FrancophonIA/ELRC3.0 huggingface dataset:
English: The expected degradation products are small peptides and individual amino acids which are eliminated by glomerular filtration.
Danish: De forventede nedbrydningsprodukter er små peptider og individuelle aminosyrer, der elimineres ved glomerulær filtration.
English: Overall less than 1% of patients discontinued therapy because of acute flu-like symptoms.
Danish: Totalt var det mindre end 1 % af patienterne, som afbrød behandlingen pga. akutte influenza-lignende symptomer.
English: There are no adequate data from the use of efalizumab in pregnant women.
Danish: Der foreligger ikke tilstrækkelig data om brugen af efalizumab hos gravide kvinder.
English: Inflammatory polyradiculoneuropathy*
Danish: Inflammatorisk polyradikuloneuropati*
English: These changes, which may be associated with the use of Raptiva, can usually only be detected with blood tests.
Danish: Disse ændringer, som kan være forbundet med anvendelsen af Raptiva, kan normalt kun opdages ved
English: If you administer Raptiva, please read the following instructions carefully and follow then step by
Danish: Hvis De selv indsprøjter Raptiva, læs da nedenstående anvisninger omhyggeligt, og følg dem derefter
English: Pharmacotherapeutic group: selective immunosuppressive agents, ATC code: L04AA21
Danish: Farmakoterapeutisk gruppe: selektive immunhæmmende stoffer, ATC-kode: L04AA21
English: These symptoms are very common and occur most often after the first two doses and decrease with continued use.
Danish: Disse symptomer er meget almindelige, og vil ofte vise sig efter de to første doser og aftage ved længerevarende brug.
English: The safety profile in the target population as defined in section 4.1 is similar to the safety profile in the overall population treated during clinical development of Raptiva as presented above.
Danish: Sikkerhedsprofilen hos målgruppen, der er defineret i afsnit 4.1, er lig den sikkerhedsprofil hos den samlede population, der er behandlet under den kliniske udvikling af Raptiva, der vises ovenfor.
English: Do not shake (Shaking will cause foaming of the Raptiva solution).
Danish: Ryst ikke hætteglasset (det kan medføre, at der dannes skum på Raptiva-opløsningen).
English: The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
Danish: Klinikeren bør undersøge patienten for at afgøre, hvorvidt dennes symptomer viser tegn på neurologisk dysfunktion, og i så fald afgøre hvorvidt disse symptomer antyder muligheden for PML.
English: Therefore, conventional non-clinical safety data with the medicinal product are limited and do not allow for a comprehensive safety assessment.
Danish: Derfor findes der kun begrænsede non-kliniske sikkerhedsdata for lægemidlet, hvilket ikke kan danne grundlag for en omfattende sikkerhedsvurdering.
English: Patients with active tuberculosis and other severe infections.
Danish: Patienter med aktiv tuberkulose og andre svære infektioner.
English: Four of these patients had clinical signs of thrombocytopenia.
Danish: Fire af disse patienter viste kliniske tegn på trombocytopeni.
English: If PML is suspected, further dosing must be suspended until PML has been excluded.
Danish: Hvis der er mistanke om PML, skal yderligere doseringer seponeres, indtil mistanken om PML er udelukket.
English: A pneumococcal vaccine administered 6 weeks after discontinuation of Raptiva yielded normal results.
Danish: En pneumokok vaccine administreret 6 uger efter ophør af Raptiva behandlingen gav normale resultater.
English: Pull back the plunger very slightly.
Danish: Træk stemplet ganske let tilbage.
English: In clinical trials, visible side effects at the injection site and injection site pain were uncommon.
Danish: I de kliniske undersøgelser var synlige bivirkninger på og smerte på injektionsstedet ualmindelige.
English: Data from extended treatment (more than 12 weeks) have been obtained from 4311 patients in open label uncontrolled studies.
Danish: Data fra forlænget behandling (mere end 12 uger) er indsamlet fra 4311 patienter i ublindede, ukontrollerede forsøg.
English: Limited data are available on the effects of vaccination.
Danish: Der findes begrænset data, der beskriver virkningen af vaccination.
English: The percentage of patients reporting flu-like symptoms was greatest with the first injection and decreased by more than 50% with the second injection.
Danish: Procentdelen af patienter, der rapporterede influenza-lignende symptomer, var størst ved den første injektion og faldt derefter med over 50 % ved den anden injektion.
English: HOW TO USE RAPTIVA
Danish: HVORDAN DE ANVENDER RAPTIVA
English: Your doctor will advise you what to do when insufficient response to treatment or worsening of your disease is observed.
Danish: Deres læge vil fortælle Dem, hvad De skal gøre, hvis behandlingen er utilstrækkelig eller Deres sygdom forværres.
English: The full effect was seen 24 to 48 hours after the first dose, and was maintained between weekly doses.
Danish: Den fulde effekt sås 24 til 48 timer efter første dosis og blev opretholdt mellem ugentlige doser.
English: * The efalizumab used in the study is the Genentech manufactured product
Danish: * Det efalizumab, som er brugt i undersøgelsen, er et produkt
English: If you are a woman of childbearing potential, you are advised not to become pregnant and to use adequate contraception while using Raptiva.
Danish: Hvis De er kvinde i den fødedygtige alder, tilrådes det, at De ikke bliver gravid, og at De bruger tilstrækkelig prævention, mens De anvender Raptiva.
English: From a microbiological point of view, the product should be used immediately after first opening and reconstitution.
Danish: Fra et mikrobiologisk synspunkt bør produktet anvendes straks efter anbrud og blanding.
English: A higher rate of malignancies has been associated with therapies affecting the immune system.
Danish: Højere forekomst af maligniteter er blevet forbundet med behandlingsformer, som påvirker immunsystemet.
English: In the same population two cases of severe thrombocytopenia (0.6%) of rapid onset were observed (See section 4.4).
Danish: I den samme population blev 2 tilfælde af hurtigt indsættende alvorlig trombocytopeni (0,6%) observeret (Se afsnit 4.4).
English: If you have injected more Raptiva than told by your doctor, please contact your doctor or pharmacist.
Danish: Hvis De har indsprøjtet mere Raptiva, end Deres læge har anvist, kontakt da Deres læge eller apotek.
English: Raptiva should be used with caution in this patient population.
Danish: Raptiva bør anvendes med forsigtighed til denne patient gruppe.
English: Treatment with Raptiva should be initiated by a physician specialised in dermatology.
Danish: Behandling med Raptiva bør påbegyndes af en speciallæge i dermatologi.
English: Raptiva is injected just under the skin (subcutaneous).
Danish: Raptiva indsprøjtes subkutant lige under huden (subkutant).
English: The solution should reconstitute in not more than 5 minutes.
Danish: Blandingen af opløsningen bør ikke vare i mere end 5 minutter.
English: Certain laboratory tests may change, such as the number of white or red blood cells (including leukocytes and lymphocytes) as well as alkaline phosphatase and ALT values (blood laboratory values).
Danish: Der kan forekomme ændringer i visse laboratorieprøver: antallet af hvide blodlegemer (herunder leukocytter og lymfocytter) samt værdier for alkalisk fosfatase og ALAT (blodlaboratorieværdier).
English: Excretion of efalizumab in human milk has not been investigated, however immunoglobulins are expected to be excreted in human milk.
Danish: Udskillelse af efalizumab i human mælk er ikke undersøgt, dog forventes det, at immunoglobuliner udskilles i human mælk.
English: If any of these symptoms are severe or persist, you should contact your doctor.
Danish: Hvis nogle af disse symptomer er alvorlige eller varer ved, bør De kontakte Deres læge.
English: Both occurrences fully resolved without any sequelae.
Danish: Begge hændelser fortog sig helt uden følgetilstande.
English: The use of Raptiva may be associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML).
Danish: Brugen af Raptiva kan være forbundet med en øget risiko for Progressiv Multifocal Leukoencephalopati (PML).
English: All values were between 2.5 fold and 3.5 fold the ULN (Upper Limit of Normal).
Danish: Alle værdier var på mellem 2,5 gange og 3,5 gange ULN (øvre normalgrænse).
English: Do not inject but withdraw the needle and repeat the injection procedure.
Danish: Indsprøjt i så fald ikke opløsningen, træk i stedet kanylen ud og gentag injektionsproceduren.
English: Efalizumab does not cross-react with CD11a from species other than humans and chimpanzees.
Danish: Efalizumab krydsreagerer ikke med CD11a fra andre arter end mennesker og chimpanser.
English: Interstitial pneumonitis*
Danish: Interstitiel pneumoni*
English: Raptiva is a systemic psoriasis medicine.
Danish: Raptiva er systemisk psoriasismedicin.
English: Detailed instructions for use are provided in the package leaflet.
Danish: Detaljeret brugervejledning findes i indlægssedlen.
English: • Notice serious hypersensitivity or allergic reactions, such as anaphylaxis.
Danish: • Oplever alvorlig overfølsomhed eller allergiske reaktioner, som f.eks. anafylaksi.
English: In general, immunoglobulins are known to cross the placental barrier.
Danish: Det er almindeligt kendt, at immunoglobuliner kan krydse placentabarrieren.
English: Animal studies indicate an impairment of the immune function of the offspring (see section 5.3).
Danish: Dyreforsøg indikerer en reversibel hæmning af immunfunktionen hos afkommet (se afsnit 5.3).
English: c) Malignancies and lymphoproliferative disorders
Danish: c) Maligniteter og lymfoproliferative sygdomme
English: If you notice that any of these reactions do not vanish after the second injection, tell your doctor.
Danish: Hvis De oplever, at nogen af disse reaktioner ikke forsvinder efter den anden injektion, skal De
English: Some foam or bubbles may remain in the vial.
Danish: Der kan være en lille smule skum eller bobler tilbage i hætteglasset.
English: The most frequent serious infections were pneumonia, cellulitis, infections not otherwise specified and sepsis.
Danish: De hyppigste alvorlige infektioner var lungebetændelse, flegmone, andre ikke definerede infektioner og sepsis.
English: Seventeen of these events occurred after discontinuation of Raptiva, while 22 occurred during treatment.
Danish: Sytten af disse bivirkninger optrådte efter behandlingsstop mens 22 optrådte under behandlingen.
English: In such circumstances, Raptiva should be discontinued.
Danish: I sådanne tilfælde bør Raptiva seponeres.
English: No teratogenic effects were seen in mice during organogenesis.
Danish: Der blev ikke observeret nogen fosterbeskadigende effekt hos mus under organogenese.
English: Raptiva is for subcutaneous injection.
Danish: Raptiva er til subkutan injektion.
English: Raptiva is a medicine containing efalizumab, made by means of biotechnology.
Danish: Raptiva indeholder efalizumab, som fremstilles ved hjælp af bioteknologi.
English: Following booster vaccination with tetanus toxoid (recall antigen), the ability to mount an immune response to the tetanus toxoid was preserved in those patients undergoing Raptiva therapy.
Danish: Efter en booster vaccination med tetanus toxoid (recall antigen) var evnen til at opbygge et immunrespons overfor tetanus toxoid bevaret hos patienterne i behandling med Raptiva.
English: Approximately half of the patients treated for more than 1 year were PASI 75 responders (when all dropouts were considered as non-responders).
Danish: Ca. halvdelen af patienterne, der var behandlet mere end 1 år, var PASI 75 respondenter (når alle drop-outs blev betragtet som ikke-respondenter).
English: No lymphomas were observed following 6 months treatment with an antibody analogue of efalizumab in a 6 months study with p53 +/+ wild type mice.
Danish: Der blev ikke observeret lymfomer efter 6 måneders behandling med et antistof, der er analogt med efalizumab, i en undersøgelse på over 6 måneder med vilde mus af typen p53 +/+.
English: The increase included CD4 T-lymphocytes, CD8 T-lymphocytes, B-lymphocytes, and natural killer (NK) cells, although NK cells and CD4 cells increased less relative to other cell types.
Danish: Denne stigning omfattede CD4 T-lymfocytter, CD8 T-lymfocytter, B-lymfocytter og naturlige dræberceller (NK-celler), selvom værdierne for NK-celler og CD4-celler steg mindre end for andre celletyper.
English: Before vaccination, treatment with Raptiva should be withheld for 8 weeks and can resume 2 weeks after vaccination.
Danish: Behandling med Raptiva bør stoppes 8 uger før vaccination og kan genoptages 2 uger efter vaccination.
English: All occurrences were asymptomatic and values above 2.5 fold ULN were not more frequent in the Raptiva group than in the placebo group.
Danish: Alle tilfælde var asymptomatiske, og værdier over 2,5 gange den øvre normalgrænse var ikke hyppigere i Raptiva-gruppen end i placebo-gruppen.
English: The injection can be self-administered or given by another person, for example a family member or your doctor.
Danish: De kan selv injicere Raptiva eller få andre til det, f.eks. et familiemedlem eller Deres læge.
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Særlige forhold ved bortskaffelse og anden håndtering
English: The pH of the reconstituted solution is 5.9 - 6.5.
Danish: Den tilberedte opløsning har en pH-værdi på 5,9 - 6,5.
English: Do not use if you notice that the solution is not clear or contains particles.
Danish: Brud ikke Raptiva hvis De ser, at opløsningen ikke er klar eller indeholder partikler.
English: If blood comes into the syringe, the needle has entered a blood vessel.
Danish: Hvis der kommer blod ind i injektionssprøjten, er kanylen gået ind i en blodåre.
English: • Immediately inject the solution as follows: Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Danish: • Indsprøjt opløsningen med det samme på følgende måde: Klem huden sammen og stik hurtigt kanylen ind i en 45 til 90 graders vinkel.
English: There have been no formal drug interaction studies performed with Raptiva.
Danish: Der er ikke udført formaliserede interaktionsundersøgelser med Raptiva.
English: Please check with your doctor if you are planning to receive any vaccine (see “Take special care with
Danish: Spørg Deres læge, hvis De påtænker at blive vaccineret (se "Vær særlig forsigtig med at anvende
English: Over long term treatment, the incidence of serious infection was 1.8 per 100 patient years (see section 4.
Danish: Ved landtidsbehandling var incidensen af alvorlige infektioner 1,8 pr. 100 patientår(Se afsnit 4.4).
English: Raptiva should be discontinued if a malignancy develops while the patient is on treatment (see sections 4.3 and 4.8).
Danish: Behandling med Raptiva bør af brydes, hvis der udvikles malignitet, mens patienten er i behandling (se afsnit 4.3 og 4.8).
English: Otherwise, the effects observed in non-clinical studies could be related to the pharmacology of
Danish: Ellers kunne de effekter, der blev observeret i non-kliniske undersøgelser, relateres til efalizumabs farmakologi.
English: In a study of 66 patients with moderate plaque psoriasis, immune responses during and after Raptiva treatment were investigated.
Danish: I et studie med 66 patienter med moderat plaque psoriasis blev immunresponset undersøgt under og efter behandling med Raptiva.
English: Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML (such as impaired cognition, visual disturbances, hemiparesis, altered mental state or behavioural changes).
Danish: Patienter bør monitoreres med regelmæssige mellemrum for eventuelle nye eller forværrede neurologiske symptomer eller tegn, som tyder på eller minder om PML (så som kognitiv forringelse, synsforstyrrelser, hemiparese, ændringer i mentaltilstand eller adfærd).
English: Not all pack sizes may be available in each
Danish: Ikke alle pakningsstørrelser markedsføres nødvendigvis i alle lande.
English: It appeared that the receptor mediated clearance of efalizumab was saturated when plasma efalizumab concentrations were above 1 μg/ml.
Danish: Det viste sig, at den receptor-formidlede clearance af efalizumab var mættet, når plasma-efalizumab-koncentrationerne var højere end 1 μg/ml.
English: The vial of powder is designed to be reconstituted (mixed) with the solvent.
Danish: Hætteglasset med pulveret er fremstillet til at blive opløst (blandet) med solvensen.
English: Among 3291 patients in the combined safety database, 39 patients presented an erythrodermic or pustular psoriasis (1.2%).
Danish: Blandt 3291 patienter i den centrale sikkerhedsdatabase fik 39 patienter erythrodermisk eller pustuløs psoriasis (1,2 %).
English: • Notice severe headache accompanied with nuchal rigidity.
Danish: • Oplever svær hovedpine ledsaget af nakkestivhed.
English: Dosing for adults (18-64 years) and the elderly (≥ 65 years) The usual dose is an initial single injection of 0.7 mg/kg followed by weekly injections of 1.0 mg/kg.
Danish: Dosering til voksne (18-64 år) og ældre (≥ 65 år) Den normale dosis er en enkelt førstegangsindsprøjtning på 0,7 mg/kg efterfulgt af ugentlige indsprøjtninger på 1,0 mg/kg.
English: Other studies: p-values compared each efalizumab group with placebo using Fisher's exact test within each study.
Danish: Andre studier:p:værdier sammenligner hver efalizumab gruppe med placebo ved hjælp af Fishers eksakte test for hver studie.
English: If any doubt exists, further evaluation, including Magnetic Resonance Imaging (MRI) scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC viral DNA and repeat neurological assessment, should be considered.
Danish: I tvivlstilfælde bør yderligere undersøgelser overvejes så som magnetisk resonans-skanning (MRI) helst med kontraststof, cerebrospinalvæske (CSF) test for JC viral DNA og gentagen neurologisk vurdering.
English: Immune mediated haemolytic anaemia*
Danish: Immun medieret hæmolytisk anæmi*
English: Patients have recovered after discontinuation of Raptiva, therefore Raptiva should be stopped following the diagnosis of inflammatory polyradiculoneuropathy.
Danish: Patienter restitueredes efter ophør med Raptiva, hvorfor behandling med Raptiva bør stoppes, efter diagnosen inflammatorisk polyradikuloneuropati er stillet.
English: The largest study IMP24011 (n=793) included patients (n=526) who were not controlled by, contraindicated to, or intolerant to two or more systemic therapies as judged from the patients' histories of psoriasis treatment.
Danish: Den største studie IMP24011 (n=793) omfattede patienter (n=526), som ikke blev kontrolleret af, kontraindiceret til eller intolerant over for to eller flere systemiske behandlinger bedømt udfra patientens tidligere psoriasisbehandlingsforløb.
English: It is not yet known whether or not Raptiva can increase the risk of lymphoproliferative disorders or other malignancies in psoriasis patients.
Danish: Det vides endnu ikke, om Raptiva kan øge risikoen for lymfoproliferative sygdomme eller andre maligniteter hos psoriasis-patienter.
English: Inhibitory effects were observed on the humoral and T-cell dependent immune responses.
Danish: Der blev observeret hæmmende effekter på de humorale og T-celle-afhængige immunresponser.
English: After reconstitution, an immediate use is recommended (see also section 6.4).
Danish: Det anbefales, at produktet anvendes straks efter blanding (se ligeledes afsnit 6.4).
English: It has the potential to increase the risk or the severity of infections, e.g. tuberculous pneumonia, and reactivate latent, chronic infections e.g. JC virus infection.
Danish: Det har potentialet til at øge risikoen for eller alvorligheden af infektioner, som for eksempel tuberkuløs lungebetændelse samt reaktivere latente kroniske infektioner f.eks. JC
English: When taking Raptiva you might be more vulnerable to infections (see Take special care with Raptiva) this effect might be enhanced by other medicines that are used to treat psoriasis and that also make you more vulnerable to infections.
Danish: Når De anvender Raptiva kan De være mere modtagelig for infektioner (se "Vær særlig forsigtig med at anvende Raptiva"), denne effekt kan forstærkes, hvis De bruger andre former for medicin til behandling af psoriasis, som også gør Dem mere modtagelig overfor infektioner.
English: In post-marketing surveillance, isolated cases of severe haemolytic anaemia have been reported during treatment with Raptiva.
Danish: I post-marketing studier har der været rapporteret isolerede tilfælde af alvorlig hæmolytisk anæmi under behandlingen med Raptiva.
English: • Signs of facial paralysis usually on one side of the face (such as weakness of face muscles and dribbling) possibly preceded by pain in the ear area.
Danish: • Tegn på facialisparese oftest i den ene halvdel af ansigtet (som f.eks. lammelse af ansigtsmusklerne og savlen) muligvis forbundet med smerter bag øret.
English: Another pharmacodynamic marker, consistent with the mechanism of action of efalizumab, was the increase in the absolute counts of circulating leukocytes observed during efalizumab treatment.
Danish: En anden farmakodynamisk markør, forenelig med efalizumabs virkningsmekanisme, var en stigning i det absolutte cirkulerende leukocyttal observeret i løbet af behandlingen med efalizumab.
English: The elimination half-life was about 5.5-10.5 days at 1 mg/kg/ week subcutaneous.
Danish: Eliminationshalveringstid var ca. 5,5-10,5 dage ved 1 mg/kg/uge givet subkutant.
English: Other therapies that alter T-lymphocyte function have been associated with increased risk of developing serious infections.
Danish: Andre behandlingsformer, der ændrer T-lymfocytfunktionerne, er blevet associeret med forhøjet risiko for alvorlige infektioner.
English: Given the mechanism of action of efalizumab, its effects on the immune system may be potentiated by systemic immunosuppressives commonly used for the treatment of psoriasis (see section 4.4).
Danish: På grund af efalizumabs virkningsmekanisme kan dets effekt på immunsystemet forstærkes af almindeligt anvendte systematiske immunsuppressive midler til behandling af psoriasis (se afsnit 4.4).
English: If you discontinue treatment with Raptiva without substitution treatment, your psoriasis may significantly worsen.
Danish: Hvis behandlingen med Raptiva afbrydes uden erstatningsbehandling, kan Deres psoriasis forværres betydeligt.
English: After initiation of therapy, these reactions were generally less frequent and occurred at similar rates to that seen in the placebo group from the third and subsequent weekly injections.
Danish: Efter påbegyndt behandling faldt hyppigheden af disse reaktioner generelt til samme niveau som hos placebogruppen fra den tredje og for de følgende ugentlige injektioner.
English: - If you have been diagnosed as having a disorder of your immune system.
Danish: - Hvis Deres læge har diagnosticeret, at De har defekt immunsystem.
English: If a patient develops PML, the dosing of Raptiva must be permanently discontinued.
Danish: Hvis en patient udvikler PML, skal behandling med Raptiva permanent seponeres.
English: Tell your doctor and discuss with him your general health if you notice any of the following:
Danish: Tal med lægen om Deres generelle helbredstilstand, hvis De oplever en eller flere af de følgende
English: Efalizumab is a monoclonal antibody.
Danish: Efalizumab er et monoklonalt antistof.
English: The largest increase occurred in the absolute count of circulating lymphocytes.
Danish: Den største stigning viste sig i det absolutte cirkulerende lymfocyttal.
English: Antibody response to an experimental neo-antigen (∅X174) was reduced during Raptiva therapy, but began to normalize 6 weeks after discontinuation of Raptiva therapy and did not demonstrate tolerance induction.
Danish: Antistofresponset mod et eksperimentelt neoantigen (ØX174) blev reduceret under Raptiva behandlingen, men begyndte at blive normaliseret 6 uger efter seponering af Raptiva behandlingen og udviste ingen tegn på tolerance udvikling.