FrancophonIA/ELRC3.0 huggingface dataset:
English: If Ledaga gets in your eyes, rinse your eyes right away for at least 15 minutes with large amounts of water, a solution known as “0.9% sodium chloride solution” or an eye-wash solution, and seek medical assistance (including an eye doctor) as soon as possible.
Danish: Hvis du får Ledaga i øjnene, skal du skylle øjnene med det samme i mindst 15 minutter med store mængder vand, en opløsning kaldet en “0,9 % natriumchloridopløsning” eller en øjenskyllevæske og søge læge (herunder øjenlæge) snarest muligt.
English: CAILS Overall Response (CR+PR)
Danish: CAILS samlet respons (CR+PR)
English: • irrigation should be performed immediately for at least 15 minutes with copious amounts of water (or sodium chloride 9 mg/ml (0.9%) solution for injection, or a balanced salt ophthalmic irrigating solution may be used if there is eye exposure), and
Danish: • straks skal skylle området i mindst 15 minutter med rigelige mængder vand (eller natriumchloridinjektionsvæske 9 mg/ml (0,9 %), eller der kan anvendes en øjenskyllevæske med balanceret saltindhold, hvis øjnene er eksponeret), og
English: MF-type CTCL is a condition in which certain cells of the body's immune system called Tlymphocytes become cancerous and affect the skin.
Danish: CTCL af MF-typen er en tilstand, hvor visse celler i kroppens immunsystem, kaldet T-lymfocytter, bliver til kræftceller og påvirker huden.
English: The dosing recommendation for elderly patients ( ≥ 65 years old) is the same as for younger adult patients (see section 4.8).
Danish: Doseringsanbefalingen for ældre patienter ( ≥ 65 år) er den samme som for yngre voksne patienter (se pkt.
English: • Emollients (moisturisers) or other topical products may be applied to the treated areas 2 hours before or 2 hours after application of Ledaga.
Danish: • Blødgørende (fugtighedscremer) eller andre topikale præparater kan påføres de behandlede områder 2 timer før eller 2 timer efter påføring af Ledaga.
English: Similarly, patients who received chlormethine gel 0.04% in a follow-up study (Study 202) had no measurable concentrations of chlormethine or its degradation product (half-mustard) in blood collected 1 hour post-application on Day 1 or after 2, 4, or 6 months of treatment.
Danish: Tilsvarende havde patienter, som fik chlormethin-gel 0,04 % i et opfølgningsstudie (studie 202), ingen målbare koncentrationer af chlormethin eller dets nedbrydningsprodukt (halv-sennepsgas) i blod, der blev indsamlet 1 time efter applicering på dag 1, eller efter 2, 4 og 6 måneders behandling.
English: After defrosting 60 days in the refrigerator (+2 °C to +8 °C).
Danish: Efter optøning 60 dage i køleskab (+2 °C til +8 °C).
English: Direct skin contact with Ledaga should be avoided in individuals other than the patient.
Danish: Direkte hudkontakt med Ledaga hos andre personer end patienten skal undgås.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing severity.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne anført efter, hvor alvorlige de er.
English: Contact with mucous membranes, especially those of the eyes, must be avoided.
Danish: Kontakt med slimhinder, især i øjnene, skal undgås.
English: Ledaga is an alcohol-based product and is flammable.
Danish: Ledaga er et alkoholbaseret præparat og er brandfarligt.
English: For dose modification information in case of skin reactions, see section 4.2.
Danish: For oplysninger om dosisjustering i tilfælde af hudreaktioner, se pkt.
English: If you stop using Ledaga
Danish: Hvis du holder op med at bruge Ledaga
English: Pharmacotherapeutic group: Antineoplastic agents, nitrogen mustard analogues, ATC code: L01AA05.
Danish: Farmakoterapeutisk klassifikation: Antineoplastisk midler, kvælstofsennepsgas-analoger, ATC-kode: L01AA05.
English: • Ledaga should be applied immediately or within 30 minutes after removal from the refrigerator.
Danish: • Ledaga skal appliceres straks eller inden for 30 minutter efter, det er taget ud af køleskab.
English: Dosing could be suspended or continued at reduced frequency in the case of skin reactions.
Danish: Behandlingen kunne seponeres eller fortsættes ved nedsat doseringshyppighed i tilfælde af hudreaktioner.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Ledaga therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the breastfeeding mother.
Danish: Det skal besluttes, om amning eller behandling med Ledaga skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: - Allow the area to dry for 5 to 10 minutes after applying your medicine and before covering with clothing.
Danish: - Lad området tørre i 5 til 10 minutter efter påføring af medicinen, inden området dækkes med beklædning.
English: Caregivers should remove gloves carefully (turning them inside out during the removal to avoid contact with Ledaga) and wash hands thoroughly with soap and water after removal of gloves.
Danish: Handskerne skal tages forsigtigt af (ved at krænge indersiden ud for at undgå kontakt med Ledaga) og hænderne vaskes grundigt med sæbe og vand efter aftagning af handskerne.
English: The median daily usage of Ledaga was 1.8 g. The maximum individual daily usage in the trial was 10.5 g of gel (i.e., 2.1 mg of chlormethine HCl).
Danish: Det maksimale, individuelle daglige forbrug i forsøget var 10,5 g gel (dvs. 2,1 mg chlormethinhydrochlorid).
English: The medicinal product contains propylene glycol and butylhydroxytoluene, which may cause skin irritation (e.g., contact dermatitis).
Danish: Lægemidlet indeholder propylenglycol og butylhydroxytoluen, som kan forårsage hudirritation (f.eks. kontaktdermatitis).
English: Store and transport frozen (−15 °C to −25 °C) After defrosting, store in a refrigerator (+2 °C to +8 °C) Keep Ledaga in its box and inside the child-resistant plastic bag
Danish: Opbevares og transporteres nedfrosset (-15 °C til -25 °C) Efter optøning skal præparatet opbevares i køleskab (+2 °C til +8 °C) Opbevar Ledaga i æsken og i den børnesikrede plasticpose.
English: Exposure of the eyes to chlormethine causes pain, burns, inflammation, photophobia, and blurred vision.
Danish: Eksponering af øjnene for chlormethin forårsager smerter, forbrændinger, inflammation, fotofobi og sløret syn.
English: • Ledaga should be applied to completely dry skin at least 4 hours before or 30 minutes after showering or washing.
Danish: • Ledaga skal appliceres på fuldstændigt tør hud mindst 4 timer før eller 30 minutter efter brusebad eller vask.
English: - If this medicine gets in your mouth or nose, it can cause pain, redness, and ulcers that may be severe.
Danish: - Hvis du får denne medicin i munden eller næsen, kan det forårsage smerter, rødme og sår, der kan være alvorlige.
English: Unopened tube 3 years in the freezer (-15 °C to -25 °C).
Danish: Uåbnet tube 3 år i dybfryser (-15 °C til -25 °C).
English: - Apply a thin layer of this medicine to completely dry skin at least 4 hours before or 30 minutes after showering or washing.
Danish: - Påfør et tyndt lag af medicinen på fuldstændig tør hud mindst 4 timer før eller 30 minutter efter brusebad eller vask.
English: If you forget to use Ledaga
Danish: Hvis du har glemt at bruge Ledaga
English: In addition, butylhydroxytoluene may also cause irritation to the eyes and mucous membranes (i.e., mouth and nose).
Danish: Desuden kan butylhydroxytoluen forårsage irritation i øjne og slimhinder (dvs. mund og næse).
English: Studies in animals have shown reproductive toxicity after systemic administration (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet efter systemisk administration (se pkt.
English: Ask your pharmacist how to throw away used nitrile gloves, the plastic bag and the medicine you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe nitrilhandsker, plasticpose og medicinrester.
English: Patients should be advised that if any mucous membrane exposure occurs:
Danish: Patienterne skal informeres om, at de i tilfælde af eksponering af slimhinderne:
English: Caregivers must wear nitrile gloves when handling Ledaga.
Danish: Omsorgspersoner skal bruge nitrilhandsker, når de håndterer Ledaga.
English: For storage conditions after defrosting Ledaga, see section 6.3.
Danish: Opbevaringsforhold efter optøning af Ledaga, se pkt.
English: These reactions may include some or all of the following symptoms: - Swelling of the lips, face, throat or tongue
Danish: Disse reaktioner kan omfatte nogle eller alle af følgende symptomer: - Hævelse af læber, ansigt, svælg eller tunge - Udslæt - Vejrtrækningsbesvær
English: Very common side effects on the treatment area (may affect more than 1 in 10 people): - Skin inflammation - Infections of the skin - Itching (pruritus)
Danish: Meget almindelige bivirkninger på behandlingsområdet (kan berøre flere end 1 ud af 10 personer): - Inflammation i huden - Hudinfektioner - Kløe
English: There are limited data from the use of chlormethine in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af chlormethin til gravide kvinder.
English: Risks of direct skin contact include inflammation of the skin (dermatitis), injury to their eyes, mouth, or nose, and skin cancers.
Danish: Risiciene ved direkte hudkontakt omfatter inflammation i huden (dermatitis), øjen-, mund- eller næseskade og hudkræft.
English: Any unused medicinal product or waste material, including the plastic bag and the nitrile gloves used for application, must be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf, inklusive plasticpose og nitrilhandsker brugt til applicering, skal bortskaffes i henhold til lokale retningslinjer.
English: Patients should be monitored for development of skin cancers during and after discontinuation of treatment with chlormethine.
Danish: Patienterne skal monitoreres for udvikling af hudkræft under behandling med chlormethin og efter seponering.
English: Hypersensitivity reactions, including isolated cases of anaphylaxis, have been reported in the literature after the use of topical formulations of chlormethine (see sections 4.3 and 4.8).
Danish: Overfølsomhedsreaktioner, herunder isolerede tilfælde af anafylaksi, er blevet rapporteret i litteraturen efter brug af topikale formuleringer af chlormethin (se pkt.
English: Patients should be assessed during treatment for skin reactions such as dermatitis (e.g., redness, swelling, inflammation), pruritus, blisters, ulceration, and skin infections.
Danish: Patienter skal evalueres under behandlingen for hudreaktioner såsom dermatitis (f.eks. rødme, hævelse, inflammation), pruritus, blister, ulceration og hudinfektioner.
English: This is an anti-cancer medicine used on the skin to treat mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL).
Danish: Det er et lægemiddel mod kræft, der anvendes på huden til behandling af kutant T-celle-lymfom af typen mycosis fungoides (CTCL af MF-typen).
English: Adverse reactions reported with Ledaga in an active-controlled trial in patients with MF-type CTCL are shown below.
Danish: Bivirkninger rapporteret med Ledaga i et aktivt kontrolleret studie hos patienter med CTCL af MFtypen vises herunder.
English: Therefore, the use of this medicine is not recommended during pregnancy and in women of childbearing age not using contraception.
Danish: Denne medicin må derfor ikke anvendes under graviditet eller til frugtbare kvinder, som ikke anvender sikker prævention.
English: Treatment with Ledaga should be stopped for any grade of skin ulceration or blistering, or moderately severe or severe dermatitis (e.g., marked skin redness with oedema).
Danish: Behandling med Ledaga bør afbrydes ved alle grader af hudulceration eller blærer og ved moderat til svær dermatitis (f.eks. udtalt hudrødme med ødem).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ledaga in all subsets of the paediatric population in cutaneous T-cell lymphoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Ledaga i alle undergrupper af den pædiatriske population med kutant T-celle-lymfom (se pkt.
English: Management of overdose should consist of washing the exposed area with water.
Danish: Ved overdosering skal det eksponerede område vaskes med vand.
English: - Apply Ledaga to affected areas of the skin.
Danish: - Påfør Ledaga på de berørte områder af huden.
English: o The plastic bag should not be used for any other purposes and must be disposed after 60 days, together with unused refrigerated Ledaga and any waste material, including nitrile gloves in accordance with local requirements.
Danish: o Plasticposen må ikke bruges til noget andet formål og efter opbevaring i køleskab i 60 dage skal plasticposen bortskaffes sammen med ikke anvendt Ledaga og andet affaldsmateriale, herunder nitrilhandsker, i henhold til de lokale retningslinjer.
English: The patient should allow treated areas to dry for 5 to 10 minutes after application before covering with clothing.
Danish: De behandlede hudområder skal tørre i 5 til 10 minutter efter påføring, inden områderne dækkes med beklædning.
English: Common side effects on the treatment area (may affect up to 1 in 10 people): - Skin ulcers - Blisters - Darkening of the skin
Danish: Almindelige bivirkninger på behandlingsområdet (kan berøre op til 1 ud af 10 personer): - Hudsår - Blister - Mørkfarvning af huden
English: SWAT Overall Response (CR+PR)
Danish: SWAT samlet repons (CR+PR)
English: After defrosting, store in a refrigerator.
Danish: Efter optøning skal præparatet opbevares i køleskab.
English: • Caregivers must wear disposable nitrile gloves when applying Ledaga to patients.
Danish: • Omsorgspersoner skal bruge nitril-engangshandsker, når de applicerer Ledaga på patientens hud.
English: - If Ledaga gets in your eyes, it can cause pain, burning, swelling, redness, sensitivity to light, and blurred vision.
Danish: - Hvis du får Ledaga i øjnene, kan det forårsage smerter, en brændende fornemmelse, hævelse, rødme, øget følsomhed for lys og sløret syn.
English: Store and transport frozen (−15 °C to −25 °C).
Danish: Opbevares og transporteres nedfrosset ( -15 °C til -25 °C).
English: Risks of secondary exposure may include skin reactions, mucosal injury, and skin cancers.
Danish: Risici ved sekundær eksponering kan omfatte hudreaktioner, slimhindeskade og hudkræft.
English: - Apply Ledaga immediately or within 30 minutes of removing it from the refrigerator.
Danish: - Påfør Ledaga med det samme eller inden for 30 minutter efter, det blev taget ud af køleskabet.
English: With clean hands, the tube should be placed back into the original box and the box should be placed in the supplied transparent, sealable, plastic bag for storage in the refrigerator.
Danish: Efter vask af hænder lægges tuben tilbage i den oprindelige æske, og æsken anbringes i den medfølgende gennemsigtige plasticpose med forsegling til opbevaring i køleskabet.
English: Contents of the pack and other information What Ledaga contains
Danish: Pakningsstørrelser og yderligere oplysninger Ledaga indeholder:
English: Other medicines and Ledaga
Danish: Brug af anden medicin sammen med Ledaga
English: Propylene glycol and butylhydroxytoluene may also cause skin irritation.
Danish: Propylenglycol og butylhydroxytoluen kan også forårsage hudirritation.
English: Skin ulceration and blistering, skin hyperpigmentation
Danish: Hudulceration og blærer, hyperpigmentering
English: Dispose of the tube, plastic bag and nitrile gloves in accordance with local requirements.
Danish: Tuben, plasticposen og nitrilhandskerne skal bortskaffes i henhold til lokale retningslinjer.
English: If there is accidental skin exposure to Ledaga, caregivers must immediately wash exposed areas thoroughly with soap and water for at least 15 minutes.
Danish: Hvis huden utilsigtet eksponeres for Ledaga, skal de eksponerede områder straks vaskes grundigt med sæbe og vand i mindst 15 minutter.
English: Package leaflet: Information for the patient Ledaga 160 micrograms/g gel chlormethine
Danish: Indlægsseddel: Information til patienten Ledaga 160 mikrogram/g gel chlormethin
English: The risk for inflammation of the skin is increased if you apply Ledaga to your face, genital area, anus or skin folds.
Danish: Risikoen for inflammation i huden øges, hvis du påfører Ledaga i ansigtet, på kønsdelene, i endetarmsåbningen eller i hudfolder.
English: Ledaga 160 micrograms/g gel
Danish: Ledaga 160 mikrogram/g gel
English: Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients (see section 5.1).
Danish: Ledaga er indiceret til topikal behandling af kutant T-celle-lymfom af typen mycosis fungoides (MF-type CTCL) hos voksne patienter (se pkt.
English: Ledaga contains propylene glycol and butylhydroxytoluene
Danish: Ledaga indeholder propylenglycol og butylhydroxytoluen
English: The MAH must agree about the content and format of the text prior to the launch of Ledaga in each MS with the National Competent Authority (NCA).
Danish: MAH skal sammen med den relevante myndighed godkende indholdet og formen af teksten, inden Ledaga markedsføres i det enkelte medlemsland.
English: Your doctor may stop your treatment if you develop severe inflammation of the skin (i.e., redness and swelling), blisters and ulcers.
Danish: Din læge kan stoppe behandlingen, hvis du udvikler svær inflammation i huden (f.eks. rødme og hævelse), blister og sår.
English: • The other ingredients are: diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol, lactic acid, hydroxypropylcellulose, sodium chloride, menthol racemic, disodium edetate, and butylhydroxytoluene.
Danish: • Øvrige indholdsstoffer: diethylenglycolmonoethylether, propylenglycol, isopropylalkohol, glycerol, mælkesyre, hydroxypropylcellulose, natriumchlorid, racemisk menthol, dinatriumedetat og butylhydroxytoluen.
English: Each aluminium tube contains 60 grams of gel and has a white screw cap.
Danish: Hver aluminiumstube indeholder 60 gram gel og har en hvid skruehætte.
English: Unused refrigerated Ledaga should be discarded after 60 days, together with the plastic bag.
Danish: Efter opbevaring i køleskab i 60 dage skal ikke anvendt Ledaga bortskaffes sammen med plasticposen.
English: - Use Ledaga exactly as your doctor or pharmacist tells you.
Danish: - Brug Ledaga nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Ledaga is not recommended in women of childbearing potential not using contraception.
Danish: Ledaga bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: The following instructions should be followed by patients or caregivers when applying Ledaga:
Danish: Følgende anvisninger for applicering af Ledaga skal følges af patienter og omsorgspersoner:
English: Diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol, lactic acid, hydroxypropylcellulose, sodium chloride, menthol racemic, disodium edetate, butylhydroxytoluene.
Danish: Diethylenglycolmonoethylether, propylenglycol, isopropylalkohol, glycerol, mælkesyre, hydroxypropylcellulose, natriumchlorid, racemisk menthol, dinatriumedetat, butylhydroxytoluen.
English: The tube should not be used and the pharmacist should be contacted if the seal is missing, punctured, or lifted.
Danish: Hvis forseglingen mangler, er punkteret eller løftet op, bør tuben ikke anvendes, og apotekspersonalet skal kontaktes.
English: - This medicine can cause skin reactions, such as inflammation of your skin (redness and swelling), itching, blisters, ulcers and skin infections (see section 4).
Danish: - Denne medicin kan forårsage hudreaktioner, såsom inflammation (en betændelseslignende reaktion) i huden (rødme og hævelse), kløe, blister, sår og hudinfektioner (se punkt 4).
English: The cap should be used to puncture the seal.
Danish: Hætten bruges til at punktere forseglingen.
English: In addition, butylhydroxytoluene has been reported to cause irritation to the eyes and mucous membranes.
Danish: Desuden er butylhydroxytoluen rapporteret at forårsage øjen- og slimhindeirritation.
English: Each tube contains 10.5 grams of propylene glycol and 6 micrograms of butylhydroxytoluene.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tube indeholder 10,5 gram propylenglycol og 6 mikrogram butylhydroxytoluen.
English: Ledaga is provided in a white aluminium tube with an inner lacquer and an aluminium seal and a white polypropylene screw cap. Each tube contains 60 g of gel.
Danish: Ledaga leveres i en hvid aluminiumstube, der er lakeret indvendigt og forsynet med en aluminiumsforsegling og en hvid skruehætte af polypropylen.
English: Each gram of gel contains chlormethine hydrochloride equivalent to 160 micrograms of chlormethine.
Danish: Hvert gram gel indeholder chlormethinhydrochlorid svarende til 160 mikrogram chlormethin.
English: Ledaga 160 micrograms/g gel chlormethine
Danish: Ledaga 160 mikrogram/g gel chlormethin
English: - Keep away from children and contact with food by storing Ledaga in its box and inside the plastic bag.
Danish: - Opbevar Ledaga utilgængeligt for børn og uden kontakt med mad ved at lægge det i æsken og derefter i plasticposen.
English: - Ledaga is supplied within a child-resistant transparent, sealable, plastic bag.
Danish: - Sammen med Ledaga leveres en børnesikret, gennemsigtig plasticpose med forsegling.
English: Therefore, it is not recommended to breast-feed while taking this medicine.You should talk to your doctor before breast-feeding to determine whether or not it is best to breast-feed or to use Ledaga.
Danish: Du skal tale med din læge, inden du ammer, for at beslutte, om det er bedst at amme eller at anvende Ledaga.
English: - For patients applying the gel, wash your hands with soap and water immediately after applying.
Danish: - Når patienter påfører gelen, skal de vaske hænderne med sæbe og vand umiddelbart efter påføring af gelen.
English: Cytotoxic Flammable
Danish: Cytotoksisk Brandfarlig
English: Sodium chloride Menthol racemic Disodium edetate Butylhydroxytoluene
Danish: Hydroxypropylcellulose Natriumchlorid Menthol, racemisk Dinatriumedetat Butylhydroxytoluen
English: In animals, adverse effects of chlormethine on male fertility after systemic administration have been documented (see section 5.3).
Danish: Der er påvist ugunstige virkninger på hanlig fertilitet hos dyr efter systemisk administration af chlormethin (se pkt.
English: Intravenously administered chlormethine impaired male fertility in rats at a daily dose of ≥ 0.25 mg/kg for 2 weeks.
Danish: Intravenøs administration af chlormethin i en daglig dosis på ≥ 0,25 mg/kg i 2 uger forårsagede nedsat fertilitet hos hanrotter.
English: Each gram of gel contains 160 micrograms of chlormethine.
Danish: Hvert gram gel indeholder 160 mikrogram chlormethin.
English: Ledaga is for topical application to the skin.
Danish: Ledaga er til applicering på huden.
English: What you need to know before you use Ledaga Do not use Ledaga
Danish: Det skal du vide, før du begynder at bruge Ledaga Brug ikke Ledaga:
English: Patients should apply Ledaga to affected areas of the skin.
Danish: Patienter skal applicere Ledaga på de afficerede hudområder.
English: - Until Ledaga has dried on the skin, avoid contact with an open flame or a lit cigarette.
Danish: - Undgå kontakt med åben ild eller en tændt cigaret, indtil Ledaga er tørret på huden.
English: Mucosal or eye exposure
Danish: Eksponering af slimhinder og øjne
English: A thin film of Ledaga should be applied once daily to affected areas of the skin.
Danish: Ledaga appliceres i en tynd film på de afficerede hudområder én gang dagligt.
English: - Caregivers must wear disposable nitrile gloves when applying this medicine to patients (this is a special type of glove; ask your doctor or pharmacist if you have questions).
Danish: - Omsorgspersoner skal bruge nitril-engangshandsker, når de påfører medicinen på patienters hud (Det er en speciel handsketype.