natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
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.
Du må kun anvende pærer med en maksimal effekt på 60 watt (for glødepærer), 6 watt (for LED-lys) eller 12 watt (for lavenergipærer). 
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).
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. 
When activated with 753 nm wavelength laser light, padeliporfin triggers a cascade of pathophysiological events resulting in focal necrosis within a few days.
14 Unormal blodkoagulation (forhøjet fibrin D-dimer, forlænget aPTT, forhøjet INR). 
Abnormal clotting (fibrin D dimer increased, aPTT prolonged, INR increased).
• 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 
• 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
TOOKAD aktiveres straks efter injektionen ved, at der sendes lys gennem fibrene fra et tilkoblet laserapparat. 
TOOKAD is activated immediately after injection by shining light through the fibres from a connected laser device.
Inden for hver hyppighed er bivirkningerne opstillet efter, hvor alvorlige de er. 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Der er ikke udført in vitro- eller in vivo-undersøgelser med radioaktivt mærket padeliporfin. 
No in vitro or in vivo studies have been conducted with radiolabelled padeliporfin.
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. 
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.
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. 
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.
Urinretention lige efter proceduren har skyldtes forbigående prostataødem, og generelt har det kun været nødvendigt at anlægge kateter i kort tid. 
Urinary retention immediately post procedure has been attributed to transient prostatic oedema and generally only short term recatheterisation was required.
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. 
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).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1228/001 
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1228/001
Der er set kortvarig urininkontinens, og det kan skyldes urinvejsinfektion eller tissetrang som følge af irritation af urinrøret efter proceduren. 
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.
I den europæiske fase III-undersøgelse oplevede 25 patienter (12,7 %) urininkontinens (herunder inkontinens, stressurininkontinens og urgeinkontinens). 
In the Phase III European study, 25 (12.7 %) patients experienced urinary incontinence (including incontinence, stress urinary incontinence and urge incontinence).
Minimal degenerering af det seminiferøse epitel er set hos ét handyr med vakuolisering efter indgift af en høj dosis. 
Minimal seminiferous epithelial degeneration was also recorded in one high-dose male with vacuolation.
Ikke almindelig Øjenirritation Fotofobi 
Eye irritation Photophobia
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. 
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.
Hos patienter med lokaliseret prostatacancer, der fik TOOKAD-VTP, sås nekrose på dag 7 konstateret ved MR-scanning (magnetisk resonansscanning). 
In patients with localised prostate cancer who received TOOKAD-VTP, necrosis was observed by Magnetic Resonance Imaging (MRI) at day 7.
Generelt indeholder TOOKAD-dosen mindre end 1 mmol (39 mg) kalium, dvs. den er i det væsentlige kaliumfri. 
In general, the dose of TOOKAD contains less than 1 mmol (39 mg) potassium, i.e. essentially ‘potassium free'.
Der kan være øget risiko for øjenlysfølsomhed hos patienter, der har fået intraokulær anti-VEGFbehandling. 
There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF therapy.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1228/002 
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1228/002
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. 
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.
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. 
If you have received prior VEGF therapy, you should take particular care to protect your eyes from light for 48 hours post TOOKAD injection.
Lysfølsomhed Der er risiko for lysfølsomhed i hud og øjne ved eksponering for lys efter TOOKAD-VTP. 
Photosensitivity There is a risk of skin and eye photosensitivity with exposure to light post TOOKAD-VTP.
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. 
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.
Ingen patienter med lysfølsomhedstilstande som f.eks. porfyri, tidligere følsomhed over for sollys eller lysfølsom dermatitis har fået TOOKAD i kliniske undersøgelser. 
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.
Den mediane tid til debut af urinretention var 3 dage (1-417). 
The median time to onset of urinary retention was 3 days (1-417).
Samtidig anvendelse af systemiske VEGF-hæmmere og TOOKAD anbefales ikke. 
Concomitant use of systemic VEGF inhibitors is not recommended with TOOKAD.
Du må ikke få TOOKAD: - hvis du er allergisk over for padeliporfin eller et af de øvrige indholdsstoffer i TOOKAD 
TOOKAD must not be used if: - You are allergic to padeliporfin or any of the other ingredients of this medicine (listed in section 6).
Erytem ved applikationsstedet 
Application site erythema
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). 
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.
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. 
If the patient must go outdoors during daylight hours, he should wear protective clothes and high protection goggles to shield his skin and eyes.
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. 
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.
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. 
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.
Placeringen af de optiske fibre skal bestemmes i starten af proceduren ved brug af guide-softwaren. 
Planning of optical fibre positioning should be performed at the beginning of the procedure using the treatment guidance software.
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. 
Patients who have received prior VEGF therapy should take particular care to protect the eyes from light for 48 hours post TOOKAD injection.
13 Hævelser i penis (balanopostitis). 
Penile swelling (balanoposthitis).
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. 
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).
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. 
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.
1 ml rekonstitueret opløsning indeholder 9,15 mg padeliporfin. 
1 mL of reconstituted solution contains 9.15 mg of padeliporfin.
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. 
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.
Aktuel forværring af inflammatorisk sygdom i endetarmen (se pkt. 
Current exacerbation of rectal inflammatory bowel disease (see section 4.4).
Han skal have mørkt tøj på og være forsigtig, når han udsætter ansigt og hænder for sollys. 
He should wear dark clothes and take care when exposing hands and face to the sun.
Målzonens volumen måles efter afgrænsning af prostata ved brug af guide-softwaren. 
Its volume is measured after prostate delineation using the treatment guidance software.
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. 
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.
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. 
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.
Når der sker aktivering inde i de belyste tumorkar, dannes der iltradikaler (•OH, O• 
Activation within the illuminated tumour vasculature, generates oxygen radicals (•OH, O•
L-2613 Luxembourg 
7 Place du Théâtre L-2613 Luxembourg Luxembourg
I den europæiske fase III-undersøgelse oplevede 60 patienter i TOOKAD-VTP-gruppen (30,5 %) erektil dysfunktion, og 16 (8,1 %) oplevede manglende ejakulation. 
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.
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. 
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.
Patienter med unormal blodstørkning kan bløde kraftigt fra det sted, hvor nålene stikkes ind for at placere de fibre, som guider laserlyset. 
Patients with abnormal clotting may bleed excessively from the insertion of the needles required to position the fibres that guide the laser light.
TOOKAD udskilles kun i meget ringe grad i nyrerne, og det er derfor ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion. 
There is minimal renal excretion of TOOKAD so no adjustment in dose is required in patients with renal impairment.
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. 
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.
Dette kan også forårsage blå mærker, hæmaturi og/eller lokale smerter. 
This may also cause bruising, haematuria and/or local pain.
Dette krævede uretradilatation (se pkt. 
This required urethral dilatation (see section 4.4).
Meget almindelig Smerter i perineum9 Seksuel dysfunktion hos mænd10 
Very common Perineal pain Male sexual dysfunction
I den europæiske fase III-undersøgelse oplevede 30 patienter urinretention (15,2 %). 
In the Phase III European study, 30 (15.2 %) patients experienced urinary retention.
Sensoriske forstyrrelser Myrekryb 
Sensory disturbance Formication
Opfølgning efter TOOKAD-VTP 
Follow-up post TOOKAD-VTP
Perineumlæsion, smerter i perineum og prostatitis Perineumlæsion og smerter i perineum sås hos 46 patienter (23,4 %) i den kontrollerede europæiske fase III-undersøgelse. 
Perineal injury and perineal pain occurred in 46 (23.4 %) patients in the controlled Phase III European study.
De fibre, der skal guide laserlyset, indsættes i prostatakirtlen ved hjælp af hule nåle. 
Fibres to carry the laser light are inserted into the prostate gland by using hollow needles.
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. 
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.
Patienten skal opholde sig i omgivelser med dæmpet lys, hvor hud og øjne ikke eksponeres for direkte dagslys. 
The patient must stay in a dimmed light environment without any direct exposure of the skin and the eyes to daylight.
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. 
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.
Udseende og pakningsstørrelser TOOKAD er et mørkt pulver. 
What TOOKAD looks like and contents of the pack TOOKAD is a dark powder.
Der er en vejledning til sundhedspersoner i rekonstitution (fortynding) af TOOKAD før injektion i afsnittet "Rekonstitution af TOOKAD-pulver til injektionsvæske, opløsning". 
For instructions to healthcare professionals on reconstitution of TOOKAD before injection, see “Reconstitution of the TOOKAD powder for solution for injection”.
Lad sprøjten hvile i lodret position i 3 minutter for at sikre, at eventuelt skum forsvinder. 
Allow the opaque syringe to rest in a vertical position for 3 minutes to ensure any foam disappears.
Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
• 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 
• 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
Tabel 3 beskriver de co-primære effektmål i hele prostata og i den behandlede lap (ITT-population og patienter, der opfylder indikationskriterierne). 
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).
Tidligere indgreb i prostata, hvor den indre blæreringmuskel kan være blevet beskadiget, herunder transuretral resektion af væv fra prostata (TURP) ved godartet prostatahypertrofi. 
Any previous prostatic interventions where the internal urinary sphincter may have been damaged, including trans-urethral resection of the prostate (TURP) for benign prostatic hypertrophy.
A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG 
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Da proceduren gennemføres under fuld narkose, bør patienten ikke udføre komplekse opgaver som at føre motorkøretøj eller betjene maskiner før 24 timer efter indgrebet. 
However, as the procedure includes general anaesthesia, patients should not perform complex tasks like driving or using machines until 24 hours after a general anaesthetic is employed.
Patienter med kolestase. 
Patients who have been diagnosed with cholestasis.
Der kan forekomme ekstraprostatisk nekrose i det periprostatiske fedt, uden at det er forbundet med kliniske symptomer. 
Extraprostatic necrosis There may be extraprostatic necrosis in the peri-prostatic fat not associated with clinical symptoms.
Hætteglasset skal derefter drejes forsigtigt rundt i 2 minutter. 
The vial should then be swirled gently for 2 minutes.
TOOKAD er kontraindiceret hos patienter med kolestase (se pkt. 
TOOKAD is contraindicated in patients who have been diagnosed with cholestasis (see section 4.3).
Prostatacancer af moderat eller højere risiko var defineret ved ét af følgende: > 3 manifest cancerpositive knuder; primært eller sekundært Gleason-mønster ≥ 4; mindst 1 knudelængde > 5 mm; PSA > 10 ng/ml i 3 på hinanden følgende målinger; prostatacancer i stadie T3; metastaser; prostatacancerrelateret død. 
Moderate/higher risk prostate cancer was defined as any of the following: > 3 cores definitively positive for cancer; Gleason primary or secondary pattern ≥ 4; at least 1 cancer core length > 5 mm; PSA > 10 ng/mL in 3 consecutive measures; T3 prostate cancer; metastasis; prostate cancer-related death.
Ældre En specifik tilpasning af dosis er ikke nødvendig hos ældre (se pkt. 
Elderly No specific posology adjustment is necessary in this population (see section 5.2).
Opbevares i den ydre æske for at beskytte mod lys. 
Store in the outer carton in order to protect it from light.