natgillin/translations-raw huggingface dataset:
Provenge skal generelt anvendes med forsigtighed til immunkompromitterede patienter, herunder patienter i systemisk immunsupprimerende behandling, idét det i hvert enkelt tilfælde skal overvejes nøje, om de potentielle fordele opvejer den potentielle risiko.
Provenge should be used with caution in immunocompromised patients in general including patients taking systemic immunosuppressive therapy, after careful consideration of the potential risk-benefit on an individiual basis.
Efter markedsføring er der rapporteret alvorlige akutte infusionsreaktioner - hypotension og synkoper.
In the post-marketing setting, serious acute infusion reactions involving hypotension and syncope have been reported.
• Yderemballagen (forsendelseskassen) åbnes, og de produkt- og patient-specifikke etiketter øverst på den isolerede beholder verificeres.
• The outer shipping box should be opened to verify the product and patient-specific labels located on the top of the insulated container.
Inden den første leukafereseprocedure skal der udføres komplet blodtælling, der skal ligge inden for det område, som det lokale center kan acceptere.
Prior to the first leukapheresis procedure, a complete blood count (CBC) test should be performed and be within ranges acceptable for the local facility.
Advarsler og forsigtighedsregler Tal med lægen, inden du får Provenge, hvis noget af nedenstående gælder for dig, da du i så fald skal overvåges nøje under og efter infusionen:
Warnings and precautions Tell your doctor if you have any of the conditions listed below as you will have to be closely monitored during and after your infusion:
Det anbefalede behandlingsforløb er 3 doser givet med ca. 2 ugers mellemrum.
The recommended course of treatment is 3 doses at approximately 2 week intervals.
Oversigt over studieresultaterne Tabel 2 viser resultaterne for samlet overlevelse observeret i IMPACT, D9901- og D9902A-studierne.
Summary of study results Table 2 presents overall survival results observed in IMPACT, study D9901, and study D9902A.
Instruktionsmaterialet til patienter og/eller plejere:
Educational material for patients and/or carers to explain:
Administration Provenge er udelukkende beregnet til autolog brug ved intravenøs infusion.
Method of administration Provenge is solely intended for autologous use via intravenous infusion.
Provenge er en behandling med autologe celler.
Provenge is an autologous cellular therapy.
Det primære effektmål var tid til sygdomsprogression, og det sekundære effektmål var samlet overlevelse.
The primary endpoint was time to disease progression and the secondary endpoint was overall survival.
For at minimere risikoen for akutte infusionsreaktioner som kulderystelser og/eller feber anbefales det, at patienterne præmedicineres oralt med paracetamol og et antihistamin ca. 30 minutter før administrationen af Provenge.
To minimize potential acute infusion reactions such as chills and/or fever, it is recommended that patients be pre-medicated orally with paracetamol and an antihistamine approximately 30 minutes prior to administration of Provenge.
Ingen akutte infusionsreaktioner af grad 4 eller 5 blev rapporteret hos patienterne i Provenge-gruppen.
No Grade 4 or 5 acute infusion reactions were reported in patients in the Provenge group.
Inden du håndterer eller administrerer Provenge
Before handling or administering Provenge
• feber, kulderystelser og åndedrætsbesvær
• high temperature, chills, breathing difficulties
• Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale
• Any unused product or waste material should be disposed of in accordance with local
Patienterne i kontrolgruppen kunne deltage i en åben protokol og få forsøgsbehandling med autologe celler fremstillet af celler, der var blevet kryopræserveret, da kontrolproduktet blev lavet.
Patients in the control group could enrol in an open-label protocol and receive an investigational autologous cellular therapy manufactured from cells cryopreserved at the time the control product was prepared.
Når Provenge gives som drop (infusion) gennem en vene, fungerer det ved at lære dine immunceller at genkende prostatakræftceller og gå til angreb på dem.
When given as a drip (infusion) into your vein, Provenge works by teaching your immune cells to recognise and attack prostate cancer cells.
Patienterne skal informeres om muligheden for senreaktioner og have at vide, at de skal kontakte en læge, hvis de får symptomer som dyspnø, bronkospasmer, svimmelhed, udslæt eller pyreksi.
Patients should be informed of the possibility of late onset reactions and instructed to contact their physician if symptoms of dyspnoea, bronchospasm, dizziness, rash, or pyrexia occur.
Udløbsdato (dd måned åååå), klokkeslæt, tidszone
Date {DD month YYYY}, Exp. Time {hh:mm}, Time Zone
Det skal sikres, at den GODKENDTE Final Product Disposition Notification-formular er modtaget fra indehaveren af markedsføringstilladelsen, og at produktets udløbsdato ikke er overskredet (se pkt.
It must be ensured that the APPROVED Final Product Disposition Notification form has been received from the marketing authorisation holder and the product has not expired (see section 6.6).
Formålet med Provenge er at stimulere dit immunsystem, og det kan derfor være uhensigtsmæssigt for dig at blive behandlet med Provenge, hvis du tager andre lægemidler, som kan påvirke dit immunsystems evne til at blive stimuleret af Provenge, f.eks. immundæmpende medicin som den, der bruges til at forebygge organafstødning efter transplantation, og visse lægemidler, som bruges til at behandle leddegigt, dissemineret sklerose, Crohns sygdom og ulcerøs tyktarmsbetændelse.
Provenge is designed to stimulate your immune system, and therefore it may not be appropriate to be treated with Provenge if you are currently taking other treatments that could affect the ability of your immune system to respond to Provenge e.g., 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.
Derudover er der spontant post-marketing blevet rapporteret trombocytopeni, som har haft tidsmæssig sammenhæng med leukaferesen.
Additionally, there have been reports of thrombocytopenia received in spontaneous post-marketing reporting that have been temporally associated with leukapheresis.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Provenge i alle undergrupper af den pædiatriske population i behandlingen af prostatacancer (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Provenge in all subsets of the paediatric population in the treatment of prostate cancer (see section 4.2 for information on paediatric use).
• hvis du følger en natrium- eller kaliumfattig diæt eller har nedsat nyrefunktion.
• You are on a controlled sodium/potassium diet or you have reduced kidney function.
• beskriver udvælgelsen af patienter, der kan behandles med Provenge
• Selection of patients for treatment with Provenge
Det anbefales på det kraftigste efter hver enkelt infusion at fjerne den patientspecifikke etiket med patientens navn, produktnavnet og identitetskæde/lot-nummeret fra infusionsposen og sætte den ind patientens journal, så forbindelsen mellem patienten og produktets lot-nummer bibeholdes.
It is strongly recommended that upon completion of each Provenge infusion, the patient specific label on the infusion bag, which contains the patient name, product name, and chain of identity (COI) product lot number, is removed and adhered to the patient file in order to maintain a link between the patient and the lot of the product.
Der var sammenhæng mellem cellulær respons og antistofreaktioner på PAP og PAP-GM-CSF i Provengegruppen og forbedret overlevelse.
There was a correlation between cellular or antibody responses to PAP or PAP-GM-CSF in the Provenge group and improved survival.
Dendreon UK Limited 41 Chalton Street London, NW1 1JD England
Dendreon UK Limited 41 Chalton Street London, NW1 1JD United Kingdom
Eksklusionskriterierne omfattede viscerale (lever-, lungeeller hjerne-) metastaser, malign pleuraeffusion eller malign ascites, patologiske frakturer af lange knogler, overhængende risiko for patologiske frakturer af lange knogler (kortikal erosion ved røntgen > 50%), rygmarvskompression, moderate til svære prostatacancer-relaterede smerter, brug af opioider til lindring af cancerrelaterede smerter samt kemoterapi inden for de sidste tre måneder før randomiseringen.
Exclusion criteria included visceral (liver, lung, or brain) metastases, malignant pleural effusions or malignant ascites, pathologic long bone fractures, imminent pathologic long-bone fractures (cortical erosion on radiography >50%), spinal cord compression, moderate to severe prostate cancer-related pain and use of narcotics for cancerrelated pain, and treatment with chemotherapy at least 3 months prior to randomisation.
Kontakt omgående lægen, hvis du pludseligt oplever synssvigt på det ene øje, talebesvær, følelsesløshed og/eller svaghedsfornemmelse i den ene side af kroppen, da disse symptomer kan være tegn på et slagtilfælde.
Contact a doctor immediately if you experience sudden vision loss in one eye, difficulty speaking, numbness and/or weakness affecting one side of the body as any of these may be signs of a stroke.
Indsende resultaterne fra studie P-11, et randomiseret, dobbeltblindet studie til vurdering af Provenge versus placebo hos patienter med ikke-metastatisk prostatacancer, der fik PSA-forhøjelse efter radikal prostatektomi
To submit the results from study P-11, a randomised, double-blind trial evaluating Provenge versus placebo in patients with non-metastatic prostate cancer who experience PSA elevation following radical prostatectomy
Produktkarakterisering viser, at PAP- og PAP-GM-CSFfusionsproteinspecifikke T-celler genereres under Provenge-behandling og kan påvises i patienternes perifere blod efter behandlingen.
Product characterization shows that PAP and PAP-GM-CSF fusion protein-specific T cells are generated during treatment and are detected in the peripheral blood of patients after treatment with Provenge.
• Provenge sendes direkte til den afdeling, hvor infusionsvæsken skal administreres.
• Provenge is shipped directly to the medical facility where the infusion will be administered.
Patienterne skal vurderes nøje for at afgøre, om det er klinisk hensigtsmæssigt at seponere immunsupprimerende stoffer inden behandlingen med Provenge (se pkt.
Patients should be carefully evaluated to determine whether it is medically appropriate to discontinue immunosuppressive agents prior to treatment with Provenge (see section 4.4).
Fortæl altid lægen eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Der skal gives passende medicinsk behandling efter behov, herunder f.eks. paracetamol, intravenøs H1- og/eller H2-blokker samt intravenøs pethidin i lav dosis.
Appropriate medical therapy, which could include paracetamol, intravenous H1 and/or H2 blockers, and low dose intravenous pethidine, should be administered as needed.
Giv ikke infusionen, hvis præparatet er udløbet, har været opbevaret mere end 3 timer ved stuetemperatur (25 °C) eller har synlige partikler eller klumper trods forsigtig manual blanding.
Do not initiate infusion if expired, after 3 hours at room temperature (25°C), or if particles/clumps are visible despite gentle manual mixing.
Dendreon UK Ltd. 41 Chalton Street London, NW1 1JD England
Dendreon UK Ltd. 41 Chalton Street London, NW1 1JD United Kingdom
I det kliniske studie D9902B (IMPACT) blev 237 ud af de 512 randomiserede patienter vurderet for udvikling af humorale eller cellulære immunreaktioner (T-celleproliferation og gamma-interferon-(γ-interferon)-ELISPOT) på målantigener ved baseline i uge 6, 14 og 26.
In clinical study D9902B (IMPACT), 237 out of the 512 patients randomized were evaluated for the development of humoral or cellular immune responses (T cell proliferation and gamma-interferon
Du vil få 3 Provenge-infusioner i alt med ca. 2 ugers mellemrum.
You will receive a total of 3 infusions of Provenge at approximately 2 week intervals.
Det kan ske, at patienten ikke er i stand til at få en planlagt Provenge-infusion.
In some cases, the patient may be unable to receive a scheduled infusion of Provenge.
De bivirkninger, der hyppigst blev rapporteret senest 1 dag efter en leukafereseprocedure i kontrollerede kliniske studier, omfattede citrattoksicitet (14,6 %), oral paræstesi (12,0 %) og paræstesi (11,1 %).
Adverse reactions that were reported most commonly ≤ 1 day following a leukapheresis procedure in controlled clinical trials included citrate toxicity (14.6%), oral paraesthesia (12.0%), and paraesthesia (11.1%).
6.5 Emballagetype og pakningsstørrelser og specielt udstyr til anvendelse, administration
6.5 Nature and contents of container and special equipment for use, administration or implantation
• Hvis du ikke har modtaget Final Product Disposition Notification-formularen.
• You have not received the Final Product Disposition Notification form.
Provenge benyttes til at få din prostatakræft under kontrol.
Provenge is used to control your prostate cancer.
Gennemføre studie P12-1 til vurdering af de karakteristika, der er prædiktive for en positiv billeddiagnostik, hvad angår fjernmetastaser hos patienter med kastrationsresistent prostatacancer.
To conduct study P12-1 to evaluate characteristics predictive of a positive imaging study for distant metastases in patients with castrate-resistant prostate cancer.
Hvis patienten af en eller anden grund er ude af stand til at få en planlagt Provenge-infusion, skal han gennemgå en yderligere leukafereseprocedure, inden behandlingsforløbet kan fortsætte.
If, for any reason, the patient is unable to receive a scheduled infusion of Provenge, the patient will need to undergo an additional leukapheresis procedure if the course of treatment is to be continued.
Provenges påvirkning af mænds frugtbarhed kendes ikke på nuværende tidspunkt.
The effects of Provenge on male fertility are not known at this time.
Analyser af tid til objektiv sygdomsprogression, tid til klinisk progression og fordoblingstid for PSA viste ikke statistisk signifikante resultater.
Analyses of time to objective disease progression, time to clinical progression, or PSA doubling time (PSADT) did not meet statistical significance.
Hele infusionsposens indhold skal bruges.
The entire volume of the infusion bag should be used.
Når dette lægemiddel er taget ud af den isolerede beholder, skal det bruges med det samme.
After removal from the insulated container, the medicinal product should be used immediately.
Afhængigt af sygdomsudvikling fik patienterne anden anticancerbehandling efter lægens skøn.
Following disease progression, patients were treated at the physician's discretion with other anti-cancer interventions.
Håndteringsvejledning
Handling instructions
Der er rapporteret om alvorlige infektioner i forbindelse med overvågning efter markedsføringen, herunder device-relateret infektion, device-relateret sepsis, pneumoni, sepsis, bakteriæmi og urinvejsinfektioner.
Reports of serious infection have been received in post-marketing surveillance including devicerelated infection, device-related sepsis, pneumonia, sepsis, bacteraemia, and urinary tract infection.
I de kliniske studier var der omkring en fjerdedel af patienterne, hvor mere end tre leukafereser var nødvendige, for at patienten kunne få tre infusioner med Provenge.
In clinical studies, about one quarter of the patients required more than 3 leukapheresis procedures in order to receive 3 infusions of Provenge.
Det kan være, du skal komme til et eller flere yderligere besøg for at få dit blod undersøgt inden leukaferesen (afhængigt af praksis på den afdeling eller klinik, hvor du behandles).
You may need one or more additional visits in order to have your blood tested before your leukapheresis procedure (depending on the usual pratice in the clinic where you are having your treatment), or your blood may be tested during your leukapheresis visits:
Samtidig brug af immunsupprimerende stoffer som f.eks. systemiske kortikosteroider kan ændre virkningen af og/eller sikkerheden ved Provenge.
Concurrent use of immunosuppressive agents (such as systemic corticosteroids) may alter its efficacy and/or safety.
• understreger nødvendigheden af at udlevere instruktionsmateriale til patienterne og forklare
• The need to provide patients with the educational material and explain the use of the patient
Posen skal tages ud af den isolerede polyuretanbeholder og undersøges for lækager, ydre skader, fremmede partikler og klumper.
The bag should be removed from the insulated polyurethane container and inspected for leaks, external damage, foreign particulate matter, or clumps/clots.
Der er observeret akutte infusionsreaktioner hos patienter, der blev behandlet med Provenge.
Acute infusion reactions have been observed in patients treated with Provenge.
Derfor er det vigtigt, at procedurerne for håndtering og administration af Provenge følges nøje (se pkt.
Hence it is important that the procedures for handling and administering the product are precisely followed (see section 6.6).
Du får Provenge via et drop (infusion) i en af dine blodårer (en vene - intravenøs indgift).
Your Provenge treatment will be given by a drip (infusion) into one of your veins (intravenous use).
Provenge skal administreres under supervision af en læge, der har erfaring med medicinsk behandling af prostatacancer, og på et sted, hvor der er genoplivningsudstyr til rådighed.
Provenge must be administered under the supervision of a physician experienced in the medical treatment of prostate cancer and in an environment where availability of resuscitation equipment must be ensured.
Det er ikke relevant at bruge Provenge til børn og unge under 18 år til indikationen asymptomatisk eller minimalt symptomatisk metastatisk (ikke-visceral) kastrationsresistent prostatacancer hos voksne mænd, hos hvem kemoterapi endnu ikke er klinisk indiceret.
There is no relevant use of Provenge in the paediatric population in children and adolescents less than 18 years of age in the indication of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter):
Common side effects (may affect up to 1 in 10 patients):
Provenge bliver ikke testet for overførbare infektiøse stoffer.
Provenge is not tested for transmissible infectious agents.
Det skal du tjekke inden infusion
What to check prior to infusion
For at mindske disse reaktioner kan lægen foreslå, at du tager paracetamol og antihistamin ca. 30 minutter før behandlingen med Provenge.
To reduce these reactions your doctor may suggest that you take paracetamol and an antihistamine medicine about 30 minutes before your treatment with Provenge.
Akutte infusionsreaktioner
Acute infusion reactions
Under ex vivo-dyrkning af PAP-GM-CSF optager og omdanner aktiverede APC'er (antigenpræsenterende celler) det rekombinante målantigen til peptider, som derefter præsenteres for T-celler.
During ex vivo culture with PAP-GM-CSF, activated APCs (antigen presenting cells) take up and process the recombinant target antigen into peptides that are then presented to T cells.
Sekundære effektmål omfattede tid til objektiv sygdomsprogression, tid til klinisk progression og fordoblingstid for PSA.
Secondary endpoints included time to objective disease progression, time to clinical progression, and PSA doubling time (PSADT).
Behandling af de deltagende patienter med kirurgisk eller medicinsk kastration (f.eks. luteiniserende hormonfrigivende hormon-agonist (LHRH) eller gonadotropinfrigivende hormon-antagonist (GnRh)) var mislykkedes, og de havde metastaser i bløddele og/eller knogler.
The patients enrolled in these trials had failed surgical or medical castration (e.g. luteinising hormone-releasing hormone [LHRH] agonist or gonadotropin-releasing hormone [GnRh] antagonist) therapies and had metastatic disease in the soft tissue and/or bone.
I kontrollerede kliniske studier blev der observeret myokardieinfarkt hos 0,8 % af patienterne i Provenge-gruppen sammenlignet med hos 0,3 % af patienterne i kontrolgruppen.
In controlled clinical trials, myocardial infarctions were observed in 0.8% of patients in the Provenge group compared with 0.3% of patients in the control group.
• Provenge fremstilles ud fra blod fra den specifikke patient og bliver ikke testet for overførbare infektiøse stoffer.
• Provenge is prepared from human blood of the specific patient and is not tested for transmissible infectious agents.
Alvorlige infektioner opstod hos 4,7 % af forsøgspersonerne i Provenge-gruppen og hos 4,0 % af forsøgspersonerne i kontrolgruppen.
Serious infections occurred in 4.7% of subjects in the Provenge group and 4.0% of subjects in the control group.
Til intravenøs infusion.
For intravenous infusion.
VIGTIGT - Du må ikke administrere Provenge
IMPORTANT - Do not infuse Provenge if
Provenge er indiceret til behandling af asymptomatisk eller minimalt symptomatisk metastatisk (ikkevisceral) kastrationsresistent prostatacancer hos voksne mænd, hos hvem kemoterapi endnu ikke er klinisk indiceret.
Provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (nonvisceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
• 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).
• 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)
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.
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.
Nogle alvorlige tilfælde af infektion og sepsis skyldtes brug af centrale venekatetre.
Some serious infections and sepsis were related to the use of central venous catheters (CVCs).
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).
If you are allergic (hypersensitive) to the active substances or any of the ingredients of this medicine (listed in section 6).
I tilfælde af en akut infusionsreaktion kan infusionen enten afbrydes eller foretages langsommere afhængigt af reaktionens sværhedsgrad.
In the event of an acute infusion reaction, the infusion may be interrupted or slowed, depending on the severity of the reaction.
• 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.
• 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.
Graviditet Provenge er ikke beregnet til brug hos kvinder.
Pregnancy Provenge is not intended for use in women.
Skal bortskaffes i henhold til lokale retningslinjer.
Dispose of in accordance with local requirements.