletter
English: There was a slightly higher incidence of overall haematological and myelosuppression-related adverse reactions for patients who received prior radiotherapy compared to patients without prior radiotherapy in RECOURSE (54.6% versus 49.2%, respectively), of note febrile neutropenia was higher in Lonsurf-treated patients who received prior radiotherapy vs. those that did not.
Danish: I RECOURSE var der en lidt højere samlet forekomst af hæmatologiske og myelosuppressionsrelaterede bivirkninger hos patienter, der tidligere havde fået strålebehandling, sammenlignet med patienter uden forudgående strålebehandling (henholdsvis 54,6 % versus 49,2 %,), hvor det skal bemærkes, at febril neutropeni var hyppigere hos Lonsurf-behandlede patienter, som tidligere havde fået strålebehandling, end hos patienter, som ikke havde.
English: Pancytopenia Granulocytopenia Monocytopenia Erythropenia Leukocytosis Monocytosis
Danish: Pancytopeni Granulocytopeni Monocytopeni Erytropeni Leukocytose Monocytose
English: • passing out (syncope)
Danish: • besvimelse (synkope)
English: The absorbed trifluridine was metabolised, and excreted into urine as FTY and trifluridine glucuronide isomers.
Danish: Absorberet trifluridin blev metaboliseret og udskilt i urinen som FTY og trifluridinglukuronidisomere.
English: Approximately half (55.4%) of patients received prior irinotecan, 33.3% received prior ramucirumab, and 16.6% received prior HER2-targeted therapy.
Danish: Cirka halvdelen (55,4 %) af patienterne havde tidligere fået behandling med irinotecan, 33,3 % havde tidligere fået behandling med ramucisumab og 16,6 % havde tidligere fået HER2-målrettet behandling.
English: Of the 800 randomised patients, the median age was 63 years, 61% were male, 58% were Caucasian/White, 35% were Asian/Oriental, and 1% were Black/African American, and all patients had baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Danish: Hos de 800 randomiserede patienter var medianalderen 63 år, 61 % var mænd, 58 % var kaukasere/hvide, 35 % var asiater/orientalske, og 1 % var sorte/afroamerikanere, og alle patienter havde Eastern Cooperative Oncology Group (ECOG) performance status (PS) på 0 eller 1 ved baseline.
English: Based on the population PK analysis, there is no clinically relevant effect of age, gender or race on the PK of trifluridine or tipiracil hydrochloride.
Danish: Baseret på den farmakokinetiske populationsanalyse var der ingen klinisk relevant effekt af alder, køn eller race på trifluridins og tipiracilhydrochlorids farmakokinetik.
English: • increased white blood cells
Danish: • øget antal hvide blodlegemer
English: Lonsurf caused an increase in the incidence of myelosuppression including anaemia, neutropenia, leukopenia, and thrombocytopenia.
Danish: Lonsurf forårsagede en stigning i forekomsten af myelosuppression, herunder anæmi, neutropeni, leukopeni og trombocytopeni.
English: The most common adverse drug reactions (≥ 2%) in patients receiving Lonsurf that resulted in treatment discontinuation, dose reduction, dose delay, or dose interruption were neutropenia, anaemia, leukopenia, fatigue, thrombocytopenia, nausea and diarrhoea.
Danish: De bivirkninger, som hyppigst (≥ 2 %) resulterede i seponering af Lonsurf, dosisreduktion, dosisudskydelse, eller doseringsafbrydelse, var neutropeni, anæmi, leukopeni, træthed, trombocytopeni, kvalme og diarré.
English: 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.
Danish: OS- og PFS-fordelen blev observeret i alle relevante præspecificerede undergrupper, herunder race, geografisk område, alder (< 65; ≥ 65), køn, ECOG-PS, KRAS-status, tid siden diagnosticering af den første metastase, antal metastatiske steder og fokus for primær tumor.
English: • swelling of mucous membranes - this could be inside the nose, mouth, throat, eyes, vagina, lungs or gut
Danish: • hævede slimhinder - det kan være i næsen, munden, halsen, øjnene, vagina, lunger eller tarme
English: Table 3 - Recommended dose modifications for Lonsurf in case of haematological and non-haematological adverse reactions
Danish: Tabel 3 - Anbefalede dosisjusteringer for Lonsurf ved hæmatologiske og ikke-hæmatologiske bivirkninger
English: Common: may affect up to 1 in 10 people:
Danish: Almindelig: Kan forekomme hos op til 1 ud af 10 personer
English: Nearly all (99.8%) patients received prior fluoropyrimidine, 100% received prior platinum therapy and 90.5% received prior taxane therapy.
Danish: Næsten alle (99,8 %) patienter havde tidligere fået behandling med fluorpyrimidin, 100 % havde tidligere fået behandling med platin og 90,5 % havde tidligere fået behandling med taxan.
English: • you have kidney problems
Danish: • du har nyreproblemer
English: Results of animal studies did not indicate an effect of trifluridine and tipiracil hydrochloride on male and female fertility in rats.
Danish: Resultater af dyrestudier indikerede ikke indvirkning af trifluridin og tipiracilhydrochlorid på hanlig og hunlig fertilitet hos rotter.
English: • The other ingredients are: - Tablet core: lactose monohydrate, starch pregelatinised (Maize) and stearic acid.
Danish: • Øvrige indholdsstoffer er: - Tabletkerne: Lactosemonohydrat, pregelatineret stivelse (majs) og stearinsyre.
English: • blood clots, e.g. in the brain or legs
Danish: • blodpropper, f.eks. i hjernen eller benene
English: ≥ 75 × 109/L a Resumption criteria applied to the start of the next cycle for all patients regardless of whether or not the interruption criteria were met.
Danish: Kriterierne for doseringsgenoptagelse er gældende for alle patienter ved starten af næste cyklus, uanset om kriterierne for doseringsafbrydelse blev mødt eller ej.
English: Periodontal disease Tooth disorder
Danish: Periodontal sygdom Tandlidelse
English: 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).
Danish: Lonsurf er indiceret som monoterapi til behandling af metastatisk gastrisk cancer hos voksne patienter, herunder adenokarcinom i den gastroøsofageale overgang, som tidligere er blevet behandlet med mindst to forudgående systemiske behandlingsregimer for fremskreden sygdom (se pkt.
English: • Week 1 - take the dose 2 times a day for 5 days - then have 2 days off - no medicine
Danish: • Uge 1 - tag dosis 2 gange daglig i 5 dage - derefter 2 dage uden medicin
English: Studies in animals have shown excretion of trifluridine, tipiracil hydrochloride and/or their metabolites in milk (see section 5.3).
Danish: Dyrestudier har vist, at trifluridin, tipiracilhydrochlorid og/eller deres metabolitter udskilles i mælk (se pkt.
English: Anxiety Insomnia
Danish: Angst Insomni
English: 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.
Danish: Lonsurfs kliniske effekt og sikkerhed blev evalueret i et internationalt, randomiseret, dobbeltblindt, placebokontrolleret fase III-studie (TAGS) hos patienter, som tidligere var behandlet for metastatisk gastrisk cancer (herunder adenokarcinom i den gastroøsofageale overgang), og som tidligere var blevet behandlet med mindst to forudgående systemiske behandlingsregimer for fremskreden sygdom, herunder fluorpyrimidin-, platin- og enten taxan- eller irinotecan-baseret kemoterapi samt, hvis relevant, human epidermal vækstfaktor-receptor 2 (HER2)-målrettet behandling.
English: The primary efficacy endpoint was overall survival (OS), and supportive efficacy endpoints were progression-free survival (PFS), overall response rate (ORR) and disease control rate (DCR).
Danish: Det primære effektmål var samlet overlevelse (overall survival, OS), og støttende effektmål var progressionsfri overlevelse (progression-free survival, PFS), samlet responsrate (overall response rate, ORR) og sygdomskontrolrate (disease control rate, DCR).
English: Patients 65 years of age or older who received Lonsurf had a higher incidence of the following events compared to patients younger than 65 years: - metastatic colorectal cancer (RECOURSE): Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anaemia (26% vs 12%), Grade 3 or 4 leukopenia (26% vs 18%) and Grade 3 or 4 thrombocytopenia (9% vs 2%), - metastatic gastric cancer (TAGS): Grade 3 or 4 neutrophil count decrease (17.0% vs 6.6%), decreased appetite (37.3% vs 31.9%), asthenia (22.2% vs 17.0%) and stomatitis (7.2% vs 2.2%).
Danish: Patienter på 65 år og ældre, som fik Lonsurf, havde, sammenlignet med patienter under 65 år, en højere incidens af følgende bivirkninger: - metastatisk kolorektal cancer (RECOURSE): Grad 3 og 4 neutropeni (48 % versus 30 %), grad 3 anæmi (26 % versus 12 %), grad 3 og 4 leukopeni (26 % versus 18 %) og grad 3 og 4 trombocytopeni (9 % versus 2 %), - metastatisk gastrisk cancer (TAGS): Grad 3 og 4 nedsat neutrofiltal (17,0 % versus 6,6 %), nedsat appetit (37,3 % versus 31,9 %), asteni (22,2 % versus 17,0 %) og stomatitis (7,2 % versus 2,2 %).
English: • Week 2 - take the dose 2 times a day for 5 days - then have 2 days off - no medicine
Danish: • Uge 2 - tag dosis 2 gange daglig i 5 dage - derefter 2 dage uden medicin
English: 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.
Danish: 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).
English: What you need to know before you take Lonsurf
Danish: Det skal du vide, før du begynder at tage Lonsurf
English: 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.
Danish: 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 %.
English: Angina pectoris Arrhythmia Palpitations
Danish: Angina pectoris Arytmi
English: • inflammation or increased acid in your stomach or gullet, reflux
Danish: • inflammation eller øget mængde syre i maven eller spiserøret, halsbrand
English: 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.
Danish: 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.
English: 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.
Danish: Patienter med moderat nedsat nyrefunktion bør overvåges oftere for hæmatologisk toksicitet.
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: 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).
Danish: 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).
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Knoglemarvssuppression
English: 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).
Danish: 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.
English: • bad breath, tooth decay, tooth or gum problems, bleeding gums, gum infections
Danish: • dårlig ånde, huller i tænderne, problemer i tænder eller gummer, blødende gummer, infektioner i gummerne
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: • redness, swelling, pain on the palms of your hands and soles of your feet (hand-foot syndrome)
Danish: • rødme, hævelse og smerte i dine håndflader og fodsåler (hånd-fod syndrom)
English: • pain or inflammation in upper or lower part of digestive tract
Danish: • smerte eller betændelse i øvre eller nedre del af fordøjelseskanalen
English: • abnormal increase or decrease in heart rate
Danish: • unormal stigning eller fald i hjertefrekvensen (pulsen)
English: Recommended dose modifications
Danish: Anbefalede dosisjusteringer
English: The target organs identified were the lymphatic and haematopoietic systems and the gastrointestinal tract.
Danish: De identificerede målorganer var lymfesystemet og det hæmatopoietiske system samt mavetarm-kanalen.
English: The signs include difficulty in breathing, shortness of breath, with cough or fever.
Danish: Symptomerne omfatter vejrtrækningsbesvær og kortåndethed med hoste eller feber.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: There have been reports of interstitial lung disease in patients receiving Lonsurf post approval.
Danish: Efter godkendelse har der været rapporter om interstitiel lungesygdom hos patienter i behandling med Lonsurf.
English: • accumulation of fluid in the lungs
Danish: • ophobning af væske i lungerne
English: 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.
Danish: 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.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Les Laboratoires Servier Industrie
English: As for the other exposure parameters of trifluridine and tipiracil hydrochloride, those appeared to be dose proportional.
Danish: Med hensyn til de øvrige eksponeringsparametre for trifluridin og dosisintervallet 20 til 35 mg/m tipiracilhydrochlorid syntes de at være dosisproportionale.
English: Enterocolitis haemorrhagic Gastrointestinal haemorrhage Pancreatitis acute Ascites
Danish: Hæmoragisk enterocolitis Gastrointestinal blødning Akut pankreatitis Ascites
English: Results of animal studies did not indicate an effect of Lonsurf on male or female fertility (see section 5.3).
Danish: Resultater af dyrestudier indikerede ikke en effekt af Lonsurf på hanlig eller hunlig fertilitet (se pkt.
English: Τηλ: +30 210 939 1000
Danish: ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: +30 210 939 1000
English: No correlation was seen for trifluridine nor tipiracil hydrochloride between PK parameters and AST or/and total blood bilirubin.
Danish: Der blev ikke set korrelation mellem hverken trifluridins eller tipiracilhydrochloids farmakokinetiske parametre og ASAT og/eller total-bilirubin.
English: Hazard ratio [95% CI] P-valuec
Danish: Hazard ratio [95 % CI]
English: The effect was also maintained in regorafenib-naive patients (hazard ratio: 0.69, 95% CI [0.57 to 0.83]).
Danish: Effekten blev også opretholdt hos regorafenib-naive patienter (hazard ratio: 0,69, 95 % CI [0,57 til 0,83]).
English: Each film-coated tablet contains 90.735 mg of lactose monohydrate.
Danish: Hver filmovertrukket tablet indeholder 90,735 mg lactosemonohydrat.
English: a Kaplan-Meier estimates b Methodology of Brookmeyer and Crowley c Stratified log-rank test (strata: region, ECOG status at baseline, prior ramucirumab treatment)
Danish: Stratificeret log-rank test (strata: region, ECOG-status ved baseline, tidligere behandling med ramucirumab)
English: In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP1A2, CYP2B6 or CYP3A4/5.
Danish: In vitro evaluering viste, at trifluridin, tipiracilhydrochlorid og FTY ikke havde induktiv effekt på human CYP1A2, CYP2B6 eller CYP3A4/5.
English: Level 2 dose reduction: From 30 mg/m2 to 25 mg/m2 25 mg/m2
Danish: Niveau 2-dosisreduktion: Fra 30 mg/m til 25 mg/m25 mg/m a
English: 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.
Danish: 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.
English: • Mild renal impairment (CrCl 60 to 89 mL/min) or moderate renal impairment (CrCl 30 to
Danish: • Let nedsat nyrefunktion (CrCl 60 til 89 ml/min) og moderat nedsat nyrefunktion (CrCl 30 til
English: Tipiracil hydrochloride was not metabolised in human liver S9 or in cryopreserved human hepatocytes.
Danish: Tipiracilhydrochlorid blev ikke metaboliseret i en human lever S9-fraktion eller i kryopræserverede humane hepatocytter.
English: INFORMATION IN BRAILLE Lonsurf 20 mg/8.19 mg
Danish: INFORMATION I BRAILLESKRIFT Lonsurf 20 mg/8,19 mg
English: 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).
Danish: 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.
English: • painful tongue, polyps inside your mouth, mouth ulcers, retching
Danish: • smertefuld tunge, polypper i munden, mundsår, opkastning
English: 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.
Danish: C]-tipiracilhydrochlorid var den genfundne radioaktivitet 77 % af dosis og bestod af 27 % urinudskillelse og 50 % fækal udskillelse.
English: Tipiracil hydrochloride was a substrate for OCT2 and MATE1, therefore, the concentration might be increased when Lonsurf is administered concomitantly with inhibitors of OCT2 or MATE1.
Danish: Tipiracilhydrochlorid er substrat for OCT2 og MATE1, derfor kan koncentrationen blive øget, når Lonsurf administreres samtidig med hæmmere af OCT2 eller MATE1.
English: Each film-coated tablet contains 120.980 mg of lactose monohydrate.
Danish: Hver filmovertrukket tablet indeholder 120,980 mg lactosemonohydrat.
English: 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.
Danish: 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.
English: Table 6 - Efficacy results from the Phase III (RECOURSE) clinical trial in patients with metastatic colorectal cancer
Danish: Tabel 6 - Effektresultater fra det kliniske fase III-studie (RECOURSE) hos patienter med metastatisk kolorektal cancer
English: Pulmonary embolismb
Danish: Lungeemboli b