FrancophonIA/ELRC3.0 huggingface dataset:
English: • a history of auto-immune disease (a disease where the immune system attacks the body's own cells or tissues, such as systemic lupus, rheumatoid arthritis, inflammatory bowel disease or psoriasis).
Danish: • slagtilfælde, forsnævring af arterierne (systemisk perifer arteriel sygdom), hjertesygdom (for alvorlige hjerteproblemer, se ovenfor under “Tag ikke Ceplene”), tidligere autoimmun sygdom (en sygdom, hvor immunsystemet angriber kroppens egne celler eller væv, såsom systemisk lupus, rheumatoid artritis, inflammatorisk tarmsygdom eller psoriasis).
English: w.49
Danish: u.49
English: to w.39
Danish: til u.39
English: w.46
Danish: u.46
English: w.73
Danish: u.73
English: to w.63
Danish: til u.63
English: See Figure 2.
Danish: Se Figur 2.
English: w.67
Danish: u.67
English: 6.6 Special precaution for disposal and other handling
Danish: 6.6 Særlige regler for bortskaffelse
English: Figure 5
Danish: Figur 5
English: Gastrointestinal disorders nausea, dyspepsia, diarrhoea Very common vomiting, abdominal pain upper, dry mouth, gastritis, abdominal distention
Danish: Meget almindelig opkastning, mavesmerter, mundtørhed, gastritis, abdominal distension
English: Slightly pull back the plunger.
Danish: Træk stemplet let tilbage.
English: w.40
Danish: u.40
English: to w.54
Danish: til u.54
English: Figure 2
Danish: Figur 2
English: See Figure 6.
Danish: Se Figur 6.
English: to w.72
Danish: til u.72
English: Dispensing instructions for IL-2 (aldesleukin)
Danish: Dispenseringsvejledning for IL-2 (aldesleukin)
English: The solution should be visually inspected for particulate matter and discolouration prior to administration.
Danish: Inden indgivelsen skal opløsningen kontrolleres visuelt for partikler og misfarvning.
English: to w.45
Danish: til u.45
English: Cardiac disorders tachycardia
Danish: Hjerte takykardi
English: Ceplene in conjunction with IL-2 must not be used during pregnancy.
Danish: Ceplene i kombination med IL-2 må ikke anvendes under graviditet.
English: w.37
Danish: u.37
English: • Anxiety
Danish: • Angst
English: The mechanism by which Ceplene improves the anti-leukaemic function of lymphocytes in AML is not completely established; it is considered to be by inhibition of reactive oxygen species (ROS or ‘oxygen free radicals'), which are synthesised by monocytes/macrophages and granulocytes.
Danish: Det anses for sandsynligt, at det sker ved inhibering af reaktive oxygenarter (ROS eller “oxygen-frie radikaler”), som syntesiseres af monocytter/makrofager og granulocytter.
English: Tricyclic anti-depressants may have H1 and H2 receptor blocking properties and should be avoided.
Danish: -Tricykliske antidepressiver, som kan have H1- og H2-receptorblokerende egenskaber, bør undgås.
English: • Sensation of spinning (vertigo)
Danish: • Følelse af, at “det hele kører rundt” (vertigo)
English: • Inflamed granulated skin at the injection site, fatigue, fever (pyrexia), injection site redness,
Danish: • Betændt, ru hud på injektionsstedet, træthed, feber (pyreksi), rødme på injektionsstedet,
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne (se pkt.
English: Pull the needle cover straight off. With the vial standing on a flat surface, insert the needle straight through the rubber stopper into the vial.
Danish: Stil hætteglasset på en plan flade og stik kanylen lige gennem gummiproppen og ned i hætteglasset.
English: to w.36
Danish: til u.36
English: The diluted IL-2 (aldesleukin) is aseptically drawn up into sterile polypropylene tuberculin syringes and capped for each patient at 1 µg/kg dose, with a minimum standard dosage volume of 0.25 mL (50 µg) and a maximum dose of 0.5 mL (100 µg).
Danish: Doseringen til den enkelte patient er 1 μg/kg med et minimums-standarddoseringsvolumen på 0,25 ml (50 μg) og en maksimal dosis på 0,5 ml (100 μg).
English: • Tingling, prickling or numbness of the skin (paraesthesia)
Danish: • Sovende, prikkende fornemmelse eller følelsesløshed i huden (paræstesi)
English: Therefore, the treatment with Ceplene and IL-2 must not be used during pregnancy.
Danish: Derfor må der ikke behandles med Ceplene og IL-2 under graviditet.
English: Figure 7
Danish: Figur 7
English: One vial contains 0.5 mg histamine dihydrochloride in 0.5 mL solution.
Danish: Et hætteglas indeholder 0,5 mg histamindihydrochlorid i 0,5 ml opløsning.
English: Ceplene 0.5 mg/0.5 mL solution for injection histamine dihydrochloride
Danish: Ceplene 0,5 mg/0,5 ml injektionsvæske, opløsning histamindihydrochlorid
English: See Figure 3.
Danish: Se Figur 3.
English: A puncture-proof container so you can dispose of used syringes safely.
Danish: En sikker beholder til bortskaffelse af dine spidse, brugte kanyler.
English: Respiratory, thoracic, and mediastinal disorders cough, dyspnoea
Danish: Luftveje, thorax og mediastinum hoste, dyspnø
English: Withdraw and discard the syringe as instructed.
Danish: Træk kanylen ud og kassér den som anvist.
English: How to take Ceplene
Danish: Sådan skal du tage Ceplene
English: to w.27
Danish: til u.27
English: Gastrointestinal disorders constipation, abdominal distention, stomatitis
Danish: Mave-tarm-kanalen konstipation, abdominal udspilning, stomatitis
English: Do not try to inject yourself unless a qualified professional has trained you.
Danish: Forsøg ikke at give dig selv injektioner, medmindre du har fået særlig instruktion i det af en læge eller sygeplejerske.
English: Figure 4
Danish: Figur 4
English: Clear, colourless aqueous solution.
Danish: Klar, farveløs, vandig opløsning.
English: Figure 6
Danish: Figur 6
English: Figure 3
Danish: Figur 3
English: Respiratory, thoracic, and mediastinal disorders wheezing
Danish: Luftveje, thorax og mediastinum hvæsende vejrtrækning
English: • Any treatment for high blood pressure (for example thiazide diuretics [bendrofluazide], ACE inhibitors [captopril], calcium antagonists [nifedipine] and alpha-blockers [prazosin]).
Danish: • Betablokkere, såsom propranolol, metoprolol, atenolol mod angina og hjertefunktionsproblemer eller behandling af forhøjet blodtryk (for eksempel thiazid-diuretika (bendrofluazid), ACE-hæmmere (captopril), calciumantagonister (nifedipin) og alfa-blokkere (prazosin).
English: One vial of 0.5 mL of solution contains 0.5 mg histamine dihydrochloride.
Danish: Et hætteglas med 0,5 ml opløsning indeholder 0,5 mg histamindihydrochlorid.
English: • Vomiting, pain in the upper belly (abdominal pain) and dry mouth
Danish: • Opkastning, smerter i øverste del af maven og mundtørhed
English: Replace the cover on the needle.
Danish: Sæt hætten på kanylen igen.
English: • During breast feeding.
Danish: • Under amning.
English: Outer carton
Danish: Ydre æske
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Spørg din læge eller dit apotek, hvis du har yderligere spørgsmål vedrørende anvendelsen af dette lægemiddel.
English: Dose modification
Danish: Dosisjustering
English: For instructions on the initial reconstitution and subsequent dilution to 200 µg/mL of Interleukin-2 (aldesleukin) before administration, see commercially available IL-2 SmPC.
Danish: Se produktresumé for kommercielt tilgængeligt IL-2 for instruktioner angående initiel rekonstitution og efterfølgende fortynding til 200 μg/mL af Interleukin-2 (aldesleukin) før administration.
English: • Wheezing
Danish: • Vægttab
English: • Infections of the upper breathing (respiratory) tract
Danish: • Infektion i de øvre luftveje
English: 10 Holding both the vial and the syringe, turn the vial upside down.
Danish: 10. Hold fast i både hætteglas og sprøjte og vend hætteglasset om.
English: General disorders and administration site conditions injection site granuloma, fatigue, pyrexia, injection site erythema, feeling hot, injection site reaction, injection site pruritus, influenza like illness, chills, injection site inflammation, injection site pain
Danish: Meget almindelig injektionsstedet, følelse af varme, reaktion på injektionsstedet, pruritus på injektionsstedet, influenzalignende sygdom, kulderystelser, inflammation på injektionsstedet, smerter på injektionsstedet urticaria på injektionsstedet, blå mærker på injektionsstedet, udslæt på injektionsstedet, hævelse på injektionsstedet, asteni, brystsmerter
English: Skin and subcutaneous tissue disorders rash
Danish: Hud og subkutane væv udslæt
English: feeling hot, injection site reaction, itching at the injection site, flu-like symptoms, shivering
Danish: varmefølelse, reaktion på injektionsstedet, kløe på injektionsstedet, influenza-lignende symptomer, rystelser (kuldegysninger), betændelse og smerter på injektionsstedet.
English: The twice daily dosing of IL-2 and Ceplene should be separated by a minimum of 6 hours.
Danish: Der bør være mindst 6 timer mellem de to daglige doser af IL-2 og Ceplene.
English: Musculoskeletal and connective tissue disorders arthralgia, myalgia
Danish: Knogler, led, muskler og bindevæv artralgi, myalgi
English: Therefore Ceplene and IL-2 must not be used during breast-feeding.
Danish: Derfor må Ceplene og IL-2 ikke anvendes under amning.
English: Medicines must not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: -for grade 1 to 3 toxicity, treatment should be discontinued until grade 0 toxicity event has been achieved.
Danish: Patienter, der oplever grad 1-neurologisk toksicitet - Ved grad 1 til 3-toksicitet bør behandlingen seponeres, indtil toksiciteten er reduceret til grad 0.
English: It has been noted that neuromuscular blocking agents, narcotic analgesics, and various contrast media can induce the release of endogenous histamine; therefore in patients undergoing diagnostic or surgical procedures, the additive effect of Ceplene treatment should be considered prior to the procedure (see section 4.4).
Danish: Det er bemærket, at neuromuskulære blokkere, narkotiske analgetika og forskellige kontraststoffer kan forårsage frigørelse af endogent histamin.
English: IL-2 is administered twice daily as a subcutaneous injection 1 to 3 minutes prior to the administration of Ceplene; each dose of IL-2 is 16,400 IU/kg (1 µg/kg).
Danish: IL-2 administreres 2 gange dagligt som en subkutan injektion 1-3 minutter inden administration af Ceplene.
English: • Feeling your own heart beat (palpitations)
Danish: • Hjertebanken (palpitationer)
English: Date of first authorisation: Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 07/10/2008 Dato for seneste fornyelse: 26/08/2013
English: If you use more Ceplene than you should
Danish: Hvis du har taget for meget Ceplene
English: Ceplene in conjunction with IL-2 must not be used during breast-feeding.
Danish: Ceplene i kombination med IL-2 må ikke anvendes under amning.
English: Nervous system disorders paraesthesia
Danish: Nervesystemet paræstesi
English: • This medicine has been prescribed for you only.
Danish: • Lægen har ordineret Ceplene til dig personligt.
English: • If you have further questions, please ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apoteket.
English: • Inflammation of the lung (pneumonia)
Danish: • Lungebetændelse
English: • Nasal congestion
Danish: • Tilstoppet næse
English: • Hot flushes
Danish: • Hvæsende vejrtrækning
English: Place the pre-prepared syringes containing IL-2, Ceplene and an opened alcohol wipe where you can reach them.
Danish: Anbring dernæst de klargjorte sprøjter med IL-2, Ceplene og en åbnet spritserviet på et sted, hvor du kan nå dem. Af hensyn til din sikkerhed er det meget vigtigt, at du sidder, så du kan læne dig tilbage eller ligger fladt, når du foretager injektionerne.
English: What Ceplene is and what it is used for What you need to know before you use Ceplene How to use Ceplene
Danish: Det skal du vide, før du begynder at tage Ceplene Sådan skal du tage Ceplene Bivirkninger
English: Very common nasal congestion
Danish: Meget almindelig tilstoppet næse
English: • heart disease (for severe heart problems see above “Do not use Ceplene”),
Danish: (se ovenfor under “Tag ikke Ceplene”).
English: • Rash
Danish: • Rødmen
English: Very common injection site fibrosis, pain
Danish: Almene symptomer og reaktioner på injektionsstedet utilpashed, perifert ødem Meget almindelig fibrose omkring injektionsstedet, smerter
English: Ceplene and IL-2 doses should be separated by 60 minutes, which should be maintained throughout treatment.
Danish: Der skal gå 60 minutter mellem indgivelsen af Ceplenedosen og IL-2-dosen.
English: Do not drive or use machines within one hour after receiving a Ceplene injection as it may reduce blood pressure causing dizziness, light-headedness and blurred vision.
Danish: Årsagen er, at Ceplene-injektionen kan nedsætte blodtrykket og give svimmelhed i forskellige grader og uskarpt syn, hvilket kan påvirke din evne til at køre bil og betjene maskiner.
English: Injecting Ceplene yourself
Danish: Selvinjektion af Ceplene
English: In addition, a number of typographical and QRD-related changes were made.
Danish: Desuden blev der foretaget en række typografiske og QRD-relaterede ændringer.
English: The renin-angiotensin system (RAS) is a hormone system that regulates blood pressure and fluid balance.
Danish: Renin-angiotensinsystemet (RAS) er et hormonsystem, der regulerer blodtrykket og væskebalancen.
English: Corresponding changes were made, where relevant, to the currently approved product information.
Danish: Der blev foretaget tilsvarende ændringer i de nuværende godkendte produktoplysninger i det omfang, det var relevant.
English: Changes were made to the heart failure indication in section 4.4 for candesartan-containing products and in sections 4.2 and 4.4 for valsartan-containing products, in order to further harmonise the wording for the two substances.
Danish: Der blev foretaget ændringer af indikationen hjerteinsufficiens i punkt 4.4 for produkter indeholdende candesartan og i punkt 4.2 og 4.4 for produkter indeholdende valsartan med henblik på yderligere harmonisering af ordlyden for de to stoffer.
English: In particular the contraindication statements recommended by the PRAC were deleted from sections 5.1 (where proposed) and from section 4.4 for aliskiren, as these were already proposed in section 4.3 and therefore considered redundant.
Danish: Herunder blev de kontraindikationer, der var anbefalet af PRAC, slettet fra punkt 5.1 (den foreslåede placering) og fra punkt 4.4 for aliskiren, da disse allerede blev foreslået i punkt 4.3 og derfor fandtes overflødige.
English: However, the CHMP considered that minor additional changes were necessary to the wording proposed for the Summary of Product Characteristics.
Danish: CHMP fandt dog, at der behøves supplerende mindre ændringer af den foreslåede ordlyd til produktresuméet.
English: This is of particular concern, as
Danish: Ud fra følgende betragtninger:
English: RAS-acting agents include angiotensin-converting enzyme inhibitors (ACEinhibitors) such as benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril), angiotensin receptor blockers (ARBs) such as candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan and azilsartan and direct renin inhibitors such as aliskiren.
Danish: RAS-aktive stoffer omfatter angiotensinkonverteringsenzymhæmmere (ACE-hæmmere) såsom benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril og zofenopril), angiotensinreceptorantagonister (ARB) såsom candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan og azilsartan samt direkte reninhæmmere såsom aliskiren.
English: 1 - Overall summary of the scientific evaluation by PRAC
Danish: 1 - Samlet resumé af PRAC's videnskabelige vurdering
English: The PRAC therefore concluded that the product information of all RAS-acting agents should be revised to reflect the identified risks and provide guidance to prescribers and patients.
Danish: PRAC konkluderede derfor, at produktinformationen for alle RASaktive stoffer burde revideres i henhold til de konstaterede risici og burde indeholde vejledning til ordinerende læger og patienter.
English: It was noted that the Committee for Medicinal Products for Human Use (CHMP) had already conducted a review2 under Article 20 of Regulation (EC) No 726/2004 for aliskiren-containing products, concluding that these products should be contraindicated in patients with diabetes mellitus or moderate to severe renal impairment who take ACE-inhibitors or ARBs.
Danish: Det bemærkedes, at Udvalget for Lægemidler til Mennesker (CHMP) i forvejen havde foretaget en gennemgang2 i henhold til artikel 20 i forordning (EF) nr. 726/2004 af produkter indeholdende aliskiren, og herunder havde konkluderet, at disse produkter burde være kontraindiceret hos patienter, der har diabetes mellitus eller moderat til svær nyrefunktionsnedsættelse og er i behandling med ACE-hæmmere eller ARB.
English: these patients and patients with renal impaired are already particularly prone to developing hyperkalaemia.
Danish: Dette er særlig betænkeligt, fordi disse patienter og patienter med nedsat nyrefunktion i forvejen har tendens til hyperkaliæmi.
English: Having considered the matter, the PRAC therefore recommended the variation of the marketing authorisations for RAS-acting agents.
Danish: Efter gennemgang af sagen anbefalede PRAC derfor ændring af markedsføringstilladelserne for RAS-aktive midler.
English: In addition, the meta-analysis suggested that using multiple RAS-acting agents may not be more beneficial than using a single RAS-acting agent in terms of reducing overall mortality.
Danish: Desuden tyder metaanalyser på, at brug af flere RAS-aktive stoffer ikke nødvendigvis har fordele fremfor brug af et enkelt RAS-aktivt stof hvad angår reduktion af den samlede dødelighed.
English: Treatment should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Danish: Behandlingen bør kun finde sted under opsyn af speciallæge og hyppig tæt overvågning af nyrefunktion, elektrolytter og blodtryk.
English: However, new data has emerged in the past years, raising doubts over the efficacy and identifying safety concerns associated with dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren.
Danish: I de senere år er der imidlertid kommet nye oplysninger, der rejser tvivl om virkningen og viser sikkerhedsproblemer ved dobbelt RAS-blokering gennem kombineret brug af ACE-hæmmere og ARB eller aliskiren.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC initiated by Italy following the emergence of new evidence on the efficacy and safety of dual RAS blockade therapy through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren, to determine whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure;
Danish: • PRAC behandlede proceduren i henhold til artikel 31 i direktiv 2001/83/EF, der var indledt af Italien på foranledning af ny evidens om virkningen og sikkerheden af dobbelt RAS-blokering gennem kombineret anvendelse af ACE-hæmmere, angiotensin II-receptorantagonister eller aliskiren med henblik på at fastslå, om der burde foretages regulerende indgreb over for markedsføringstilladelserne for de produkter, der er omfattet af denne procedure,
English: The PRAC considered that the overall available data strongly suggests that the concerns identified with regard to safety and the lack of efficacy are a class effect and therefore considered that the conclusions of the review apply to all the active substances involved in the procedure.
Danish: PRAC fandt, at de foreliggende data som helhed tyder på, at de fundne sikkerhedsmæssige problemer og den manglende virkning er en klassevirkning, og at konklusionerne af gennemgangen derfor gælder for alle de aktive stoffer omfattet af proceduren.
English: The PRAC however clearly specified, based on data from the ONTARGET3 and VA NEPHRON-D4 studies that ACE-inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy.
Danish: PRAC præciserede på grundlag af data fra ONTARGET-3 og NEPHRON-D4-undersøgelserne, at ACE-hæmmere og ARB ikke bør anvendes i kombination hos patienter med diabetisk nefropati.
English: The CHMP, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and is of the opinion that the marketing authorisations for RAS-acting agents should be varied.
Danish: Efter gennemgang af PRAC's anbefaling tilsluttede CHMP sig PRAC's overordnede videnskabelige konklusioner og er af den opfattelse, at markedsføringstilladelserne for RAS-aktive midler bør ændres.
English: The PRAC was also of the opinion that the contraindication based on the ALTITUDE5 study data regarding the concomitant use of ACE-inhibitors or ARBs with aliskiren-containing products in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) was confirmed by the additional data reviewed and that it should also be implemented in the product information of ARBs and ACE-inhibitors.
Danish: PRAC var endvidere af den opfattelse, at de gennemgåede yderligere data bekræftede den kontraindikation, der byggede på ALTITUDE5-undersøgelsens data om anvendelse af ACE-hæmmere eller ARB sammen med aliskiren hos patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) < 60 ml/min/1,73 m2), og at den også burde indgå i produktinformationen for ARB og ACE-hæmmere.
English: The concept of dual RAS blockade through the combined use of several RAS-acting agents, emerged in the late 1990's based on an experimental model hypothesising that the combined use of an ARB, an ACE-inhibitor or aliskiren could provide a more complete blockade of the RAS which could translate into better control of blood pressure and nephroprotective and cardioprotective effects.
Danish: Konceptet dobbelt RAS-blokering gennem kombineret anvendelse af flere RAS-aktive stoffer blev lanceret sidst i 1990'erne på grundlag af en forsøgsmodel og en hypotese om, at kombineret brug af en ARB og en ACE-hæmmer eller aliskiren kunne give en mere fuldstændig hæmning af RAS, resulterende i bedre blodtrykskontrol og nefrobeskyttende og kardiobeskyttende virkning.
English: A warning was introduced to state that dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren is not recommended and, if considered absolutely necessary, should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Danish: Der blev indsat en advarsel om, at behandling med dobbelt RASblokering gennem kombineret brug af ACE-hæmmere og ARB eller aliskiren frarådes og, hvis den anses for ubetinget nødvendig, kun må ske under opsyn af speciallæge og hyppig tæt overvågning af nyrefunktion, elektrolytter og blodtryk.
English: Scientific conclusions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra PRAC's anbefaling
English: The PRAC reviewed the totality of the available data, including clinical trials, meta-analysis and publications, the MAHs' responses as well as the report from the Scientific Advisory Group in Cardiovascular Issues (SAG CVS).
Danish: PRAC gennemgik alle foreliggende data, herunder kliniske undersøgelser, metaanalyser og publikationer, besvarelserne fra markedsføringstilladelsesindehaveren samt rapporten fra den videnskabelige rådgivende gruppe vedrørende kardiovaskulære spørgsmål (SAG CVS).