natgillin/translations-raw huggingface dataset:
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)
Kriterie for doseringsafbrydelse
Interruption criteria
• nedsat antal af de hvide blodlegemer, der kaldes leukocytter - kan øge din risiko for infektion
• reduced white blood cells called leucocytes - can increase your risk for infection
Gastroøsofageal reflukssygdom Proktalgi
Gastrooesophageal reflux disease Proctalgia
Hazard ratio for progression eller død, 0,57 (95 % CI, 0,47-0,70) p<0,0001 (1-sidet og 2-sidet)
Hazard ratio for progression or death, 0.57 (95% CI, 0.47-0.70) P<0.0001 (1-sided and 2-sided)
Hazard ratio for død, 0,68 (95% CI, 0,58-0,81) P<0,0001
Hazard ratio for death, 0.68 (95% CI, 0.58-0.81) P<0.0001
Palmoplantar erytrodysæstesisyndrom c
Palmar-plantar erythrodysaesthesia syndromec
• hoste, kortåndethed, infektion i bihuler, hals, luftveje eller lunger, brystinfektioner
• cough, feeling short of breath, infection of the sinuses, throat, airway or lungs, chest infections
Trifluridins og tipiracilhydrochlorids halveringstider (t½) og akkumulationsratioer var sammenlignelige hos patienter med moderat eller let nedsat leverfunktion og normal leverfunktion.
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.
Hudeksfoliering Urticaria
Skin exfoliation Urticaria
Samlet overlevelse Antal døde, N (%) Median OS (måneder)
Number of deaths, N (%) Median OS (months)a [95% CI]b
• inflammation eller betændelse i blæren
• inflammation or infection in your bladder
Nedsat gastrisk tømning Abdominal udspiling Anal inflammation Mundsår
Impaired gastric emptying Abdominal distension Anal inflammation Mouth ulceration Dyspepsia
Metastatisk gastrisk cancer
Metastatic gastric cancer
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.
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.
OS-fordelen ved Lonsurf blev opretholdt hos disse patienter (hazard ratio: 0,75, 95 % CI [0,59 til 0,94]).
Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.75, 95% CI [0.59 to 0.94]).
C]-trifluridin var den samlede kumulative udskillelse af radioaktivitet 60 % af den administrerede dosis.
After single oral administration of Lonsurf with [14C]-trifluridine, the total cumulative excretion of radioactivity was 60% of the administered dose.
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.
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.
OS-fordelen ved Lonsurf blev opretholdt hos disse patienter (hazard ratio: 0,69, 95 % CI [0,45 til 1,05]).
Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.69, 95% CI [0.45 to 1.05]).
• følelsesløshed eller prikkende og stikkende fornemmelse i hænder eller fødder
• feeling of numbness or pins and needles in hands or feet
Lonsurf indeholder: Lonsurf 15 mg/6,14 mg tablet
What Lonsurf contains Lonsurf 15 mg/6.14 mg tablet
Det er ikke nødvendigt at justere startdosis på baggrund i patientens race (se pkt.
No adjustment of the starting dose is required on the basis of patient's race (see sections 5.1 and 5.2).
- Filmovertræk: Hypromellose, macrogol (8000), titandioxid (E171) og magnesiumstearat.
- Film coat: hypromellose, macrogol (8000), titanium dioxide (E171), and magnesium stearate.
• nedsat antal af de hvide blodlegemer, som kaldes granulocytter og monocytter - kan øge risiko for infektion
• reduced white blood cells called granulocytes or monocytes - can increase your risk for infection
• hævede hænder, ben eller fødder
• swelling in your hands or legs or feet
• appetitløshed
• decreased appetite
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 %.
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.
• svedtendens, lysfølsomhed, negleproblemer
• sweating more than normal, sensitivity to light, nail problems
< 75 x 10
< 50 × 109/L
• inflammation og betændelse i tarmen
• inflammation and infection in your gut
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%.
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.
Levertoksicitet Biliær dilatation
Hyperbilirubinaemia Hepatotoxicity Biliary dilatation
Lonsurf 15 mg/6,14 mg filmovertrukne tabletter Lonsurf 20 mg/8,19 mg filmovertrukne tabletter trifluridin/tipiracil
Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
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.
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.
• nedsat antal blodplader (trombocytopeni), som er vigtige for at stoppe blødning.
• a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding and work by clumping and clotting blood vessel injuries
Behandlingsrelateret proteinuri forekom oftere hos patienter behandlet med Lonsurf (1,8 %) end hos patienter i placebogruppen (0.9 %).
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).
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.
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.
- Filmovertræk: Hypromellose, macrogol (8000), titandioxid (E171), jernoxid rød (E172) og magnesiumstearat.
- Film coating: hypromellose, macrogol (8000), titanium dioxide (E171), iron oxide red (E172) and magnesium stearate.
Det er ikke nødvendigt at justere startdosis hos patienter ≥ 65 år (se pkt.
No adjustment of the starting dose is required in patients ≥ 65 years old (see sections 4.8, 5.1 and 5.2).
Mucosainflammation Utilpashed
Mucosal inflammation Malaise
Lonsurf 15 mg/6,14 mg filmovertrukne tabletter
Lonsurf 15 mg/6.14 mg film-coated tablets
• inflammation, hævelse eller blødning i indvoldene
• inflammation, swelling or bleeding in your bowel
Figur 2 - Kaplan-Meier kurve for progressionsfri overlevelse hos patienter med metastatisk kolorektal cancer
Figure 2 - Kaplan-Meier curves of progression-free survival in patients with metastatic colorectal cancer
Tabel 4 - Dosisreduktioner ud fra kroppens overfladeareal (BSA)
* Common terminology criteria for adverse events Table 4 - Dose reductions according to body surface area (BSA)
Nedsat synsskarphed Synsforstyrrelser Diplopi
Visual acuity reduced Vision blurred Diplopia
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.
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.
Hvis du får bivirkninger, der påvirker din evne til at koncentrere dig og reagere, må du ikke køre bil eller betjene værktøj eller maskiner.
Do not drive or use any tools or machines if you experience symptoms that affect your ability to concentrate and react.
Symptomerne inkluderer kortåndethed, træthed eller bleghed (se punkt
The signs include feeling short of breath, tiredness or looking pale (see section 2).