FrancophonIA/ELRC3.0 huggingface dataset:
English: Secondary exposure to Ledaga
Danish: Sekundær eksponering for Ledaga
English: In order to minimise and prevent the Important Identified Risk of “Toxicity to mucous membranes / eye” and the Important Potential Risk of “Secondary exposure to someone other than the patient”, the MAH shall ensure that, the following additional risk minimisation measures are fulfilled in each Member State (MS) where Ledaga is marketed:
Danish: For at minimere og forebygge den væsentlige, identificerede risiko for “Toksicitet for slimhinder / øjne” og den væsentlige, potentielle risiko for “Sekundær eksponering for en anden person end patienten” skal MAH sikre, at følgende yderligere risikominimeringsforanstaltninger er gennemført i alle de medlemslande, hvor Ledaga markedsføres:
English: Do not give this medicine to children and adolescents under the age of 18 years because the safety and effectiveness have not been established for this age group.
Danish: Dette lægemiddel må ikke bruges hos børn og unge under 18 år, da sikkerheden og virkningen ikke er klarlagt for denne aldersgruppe.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of European Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The safety and efficacy of Ledaga in children aged 0 to 18 years have not been established.
Danish: Ledagas sikkerhed og virkning hos børn i alderen 0-18 år er ikke klarlagt.
English: Results in other secondary endpoints (response in percentage of body surface area affected, time to first confirmed CAILS response, duration of first confirmed CAILS response and time to disease progression) were consistent with those for CAILS and SWAT.
Danish: Resultaterne for andre sekundære endepunkter (respons udtrykt i procentdel af det afficerede kropsoverfladeareal, tid til første bekræftede CAILS-respons, varighed af første bekræftede CAILS-respons og tid til sygdomsprogression) var i overensstemmelse med værdierne for CAILS og SWAT.
English: - Do not cover the treated area with air- or water-tight bandages after you have applied this medicine.
Danish: - Tildæk ikke det behandlede område med luft- eller vandtætte bandager, efter at du har påført medicinen.
English: In the controlled clinical trial, 31% (79/255) of the study population were aged 65 years or older.
Danish: I et kontrolleret klinisk studie var 31 % (79/255) af studiepopulationen 65 år og derover.
English: Your doctor will determine how long you should use Ledaga for and when treatment may be stopped.
Danish: Din læge vil beslutte, hvor længe du skal bruge Ledaga, og hvornår behandlingen kan stoppes.
English: The safety profile observed in elderly patients was consistent with that in the overall patient population.
Danish: Den observerede sikkerhedsprofil hos ældre patienter svarede til sikkerhedsprofilen for den samlede patientpopulation.
English: Complete Response (CR) Partial Response (PR)
Danish: Komplet respons (CR) Delvist respons (PR)
English: Store and transport frozen.
Danish: Opbevares og transporteres nedfrosset.
English: The CAILS score was adjusted by removal of the pigmentation score and simplification of the plaque elevation scale.
Danish: CAILS-scoren blev justeret gennem fjernelse af pigmenteringsscoren og forenkling af plaque-skalaniveauet.
English: Clear, colourless gel.
Danish: Klar, farveløs gel.
English: Do not apply the medicine near the eyes, to the inside of the nostrils, the inside of the ear or on the lips.
Danish: Påfør ikke medicinen nær øjnene, på indersiden af næseborene, inde i ørerne eller på læberne.
English: If reintroduction of treatment is tolerated for at least 1 week, the frequency of application can be increased to every other day for at least 1 week and then to once-daily application if tolerated.
Danish: Hvis genstart af behandling tolereres i mindst 1 uge, kan doseringshyppigheden øges til hver anden dag i mindst 1 uge og dernæst til én gang dagligt, hvis det tolereres.
English: A complete response was defined as a confirmed CAILS score of 0.
Danish: Komplet respons blev defineret som en bekræftet CAILS-score på 0.
English: It is unknown whether chlormethine is excreted in human milk.
Danish: Det er ukendt, om chlormethin udskilles i human mælk.
English: In the EE population, the percentage of patients who achieved a confirmed response by CAILS was similar between disease stages IA (79.6 %) and IB-IIA (73.2%).
Danish: I EE-populationen var den procentdel af patienterne, som fik et bekræftet respons på CAILS, sammenlignelige mellem sygdomsstadie IA (79,6 %) og IB-IIA (73,2 %).
English: The primary efficacy endpoint in Study 201 was the Composite Assessment of Index Lesion Severity (CAILS) response rate.
Danish: Det primære virkningsendepunkt i studie 201 var Composite Assessment of Index Lesion Severity (CAILS) responsraten.
English: Table 1 CAILS and SWAT-confirmed response rates by 12 months in Study 201 (efficacy evaluable population)
Danish: Tabel 1 CAILS- og SWAT-bekræftede responsrater efter 12 måneder i studie 201 (EEpopulation)
English: Apply your next dose when it is due.
Danish: Påfør din næste dosis som normalt.
English: Do not use an opened or unopened tube of Ledaga after 60 days of storage in the refrigerator.
Danish: Brug ikke en åbnet eller uåbnet tube med Ledaga, efter den har været opbevaret 60 dage i køleskab.
English: It may also cause blindness and severe permanent injury to your eyes.
Danish: Det kan også medføre blindhed og alvorlig permanent øjenskade.
English: Reductions in mean CAILS scores were observed as early as at 4 weeks, with further reductions observed with continuing therapy.
Danish: Reduktion i de gennemsnitlige CAILS-scorer blev observeret allerede efter 4 uger, og yderligere reduktion blev observeret ved fortsat behandling.
English: A response was defined as an at least 50% improvement in the baseline CAILS score, confirmed at a subsequent visit at least 4 weeks later.
Danish: Respons blev defineret som en forbedring på mindst 50 % i baseline-CAILS-scoren, bekræftet ved et efterfølgende besøg mindst 4 uger senere.
English: Non-inferiority was considered to have been demonstrated if the lower bound of the 95% confidence interval around the ratio of response rates (Ledaga/comparator) was greater than or equal to 0.75.
Danish: Non-inferioritet blev anset for påvist, hvis den nedre grænse i 95 % konfidensintervallet omkring ratioen for responsrater (Ledaga/komparator) var større end eller lig med 0,75.
English: Ledaga is a clear, colourless gel.
Danish: Ledaga er en klar, farveløs gel.
English: No cases of overdose after cutaneous use of Ledaga were reported during the clinical development programme or post-marketing period.
Danish: Der blev ikke rapporteret tilfælde af overdosering efter kutan anvendelse af Ledaga i løbet af det kliniske udviklingsprogram eller i perioden efter markedsføring.
English: Ledaga is a cytotoxic medicinal product.
Danish: Ledaga er et cytotoksisk lægemiddel.
English: Ledaga contains alcohol and is therefore considered flammable.
Danish: Ledaga indeholder alkohol og anses derfor for at være brandfarlig.
English: There were no reports of systemic tumours after topical administration of chlormethine.
Danish: Der var ingen rapporter om systemiske tumorer efter topikal administration af chlormethin.
English: Ledaga is not recommended during pregnancy.
Danish: Ledaga bør ikke anvendes under graviditet.
English: This medicine is not expected to have any effect on your ability to drive or to use machines.
Danish: Dette lægemiddel forventes ikke at påvirke din evne til at køre motorkøretøj og bruge maskiner.
English: The dose is the same for elderly patients (aged 65 years and older) as for younger adult patients (aged 18 years and older).
Danish: Dosis er den samme for ældre patienter (65 år og derover) som for yngre voksne patienter (18 år og derover).
English: - Tell your doctor if you have ever had an allergic reaction to chlormethine.
Danish: - Fortæl din læge, hvis du har haft en allergisk reaktion (overfølsomhedsreaktion) på chlormethin.
English: The ratio of response and the 95% confidence interval in the ITT population were 1.226 (0.974-1.552) for CAILS and 1.017 (0.783-1.321) for SWAT and therefore consistent with those in the EE population for both the overall CAILS and SWAT responses.
Danish: Responsratioen og 95 % konfidensintervallet hos ITT-populationen var 1,226 (0,974-1,552) for CAILS og 1,017 (0,783-1,321) for SWAT og dermed overensstemmende med de tilsvarende værdier i EE-populationen for både de samlede CAILS- og SWAT-responser.
English: The relevance to humans receiving topical chlormethine is unknown.
Danish: Relevansen af dette for mennesker, der får topikal chlormethin, er ukendt.
English: Upon improvement, treatment with Ledaga can be restarted at a reduced frequency of once every 3 days.
Danish: Efter forbedring kan behandling med Ledaga genoptages med en nedsat doseringshyppighed på én gang hver 3. dag.
English: Thus, the safety of the concomitant use of Ledaga with topical corticosteroids has not yet been established.
Danish: Sikkerheden ved samtidig anvendelse af Ledaga og topikale kortikosteroider er derfor endnu ikke klarlagt.
English: Rinse the affected area right away for at least 15 minutes with large amounts of water, and seek medical assistance as soon as possible.
Danish: Skyl det berørte område med det samme og i mindst 15 minutter med store mængder vand og søg læge snarest muligt.
English: Efficacy was evaluated in the Efficacy Evaluable (EE) population, which included all 185 patients who were treated for at least 6 months with no major protocol deviations [Table 1], and in the IntentTo-Treat (ITT) population, which included all 260 randomised patients.
Danish: Virkning blev evalueret i Efficacy Evaluable (EE)-populationen, som omfattede alle 185 patienter, der blev behandlet i mindst 6 måneder uden nogen større protokolafvigelser (tabel 1), og i intent to treat (ITT)-populationen, som omfattede alle 260 randomiserede patienter.
English: STOP taking Ledaga and tell your doctor immediately if you experience allergic reactions (hypersensitivity).
Danish: STOP med at bruge Ledaga og fortæl det straks til lægen, hvis du oplever allergiske reaktioner (overfølsomhed).
English: A partial response was defined as an at least 50% reduction in the baseline CAILS score.
Danish: Delvist respons blev defineret som en reduktion på mindst 50 % i baseline-CAILS-scoren.
English: Other findings in animals included embryo-lethality and growth retardation when administered as a single injection.
Danish: Andre fund hos dyr omfattede embryoletalitet og vækstretardering, når det blev indgivet som en enkelt injektion.
English: Recommended application instructions should be followed to prevent secondary exposure (see section 4.2).
Danish: De anbefalede appliceringsinstruktioner skal følges for at forhindre sekundær eksponering (se pkt.
English: Your doctor will check your skin for skin cancers during and after your treatment with Ledaga.
Danish: Din læge vil undersøge din hud for hudkræft under og efter din behandling med Ledaga.
English: Remove and wash contaminated clothing.
Danish: Fjern og vask kontamineret beklædning.
English: • Ledaga should be supplied with a transparent, sealable, child-resistant plastic bag to prevent secondary exposure and contamination when Ledaga is stored in the refrigerator:
Danish: • Ledaga skal leveres med en børnesikret gennemsigtig plasticpose med forsegling for at forhindre sekundær eksponering og kontaminering, når Ledaga opbevares i køleskab:
English: Chlormethine was shown to be genotoxic in bacterial, plant, and mammalian cells.
Danish: Chlormethin blev påvist at være genotoksisk i bakterie-, plante- og pattedyrceller.
English: Your doctor may restart the treatment upon improvement of your symptoms.
Danish: Lægen kan starte behandlingen igen, når dine symptomer er aftaget.
English: The recommended application instructions should be followed (see section 4.2).
Danish: De anbefalede instruktioner for applicering skal følges (se pkt.
English: • Patients must wash hands thoroughly with soap and water immediately after handling or applying Ledaga.
Danish: • Patienter skal vaske hænderne grundigt med sæbe og vand umiddelbart efter håndtering eller applicering af Ledaga.
English: As the main secondary endpoint, patients were also evaluated using the Severity Weighted Assessment Tool (SWAT), which was based on an assessment of all lesions.
Danish: Det primære sekundære endepunkt var evaluering ved hjælp af Severity Weighted Assessment Tool (SWAT), som var baseret på evaluering af alle læsioner.
English: Patients and caregivers must wash hands after handling Ledaga.
Danish: Patienter og omsorgspersoner skal vaske hænder efter håndtering af Ledaga.
English: Return it to the refrigerator after each use.
Danish: Læg det i køleskab efter hver anvendelse.
English: Dermatitis, skin infections, pruritus
Danish: Dermatitis, hudinfektioner, pruritus
English: Occlusive (air- or water-tight) dressings should not be used on areas of the skin where Ledaga was applied.
Danish: Der må ikke benyttes okklusive (luft- eller vandtætte) forbindinger på de hudområder, hvor Ledaga blev appliceret.
English: Caregivers who accidentally come into contact with Ledaga must wash the affected area right away for at least 15 minutes.
Danish: Omsorgspersoner, som ved et uheld kommer i kontakt med Ledaga, skal vaske det berørte område med det samme i mindst 15 minutter.
English: EXP Discard 60 days after defrosting: ../../....
Danish: EXP Bortskaffes 60 dage efter optøning: ../../....
English: Chlormethine is a bifunctional alkylating agent that inhibits rapidly proliferating cells.
Danish: Chlormethin er et bifunktionelt alkylerende middel, der hæmmer hurtigt delende celler.
English: • The active substance is chlormethine.
Danish: • Aktivt stof: chlormethin.
English: • medical care should be obtained immediately (including ophthalmological consultation if there is eye exposure).
Danish: • skal søge læge med det samme (herunder konsultation hos en øjenlæge, hvis der er øjeneksponering).
English: Ledaga contains the active substance chlormethine.
Danish: Ledaga indeholder det aktive stof chlormethin.
English: Tell your doctor if you get any new damaged areas or ulcers on your skin.
Danish: Fortæl det til din læge, hvis du får nye beskadigede hudområder eller sår på huden.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 60 g TUBE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE 60 g TUBE
English: There is limited experience of chlormethine in pregnant women.
Danish: Der er begrænset erfaring med chlormethin til gravide kvinder.
English: A risk to newborns/infants cannot be excluded due to the potential for topical or systemic exposure of the breast-feeding child to chlormethine through contact with the mother's skin.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes på grund af muligheden for, at det ammede spædbarn eksponeres topikalt eller systemisk for chlormethin gennem kontakt med moderens hud.
English: The efficacy and safety of Ledaga were assessed in a randomised, multicentre, observer-blinded, active-controlled, non-inferiority clinical trial (Study 201) of 260 adult patients with Stage IA (141), IB (115), and IIA (4) MF-type CTCL who had received at least one prior skin-directed therapy.
Danish: Ledagas virkning og sikkerhed blev evalueret i et randomiseret, observatørblindet, aktivt kontrolleret non-inferioritets-multicenterforsøg (studie 201) med 260 voksne patienter med stadie IA (141), IB (115) og IIA (4) CTCL af MF-typen, som havde fået mindst en tidligere hudbehandling.
English: EXP Discard 60 days after defrosting
Danish: EXP Bortskaffes 60 dage efter optøning
English: Do not use this medicine after the expiry date, which is stated on the tube label and box after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten på tuben og æsken efter ”anvendes inden”.
English: - if you are allergic (hypersensitive) to chlormethine or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk (overfølsom) over for chlormethin eller et af de øvrige indholdsstoffer i Ledaga (angivet i punkt 6).
English: In a randomised-controlled trial (n=128 exposed to Ledaga for a median duration of 52 weeks), the most frequent adverse reactions to Ledaga were skin related: dermatitis (54.7%; e.g., skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20.3%), skin infections (11.7%), skin ulceration and blistering (6.3%), and skin hyperpigmentation (5.5%).
Danish: I et randomiseret, kontrolleret studie (n = 128 eksponeret for Ledaga i en gennemsnitlig varighed på 52 uger) var de hyppigste bivirkninger ved Ledaga relateret til huden: dermatitis (54,7 %; f.eks. hudirritation, erytem, udslæt, urticaria, brændende fornemmelse i huden, hudsmerter), pruritus (20,3 %), hudinfektioner (11,7 %), hudulceration og blærer (6,3 %) og hyperpigmentering (5,5 %).
English: Talk to your doctor or pharmacist before using Ledaga.
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Ledaga.
English: Chlormethine caused foetal malformations in mice and rats when given as single injections of 1-2.5 mg/kg.
Danish: Chlormethin forårsagede fostermisdannelser hos mus og rotter, når det blev indgivet som enkeltinjektioner på 1-2,5 mg/kg.
English: The recommended dose is application as a thin film once a day to the affected areas.
Danish: Den anbefalede dosis er påføring af en tynd film på de berørte områder én gang dagligt.
English: Patients were stratified based on stage (IA vs IB and IIA) and then randomised to receive either Ledaga (equivalent to 0.02% chlormethine HCl) or the comparator (a petroleum-based 0.02% chlormethine HCl ointment).
Danish: Patienterne blev stratificeret i henhold til stadie (IA vs. IB og IIA) og dernæst randomiseret til at få enten Ledaga (svarende til 0,02 % chlormethinhydrochlorid) eller komparator (en jordoliebaseret 0,02 % chlormethinhydrochlorid-salve).
English: Ledaga has no or negligible influence on the ability to drive or use machines.
Danish: Ledaga påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The tube should be returned to the refrigerator immediately after each use.
Danish: Tuben skal lægges tilbage i køleskab straks efter hver anvendelse.
English: Contact your doctor or seek immediate medical attention if you experience allergic reactions to Ledaga (see section
Danish: Kontakt din læge eller søg lægehjælp med det samme, hvis du oplever allergiske reaktioner på Ledaga (se punkt 4).
English: The face, genitalia, anus, and intertriginous skin are at increased risk of skin reactions to topical chlormethine.
Danish: Ansigtet, genitalier, anus og intertriginøse hudområder har øget risiko for hudreaktioner på topikal chlormethin.
English: • A patient alert card, sized to be included in Ledaga outer packaging, together with the Patient Information Leaflet (PIL) is provided to all patients and caregivers who are expected to administer and use Ledaga.
Danish: • Et patient-id-kort med en størrelse, der gør det muligt at lægge det i Ledaga-emballagen, samt en indlægsseddel skal udleveres til alle patienter og omsorgspersoner, der forventes at håndtere og anvende Ledaga.
English: - Skin cancers (abnormal growth of the cells in the skin) have been reported after application of chlormethine to the skin, although it is not known whether chlormethine causes this.
Danish: - Hudkræft (unormal vækst af hudens celler) er blevet rapporteret efter påføring af chlormethin på huden, selvom det er ukendt, om chlormethin forårsager dette.
English: It is not known whether Ledaga passes into breast milk, and there may be a risk that the breast-feeding baby is exposed to Ledaga via contact with the mother's skin.
Danish: Det er ukendt, om Ledaga udskilles i mælken, og der kan være en risiko for, at det ammede spædbarn bliver udsat for Ledaga gennem kontakt med moderens hud.
English: Dermal application of chlormethine to mice at a dose of 15 mg/kg for up to 33 weeks resulted in skin tumours (squamous cell carcinomas and skin papilloma).
Danish: Dermal applicering af chlormethin i en dosis på 15 mg/kg i op til 33 uger hos mus resulterede i hudtumorer (pladecellekarcinomer og hudpapillomer).
English: Ledaga is for use in adults only.
Danish: Ledaga må anvendes hos voksne.
English: Tell your doctor or pharmacist as soon as possible if you notice any of the following side effects listed below.
Danish: Fortæl det til lægen eller apotekspersonalet snarest muligt, hvis du bemærker nogen af følgende bivirkninger:
English: Chlormethine is a type of anti-cancer medicine called an ‘alkylating agent'.
Danish: Chlormethin er en type kræftmedicin, der kaldes et ”alkylerende middel”.
English: o Instruction on how to accurately use, open and dispose a plastic bag should be printed on the plastic bag.
Danish: o Instruktioner vedrørende korrekt brug, åbning og bortskaffelse af plasticposen skal være angivet på plasticposen.
English: Ledaga is intended only for use on the skin.
Danish: Ledaga er kun beregnet til anvendelse på huden.
English: Qualifying prior therapies included topical corticosteroids, phototherapy, topical bexarotene, and topical nitrogen mustard.
Danish: Kvalificerende tidligere behandlinger omfattede topikale kortikosteroider, fototerapi, topikal bexaroten og topikal kvælstofsennepsgas.
English: Isopropyl alcohol Glycerol
Danish: Isopropylalkohol Glycerol
English: Patients who received Ledaga in Study 201 had no measurable concentrations of chlormethine in blood collected 1, 3 and 6 hours post-application on Day 1, and at the first month visit.
Danish: Patienter, som fik Ledaga i studie 201, havde ingen målbar chlormethinkoncentration i blod, der blev indsamlet 1, 3 og 6 timer efter applicering på dag 1, eller ved besøget efter den første måned.
English: Remove and wash any contaminated clothing.
Danish: Fjern og vask eventuelt forurenet beklædning.
English: - Remove the cap from the tube just before use.
Danish: - Skru hætten af tuben lige inden brug.
English: Get medical help right away if Ledaga gets into your eyes, mouth, or nose.
Danish: Søg straks læge, hvis Ledaga kommer i øjnene, munden eller næsen.
English: Chlormethine was carcinogenic in rat and mouse carcinogenicity studies after subcutaneous and intravenous administration.
Danish: Chlormethin var karcinogent i karcinogenicitetsstudier hos rotter og mus efter subkutan og intravenøs administration.
English: No dedicated animal studies on the effects of chlormethine on female fertility have been reported in the literature.
Danish: Der er ikke rapporteret specifikke dyrestudier om chlormethins indvirkning på fertiliteten hos hunner i litteraturen.
English: - Do not apply moisturisers or any other skin products (including medicines applied to the skin) for 2 hours before or 2 hours after the daily application of Ledaga.
Danish: - Påfør ikke fugtighedscremer eller andre hudprodukter (herunder medicin, der smøres på huden) i 2 timer før eller 2 timer efter den daglige påføring af Ledaga.
English: See end of section 2 for further information on propylene glycol and butylhydroxytoluene.
Danish: Se slutningen af punkt 2 for yderligere oplysninger om propylenglycol og butylhydroxytoluen.
English: Skin-directed therapies for MF-type CTCL have been associated with secondary skin cancers, although the specific contribution of chlormethine has not been established.
Danish: Behandlinger rettet mod huden for CTCL af MF-typen er blevet forbundet med sekundære former for hudkræft, selvom chlormethins specifikke bidrag ikke er klarlagt.