FrancophonIA/ELRC3.0 huggingface dataset:
English: Progressive multifocal leukoencephalopathy (PML) Cases of PML, including fatal cases, have been reported with cladribine.
Danish: Der er rapporteret om tilfælde af PML, herunder med dødelig udgang, ved behandling med cladribin.
English: Common: second malignancies * Rare: tumour lysis syndrome *
Danish: Almindelige: sekundære maligniteter * Sjældne: tumorlysesyndrom *
English: How do I give my injection?
Danish: Hvordan giver jeg mig selv indsprøjtningen?
English: What LITAK looks like and contents of the pack LITAK is available in glass vials containing 5 ml of clear, colourless solution for injection.
Danish: LITAK fås i hætteglas, som indeholder 5 ml klar, farveløs injektionsvæske, opløsning.
English: At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Danish: Sløret syn, synstab, dobbeltsyn, talebesvær, svækkelse af en arm eller et ben, ændring af den måde, De går på, eller problemer med at holde balancen, vedvarende følelsesløshed, nedsat føleevne, tab af føleevne, hukommelsestab eller forvirring.
English: LITAK is contraindicated in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) or with moderate to severe hepatic impairment (Child-Pugh score > 6) (see sections 4.3, 4.4 and 5.2).
Danish: LITAK er kontraindiceret hos patienter med moderat til alvorlig nyresvækkelse (kreatininclearance ≤ 50 ml/min) eller moderat til alvorlig leversvækkelse (Child-Pugh-score > 6) (se pkt.
English: Common: myalgia, arthralgia, arthritis, bone pain
Danish: Almindelige: myalgi, artralgi, artritis, knoglesmerte
English: Itching, itching skin eruption (urticaria), redness of the skin and skin pain.
Danish: Kløe, kløende udslæt (nældefeber), rødme af huden og smerter i huden.
English: 5 vials each containing 5 ml solution for injection
Danish: 5 hætteglas indeholdende 5 ml injektionsvæske, opløsning
English: 1 vial containing 5 ml solution for injection
Danish: 1 hætteglas indeholdende 5 ml injektionsvæske, opløsning
English: Women of childbearing potential must use effective contraception during treatment with cladribine and for 6 months after the last cladribine dose.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i 6 måneder efter behandlingen med cladribin.
English: Heart failure.
Danish: Hjertesvigt.
English: - The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid
Danish: - Øvrige indholdsstoffer: natriumklorid, natriumhydroxid (til pH-justering), saltsyre (til pH-justering) og vand til injektionsvæsker.
English: Each vial contains 10 mg of cladribine in 5 ml of solution.
Danish: Hvert hætteglas indeholder 10 mg cladribin i 5 ml opløsning.
English: Stroke.
Danish: Forstoppelse.
English: Push the needle through the rubber stopper of the vial and turn the vial and the syringe upside down.
Danish: Pres kanylen ned gennem hætteglassets gummiprop og vend hætteglasset og sprøjten på hovedet.
English: Rare: renal failure
Danish: Sjældne: nyreinsufficiens
English: Abnormal breath sounds, abnormal chest sounds, cough.
Danish: Unormale åndedrætslyde, unormale brystlyde, hoste.
English: LITAK is supplied as a ready-to-use solution for injection.
Danish: LITAK leveres som en brugsklar injektionsvæske, opløsning.
English: - a puncture-proof container for safe disposal of the used syringe.
Danish: - en beholder som ikke kan stikkes hul i, til at smide de brugte sprøjter væk i.
English: Cytotoxic.
Danish: Lægemidlet er cytotoksisk.
English: Put used syringes into a puncture-proof container and keep it out of the reach and sight of children.
Danish: Smid brugte sprøjter væk i en beholder, der ikke kan prikkes hul i. Opbevar beholderen utilgængeligt for børn.
English: Uncommon: somnolence, paraesthesia, lethargy, polyneuropathy, confusion, ataxia
Danish: Meget almindelige: hovepine, svimmelhed Almindelige: søvnmangel, ængstelse Ikke almindelige: somnolens, paræstesier, apati, polyneuropati, konfusion, ataksi
English: Rare: apoplexy, neurological disturbances in speech and swallowing
Danish: Sjældne: apopleksi, neurologisk besvær med at tale og synke Meget sjældne: depression, epileptisk anfald
English: Rare: hepatic failure
Danish: Sjældne: leversvigt
English: Common: oedema, malaise, pain
Danish: Almindelige: ødemer, utilpashed, smerte
English: What LITAK is and what it is used for What you need to know before you use LITAK How to use LITAK
Danish: Det skal De vide, før De begynder at bruge LITAK Sådan skal De bruge LITAK Bivirkninger
English: The mean plasma clearance amounts to 794 ml/min after intravenous infusion and to 814 ml/min after subcutaneous bolus injection at a dose of 0.10 mg/kg body weight/day.
Danish: efter subkutan bolusinjektion ved en dosis på 0,10 mg/kg legemsvægt/dag.
English: Use a new syringe and injection needle for each injection.
Danish: Smid sprøjten væk i en beholder, der ikke kan prikkes hul i. Brug en ny sprøjte og kanyle til den næste indsprøjtning.
English: Very common: abnormal breath sounds, abnormal chest sounds, cough
Danish: Luftveje, thorax og mediastinum Meget almindelige: unormale åndedrætslyde, unormale brystlyde, hoste
English: Weakness.
Danish: Årebetændelse.
English: Only limited QoL data are available after this period.
Danish: Kun begrænsede QoL-data var tilgængelige efter denne periode.
English: This may be due to liver problems.
Danish: Dette kan skyldes leverproblemer.
English: Number at risk:
Danish: Antal i risiko:
English: Male: 82%
Danish: Mænd: 82 %
English: Not known (proportion of people affected not known)
Danish: Ikke kendt (andelen af påvirkede mennesker er ikke kendt)
English: • A wound that does not heal.
Danish: • Et sår, der ikke heler.
English: There are no data on human fertility.
Danish: Der foreligger ingen data om human fertilitet.
English: Comparable results for OS were observed with a follow-up analysis (descriptive) at 430 events.
Danish: Der blev observeret sammenlignelige resultater for OS ved en follow-up analyse (deskriptiv) i 430 hændelser.
English: The usual dose is 60 mg, however your doctor will decide on the right dose for you.
Danish: Den sædvanlige dosis er 60 mg, men din læge vil afgøre, hvad der er den rette dosis for dig.
English: Interrupt treatment.
Danish: Afbryd behandlingen.
English: Median age: 64 years.
Danish: Medianalder: 64 år
English: Swallow the tablet with a full glass of water.
Danish: Synk tabletten hel med et helt glas vand.
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Danish: Fortæl det straks til din læge, hvis du lægger mærke til nogen af følgende bivirkninger - du kan have behov for hurtig lægehjælp:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 September 2016
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 09 september 2016
English: When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.
Danish: Når dosisreduktion er nødvendig, anbefales det at reducere til 40 mg dagligt og dernæst til 20 mg dagligt.
English: Uncommon Not Known
Danish: Almindelig Ikke almindelig Ikke kendt
English: ORR (partial responses only) Stable disease
Danish: ORR (Kun delvis respons) Stabil sygdom
English: You should continue to take this medicine until your doctor decides to stop your treatment.
Danish: Du skal fortsætte med at tage dette lægemiddel, indtil din læge beslutter at stoppe behandlingen.
English: Add supportive care as indicated.
Danish: Tilføj understøttende behandling som indiceret.
English: The tablets should be swallowed whole and not crushed.
Danish: Tabletterne skal synkes hele og må ikke knuses.
English: The clinical relevance of the observed neoplastic lesions in rats is uncertain, but likely to be low.
Danish: Den kliniske relevans af de observerede neoplastiske læsioner hos rotter er uvis, men vil sandsynligvis være ringe.
English: You should tell your doctor about every medicine, but in particular if taking:
Danish: Du skal informere lægen om alt medicin, men især hvis du tager:
English: Two dose reductions were required in 19.3% of patients.
Danish: 2 dosisreduktioner var nødvendigt hos 19,3 % af patienterne.
English: Non-disease specific quality of life (QoL) was assessed using the EuroQoL EQ-5D-5L.
Danish: Ikke-sygdomsspecifik livskvalitet (QoL) blev vurderet ved brug af EuroQoL EQ-5D-5L.
English: Subjects with untreated, or incompletely treated, varices with bleeding or high risk for bleeding were also excluded from this study.
Danish: Forsøgspersoner med ubehandlet eller ufuldstændig behandling, varicer med blødning eller høj risiko for blødning, blev også ekskluderet fra dette studie.
English: Both men and women should be advised to seek advice and consider fertility preservation before treatment.
Danish: Både mænd og kvinder bør tilrådes at søge rådgivning og overveje fertilitetsbevarende tiltag inden behandling.
English: Partial responses
Danish: Delvis respons
English: Embryo-foetal development studies were performed in rats and rabbits.
Danish: Der blev udført embryo-føtale udviklingsstudier hos rotter og kaniner.
English: Frequencies are based on all grades and defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); not known (cannot be estimated from the available data).
Danish: Hyppigheder er baseret på bivirkninger af alle grader og defineret som: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Your doctor may also prescribe other medicines to help control your side effects.
Danish: Din læge kan også ordinere andre lægemidler som hjælp til at mindske dine bivirkninger.
English: As most events occur early in the course of treatment, the physician should evaluate the patient closely during the first eight weeks of treatment to determine if dose modifications are warranted.
Danish: Da de fleste bivirkninger forekommer tidligt i behandlingsforløbet, skal lægen evaluere patienten tæt i de første otte behandlingsuger for at vurdere, om dosisændring er nødvendig.
English: Adverse reactions are listed in Table 2 according to MedDRA System Organ Class and frequency categories.
Danish: Bivirkninger er angivet i Tabel 2 i henhold til MedDRA systemorganklasser og hyppighedskategorier.
English: • Increase in the level of bilirubin in the blood (which may result in jaundice/yellow skin or eyes)
Danish: • Stigning af mængden af bilirubin i blodet (som kan medføre gulsot/gul hud eller gule øjne)
English: • Protein in urine (seen in tests)
Danish: • Protein i urinen (set i undersøgelser).
English: Patients should be monitored for signs and symptoms of hepatic encephalopathy.
Danish: Patienterne bør monitoreres for tegn og symptomer på hepatisk encefalopati.
English: Hazard ratio < 1 indicates progression-free survival in favor of cabozantinib
Danish: Hazard Ratio <1 indikerer progressionsfri overlevelse til fordel for cabozantinib.
English: Dose adjustment is usually not required.
Danish: Dosisreduktion er sædvanligvis ikke nødvendig.
English: 1 stratified log-rank test
Danish: 1 stratificeret log-ranktest
English: Two dose reductions were required in 33% of patients.
Danish: To dosisreduktioner var nødvendige hos 33 % af patienterne.
English: Keep in mind that treatment with CABOMETYX may make you feel tired or weak and can affect your ability to drive or use machines.
Danish: Husk på, at behandling med CABOMETYX kan få dig til at føle dig træt eller svag og kan påvirke din evne til at køre motorkøretøjer og betjene maskiner.
English: Metabolic clinical laboratory parameters should be monitored at least weekly or as deemed clinically appropriate to assess any possible changing trends.
Danish: Metaboliske, kliniske laboratorieparametre bør monitoreres mindst en gang om ugen, eller hvad der anses for klinisk passende, for at vurdere mulige ændringstendenser.
English: It is not known whether cabozantinib and/or its metabolites are excreted in human milk.
Danish: Det vides ikke, om cabozantinib og/eller dets metabolitter udskilles i human mælk.
English: There is no information on the precise food-effect when taken 1 hour after administration of cabozantinib.
Danish: Der er ingen oplysninger om den nøjagtige virkning af fødeindtagelse 1 time efter administration af cabozantinib.
English: CABOMETYX is not recommended for children or adolescents.
Danish: CABOMETYX anbefales ikke til børn og unge.
English: Treatment Modification
Danish: Behandlingsændring
English: One event was Grade 3; the remainder were Grade 2.
Danish: En hændelse var grad 3, resten var grad 2.
English: This effect was not associated with a change in cardiac wave form morphology or new rhythms.
Danish: Denne virkning var ikke forbundet med en ændring i elektrokardiogrammets morfologi eller nye rytmer.
English: • Hypertension (increase in blood pressure)
Danish: • Hypertension (forhøjet blodtryk)
English: Dose reductions are recommended for events that, if persistent, could become serious or intolerable.
Danish: Dosisreduktion anbefales ved bivirkninger som, hvis de er vedvarende, kunne blive alvorlige eller uacceptable.
English: No specific dosing recommendations can be made.
Danish: Der kan ikke gives specifikke anbefalinger vedrørende dosering.
English: 4 stratified Cochran-Mantel-Haenszel (CMH) test
Danish: 4 stratificeret Cochran-Mantel-Haenszel (CMH)-test
English: If you get serious side effects, your doctor may decide to change your dose or stop treatment earlier than originally planned.
Danish: Hvis du får alvorlige bivirkninger, kan din læge beslutte at ændre din dosis eller stoppe behandlingen tidligere end oprindelig planlagt.
English: For RCC and HCC, the recommended dose of CABOMETYX is 60 mg once daily.
Danish: Til RCC og HCC er den anbefalede dosis CABOMETYX 60 mg en gang dagligt.
English: There is no specific treatment for cabozantinib overdose and possible symptoms of overdose have not been established.
Danish: Der er ingen specifik behandling af overdosering med cabozantinib, og mulige symptomer på overdosering er ikke blevet fastlagt.
English: Patients had to have intermediate or poor risk disease as defined by the International Metastatic RCC Database Consortium (IMDC) risk group categories.
Danish: Patienterne skulle have middel eller høj sygdomsrisiko som defineret af International Metastatic RCC Database Consortium´s (IMDC) risikogruppekategorier.
English: Tumor assessments were conducted every 8 weeks for the first 12 months, then every 12 weeks thereafter.
Danish: Tumorvurdering blev udført hver 8. uge de første 12 måneder og derefter hver 12. uge.
English: • Changes in blood tests used to monitor general health and function of your organs (including the liver, and kidney), low levels of electrolytes (like magnesium, or potassium)
Danish: • Ændringer i blodprøver, der bruges til at overvåge din almene helbredstilstand og funktionen af dine organer (herunder lever og nyrer), lave niveauer af elektrolytter (som magnesium eller kalium)
English: This syndrome should be considered in any patient presenting with multiple symptoms, including seizures, headache, visual disturbances, confusion or altered mental function.
Danish: Dette syndrom skal overvejes hos enhver patient, der har multiple symptomer, herunder kramper, hovedpine, synsforstyrrelser, forvirring eller ændret mental funktion.
English: Talk to your doctor about which methods of contraception are appropriate while you are taking CABOMETYX (see also under Other medicines and CABOMETYX, above).
Danish: Tal med din læge om, hvilke antikonceptionsmetoder der er passende, mens du tager CABOMETYX (se også under ”Brug af anden medicin sammen med CABOMETYX” ovenfor).
English: Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities.
Danish: Doseringsafbrydelse anbefales til kontrol af CTCAE grad 3 eller højere toksicitet eller uacceptabel grad 2 toksicitet.
English: Perforations and fistulas
Danish: Perforation og fistler
English: Partial Response Median time to First Response, months (95% CI) Stable Disease as Best Response Progressive Disease as Best Response 1 chi-squared test
Danish: Delvist respons Mediantid til første respons, måneder (95 % CI) Stabil sygdom som bedste respons Progressiv sygdom som bedste respons 1 chi i anden-test
English: Approximately 75% of patients had a nephrectomy prior to onset of treatment.
Danish: Ca. 75 % af patienterne havde fået foretaget nefrektomi før behandlingens start.
English: Female partners of male patients taking cabozantinib must also avoid pregnancy.
Danish: Kvindelige partnere til mandlige patienter, der tager cabozantinib, skal også undgå at blive gravide.
English: In case of such combination, INR values should be monitored.
Danish: INR-værdier skal monitoreres i tilfælde af en sådan kombination.
English: If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.
Danish: Hvis patienten glemmer at tage en dosis, skal den manglende dosis ikke tages, hvis der er mindre end 12 timer til den næste dosis.
English: Tumor assessments were conducted every 12 weeks.
Danish: Vurdering af tumor blev udført hver 12. uge.
English: Complete responses (CR) Partial responses (PR) ORR (CR+PR)) p-value1,4
Danish: Fuldstændigt respons (CR) Delvist respons (PR) ORR (CR+PR) p-værdi1,4
English: • A painful tear or abnormal connection of the tissues in your body
Danish: • En smertefuld rift eller unormal forbindelse mellem væv i kroppen
English: Patients could have received one other prior systemic therapy for advanced disease in addition to sorafenib.
Danish: Patienterne måtte gerne have fået en anden tidligere systemisk behandling for fremskreden sygdom ud over sorafenib.
English: You may need treatment for them, or your doctor may decide to change your dose of CABOMETYX, or stop treatment altogether.
Danish: Du har måske behov for at blive behandlet for dem, eller din læge kan beslutte at ændre din dosis af CABOMETYX eller helt stoppe behandlingen.
English: As unchanged contraceptive effect may not be guaranteed, an additional contraceptive method, such as a barrier method, is recommended.
Danish: Da uændret kontraceptiv virkning ikke kan garanteres, anbefales en yderligere antikonceptionsmetode, fx en barrieremetode.
English: Patients with a history of portal vein invasion appeared to be at higher risk of developing portal vein thrombosis.
Danish: Patienter med en anamnese med portal veneindvækst syntes at være i højere risiko for at udvikle portal venetrombose.
English: • Ringing in ears
Danish: • Ringen for ørerne
English: Studies in animals have shown embryo-foetal and teratogenic effects (see section 5.3).
Danish: Dyrestudier har vist embryo-føtale og teratogene virkninger (se pkt.
English: There is a possibility your fertility could be affected by treatment with CABOMETYX.
Danish: Der er en mulighed for, at din frugtbarhed kunne blive påvirket af behandlingen med CABOMETYX.
English: Secondary efficacy endpoints were progression-free survival (PFS) and objective response rate (ORR), as assessed by the Investigator using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Danish: Sekundære effekt-endpoints var progressionsfri overlevelse (PFS) og objektiv responsrate (ORR), som vurderet af Investigator ved anvendelse af Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
English: There are limited data in patients with cardiac impairment.
Danish: Der er begrænsede data for patienter med nedsat hjertefunktion.
English: The results from the Investigator determined analysis and IRC-determined analysis of PFS were consistent.
Danish: Resultaterne af de analyser af PFS, som investigatorerne fastlagde og de analyser, der blev fastlagt af IRC, var konsistente.
English: Adverse reactions associated with overdose are to be treated symptomatically.
Danish: Bivirkninger på grund af overdosering skal behandles symptomatisk.
English: If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished.
Danish: Hvis du eller din partner kan blive gravid, så anvend passende antikonception under behandlingen og i mindst 4 måneder efter, at behandlingen er afsluttet.
English: Seventy-two percent (72%) of patients had received one and 28% had received 2 prior systemic therapy regimens for advanced disease.
Danish: 72 % af patienterne havde tidligere modtaget én og 28 % havde tidligere modtaget to systemiske behandlingsregimer for fremskreden sygdom.
English: Film-coating Hypromellose 2910 Titanium dioxide (E171) Triacetin
Danish: Filmovertræk Hypromellose 2910 Titandioxid (E171) Triacetin
English: The Kaplan- Meier estimates for median duration of OS were 11.1 months in the cabozantinib arm versus 6.9 months in the placebo arm, an estimated 4.2-month difference in the medians.
Danish: Kaplan-Meier-estimaterne for medianvarighed af OS var 11,1 måneder i cabozantinib-armen mod 6,9 måneder i placebo-armen, en estimeret 4,2-måneders forskel i medianerne.
English: Talk to your doctor BEFORE taking CABOMETYX if you or your partner are considering or planning to have a baby after your treatment has finished.
Danish: Tal med din læge, INDEN du tager CABOMETYX, hvis du eller din partner overvejer eller planlægger at få et barn, når din behandling er afsluttet.
English: • A burning or stinging sensation of the tongue
Danish: • En brændende eller stikkende følelse i tungen
English: Cabozantinib treatment should be stopped at least 28 days prior to scheduled surgery, including dental surgery, if possible.
Danish: Cabozantinib bør om muligt seponeres mindst 28 dage forud for en planlagt operation, herunder dental kirurgi.
English: These proteins can be present in high amounts in cancer cells, and by blocking their action CABOMETYX can slow down the rate at which the tumour grows and help to cut off the blood supply that the cancer needs.
Danish: Disse proteiner kan være til stede i store mængder i kræftceller, og ved at blokere deres virkning kan CABOMETYX forsinke hastigheden, med hvilken tumoren vokser, og hjælpe med til at afskære forsyningen af blod, som kræften har brug for.
English: Grade 2 adverse reactions which are intolerable and cannot be managed with a dose reduction or supportive care
Danish: Bivirkninger af grad 2, som er uacceptable og ikke kan håndteres med dosisreduktion eller understøttende behandling.
English: Your doctor will tell you if you need your dose adjusted.
Danish: Din læge vil fortælle dig, om du har behov for at få din dosis ændret.
English: Re-initiate at a reduced dose.
Danish: Start igen ved en reduceret dosis.
English: No dose adjustment is necessary based on ethnicity (see section 5.2)
Danish: Dosisjustering er ikke nødvendig baseret på etnicitet (se pkt.
English: Aetiology for HCC included 38% hepatitis B virus (HBV), 21% hepatitis C virus (HCV), 40% other (neither HBV nor HCV).
Danish: Ætiologi for HCC omfattede 38 % hepatitis B-virus (HBV), 21 % hepatitis C-virus (HCV), 40 % andet (hverken HBV eller HCV).
English: Subjects continued blinded study treatment after radiological disease progression whilst they experienced clinical benefit or until the need for subsequent systemic or liver directed local anticancer therapy.
Danish: Forsøgspersonerne fortsatte blindet studie-behandling efter radiologisk sygdomsprogression, såfremt de oplevede klinisk effekt eller indtil behov for efterfølgende systemisk eller leverrettet lokal anticancerbehandling.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Danish: Følgende bivirkninger blev ikke iagttaget i kliniske studier, men er set hos dyr ved eksponeringsniveauer svarende til det kliniske eksponeringsniveau og er muligvis af relevans ved klinisk brug: