FrancophonIA/ELRC3.0 huggingface dataset:
English: The treatment with IL-2 and Ceplene lasts for 81 weeks and is cyclic.
Danish: Behandlingerne med IL-2 og Ceplene varer i 81 uger og sker i perioder.
English: Ceplene must be injected 1 to 3 minutes later.
Danish: Ceplene skal injiceres 1 til 3 minutter senere.
English: Do not pass it on to others.
Danish: Lad derfor være med at give Ceplene til andre.
English: H2 receptor antagonists with imidazole structures similar to histamine, e.g., cimetidine, systemic steroids and clonidine, must not be used during treatment with Ceplene (see section 4.3).
Danish: H2-receptorantagonister med imidazolstrukturer svarende til histamin, f.eks. cimetidin, systemiske steroider og clonidin, må ikke anvendes ved behandling med Ceplene (se punkt 4.3).
English: Rapid injection can cause a drop in your blood pressure and make you feel faint or even pass out.
Danish: Hurtig injektion kan medføre blodtryksfald og få dig til at føle dig svag eller tilmed besvime.
English: Very common pneumonia
Danish: Meget almindelig pneumoni
English: The European Medicines Agency will review any new information on this medicine every year and this package leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om Ceplene, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: • For the following 63 weeks: you will use IL-2 and Ceplene daily for 3 weeks, followed by a
Danish: • I de efterfølgende 63 uger skal du anvende IL-2 og Ceplene daglig i 3 uger efterfulgt af en
English: If you are taking any of the following medicines, please be sure to discuss this with your doctor or pharmacist before using Ceplene.
Danish: Hvis du anvender nogen af følgende lægemidler, skal du huske at drøfte det med din læge eller apoteket, før du anvender Ceplene.
English: No clinical data are available on the effects of Ceplene on fertility.
Danish: Der foreligger ingen kliniske data for virkningen af Ceplene på human fertilitet.
English: INSTRUCTIONS FOR INJECTION
Danish: VEJLEDNING I INJEKTION
English: Should Ceplene related toxicities occur (such as hypotension, headache), the injection time can be increased from 5 minutes to a maximum duration of 15 minutes.
Danish: Hvis der forekommer Ceplene relaterede toksiciteter (såsom hypotension, hovedpine), kan injektionstiden øges fra 5 minutters varighed til maksimalt 15 minutter.
English: Adjust the syringe so that the tip of the needle is slightly above the rubber stopper but still within the solution.
Danish: Justér sprøjten sådan, at spidsen af kanylen er lidt over gummiproppen, men stadig i opløsningen.
English: The usual time for administering a 0.5 mL Ceplene dose is 5 minutes.
Danish: Den normale indgivelsestid for en dosis på 0,5 ml Ceplene er 5 minutter.
English: If you notice a severe drop in blood pressure after use of Ceplene, please contact your physician immediately or at least prior to administration of further Ceplene injections.
Danish: Hvis du bemærker et kraftig blodtryksfald efter anvendelse af Ceplene, skal du kontakte din læge straks, eller i det mindste før du igen skal tage Ceplene,
English: Contraception in males and females
Danish: Prævention til mænd og kvinder
English: Do not use Ceplene
Danish: Tag ikke Ceplene
English: Animal studies revealed no adverse effects on fertility apart from a slight reduction in implantations and viable foetuses (see section 5.3).
Danish: Studie med dyr viste ingen uønsket virkning på fertiliteten bortset fra en svag nedgang i implantationer og levedygtige fostre (se punkt 5.3).
English: If you are using a syringe pump you must refer to the instructions provided by the pump manufacturer and the training provided by your doctor or nurse.
Danish: Hvis du bruger en sprøjtepumpe, bør du gennemlæse pumpeproducentens vejledning og få særlig instruktion hos din læge eller sygeplejerske.
English: Table 2: For treatment cycles 4-10 with Ceplene and IL-2, same as for Table 1 above, with the exception of number of cycles and duration of rest periods
Danish: Tabel 2: Behandlingscyklus 4-10 med Ceplene og IL-2 er den samme som i tabel 1 ovenfor bortset fra antallet af cyklusser og varigheden af de behandlingsfri perioder
English: For patients experiencing grade 1-4 generalised toxic dermatitis -for grade 1 toxicity, the treatment should be delayed for 48 hours or until all symptoms have been resolved.
Danish: Patienter, som oplever grad 1-4 generaliseret toksisk dermatitis - Ved grad 1-toksicitet bør behandlingen udsættes i 48 timer, eller indtil alle symptomer er afhjulpet.
English: One to 3 minutes after the subcutaneous administration of IL-2 has been completed, Ceplene should be administered by slow subcutaneous injection at a rate not to exceed 0.1 mL (0.1 mg histamine dihydrochloride) per minute.
Danish: Ét til 3 minutter efter den subkutane indgivelse af IL-2 bør Ceplene indgives ved langsom subkutan injektion med en hastighed, som ikke må overskride 0,1 ml (0,1 mg histamindihydrochlorid) pr. minut.
English: Administration of Ceplene or IL-2 by rapid infusion or into vascular spaces, at higher doses than the approved ones, may exaggerate the adverse reactions associated with Ceplene.
Danish: Indgivelse af Ceplene eller IL-2 ved hurtig injektion eller injektion i vaskulære områder i højere doser end de godkendte kan forstærke bivirkningerne ved Ceplene.
English: In the peri-post natal development study, high doses of histamine dihydrochloride caused maternal toxicity, and the offspring showed toxicity during lactation (fewer live pups at day 21 compared to lactation at day 4) but not after weaning.
Danish: I den peri/post-natale udviklingsundersøgelse forårsagede høje doser histamindihydrochlorid maternel toksicitet, og afkommet viste toksicitet i laktationsperioden (færre levende unger dag 21 sammenlignet med dag 4 i laktationsperioden), men ikke efter fravænning.
English: PHARMACEUTICAL FORM Solution for injection.
Danish: LÆGEMIDDELFORM Opløsning til injektion.
English: Yearly, simultaneously with submission of Periodic Safety Update reports
Danish: Årligt, samtidig med fremsendelse af periodiske, opdaterede sikkerhedsindberet ninger
English: Study AML-1 was exploratory, enrolling 39 AML patients in remission to determine the dose and feasibility of Ceplene administered together with IL-2.
Danish: AML-1 var en eksplorativ undersøgelse, som omfattede 39 AML-patienter i remission med henblik på at fastlægge doseringen samt muligheden for at give Ceplene sammen med IL-2.
English: • If you are receiving one of the following medicines: - Steroids such as prednisone and dexamethasone.
Danish: • Hvis du får et af følgende lægemidler: - Steroider såsom prednison og dexamethason.
English: Ceplene should not be injected into the same anatomic region as IL-2.
Danish: Ceplene bør ikke injiceres i samme anatomiske område som IL-2.
English: Caution should be used for patients with any of the following: symptomatic peripheral arterial disease, past or present peptic or oesophageal ulcer disease with a history of bleeding, clinically significant renal disease and stroke within the last 12 months.
Danish: Der bør udvises forsigtighed hos patienter med en eller flere af følgende lidelser: symptomatisk perifer arteriesygdom, tidligere eller eksisterende peptisk eller øsofageal ulcussygdom med blødning, klinisk signifikant nyresygdom og apopleksi i anamnesen inden for de sidste 12 måneder.
English: Patients with cardiac disease should be evaluated for ventricular ejection fraction and wall function by echocardiography or nuclear medicine stress test and then treated with caution.
Danish: Patienter med hjertesygdom bør vurderes med hensyn til ventrikulær uddrivningsfraktion og hjertevæg-funktion ved hjælp af ekkokardiografi eller nuklearmedicinsk stresstest, og de skal behandles med forsigtighed.
English: • Altered taste (dysgeusia)
Danish: • Smagsforandring (dysgeusi)
English: Abnormal WBC counts - the dose of IL-2 can be reduced by 20% for the remaining duration of the treatment course and if abnormal WBC counts re-occur during the following cycle a permanent IL-2 reduction is recommended.
Danish: Abnormt leukocyttal - IL-2-dosis kan reduceres med 20 % i den resterende del af behandlingsforløbet, og hvis abnorme leukocyttal forekommer igen i den efterfølgende cyklus, anbefales en permanent IL-2-reduktion.
English: Dispensing of dilute IL-2 (aldesleukin) for each patient
Danish: Dispensering af fortyndet IL-2 (aldesleukin) til den enkelte patient
English: A decrease of blood pressure may occur.
Danish: Du kan opleve blodtryksfald.
English: Always use Ceplene exactly as your doctor has instructed.
Danish: Tag altid Ceplene efter lægens anvisning.
English: Method
Danish: Metode
English: Ceplene and low dose IL-2 have been investigated in other clinical studies at different doses (1 mg histamine dihydrochloride twice a day) and with different dose regimens of low-dose IL-2 and interferon-alfa.
Danish: Ceplene og lave doser af IL-2 er undersøgt i andre kliniske studier med forskellige doser (1,0 mg histamindihydrochlorid to gange daglig) og med forskellige dosisregimer med lave doser af IL-2 og interferon-alfa.
English: Plasma Ceplene levels are higher in patients with moderate and severe liver impairment, and these patient groups tend to experience more tachycardia and lower blood pressure after Ceplene dosing than do patients with normal or mildly affected liver function.
Danish: Plasmaniveauerne af Ceplene er højere hos patienter med moderat og svær leverinsufficiens, og disse patientgrupper har en tendens til at opleve mere takykardi og lavere blodtryk efter Ceplene-doser end patienter med normal eller mild leverinsufficiens.
English: Push the plunger of the syringe down to inject air into the vial.
Danish: Skub sprøjtens stempel ned for at sprøjte luft ind i hætteglasset.
English: Hypotension (low blood pressure) may occur very commonly and may lead to light-headedness and fainting.
Danish: Hypotension (lavt blodtryk) kan forekomme meget almindeligt og fører til svimmelhed og besvimelse.
English: Interleukin-2 (IL-2) is commercially available as a recombinant IL-2; aldesleukin.
Danish: Interleukin-2 (IL-2) er kommercielt tilgængeligt som rekombinant IL-2; aldesleukin.
English: If bubbles appear in the syringe, push the solution slowly back into the vial and withdraw the solution again.
Danish: Hvis der kommer bobler til syne i sprøjten, trykker du opløsningen langsomt tilbage i hætteglasset, og trækker den op i sprøjten igen.
English: Metabolism and nutrition disorders anorexia
Danish: Metabolisme og ernæring anoreksi
English: Patients with a prior history of autoimmune disease (including systemic lupus, inflammatory bowel disease, psoriasis and rheumatoid arthritis) should be treated with caution.
Danish: Patienter, der tidligere har haft en autoimmun sygdom i anamnesen (såsom systemisk lupus, inflammatorisk tarmsygdom, psoriasis og rheumatoid artritis) bør behandles med forsigtighed.
English: The role of Ceplene is to protect lymphocytes, in particular NK cells and T cells, which are responsible for the immune-mediated destruction of residual leukaemic cells.
Danish: Ceplenes rolle er at beskytte lymfocytterne, især NK-celler og T-celler, som er ansvarlige for den immunmedierede destruktion af resterende leukæmiceller.
English: What Ceplene contains
Danish: Ceplene indeholder:
English: Very common erythema, hyperhidrosis, night sweats, pruritus
Danish: Meget almindelig erythem, hyperhidrose, nattesved, pruritus
English: Ceplene should be administered in the clinic under supervision of the physician on day 1 of the initial treatment cycle.
Danish: Ceplene bør gives på hospitalet under overvågning af lægen på dag 1 i den første behandlingscyklus.
English: Refer to the IL-2 SmPC for information on pregnancy and breast-feeding with IL-2.
Danish: Der henvises til produktresuméet for IL-2 vedrørende information om graviditet og amning under brug af IL-2.
English: • Accumulation of fluid in the body especially in the legs (oedema)
Danish: • Væskeansamling i kroppen, især i benene (ødem)
English: Up to two weeks supply of pre-filled capped tuberculin syringes may be provided to patients for home administration, with instructions that the syringes be stored under refrigeration at 2°C - 8°C prior to administration.
Danish: Op til 2 ugers forbrug af fyldte tuberculinsprøjter med hætte kan udleveres til patienten til hjemmeadministration med instruktioner om, at sprøjterne skal opbevares i køleskab ved 2°C - 8°C indtil brug.
English: There may be a small amount of solution left in the vial.
Danish: Der kan være en lille smule opløsning tilbage i hætteglasset.
English: The two medicines, IL-2 and Ceplene, are both injected twice a day, with a minimum of 6 hours between injections.
Danish: De to lægemidler IL-2 og Ceplene skal begge injiceres to gange daglig med minimum 6 timers mellemrum mellem injektionerne.
English: If you stop taking Ceplene
Danish: Hvis du holder op med at tage Ceplene
English: Use an alcohol wipe to clean the rubber part of the stopper.
Danish: Brug en spritserviet til at rengøre gummidelen af proppen.
English: The number of CR1 patients remaining leukaemia-free for 3 years was 40% after Ceplene+IL-2 versus 26% in patients not receiving this treatment (p=0.01).
Danish: Andelen af CR1-patienter, som forblev leukæmifri i 3 år efter behandling med Ceplene+IL-2, var 40 % mod 26 % af de patienter, som ikke fik denne behandling (p=0,01).
English: Subcutaneous use only.
Danish: Kun til subkutan brug.
English: w.13 to w.15 (Days 1-21)
Danish: u.13 til u.15 (Dag 1-21)
English: Endocrine disorders hypothyroidism
Danish: Det endokrine system hypotyroidisme
English: If you forget to take Ceplene
Danish: Hvis du har glemt at tage Ceplene
English: What you need to know before you use Ceplene
Danish: Det skal du vide, før du begynder at tage Ceplene
English: H1 receptor blocking antihistamines or neuroleptics (anti-psychotics) with H1 receptor blocking properties that might decrease efficacy of Ceplene should be avoided.
Danish: H1-receptorblokerende antihistaminer eller neuroleptika (antipsykotika) med H1-receptorblokerende egenskaber, som kan nedsætte virkningen af Ceplene, bør undgås.
English: The first dose of Ceplene and IL-2 on day 1 of the initiation of the first cycle of treatment should be administered in the clinic under direct supervision by a physician.
Danish: Den første dosis Ceplene og IL-2 på dag 1 ved initiering af første behandlingscyklus bør indgives på klinikken/afdelingen under direkte overvågning af en læge.
English: Alcohol wipe(s).
Danish: Spritserviet(ter).
English: • Increase in the number of a certain type of white blood cells in the blood (eosinophilia) and decrease in the number of blood platelets (thrombocytopenia)
Danish: • Forhøjelse i antallet af en vis type hvide blodlegemer i blodet (eosinofili) og en reduktion i antallet af blodplader (trombocytopeni)
English: Infections and infestations upper respiratory tract infections
Danish: Infektioner og parasitære sygdomme øvre luftvejsinfektioner
English: Ceplene is used in adult patients, together with IL-2, to treat a particular type of leukaemia called acute myeloid leukaemia (AML) which is a cancer of blood forming cells in the bone marrow.
Danish: Ceplene anvendes til voksne patienter sammen med IL-2 til behandling af en særlig form for leukæmi, som kaldes akut myeloid leukæmi (AML), som kræft i knoglemarvens bloddannende celler.
English: Very common depression
Danish: Meget almindelig depression
English: However, no Ceplene dose reduction is normally required in renally impaired patients.
Danish: Dosisreduktion af Ceplene er dog normalt ikke påkrævet hos patienter med nyreinsufficiens.
English: Dose reduction of Ceplene is normally not required in hepatically impaired patients, but caution should be used in these patients.
Danish: Dosisreduktion af Ceplene er normalt ikke påkrævet hos patienter med leverinsufficiens, men der bør udvises forsigtighed hos disse patienter.
English: A study was performed to measure the PK of histamine in normal volunteers compared to patients with mild, moderate, and severe hepatic impairment.
Danish: En undersøgelse blev gennemført for at måle histamins PK hos raske frivillige sammenlignet med patienter med mild, moderat eller svær leverinsufficiens.
English: The usual dose of Ceplene is 0.5 mL of solution twice a day given as a slow subcutaneous injection (in the layer of tissue just under the skin).
Danish: Den normale dosis Ceplene er 0,5 ml opløsning to gange daglig givet som en langsom subkutan injektion (i vævslaget lige under huden).
English: Ceplene is available in pack sizes of 14 vials.
Danish: Ceplene fås i pakninger med 14 hætteglas.
English: The excretion of histamine in milk has not been studied in animals, but at maternotoxic doses in rats, offspring showed slight toxicity during early lactation (see section 5.3).
Danish: Udskillelse af histamin i mælk er ikke undersøgt hos dyr, men ved maternotoksiske doser hos rotter blev der observeret svag toksicitet hos rotteunger i den tidlige laktationsperiode (se punkt 5.3).
English: Ceplene can be administered via an ambulatory infusion syringe pump or by controlled manual subcutaneous injection by syringe with a timer.
Danish: Ceplene kan gives intravenøst med en bærbar infusionspumpe eller subkutant ved kontrolleret manuel injektion med en tidsstyret injektionssprøjte.
English: 1 prepared syringe for your IL-2 injection (refer to the IL-2 package leaflet and your doctor's dose instructions).
Danish: 1 klargjort sprøjte til din IL-2-injektion (følg indlægssedlen for IL-2 og din læges dosisvejledning).
English: Ceplene/IL-2 is an immunotherapy which aims to induce immune-mediated destruction of residual myeloid leukaemic cells and thereby to prevent relapse of leukaemia.
Danish: Ceplene/IL-2 er en immunterapi, som har til formål at inducere immunmedieret destruktion af resterende akut myeloid leukæmiceller og derved forhindre leukæmi-recidiv.
English: Ceplene has moderate influence on the ability to drive and use machines.
Danish: Ceplene påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
English: 1 Take 1 vial out of the carton.
Danish: 1 Tag 1 hætteglas ud af æsken.
English: The most common adverse reactions experienced by 30% or more of patients receiving IL-2 and Ceplene (listed in descending order of frequency) were: flushing, headache, fatigue, injection site granuloma, pyrexia and injection site erythema.
Danish: De mest almindelige bivirkninger (anført i faldende hyppighedsgrad), som blev oplevet af 30 % eller flere af patienterne i behandling med IL-2 og Ceplene, var følgende: Rødmen, hovedpine, træthed, granulom på injektionsstedet, pyreksi og erythem på injektionsstedet.
English: ROS are known to limit the anti-leukaemic effects of lymphocyte activators such as IL-2, by triggering dysfunction and death by apoptosis in NK cells and T cells.
Danish: ROS vides at begrænse den antileukæmiske virkning af lymfocyt-aktivatorer som IL-2 ved at udløse dysfunktion og død ved apoptose i NK-celler og T-celler.
English: Ceplene and IL-2 are administered for 10 treatment cycles: each cycle consists of a treatment period of 21 days (3 weeks) followed by a three-week or six-week treatment-free period.
Danish: Ceplene og IL-2 gives over 10 behandlingscyklusser: Hver cyklus består af en behandlingsperiode på 21 dage (3 uger) efterfulgt af en 3-ugers eller 6-ugers behandlingsfri periode.
English: In female rats dosed before mating to gestation day 7, slightly reduced numbers of implantations and viable foetuses were found, but without any dose-response and within the range of historical control data.
Danish: Hos hunrotter, som blev doseret før gestationsdag 7, fandtes en svag nedgang i fertilitet i form af nedsat implantering af æg og levedygtige fostre, men uden nogen dosisrespons og inden for området af historiske kontroldata.
English: No altered dose recommendations with the exception of grade 1 neurologic toxicity and grade 1 generalised toxic dermatitis.
Danish: Patienter, som oplever grad 1-toksicitet hændelser Ingen anbefalinger om ændret dosis undtagen ved grad 1-neurologisk toksicitet og grad 1generaliseret toksisk dermatitis.
English: Treatment with Ceplene in conjunction with IL-2 should be used with caution in patients with poorly compensated cardiac function.
Danish: Behandling med Ceplene i forbindelse med IL-2 bør foretages med forsigtighed hos patienter med dårligt afhjulpet hjerteinsufficiens.
English: Slowly pull back the plunger to draw the solution into the syringe, filling it to the level (number of millilitres) instructed by your doctor.
Danish: Træk stemplet langsomt tilbage for at trække opløsningen op i sprøjten, så den fyldes op til den niveaumarkering (antal milliliter), din læge har angivet.
English: Very common palpitations
Danish: Meget almindelig palpitationer
English: If you have missed one of your doses in a day, contact your doctor or pharmacist.
Danish: Hvis du har glemt en af dine daglige doser, skal du kontakte din læge eller apoteket.
English: • Nausea, indigestion (dyspepsia) and diarrhoea
Danish: • Kvalme, fordøjelsesbesvær (dyspepsi) og diarré
English: It is provided in a glass vial with a grey rubber stopper and a blue peel flip off aluminium tamper evident over seal.
Danish: Den leveres i et hætteglas af glas med en grå gummiprop og en blå sikkerhedsforsegling af aluminium, som vippes og trækkes af.
English: Concurrent administration of medicinal products with cardiotoxicity or blood pressure lowering effects may increase the toxicity of Ceplene.
Danish: Samtidig anvendelse af lægemidler med kardiotoksisk virkning eller med blodtrykssænkende virkninger kan forøge Ceplenes toksicitet.
English: Ear and labyrinth disorders vertigo
Danish: Øre og labyrint vertigo
English: Make sure that the area of the skin you select is exposed.
Danish: Kontrollér, at der er adgang til det hudområde, du har valgt.
English: It is not known whether Ceplene appears in breast milk.
Danish: Det vides ikke, om Ceplene udskilles i mælk.
English: • Steroids such as prednisone and dexamethasone.
Danish: Det drejer sig om steroider såsom prednison og dexamethason.
English: For instructions on reconstitution and dilution of Interleukin-2 (aldesleukin) before administration, see commercially available IL-2 SmPC.
Danish: For instruktioner om rekonstitution og fortynding af Interleukin-2 (aldesleukin) før administration, se produktresumé for kommercielt tilgængeligt IL-2.
English: For patients experiencing grade 3 and 4 (including hypotension, arrhythmia) toxicities - treatment should be discontinued until the event is resolved.
Danish: Patienter, som oplever grad 3- og 4-toksicitet (inklusive hypotension, arytmi) - Behandling bør seponeres, indtil hændelsen er afhjulpet.
English: - the dose amount of both Ceplene and IL-2 should be reduced by 20%.
Danish: - Dosis for både Ceplene og IL-2 bør reduceres med 20 %.
English: For the full list of excipients, see section 6.1.
Danish: En liste over alle hjælpestoffer er anført under punkt 6.1.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 personer)
English: They are used to inhibit activity of the immune system (immunosuppressant) and to reduce inflammation.
Danish: • Medicin anvendes til at hæmme immunsystemets aktivitet (immunsuppressiva) og til at reducere betændelsestilstande.
English: • Abnormal redness of the skin (erythema), increased sweating (hyperhidrosis), night sweats and itching (pruritus)
Danish: • Abnorm hudrødme (erythem), øget svedafsondring (hyperhidrose), nattesved og kløe (pruritus)
English: Although the degree of renal impairment has little effect on the PK disposition of histamine, caution should be used in the administration of histamine to patients with severe renal impairment.
Danish: Selvom graden af nyreinsufficiens kun har lille indflydelse på histamins PK-disposition, bør der udvises forsigtighed ved anvendelse af histamin til patienter med svær nyreinsufficiens.
English: • Antihistamines used to treat allergy.
Danish: • Medicin, som anvendes til behandling af allergi (antihistaminer)
English: • Joint and muscle pain (arthralgia and myalgia)
Danish: • Led- og muskelsmerter (artralgi og myalgi)