FrancophonIA/ELRC3.0 huggingface dataset:
English: Grounds for the granting of the marketing authorisation for Suifertil 4 mg/ml Oral Solution for Pigs
Danish: Begrundelse for udstedelse af markedsføringstilladelse for Suifertil, oral opløsning, 4 mg/ml, til svin.
English: Overall summary of the scientific evaluation of Suifertil 4 mg/ml Oral Solution for Pigs
Danish: Samlet resumé af den videnskabelige vurdering af Suifertil, oral opløsning, 4 mg/ml, til svin, og relaterede navne
English: Content Package size
Danish: Indgivelsesvej Emballage Indhold Pakningss tørrelse
English: Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform Dyrearter , som lægemidlet er beregnet til
English: Median time to event (days)
Danish: Median tid til event (dage)
English: Also, you need to be particularly careful if you are taking any of the following:
Danish: Du skal også være særlig forsigtig, hvis du tager:
English: PRIMARY ANALYSIS
Danish: PRIMÆRE ANALYSE
English: Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
Danish: Din læge vil fortælle dig, hvilken dosis du skal tage, hvornår du skal tage den, og hvor længe du skal tage lægemidlet.
English: Rare/Very rare (Post-marketing experience)
Danish: Sjælden/meget sjælden (erfaringer efter markedsføring)
English: Palmar-plantar erythrodysaesthesia syndrome**
Danish: Palmar-plantar erythrodysæstesi syndrom**
English: • It is important that you take all your medicine as prescribed by your doctor.
Danish: • Det er vigtigt, at du tager al din medicin som foreskrevet af din læge.
English: • Take the tablets in the morning and evening as prescribed by your doctor.
Danish: • Tag tabletterne morgen og aften som foreskrevet af din læge.
English: This 21 day period is one treatment cycle.
Danish: Denne 21 dages-periode er en behandlingsserie.
English: • if you have a history of eye problems as you may need extra monitoring of your eyes,
Danish: • hvis du tidligere har haft problemer med øjnene, da du herved kan have brug for ekstra kontrol af dine øjne
English: • If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.
Danish: • Hvis der forekommer kontraindikationer til et af lægemidlerne i kombinationsregimet, bør det pågældende lægemiddel ikke anvendes.
English: Ethnic factors
Danish: Etniske faktorer
English: About 3 % of the administered dose is excreted in urine unchanged.
Danish: Ca. 3 % af den indgivne dosis udskilles uændret i urinen.
English: • Infection: if you experience signs of infection caused by bacteria or virus, or other organisms.
Danish: • Infektion: hvis du oplever tegn på infektion forårsaget af bakterier eller virus eller andre organismer.
English: • Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow whole with water.
Danish: • Tag tabletterne senest 30 min efter et måltid (morgenmad og aftensmad) og slug dem hele med vand.
English: • Fever: if you have a temperature of 38 °C or greater.
Danish: • Feber: hvis din temperatur stiger til 38 °C eller derover.
English: ADDITIONAL 6 MONTHS OF FOLLOW UP
Danish: 6 MÅNEDERS YDERLIGERE FOLLOW-UP
English: HR (97.5 % CI)
Danish: HR (97,5 % KI)
English: The AUC of 5-FU was 30 % - 35 % higher on day 14.
Danish: AUC for 5-FU var 30 - 35 % højere på dag 14.
English: Your doctor will prescribe a dose and treatment regimen that is right for you.
Danish: Din læge vil ordinere en dosis og en behandling, som er rigtig for dig.
English: Faecal excretion is minimal (2.6 %).
Danish: Udskillelse i fæces er minimal (2,6 %).
English: Severe and/or life-threatening (grade 3 - 4) or considered medically relevant
Danish: Alvorlig og/eller livstruende (grad 34) eller vurderet som klinisk relevant
English: The major metabolite excreted in urine is FBAL, which represents 57 % of the administered dose.
Danish: Hovedmetabolitten, som udskilles i urinen, er FBAL, der repræsenterer 57 % af den indgivne dosis.
English: Careful monitoring of patients ≥ 60 years of age is advisable.
Danish: Omhyggelig monitorering af patienter ≥ 60 år tilrådes.
English: Do not store above 30 °C.
Danish: Må ikke opbevares ved temperaturer over 30 °C
English: Not applicable *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Danish: Ikke relevant * ifølge National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) eller Common Terminology Criteria for Adverse Events (CTCAE) fra Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
English: In addition to the above, when Capecitabine medac is used alone, very common side effects which may affect more than 1 in 10 people are:
Danish: Udover dette kan Capecitabine medac, når det anvendes alene, have følgende meget almindelige bivirkninger, som kan påvirke flere end 1 ud af 10 personer:
English: 820 Patients were randomised to receive either sequential treatment (n = 410) or combination treatment (n = 410).
Danish: 820 patienter blev randomiseret til at få enten sekventiel behandling (n = 410) eller kombinationsbehandling (n = 410).
English: Interrupt until resolved to grade 0-1
Danish: Afbryd behandlingen, indtil toksiciteten er reduceret til grad 0-1
English: Date of latest renewal: 16 June 2017
Danish: Dato for første markedsføringstilladelse: 19. november 2012 Dato for seneste fornyelse: 16. juni 2017
English: In this trial, 1,002 patients were randomised in a 2x2 factorial design to one of the following 4 arms:
Danish: I dette studie blev 1.002 patienter randomiseret i et 2 x 2 faktor design til en af følgende fire arme:
English: Capecitabine can induce the occurrence of diarrhoea, which has been observed in up to 50 % of patients.
Danish: 4.4) Capecitabin kan inducere forekomsten af diarré, hvilket er observeret i op til 50 % af patienterne.
English: Capecitabine medac tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Danish: Capecitabine medac-tabletter tages normalt i 14 dage efterfulgt af 7 dages pause (hvor der ikke tages tabletter).
English: Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis .
English: Persistent or severe HFS (Grade 2 and above) can eventually lead to loss of fingerprints which could impact patient identification.
Danish: Vedvarende eller svært HFS (grad 2 og højere) kan i sidste ende forårsage, at fingeraftrykket forsvinder, som kan påvirke patientens identifikation.
English: • inflammation of the skin causing red scaly patches due to an immune system illness
Danish: • inflammation i huden, der medfører røde skællende pletter på grund af en sygdom i immunsystemet
English: Hazard ratio 95 % CI P value
Danish: Hazard ratio 95 % konfidensinterval p-værdi
English: Cytochrome P450 2C9 (CYP2C9) substrates
Danish: Cytokrom P450 2C9 (CYP2C9)-substrater
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or fluorouracil,
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt 6.1 eller fluorouracil,
English: The AUC of FBAL increased with age (20 % increase in age results in a 15 % increase in the AUC of FBAL).
Danish: FBAL's AUC steg med alderen (20 % stigning i alder medførte 15 % stigning i FBAL's AUC).
English: Capecitabine medac may be used either alone or in combination with other medicines.
Danish: Capecitabine medac kan anvendes enten alene eller i kombination med andre lægemidler.
English: Finally, β-ureido-propionase cleaves FUPA to FBAL which is cleared in the urine.
Danish: Endeligt spalter β-ureido-propionase FUPA til FBAL, som udskilles i urinen.
English: Although sensitivity analyses show that differences in regimen schedules and timing of tumour assessments impact the on-treatment PFS analysis, a full explanation for this result has not been found.
Danish: Selvom sensitivitetsanalyser viser, at forskelle i behandlingsskemaer og tidspunkt for tumorvurdering påvirker analysen for PFS ontreatment, er der ikke fundet en fyldestgørende forklaring på dette fund.
English: • if you have diarrhoea,
Danish: • hvis du har diarré
English: This will help reduce the likelihood that the side effect continues or becomes severe.
Danish: Dermed nedsættes sandsynligheden, for at bivirkningen fortsætter eller forværres.
English: • bruising or reaction at the injection site (caused by medicines given by injection at the same time)
Danish: • blå mærker eller reaktioner på injektionsstedet (forårsaget af lægemidler, der indsprøjtes på samme tid)
English: Discontinue treatment permanently
Danish: Seponér behandlingen permanent
English: HR (95 % CI)
Danish: HR (95 % KI)
English: The dose of Capecitabine medac is based on your body surface area.
Danish: Din dosis af Capecitabine medac er baseret på arealet af din legemsoverflade.
English: • if you have brain diseases (for example cancer that has spread to the brain) or nerve damage
Danish: • hvis du har sygdomme i hjernen (f.eks. kræft, der har spredt sig til hjernen) eller nerveskader
English: (neuropathy),
Danish: (neuropati)
English: Parameter: Progression-free survival
Danish: Parameter: Progressionsfri overlevelse
English: Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Capecitabine medac.
Danish: Lægen vil måske bede dig om at sætte dosis ned og/eller midlertidigt afbryde behandlingen med Capecitabine medac.
English: • specific changes in the electrocardiogram (QT prolongation)
Danish: • visse ændringer i elektrokardiogrammer (kaldet QT-forlængelse)
English: ** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4)
Danish: ** Baseret på erfaringer efter markedsføring kan vedvarende eller svært palmar-plantar erytrodysæstesi syndrom i sidste ende forårsage, at fingeraftrykket forsvinder (se pkt.
English: • if you cannot keep food or water in your body because of severe nausea and vomiting,
Danish: • hvis du ikke kan holde på mad eller vand pga. svær kvalme og opkastning
English: Japanese patients had also about 25 % lower Cmax and 34 % lower AUC for FBAL than Caucasian patients.
Danish: Patienter af japansk oprindelse havde også omkring 25 % lavere Cmax og 34 % lavere AUC for FBAL end patienter af kaukasisk oprindelse.
English: STOP taking Capecitabine medac immediately and contact your doctor if any of these symptoms occur:
Danish: STOP øjeblikkeligt med at tage Capecitabine medac og kontakt lægen hvis nogle af følgende symptomer viser sig:
English: It is therefore possible that Capecitabine medac could affect your ability to drive a car or operate machines.
Danish: Det er derfor muligt, at Capecitabine medac kan påvirke din evne til at køre bil, og betjene maskiner.
English: • Diarrhoea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhoea at night.
Danish: • Diarré: hvis du har en øgning på 4 eller flere afføringer om dagen sammenlignet med dit normale antal daglige afføringer eller hvis du får diarré om natten.
English: Hand and foot skin-reaction can lead to loss of fingerprint, which could impact your identification by fingerprint scan.
Danish: Hudsymptomer på hænder og fødder kan forårsage, at fingeraftrykket forsvinder, som kan påvirke din identifikation med fingeraftryksscanner.
English: Doses of capecitabine omitted for toxicity are not replaced.
Danish: Capecitabin-doser, som ikke tages på grund af toksicitet, erstattes ikke.
English: Tell your doctor immediately if you experience any of these symptoms.
Danish: Kontakt straks din læge, hvis du får et eller flere af disse symptomer.
English: Capecitabine was not mutagenic in vitro to bacteria (Ames test) or mammalian cells (Chinese hamster V79/HPRT gene mutation assay).
Danish: Capecitabin var ikke mutagent in vitro over for bakterier (Ames test) eller over for celler fra pattedyr (kinesisk hamster V79/HPRT gene mutation assay).
English: • if you are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy.
Danish: • hvis du bliver behandlet på nuværende tidspunkt eller inden for de sidste 4 uger har været behandlet med brivudin som en del af herpes zosterbehandling (skoldkopper eller helvedesild)
English: 5-FU is further catabolised by the enzyme DPD to the much less toxic dihydro-5-fluorouracil (FUH2).
Danish: 5-FU nedbrydes yderligere af enzymet DPD til det meget mindre toksiske dihydro-5-fluoruracil (FUH2).
English: The overall objective response rates (investigator assessment) were 20 % (first trial) and 25 % (second trial).
Danish: De totale objektive responsrater (investigators vurdering) var 20 % (første studie) og 25 % (andet studie).
English: • ringing or buzzing in the ears (tinnitus), loss of hearing
Danish: • ringen eller summen for ørerne (tinnitus), tab af hørelse
English: Further catalytic activation of 5'-DFUR then occurs by ThyPase.
Danish: Den videre katalytiske aktivering af 5'-DFUR sker derefter ved hjælp af ThyPase.
English: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Danish: De efterfølgende overskrifter rangerer bivirkningerne efter frekvens: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
English: Table 6 Treatment regimens in study NO16966 (mCRC) Treatment
Danish: Tabel 6 Behandlingsregimer i studie NO16966 (mCRC) Behandling Startdosis
English: In an interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57 %) of S-warfarin.
Danish: I et interaktionsstudie med enkeltdosis-administration af warfarin var der en signifikant stigning i middel-AUC (+ 57 %) af S-warfarin.
English: Some of these side effects are more common when capecitabine is used with other medicines for the treatment of cancer.
Danish: Nogle af disse bivirkninger er mere almindelige, når capecitabin anvendes sammen med andre lægemidler til behandling af kræft.
English: However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥ 60 years of age compared to younger patients.
Danish: Behandlingsrelaterede bivirkninger af sværhedsgrad 3 eller 4 var dog hyppigere hos patienter ≥ 60 år sammenlignet med yngre patienter.
English: In a pre-planned multivariate Cox analysis, superiority of capecitabine compared with bolus 5-FU/LV was demonstrated.
Danish: I en forudplanlagt multivariat Cox-analyse blev det vist, at capecitabin er bedre sammenlignet med bolus 5-FU/LV.
English: Discontinue permanently or If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1
Danish: Seponér behandlingen permanent eller hvis lægen skønner, at det bedste for patienten er at fortsætte, så afbryd behandlingen, indtil toksiciteten er reduceret til grad 0-1
English: Modified XELIRI + bevacizumab (ITT: N = 120)
Danish: Modificeret XELIRI + bevacizumab (ITT: N = 120)
English: At the end of treatment, 37 % of patients in the XELIRI and 26 % of patients in the FOLFIRI arm were without evidence of the disease (p = 0.56).
Danish: Ved afslutningen af behandlingen havde 37 % af patienterne i XELIRI-armen og 26 % af patienterne i FOLFIRI-armen ingen tegn på sygdommen (p = 0,56).
English: • blood-thinning medicines (coumarin, warfarin)
Danish: • blodfortyndende medicin (coumarin eller warfarin)
English: The following factors were pre-specified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomisation, gender, carcinoembryonic antigen (CEA) levels at baseline, lymph nodes at baseline, and country.
Danish: Følgende faktorer var præspecificerede i den statistiske analyseplan for inklusion i modellen: Alder, tid fra operation til randomisering, køn, karcinoembryonisk antigen (CEA)-værdier ved baseline, lymfeknuder ved baseline samt land.
English: Neurotoxicity, Tremor, Neuralgia,
Danish: Neurotoksicitet, Tremor, Neuralgi,
English: These results suggest an interaction, probably due to an inhibition of the cytochrome P450 2C9 isoenzyme system by capecitabine.
Danish: Disse resultater tyder på en interaktion, sandsynligvis på grund af capecitabins hæmning af cytokrom P450 2C9-isoenzymsystemet.
English: Dose changes within a treatment cycle Dose adjustment for next cycle/dose (% of starting dose)
Danish: Dosisjustering for næste serie/dosis (% af begyndelsesdosis)
English: Creatinine clearance was found to influence the systemic exposure to 5'-DFUR (35 % increase in AUC when creatinine clearance decreases by 50 %) and to FBAL (114 % increase in AUC when creatinine clearance decreases by 50 %).
Danish: Creatininclearance påvirkede den systemiske eksponering af 5'-DFUR (35 % stigning i AUC, når creatininclearance aftog med 50 %) og FBAL (114 % stigning i AUC, når creatininclearance aftog med 50 %).
English: • if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil),
Danish: • hvis du tidligere har reageret kraftigt på behandling med fluorpyrimidin (en gruppe lægemidler mod kræft, bl.a. fluorouracil)
English: Oxaliplatin on Day 1, every 2 weeks
Danish: Oxaliplatin på dag 1, hver 2. uge
English: Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months.
Danish: Adjuverende behandling af patienter med stadium III-kolonkræft anbefales i en periode på 6 måneder.
English: Capecitabine 1,000 mg/m² oral twice daily
Danish: Capecitabin 1.000 mg/m² oral 2 gange daglig
English: When capecitabine and cisplatin are used in combination, the use of vitamin B6 (pyridoxine) is not advised for symptomatic or secondary prophylactic treatment of HFS, because of published reports that it may decrease the efficacy of cisplatin.
Danish: Hvis capecitabin og cisplatin anvendes i kombination, frarådes anvendelse af vitamin B6 (pyridoxin) til behandling af symptomatisk eller sekundær profylaktisk behandling af HFS, da der er offentliggjort meddelelser om, at det kan nedsætte virkningen af cisplatin.
English: Method of administration Capecitabine medac tablets should be swallowed with water within 30 minutes after a meal.
Danish: Administration Capecitabine medac tabletter skal synkes sammen med vand inden for 30 minutter efter et måltid.
English: • if you have or had heart problems (for example an irregular heart beat or pains to the chest, jaw and back, brought on by physical effort and due to problems with the blood flow to the heart),
Danish: • hvis du har eller har haft hjerteproblemer (f.eks. uregelmæssig hjerterytme eller smerter i brystet, kæben og ryggen ved fysisk anstrengelse på grund af problemer med blodtilførslen til hjertet)
English: After oral administration, capecitabine is rapidly and extensively absorbed, followed by extensive conversion to the metabolites, 5'-DFCR and 5'-DFUR.
Danish: Efter oral administration absorberes capecitabin hurtigt og i stort omfang efterfulgt af en omfattende omdannelse til metabolitterne 5'-DFCR og 5‘-DFUR.
English: Pharmacotherapeutic group: Pyrimidine analogues, antineoplastic agents, ATC code: L01BC06
Danish: Farmakoterapeutisk klassifikation: Pyrimidin-analoger, antineoplastiske stoffer, ATC-kode: L01BC06
English: You must inform your doctor if you know that you have an allergy or over-reaction to this medicine,
Danish: Du skal fortælle din læge, hvis du er overfølsom over for eller reagerer kraftigt på dette lægemiddel
English: Table 3 Capecitabine dose reduction schedule (3-weekly cycle or continuous treatment) Toxicity grades*
Danish: Tabel 3 Dosisreduktion af capecitabin (3-ugers-serier eller kontinuerlig behandling) Toksicitet graduering*
English: Other side-effects seen in this setting are the following:
Danish: Andre bivirkninger, der er set i denne forbindelse, er:
English: In combination with other medicines the usual dose for adults may be less than 1,250 mg/m² of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period).
Danish: I kombination med andre lægemidler kan den almindelige dosis for en voksen være mindre end 1.250 mg/m² legemsoverfladeareal, og det kan være nødvendigt, at du tager tabletterne i et andet tidsinterval (for eksempel hver dag uden pause).
English: The incorporation of 5-FU also leads to inhibition of ribonucleic acid (RNA) and protein synthesis.
Danish: Inkorporeringen af 5-FU medfører hæmning af ribonukleinsyre (RNA) og proteinsyntesen.
English: No significant differences occurred in the exposure to other metabolites (5'-DFCR, 5'-DFUR, and 5-FU).
Danish: Der forekom ingen signifikant forskel i eksponeringen for andre metabolitter (5´-DFCR, 5´-DFUR og 5-FU).
English: Parameter: Progression-free survival EPP ITT Parameter: Overall survival EPP ITT
Danish: Parameter: Progressionsfri overlevelse EPP ITT Parameter: Samlet overlevelse EPP ITT
English: The XELIRI has been compared with 5-FU + irinotecan (FOLFIRI) in three randomised studies in patients with metastatic colorectal cancer.
Danish: XELIRI er blevet sammenlignet med 5-FU + irinotecan (FOLFIRI) hos patienter med metastatisk kolorektalkræft i tre randomiserede studier.
English: Capecitabine can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Danish: Capecitabin kan inducere alvorlige hudreaktioner såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse.
English: Toxicity due to capecitabine administration may be managed by symptomatic treatment and/or modification of the dose (treatment interruption or dose reduction).
Danish: Toksicitet, som skyldes administration af capecitabin, kan behandles symptomatisk og/eller med modifikation af capecitabin-dosis (afbrydelse af behandlingen eller reduktion af dosis).
English: Furthermore, Capecitabine medac is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Danish: Desuden anvendes Capecitabine medac til forebyggelse af ny optræden af tyktarmskræft efter fuldstændig fjernelse af svulsten ved operation.
English: Capecitabine dose reduction decreases systemic exposure to 5-FU more than dose-proportionally, due to non--linear pharmacokinetics for the active metabolite.
Danish: Dosisreduktion af capecitabin nedsætter den systemiske eksponering for 5-FU mere end svarende til dosisproportionaliteten på grund af den aktive metabolits non-lineære farmakokinetik.
English: Hypo- or hypercalcaemia
Danish: Hypo- eller hyperkalcæmi
English: Interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU.
Danish: Der er set interaktion mellem allopurinol og 5-FU med mulig nedsat effekt af 5-FU.
English: -2nd appearance
Danish: - ved 2. forekomst
English: Since current safety and efficacy data are based upon administration with food, it is recommended that capecitabine be administered with food.
Danish: Da sikkerheds- og effektdata er baseret på administration sammen med maden, anbefales det at tage capecitabin sammen med et måltid.
English: Table 7 Key efficacy results for the non-inferiority analysis of study NO16966
Danish: Tabel 7 Nøgleresultaterne for effekt af non-inferioritetsanalysen af studie NO16966
English: Following grade 3 HFS, subsequent doses of capecitabine should be decreased.
Danish: Efter grad 3-HFS skal dosis af capecitabine sættes ned.
English: No information is available on hepatic impairment due to cirrhosis or hepatitis.
Danish: Der er ingen tilgængelige data vedrørende leverinsufficiens på grund af cirrhose eller hepatitis.
English: The pooled analysis includes 3,097 patients treated with capecitabine-containing regimens and 3,074 patients treated with 5-FU-containing regimens.
Danish: Den poolede analyse omfatter 3.097 patienter, som blev behandlet med regimer, som indeholdt capecitabin, og 3.074 patienter, som blev behandlet med regimer, som indeholdt 5-FU.