FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood and lymphatic system disorders anaemia
Danish: Blod- og lymfesystem anæmi
English: Sodium chloride, water for injections, and sodium hydroxide and/or hydrochloric acid to adjust the pH.
Danish: Natriumchlorid,vand til injektionsvæsker og natriumhydroxid og/eller hydrogenchlorid til justering af pH-værdien.
English: The role of IL-2 is to promote the functions of NK cells and T cells by activating the anti-leukaemic properties of these cells and by expanding these cell populations by inducing cell cycle proliferation.
Danish: IL-2's rolle er at fremme NK-cellernes og T-cellernes funktion ved at aktivere disse cellers antileukæmiske egenskaber og ved celledeling øge antallet af disse celler.
English: Although the degree of renal impairment has no demonstrable effect on the pharmacokinetic disposition of Ceplene, caution is warranted when Ceplene is administered to patients with severe renal impairment.
Danish: Selvom graden af nyreinsufficiens ikke har nogen påviselig effekt på Ceplenes farmakokinetiske egenskab, anbefales det, at der udvises forsigtighed, når Ceplene gives til patienter med svær nyreinsufficiens.
English: If not, use another vial and inform your doctor or pharmacist.
Danish: Er den ikke det, bør du bruge et andet hætteglas og informere din læge eller apoteket.
English: It is recommended that you always have someone with you when injecting this medicine, such as an adult family member, friend or other care provider who could help you if you feel light-headed or faint.
Danish: Det anbefales, at du altid har nogen hos dig, når du injicerer lægemidlet, som f.eks. et voksent familiemedlem, en ven eller anden omsorgsperson, som kan hjælpe dig, hvis du føler dig svimmel eller besvimer.
English: Talk to your doctor or pharmacist before using Ceplene.
Danish: Kontakt lægen eller apoteketspersonalet, før du tager Ceplene.
English: 2 mL type I glass vial, with bromobutyl rubber stopper and flip-off aluminium over seal, containing 0.5 mL of solution (0.70 mL including overfill).
Danish: 2 ml hætteglas af type I, af glas, med brombutyl-gummiprop forseglet med “flip-off” aluminiumkapsel indeholdende 0,5 ml opløsning (0,70 ml inklusive overfyldning).
English: w.7 to w.9 (Days 1-21)
Danish: u.7 til u.9 (Dag 1-21)
English: Women of childbearing potential and sexually active men must use effective methods of contraception during treatment with Ceplene and IL-2.
Danish: Fertile kvinder og seksuelt aktive mænd bør anvende effektive præventionsmetoder under behandling med Ceplene og IL-2.
English: It is recommended that you always have someone with you when injecting Ceplene, such as an adult family member, friend, or other care provider to help you if you feel light-headed or faint.
Danish: Det anbefales, at du altid har nogen hos dig, når du injicerer Ceplene, som f.eks. et voksent familiemedlem, en ven eller anden omsorgsperson, som kan hjælpe dig, hvis du føler dig svimmel eller besvimer.
English: The concomitant administration of Ceplene and IL-2 therefore aims to optimise the anti-leukaemic functions of NK cells and T cells.
Danish: Samtidig anvendelse af Ceplene og IL-2 har derfor til formål at optimere de antileukæmiske funktioner af NK-celler og T-celler.
English: Push down the syringe plunger and inject one-tenth of a millilitre (0.1 mL) every minute, or more slowly if instructed to do so by your doctor.
Danish: Tryk stemplet ned og injicér en tiendedel milliliter (0,1 ml) i minuttet eller langsommere, hvis din læge har instrueret dig om det. Se Figur 7.
English: • Constipation, swollen stomach, inflamed mouth
Danish: • Forstoppelse, oppustet mave, mundbetændelse
English: For persistent hypotension, headache, arrhythmia, cardiac, hepatic and renal toxicities - the time of injection of the dose of Ceplene should be extended to a maximum of 15 minutes.
Danish: Ved vedvarende hypotension, hovedpine, arytmi samt kardial, hepatisk, renal toksicitet - Injektionstiden for Ceplene bør udvides til maksimalt 15 minutter.
English: For both men and women using this treatment, an effective method of contraception must be used as it is important not to conceive a child while being treated with Ceplene and IL-2.
Danish: Både mænd og kvinder, som får denne behandling, skal anvende præventionsmidler, da det er vigtigt, at der ikke opstår graviditet under behandling med Ceplene og IL-2.
English: IL-2 (aldesleukin) should be aseptically reconstituted, diluted and dispensed in capped polypropylene tuberculin syringes by the pharmacy based on the individual patient's weight (see administration chart for aldesleukin below) at the recommended dose of 16 400 IU/kg (1 µg/kg).
Danish: IL-2 (aldesleukin) skal af apoteket rekonstitueres, aseptisk, fortyndes og dispenseres i polypropylentuberculinsprøjter med hætte, baseret på den enkelte patients vægt med en anbefalet dosis på 16.400 IE/kg (1 μg/kg) (se nedenstående administrationsskema for aldesleukin).
English: To prepare a dose of Ceplene you will need the following: 1 vial of Ceplene solution (0.5 mL) 1 sterile graduated syringe with needle 1 alcohol wipe
Danish: Til klargøring af en dosis Ceplene skal du bruge følgende: 1 hætteglas med Ceplene-opløsning (0,5 ml) 1 steril sprøjte med kanyle
English: • Difficulty in sleeping (insomnia)
Danish: • Søvnbesvær (insomni)
English: Ceplene maintenance therapy should be administered following completion of consolidation therapy in patients concomitantly treated with IL-2 under the supervision of a physician experienced in the management of acute myeloid leukaemia.
Danish: Vedligeholdelsesbehandling med Ceplene bør gennemføres efter afsluttet konsolideringsbehandling af patienter, som er under behandling med IL-2, under overvågning af en læge med erfaring i behandling af akut myeloid leukæmi.
English: For patients experiencing grade 2 (including cardiac function, renal, hepatic) toxicity - treatment should be discontinued until the event has returned to grade 1 - the time of injection of the dose of Ceplene should be extended to a maximum of 15 minutes.
Danish: Patienter, som oplever grad 2-toksicitet (inklusive kardial, renal, hepatisk funktion) - Behandling bør seponeres, indtil hændelsen er returneret til grad 1 - Injektionstiden for Ceplene bør udvides til maksimalt 15 minutter.
English: Ceplene is indicated for use in adults.
Danish: Ceplene er indiceret til voksne patienter.
English: Double check the vial label to make sure you are using the correct medicine.
Danish: Kontrollér hætteglasset en gang til for at sikre dig, at du anvender den rigtige medicin.
English: By inhibiting oxidase function and reducing ROS production, Ceplene protects IL-2-activated NK cells and T cells from oxygen free radical-induced inhibition and apoptosis.
Danish: Ved at hæmme oxidasefunktionen og nedsætte produktionen af ROS beskytter Ceplene de NK-celler og T-celler, som aktiveres af IL-2, mod hæmning og apoptose forårsaget af oxygenfrie radikaler.
English: Treatment should then be resumed at a 20% dose reduction for both Ceplene and IL-2.
Danish: Behandling bør derefter genoptages med 20 % dosisreduktion for både Ceplene og IL-2.
English: The adverse reactions considered at least possibly related to the treatment of low-dose IL-2 with Ceplene in AML studies (n=280 for the IL-2 and Ceplene treatment arm) are listed below by body system organ, class and frequency.
Danish: De bivirkninger, som anses for med rimelighed at kunne henføres til behandlingen med lave doser af IL-2 i kombination med Ceplene i AML-studierne (n=280 for IL-2 plus Ceplene-behandlingsgruppen), er anført nedenfor efter organklasse og hyppighed.
English: You will have to inject Ceplene and IL-2 twice a day by subcutaneous injection (in the layer of tissue just under the skin), according to the directions provided by your doctor.
Danish: Du skal injicere Ceplene og IL-2 to gange daglig ved subkutan injektion (i vævslaget lige under huden) efter de retningslinjer, du har fået af din læge.
English: - H1 blocking agents and neuroleptics (anti-psychotics) with H1 receptor blocking properties.
Danish: - H1-blokkere og neuroleptika (antipsykotika) med H1-receptorblokerende egenskaber.
English: • H2 blockers such as cimetidine, ranitidine, famotidine or nizatidine.
Danish: Det drejer sig om såkaldte H2-blokkere såsom cimetidin, ranitidin, famotidin eller nizatidin.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Danish: Natriumhydroxid (til pH-justering) Saltsyre (til pH-justering) Vand til injektionsvæsker
English: Thus, subjects with severe renal impairment may be more sensitive to the blood pressure lowering effects of exogenously administered histamine than subjects with normal renal function or subjects with mild or moderate renal impairment.
Danish: Personer med alvorlig nyreinsufficiens kan således være mere følsomme over for den blodtrykssænkende virkning af eksogent indgivet histamin end personer med normal nyrefunktion eller personer med mild eller moderat nyreinsufficiens.
English: Dilute IL-2 dispensed in capped polypropylene tuberculin syringes is to be prepared by the pharmacy in a controlled aseptic environment and stored in a refrigerator at 2°C - 8°C.
Danish: Fortyndet IL-2 dispenseret i polypropylen-tuberculinsprøjter med hætte skal fremstilles på apoteket under kontrollerede aseptiske forhold og opbevares i køleskab ved 2°C - 8°C.
English: Remove the plastic cap from the vial, exposing the stopper with the inner rubber circle.
Danish: Tag plastichætten af hætteglasset, så proppen med den indvendige gummicirkel kan ses.
English: If you have liver problems, talk to your doctor before using this medicine.
Danish: Hvis du har leverproblemer, så tal med din læge, før du tager denne medicin.
English: For cycles 1-3, each cycle consists of 3 weeks of treatment, followed by a 3-week treatment free period.
Danish: For cyklus 1-3 består hver cyklus af 3 ugers behandling efterfulgt af en 3-ugers behandlingsfri periode.
English: • Headache and dizziness
Danish: • Hovedpine og svimmelhed
English: The vials contain 0.70 mL of solution (including overfill) to facilitate the dose extraction of a single 0.5 mL dose.
Danish: Hætteglassene indeholder 0,70 ml opløsning (inklusiv overskud) for at lette udtagning af en enkelt 0,5 ml dosis.
English: The MAH shall provide yearly updates on any new information concerning efficacy and safety of the product in patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2).
Danish: Indehaveren af markedsføringstilladelsen skal give årlige opdateringer om eventuelle nye oplysninger om lægemidlets virkning og sikkerhed hos patienter med akut myeloid leukæmi i første remission, som er under behandling med interleukin-2 (IL-2).
English: Studies have shown chemical stability and sterility of diluted aldesleukin (dispensed in capped polypropylene tuberculin syringes) for up to three weeks when prepared in a controlled aseptic environment and stored under refrigeration at 2°C - 8°C.
Danish: Studier har vist, at fortyndet aldesleukin (dispenseret i polypropylen-tuberculinsprøjter med hætte) er kemisk stabilt og sterilt i op til 3 uger, hvis opløsningen er tilberedt i et kontrolleret aseptisk miljø og opbevares i køleskabet ved 2°C - 8°C.
English: Periodic Safety Update Reports
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: • Decrease in the number of red blood cells (anaemia)
Danish: • Fald i antallet af røde blodlegemer (anæmi)
English: For cycles 4-10, each cycle consists of 3 weeks of treatment, followed by a 6-week treatment free period.
Danish: For cyklus 4-10 består hver cyklus af 3 ugers behandling efterfulgt af en 6-ugers behandlingsfri periode.
English: For dosing instructions for Ceplene in combination with IL-2, see posology below.
Danish: Doseringsvejledningen for Ceplene i kombination med IL-2 fremgår nedenfor.
English: w.58
Danish: u.58
English: Week number (w)*
Danish: Ugenummer (u)*
English: Double check the syringe to make sure that you have withdrawn the correct amount.
Danish: Kontrollér sprøjten en ekstra gang for at sikre dig, at du har trukket den rette mængde op. 16.
English: IL-2 is injected twice daily as a subcutaneous injection (in the layer of tissue just under the skin) 1 to 3 minutes before the injection of Ceplene.
Danish: IL-2 injiceres to gange daglig som en subkutan injektion (i vævslaget lige under huden) 1 til 3 minutter før injektionen med Ceplene.
English: Ceplene should be administered 1 to 3 minutes after IL-2 administration, and not concomitantly.
Danish: Ceplene bør gives 1 til 3 minutter efter indgivelsen af IL-2 - og ikke samtidigt.
English: Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia (AML) in first remission concomitantly treated with interleukin-2 (IL-2).
Danish: Ceplene vedligeholdelsesbehandling er indiceret til voksne patienter med akut myeloid leukæmi i første remission, som er under behandling med interleukin-2 (IL-2).
English: -for grade 3 and 4 toxicity, treatment should be discontinued and not resumed until events have been resolved.
Danish: - Ved grad 3 til 4-toksicitet bør behandlingen seponeres og først genoptages, når hændelserne ikke længere forekommer.
English: Dispose of the syringe in the puncture-proof container as instructed.
Danish: Kassér kanylen i den sikre beholder til spidse genstande i henhold til de givne instrukser.
English: • The other ingredients are water for injections and sodium chloride, and it may also contain sodium hydroxide and/or hydrochloric acid for pH adjustment.
Danish: • Øvrige indholdsstoffer: vand til injektionsvæsker, natriumchlorid og eventuelt natriumhydroxid og/eller saltsyre for at justere pH-værdien.
English: - H2 blockers such as cimetidine, ranitidine, famotidine or nizatidine which are used to treat stomach ulcers, indigestion (dyspepsia) or heartburn.
Danish: - H2-blokkere såsom cimetidin, ranitidin, famotidin eller nizatidin, som anvendes til behandling af mavesår, fordøjelsesbesvær (dyspepsi) eller halsbrand.
English: While posology differs, when Ceplene is used in conjunction with IL-2, physicians should also refer to the Summary of Product Characteristics (SmPC) for IL-2 and observe the respective medicinal product interactions.
Danish: Da doseringen varierer, når Ceplene anvendes sammen med IL-2, bør lægerne også gøre sig bekendt med produktresuméet for IL-2 og de respektive lægemiddelinteraktioner, som er angivet heri.
English: Very common pain in extremity, back pain Common
Danish: Meget almindelig smerter i ekstremiteter, rygsmerter
English: to w.81
Danish: til u.81
English: - Monoamine oxidase inhibitors and anti-malarial and anti-trypanosomal agents.
Danish: - Monoaminoxidasehæmmere og malariamidler og antitrypanosomale midler.
English: The pharmacokinetics of histamine are similar in healthy volunteers with normal renal function compared to volunteers with mild, moderate, or severe renal impairment.
Danish: Farmakokinetikken for histamin hos raske frivillige med normal nyrefunktion svarer til den hos frivillige med mild, moderat eller svær nyreinsufficiens.
English: Administration of Ceplene can cause hypotension and may result in dizziness, light-headedness and blurred vision.
Danish: Anvendelsen af Ceplene kan forårsage hypotension og kan resultere i svimmelhed af forskellig grad og uklart syn.
English: PREPARATION FOR INJECTION OF CEPLENE
Danish: KLARGØRING TIL INJEKTION AF CEPLENE
English: • Decrease in the number of a certain type of white blood cells (neutropenia)
Danish: • Nedsat antal af en bestemt type hvide blodlegemer (neutropeni)
English: Use an alcohol wipe to clean it.
Danish: Brug en spritserviet til at rense huden.
English: w.31
Danish: u.31
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicine.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel, fordi det drejer sig om en sjælden sygdom.
English: • For the first 18 weeks: you will use IL-2 and Ceplene daily for 3 weeks, followed by a 3 week break (no treatment at all).
Danish: • I de første 18 uger skal du anvende IL-2 og Ceplene daglig i 3 uger efterfulgt af en 3 ugers pause
English: • Cough, difficulty in breathing (dyspnoea)
Danish: • Hoste, åndedrætsbesvær (dyspnø)
English: With the needle cover on, pull back the plunger and draw air into the syringe to the level (number of millilitres) instructed by your doctor.
Danish: Træk sprøjten tilbage, mens kanylehætten stadig sidder på, og træk luft ind i sprøjten op til det niveau (antal milliliter), du har fået besked på af din læge.
English: NOTE: The vial of Ceplene contains an overfill to facilitate the dose extraction of a single 0.5 mL dose.
Danish: BEMÆRK: Hætteglassene indeholder et overskud af opløsning (overfyldning) for at lette udtagning af en enkelt 0,5 ml dosis.
English: INSTRUCTIONS FOR SELF-INJECTION OF CEPLENE
Danish: VEJLEDNING I SELVINJEKTION AF CEPLENE
English: Nervous system disorders headache, dizziness, dysgeusia Very common
Danish: Nervesystemet hovedpine, svimmelhed, dysgeusi
English: Ceplene and IL-2 are not to be injected at the same time.
Danish: Ceplene og IL-2 må ikke injiceres samtidig.
English: Psychiatric disorders insomnia
Danish: Psykiske forstyrrelser insomni
English: to w.48
Danish: til u.48
English: They are used to treat stomach ulcers, indigestion (dyspepsia) or heartburn (see above “Do not use Ceplene”).
Danish: • Medicin, som anvendes til behandling af mavesår, fordøjelsesbesvær (dyspepsi) eller halsbrand (se ovenfor under “Tag ikke Ceplene”).
English: Ceplene must be injected 1 to 3 minutes after IL-2.
Danish: Ceplene skal injiceres 1 til 3 minutter efter IL-2.
English: • Tricyclic antidepressant medicines such as amitryptiline, imipramine, or monoamine oxidase inhibitors, such as phenelzine, isocarboxazide, tranylcypromine or moclobemide.
Danish: • Visse typer medicin mod depression: tricykliske antidepressiva, såsom amitryptilin, imipramin eller monoaminoxidase-hæmmere, såsom phenelzin, isocarboxazid, tranylcypromin eller moclobemid.
English: Skin and subcutaneous tissue disorders dry skin
Danish: Hud og subkutane væv tør hud
English: • Rapid heart beat (tachycardia)
Danish: • Hurtig puls (takykardi)
English: 1 prepared syringe containing Ceplene.
Danish: 1 klargjort sprøjte med Ceplene.
English: Do not use Ceplene after the expiry date which is stated on the carton and vial label.
Danish: Brug ikke Ceplene efter den udløbsdato, der står på æsken og hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: For the dose recommendations for these grade 1 toxicity events refer to the relevant sections below:
Danish: Se de relevante afsnit herunder vedrørende anbefalinger vedrørende disse hændelser af grad 1-toksicitet:
English: *Injection volume rounded up to the nearest 0.05 mL ** Injection volumes based on 20% reductions are rounded thus actual dose reductions vary from 15%-25%
Danish: Injektionsvoluminer baseret på 20 % reduktion er afrundet således, at den aktuelle dosisreduktion varierer mellem 15 % og 25 %.
English: Treatment should then be resumed using the full dose of Ceplene, but reducing the IL-2 dose by 20%.
Danish: Behandling bør derefter genoptages med fuld dosis Ceplene, men med 20 % reduktion af IL-2-dosis.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Danish: I de prækliniske studier blev der kun set virkninger efter doser, der i væsentlig grad overstiger den maksimale humane eksponering.
English: • Inflammation of the stomach (gastritis)
Danish: • Betændelse i maven (gastritis)
English: Investigations weight decreased
Danish: Investigations vægtreduktion
English: Apply gentle pressure with the alcohol wipe over the injection site without rubbing it. 14.
Danish: Tryk let på injektionsstedet med spritservietten uden at gnide.
English: Blood and lymphatic system disorders eosinophilia, thrombocytopenia Very common leucopenia, neutropenia
Danish: Blod- og lymfesystem eosinofili, trombocytopeni
English: Table 3: Administration chart for IL-2 (aldesleukin)
Danish: Tabel 3: Administrationsskema for IL-2 (aldesleukin)
English: • Bloating of the belly (abdominal distension)
Danish: • Opsvulmet mave (abdominal distension)
English: to w.66
Danish: til u.66
English: For Ceplene, no clinical data on exposed pregnancies are available.
Danish: Der foreligger ingen tilgængelige kliniske data om graviditeter eksponeret for Ceplene.
English: Vascular disorders flushing, hypotension
Danish: Vaskulære sygdomme rødmen, hypotension
English: • Certain anti-psychotics such as chlorpromazine, flupenthixol, thoridazine, clozapine and risperidone.
Danish: • Visse typer medicin, som anvendes til behandling af psykiske lidelser (antipsykotika) så som chlorpromazin, flupenthixol, thoridazin, clozapin og risperidon.
English: w.28
Danish: u.28
English: 12 Take the needle out of the vial.
Danish: Tag nålen ud af hætteglasset.
English: Psychiatric disorders anxiety
Danish: Psykiske forstyrrelser angst
English: Other medicines and Ceplene
Danish: Brug af anden medicin sammen med Ceplene
English: Patients should not drive or operate machines for at least 1 hour after receiving Ceplene.
Danish: Efter indgivelsen af Ceplene bør patienten vente i mindst en time, inden han / hun fører motorkøretøj eller betjener maskiner.
English: Ceplene is administered 1 to 3 minutes after each injection of IL-2.
Danish: Ceplene gives 1 til 3 minutter efter hver injektion af IL-2.
English: Adverse reactions were reported to be at least possibly related to IL-2 and Ceplene treatment in almost all patients in studies in AML.
Danish: Der er indberettet bivirkninger, som med rimelighed kan henføres til behandling med IL-2 og Ceplene for næsten alle patienter i studier af akut myeloid leukæmi (AML).
English: - Tricyclic anti-depressants that may have H1 and H2 receptor blocking properties.
Danish: - Tricykliske antidepressiver, som kan have H1-og H2-receptorblokerende egenskaber.
English: If you have kidney problems, talk to your doctor before using this medicine.
Danish: Hvis du har nyreproblemer, så tal med din læge, før du tager denne medicin.
English: Treatment can be resumed by administering Ceplene at the full dose and IL-2 at 50%.
Danish: Behandlingen kan genoptages med en fuld dosis Ceplene og en 50 % IL-2-dosis.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apoteket, hvis du anvender anden medicin eller har anvendt det for nylig.
English: Place the syringe on a clean flat surface.
Danish: Anbring sprøjten på en ren, plan flade.
English: to w.21
Danish: til u.21
English: Ceplene 0.5 mg/0.5 mL solution for injection
Danish: Ceplene 0,5 mg/0,5 ml til injektionsvæske, opløsning
English: Figure 1
Danish: Figur 1
English: • If you are breast-feeding.
Danish: • Hvis du ammer.
English: Inspect each vial visually for particulate matter and discolouration prior to administration.
Danish: Kontroller visuelt hvert hætteglas for partikler og misfarvning inden indgivelse.
English: Ceplene and IL-2 must not be injected into the same region.
Danish: Ceplene og IL-2 må ikke injiceres i samme område.
English: • Decrease in the number of white blood cells (leucopenia)
Danish: • Nedsat antal hvide blodlegemer (leukopeni)
English: • Hives, bruising, rash and swelling at the injection site, weakness (asthenia) and chest pain
Danish: • Nældefeber, blå mærker, udslæt og hævelse på injektionsstedet, svækkelse (asteni) og brystsmerter
English: - for cardiac, hepatic or renal toxicities the dose should be reduced by 20% for both Ceplene and IL-2.
Danish: - Ved kardial, hepatisk eller renal toksicitet bør dosis reduceres med 20 % for både
English: Special populations
Danish: Specielle patientpopulationer
English: w.76
Danish: u.76
English: Inject IL-2 as you have been instructed.
Danish: Injicér IL-2 i henhold til vejledningen.
English: to w.75
Danish: til u.75
English: See Figure 1.
Danish: Se Figur 1.