FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ledaga has shown comparable safety and effectiveness to Caryolysine and has shown satisfactory quality.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Ledaga er påvist at være af sammenlignelig sikkerhed og effektivitet med Caryolysin og udviser tilfredsstillende kvalitet.
English: Effectiveness was measured as complete or partial improvement in the ‘CAILS' score, which takes into account different features of the cancer, such as the size and appearance of the skin damage.
Danish: Virkningen blev målt som fuldstændig eller delvis forbedring i "CAILS"-score, som er en vurdering af forskellige af kræftens egenskaber såsom hudskadens størrelse og fremtræden.
English: Alkylating agents work by attaching to the DNA of cells while the cells are dividing.
Danish: Alkylerende midler virker ved at bindes til cellernes DNA, når cellerne deler sig.
English: Treatment should be stopped if patients develop blisters or open sores.
Danish: Behandlingen skal stoppes, hvis patienten får blærer eller åbne sår.
English: The full EPAR for Ledaga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ledaga findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The materials will include a sealable, child-resistant plastic bag for safely storing the medicine in a refrigerator, together with a patient alert card with instructions on the correct way to apply the medicine.
Danish: Materialerne vil omfatte en pose med børnesikker lukning til opbevaring af lægemidlet i køleskab, foruden et patientkort med anvisninger om, hvordan lægemidlet påføres korrekt.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ledaga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Ledaga findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The medicine contains the active substance chlormethine.
Danish: Lægemidlet indeholder det aktive stof chlormethin.
English: For more information about treatment with Ledaga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ledaga, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The ointment's effectiveness was considered comparable to that of the reference medicine, Caryolysine.
Danish: Salvens virkning blev anset for at være sammenlignelig med virkningen af referencelægemidlet Caryolysin.
English: The difference between Ledaga and Caryolysine is that Ledaga is available as a gel and Caryolysine was available as a liquid for diluting before applying to the skin.
Danish: Forskellen mellem Ledaga og Caryolysin er, at Ledaga fås som en gel, mens Caryolysin kunne fås som en væske, der fortyndes, før den påføres på huden.
English: Ledaga, which is available as a gel, is applied as a thin film to the affected areas of the skin once a day.
Danish: Ledaga, der fås som en gel, påføres i et tyndt lag på de berørte dele af huden én gang dagligt.
English: Therefore, the CHMP's view was that, as for Caryolysine, the benefits outweigh the identified risks.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Caryolysin.
English: Ledaga can only be obtained with a prescription.
Danish: Lægemidlet Ledaga udleveres kun efter recept.
English: The company provided data from the published literature showing that chlormethine, the active substance in Ledaga, is effective in treating mycosis fungoides-type cutaneous T-cell lymphoma.
Danish: Virksomheden fremlagde data fra den videnskabelige litteratur, der viser at chlormethin, det aktive stof i Ledaga, er effektivt til behandling af kutant T-cellelymfom af typen mycosis fungoides.
English: Ledaga is a medicine used to treat adults with a skin cancer called mycosis fungoides-type cutaneous T-cell lymphoma.
Danish: Ledaga er et lægemiddel til behandling af voksne med en hudkræftform, der kaldes kutant Tcellelymfom af typen mycosis fungoides.
English: What benefits of Ledaga have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ledaga?
English: How is Ledaga used?
Danish: Hvordan anvendes Ledaga?
English: For practical information about using Ledaga, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ledaga, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ledaga have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ledaga.
English: The active substance in Ledaga, chlormethine, belongs to the group of cancer medicines called ‘alkylating agents'.
Danish: Det aktive stof i Ledaga, chlormethin, er et kræftmiddel i gruppen alkylerende midler.
English: How does Ledaga work?
Danish: Hvordan virker Ledaga?
English: • every month during treatment.
Danish: • hver måned under behandlingen.
English: *Event refers to disease progression or death due to any reason.
Danish: *Hændelse henviser til sygdomsprogression eller død uanset årsag.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 14 August 2015
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 14. august 2015
English: • at least 7 days before starting treatment - to make sure that you are not already pregnant
Danish: • mindst 7 dage før behandlingen starter - for at være sikker på at du ikke allerede er gravid
English: • has menstruated at any time during the previous 12 consecutive months,
Danish: • har menstrueret på et hvilket som helst tidspunkt i de foregående 12 på hinanden følgende måneder,
English: Responder (Complete Response/Partial Response) Stable Disease
Danish: Respondent (komplet respons/partielt respons) Stabil sygdom
English: Most effects occurred close to the intended human exposures.
Danish: De fleste virkninger forekom tæt på den tilsigtede humane eksponering.
English: • Take your capsule at about the same time each day.
Danish: • Tag kapslen på nogenlunde samme tidspunkt hver dag.
English: The normal growth of cells is controlled by various chemical signals.
Danish: Den normale udvikling af celler kontrolleres af forskellige kemiske signaler.
English: UNIQUE IDENTIFIER -HUMAN READABLE DATA PC:
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC:
English: Local investigator laBCC
Danish: Lokal investigator laBCC
English: Talk to your doctor if you plan to have children in the future.
Danish: Tal med din læge, hvis du har planer om at få børn i fremtiden.
English: • you think your contraception has not worked for any reason
Danish: • du tror, din prævention af en eller anden grund ikke har virket
English: NE: not estimable
Danish: NE: kan ikke estimeres (not estimable)
English: It is an anti-cancer medicine.
Danish: Det er medicin mod kræft.
English: Please refer to these documents for further information.
Danish: Se disse dokumenter for yderligere oplysninger.
English: 20 months after their final dose
Danish: 20 måneder efter deres sidste dosis
English: Effect of age, weight and gender
Danish: Påvirkning af alder, vægt og køn
English: • disturbed sense of taste or strange taste in the mouth
Danish: • smagsforstyrrelser eller en mærkelig smag i munden
English: In the event of pregnancy, treatment must not be initiated.
Danish: I tilfælde af graviditet, må behandlingen ikke initieres.
English: Sonidegib was evaluated in rats and dogs.
Danish: Sonidegib blev evalueret i rotter og hunde.
English: Treatment interruptions of up to 3 weeks were allowed based on individual tolerability.
Danish: Det var tilladt at afbryde behandlingen i op til 3 uger, baseret på individuel tolerabilitet.
English: FAS: Full analysis set
Danish: FAS: fuldt analysesæt
English: - Never give this medicine to anyone else.
Danish: - Giv aldrig denne medicin til andre.
English: Problems with growing teeth and bones were seenwith this medicine.
Danish: Problemer med voksende tænder og knogler er set med dette lægemiddel.
English: • low level of white blood cells.
Danish: • lav mængde hvide blodlegemer.
English: All the metabolites were deemed 4 to 90 times less potent than sonidegib.
Danish: Alle metabolitterne blev vurderet til at være 4 til 90 gange mindre potente end sonidegib.
English: There are no data on the use of sonidegib in pregnant women.
Danish: Der er ingen data fra anvendelse af sonidegib til gravide kvinder.
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelig: Kan forekomme hos flere end 1 ud af 10 personer
English: Tell your doctor if you notice any changes in your skin.
Danish: Fortæl det til lægen, hvis du bemærker forandringer på din hud.
English: Do not change your dose without talking to your doctor.
Danish: Du må ikke ændre din dosis uden at tale med din læge.
English: • The national part of the DHPC
Danish: • Den nationale del af DHCP
English: • vitamin B3, also known as niacin
Danish: • B3-vitamin, som også kaldes niacin
English: Do not take Odomzo if any of the above apply to you.
Danish: Tag ikke Odomzo, hvis noget af ovenstående gælder for dig.
English: The following are recommended barrier methods
Danish: Følgende barrieremetoder anbefales
English: It may lead to the death of a baby before it is born or shortly after being born.
Danish: Det kan medføre, at et barn dør før fødslen eller kort tid efter fødslen.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl
English: − Distribution of the product
Danish: − Distribution af produktet
English: Patients should be instructed never to give this medicinal product to another person.
Danish: Patienter skal vejledes i aldrig at give dette lægemiddel til en anden person.
English: 12 months a Full analysis set included all randomised patients (intent-to-treat population).
Danish: 12 måneder a Fuldt analysesæt omfattede alle randomiserede patienter (”intent-to-treat”-population).
English: Your doctor will perform blood tests before treatment, and possibly during treatment as well.
Danish: Din læge vil tage blodprøver før behandlingen og eventuelt også under behandlingen.
English: • Information on the recommended forms of contraception both for women and men
Danish: • Information om de anbefalede former for prævention for både kvinder og mænd
English: Your doctor will discuss with you the best method of contraception for you.
Danish: Din læge vil drøfte med dig, hvilken præventionsmetode der passer bedst til dig.
English: For a composite Complete Response, all modalities used for assessment had to demonstrate absence of tumour.
Danish: For et samlet overordnet respons skulle alle modaliteter brugt til vurdering vise fravær af tumor.
English: • The need for adequate contraception and definition of adequate contraception
Danish: • Nødvendigheden af tilstrækkelig prævention og definition af tilstrækkelig prævention
English: Odomzo is for oral use.
Danish: Odomzo er til oral anvendelse.
English: Each pack contains either 10 or 30 hard capsules.
Danish: Hver pakning indeholder enten 10 eller 30 hårde kapsler.
English: The majority of patients experienced maintenance and/or improvement in their disease-related symptoms, functioning, and health status.
Danish: Hovedparten af patienterne oplevede stabilitet og/eller bedring i deres sygdomsrelaterede symptomer, funktionsevne og sundhedsstatus.
English: Progressive Disease
Danish: Progressiv sygdom
English: Steady state was reached approximately 4 months after starting sonidegib.
Danish: Steady state blev opnået ca. 4 måneder efter initiering af sonidegib.
English: Time to deterioration in the pre-specified PRO scales (corresponding to >10-point worsenings without subsequent improvement) essentially mirrored the estimated PFS.
Danish: Tid til forværring i de forud specificerede PRO-skalaer (svarende til >10 points forværring uden efterfølgende bedring) svarede i det væsentlige til den estimerede PFS.
English: During treatment and during the 20 months after your treatment has finished, tell your doctor straight away if:
Danish: Under behandlingen og i de første 20 måneder efter, at din behandling er afsluttet, skal du straks fortælle det til lægen, hvis:
English: * The above recommendations for dose modifications are based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.03, developed by the National Cancer Institute (USA).
Danish: * Ovenstående anbefalinger mht. dosisjusteringer er baseret på Common Terminology Criteria for Adverse Events (CTCAE) v4.03, der er udviklet af National Cancer Institute (USA).
English: • National specific requirements as agreed with the National Competent Authority regarding:
Danish: • Specifikke nationale krav, som der er nået til enighed om med den nationale lægemiddelmyndighed vedørende:
English: Results show a lack of significant efficacy despite the enrichment strategy focussed on Hh-activated medulloblastoma.
Danish: Resultaterne viser en manglende betydelig effektivitet på trods af berigelsesstrategien med fokus på Hh-aktiveret medulloblastoma.
English: Cr: creatinine; ULN: upper limit of normal
Danish: Cr: creatinine (kreatinin); ULN: upper limit of normal (øvre normalgrænse)
English: • Requirements in the event of pregnancy
Danish: • Foranstaltninger i tilfælde af graviditet
English: The following are recommended forms of highly effective methods
Danish: Følgende yderst effektive metoder anbefales
English: • surgical sterilisation.
Danish: • kirurgisk sterilisation.
English: The CTCAE is a standardised classification of side effects used in assessing medicinal products for cancer therapy.
Danish: CTCAE er en standardiseret klassificering af bivirkninger, som anvendes til vurdering af lægemidler til cancerbehandling.
English: These can alert your doctor to possible changes in the function of some parts of your body, for example:
Danish: Disse kan advare din læge om mulige ændringer i, hvordan dele af din krop fungerer, fx:
English: Odomzo is contraindicated during pregnancy.
Danish: Odomzo er kontraindiceret under graviditet.
English: These could be signs that your muscle fibre is breaking down, which is harmful to your kidneys.
Danish: Dette kan være tegn på, at dine muskelfibre nedbrydes, hvilket er skadeligt for dine nyrer.
English: Usually this type of cancer appears on sun-damaged skin, does not spread and can be cured.
Danish: Denne type kræft opstår som regel på solskadet hud, spreder sig ikke og kan kureres.
English: • Check renal function (serum creatinine) regularly and ensure that patient is adequately hydrated.
Danish: • Kontrollér nyrefunktionen (serumkreatinin) regelmæssigt og sørg for, at patienten er tilstrækkeligt hydreret.
English: Among these women, amenorrhoea was observed in 1 patient (20%).
Danish: Hos 1 ud af disse kvinder blev der observeret amenorré (20 %).
English: Very common * Based on worst laboratory value post-treatment regardless of baseline, grading by CTCAE version 4.03
Danish: Meget almindelig * Baseret på dårligste laboratorieværdi efter behandlingen uanset baseline, vurderet efter CTCAE version 4.03
English: The dose of sonidegib used prior to initiation of the strong inducer should be resumed if the strong inducer is discontinued.
Danish: Den dosis sonidegib, der blev anvendt før initiering af den stærke inducer, skal genoptages, hvis den stærke inducer seponeres.
English: They are imprinted with “SONIDEGIB 200MG” and “NVR”.
Danish: De er præget med “SONIDEGIB 200MG” og “NVR”.
English: Therefore, therapeutic doses of Odomzo are not expected to cause clinically significant QTc prolongation.
Danish: Terapeutiske Odomzo-doser forventes derfor ikke at forårsage klinisk betydende QTc-forlængelse.
English: These medicines should be used with caution or may need to be avoided during your treatment with Odomzo.
Danish: Disse typer medicin skal anvendes med forsigtighed eller skal måske undgås under din behandling med Odomzo.
English: • A core text as agreed by the CHMP
Danish: • En grundlæggende tekst, som der er nået til enighed om med CHMP
English: Objective response rate, n (%) 95% CI Best overall response, n (%) Complete response
Danish: Objektiv responsrate, n (%) 95 % CI Bedste samlede respons, n (%) Komplet respons
English: − Measures to ensure that all appropriate actions have been performed prior to Odomzo being prescribed and dispensed
Danish: − Foranstaltninger til at sikre, at alle hensigtsmæssige handlinger er udført inden Odomzo udskrives og udleveres
English: Odomzo should not be used in children and adolescents below the age of 18.
Danish: Odomzo må ikke bruges til børn og unge under 18 år.
English: Pregnancy tests should have a minimum sensitivity of 25 mIU/ml as per local availability.
Danish: Graviditetstestens følsomhed bør mindst være 25 mIE/ml, hvis en sådan er tilgængelig lokalt.
English: To avoid potential foetal exposure during pregnancy, a male patient must understand that:
Danish: For at undgå potentiel føtal eksponering under graviditet, skal en mandlig patient være klar over følgende:
English: Efficacy and safety of sonidegib have been studied in two clinical studies involving a total of 62 paediatric patients.
Danish: Effektivitet og sikkerhed i forbindelse med sonidegib er blevet undersøgt i to kliniske studier med i alt 62 pædiatriske patienter.
English: MRI tumour response was evaluated by RECIST 1.1.
Danish: MRI-tumorrespons blev evalueret efter RECIST 1.1.
English: Of the 230 patients, 16 had a diagnosis of Gorlin Syndrome (15 laBCC and 1 mBCC).
Danish: Af de 230 patienter havde 16 diagnosen Gorlins syndrom (15 laBCC og 1 mBCC).
English: • you stop using contraception
Danish: • du holder op med at bruge prævention
English: Read carefully and follow the instructions of the patient brochure and reminder card given to you by your doctor.
Danish: Læs og følg anvisningerne i patientbrochuren og patientkortet, som du får af din læge, grundigt.
English: • dark urine, decreased urine output or no urine output.
Danish: • mørk urin, nedsat urinmængde eller ingen urinproduktion.
English: They must not be chewed or crushed.
Danish: De må ikke tygges eller knuses.
English: Women of childbearing potential whose periods are irregular or have stopped must follow all the advice on effective contraception.
Danish: Fertile kvinder hvis menstruationer er uregelmæssige eller er ophørt, skal følge samtlige råd om effektiv prævention.
English: Embryofoetal death or severe birth defects
Danish: Embryoføtal død eller svære fødselsdefekter
English: You must keep doing this for 6 months after your treatment has finished.
Danish: Det skal du fortsat gøre i 6 måneder efter, at din behandling er afsluttet.
English: Patients with advanced BCC have an increased risk of developing cuSCC.
Danish: Patienter med fremskredent BCC har en øget risiko for at udvikle cuSCC.
English: Take the medicine and its packaging and leaflet with you.
Danish: Tag medicinen samt emballagen og indlægssedlen med.
English: It is used when the cancer has spread locally and cannot be treated with surgery or radiation.
Danish: Det bruges, når kræften har spredt sig lokalt og ikke kan behandles med operation eller strålebehandling.
English: Warnings and precautions - Odomzo may cause muscle problems.
Danish: Advarsler og forsigtighedsregler - Odomzo kan give muskelproblemer.
English: • has not undergone a hysterectomy or a bilateral oophorectomy, or who does not have medically-confirmed permanent premature ovarian failure,
Danish: • ikke har fået foretaget hysterektomi eller bilateral ooforektomi, eller som ikke har lægeligt bekræftet permanent præmatur ovariesvigt,
English: This switches on signals that make the cancer cells grow out of control.
Danish: Dette aktiverer signalet, som får kræftceller til at vokse ude af kontrol.
English: The recommended dose is 200 mg (1 capsule) a day.
Danish: Den anbefalede dosis er 200 mg (1 kapsel) om dagen.
English: Effect of ethnicity
Danish: Påvirkningen af etnicitet
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 kapsel.
English: Talk to your doctor or pharmacist regarding where to return the capsules.
Danish: Spørg din læge eller apotekspersonalet om, hvor du kan returnere kapslerne.
English: Best % change from baseline (target lesions)
Danish: Bedste %-vise ændring fra baseline (mållæsioner)
English: It is important to check with your doctor whether there is a risk that you could become pregnant.
Danish: Det er vigtigt, at du spørger lægen, om der er risiko for, at du kan blive gravid.
English: Therefore, all patients should be monitored routinely while taking Odomzo, and cuSCC should be treated according to the standard of care.
Danish: Alle patienter skal derfor monitoreres rutinemæssigt, mens de tager Odomzo, og cuSCC skal behandles i overensstemmelse med standardpraksis.
English: • your periods stop
Danish: • dine menstruationer stopper
English: • Brief background on Odomzo, its licensed indication and posology
Danish: • Kort baggrund om Odomzo, dets godkendte indikation og dosering
English: • becomes amenorrhoeic following cancer therapy, including treatment with Odomzo.
Danish: • oplever amenorré efter cancerterapi, inklusive behandling med Odomzo.
English: This is because Odomzo can affect the way some medicines work.
Danish: Dette skyldes, at Odomzo kan påvirke måden medicinen virker på.
English: Stop taking Odomzo and tell your doctor straight away if you notice any of the following as these could be signs of an allergic reaction:
Danish: Hold straks op med at tage Odomzo, og fortæl det til lægen, hvis du bemærker en eller flere af følgende, da det kan være tegn på en allergisk reaktion:
English: The effect of renal impairment on the systemic exposure of sonidegib has not been studied.
Danish: Effekten af nedsat nyrefunktion på den systemiske eksponering for sonidegib er ikke undersøgt.
English: Prescriptions of Odomzo should be limited to 30 days of treatment, with continuation of treatment requiring a new prescription.
Danish: Recepter på Odomzo skal være begrænset til 30 dages behandling, hvorefter forsat behandling kræver en ny recept.
English: Re-introduce sonidegib at 200 mg every other day and follow the same monitoring recommendations.
Danish: Genoptag sonidegib med 200 mg hver anden dag og følg de samme monitoreringsanbefalinger.
English: You must follow the contraception instructions contained in this leaflet.
Danish: Du skal følge vejledningen om prævention, som er i denne indlægsseddel.
English: Effects of sonidegib on other medicinal products
Danish: Sonidegibs effekt på andre lægemidler
English: • swelling of the face, lips, tongue or throat
Danish: • hævelse af ansigt, læber, tunge eller hals
English: • low level of haemoglobin (needed to transport oxygen in the blood)
Danish: • lav hæmoglobinværdi (nødvendigt for transport af ilt i blodet)
English: The size of the capsule is “Size #00” (dimensions 23.3 x 8.53 mm).
Danish: Kapslen har størrelsen “Størrelse #00” (mål 23,3 x 8,53 mm).
English: During Odomzo treatment, you may also have some abnormal blood test results.
Danish: Under behandlingen med Odomzo kan du også få nogle unormale blodprøveresultater.
English: It is available in pack sizes of 10 and 30 capsules.
Danish: Produktet fås i pakningsstørrelser på 10 og 30 kapsler.