FrancophonIA/ELRC3.0 huggingface dataset:
English: • You are immunocompromised (your immune system's ability to fight infections is reduced) or taking any immunosuppressant medicines (such as those used to treat or prevent organ rejection and certain medicines used to treat rheumatoid arthritis, multiple sclerosis, Crohn's disease, and ulcerative colitis)
Danish: • hvis du har nedsat immunforsvar (dit immunsystems evne til at bekæmpe infektioner er nedsat) eller tager immundæmpende medicin (f.eks. lægemidler, der bruges til at behandle eller forebygge organafstødning efter en transplantation, og visse lægemidler til behandling af leddegigt, dissemineret sklerose, Crohns sygdom og ulcerøs tyktarmsbetændelse).
English: Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory events (dyspnoea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia.
Danish: Akutte infusionsreaktioner (rapporteret inden for 1 dag efter infusionen) omfattede blandt andet, men var ikke begrænset til feber, kulderystelser, respirationsproblemer (dyspnø, hypoksi og bronkospasmer), kvalme, opkastning, træthed, hypertension og takykardi.
English: Some serious infections and sepsis were related to the use of central venous catheters (CVCs).
Danish: Nogle alvorlige tilfælde af infektion og sepsis skyldtes brug af centrale venekatetre.
English: If you are allergic (hypersensitive) to the active substances or any of the ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Provenge hvis du er allergisk (overfølsom) over for de aktive stoffer eller et af de øvrige indholdsstoffer i Provenge (angivet i afsnit 6).
English: In the event of an acute infusion reaction, the infusion may be interrupted or slowed, depending on the severity of the reaction.
Danish: I tilfælde af en akut infusionsreaktion kan infusionen enten afbrydes eller foretages langsommere afhængigt af reaktionens sværhedsgrad.
English: • Once the patient is prepared for infusion and the APPROVED Final Product Disposition Notification form has been received, the Provenge bag should be removed from the insulated container and inspected for leaks, external damage, foreign particulate matter, or clumps/clots.
Danish: • Når patienten er gjort klar til infusion, og den GODKENDTE Final Product Disposition Notification-formular er modtaget, tages Provenge-posen ud af den isolerede beholder og kontrolleres for utætheder, ydre skader, fremmede partikler og klumper.
English: Pregnancy Provenge is not intended for use in women.
Danish: Graviditet Provenge er ikke beregnet til brug hos kvinder.
English: Dispose of in accordance with local requirements.
Danish: Skal bortskaffes i henhold til lokale retningslinjer.
English: Do not throw away any medicines via wastewater.
Danish: Hæld ikke noget af medicinen i afløbet.
English: Hyperkalaemia should be corrected prior to Provenge administration (see section 4.2).
Danish: Hyperkaliæmi skal korrigeres før administration af Provenge (se pkt.
English: • An infection which affects your whole body (e.g., sepsis, seen as high temperature, increased heart rate or breathing)
Danish: • hvis du har en infektion, der påvirker hele kroppen, f.eks. sepsis (”blodforgiftning”), som viser sig ved høj temperatur og hurtig hjerterytme (puls) eller vejrtrækning.
English: In post-marketing experience of greater than 5,000 patients treated, this incidence is approximately 19% (see section 4.2).
Danish: Erfaringerne efter markedsføring, som omfatter over 5.000 behandlede patienter, viste en hyppighed på ca. 19 % (se pkt.
English: PSA doubling time, the number of patients who develop metastatic disease, subsequent therapies received after diagnosis of metastatic disease, and efficacy parameters following subsequent therapies, including PSA progression, PSA progression-free survival, time to next line therapy, and overall survival.
Danish: Studiet skal sammenfatte patientkarakteristika ved baseline, herunder PSA og fordoblingstiden for PSA, antallet af patienter, der udvikler metastatisk sygdom, de behandlinger, patienterne får efter diagnosticering af metastatisk sygdom, samt effektparametrene efter de efterfølgende behandlinger, herunder PSA-progression, PSAprogressionsfri overlevelse, tid til anden- eller tredjevalgsbehandling samt samlet overlevelse
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INSULATED POLYURETHANE CONTAINER
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ISOLERET POLYURETANBEHOLDER
English: Driving and using machines You may feel tired, faint, or dizzy or have a headache or chills after receiving your Provenge infusion.
Danish: Du kan føle dig træt, kraftesløs eller svimmel eller få hovedpine, når du har fået en Provenge-infusion.
English: Additional adverse reactions that were seen commonly ≤ 1 day following a leukapheresis procedure in controlled clinical trials included fatigue (5.5%), muscle spasm (4.0%), chills (3.0%), dizziness (2.8%), and anaemia (2.8%).
Danish: Yderligere bivirkninger, der ofte blev rapporteret senest 1 dag efter en leukafereseprocedure i kontrollerede kliniske studier, omfattede træthed (5,5 %), muskelspasmer (4,0 %), kulderystelser (3,0 %), svimmelhed (2,8 %) og anæmi (2,8 %).
English: Eligible patients had metastatic disease in the soft tissue and/or bone with current or historical evidence of disease progression concomitant with surgical or medical castration, as evidenced by progression of serum prostate specific antigen (PSA) and/or bone or soft tissue disease, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Danish: De kvalificerede patienter havde metastaser i bløddele og/eller knogler med aktuel eller historisk dokumenteret sygdomsprogression samtidig med kirurgisk eller medicinsk kastration, dokumenteret ved progression af prostataspecifikt antigen (PSA) i serum og/eller sygdom i knogler eller bløddele samt ECOG-performancestatus på 0 eller 1.
English: Paraesthesia* Paraesthesia oral* Headache
Danish: Oral paræstesi* Hovedpine
English: Cerebrovascular accident Transient ischaemic attack Tremor
Danish: Cerebrovaskulær hændelse Transitorisk cerebral iskæmi Tremor
English: 36-month survival (%) a Hazard ratio and p-value based on the Cox Model adjusted for PSA (ln) and LDH (ln) and stratified by bisphosphonate use, number of bone metastases, and primary Gleason grade.
Danish: 36-månedersoverlevelse a Risikoforhold og p-værdi baseret på Cox-modellen korrigeret for PSA (ln) og LDH (ln) og stratificeret ud fra anvendelse af bisfosfonat, antal knoglemetastaser og primær Gleason-grad. b Risikoforhold baseret på den ukorrigerede Cox-model.
English: Serious adverse reactions include acute infusion reactions, catheter sepsis, staphylococcal bacteraemia, myocardial infarction, and cerebrovascular events.
Danish: Alvorlige bivirkninger inkluderer akutte infusionsreaktioner, katetersepsis, stafylokokbakteriæmi, myokardieinfarkt og cerebrovaskulære hændelser.
English: Preparing the infusion • Take care to ensure aseptic handling when preparing the infusion.
Danish: Klargøring af infusionen • Sørg for aseptisk håndtering, når du klargør infusionen.
English: The insulated container and the gel packs within are designed to maintain the appropriate transportation and storage temperature of Provenge until infusion.
Danish: Den isolerede beholder og gelpakkerne i beholderen er udformet til at sikre, at Provengeinfusionsvæsken opretholder en passende transport- og opbevaringstemperatur, indtil den
English: Intermediate results were observed in patients with baseline PSA > 22.1 to 50.1 ng/mL [HR=0.685 (95% CI: 0.431, 1.088)] and patients with baseline PSA > 50.1 to 134.1 ng/mL [HR=0.819 (95% CI: 0.532, 1.262)].
Danish: Der blev observeret en middel behandlingseffekt hos patienter med baseline-PSA 22,1-50,1 ng/ml (HR = 0,685 (95 %-KI: 0,431-1,088)) og hos patienter med baseline-PSA 50,1-134,1 ng/ml (HR = 0,819 (95 %-KI: 0,5321,262)).
English: Submission of study protocol within 1 month of authorisation
Danish: Indsendelse af studieprotokol senest 1 måned efter godkendelse Årlig opdatering af resultaterne fra studiet
English: The IMPACT study was a randomised, double-blind, controlled, multicentre trial in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.
Danish: IMPACT-studiet var et randomiseret, dobbeltblindet, kontrolleret multicenterstudie med patienter med asymptomatisk eller minimalt symptomatisk metastatisk kastrationsresistent prostatacancer.
English: The degree of CD54 upregulation correlates with overall survival in the randomised controlled clinical trials carried out with Provenge in metastatic castrate resistant prostate cancer.
Danish: Graden af opregulering af CD54 korrelerer med den generelle overlevelse observeret i de randomiserede, kontrollerede kliniske studier foretaget med Provenge til behandling af metastatisk kastrationsresistent prostatacancer.
English: The entire volume of the bag should be infused.
Danish: Hele posens indhold skal infunderes.
English: Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Bortskaffelse Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: In controlled clinical trials, 71.2% of patients in the Provenge group developed an acute infusion reaction.
Danish: Akutte infusionsreaktioner I kontrollerede kliniske studier udviklede 71,2 % af patienterne i Provenge-gruppen en akut infusionsreaktion.
English: Peripheral blood mononuclear cells collected from the patients are cultured with PAP-GM-CSF, a fusion protein consisting of PAP linked to granulocyte-macrophage colony-stimulating factor (GM-CSF) an immune cell activator.
Danish: Mononukleære celler fra perifert blod, opsamlet fra patienterne, dyrkes med PAP-GM-CSF, et fusionsprotein bestående af PAP knyttet til granulocyt/makrofag-kolonistimulerende faktor (GMCSF), som er en immunaktivator.
English: Tell your doctor after your Provenge treament if you get any symptoms of an infection, for example, a fever or high temperature above 38°C, chills, a fast heartbeat, fast breathing, dizziness on standing up, confusion or feeling/being sick.
Danish: Fortæl det til din læge, hvis du efter Provenge-behandlingen får symptomer på infektion, f.eks. feber (over 38 °C), kulderystelser, hurtige hjerteslag (puls), hurtigt åndedræt, svimmelhed, når du rejser dig, forvirring (konfusion), kvalme eller opkastning.
English: IgG) responses against both PAP-GM-CSF and the PAP antigens were observed in the Provenge group through the follow up period.
Danish: Antistofreaktioner (IgM og IgG) på både PAP-GM-CSF og PAP-antigenerne blev observeret i Provenge-gruppen i løbet af opfølgningsperioden.
English: A retrospective subgroup analysis has suggested a greater Provenge treatment effect in patients with a baseline PSA < 22.1 ng/mL [HR= 0.521 (95% CI: 0.309, 0.879)].
Danish: En retrospektiv delgruppeanalyse indikerer størst effekt af Provenge-behandlingen hos patienter med baseline-PSA-niveau under 22,1 ng/ml (HR = 0,521 (95 %-KI: 0,309-0,879)).
English: Provenge is used as treatment for prostate cancer that has spread outside of the prostate but not to the liver, lung or brain, and no longer responds to medicines that lower the levels of the male hormone testosterone in patients who are not considered appropriate for treatment with chemotherapy.
Danish: Provenge bruges til behandling for prostatakræft, der har spredt sig uden for prostata (men ikke til lever, lunge og hjerne), og som ikke længere påvirkes af lægemidler, som sænker indholdet af det mandlige kønshormon testosteron.
English: Control (N=171)
Danish: Kontrol (N=171)
English: In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the Provenge group.
Danish: I kontrollerede kliniske studier blev der rapporteret svære (grad 3) akutte infusionsreaktioner hos 3,5 % af patienterne i Provenge-gruppen.
English: Eighty-two percent of patients had an ECOG performance status of 0; 75% had a Gleason sum ≤ 7; 44% had bone and soft tissue disease; 48% had bone-only disease; 7% had soft tissue-only disease; and 43% had greater than ten bony metastases.
Danish: 44 % havde metastaser i knogler og bløddele, 48 % havde kun metastaser i knogler, 7 % havde kun metastaser i bløddele, og 43 % havde over 10 knoglemetastaser.
English: • It must be ensured that the Final Product Disposition Notification form containing the patient identifiers, expiration date and time, and the disposition status (approved for infusion or rejected), has been received from the marketing authorisation holder.
Danish: • Det skal sikres, at Final Product Disposition Notification-formularen med patientens identifikationsoplysninger, udløbsdato og -tidspunkt samt godkendelsesstatus (godkendt til infusion eller afvist) er modtaget fra indehaveren af markedsføringstilladelsen.
English: What Provenge looks like and contents of the pack Provenge is a slightly cloudy dispersion of cream-to-pink colour and is supplied in a plastic bag with 3 sample ports.
Danish: Provenge er en lettere uklar, råhvid til lyserød dispersion, som leveres i en plasticpose med tre prøveporte.
English: • The essential unique patient information on the infusion bag does not match that of the
Danish: • Hvis de obligatoriske, entydige patientoplysninger på infusionsposen ikke svarer til den
English: Precautions to be taken before handling or administering the medicinal product Provenge is not tested for transmissible infectious diseases and hence may carry the risk of transmitting infectious diseases to healthcare professionals handling the product.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Provenge bliver ikke testet for overførbare smitsomme sygdomme, og der er derfor en risiko for, at lægemidlet kan overføre smitsomme sygdomme til det sundhedspersonale, der håndterer det. Der skal tages passende forholdsregler ved håndtering af Provenge (se pkt.
English: Provenge is intended solely for autologous use.
Danish: Provenge er kun beregnet til autolog anvendelse.
English: Each dose of Provenge is preceded by a standard leukapheresis procedure approximately 3 days prior to the scheduled infusion date.
Danish: Hver indgift af Provenge forudgås af en standard-leukafereseprocedure ca. 3 dage inden den planlagte infusion.
English: Additional CBC tests may be performed in accordance with local requirements.
Danish: Yderligere blodtællinger kan gennemføres i overensstemmelse med lokale retningslinjer.
English: Control (N=33)
Danish: Kontrol (N = 33)
English: For full instructions on the preparation and handling of Provenge, see section 6.6.
Danish: Fuldstændige anvisninger i klargøring og håndtering af Provenge er anført i pkt.
English: Control (N=45)
Danish: Kontrol (N = 45)
English: Patients with renal impairment and/or hyperkalaemia The content of sodium and potassium per infusion should be taken into account if administered in patients with cardiovascular diseases and/or renal impairment.
Danish: Patienter, som har nedsat nyrefunktion og/eller hyperkaliæmi Der skal tages højde for natrium- og kaliumindholdet i den enkelte infusion, hvis Provenge gives til patienter med kardiovaskulære sygdomme eller nedsat nyrefunktion.
English: Cerebrovascular disease
Danish: Cerebrovaskulær sygdom
English: Study D9901 was a randomised, double-blind, controlled, multicentre trial in patients with metastatic castrate resistant prostate cancer and no cancer-related pain.
Danish: D9901-studiet var et randomiseret, dobbeltblindet, kontrolleret multicenterstudie med patienter med metastatisk kastrationsresistent prostatacancer uden cancerrelaterede smerter.
English: If you miss an appointment and you cannot be given your Provenge infusion, it will no longer be usable.
Danish: Hvis du udebliver fra en aftale, så du ikke får din Provenge-infusion, vil infusionsvæsken ikke kunne bruges.
English: Common symptoms include a fainting episode, bluish discoloration of the skin, lips and/or nail beds due to low levels of oxygen in the blood, wheezing, high or low blood pressure and difficulty breathing.
Danish: Du kan også opleve nogle almindelige bivirkninger: besvimelse, blålig misfarvning af huden, læberne og/eller neglene på grund af nedsat iltindhold i blodet, hvæsende vejrtrækning, højt eller lavt blodtryk og åndedrætsbesvær.
English: In controlled clinical trials, the dosing interval range was 115 weeks (see section 5.1).
Danish: I kontrollerede kliniske studier var doseringsintervallet 1-15 uger (se pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING INFUSION BAG
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE INFUSIONSPOSE
English: Visit 5 - Blood cell collection (leukapheresis)
Danish: Besøg 5 - Blodcelleopsamling (leukaferese)
English: Reactions included chills, fever, fatigue, asthenia, dyspnoea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting.
Danish: Disse reaktioner omfattede kulderystelser, feber, træthed, asteni, dyspnø, hypoksi, bronkospasmer, svimmelhed, hovedpine, hypertension, muskelsmerter, kvalme og opkastning.
English: Preparing the infusion Take care to ensure aseptic handling when preparing the infusion.
Danish: Klargøring af infusionen Sørg for aseptisk håndtering, når du klargør infusionen.
English: During or within 24 hours of the infusion, you may develop very common symptoms such as chills, fever, tiredness, feeling weak, headache, feeling sick (nausea), being sick (vomiting), muscle ache, and dizziness,.
Danish: Under infusionen eller i løbet af de efterfølgende 24 timer kan du få en række meget almindelige symptomer: kulderystelser, feber, træthed, svaghedsfornemmelse, hovedpine, kvalme, opkastning, muskelsmerter og svimmelhed.
English: Therefore patient leukapheresis material and Provenge may carry the risk of transmitting infectious diseases to healthcare professionals handling the product.
Danish: Derfor er der risiko for overførsel fra leukaferesemateriale og fra Provenge af smitsomme sygdomme til det sundhedspersonale, der håndterer produktet.
English: Visit 3 - Blood cell collection (leukapheresis)
Danish: Besøg 3 - Blodcelleopsamling (leukaferese)
English: Interim data submitted in each PSUR Final study report by 30 September 2016
Danish: Endelig studierapport 30. september 2016
English: Provenge is for use in adult men only.
Danish: Provenge er udelukkende beregnet til voksne mænd.
English: In controlled clinical trials, cerebrovascular events (hemorrhagic and ischaemic strokes) were observed in 3.5% of patients in the Provenge group compared with 2.6% of patients in the control group.
Danish: I kontrollerede kliniske studier blev cerebrovaskulære hændelser (hæmoragisk og iskæmisk apopleksi) observeret hos 3,5 % af patienterne i Provenge-gruppen mod 2,6 % af patienterne i kontrolgruppen.
English: To mitigate such reactions, premedication, consisting of paracetamol and an antihistamine was administered in clinical studies prior to infusion.
Danish: For at mindske sådanne reaktioner blev patienterne i kliniske studier præmedicineret med paracetamol og et antihistamin inden infusionen.
English: What Provenge contains
Danish: Provenge indeholder:
English: Posology One dose of Provenge contains a minimum of 50 x 106 autologous CD54+ cells activated with
Danish: Dosering Hver dosis Provenge indeholder minimum 50 x 106 autologe CD54+-celler aktiveret med
English: Prior to the first leukapheresis proceedure, a complete blood count (CBC) test should be performed.
Danish: Forud for hver leukafereseprocedure skal der udføres komplet blodtælling.
English: Tests
Danish: Blodprøver
English: Provenge has not been investigated in patients with hepatic impairment.
Danish: Provenge er ikke blevet undersøgt hos patienter med nedsat nyrefunktion.
English: Infusion-related side effects
Danish: Bivirkninger, der skyldes infusionen
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal der tages højde for, hvis patienten følger en natriumkontrolleret diæt.
English: Visit 2 - Provenge infusion
Danish: Besøg 2 - Provenge-infusion
English: • approximately 800 mg sodium per infusion.
Danish: • ca. 800 mg natrium pr. infusion.
English: • Contents of the bag will be slightly cloudy, with a cream to pink colour.
Danish: • Posens indhold er lettere uklart og har en råhvid til lyserød farve.
English: A smaller treatment effect was observed in those with baseline PSA > 134.1 ng/mL [HR=0.853 (95% CI: 0.554, 1.315)].
Danish: Patienter med baseline-PSA-niveau over 134,1 ng/ml oplevede en mindre effekt af behandlingen (HR = 0,853 (95 %-KI: 0,554-1,315)).
English: Other medicines and Provenge
Danish: Brug af anden medicin sammen med Provenge
English: • approximately 45 mg potassium per infusion.
Danish: • ca. 45 mg kalium pr. infusion.
English: Steps before Provenge treatment
Danish: Inden behandlingen med Provenge
English: Chills Fatigue Pyrexia Pain Asthenia
Danish: Kulderystelser Træthed Pyreksi Smerter Asteni
English: Visit 4 - Provenge infusion
Danish: Besøg 4 - Provenge-infusion
English: If your infusion of Provenge has to be interrupted for any reason, your doctor will not be able to restart the infusion if the medicine has been at room temperature for more than 3 hours.
Danish: Hvis Provenge-infusionen af en eller anden grund må afbrydes, må lægen ikke genoptage infusionen, hvis lægemidlet har været opbevaret ved stuetemperatur i over 3 timer.
English: The most commonly reported adverse reactions are chills, fatigue, pyrexia, nausea, arthralgia, headache, and vomiting.
Danish: De hyppigst rapporterede bivirkninger er kulderystelser, træthed, pyreksi, kvalme, artralgi, hovedpine og opkastning.
English: - tingling, numbness or abnormal sensation (paraesthesia) around lips, in mouth, or in the arms and/or legs during the leukapheresis procedure - muscle spasms, chest pain, and low blood pressure during the leukapheresis procedure
Danish: - prikkende fornemmelse, følelsesløshed eller føleforstyrrelser omkring læberne, i munden eller i arme og ben, mens leukaferesen står på - muskelspasmer, brystsmerter og lavt blodtryk i løbet af leukaferesen på grund af et lægemiddel (citrat), som bruges til at forebygge blodpropper.
English: In controlled clinical trials, 25.4% of patients treated with Provenge required more than 3 leukapheresis procedures in order to receive 3 infusions.
Danish: I kontrollerede kliniske studier var mere end tre leukafereseprocedurer nødvendige hos 25,4 % af patienterne, for at de kunne få tre infusioner.
English: This medicinal product contains approximately 800 mg sodium per infusion.
Danish: Dette lægemiddel indeholder ca. 800 mg natrium pr. infusion.
English: After removal from the insulated container, Provenge should be used immediately.
Danish: Når Provenge-infusionsvæsken er taget ud af den isolerede beholder, skal den bruges med det samme.
English: Patient leukapheresis material is tested for transmissible infectious agents in line with applicable member state requirements.
Danish: Leukaferesemateriale fra patienten bliver testet for infektiøse stoffer i overensstemmelse med gældende krav i de enkelte medlemsstater.
English: Embolic and thrombotic events Provenge should be used with caution in patients with a history of embolic and thrombotic disorders.
Danish: Provenge skal anvendes med forsigtighed til patienter med emboliske og trombotiske sygdomme i anamnesen.
English: PAP-GM-CSF were observed in cells collected from peripheral blood of patients through the follow-up period in the Provenge treatment group but not in controls.
Danish: T-celleproliferation og γ-interferon-ELISPOTreaktioner på PAP og PAP-GM-CSF blev observeret i celler fra perifert blod opsamlet i løbet af opfølgningsperioden fra patienter i Provenge-gruppen, men ikke i kontrolgruppen.
English: If not used immediately, in use storage times and conditions should not exceed 3 hours at room temperature (25°C).
Danish: Hvis det ikke bruges med det samme, må opbevaringstiden under anvendelse ikke overskride 3 timer ved stuetemperatur (25 °C).
English: Provenge 50 x 106 CD54+ cells/250 mL dispersion for infusion
Danish: Provenge 50 x 106 CD54+-celler/250 ml dispersion til infusion