FrancophonIA/ELRC3.0 huggingface dataset:
English: Educational material for Healthcare professionals 3.
Danish: Instruktionsmateriale til sundhedspersoner 4.
English: The primary endpoint was time to disease progression, which did not reach statistical significance.
Danish: Det primære effektmål var tid til sygdomsprogression, hvilket ikke nåede statistisk signifikans.
English: Practical information for medical or healthcare professionals on handling and administration of Provenge dispersion for infusion
Danish: Praktiske oplysninger til læger og sundhedspersonale om håndtering og administration af Provenge-infusionsvæske, dispersion til infusion
English: In such cases, the patient may need to undergo an additional leukapheresis procedure if the treatment is to be continued.
Danish: I sådanne tilfælde patienten er nødt til at gennemgå en ekstra leukafereseprocedure, hvis behandlingen skal fortsætte.
English: Immunocompromised patients and patients taking systemic immunosuppressive therapy were excluded from controlled clinical trials.
Danish: Immunkompromitterede patienter og patienter i systemisk immunsupprimerende behandling blev ekskluderet fra de kontrollerede kliniske studier.
English: If the sterility results become positive for microbial contamination after Provenge has been approved for infusion, the marketing authorisation holder will notify the treating physician and may request additional information from the physician in order to determine the source of contamination.
Danish: Hvis testresultaterne for sterilitet bliver positive for kontaminering med mikroorganismer efter, at Provenge er blevet godkendt til infusion, skal indehaveren af markedsføringstilladelsen give den behandlende læge besked om dette og kan bede om yderligere oplysninger fra lægen for at fastslå kilden til kontamineringen.
English: This test will determine whether you have enough blood cells to allow the leukapheresis procedure to be safely carried out.
Danish: Blodtællingen skal vise, om du har nok blodceller til, at leukaferesen kan udføres sikkert.
English: This will be added to your Patient Alert Card that you should bring to each appointment.
Danish: Tiderne bliver skrevet på dit patientkort, som du skal tage med til hvert besøg.
English: Fertility Effect on male fertility is not known.
Danish: Fertilitet Indvirkningen på mænds fertilitet er ikke kendt.
English: Patients treated with Provenge had a statistically significant survival advantage compared with control.
Danish: Patienter, der blev behandlet med Provenge, havde en statistisk signifikant bedre overlevelse i forhold til patienter, der havde fået kontrol.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Danish: Tabel over bivirkninger Følgende liste over bivirkninger er baseret på erfaringer fra kliniske studier og efter markedsføring og er opstillet efter systemorganklasse og hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden
English: Do not refrigerate or freeze the container.
Danish: Beholderen må ikke opbevares i køleskab eller nedfryses.
English: • A heart condition including blocked blood vessels which could lead to a heart attack
Danish: • hvis du har hjerteproblemer, herunder blokerede blodårer, som kan medføre et hjerteanfald.
English: Like all medicines, Provenge can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Patients should be advised not to drive or use machines if they experience these symptoms following their infusion.
Danish: Patienterne skal rådes til ikke at køre bil eller betjene maskiner, hvis de oplever de nævnte symptomer, når de har fået Provengeinfusion.
English: 250 mL dispersion in a bag (breathable polyolefin tri-laminate with 3 sample ports (2 spike ports and 1 port with sealed tubing)).
Danish: 250 ml dispersion i en pose (åndbar polyolefin-trilaminatpose med 3 prøveporte (2 porte med spids og 1 port med forseglet rør)).
English: Do not use this medicine after the expiration date and time, which is stated on the insulated container and the infusion bag.
Danish: Brug ikke dette lægemiddel efter den udløbsdato og det udløbstidspunkt, der er angivet på den isolerede beholder og på infusionsposen.
English: It consists of immune cells (part of your body's natural defense system) taken from your own blood (also called autologous immune cells).
Danish: Provenge består af immunceller (en del af kroppens naturlige forsvarssystem), der er taget fra dit blod (kaldes også autologe immunceller).
English: To reduce the risk of catheter-related infections, CVCs should be considered only for patients with poor peripheral venous access.
Danish: For at reducere risikoen for kateterrelaterede infektioner skal centralt venekateter kun anvendes til patienter med utilstrækkelig adgang til de perifere vener.
English: • increased heart rate, high blood pressure, low blood pressure, fainting.
Danish: • hurtig hjerterytme (puls), forhøjet blodtryk, lavt blodtryk og besvimelse.
English: Provenge is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth.
Danish: Provenge frigives til infusion på baggrund af resultater af flere mikrobiologiske test og sterilitetstest: bestemmelse af mikrobiel kontaminering ved hjælp af Gram Stain, endotoksinindhold og procesintern sterilitet med 2 dages inkubation med henblik på at fastlægge fravær af mikrobiologisk vækst.
English: Tell the doctor or nurse if you do not feel well during the infusion.
Danish: Sig det til lægen eller sundhedspersonalet, hvis du får det dårligt under infusionen.
English: The nature of Provenge is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Danish: Provenge er af en sådan beskaffenhed, at konventionelle studier inden for farmakokinetik, absorption, fordeling, metabolisme og elimination ikke er relevante.
English: • Only one of the 2 spike ports should be used and should not be opened prior to administration in order to avoid contamination.
Danish: • Kun én af de to spidsporte skal bruges, og for at undgå kontaminering må den ikke åbnes
English: Vital signs should be taken at least 30 minutes prior to and 30 minutes following each infusion.
Danish: Vitale tegn skal måles mindst 30 minutter før og 30 minutter efter hver infusion.
English: • If the Provenge bag leaks, is damaged, or if particles or clumps remain in the bag after gentle manual mixing, the product must not be used.
Danish: • Hvis Provenge-posen lækker eller er beskadiget, eller hvis der fortsat er partikler eller klumper i posen efter forsigtig manuel blanding, må produktet ikke anvendes.
English: Provenge is intended solely for autologous use and should under no circumstances be administered to other patients.
Danish: Provenge er udelukkende til autolog brug og må under ingen omstændigheder gives til andre patienter.
English: On the first day of the infusion, Provenge may cause infusion-related reactions such as:
Danish: Behandling med Provenge kan i løbet af den første dag medføre reaktioner, som skyldes infusionen, f.eks.:
English: The first step in your Provenge treatment is to collect your blood cells in order to manufacture your personal infusion of Provenge.
Danish: Det første trin i behandlingen er at opsamle dine blodceller for at fremstille din helt personlige Provenge-infusionsvæske.
English: The MAH shall ensure that all healthcare professionals who are expected to prescribe or use Provenge are provided with the following items:
Danish: MAH skal sikre, at alle sundhedspersoner, der forventes at ordinere eller bruge Provenge, får udleveret følgende: 1.
English: The control was nonactivated autologous peripheral blood mononuclear cells.
Danish: Kontrollen bestod af ikke-aktiverede autologe mononukleære celler fra perifert blod.
English: CD54 is an adhesion and costimulatory molecule essential in the formation of the immunological synapse between an APC and a T cell.
Danish: CD54 er et kombineret adhæsionsmolekyle og co-stimulerende molekyle, som er afgørende for dannelsen af den immunologiske synapse mellem en APC og en T-celle.
English: As it has to be given to you shortly after it has been manufactured, the final sterility results may not always be available before you are given your infusion of Provenge.
Danish: Da det skal gives kort tid efter fremstillingen, foreligger de endelige sterilitetsresultater for Provenge ikke altid, når du får infusionen.
English: The primary endpoint was overall survival.
Danish: Det primære effektmål var den samlede overlevelse.
English: • Training completion form as agreed with the national competent authority
Danish: • omfatter en blanket for gennemført kursus i henhold til aftale med den relevante nationale
English: Do not administer if the bag leaks during handling or if particles or clumps remain in the bag.
Danish: Infunder ikke, hvis posen lækker i forbindelse med håndteringen, eller hvis der fortsat er partikler eller klumper i posen.
English: Hyperhidrosis Pruritus Urticaria
Danish: Udslæt Hyperhidrose Pruritus Urticaria
English: Tell your doctor or nurse if you develop any of these symptoms, as the infusion may need to be slowed down or stopped.
Danish: Sig det til lægen eller sundhedspersonalet, hvis du får nogen af disse symptomer, da det kan være nødvendigt at nedsætte infusionshastigheden eller afbryde infusionen.
English: The safety evaluation of Provenge is based on data from 601 prostate cancer patients in four randomized, controlled clinical trials (3 studies in metastatic castrate resistant prostate cancer and 1 study in androgen dependent prostate cancer) and post-marketing surveillance.
Danish: Sikkerhedsvurderingen af Provenge er baseret på data fra 601 prostatacancerpatienter i fire randomiserede, kontrollerede kliniske studier (3 studier med metastatisk kastrationsresistent prostatacancer og 1 studie med androgenafhængig protatacancer) samt i forbindelse med overvågning efter markedsføringen.
English: Physicians must provide the educational materials to the patient as well as the package leaflet and the Patient Alert Card.
Danish: Lægerne skal udlevere undervisningsmaterialet til patienten sammen med indlægssedlen og patientkortet.
English: The most frequently occurring serious infections in the Provenge group were catheter sepsis (0.7%), staphylococcal bacteraemia (0.7%), sepsis (0.7%), staphylococcal sepsis (0.5%), and pneumonia (0.5%).
Danish: De hyppigste alvorlige infektioner i Provenge-gruppen var katetersepsis (0,7 %), stafylokokbakteriæmi (0,7 %), sepsis (0,7 %), stafylokoksepsis (0,5 %) og pneumoni (0,5 %).
English: • Infusion must begin prior to the expiration date and time indicated on the Final Product Disposition Notification form and bag label.
Danish: • Infusionen skal påbegyndes inden den udløbsdato og det udløbstidspunkt, der er angivet på Final Product Disposition Notification-formularen og posens etiket.
English: Therefore, concurrent use of immunosuppressive agents (such as systemic corticosteroids) should be avoided during Provenge treatment.
Danish: Derfor skal samtidig brug af immunsupprimerende stoffer som f.eks. systemiske kortikosteroider undgås under Provenge-behandlingen.
English: In such cases, if your doctor decides that the course of treatment should be continued, he or she will arrange for another collection of your blood cells (leukapheresis) and the manufacturing process will be repeated (see information on leukapheresis in section 3).
Danish: Hvis lægen i sådanne tilfælde beslutter, at behandlingsforløbet skal fortsætte, vil der blive gennemført en ny opsamling af blodceller (leukaferese), og fremstillingsprocessen vil blive gentaget - se oplysningerne om leukaferese iafsnit 3.
English: Prior to launch of Provenge in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational materials with the National Competent Authority.
Danish: Yderligere risikominimeringsforanstaltninger Inden lanceringen af Provenge i den enkelte medlemsstat skal indehaveren af markedsføringstilladelsen (MAH) aftale instruktionsmaterialets indhold og format med den relevante nationale myndighed.
English: Fax: (0)20 7554 2201 dendreonuk@dendreon.com
Danish: Tlf.: +44 (0)20 7554 2222 Fax: +44 (0)20 7554 2201 dendreonuk@dendreon.com
English: Therefore, vaccinations with live attenuated or inactivated vaccines whilst receiving Provenge should be carefully considered.
Danish: Derfor skal vaccination med levende svækkede og inaktiverede vacciner under behandlingen med Provenge overvejes nøje.
English: IMPACT study
Danish: IMPACT-studiet
English: For patients with cardiovascular disease or those at risk for cardiac ischaemia, physicians should consider observing patients for at least 60 minutes following each infusion with vital signs taken at 30 minutes and 60 minutes following the infusion.
Danish: Hvis patienten lider af kardiovaskulær sygdom eller har risiko for kardiel iskæmi, skal lægerne overveje at observere ham i mindst 60 minutter efter hver infusion og måle vitale tegn 30 og 60 minutter efter infusionen.
English: A statistically significant improvement in overall survival was seen in patients treated with Provenge, with a 22.5% reduction in the risk of death compared with control (see Table 2 and Figure 1).
Danish: En statistisk signifikant forbedring i den samlede overlevelse blev observeret hos patienter, som blev behandlet med Provenge: 22,5 % reduktion i dødsrisikoen sammenlignet med de patienter, der fik kontrol (se tabel 2 og figur 1).
English: Patients did not require opioid analgesics for pain management and the majority had not received prior chemotherapy.
Danish: Patienterne havde ikke behov for opioidanalgetika for at dæmpe smerter, og flertallet af dem havde ikke fået kemoterapi inden studierne.
English: • Specific handling and administration requirements for Provenge
Danish: • beskriver de specifikke krav til håndtering og administration af Provenge
English: The efficacy and safety of Provenge in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer were studied in three similar Phase III, randomised, double-blind, controlled, multicentre trials: D9902B (IMPACT), D9901, and D9902A.
Danish: Klinisk virkning og sikkerhed Provenges virkning og sikkerhed ved behandling af patienter med asymptomatisk eller minimalt symptomatisk metastatisk kastrationsresistent prostatacancer blev undersøgt i tre randomiserede, dobbeltblindede, kontrollerede, multicenter fase III-studier, der lignede hinanden: D9902B (IMPACT), D9901 og D9902A.
English: Provenge undergoes several tests before use to show that it is sterile.
Danish: Provenge underkastes flere tests for at sikre, at det er sterilt.
English: A third study, D9902A, similar in design to study D9901, was terminated prior to completion of planned accrual based on the time to disease progression results in study D9901.
Danish: Et tredje studie, D9902A, som svarede til D9901-studiet mht. design, blev afsluttet, inden den planlagte tilgang baseret på resultaterne for tid til sygdomsprogression i D9901-studiet var nået.
English: The risks and benefits of vaccinating patients during the course of treatment with Provenge have not been studied.
Danish: Vaccinationer Fordelene og risiciene ved at vaccinere patienten i løbet af Provenge-behandlingsforløbet er ikke blevet undersøgt.
English: Patient Alert card to record the scheduled leukapheresis and infusion dates
Danish: Patientkort til registrering af de fastsatte datoer for leukaferese og infusion.
English: To establish and keep an observational EU-based registry of men with mCRPC to evaluate overall survival, the risk of ischemic stroke or myocardial infarction following treatment with Provenge and other identified and potential risks (observational study P13-1)
Danish: Oprette og føre et EU-baseret observationsregister over mænd med metastatisk kastrationsresistent prostatacancer (mCRPC) for at vurdere den samlede overlevelse, risikoen for iskæmisk apopleksi og myokardieinfarkt efter behandling med Provenge samt andre identificerede og potentielle risici (observationsstudie P13-1)
English: No specific dose recommendation can be provided in these patients.
Danish: Der kan ikke gives nogen specifikke dosisanbefalinger vedrørende sådanne patienter.
English: Cases in which Provenge cannot be infused
Danish: Tilfælde, hvor Provenge ikke kan infunderes
English: However, as Provenge is an autologous product, a positive test does not preclude the manufacture of the product.
Danish: Da Provenge er et autologt produkt, udelukker en positiv test imidlertid ikke fremstillingen af produktet.
English: Provenge is manufactured specifically for you using your own blood and must not be used in anyone else.
Danish: Provenge er fremstillet til dig personligt ved brug af dit eget blod og må ikke anvendes til andre end dig.
English: Conventional toxicology, carcinogenicity, mutagenicity, and reproductive toxicity studies have not been performed.
Danish: Der er ikke blevet udført konventionelle studier af toksikologi, karcinogenicitet, mutagenicitet og reproduktionstoksicitet.
English: Serious infections including sepsis have been observed in patients treated with Provenge.
Danish: Der er observeret alvorlige infektioner, herunder sepsis, hos patienter, der blev behandlet med Provenge.
English: The infusion bag is placed inside an insulated polyurethane container and packed in a shipping box.
Danish: Infusionsposen ligger i en isoleret polyuretanbeholder, som er pakket i en forsendelseskasse.
English: As part of lot release, each product is assessed for activation of antigen presenting cells (APCs) by virtue of increased surface CD54 expression after culture with PAP-GM-CSF.
Danish: Som en del af batchfrigivelsen bliver hvert produkt vurderet med hensyn til aktivering af antigenpræsenterende celler (APC'er) ud fra forøget overflade-CD54-ekspression efter dyrkning med PAP-GM-CSF.
English: Neutralising antibody responses to GM-CSF were transient.
Danish: Neutraliserende antistofreaktioner på GM-CSF var forbigående.
English: Before, or on the day, your blood cells are collected, a blood sample will be taken from you for a complete blood count (CBC) test.
Danish: Før eller på den dag, hvor dine blodceller bliver opsamlet, får du taget en blodprøve, der skal bruges til en komplet blodtælling.
English: The MAH shall also agree with the National Competent Authority any requirements for prior audit of apheresis centres and training courses for healthcare professionals in the use of Provenge.
Danish: MAH skal også efter aftale med den relevante nationale myndighed fastsætte eventuelle krav, hvad angår forudgående inspektion af aferesecentre og kurser i brug af Provenge for sundhedspersoner.
English: Some (1.2%) patients in the Provenge group were hospitalized within 1 day of infusion for management of acute infusion reactions.
Danish: Nogle patienter (1,2 %) i Provengegruppen blev indlagt inden for 1 dag efter infusionen for at få behandling for de akutte infusionsreaktioner.
English: Very common side effects (may affect more than 1 in 10 patients):
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter):
English: As Provenge is made from your own blood cells, your cells will be collected approximately 3 days before each scheduled infusion.
Danish: Provenge fremstilles ud fra dine egne blodceller, og de bliver opsamlet ca. 3 dage før hver planlagt infusion.
English: Forty-eight percent of patients were receiving bisphosphonates and 18% had received prior chemotherapy, including docetaxel.
Danish: 48 % af patienterne var i behandling med bisfosfonater, og 18 % havde tidligere fået kemoterapi, herunder docetaxel.
English: • The existence of the EU Registry of patients treated for metastatic castrate resistant prostate cancer and how to enter patients in it.
Danish: • henleder opmærksomheden på EU-registret over patienter, der behandles for metastatisk kastrationsresistent prostatacancer, og forklarer, hvordan man registrerer patienterne heri.
English: The other ingredients are: sodium chloride, sodium lactate, potassium chloride, and calcium chloride.
Danish: Øvrige indholdsstoffer: natriumchlorid, natriumlactat, kaliumchlorid og calciumchlorid.
English: Additionally, there is the small possibility/risk of transmitting infectious viruses to a patient if he is not the intended recipient of the product.
Danish: Der er desuden en lille mulighed/risiko for overførsel af infektiøse vira til en patient, som ikke er den person, der skal behandles med Provenge.
English: • a delay in Provenge reaching the clinic where you will be given your treatment.
Danish: • at produktet når for sent frem til den afdeling, hvor du skal have din behandling
English: Contact a doctor immediately if you experience chest pain, pain in the left arm and/or shortness of breath as any of these may be signs of a heart attack.
Danish: Kontakt omgående lægen, hvis du får brystsmerter, smerter i venstre arm og/eller åndenød, da disse symptomer kan være tegn på et hjerteanfald.
English: • damage to the product when it arrives at the clinic; for example, the bag containing the product has leaked, or the cells have formed clumps that cannot be dispersed.
Danish: • at produktet er beskadiget ved ankomst til afdelingen - f.eks. hvis posen med produktet er utæt, eller hvis cellerne har dannet klumper, der ikke kan opslæmmes.
English: Provenge can only be administered by a doctor or nurse who has been trained in using this medicine.
Danish: Provenge må kun gives af en læge eller sygeplejerske, der er uddannet i at give Provenge.
English: Provenge has moderate influence on the ability to drive and use machines, as it may cause fatigue, dizziness, syncope, chills, and headache.
Danish: Provenge påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner, da det kan forårsage træthed, svimmelhed, synkope, kulderystelser og hovedpine.
English: PAP-GM-CSF, suspended in 250 mL of Lactated Ringer's Injection, in a sealed, patient-specific polyolefin bag.
Danish: PAP-GM-CSF, opslæmmet i 250 ml Ringer-lactat-infusionsvæske, i en forseglet patient-specifik polyolefinpose.
English: Other side effects with Provenge include:
Danish: Andre bivirkninger ved Provenge kan være:
English: Provenge is an autologous cellular immunotherapy designed to induce an immune response targeted against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers.
Danish: Virkningsmekanisme Provenge er en autolog cellulær immunterapi, designet til at udløse en immunreaktion, der er målrettet prostatic acid phosphatase (PAP), et antigen, der udtrykkes i de fleste prostatacancertyper.
English: Patients with positive serology tests for human immunodeficiency virus [HIV] 1 and 2, human T cell lymphotropic virus [HTLV] 1, and hepatitis B and C were excluded from controlled clinical trials.
Danish: Patienter med positiv serologisk test for humant immundefektvirus (HIV) 1 og 2, humant T-cellelymfotropt virus (HTLV) 1 og hepatitis B og C blev ekskluderet fra de kontrollerede kliniske studier.
English: Patients with cardiac or pulmonary conditions should be closely monitored (see section 4.8).
Danish: Patienter med hjerte- eller lungesygdomme skal overvåges nøje (se pkt.
English: Acute infusion reactions such as chills, fatigue, fever, nausea, and joint ache were frequently observed in clinical studies.
Danish: Akutte infusionsreaktioner såsom kulderystelser, træthed, feber, kvalme og ledsmerter blev ofte observeret i kliniske studier.
English: Do not remove this insulated container from the shipping box, or open the lid of the insulated container, until the patient is ready for
Danish: Tag ikke den isolerede beholder ud af forsendelseskassen, og undlad at åbne låget på den isolerede beholder, før patienten er klar