FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma protein binding of tipiracil hydrochloride was below 8%.
Danish: Plasmaproteinbindingen af tipiracilhydrochlorid var under 8 %.
English: Survival Probability (%)
Danish: Sandsynlighed for overlevelse (%)
English: Taking this medicine
Danish: Hvordan du tager denne medicin
English: Medical management of an overdose should include customary therapeutic and supportive medical intervention aimed at correcting the presenting clinical manifestations and preventing their possible complications.
Danish: Behandling af overdosering bør omfatte sædvanlig terapeutisk og støttende intervention, rettet mod at afhjælpe de kliniske symptomer og forebygge deres mulige komplikationer.
English: The majority of recovered radioactivity was eliminated into urine (55% of the dose) within 24 hours, and the excretion into faeces and expired air was less than 3% for both.
Danish: Størstedelen af den genfundne radioaktivitet var elimineret i urinen (55 % af dosis) inden for 24 timer, og udskillelsen i fæces og udåndingsluft var mindre end 3 % for begge.
English: Lonsurf should be prescribed by physicians experienced in the administration of anticancer therapy.
Danish: Lonsurf bør ordineres af læger med erfaring i administration af anticancerbehandling.
English: The primary anticipated complication of an overdose is bone marrow suppression.
Danish: Den primære forventede komplikation af overdosering er knoglemarvssuppression.
English: • low levels of albumin or total protein in the blood
Danish: • lavt indhold af albumin eller totalt protein i blodet
English: DATE OF REVISION OF THE TEXT MM/YYYY
Danish: DATO FOR ÆNDRING AF TEKSTEN MM/ÅÅÅÅ
English: The CHMP reviewed the data submitted by the marketing authorisation holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication brings significant clinical benefit in comparison with existing therapies as further explained in the European Public Assessment Report.
Danish: CHMP gennemgik de oplysninger, som indehaveren af markedsføringstilladelsen havde indsendt, jf. artikel 14, stk. 11, i forordning (EC) nr. 726/2004, og er af den opfattelse, at den nye terapeutiske indikation giver en væsentlig klinisk fordel sammenlignet med eksisterende behandlinger.
English: If you forget to take Lonsurf
Danish: Hvis du har glemt at tage Lonsurf
English: Each pack contains 20, 40 or 60 film-coated tablets.
Danish: Hver pakning indeholder 20, 40 eller 60 filmovertrukne tabletter.
English: In particular tell your doctor or pharmacist if you are taking medicines used for treatment of HIV, such as zidovudine.
Danish: Fortæl det især til lægen eller apotekspersonalet, hvis du tager medicin, der bruges til behandling af HIV, såsom zidovudin.
English: The tablets must be taken with a glass of water within 1 hour after completion of the morning and evening meals.
Danish: Tabletterne skal tages sammen med et glas vand en time efter afslutning af morgen- og aftenmåltiderne.
English: • Vomiting (very common) and diarrhoea (very common), which may lead to a dehydration if severe or persistent.
Danish: • Opkastning (meget almindelig) og diarré (meget almindelig), som kan føre til væskemangel (dehydrering), hvis den er svær eller vedvarende.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 April 2016
Danish: Dato for første markedsføringstilladelse: 25. april 2016
English: Progression-Free Survival Number of Progression or Death, N (%)
Danish: Progressionsfri overlevelse Antal med progression eller død, N (%)
English: The primary site of disease was colon (62%) or rectum (38%).
Danish: Det primære fokus for sygdommen var kolon (62 %) eller rektum (38 %).
English: Women should avoid becoming pregnant while taking Lonsurf and for up to 6 months after ending treatment.
Danish: Kvinder bør undgå at blive gravide, mens de tager Lonsurf og i op til 6 måneder efter endt behandling.
English: Buccal polyp
Danish: Bukkal polyp
English: • You will take a dose 2 times a day.
Danish: • Du skal tage dosis 2 gange dagligt.
English: The protein binding of trifluridine in human plasma was over 96% and trifluridine bound mainly to human serum albumin.
Danish: Proteinbindingen af trifluridin i humant plasma var over 96 %, og trifluridin blev hovedsageligt bundet til humant serumalbumin.
English: You can help by reporting any side effects you may experience.
Danish: Du kan hjælpe ved at indberette alle de bivirkninger, du får.
English: Lonsurf is a type of cancer chemotherapy which belongs to the group of medicines called "cytostatic antimetabolite medicines".
Danish: Lonsurf er en type kemoterapi mod kræft, som tilhører gruppen af lægemidler, som kaldes "cytostatisk antimetabolit-medicin".
English: Aluminium/Aluminium blister with laminated desiccant (Calcium oxide) containing 10 tablets.
Danish: Aluminium/aluminiumblister med lamineret tørremiddel (calciumoxid) indeholdende 10 tabletter.
English: It is unknown whether Lonsurf or its metabolites are excreted in human milk.
Danish: Det vides ikke, om Lonsurf eller dets metabolitter udskilles i human mælk.
English: If you take more Lonsurf than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har taget flere Lonsurf, end du skal, skal du tale med en læge eller tage på hospitalet med det samme.
English: • Take within 1 hour after your morning and evening meal.
Danish: • Tag tabletterne inden for 1 time efter din morgen- og aftensmad.
English: The 2 treatment groups were comparable with respect to demographic and baseline disease characteristics.
Danish: De 2 behandlingsgrupper var sammenlignelige med hensyn til demografiske og baseline-sygdomskarakteristika.
English: • blood test results indicating problems with clotting making you bleed more easily
Danish: • resultat af blodprøver indikerer problemer med blodets størkning, som gør, at du lettere bløder
English: Complete blood cell counts must be obtained prior to initiation of therapy and as needed to monitor toxicity, but at a minimum, prior to each treatment cycle.
Danish: For at overvåge toksiciteten skal komplet blodtælling foretages før initiering af behandlingen samt efter behov, men som minimum før hver behandlingscyklus.
English: Estimated (CrCl) was a significant covariate for CL/F in both final models of trifluridine and tipiracil hydrochloride.
Danish: Estimeret (CrCl) var en signifikant kovariat for CL/F i begge de endelige modeller for trifluridin og tipiracilhydrochlorid.
English: • problems passing water (urine retention), loss of bladder control (incontinence)
Danish: • problemer med at lade vandet (urinretention), manglende blærekontrol (inkontinens)
English: Dose modifications (delay and/or reduction) should be applied as necessary (see section 4.2).
Danish: Doseringsmodifikation (udskydelse og/eller dosisreduktion) skal foretages efter behov (se pkt.
English: Lonsurf contains two different active substances: trifluridine and tipiracil.
Danish: Lonsurf indeholder 2 forskellige aktive stoffer: Trifluridin og tipiracil.
English: It is not known whether Lonsurf changes your ability to drive or use machines.
Danish: Det vides ikke, om Lonsurf ændrer din evne til at køre bil eller betjene maskiner.
English: Dose escalation is not permitted after it has been reduced.
Danish: Optrapning af dosis efter dosisreduktion er ikke tilladt.
English: C-reactive protein increased
Danish: Forhøjet C-reaktivt protein
English: The highest dose of Lonsurf administered in clinical trials was 180 mg/m2 per day.
Danish: Den højeste dosis Lonsurf, der blev administreret i kliniske studier, var 180 mg/m pr. dag.
English: • changes in your heart trace (ECG - electrocardiogram)
Danish: • ændringer i optagelsen af hjertets elektriske aktivitet (EKG - elektrokardiogram)
English: In RECOURSE and TAGS studies, 9.4% and 17.3% of patients in the Lonsurf group respectively received G-CSF mainly for therapeutic use.
Danish: I RECOURSE- og TAGS-studierne fik henholdsvis 9,4 % og 17,3 % af patienterne i Lonsurf-gruppen G-CSF, hovedsageligt anvendt terapeutisk.
English: Lonsurf had no clinically relevant effect on QT/QTc prolongation compared with placebo in an open label study in patients with advanced solid tumours.
Danish: Lonsurf havde ikke en klinisk relevant effekt på QT/QTc-forlængelse sammenlignet med placebo i et åbent studie hos patienter med avancerede solide tumorer.
English: • a reduced number of red blood cells (anaemia)
Danish: • nedsat antal røde blodlegemer (anæmi)
English: • increased bilirubin in your blood - can cause yellowing of skin or eyes
Danish: • øget indhold af bilirubin i blodet - kan medføre gulfarvning af hud eller øjne
English: • Thrombocytopenia (very common).
Danish: • Trombocytopeni (meget almindelig).
English: This medicine does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen specielle opbevaringsbetingelser.
English: Such medicinal products, if used concomitantly with Lonsurf, may compete with the effector, trifluridine, for activation via thymidine kinases.
Danish: Disse lægemidler kan, hvis de anvendes samtidigt med Lonsurf, konkurrere med effektoren trifluridin om aktivering via thymidinkinaser.
English: It is currently unknown whether Lonsurf may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier contraceptive method.
Danish: Det vides i øjeblikket ikke, om Lonsurf kan nedsætte virkningen af hormonelle præventionsmidler, og derfor bør kvinder, der anvender hormonale præventionsmidler, også anvende en barriere-præventionsmetode.
English: Each pack contains 20 film-coated tablets (2 blisters of 10 tablets each) or 40 film-coated tablets (4 blisters of 10 tablets each), or 60 film-coated tablets (6 blisters of 10 tablets each).
Danish: Hver pakning indeholder 20 filmovertrukne tabletter (2 blisterkort med 10 tabletter i hver), 40 filmovertrukne tabletter (4 blisterkort med 10 tabletter i hver) eller 60 filmovertrukne tabletter (6 blisterkort med 10 tabletter i hver).
English: • burning sensation, unpleasant, increased or loss of sense of touch and other non-severe neurological troubles
Danish: • brændende fornemmelse, ubehagelig øget eller nedsat følesans og andre ikke-alvorlige neurologiske problemer
English: The specific dosing schedule is as follows:
Danish: Det specifikke doseringsinterval er således:
English: There are no data available on the effects of Lonsurf on human fertility.
Danish: Der er ikke tilgængelige data om virkningerne af Lonsurf på menneskets fertilitet.
English: • Neutropenia (very common), febrile neutropenia (common) and septic shock (uncommon).
Danish: • Neutropeni (meget almindelig), febril neutropeni (almindelig) og septisk shock (ikke almindelig).
English: How to take You will take Lonsurf for 10 days during the first 2 weeks, and then have 2 weeks off.
Danish: Hvordan skal det tages Du skal tage Lonsurf i 10 dage de første 2 uger og derefter have 2 uger uden medicin.
English: If you or your partner becomes pregnant during this time, you must talk to your doctor or pharmacist straight away.
Danish: Hvis du eller din partner bliver gravid i løbet af den periode, skal du tale med din læge eller apotekspersonalet med det samme.
English: Do not breast-feed if you are taking Lonsurf as it is not known whether Lonsurf passes into the mother's milk.
Danish: Du må ikke amme, hvis du tager Lonsurf, da det ikke vides, om Lonsurf udskilles i mælken.
English: The incidences of Grade ≥3 neutropenia were higher in the high trifluridine AUC group (47.8%) compared with the low-trifluridine AUC group (30.4%).
Danish: Forekomsten af grad ≥3 neutropeni var højere i gruppen med høj trifluridin-AUC (47,8 %) i forhold til gruppen med lav trifluridin-AUC (30,4 %).
English: Hyperhidrosis Blister
Danish: Hyperhidrose Blister
English: There is no relevant use of Lonsurf in the paediatric population for the indications of metastatic colorectal cancer and metastatic gastric cancer.
Danish: Det er ikke relevant at anvende Lonsurf hos den pædiatriske population til indikationerne metastatisk kolorektal cancer og metastatisk gastrisk cancer.
English: There is limited data in Lonsurf treated patients aged 75 years and above (87 patients (10%) in pooled data of the RECOURSE and TAGS studies, of which 2 patients were 85 years or older).
Danish: Der er begrænsede data for patienter fra 75 år og derover behandlet med Lonsurf (87 patienter (10 %) i poolede data fra RECOURSE- og TAGS-studierne, hvor 2 patienter var 85 år eller ældre).
English: KRAS status was wild (49%) or mutant (51%) at study entry.
Danish: Ved studiestart var KRAS-status vild (49 %) eller muteret (51 %).
English: Serum albumin was found to significantly affect trifluridine clearance, with a negative correlation.
Danish: Serumalbumin viste sig at have signifikant effekt på trifluridin-clearance, med en negativ korrelation.
English: c. Hand-foot skin reaction.
Danish: c. Hånd-fod-hudreaktion.
English: In clinical studies Lonsurf was administered within 1 hour after completion of the morning and evening meals (see section 4.2).
Danish: I kliniske studier blev Lonsurf administreret indenfor 1 time efter afslutning af morgen- og aftenmåltiderne (se pkt.
English: Les Laboratoires Servier 50 rue Carnot 92284 Suresnes Cedex France
Danish: Les Laboratoires Servier 50 rue Carnot 92284 Suresnes Cedex Frankrig
English: • When resuming dosing, decrease the dose level by 5 mg/m2/dose from the previous dose level (Table 4).
Danish: • Ved genoptagelse af dosering nedsættes dosisniveauet med 5 mg/m 2/dosis fra det tidligere dosisniveau (tabel 4)
English: Other minor metabolites, 5-carboxyuracil and 5-carboxy-2'-deoxyuridine, were detected, but those levels in plasma and urine were at low or trace levels.
Danish: Andre ubetydelige metabolitter, 5-carboxyuracil og 5-carboxy-2'deoxyuridin, blev fundet, men niveauerne i plasma og urin var lave eller under detektionsgrænsen.
English: Adverse drug reactions are grouped according to their frequencies.
Danish: Bivirkningerne er grupperet efter frekvens.
English: Talk to your doctor or pharmacist before taking Lonsurf if:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Lonsurf hvis:
English: Based upon limited data with a considerable variability, no statistically significant differences were observed in the pharmacokinetics in patients with normal hepatic function versus patients with mild or moderate hepatic impairment.
Danish: Baseret på begrænsede data med betydelige variationer blev der ikke observeret statistisk signfikante forskelle i farmakokinetikken hos patienter med normal leverfunktion i forhold til patienter med let eller moderat nedsat leverfunktion.
English: Based on the mechanism of action, trifluridine is suspected to cause congenital malformations when administered during pregnancy.
Danish: Baseret på virkningsmekanismen er trifluridin mistænkt for at forårsage medfødte misdannelser, når det administreres under graviditet.
English: If you are pregnant or breast-feeding, or if you think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: It is unknown whether Lonsurf may reduce the effectiveness of hormonal contraceptives.
Danish: Det vides ikke, om Lonsurf kan nedsætte virkningen af hormonelle præventionsmidler.
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC59 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, antimetabolitter, ATC-kode: L01BC59 Virkningsmekanisme
English: Photosensitivity reaction Erythema
Danish: Fotosensitivitetsreaktion Erytem
English: Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy (see section 4.8).
Danish: Monitorering af proteinuri med urinstix anbefales før start og under behandlingen (se pkt.
English: Thus trifluridine and tipiracil hydrochloride are not expected to cause or be subject to a significant medicinal product interaction mediated by CYP.
Danish: Trifluridin og tipiracilhydrochlorid forventes derfor ikke at forårsage eller være årsag til signifikant lægemiddelinteraktion medieret af CYP.
English: Within each frequency group, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: In vitro studies indicated that trifluridine is a substrate for the nucleoside transporters CNT1, ENT1 and ENT2.
Danish: In vitro studier indikerede, at trifluridin er et substrat for nukleosid-transportørerne CNT1, ENT1 og ENT2.
English: • a reduced number of certain types of white blood cells (neutropenia) which are important for protecting the body against bacterial or fungal infections.
Danish: • nedsat antal af visse typer hvide blodlegemer (neutropeni), som er vigtige for at beskytte din krop mod bakterie- og svampeinfektioner.
English: Lonsurf contains lactose
Danish: Lonsurf indeholder lactose
English: Post-marketing experience in patients with unresectable advanced or recurrent colorectal cancer
Danish: Erfaring efter markedsføring hos patienter med ikke-resektabel fremskreden eller recidiverende kolorektal cancer
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis din læge har fortalt dig, at du ikke tåler visse sukkerstoffer, skal du kontakte din læge, før du tager denne medicin.
English: • Interrupt dosing until toxicity resolves to Grade 1 or baseline.
Danish: • Afbryd doseringen, indtil bivirkningen bliver grad 1 eller som ved baseline
English: However, there was no accumulation for tipiracil hydrochloride, and no further accumulation of trifluridine with successive cycles (Day 12 of Cycles 2 and 3) of administration of Lonsurf.
Danish: Der var ingen akkumulering af tipiracilhydrochlorid og ingen yderligere akkumulering af trifluridin ved successive cykler (dag 12 i cyklus 2 og 3) efter administration af Lonsurf.
English: OS appeared more favourable in the high AUC group compared to the low AUC group (median OS of 9.3 vs. 8.1 months, respectively).
Danish: OS var mere favorabel i gruppen med høj AUC sammenlignet med gruppen med lav AUC (median OS på henholdsvis 9,3 og 8,1 måneder).
English: • protein in your urine
Danish: • protein i urinen
English: Based on findings in animals, trifluridine may cause foetal harm when administered to pregnant women.
Danish: Baseret på resultater fra dyr kan trifluridin forårsage fosterskader ved administration til gravide kvinder.
English: The dosage is calculated according to body surface area (BSA) (see Table 1).
Danish: Dosis beregnes ud fra kroppens overfladeareal (body surface area, BSA) (se tabel 1).
English: Eighteen percent (18%, N = 144) of all randomised patients received regorafenib prior to randomisation.
Danish: 18 % (N = 144) af alle randomiserede patienter fik regorafenib før randomiseringen.
English: All but 1 patient received bevacizumab, and all but 2 patients with KRAS wild type tumours received panitumumab or cetuximab.
Danish: Alle, bortset fra 1 patient, fik bevacizumab, og alle, bortset fra 2 patienter med KRAS-vildtype-tumorer fik panitumumab eller cetuximab.
English: Primary cancer was gastric (71.0%) or gastroesophageal junction cancer (28.6%) or both (0.4%).
Danish: De primære cancerformer var gastrisk cancer (71,0 %), cancer i den gastroøsofageale overgang (28,6 %) eller begge (0,4 %).
English: In the event of haematological and/or non-haematological toxicities patients should follow the dose interruption, resumption and reduction criteria stated in Table 2, Table 3 and Table 4.
Danish: I tilfælde af hæmatologisk og/eller ikke-hæmatologisk toksicitet skal patienten følge kriterierne for doseringsafbrydelse, doseringsgenoptagelse og dosisreduktion i tabel 2, tabel 3 og tabel 4.
English: Patients continued therapy until disease progression or unacceptable toxicity (see section
Danish: Patienterne fortsatte behandlingen indtil sygdomsprogression eller uacceptabel toksicitet (se pkt.
English: The signs include chills, fever, sweating or other sign of bacterial or fungal infection (see section 2).
Danish: Symptomerne inkluderer kulderystelser, feber, sveden eller andre tegn på bakterie- eller svampeinfektion (se punkt 2).
English: No long term studies evaluating the carcinogenic potential of trifluridine/tipiracil hydrochloride in animals have been performed.
Danish: Der er ikke udført langtidsstudier, som evaluerer det karcinogene potentiale af trifluridin/tipiracilhydrochlorid hos dyr.
English: LIST OF EXCIPIENTS Contains lactose monohydrate, see leaflet for further information.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactosemonohydrat, se indlægssedlen for yderligere information.
English: • CTCAE* non-haematologic Grade 3 or Grade 4 adverse reaction; except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or diarrhoea responsive to antidiarrhoeal medicinal products
Danish: • CTCAE* grad 3 eller grad 4 ikkehæmatologisk bivirkning med undtagelse af grad 3 kvalme og/eller opkastning, som kontrolleres med antiemetisk behandling, og diarré, som reagerer på anti-diarré-lægemidler
English: The median number of prior regimens of therapy for metastatic disease was 3.
Danish: Mediantallet af tidligere behandlingsregimer for metastatisk sygdom var 3.
English: Given that the majority were reported in the context of bone marrow suppression, the patient's condition should be monitored closely, and appropriate measures, such as antimicrobial agents and granulocyte-colony stimulating factor (G-CSF), should be administered as clinically indicated.
Danish: Da størstedelen blev rapporteret i forbindelse med knoglemarvssuppression, skal patientens tilstand overvåges nøje, og passende behandling, såsom antimikrobielle midler og granulocyt-kolonistimulerende faktor (G-CSF), skal administreres som klinisk indiceret.
English: • increased number of white blood cells called monocytes
Danish: • øget antal af de hvide blodlegemer, som kaldes monocytter
English: However, the incidence of serious, severe AEs and AEs leading to dose modification tends to increase with advancing levels of renal impairment.
Danish: Forekomsten af alvorlige, svære bivirkninger og bivirkninger, som medfører dosismodifikation, har tendens til at øges i takt med stigende niveauer af nedsat nyrefunktion.
English: All changes, i.e., leukopenia, anaemia, bone marrow hypoplasia, atrophic changes in the lymphatic and haematopoietic tissues and the gastrointestinal tract, were reversible within 9 weeks of drug withdrawal.
Danish: Alle ændringer, dvs. leukopeni, anæmi, knoglemarvshypoplasi, atrofiske forandringer i lymfatiske og hæmatopoietiske væv og mave-tarm-kanalen, var reversible inden for 9 uger efter seponering.
English: No peri/post-natal developmental toxicity studies have been performed.
Danish: Der er ikke udført peri- eller postnatale studier af udviklingstoksicitet.
English: Progression-free Survival Probability (%)
Danish: Sandsynlighed for progressionsfri overlevelse (%)
English: See Section 4.8 for how to report adverse reactions.
Danish: 4.8, hvordan bivirkninger indberettes.
English: A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 twice daily.
Danish: Maksimalt 3 dosisreduktioner er tilladt til en minimumdosis på 20 mg/m to gange dagligt.
English: Dysgeusia Neuropathy peripheral
Danish: Dysgeusi Perifer neuropati
English: For low albumin values ranging from 2.2 to 3.5 g/dL, the corresponding clearance values range from 4.2 to 3.1 L/h.
Danish: Ved lave albuminværdier, i intervallet 2,2 til 3,5 g/dl, var de tilsvarende clearanceværdier fra 4,2 til 3,1 l/time.