FrancophonIA/ELRC3.0 huggingface dataset:
English: SPECIAL STORAGE CONDITIONS Store the bag in the insulated container to maintain the correct storage temperature (2°C-8°C) until infusion.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar posen i den isolerede beholder for at opretholde den korrekte opbevaringstemperatur (2 °C-8 °C), indtil infusionen skal indgives.
English: Your doctor will give you a schedule for your cell collection and infusion appointments.
Danish: Lægen giver dig en tidsplan for, hvornår der skal foretages celleopsamling og Provenge-infusion.
English: Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T)
Danish: Autologe mononukleære celler fra perifert blod aktiveret med PAP-GM-CSF (Sipuleucel-T)
English: If you have severe reactions during the infusion your doctor may either slow down the infusion or stop it. You may also be given other medicines if needed.
Danish: Hvis du får alvorlige reaktioner under infusionen, kan lægen enten sænke infusionshastigheden eller stoppe infusionen.
English: You will have to have this procedure on at least 3 occasions approximately 3 days before each of your 3 Provenge infusion treatments.
Danish: Du skal gennemgå en leukaferese ca. 3 dage før hver af dine 3 Provenge
English: Potassium chloride Calcium chloride.
Danish: Calciumchlorid.
English: Accordingly, healthcare professionals should employ appropriate precautions when handling leukapheresis material or Provenge.
Danish: Sundhedspersonalet skal således tage passende forholdsregler i forbindelse med håndteringen af leukaferesemateriale eller Provenge.
English: Cerebral infarction
Danish: Cerebralt infarkt
English: Adverse reactions associated with leukapheresis
Danish: Bivirkninger med relation til leukaferese
English: In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction.
Danish: I tilfælde af en akut infusionsreaktion kan infusionen enten foretages langsommere eller afbrydes afhængigt af reaktionens sværhedsgrad.
English: Accordingly, healthcare professionals should employ appropriate precautions when handling leukapheresis material or Provenge (see section 4.4).
Danish: Sundhedspersonalet skal derfor tage passende forholdsregler i forbindelse med håndtering af leukaferesemateriale eller Provenge (se pkt.
English: • The product integrity has been breached in any way (the infusion bag is damaged, leaks, or particles/clumps remain in the bag after gentle manual mixing).
Danish: • Hvis produktets anvendelighed på nogen måde kan betvivles (hvis infusionsposen f.eks. er beskadiget eller utæt, eller hvis der fortsat er partikler/klumper i posens indhold efter forsigtig
English: In controlled clinical trials, infection occurred in 27.5% of subjects in the Provenge group and 27.7% of subjects in the control group.
Danish: I kontrollerede kliniske studier fik 27,5 % af forsøgspersonerne i Provenge-gruppen og 27,7 % af forsøgspersonerne i kontrolgruppen infektioner.
English: Accordingly, healthcare professionals should employ appropriate precautions when handling the leukapheresis material or Provenge.
Danish: Af denne grund skal læger og sundhedspersonale træffe passende forholdsregler, når de håndterer leukaferesemateriale eller Provenge.
English: Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T).
Danish: Autologe mononukleære celler fra perifert blod aktiveret med PAP-GM-CSF (Sipuleucel-T).
English: • a problem at the time your blood cells are taken for the manufacturing of Provenge.
Danish: • at der er et problem på det tidspunkt, hvor dine blodceller bliver indsamlet inden
English: • The Final Product Disposition Notification form is marked REJECTED.
Danish: • Hvis der står REJECTED (AFVIST) på Final Product Disposition Notification-formularen.
English: In some cases, you may be unable to receive a scheduled infusion of Provenge.
Danish: Det kan ske, at en planlagt Provenge-infusion ikke kan gennemføres.
English: Of the control arm patients, 64% crossed over to receive an investigational autologous cellular immunotherapy manufactured from cells cryopreserved at the time the control was manufactured; patients were not randomised to subsequent autologous cellular immunotherapy.
Danish: Af patienterne i kontrolgruppen gik 64 % over til at få forsøgsbehandling med autologe celler fremstillet af celler, der var blevet kryopræserveret, da kontrolproduktet blev lavet.
English: • Upon completion of the infusion, the patient specific label on the infusion bag should be removed and adhered to the patient file.
Danish: Efter infusionen • Når infusionen er færdig, skal den patientspecifikke etiket på infusionsposen tages af og
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: Shelf life and special precautions for storage
Danish: Opbevaringstid og særlige opbevaringsforhold
English: Your doctor will work with you to schedule new appointments for cell collection and infusion.
Danish: Så må lægen lave en ny aftale med dig om celleopsamling (leukaferese) og infusion.
English: The product also contains approximately 45 mg potassium per infusion.
Danish: Dette lægemiddel indeholder desuden ca. 45 mg kalium pr. infusion.
English: Therefore, Provenge may carry the risk of transmitting infectious viruses (HIV 1 and 2, hepatitis B and C) to health care professionals handling the product.
Danish: Derfor er der risiko for, at der overføres infektiøse vira (HIV 1 og 2 samt hepatitis B og C) fra leukaferesemateriale og Provenge til det sundhedspersonale, der håndterer produktet.
English: Store the bag in the insulated container to maintain the correct storage temperature (2°C-8°C) until infusion.
Danish: Opbevar posen i den isolerede beholder for at opretholde den korrekte opbevaringstemperatur (2 °C-8 °C), indtil infusionen gives.
English: In controlled clinical trials, 23.8% of patients treated with Provenge required opioids (a single dose of pethidine) on the day of infusion for infusion reactions (see sections 4.2 and 4.8).
Danish: I kontrollerede kliniske studier havde 23,8 % af de patienter, der blev behandlet med Provenge, behov for opioid (én dosis pethidin) på infusionsdagen for at afhjælpe infusionsreaktioner (se pkt.
English: NAME OF THE MEDICINAL PRODUCT PROVENGE 50 x 106 CD54+ cells/250 mL dispersion for infusion.
Danish: LÆGEMIDLETS NAVN Provenge 50 x 106 CD54+-celler/250 ml dispersion til infusion.
English: In controlled clinical trials, 23.8% of patients in the Provenge group required opioids (a single dose of pethidine) on the day of infusion for infusion reactions compared with 2.4% of patients in control group (see sections 4.2 and 4.4).
Danish: I kontrollerede kliniske studier havde 23,8 % af de patienter, der blev behandlet med Provenge, behov for opioid (én dosis pethidin) på infusionsdagen for at afhjælpe infusionsreaktioner, mens tallet for patienterne i kontrolgruppen var 2,4 % (se pkt.
English: To be taken into consideration by patients with reduced kidney function or on a controlled potassium diet.
Danish: Dette skal der tages højde for, hvis patienten har nedsat nyrefunktion eller følger en kaliumkontrolleret diæt.
English: Sodium chloride Sodium lactate Potassium chloride Calcium chloride
Danish: Natriumchlorid Natriumlactat Kaliumchlorid Calciumchlorid
English: Practical information for handling and administration of Provenge for the doctor or nurse can be found at the end of this leaflet.
Danish: Sidst i denne indlægsseddel findes instruktion til lægen og sundhedspersonalet i at håndtere og give Provenge.
English: Atrial fibrillation Myocardial infarction Myocardial ischaemia
Danish: Atrieflimren Myokardieinfarkt Myokardieiskæmi
English: Bacteraemia
Danish: Bakteriæmi
English: The identity of the patient must be matched with the essential unique patient information on the infusion bag and the Final Product Disposition Notification form prior to infusion.
Danish: Patientens identitet skal sammenholdes med de obligatoriske, entydige patientoplysninger på infusionsposen og på Final Product Disposition Notification-formularen, inden infusionsvæsken administreres.
English: • The disposition form verifying the product has been APPROVED has been provided
Danish: • Du har modtaget Final Product Disposition Notification-formularen, som bekræfter, at produktet er GODKENDT.
English: Before infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the Provenge bag and on the Final Product Disposition Notification form.
Danish: Inden infusion skal det bekræftes, at patientens identitet svarer til de obligatoriske, entydige patientoplysninger på Provenge-posen og på Final Product Disposition Notification-formularen.
English: How Provenge is given and duration of treatment Your doctor may suggest you take paracetamol and an antihistamine medicine about 30 minutes before your infusion to reduce the possible reactions to Provenge.
Danish: Sådan foregår behandlingen med Provenge, og så længe varer den For at dæmpe eventuelle reaktioner på behandlingen kan lægen foreslå, at du tager paracetamol og antihistamin ca. 30 minutter før infusionen.
English: Handling precautions for control of infectious disease Provenge is prepared from human blood of the specific patient and is not tested for transmissible infectious agents.
Danish: Provenge fremstilles ud fra blod fra den specifikke patient og bliver ikke testet for overførbare infektiøse stoffer.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot/COI {lot number/chain of identity} First Name, Middle Initial, Last Name {patient name} DOB {patient date of birth}
Danish: FREMSTILLERENS BATCHNUMMER, DONATIONS- OG PRODUKTKODER Lot-nummer/identitetskæde
English: To be taken into consideration by patients with heart conditions or those on a controlled sodium diet.
Danish: Dette skal tages i betragtning hos patienter, der har hjerteproblemer eller følger en natriumfattig diæt.
English: The dispersion is slightly cloudy, with a cream-to-pink colour.
Danish: Dispersionen er råhvid til lyserød og lettere uklar.
English: This medicinal product contains approximately 800 mg of sodium and 45 mg of potassium per infusion.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Dette lægemiddel indeholder ca. 800 mg natrium og 45 mg kalium pr. infusion.
English: Gently mix and re-suspend the contents of the bag, inspecting for particles, clumps or clots.
Danish: Bland og genopslæm forsigtigt posens indhold, og undersøg det for partikler og klumper.
English: Due dates
Danish: Tidsfrist
English: How to store Provenge
Danish: Infusion af Provenge
English: The educational material for healthcare professionals will include the following key elements:
Danish: Instruktionsmaterialet til sundhedspersoner:
English: Prior to infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the Provenge bag and on the Final Product Disposition Notification form (see sections 4.2 and 6.6).
Danish: Inden infusionen skal det bekræftes, at patientens identitet svarer til de obligatoriske, entydige patientoplysninger på Provenge-posen og på Final Product Disposition Notificationformularen (se pkt.
English: • If the infusion of Provenge must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours.
Danish: • Hvis det er nødvendigt at afbryde infusionen med Provenge, må den ikke genoptages, hvis infusionsposen har været opbevaret ved stuetemperatur (25 °C) i over 3 timer.
English: Gently mix and resuspend the contents of the bag, inspecting for clumps and clots.
Danish: Bland og genopslæm forsigtigt posens indhold, og undersøg det for klumper.
English: • It must be ensured that the patient's identity matches the essential unique patient information on the Provenge bag and the Final Product Disposition Notification form.
Danish: • Det skal bekræftes, at patientens identitet svarer til de obligatoriske, entydige patientoplysninger på Provenge-posen og på Final Product Disposition Notificationformularen.
English: If you need more information on the testing of your blood please ask your doctor or nurse.
Danish: Det kan være, at du skal have foretaget flere blodtællinger i løbet af behandlingen, hvis reglerne i dit land eller på dit behandlingssted foreskriver det. Spørg lægen eller sundhedspersonalet, hvis du vil have mere at vide om undersøgelsen af dit blod.
English: Gently mix and re-suspend the contents of the bag.
Danish: Bland og genopslæm posens indhold forsigtigt.
English: If the infusion of Provenge must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours (see section 6.3).
Danish: Hvis det er nødvendigt at afbryde infusionen med Provenge, må den ikke genoptages, hvis infusionsposen har været opbevaret ved stuetemperatur (25 °C) i mere end 3 timer (se pkt.
English: Hypoxia Wheezing Dyspnoea Bronchospasm
Danish: Hvæsende vejrtrækning Dyspnø
English: If the infusion of Provenge must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours.
Danish: Hvis det er nødvendigt at afbryde infusionen med Provenge, må den ikke genoptages, hvis infusionsposen har været opbevaret ved stuetemperatur (25 °C) i mere end 3 timer.
English: - increase in a type of white blood cells called eosinophils - infusion site reaction (a reaction of the skin area where the infusion drip was inserted)
Danish: - overfølsomhedsreaktion på indstiksstedet (det sted i huden, hvor droppet er sat i).
English: Provenge treatment checklists
Danish: Oversigt over indlægssedlen
English: 0.331 c
Danish: 0,786b (0,484-1,278) 0,331c
English: Visit 6 - Provenge infusion
Danish: Besøg 6 - Provenge-infusion.
English: Musculoskeletal and connective tissue disorders
Danish: Emboliske og trombotiske hændelser
English: Dizziness
Danish: Hypæstesi
English: See leaflet for further information.
Danish: Der er flere oplysninger i indlægssedlen.
English: - decrease of platelets in the blood due to the leukapheresis procedure Uncommon side effects (may affect up to 1 in 100 patients - severe infection in the blood from a contaminated catheter (catheter sepsis) - infection from a contaminated catheter (catheter-related infection) - skin infection of the area where the infusion drip was inserted
Danish: - infektion fra et forurenet kateter - infektion i det hudområde, hvor droppet indføres - hjerteanfald - symptomer på hjerteanfald - forhøjet antal af en type hvide blodlegemer kaldet eosinofile leukocytter.
English: Haematuria
Danish: Svimmelhed
English: • tiredness
Danish: Katetersepsis
English: In the pivotal randomised controlled study (D9902B, IMPACT, see section 5.1) Provenge was discontinued in 1.5% of patients due to adverse reactions.
Danish: I det randomiserede, kontrollerede pivotalstudie (D9902B, IMPACT, se pkt.
English: • shortness of breath, wheezing, dizziness, rash, or fever.
Danish: - udslæt, herunder hævet, kløende udslæt (nældefeber) eller kløe
English: If you experience any of the following side effects several days after the infusion, contact a doctor immediately:
Danish: Hvis du får nogen af følgende bivirkninger flere dage efter infusionen, skal du straks søge læge: • stakåndethed, hvæsende vejrtrækning, svimmelhed, udslæt eller feber.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot /COI {lot number/chain of identity} First Name, Middle Initial, Last Name {patient name} DOB {patient date of birth}
Danish: Patientens fornavn, mellemnavnsinitial, efternavn Patientens fødselsdato
English: Patients with renal impairment and/or hyperkalaemia and/or on a controlled potassium diet Provenge has not been investigated in patients with renal impairment.
Danish: Patienter med nedsat nyrefunktion og/eller hyperkaliæmi, og/eller som følger en kaliumkontrolleret diæt
English: One bag containins autologous peripheral blood mononuclear cells activated with PAP-GM-CSF, including a minimum of 50 x 106 autologous CD54+ cells.
Danish: Én pose indeholder autologe mononukleære celler fra perifert blod aktiveret med PAP-GM-CSF og indeholder minimum 50 x 106 autologe CD54+-celler.
English: Vascular disorders
Danish: Rygmarvskompression Synkope
English: One bag contains autologous peripheral blood mononuclear cells activated with PAP-GM-SF (prostatic acid phosphatase-granulocyte macrophage-colony stimulating factor), including a minimum of 50 x 106 autologous CD54+ cells.
Danish: Én pose indeholder autologe mononukleære celler fra perifert blod aktiveret med PAP-GM-CSF (prostatic acid phosphatase-granulocyt/makrofag-kolonistimulerende faktor) og indeholder minimum inklusive minimum 50 x 106 autologe CD54+ -celler.
English: Tel: (0)20 7554 2222
Danish: 0,775a (0,614-0,979)
English: • feeling or being sick (nausea and vomiting)
Danish: • kvalme eller opkastning
English: One bag contains autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (prostatic acid phosphatase-granulocyte macrophage-colony stimulating factor), including a minimum of 50 x 106 autologous CD54+ cells
Danish: Én pose indeholder autologe mononukleære celler fra perifert blod aktiveret med PAP-GM-CSF (prostatic acid phosphatase-granulocyt/makrofag-kolonistimulerende faktor) og indeholder minimum 50 x 106 autologe CD54+-celler.
English: Sodium lactate
Danish: Kaliumchlorid
English: The active substance is autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (prostatic acid phosphatase-granulocyte macrophage-colony stimulating factor), including a minimum of 50 x 106 autologous CD54+ cells.
Danish: Aktivt stof: Provenge indeholder autologe mononukleære celler fra perifert blod aktiveret med PAPGM-CSF (prostatic acid phosphatase-granulocyt/makrofag-kolonistimulerende faktor) og indeholder minimum 50 x 106 autologe CD54+-celler.
English: Influenza-like illness Chest discomfort
Danish: Influenzalignende sygdom Gener i brystet
English: If you have any further questions, ask your doctor or nurse.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Pregnancy, breast-feeding and fertility Provenge is for use in men only.
Danish: Graviditet, amning og fertilitet
English: It is available as tablets (375 mg).
Danish: Det fås som tabletter (375 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske
English: This is a summary of the European public assessment report (EPAR) for Incivo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Incivo.
English: The full EPAR for Incivo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Incivo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Alternatively, two Incivo tablets can be taken every eight hours with food.
Danish: Alternativt kan to Incivo tabletter tages hver 8. time i forbindelse med et måltid.
English: What measures are being taken to ensure the safe use of Incivo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Incivo?
English: In addition, treatment could be shortened for many patients and the benefits could be seen across different patient types with different degrees of liver damage.
Danish: Hertil kommer, at behandlingen kan afkortes for mange patienter, og at fordelene kan ses hos forskellige patienttyper med forskellige grader af leverskader.
English: The CHMP considered that adding Incivo to standard treatment represents a major advance in treating the most common type of hepatitis C virus.
Danish: CHMP var af den opfattelse, at tilføjelsen af Incivo til standardbehandlingen udgør et stort fremskridt i behandlingen af den mest almindelige type hepatitis C-virus.
English: The company that markets Incivo will provide all doctors who are expected to prescribe it with an educational pack containing important safety information on the main risks with Incivo, in particular the risk of rash and severe skin reactions.
Danish: Den virksomhed, der markedsfører Incivo, vil give alle læger, som forventes at ordinere lægemidlet, undervisningsmateriale med vigtig sikkerhedsinformation om de største risici ved Incivo, navnlig risikoen for udslæt og svære hudreaktioner.
English: Treatment with Incivo should be started and monitored by a doctor experienced in managing chronic
Danish: Behandling med Incivo skal indledes og overvåges af en læge med erfaring i behandling af kroniske
English: Incivo is a medicine that contains the active substance telaprevir.
Danish: Incivo er et lægemiddel, der indeholder det aktive stof telaprevir.
English: Incivo must not be given in combination with several other medicines, including those which are affected by or affect the CYP3A gene and Class Ia or III antiarrhythmics.
Danish: Incivo må ikke gives i kombination med adskillige andre lægemidler, herunder lægemidler, der påvirkes af eller kan påvirke CYP3A-genet og klasse Ia- eller III-antiarytmika.
English: This stops the hepatitis C virus from replicating in the infected host cells of the body.
Danish: Dette hindrer hepatitis C-virus i at formere sig i kroppens inficerede værtsceller.
English: What is the risk associated with Incivo?
Danish: Hvilke risici er der forbundet med Incivo?
English: The CHMP therefore concluded that the benefits of Incivo were greater than its risks, and recommended it be granted marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Incivo opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Three Incivo tablets should be swallowed whole twice a day with food for a period of 12 weeks.
Danish: Der tages dagligt to gange tre Incivo-tabletter, som synkes hele i forbindelse med et måltid i en periode på 12 uger.
English: In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus six months after the end of
Danish: I alle tre undersøgelser var det primære effektmål antallet af patienter, hvis blodprøver ikke viste nogen tegn på hepatitis C-virus seks måneder efter behandlingens afslutning.
English: The active substance in Incivo, telaprevir, is a protease inhibitor.
Danish: Det aktive stof i Incivo, telaprevir, er en proteasehæmmer.
English: The Committee noted that in both previously untreated patients and patients who had already been treated, adding Incivo to standard treatment considerably increased the number showing no sign of infection after six months.
Danish: Udvalget bemærkede, at hos ikke tidligere behandlede patienter og hos tidligere behandlede patienter øgede tilføjelsen af Incivo til standardbehandlingen i væsentlig grad antallet af patienter, der ikke viste noget tegn på infektion efter seks måneder.
English: Incivo must not be used in patients who are hypersensitive (allergic) to telaprevir or any of the other ingredients.
Danish: Incivo må ikke anvendes til patienter, der er overfølsomme (allergiske) over for telaprevir eller andre af indholdsstofferne.
English: It blocks the action of an enzyme called NS3-4A protease in the hepatitis C virus, which is essential for its life cycle.
Danish: Det hæmmer virkningen af et enzym i hepatitis C-virus, der kaldes NS3-4A-protease, og som er vigtigt for dets livscyklus.
English: How does Incivo work?
Danish: Hvordan virker Incivo?
English: When Incivo is added to peginterferon alfa and ribavirin (the current standard treatment for hepatitis C) this increases the likelihood of the virus being killed.
Danish: Når Incivo føjes til peginterferon alfa og ribavirin (den almindelige standardbehandling for hepatitis C), øger dette sandsynligheden for, at virussen bliver dræbt.