FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported adverse reactions in the Phase II and III clinical studies were urinary and reproductive system disorders: dysuria (25.1 %), erectile dysfunction (21.1 %), haematuria (19.6 %), perineal pain/haematoma (15.3 %), urinary retention (13.3 %), micturition urgency (9.0 %), pollakiuria (7.3 %), urinary tract infection (5.5 %), incontinence (5.3 %) and ejaculation failure
Danish: De hyppigst indberettede bivirkninger i kliniske fase II- og III-undersøgelser var forstyrrelser i urinvejene og det reproduktive system: dysuri (25,1 %), erektil dysfunktion (21,1 %), hæmaturi (19,6 %), smerter/hæmatom i perineum (15,3 %), urinretention (13,3 %), vandladningstrang (9,0 %), pollakisuri (7,3 %), urinvejsinfektion (5,5 %), inkontinens (5,3 %) og manglende ejakulation (5,0 %).
English: The recommended dose of TOOKAD is one single dose of 3.66 mg per kg of body weight, injected into a vein.
Danish: Den anbefalede dosis TOOKAD er én enkelt dosis på 3,66 mg pr. kg legemsvægt, som sprøjtes ind i en blodåre.
English: Transfer the contents of the vial into an opaque syringe.
Danish: Overfør indholdet af hætteglasset til en uigennemsigtig sprøjte.
English: If you have had an active inflammatory bowel disease or any condition that may increase the risk of causing abnormal connection between the rectum and the urethra (recto-urethral fistula), the treatment should be given only after careful evaluation.
Danish: Hvis du har haft en aktiv inflammatorisk tarmsygdom eller andre lidelser, der kan øge risikoen for, at der opstår en unormal forbindelse mellem endetarmen og urinrøret (rekto-uretrafistel), bør behandlingen kun administreres efter en omhyggelig vurdering.
English: You should wear dark clothes and take care to protect your hands and face from the sun.
Danish: Du skal bære mørkt tøj og sørge for at beskytte dit ansigt og dine hænder mod sollys.
English: As shown in Table 6, in the VTP arm of PCM301 study, erectile function domain scores of the 15-question International Index of Erectile Function (IIEF-15) questionnaire showed a marked decrease, 7 days after the VTP procedure followed by a subsequent improvement in the following months up to Month 24, in the ITT population and in patients meeting the indication criteria.
Danish: Som det fremgår af tabel 6 vedrørende VTP-gruppen i PCM301-undersøgelsen, viste IIEF-15spørgeskemaet (International Index of Erectile Function med 15 spørgsmål), hvad angår erektil funktion, et markant fald 7 dage efter VTP-proceduren efterfulgt af en bedring i de følgende måneder frem til måned 24 i ITT-populationen og hos de patienter, der opfylder indikationskriterierne.
English: Abnormal clotting is not expected to affect how well the treatment works ; however, it is recommended that drugs that affect clotting are stopped prior to and for the immediate period following the VTP procedure.
Danish: Unormal blodstørkning forventes ikke at have betydning for, hvor godt behandlingen virker; det anbefales dog, at stoffer, der kan påvirke størkningen, stoppes før VTP-proceduren og i perioden umiddelbart derefter.
English: Only use light bulbs with a maximum power of 60 watts (for an incandescent light bulb) or 6 watts (for LED lights), or 12 watts (for fluorescent low-energy lights).
Danish: Du må kun anvende pærer med en maksimal effekt på 60 watt (for glødepærer), 6 watt (for LED-lys) eller 12 watt (for lavenergipærer).
English: When activated with 753 nm wavelength laser light, padeliporfin triggers a cascade of pathophysiological events resulting in focal necrosis within a few days.
Danish: Når padeliporfin aktiveres med laserlys med en bølgelængde på 753 nm, udløser det en kaskade af patofysiologiske hændelser, der fører til fokal nekrose i løbet af et par dage.
English: Abnormal clotting (fibrin D dimer increased, aPTT prolonged, INR increased).
Danish: 14 Unormal blodkoagulation (forhøjet fibrin D-dimer, forlænget aPTT, forhøjet INR).
English: • Information on the potential benefits, risks and uncertainties of VTP with TOOKAD, including: uncertainties on long-lasting benefit of TOOKAD; uncertainties on long-term safety of TOOKAD and efficacy/safety of any further treatments required such as radical prostatectomy
Danish: • Oplysninger om mulige fordele, risici og usikkerheder ved VTP med TOOKAD, herunder usikkerhed med hensyn til den langsigtede fordel ved TOOKAD, usikkerhed med hensyn til den langsigtede sikkerhed ved TOOKAD og virkning/sikkerhed ved eventuelle yderligere nødvendige behandlinger som f.eks. radikal prostatektomi
English: TOOKAD is activated immediately after injection by shining light through the fibres from a connected laser device.
Danish: TOOKAD aktiveres straks efter injektionen ved, at der sendes lys gennem fibrene fra et tilkoblet laserapparat.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighed er bivirkningerne opstillet efter, hvor alvorlige de er.
English: No in vitro or in vivo studies have been conducted with radiolabelled padeliporfin.
Danish: Der er ikke udført in vitro- eller in vivo-undersøgelser med radioaktivt mærket padeliporfin.
English: After reconstitution with a 5 % glucose solution in its vial, the chemical and physical stability of TOOKAD has been demonstrated for 8 hours at 15°C-25°C and at 5°C ± 3°C.
Danish: Efter rekonstitution med en 5 %-glucoseopløsning i hætteglasset er TOOKAD's kemiske og fysiske brugsstabilitet påvist i 8 timer ved 15-25 °C og ved 5 °C ± 3 °C.
English: During the procedure, the number and the length of the optical fibres are selected depending on the shape and the size of the prostate and the optical fibres are positioned transperineally into the prostate gland under ultrasound guidance to achieve a Light Density Index (LDI) ≥ 1 in the targeted tissue.
Danish: Under proceduren vælges antallet af optiske fibre og deres længde ud fra prostatas form og størrelse, og de optiske fibre indføres transperinealt i prostata under ultralydsvejledning, så der opnås et lysdensitetsindeks (LDI) ≥ 1 i målvævet.
English: Urinary retention immediately post procedure has been attributed to transient prostatic oedema and generally only short term recatheterisation was required.
Danish: Urinretention lige efter proceduren har skyldtes forbigående prostataødem, og generelt har det kun været nødvendigt at anlægge kateter i kort tid.
English: TOOKAD-VTP should only be administered after careful clinical evaluation, to patients with a history of active rectal inflammatory bowel disease or any condition that may increase the risk of recto-urethral fistula formation (see section 4.3).
Danish: TOOKAD-VTP bør kun efter omhyggelig klinisk vurdering administreres til patienter med tidligere aktiv inflammatorisk sygdom i endetarmen eller tilstande, der kan øge risikoen for dannelse af rekto-uretrale fistler (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1228/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1228/001
English: Short-term urinary incontinence has been observed and may result from urinary tract infection or from urgency caused by irritation to the urethra from the procedure.
Danish: Der er set kortvarig urininkontinens, og det kan skyldes urinvejsinfektion eller tissetrang som følge af irritation af urinrøret efter proceduren.
English: In the Phase III European study, 25 (12.7 %) patients experienced urinary incontinence (including incontinence, stress urinary incontinence and urge incontinence).
Danish: I den europæiske fase III-undersøgelse oplevede 25 patienter (12,7 %) urininkontinens (herunder inkontinens, stressurininkontinens og urgeinkontinens).
English: Minimal seminiferous epithelial degeneration was also recorded in one high-dose male with vacuolation.
Danish: Minimal degenerering af det seminiferøse epitel er set hos ét handyr med vakuolisering efter indgift af en høj dosis.
English: Eye irritation Photophobia
Danish: Ikke almindelig Øjenirritation Fotofobi
English: One patient had Grade 3 perineal pain that started 35 weeks after the VTP procedure, and lasted for about 35 weeks before resolving without sequelae.
Danish: Én patient havde grad 3-smerter i perineum, der startede 35 uger efter VTPproceduren, og som varede i ca. 35 uger, før de fortog sig uden sequelae.
English: In patients with localised prostate cancer who received TOOKAD-VTP, necrosis was observed by Magnetic Resonance Imaging (MRI) at day 7.
Danish: Hos patienter med lokaliseret prostatacancer, der fik TOOKAD-VTP, sås nekrose på dag 7 konstateret ved MR-scanning (magnetisk resonansscanning).
English: In general, the dose of TOOKAD contains less than 1 mmol (39 mg) potassium, i.e. essentially ‘potassium free'.
Danish: Generelt indeholder TOOKAD-dosen mindre end 1 mmol (39 mg) kalium, dvs. den er i det væsentlige kaliumfri.
English: There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF therapy.
Danish: Der kan være øget risiko for øjenlysfølsomhed hos patienter, der har fået intraokulær anti-VEGFbehandling.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1228/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1228/002
English: This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet where a rise in serum potassium would be considered detrimental.
Danish: Der skal tages hensyn til dette hos patienter med nedsat nyrefunktion og patienter på kaliumkontrolleret diæt, hvis det vurderes, at en stigning i serumkalium kan være skadeligt.
English: If you have received prior VEGF therapy, you should take particular care to protect your eyes from light for 48 hours post TOOKAD injection.
Danish: Hvis du tidligere har fået anti-VEGF-behandling, skal du være særligt omhyggelig med at beskytte dine øjne mod lys i 48 timer efter TOOKAD-injektionen.
English: Photosensitivity There is a risk of skin and eye photosensitivity with exposure to light post TOOKAD-VTP.
Danish: Lysfølsomhed Der er risiko for lysfølsomhed i hud og øjne ved eksponering for lys efter TOOKAD-VTP.
English: Medicinal products which have potential photosensitising effects (such as tetracyclines, sulphonamides, quinolones, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin or amiodarone) should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.
Danish: Lægemidler med potentiel fotosensibiliserende virkning (f.eks. tetracykliner, sulfonamider, quinoloner, phenothiaziner, sulfonylurinstof-holdige hypoglykæmiske midler, thiaziddiuretika, griseofulvin eller amiodaron) bør seponeres mindst 10 dage før og i mindst 3 dage efter TOOKADproceduren eller erstattes med andre midler uden fotosensibiliserende egenskaber.
English: No patients with light-sensitive conditions such as porphyria, a history of sensitivity to sunlight or a history of photosensitive dermatitis have received TOOKAD in clinical studies.
Danish: Ingen patienter med lysfølsomhedstilstande som f.eks. porfyri, tidligere følsomhed over for sollys eller lysfølsom dermatitis har fået TOOKAD i kliniske undersøgelser.
English: The median time to onset of urinary retention was 3 days (1-417).
Danish: Den mediane tid til debut af urinretention var 3 dage (1-417).
English: Concomitant use of systemic VEGF inhibitors is not recommended with TOOKAD.
Danish: Samtidig anvendelse af systemiske VEGF-hæmmere og TOOKAD anbefales ikke.
English: TOOKAD must not be used if: - You are allergic to padeliporfin or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få TOOKAD: - hvis du er allergisk over for padeliporfin eller et af de øvrige indholdsstoffer i TOOKAD
English: Application site erythema
Danish: Erytem ved applikationsstedet
English: There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF (medicines used to prevent new blood vessel growth) therapy.
Danish: Der kan være øget risiko for øjenlysfølsomhed hos patienter, der har fået såkaldt intraokulær antiVEGF-behandling (lægemidler, der anvendes til at forhindre vækst af nye blodkar).
English: If the patient must go outdoors during daylight hours, he should wear protective clothes and high protection goggles to shield his skin and eyes.
Danish: Hvis patienten bliver nødt til at gå udenfor i dagtimerne, skal han bære beskyttende tøj og effektive beskyttelses-solbriller for at skærme hud og øjne.
English: If the patient reports discomfort to the skin or eyes during hospitalisation, reduce the level of lighting and take extra care to shield the patient from artificial and natural light.
Danish: Hvis patienten fortæller om ubehag i huden eller øjnene under indlæggelsen, skal lysniveauet reduceres, og patienten skal skærmes ekstra godt mod kunstigt og naturligt lys.
English: One patient had Grade 3 prostatitis considered as serious that started 4 days after the VTP procedure, and lasted for 31 days before resolving without sequelae.
Danish: Én patient havde alvorlig grad 3-prostatitis, der startede 4 dage efter VTP-proceduren, og som varede i 31 dage, før tilstanden fortog sig uden sequelae.
English: Planning of optical fibre positioning should be performed at the beginning of the procedure using the treatment guidance software.
Danish: Placeringen af de optiske fibre skal bestemmes i starten af proceduren ved brug af guide-softwaren.
English: Patients who have received prior VEGF therapy should take particular care to protect the eyes from light for 48 hours post TOOKAD injection.
Danish: Patienter, der tidligere har fået anti-VEGF-behandling, skal være særligt omhyggelige med at beskytte øjnene mod lys i 48 timer efter en TOOKAD-injektion.
English: Penile swelling (balanoposthitis).
Danish: 13 Hævelser i penis (balanopostitis).
English: If it is not possible to stop a photosensitising medicinal product (such as amiodarone), the patient should be advised that increased sensitivity to sunlight may occur and they may need to protect themselves from direct light exposure for a longer period (see section 4.2).
Danish: Hvis det ikke er muligt at seponere et fotosensibiliserende lægemiddel (f.eks. amiodaron), skal patienterne have at vide, at der kan opstå øget følsomhed over for sollys, og at de kan være nødt til at beskytte sig mod lyseksponering i en længere periode (se pkt.
English: When the analysis was restricted to patients that underwent unilateral VTP, 33 (16.8 %) patients experienced erectile dysfunction for more than 6 months, including 17 (8.6 %) patients in whom the erectile dysfunction had not resolved at the end of the study.
Danish: Når analysen blev begrænset til patienter, der fik foretaget unilateral VTP, oplevede 33 (16,8 %) patienter erektil dysfunktion i over 6 måneder; hos 17 (8,6 %) af disse havde den erektile dysfunktion ikke fortaget sig ved undersøgelsens afslutning.
English: 1 mL of reconstituted solution contains 9.15 mg of padeliporfin.
Danish: 1 ml rekonstitueret opløsning indeholder 9,15 mg padeliporfin.
English: In case you need to go out during the day, you must wear protective clothing and high-protection goggles to shield your skin and eyes.
Danish: Hvis du får brug for at gå ud i løbet af dagen, skal du bruge beskyttelsestøj og solbriller med høj beskyttelse for at beskytte din hud og dine øjne.
English: Current exacerbation of rectal inflammatory bowel disease (see section 4.4).
Danish: Aktuel forværring af inflammatorisk sygdom i endetarmen (se pkt.
English: He should wear dark clothes and take care when exposing hands and face to the sun.
Danish: Han skal have mørkt tøj på og være forsigtig, når han udsætter ansigt og hænder for sollys.
English: Its volume is measured after prostate delineation using the treatment guidance software.
Danish: Målzonens volumen måles efter afgrænsning af prostata ved brug af guide-softwaren.
English: Reconstitute the solution by adding: - for TOOKAD 183 mg: 20 mL of a 5 % glucose solution in the vial containing the powder; - for TOOKAD 366 mg: 40 mL of a 5 % glucose solution in the vial containing the powder.
Danish: Rekonstituér opløsningen ved at tilsætte: - for TOOKAD 183 mg: 20 ml 5 %-glucoseopløsning i hætteglasset med pulver - for TOOKAD 366 mg: 40 ml 5 %-glucoseopløsning i hætteglasset med pulver.
English: In 18 patients the adverse event resolved with a median duration of 63.5 days (1-360), and the adverse event was still ongoing at the end of the study for 7 patients.
Danish: Hos 18 patienter fortog denne bivirkning sig efter en median varighed på 63,5 dage (1-360); hos 7 patienter havde den ikke fortaget sig ved forsøgets afslutning.
English: Activation within the illuminated tumour vasculature, generates oxygen radicals (•OH, O•
Danish: Når der sker aktivering inde i de belyste tumorkar, dannes der iltradikaler (•OH, O•
English: 7 Place du Théâtre L-2613 Luxembourg Luxembourg
Danish: L-2613 Luxembourg
English: In the Phase III European study, 60 (30.5 %) of patients in the TOOKAD-VTP arm experienced erectile dysfunction and 16 (8.1 %) experienced ejaculation failure.
Danish: I den europæiske fase III-undersøgelse oplevede 60 patienter i TOOKAD-VTP-gruppen (30,5 %) erektil dysfunktion, og 16 (8,1 %) oplevede manglende ejakulation.
English: Effect on urinary morbidity (IPSS) and erectile function (IIEF) following TOOKAD-VTP As shown in Table 5, in PCM301 study, the International Prostate Symptoms Score (IPSS) showed, a moderate increase 7 days after the VTP procedure, in both the ITT population and in patients meeting the indication criteria.
Danish: Effekt på urinvejsmorbiditet (IPSS) og erektil funktion (IIEF) efter TOOKAD-VTP Som det fremgår af tabel 5 vedrørende PCM301-undersøgelsen, viste IPSS-scoren (International Prostate Symptoms Score) en moderat stigning 7 dage efter VTP-proceduren i såvel ITT-populationen som hos de patienter, der opfylder indikationskriterierne.
English: Patients with abnormal clotting may bleed excessively from the insertion of the needles required to position the fibres that guide the laser light.
Danish: Patienter med unormal blodstørkning kan bløde kraftigt fra det sted, hvor nålene stikkes ind for at placere de fibre, som guider laserlyset.
English: There is minimal renal excretion of TOOKAD so no adjustment in dose is required in patients with renal impairment.
Danish: TOOKAD udskilles kun i meget ringe grad i nyrerne, og det er derfor ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion.
English: The use of medicinal products that are substrates of OATP1B1 or OATP1B3 (repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide) for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.
Danish: Brug af lægemidler, der er substrater for OATP1B1 eller OATP1B3 (repaglinid, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburid), hvor der er set koncentrationsafhængige alvorlige bivirkninger, bør undgås på dagen for TOOKAD-infusion og i mindst 24 timer efter administrationen.
English: This may also cause bruising, haematuria and/or local pain.
Danish: Dette kan også forårsage blå mærker, hæmaturi og/eller lokale smerter.
English: This required urethral dilatation (see section 4.4).
Danish: Dette krævede uretradilatation (se pkt.
English: Very common Perineal pain Male sexual dysfunction
Danish: Meget almindelig Smerter i perineum9 Seksuel dysfunktion hos mænd10
English: In the Phase III European study, 30 (15.2 %) patients experienced urinary retention.
Danish: I den europæiske fase III-undersøgelse oplevede 30 patienter urinretention (15,2 %).
English: Sensory disturbance Formication
Danish: Sensoriske forstyrrelser Myrekryb
English: Follow-up post TOOKAD-VTP
Danish: Opfølgning efter TOOKAD-VTP
English: Perineal injury and perineal pain occurred in 46 (23.4 %) patients in the controlled Phase III European study.
Danish: Perineumlæsion, smerter i perineum og prostatitis Perineumlæsion og smerter i perineum sås hos 46 patienter (23,4 %) i den kontrollerede europæiske fase III-undersøgelse.
English: Fibres to carry the laser light are inserted into the prostate gland by using hollow needles.
Danish: De fibre, der skal guide laserlyset, indsættes i prostatakirtlen ved hjælp af hule nåle.
English: The chemical and physical stability of TOOKAD after reconstitution with 5 % glucose solution, in its vial, has been demonstrated for 8 hours at 15°C-25°C and at 5°C ± 3°C.
Danish: TOOKAD's kemiske og fysiske stabilitet efter rekonstitution med glucoseopløsning 5 % i hætteglasset opretholdes i 8 timer ved 15-25 °C og ved 5 °C ± 3 °C.
English: The patient must stay in a dimmed light environment without any direct exposure of the skin and the eyes to daylight.
Danish: Patienten skal opholde sig i omgivelser med dæmpet lys, hvor hud og øjne ikke eksponeres for direkte dagslys.
English: Unspecific adverse events probably linked to the general anaesthesia were also observed: transient global amnesia, bradycardia, sinus arrhythmia, atrial fibrillation, hypotension, bronchospasm, pharyngeal inflammation, respiratory tract congestion, nausea, vomiting, constipation, pyrexia, procedural hypotension.
Danish: Der sås også uspecifikke symptomer, der sandsynligvis var relateret til den fulde narkose: forbigående generel amnesi, bradykardi, sinusarytmi, atrieflimren, hypotension, bronkospasme, svælgbetændelse, tilstopning af luftvejene, kvalme, opkastning, forstoppelse, pyreksi, procedurerelateret hypotension.
English: What TOOKAD looks like and contents of the pack TOOKAD is a dark powder.
Danish: Udseende og pakningsstørrelser TOOKAD er et mørkt pulver.
English: For instructions to healthcare professionals on reconstitution of TOOKAD before injection, see “Reconstitution of the TOOKAD powder for solution for injection”.
Danish: Der er en vejledning til sundhedspersoner i rekonstitution (fortynding) af TOOKAD før injektion i afsnittet "Rekonstitution af TOOKAD-pulver til injektionsvæske, opløsning".
English: Allow the opaque syringe to rest in a vertical position for 3 minutes to ensure any foam disappears.
Danish: Lad sprøjten hvile i lodret position i 3 minutter for at sikre, at eventuelt skum forsvinder.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: • The approaches (including VTP with TOOKAD) for the treatment of his prostate cancer and the potential benefits, risks and uncertainties of VTP with TOOKAD: o To state that information beyond two years after the TOOKAD -VTP procedure is limited and consequently, data on the long-term efficacy and safety of TOOKADVTP are currently not available o Information on the efficacy/safety of any subsequent treatments required, such as radical prostatectomy, is currently lacking
Danish: • Behandlingsmulighederne (herunder VTP med TOOKAD) for denne type prostatacancer og de mulige fordele, risici og usikkerheder ved VTP med TOOKAD: o Information om, at der kun foreligger begrænsede data fra to år efter TOOKAD-VTPproceduren, og at oplysninger om den langsigtede virkning og sikkerhed ved TOOKAD-VTP derfor ikke er tilgængelige aktuelt o Information om, at oplysninger om virkning/sikkerhed ved eventuelle efterfølgende nødvendige behandlinger som f.eks. radikal prostatektomi i øjeblikket mangler
English: Table 3 describes the co-primary efficacy endpoints in the whole prostate gland and in the treated lobe (ITT population and patients meeting the indication criteria).
Danish: Tabel 3 beskriver de co-primære effektmål i hele prostata og i den behandlede lap (ITT-population og patienter, der opfylder indikationskriterierne).