FrancophonIA/ELRC3.0 huggingface dataset:
English: WABOSAN
Danish: Funchal
English: Amdipharm Ltd. 3, Burlington Road, Temple Chambers, Dublin 4
Danish: 3, Burlington Road, Temple Chambers, Dublin 4
English: Solution
Danish: Styrke
English: Teofarma srl Via Fratelli Cervi, 8 27010 Valle Salimbene Pavia
Danish: 27010 Valle Salimbene
English: EU number
Danish: EU Nummer
English: Pharmaceutical Form Route of administration
Danish: Lægemiddel form
English: Packaging Content
Danish: Emballage
English: Strength
Danish: Indhold
English: 3750 U
Danish: 3.750 E
English: Powder for solution for injection/infusion
Danish: Pulver til injektions-/ infusionsvæske, opløsning
English: Cimzia received a marketing authorisation valid throughout the EU on 1 October 2009.
Danish: Cimzia fik en markedsføringstilladelse med gyldighed i hele EU den 1. oktober 2009.
English: Further information on Cimzia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/cimzia.
Danish: Yderligere information om Cimzia findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/cimzia.
English: Similar results were seen in a study with patients who had not adequately responded to other medicines such as methotrexate.
Danish: Lignende resultater sås i et studie med patienter, der ikke havde responderet tilstrækkeligt på andre lægemidler som f.eks. methotrexat.
English: However, the dose of Cimzia used in this study was higher than the usual dose.
Danish: Den dosis Cimzia, der blev anvendt i dette studie, var dog højere end den sædvanlige dosis.
English: These packs will include information on the safety of the medicine.
Danish: Informationsmaterialet vil indeholde oplysninger om lægemidlets sikkerhed.
English: Patients will be given a reminder card with safety information that they should carry with them.
Danish: Patienterne får udleveret et særligt påmindelseskort med sikkerhedsoplysninger, som de bør bære på sig.
English: Other information about Cimzia
Danish: Andre oplysninger om Cimzia
English: Cimzia is a medicine that is used in adults to treat the following diseases:
Danish: Cimzia er et lægemiddel, der anvendes hos voksne til behandling af følgende sygdomme:
English: The most common side effects with Cimzia (affecting up to 1 in 10 people) are bacterial infections including abscesses (a swollen area where pus has collected), viral infections (including herpes, papillomavirus and influenza), eosinophilic disorders (disorders of eosinophils, a type of white blood cell), leucopenia (low white blood cell counts), nausea (feeling sick), headaches (including migraine), sensory abnormalities (such as numbness, tingling and burning sensation), high blood pressure, hepatitis (liver inflammation) including increased levels of liver enzymes, rash, fever, pain, weakness, itching and reactions at the injection site.
Danish: De hyppigste bivirkninger ved Cimzia (som kan forekomme hos op til 1 ud af 10 personer) er bakterieinfektioner, herunder bylder (hævet område med pusansamling), virusinfektioner (herunder herpes, papillomavirus og influenza), eosinofili (lidelser i forbindelse med eosinofiler, som er en type hvide blodlegemer), leukopeni (lavt antal hvide blodlegemer), kvalme, hovedpine (herunder migræne), føleforstyrrelser (såsom følelsesløshed, prikken og en brændende fornemmelse), højt blodtryk, hepatitis (leverbetændelse), herunder forhøjede leverenzymniveauer, udslæt, feber, smerter, kraftesløshed, kløe og reaktioner på injektionsstedet.
English: What measures are being taken to ensure the safe and effective use of Cimzia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cimzia?
English: As for all medicines, data on the use of Cimzia are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Cimzia løbende overvåget.
English: A monoclonal antibody is a protein that has been designed to recognise and attach to a specific structure in the body.
Danish: Et monoklonalt antistof er et protein, der er opbygget, så det genkender og binder sig til en specifik struktur i kroppen.
English: Cimzia must not be used in patients with active tuberculosis, other severe infections, or moderate to severe heart failure (inability of the heart to pump enough blood around the body).
Danish: Cimzia må ikke anvendes til patienter med aktiv tuberkulose, andre svære infektioner eller moderat til svær hjerteinsufficiens (hjertets manglende evne til at pumpe tilstrækkeligt blod rundt i kroppen).
English: The European Medicines Agency decided that Cimzia's benefits are greater than its risks and that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Cimzia opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Nine main studies involving over 3,000 patients have found Cimzia effective for reducing symptoms of inflammatory conditions.
Danish: Ni hovedstudier med deltagelse af flere end 3.000 patienter har vist, at Cimzia er effektivt til at reducere symptomerne på betændelsestilstande.
English: Cimzia is mostly used for conditions that are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Danish: Cimzia bruges oftest, når tilstanden er svær eller moderat svær eller forværres, eller når patienterne ikke kan få andre behandlinger.
English: Side effects reported with Cimzia are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Cimzia vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: A third study compared Cimzia with placebo as well as another medicine called etanercept.
Danish: I et tredje studie blev Cimzia sammenlignet med placebo samt et andet lægemiddel, der kaldes etanercept.
English: The studies included adults with active rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and moderate to severe plaque psoriasis:
Danish: Studierne omfattede voksne med aktiv reumatoid artritis, aksial spondyloartritis, psoriasisartritis og moderat til svær plaque psoriasis:
English: Treatment starts with a 400-mg dose given as two injections, followed by a further 400-mg dose 2 and 4 weeks later.
Danish: Behandlingen starter med en dosis på 400 mg, der gives som to injektioner, efterfulgt af endnu en dosis på 400 mg to og fire uger senere.
English: Why is Cimzia authorised in the EU?
Danish: Hvorfor er Cimzia godkendt i EU?
English: An overview of Cimzia and why it is authorised in the EU
Danish: En oversigt over Cimzia, og hvorfor det er godkendt i EU
English: Pegylation decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.
Danish: Pegylering bevirker, at stoffet udskilles langsommere af kroppen, så medicinen ikke skal gives så ofte.
English: What is Cimzia and what is it used for?
Danish: Hvad er Cimzia, og hvad anvendes det til?
English: The company that markets Cimzia will provide educational packs for doctors who will prescribe Cimzia.
Danish: Den virksomhed, der markedsfører Cimzia, vil udlevere informationsmateriale til læger, som ordinerer Cimzia.
English: For more information about using Cimzia, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Cimzia, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: What are the risks associated with Cimzia?
Danish: Hvilke risici er der forbundet med Cimzia?
English: Also, X-rays showed that joint damage worsened to a lesser extent in patients who received Cimzia.
Danish: Endvidere viste røntgenundersøgelser, at ledskader forværredes i mindre grad hos patienter, der fik Cimzia.
English: After this, depending on the condition being treated, patients should continue with 200 mg or 400 mg, given as one or two injections every 2 or 4 weeks.
Danish: Afhængigt af den tilstand, der behandles, bør patienterne derefter fortsætte med 200 mg eller 400 mg givet som én eller to injektioner hver 2. eller 4. uge.
English: Cimzia can only be obtained with a prescription and treatment should only be started by a specialist doctor who has experience in diagnosing and treating the diseases that Cimzia is used to treat.
Danish: Cimzia fås kun på recept, og behandlingen bør kun iværksættes af en speciallæge med erfaring i diagnosticering og behandling af de sygdomme, som Cimzia anvendes mod.
English: Cimzia contains the active substance certolizumab pegol.
Danish: Cimzia indeholder det aktive stof certolizumab pegol.
English: The main measure of effectiveness was the number of patients who responded to treatment after 16 weeks, meaning that symptom scores improved by 75% or more.
Danish: Virkningen blev hovedsageligt bedømt på antallet af patienter, som reagerede på behandlingen efter 16 uger, dvs. hvis symptomscore forbedredes med mindst 75 %.
English: By blocking TNF-alpha, certolizumab pegol reduces inflammation and other symptoms of the diseases.
Danish: Ved at blokere TNF-alfa mindsker certolizumab pegol betændelsen og andre symptomer på sygdommene.
English: It is made up of a monoclonal antibody, certolizumab, which has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: Det består af et monoklonalt antistof, certolizumab, som er blevet "pegyleret" (forbundet med et kemisk stof, der kaldes polyethylenglycol).
English: In patients with active rheumatoid arthritis who had never received DMARDs, treatment with Cimzia led to sustained remission (no detectable disease activity) after 52 weeks of treatment.
Danish: Hos patienter med aktiv reumatoid artritis, der ikke tidligere var blevet behandlet med DMARD'er, medførte behandling med Cimzia vedvarende remission (ingen påviselig sygdomsaktivitet) efter 52 ugers behandling.
English: The active substance in Cimzia, certolizumab pegol, reduces the activity of the immune system (the body's defences).
Danish: Det aktive stof i Cimzia, certolizumab pegol, hæmmer immunsystemets aktivitet (kroppens naturlige forsvar).
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Cimzia is used for.
Danish: Dette signalstof er en medvirkende årsag til betændelse og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Cimzia.
English: • In the treatment of moderate to severe plaque psoriasis, Cimzia was compared with placebo in two main studies.
Danish: • Med hensyn til behandling af patienter med moderat til svær plaque psoriasis blev Cimzia sammenlignet med placebo i to hovedstudier.
English: Certolizumab pegol has been designed to attach to a messenger protein in the body called tumour necrosis factor alpha (TNF-alpha).
Danish: Certolizumab pegol er opbygget, så det binder sig til et af kroppens signalproteiner, der kaldes tumornekrosefaktor-alpha (TNF-alpha).
English: For patients receiving Cimzia 400 mg every four weeks 52% saw an improvement.
Danish: I gruppen af patienter, der fik 400 mg Cimzia hver 4. uge, oplevede 52 % en bedring.
English: In a study in 879 patients who had never received DMARDs, treatment with Cimzia and methotrexate led to remission in almost 29% of patients (189 out of 655), compared with 15% (32 out of 213) of patients receiving placebo with methotrexate.
Danish: I et studie med 879 patienter, der ikke tidligere var blevet behandlet med DMARD'er, medførte behandling med Cimzia og methotrexat remission hos næsten 29 % af patienterne (189 ud af 655) sammenholdt med 15 % (32 ud af 213) af de patienter, der fik placebo sammen med methotrexat.
English: • plaque psoriasis, a disease causing red, scaly patches on the skin.
Danish: • plaque psoriasis, en sygdom, der forårsager røde, skællende hudområder
English: • active rheumatoid arthritis (a disease causing inflammation of the joints) when it is used in combination with another medicine, methotrexate, or given alone when treatment with
Danish: • aktiv reumatoid artritis (en sygdom, som forårsager betændelse i leddene), når det gives i kombination med et andet lægemiddel, methotrexat, eller gives alene, når behandling med methotrexat ikke er hensigtsmæssig.
English: Treatment with Cimzia 200 mg every two weeks in the two studies led to 66.5% and 52.6% of patients responding compared with 6.5% and 4.5% of patients receiving placebo.
Danish: Ved behandling med 200 mg Cimzia hver 2. uge i de to studier opnåede hhv. 66,5 % og 52,6 % af patienterne en bedring sammenholdt med hhv. 6,5 % og 4,5 % af de patienter, der fik placebo.
English: For the full list of side effects of Cimzia, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Cimzia fremgår af indlægssedlen.
English: After training, patients may inject Cimzia themselves if their doctor agrees.
Danish: Efter oplæring og med lægens godkendelse kan patienten selv foretage injektionen med Cimzia.
English: In the first study, symptoms were reduced by at least 20% in 57% of patients who received Cimzia (141 out of 246) compared with 9% of patients who received placebo (11 out of 127).
Danish: I det første studie blev symptomerne reduceret med mindst 20 % hos 57 % af de patienter, der fik Cimzia (141 ud af 246), sammenholdt med 9 % af de patienter, der fik placebo (11 ud af 127).
English: It is given by injection under the skin, usually in the thigh or abdomen (belly).
Danish: Cimzia gives som injektion under huden, sædvanligvis i låret eller maven.
English: • A study in patients with axial spondyloarthritis showed that symptoms improved by at least 20% after 12 weeks in around 60% of patients treated with Cimzia compared with around 40% of patients receiving placebo.
Danish: • Et studie hos patienter med aksial spondyloartritis viste en bedring af symptomerne med mindst 20 % efter 12 uger hos ca. 60 % af de patienter, der fik Cimzia, sammenholdt med ca. 40 % af de patienter, der fik placebo.
English: After 12 weeks of treatment, Cimzia 200 mg every two weeks led to 61% of patients responding and 67% responding with Cimzia 400 mg every two weeks compared with 53% of patients receiving etanercept and 5% of patients receiving placebo.
Danish: Efter 12 uger førte behandling med Cimzia 200 mg hver anden uge til en bedring hos 61 % af patienterne og behandling med Cimzia 400 mg hver anden uge til en bedring hos 67 % af patienterne sammenholdt med 53 % af de patienter, der fik etanercept, og 5 % af de patienter, der fik placebo.
English: Cimzia is available as pre-filled syringes, prefilled pens and dose-dispenser cartridge.
Danish: Cimzia findes som fyldte sprøjter, fyldte penne og patroner til dosisdispensere.
English: • For active rheumatoid arthritis that had not improved adequately with disease-modifying antirheumatic drug (DMARD) treatment, two main studies found Cimzia effective when used with methotrexate when compared with placebo (dummy treatment).
Danish: • Ved aktiv reumatoid artritis, hvor der ikke kunne konstateres en tilstrækkelig bedring ved behandling med et sygdomsmodificerende antireumatisk lægemiddel (DMARD), viste Cimzia sig at være effektivt i to studier ved brug sammen med methotrexat i forhold til placebo (ikke-aktivt stof).
English: How is Cimzia used?
Danish: Hvordan anvendes Cimzia?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cimzia have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Cimzia.
English: In the other main study, symptoms were reduced by at least 20% in 59% of patients who received Cimzia (228 out of 388) compared with 14% of patients who received placebo (27 out of 198).
Danish: I det andet hovedstudie blev symptomerne reduceret med mindst 20 % hos 59 % af de patienter, der fik Cimzia (228 ud af 388), sammenholdt med 14 % af de patienter, der fik placebo (27 ud af 198).
English: How does Cimzia work?
Danish: Hvordan virker Cimzia?
English: What benefits of Cimzia have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Cimzia?
English: • For psoriatic arthritis, symptoms improved by at least 20% in 58% of patients treated with Cimzia 200 mg every two weeks compared with 24% of patients receiving placebo.
Danish: • Ved psoriasisartritis blev der påvist en bedring af symptomerne med mindst 20 % hos 58 % af de patienter, der blev behandlet med 200 mg Cimzia hver 2. uge, sammenholdt med 24 % af de patienter, der fik placebo.
English: Patients on Cimzia 400 mg every two weeks led to 75.8% and 55.4% of patients responding.
Danish: Blandt de patienter, der fik 400 mg Cimzia hver 2. uge, oplevede hhv. 75,8 % og 55,4 % af patienterne en bedring.
English: For detailed information on the use of Cimzia in all conditions, see the summary of product characteristics.
Danish: Nærmere oplysninger om anvendelsen af Cimzia til alle sygdomme fremgår af produktresuméet.
English: including ankylosing spondylitis and when the X-ray does not show disease but there are clear signs of inflammation.
Danish: • aksial spondyloartritis (en sygdom, der forårsager betændelse og smerter i rygleddene), herunder ankyloserende spondylitis, og når der er tydelige tegn på betændelse, men ved røntgen ikke ses nogen tegn på sygdom
English: - if you are pregnant or if there is a possibility that you might be pregnant (see below).
Danish: - hvis De er gravid, eller hvis der er mulighed for, at De er gravid (se nedenfor).
English: Intravenous administration should not be protracted over more than 2 hours.
Danish: Intravenøs indgivelse bør ikke forhales mere end 2 timer.
English: However, should this occur, you will receive appropriate treatment from your doctor.
Danish: Hvis dette alligevel skulle ske, vil De modtage passende behandling af Deres læge.
English: 4.5 Interactions with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Timepoints for measurements were 5 minutes, 1 hour, 6 hours, 1 day, 4 days and 15 days.
Danish: Målingstidspunkterne var 5 minutter, 1 time, 6 timer, 1 døgn, 4 døgn og 15 døgn.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/250/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/250/001
English: Activity may be measured using an ionisation chamber.
Danish: Aktiviteten kan måles ved hjælp af et ioniseringskammer.
English: Date of the last renewal: 24/03/2008
Danish: Dato for seneste fornyelse: 24/03/2008
English: 7 days from the date/hour of manufacture.
Danish: 7 døgn fra fremstillingsdato/-klokkeslæt.
English: In any case the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of damage to the blood marrow.
Danish: I alle tilfælde skal patientens blodparametre monitoreres, og der skal øjeblikkelig tages relevante forholdsregler, hvis der er tegn på beskadigelse af marven.
English: In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Danish: I alle tilfælde er det nødvendigt at sikre, at risikoen fra strålingen er mindre end risikoen fra selve sygdommen.
English: A.LABELLING
Danish: A. ETIKETTERING
English: It is important to tell your doctor if there is any possibility that you are pregnant.
Danish: Det er vigtigt, at De taler med Deres læge, hvis der er en mulighed for, at De er gravid.
English: YTRACIS is only to be used by specialists with the appropriate experience.
Danish: YTRACIS må kun anvendes af specialister med relevant erfaring.
English: (GBq : GigaBecquerel, Becquerel is the unit in which radioactivity is measured).
Danish: (GBq: GigaBecquerel er måleenheden for radioaktivitet).
English: Since YTRACIS is administered by a doctor under strictly controlled conditions there is little chance of possible overdose.
Danish: Da YTRACIS indgives af en læge under strengt kontrollerede forhold, er der kun en lille risiko for en mulig overdosering.
English: Organ Adult male 70 kg
Danish: Voksen mand 70 kg
English: Activity measurements using an ionisation chamber are very sensitive to geometric factors and therefore should be performed only under geometric conditions which have been appropriately validated.
Danish: Aktivitetsmålinger med et ioniseringskammer er meget følsomme over for geometri-faktorer og må derfor kun udføres i geometriske opstillinger, der er passende valideret.
English: Like all medicines, YTRACIS can cause side effects, although not everybody gets them.
Danish: YTRACIS kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.
Danish: Hospitalspersonalet vil sikre, at præparatet opbevares korrekt og ikke indgives til Dem efter den anførte udløbsdato.
English: These complexes are rapidly eliminated by the kidneys.
Danish: Disse komplekser udskilles hurtigt via nyrerne.
English: Because there are strict laws covering the use, handling and disposal of radioactivity, YTRACIS will always be used in a hospital or a similar setting.
Danish: Da der er en streng lovgivning vedrørende brugen, håndteringen og bortskaffelsen af radioaktive stoffer, vil YTRACIS altid blive anvendt på et hospital eller et lignende sted.
English: It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Danish: Det vil kun blive håndteret og indgivet af personale, som er uddannet og kvalificeret i sikker håndtering af radioaktivt materiale.
English: Do not use after the expiry date and time stated on the label.
Danish: Må ikke anvendes efter den udløbsdato og det klokkeslæt, som er angivet på etiketten.
English: The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended therapeutic result.
Danish: Den indgivne aktivitet skal være af et sådant omfang, at den resulterende strålingsdosis er så lav som rimeligt mulig under hensyntagen til behovet for at opnå det påtænkte behandlingsresultat.
English: 90Y-yttrium has a half-life of 2.67 days (64.1 hours).
Danish: Y (yttrium-90) har en halveringstid på 2,67 døgn (64,1 timer).
English: Store in the original package.
Danish: Opbevares i den originale emballage.
English: Kidneys Liver Bladder Ovaries Uterus Spleen 0.85 Bone Heart Lungs Intestines Muscles Testes
Danish: Nyrer Lever Blære Ovarier Uterus Milt Knogle Hjerte Lunger Tarme Muskler Testikler
English: For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit.
Danish: For hver patient skal eksponering til ioniserende stråling være begrundet af den sandsynlige kliniske fordel.
English: Yttrium (90Y) is a beta pure emitter.
Danish: Yttrium (90Y) er en ren beta-emitter.
English: Radionuclide procedures carried out in pregnant women also involve radiation doses to the foetus.
Danish: Radionuklidprocedurer, der udføres på gravide kvinder, medfører også strålingsdoser til fostret.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt inden De begynder at bruge medicinen.
English: In the liver, 18 % of the injected activity is taken up 5 min after injection.
Danish: I leveren optages 18% af den injicerede aktivitet 5 minutter efter injektion.
English: At 1 and 24 hours, blood radioactivity decreases from 11 % to 0.14 % of the administered activity.
Danish: Efter 1 og 24 timer formindskes blodets radioaktivitet fra 11% til 0,14% af den indgivne aktivitet.
English: 4.7 Effects on ability to drive or use machines
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner