FrancophonIA/ELRC3.0 huggingface dataset:
English: Women of childbearing potential have to use appropriate contraception during treatment.
Danish: Kvinder i den fødedygtige alder skal anvende effektiv antikonception under behandlingen.
English: This restriction of the indication of Raptiva is based on the present efficacy data and limited long-term
Danish: Begræsningen i indikationen af Raptiva er baseret på seneste data vedrørende virkningen af og begrænset langtidserfaring med Raptiva.
English: - If you develop cancer while undergoing treatment, please contact your doctor who will determine if it is necessary for you to stop using Raptiva.
Danish: - Hvis De får kræft, mens De anvender Raptiva, kontakt Deres læge, som vil afgøre, om De skal holde op med at bruge Raptiva.
English: Do not inject directly into a vein.
Danish: Sprøjt ikke opløsningen direkte ind i en blodåre.
English: Withdraw the solution slowly into the syringe, taking more than the dose you need.
Danish: Træk opløsningen tilbage i sprøjten, således at De får mere opløsning end den dosis, De behøver.
English: Driving and using machines The use of Raptiva is not expected to affect your ability to drive and use machines.
Danish: Bilkørsel og betjening af maskiner Anvendelse af Raptiva forventes ikke at påvirke Deres evne til at køre bil eller betjene maskiner.
English: The median time to relapse among PASI responders ranged from 58 to 74 days following the last Raptiva dose in the initial treatment period.
Danish: Medianen for tid til tilbagefald i PASI respondenter var fra 58 til 74 dage efter den sidste Raptiva-dosis i den indledende behandlingsperiode.
English: Subsequent doses: 1 mg/kg
Danish: Enkelt initialdosis:1 mg/kg
English: An initial single dose of 0.7 mg/kg body weight is given followed by weekly injections of 1.0 mg/kg body weight (maximum single dose should not exceed a total of 200 mg).
Danish: Der indgives initialt en enkeltdosis på 0,7 mg/kg legemsvægt, som efterfølges af ugentlige injektioner af 1,0 mg/kg legemsvægt (maksimum enkeltdosis må ikke overstige 200 mg).
English: If you develop a new infection or notice any new or sudden change in thinking, balance, strength, talking, walking or vision, please contact your doctor.
Danish: Hvis De får en ny infektion, eller hvis De bemærker en ny eller pludeslig ændring i tankegang, balance, kræfter, tale, gang eller syn,, kontakt da Deres læge.
English: The safety and efficacy of Raptiva in moderate to severe plaque psoriasis patients has been demonstrated in five randomized, double-blind, placebo-controlled trials at the recommended dose (n=1742).
Danish: Sikkerheden og effekten af Raptiva hos patienter med moderat til svær plaque psoriasis blev vurderet i fem randomiserede, dobbeltblindede, placebokontrollerede studier med den anbefalede dosis (n=1742).
English: • Notice signs of nerve disorder such as tingling or onset of weakness in legs or arms or new or sudden change in thinking, balance, strength, talking, walking or vision.
Danish: • Oplever tegn på nervepåvirkning såsom prikken eller begyndende svaghed i ben og arme eller oplever en en ny eller pludeslig ændring i tankegang, balance, kræfter, tale, gang eller syn.
English: Erythema multiforme*
Danish: Erytem multiform*
English: Raptiva is a selective immunosuppressor that alters T-lymphocyte function and may affect host defences against infections.
Danish: Raptiva er et selektiv immunsuppressiv, som ændrer T-lymfocyt funktionen og kan påvirke kroppens forsvar mod infektioner.
English: • A relapse or flare or strong worsening of psoriasis or red, inflamed psoriatic plaques, sometimes with swelling of your arms or legs or joint inflammation, especially after stopping Raptiva.
Danish: • Et tilbagefald eller et stærkt forværret udbrud af psoriasis eller røde, betændte psoriatiske plaques, undertiden med hævede arme eller ben eller betændelse i leddene særligt efter at De har afsluttet behandlingen med Raptiva.
English: Through population pharmacokinetic analysis, weight was found to affect efalizumab clearance.
Danish: Ved hjælp af farmakokinetiske analyser af populationer blev det konstateret, at vægt påvirkede clearance af efalizumab.
English: In case of overdose, it is recommended that the patient be monitored under close medical care and appropriate symptomatic treatment instituted immediately.
Danish: I tilfælde af overdosis anbefales det, at patienten holdes under grundig medicinsk observation, og at den rette symptombehandling
English: - If you develop signs and symptoms associated with anaemia (a reduction in red blood cells which can make the skin pale and cause weakness or breathlessness) while undergoing treatment, please contact your doctor who will determine if it is necessary for you to stop using
Danish: - Hvis De udvikler tegn og symptomer forbundet med anæmi (en reduktion i røde blodceller som kan få huden til at se bleg ud og give følelsen af svaghed eller åndeløshed) imens De er i behandling, kontakt da Deres læge som vil afgøre om det er nødvendigt for Dem at stoppe med
English: • Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container.
Danish: • Smid alle brugte genstande væk: Umiddelbart efter De har indsprøjtet opløsningen, skal alle kanyler og tomme glasbeholdere kasseres i en kanyleboks.
English: Discontinuation of treatment may cause a recurrence or exacerbation of plaque psoriasis including erythrodermic and pustular psoriasis, especially in patients not responding to treatment.
Danish: Behandlingsstop kan forårsage, at plaque psoriasis blusser op igen eller forværres, herunder erythrodermisk og pustuløs psoriasis, navnlig hos patienter, som ikke responderer på behandling.
English: - If your weight changes unexpectedly, please contact your doctor.
Danish: - Hvis De oplever uventede ændringer i Deres vægt, kontakt da Deres læge.
English: Excipients: 2.5 mg polysorbate 20, 3.55 mg histidine, 5.70 mg histidine hydrochloride monohydrate,
Danish: Hjælpestoffer: 2,5 mg polysorbat 20, 3,55 mg histidin, 5,70 mg histidinhydrochloridmonohydrat,
English: Anaphylaxis is a more serious allergic reaction that may involve dizziness, vomiting, low blood pressure, and difficulty with breathing.
Danish: Anafylaksi er en alvorlig allergisk reaktion, som kan medføre svimmelhed, opkastninger, lavt blodtryk og åndedrætsbesvær.
English: It is produced by genetically engineered mammalian cells.
Danish: Det laves af genmanipulerede pattedyrsceller.
English: Like all medicines, Raptiva can cause side effects, although not everybody gets them.
Danish: HVILKE MULIGE BIVIRKNINGER RAPTIVA HAR Som alle andre lægemidler kan Raptiva have bivirkninger, selvom ikke alle får bivirkninger.
English: The volume to be injected
Danish: Det injicerede volumen
English: In one patient, thrombocytopenia occurred 3 weeks after treatment discontinuation.
Danish: Hos en patient forekom trombocytopenia 3 uger efter behandlingsstop.
English: Aseptic meningitis*, Severe infections*, JC virus infection resulting in progressive multifocal leukoencephalopathy*
Danish: Aseptisk meningitis*, alvorlige infektioner* JC virusinfektio n som resulterer i Progressiv Multifocal Leukoenceph alopati (PML).
English: Powder:
Danish: Psoriasis:
English: Based on the pharmacological mechanism of action of efalizumab, the use of Raptiva is not expected to affect patient's ability to drive and use machines.
Danish: På baggrund af efalizumabs farmakologiske virkningsmekanisme forventes brugen af Raptiva ikke at påvirke patientens evne til at føre motorkøretøj eller betjene maskiner.
English: In the cases occurring during treatment, most of these events (16/22) occurred in patients presenting no response to Raptiva.
Danish: I de tilfælde, hvor bivirkningerne optrådte under behandlingen, forekom de fleste bivirkninger (16/22) hos patienter, der ikke respondere på behandlingen med Raptiva.
English: Limited data are available on the effects of vaccination in patients receiving Raptiva.
Danish: Der findes begrænset data, der beskriver virkningen af vaccination hos patienter i behandling med Raptiva.
English: Efalizumab shows dose-dependent nonlinear pharmacokinetics which can be explained by its saturable specific binding to cell surface receptors CD11a.
Danish: Efalizumab viser dosisafhængig nonlineær farmakokinetik, der kan forklares ved dets mættende, specifikke binding til celleoverflade-receptorerne CD11a.
English: Inject under the skin, as you were taught.
Danish: Sprøjt opløsningen ind under huden, som De har fået besked på.
English: These symptoms diminished thereafter to a percentage comparable to that of patients treated with placebo.
Danish: Disse symptomer faldt derefter til en procentdel svarende til den, der blev målt hos placebogruppen.
English: As with any recombinant product, Raptiva is potentially immunogenic.
Danish: Som ethvert andet rekombinant produkt er Raptiva et potentielt allergen.
English: The powder is a white to off-white cake and the solvent is a colourless liquid.
Danish: Pulveret er i fast form med en hvid til off-white farve, mens solvensen er en farveløs væske.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: De bør altid konsultere Deres læge eller apotek, hvis De er usikker.
English: • Each pre-filled syringe of solvent contains sufficient water for injections to make up the solution
Danish: • Hver fyldt injektionssprøjte med solvens indeholder nok vand til injektionsvæsker til at lave
English: Time to relapse (≥50% loss of improvement) was evaluated in Study ACD2058g and IMP 24011 for patients who were classified as responders (≥75% improvement on PASI) after 12 weeks of treatment.
Danish: Tid til tilbagefald (≥50 % tab af forbedring) blev evalueret i forsøg ACD2058g og IMP 24011 for patienter, som var klassificeret som respondenter (≥75 % forbedring ifølge PASI) efter 12 ugers behandling.
English: There is no known antidote to Raptiva or any specific treatment for Raptiva overdose other than withholding treatment and patient observation.
Danish: Der kendes ingen modgift mod Raptiva, og der findes ingen særlig behandling mod Raptivaoverdosering udover at standse behandlingen og observere patienten.
English: Increased absolute counts were apparent within 24 hours of the first dose, remained elevated with weekly dosing, and returned to baseline after treatment cessation.
Danish: Forhøjede absolutte tal viste sig inden for 24 timer efter første dosis, forblev høje med den ugentlige dosis og vendte tilbage til udgangsværdien efter ophørt behandling.
English: The side effects in this section are given with an estimation of the frequency with which they may occur.
Danish: Bivirkninger beskrevet i dette afsnit angives udfra, hvor ofte de forekommer.
English: Inject the solution by pushing gently on the plunger.
Danish: Indsprøjt opløsningen ved at trykke let på stemplet.
English: Antibodies to efalizumab were detected in only 6% of patients.
Danish: Der blev observeret antistoffer mod efalizumab i kun 6 % af patienterne.
English: Failure on prior systemic therapies is defined as insufficient response (PASI < 50 or PGA less than good), or worsening of disease in patients while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the 3 major systemic therapies as
Danish: Manglende effekt i tidligere systemiske terapier defineres med utilstrækkelig respons (PASI< 50 eller PGA mindre end god), eller forværring af sygdommen hos patienter, der var i behandling og som fik en passende dosis af en tilstrækkelig lang varighed, således at respons kunne måles hos mindst 3 af de største systemiske terapier, der var tilgængelig.
English: (see section 4.5).
Danish: (se afsnit 4.5).
English: In pups of mice treated with an antibody analogue of efalizumab, a decrease in T-cell dependent immunity was observed up to at least 11 weeks of age.
Danish: Hos museunger, der blev behandlet med et antistof, der er analogt med efalizumab, blev der observeret en nedgang i T-celle-afhængig immunitet til de var mindst 11 uger gamle.
English: Another subject who received 10 mg/kg intravenous dose experienced severe vomiting following administration of efalizumab, which also required hospitalization.
Danish: En anden forsøgsperson, som fik en dosis på 10 mg/kg intravenøst, oplevede efter administrationen af efalizumab svære opkastninger ligeledes krævede hospitalsindlæggelse.
English: Efalizumab is a recombinant humanized monoclonal antibody produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
Danish: Efalizumab er et rekombinant humaniseret monoklonalt antistof fremstillet i gensplejsede ovarieceller fra kinesisk hamster (CHO-celler).
English: (See section 4.4).
Danish: (Se afsnit 4.4).
English: The efficacy of Raptiva versus other systemic therapies in patients with moderate to severe psoriasis has not been evaluated in studies directly comparing Raptiva with other systemic therapies.
Danish: Effekten af Raptiva i forhold til andre systemiske behandlinger hos patienter med moderat til svær psoriasis er ikke blevet evalueret i undersøgelser, hvor man direkte sammenligner Raptiva med andre systemiske terapier.
English: In this small number of patients no differences were observed in pharmacokinetics, pharmacodynamics, clinically noteworthy adverse events or clinical efficacy.
Danish: Hos denne lille gruppe af patienter, blev der ikke observeret forskelle i farmakokinetik, farmakodynamiske, klinisk betydningsfulde bivirkninger eller klinisk effekt..
English: In case of recurrence or exacerbation of disease, as well as in patients who discontinue Raptiva and are non-responders, the treating physician should institute the most appropriate psoriasis treatment as necessary.
Danish: I tilfælde af at sygdommen blusser op igen eller forværres, ligesom hos patienter, som afbryder Raptivabehandling og ikke reagerer på denne, bør den behandlende læge påbegynde den nødvendige psoriasisbehandling.
English: Mean steady state clearance is 24 ml/kg/day (range 5-76 ml/kg/day) at 1 mg/kg/ week subcutaneous.
Danish: Middelværdien for steady state clearance er 24 ml/kg/dag (5-76 ml/kg/dag) ved 1 mg/kg/uge givet subkutant.
English: In case re-treatment with Raptiva is needed you should follow the guidance of your doctor.
Danish: Hvis behandlingen med Raptiva genoptages, skal De følge Deres læges vejledning.
English: In large placebo-controlled clinical studies, the percentage of patients experiencing an adverse event suggestive of hypersensitivity, including urticaria, rash and allergic reactions was slightly higher in the Raptiva group (8%) than in the placebo group (7%).
Danish: I store placebokontrollerede kliniske undersøgelser var den procentdel af patienter, som oplevede en bivirkning, der mindede om hypersensitivitet, herunder urticaria, udslæt og allergiske reaktioner, lidt højere i Raptiva-gruppen (8 %) end i placebogruppen (7 %).
English: After 35 days of treatment with Raptiva, the proportion of subjects treated with efalizumab with positive skin test reactions to Candida was significantly reduced compared with the placebo group.
Danish: Efter 35 dages behandling med Raptiva var antallet af patienter behandlet med efalizumab med positive priktestreaktioner på Candida signifikant reduceret i forhold til placebo gruppen.
English: In a clinical study, where subjects were exposed to higher doses of efalizumab (up to 10 mg/kg intravenous), one subject receiving 3 mg/kg intravenous dose experienced hypertension, chills, and fever on the day of study drug dosing, which required hospitalization.
Danish: I et klinisk forsøg, hvor forsøgspersoner blev udsat for højere doser efalizumab (op til 10 mg/kg intravenøst), oplevede en forsøgsperson, som modtog en intravenøs dosis på 3 mg/kg, hypertension, kulderystelser og feber på dagen for doseringen af studiemedicinen, hvilket krævede hospitalsindlæggelse.
English: The metabolism of efalizumab is through internalisation followed by intracellular degradation as a consequence of either binding to cell surface CD11a or through endocytosis.
Danish: Metabolisme af efalizumab bliver efter systemisk fordeling fulgt af intracellulær nedbrydning som følge af binding til enten celleoverflade CD11a eller via endocytose.
English: HOW TO STORE RAPTIVA
Danish: HVORDAN DE OPBEVARER RAPTIVA
English: The injection sites should be rotated.
Danish: Injektionsstedet bør varieres.
English: Analysis following long-term use in a cohort of 339 patients with moderate to severe psoriasis receiving Raptiva 1 mg/kg/week, of which 166 patients have been treated for more than 2 years and up to 3 years, did not show any noteworthy differences in frequency of adverse events as compared to 12 weeks of exposure to Raptiva.
Danish: En analyse baseret på langtidsbrug hos en gruppe af 339 patienter (forsøg ACD 2243g) med moderat til svær psoriasis, der modtog Raptiva 1mg/kg/uge, hvori 166 patienter blev behandlet i mere end 2 år og op til 3 år, viste ikke nogen nævneværdig forskelle i hyppigheden af utilsigtede hændelser sammenlignet med 12 ugers behandling af Raptiva.
English: LFA-1 is present on activated T lymphocytes, and ICAM-1 is up-regulated on endothelial cells and keratinocytes in psoriasis plaques.
Danish: LFA-1 findes i aktiverede T-lymfocytter, og ICAM-1 er opreguleret på endoteliale celler og keratinocytter i psoriasis-plaque.
English: As regards serious infections, the overall incidence in both controlled and uncontrolled studies of up to 12 weeks was 2.8 per 100 patient-years for Raptiva-treated patients compared with 1.4 per 100 patient-years for placebo-treated patients.
Danish: Vedrørende alvorlige infektioner var den overordnede risiko i både kontrollerede og ukontrollerede forsøg i op til 12 uger 2,8 pr. 100 patientår for patienter, der blev behandlet med Raptiva sammenlignet med 1,4 pr. 100 patientår for patienter, der fik placebo.
English: Thrombocytopenia may occur during Raptiva treatment and may be associated with clinical signs such as echymoses, spontaneous bruising or bleeding from muco-cutaneous tissues.
Danish: Trombocytopeni kan opstå under behandling med Raptiva og kan vise sig ved kliniske tegn som fx ekkymose, spontan suggilation eller blødning fra mucokutant væv.
English: The maximum retrievable dose is 125 mg per 1.25 ml of Raptiva.
Danish: Den maksimale optrækningsmængde er 125 mg pr. 1,25 ml
English: You should continue to inject Raptiva as long as instructed to do so by your doctor.
Danish: De skal fortsætte med at indsprøjte Raptiva, så længe som Deres læge har givet Dem besked på.
English: This may occur rarely in particular at
Danish: Dette forekommer meget sjælden og som
English: Efalizumab reduces inflammation of the psoriatic lesions which results in improvement of the affected areas of the skin.
Danish: Efalizumab nedsætter betændelsesreaktionen i psoriasislæsionerne, hvilket medfører en bedring i det ramte hudområde.
English: 5.1 Pharmacodynamic properties
Danish: 5.2 Farmakokinetiske egenskaber
English: - If you are allergic (hypersensitive) to efalizumab or any of the other ingredients of Raptiva.
Danish: - Hvis De er allergisk (overfølsom) over for efalizumab eller et af de øvrige indholdsstoffer i
English: - If you experience a worsening of your psoriasis or you develop arthritis, please inform your doctor.
Danish: - Hvis Deres psoriasis forværres, eller De udvikler gigt, skal De kontakte Deres læge.
English: • The other ingredients are polysorbate 20, histidine, histidine hydrochloride monohydrate and
Danish: • De øvrige indholdsstoffer er polysorbat 20, histidin, histidinhydrokloridmonohydrat og
English: Patients with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or
Danish: Patienter med særlige former for psoriasis , så som guttat, erythrodermisk eller pustuløs psoriasis som
English: In the combined safety database of 3291 Raptiva-treated patients at the time of approval, there were nine occurrences (0.3%) of thrombocytopenia with less than 52,000 cells per μl reported.
Danish: I den centrale sikkerhedsdatabase, der omfattende 3291 patienter, der blev behandlet med Raptiva på tidspunktet for udstedelsen af markedsføringstilladelsen, findes der ni tilfælde (0,3 %) af trombocytopeni med mindre end 52.000 celler pr. μl rapporteret.
English: By preventing LFA-1/ICAM binding, efalizumab may alleviate signs and symptoms of psoriasis by inhibiting several
Danish: Ved at forhindre binding af LFA-1 og ICAM kan efalizumab lindre tegn og symptomer på psoriasis ved at hæmme flere stadier i
English: Raptiva acts on the immune system, which may potentially increase your risk of infectious diseases or may reactivate old infections.
Danish: Raptiva påvirker immunsystemet, hvilket kan gøre Dem mere modtagelig overfor infektionssygdomme eller gøre gamle infektioner aktive
English: Weight is the most significant covariate affecting efalizumab clearance.
Danish: Vægt er den mest signifikante variabel, der påvirker clearance af
English: Efalizumab is a recombinant humanized monoclonal antibody that binds specifically to the CD11a subunit of LFA-1 (lymphocyte function-associated antigen-1), a leukocyte cell surface protein.
Danish: Efalizumab er et rekombinant humaniseret monoklonalt antistof, der binder sig specifikt til CD11aunderenheden af LFA-1 (lymfocyt-funktionsassocieret antigen-1), et leukocyt-celleoverfladeprotein.
English: It is recommended that assessments be more frequent when initiating therapy (e.g., monthly) and may decrease in frequency with continued treatment (e.g., every 3 months).
Danish: Det anbefales, at sådanne målinger sker oftere i begyndelsen af behandlingen (fx hver måned) og derefter bliver mindre hyppige under den fortsatte behandling (fx
English: In placebo controlled clinical trials, the overall incidences of malignancy (the majority of which were non-melanoma skin cancers) were similar in Raptiva-treated patients and in placebo-treated patients.
Danish: I placebokontrollerede kliniske forsøg svarede den samlede forekomst af malignitet (hvoraf størstedelen var non-melanom hudkræft) for patienter behandlet med Raptiva til den for patienter, som fik placebo.
English: Reconstitution of the singleuse vial with 1.3 ml of the supplied water for injections yields approximately 1.5 ml of solution to deliver 100 mg per 1 ml of Raptiva.
Danish: Blandingen af indholdet af engangshætteglasset med 1,3 ml af det leverede vand til injektion giver ca. 1,5 ml opløsning, som indeholder 100 mg pr. 1 ml Raptiva.
English: To maintain sterility, Raptiva must be used immediately after first opening and reconstitution.
Danish: For at holde produktet sterilt, skal Raptiva anvendes umiddelbart efter anbrud og blanding.
English: Volume to be injected per 10 kg body weight 0.07 ml
Danish: Volume der skal injiceres pr. 10 kg legemsvægt
English: One vial of Raptiva should be reconstituted with the solvent before use.
Danish: Et hætteglas med Raptiva blandes med solvensen før brug.
English: Based on available platelet count measurements, the onset of platelet decline was between 8 and 12 weeks after the first dose of Raptiva in 5 patients, but occurred later in the other patients.
Danish: På basis af tilgængelige målinger af trombocyttal indtrådte faldet i trombocyttallene for 5 patienter mellem 8 og 12 uger efter indgift af den første dosis Raptiva, mens det først indtrådte senere hos andre patienter.
English: Moreover, an antibody analogue of efalizumab was shown to be excreted in milk of mice.
Danish: Endvidere er det påvist, at et antistof, der er analogt med efalizumab, udskilles i musemælk.
English: By this mechanism, efalizumab inhibits the binding of LFA-1 to ICAM-1, which interferes with T lymphocytes adhesion to other cell types.
Danish: Ved hjælp af denne mekanisme hæmmer efalizumab binding mellem LFA-1 og ICAM-1, der påvirker T-lymfocytters adhæsion til andre celletyper.
English: Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Danish: Træk kanylen ud med det samme, og rens huden med en spritserviet ved hjælp af
English: Women should not breastfeed during treatment with Raptiva.
Danish: Kvinder bør derfor ikke amme, mens de er i behandling med Raptiva.