natgillin/translations-raw huggingface dataset:
Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For at undersøge den langsigtede virkning af TOOKAD og dets indvirkning på sygdomsprogression nærmere, herunder den mulige indvirkning på effekten af efterfølgende radikal terapi hos patienter med lavrisikoprostatakræft, samt for at karakterisere den langsigtede sikkerhed ved TOOKAD nærmere skal indehaveren af markedsføringstilladelsen indsende resultaterne af et randomiseret fase 3-studie hos patienter med lokaliseret prostatacancer sammenholdt med aktiv overvågning (opfølgningsstudie over 7 år, herunder grundig biopsiundersøgelse) (PCM301 FU5). 
Post-authorisation efficacy study (PAES): In order to further investigate long-term efficacy of TOOKAD and its impact on disease progression including potential impact on the efficacy of subsequent radical therapy in patients with low risk prostate cancer as well as further characterise the long term safety of TOOKAD, the MAH should submit the results of a randomised phase 3 study in patients with localised prostate cancer compared to active surveillance (7-year follow-up study including in an depth biopsy study) (PCM301 FU5).
Patienter med tidligere uretrastriktur eller problemer med urinflowet kan have øget risiko for nedsat urinflow og urinretention efter TOOKAD-VTP-proceduren. 
Patients with a history of urethral stricture or with urinary flow problems may be at increased risk of poor flow and urinary retention post the TOOKAD-VTP procedure.
Den mediane tid til debut af urininkontinens var 4 dage (1-142). 
The median time to onset of urinary incontinence was 4 days (1-142).
Lægen kan udskrive antibiotika (mod infektion) og alfa-blokkere (mod vandladningsbesvær). 
Your doctor may prescribe antibiotics to prevent infection and alpha-blockers (medicines given to prevent difficulties in urinating).
Forhøjet antal hvide blodlegemer 
White blood cell count increased
Baseret på farmakokinetisk populationsanalyse er den estimerede halveringstid 1,19 t ± 0,08 ved 4 mg/kg padeliporfindikalium. 
Based on popPK analysis the estimated half-life is 1.19 h ± 0.08 at 4 mg/kg of padeliporfin di-potassium.
2 Anorektalt ubehag (proktalgi, rektal tenesmi). 
Anorectal discomfort (proctalgia, rectal tenesmus).
Brug af anden medicin sammen med TOOKAD 
Other medicines and TOOKAD
1 Urogenital infektion (urinvejsinfektion, orchitis, epididymitis, cystitis). 
Genito-urinary tract infection (urinary tract infection, orchitis, epididymitis, cystitis).
Clearance af padeliporfindikalium hos raske mænd behandlet med fra 1,25 mg/kg op til 15,0 mg/kg padeliporfindikalium var på 0,0245-0,088 l/t/kg. 
Clearance of padeliporfin di-potassium in healthy male subjects treated from 1.25 mg/kg up to 15 mg/kg of padeliporfin di-potassium ranged from 0.0245 to 0.088 L/h/kg.
Antal forsøgspersoner, der startede i radikal behandling, n (%) Antal forsøgspersoner, der startede i radikal behandling efter progression, n (%) 
Number of subjects who initiated a radical treatment after progression, n (%)
Der er set udvikling af nedsat urinflow som følge af uretrastriktur et par måneder efter proceduren. 
Poor urinary flow due to urethral stricture developed some months post procedure.
Da proceduren gennemføres under fuld bedøvelse, bør du ikke udføre komplekse opgaver som at føre motorkøretøj eller betjene maskiner før 24 timer efter indgrebet. 
However, as the procedure includes general anaesthesia, you should not perform complex tasks like driving or using machines until 24 hours after a general anaesthetic is used.
VTP-proceduren bestod af 10 minutters intravenøs injektion af 4 mg/kg TOOKAD efterfulgt af 22 minutter og 15 sekunders belysning med 753 nm laserlys ved 200 J/cm fiber afgivet ved brug af interstitielle optiske fibre, indført transperinealt i prostata. 
The VTP procedure consisted of a 10 minutes IV injection of 4 mg/kg of TOOKAD followed by 22 minutes 15 seconds of illumination with 753 nm laser light at 200 J/cm of fibre delivered using interstitial optical fibres, inserted transperineally into the prostate gland.
Prostata-absces 
Prostatic abscess
AS-gruppe N = 78 
AS arm N = 78
In vitro-undersøgelser tyder på, at TOOKAD i terapeutiske koncentrationer sandsynligvis ikke hæmmer cytokrom P450-enzymer, men godt kan hæmme transporterne OATP1B1 og OATP1B3 (se pkt. 
In vitro studies predict that TOOKAD at therapeutic concentrations is unlikely to inhibit cytochrome P450 enzymes but could inhibit OATP1B1 and OATP1B3 transporters (see section 5.2).
n Gennemsnitl ig score (SD) 
n Mean score (SD)
I den europæiske fase III-undersøgelse oplevede 20 patienter i TOOKAD-VTP-gruppen (10,2 %) urogenital infektion. 
In the Phase III European study, 20 (10.2 %) patients in the TOOKAD-VTP arm experienced genito-urinary infection.
Det forventes ikke, at den forsinkede blodkoagulation vil reducere TOOKAD-VTPbehandlingens virkning, men det anbefales, at lægemidler, der påvirker blodkoagulationen, seponeres inden og i perioden umiddelbart efter VTP-proceduren (se pkt. 
It is not expected that a delay in clotting will reduce the effectiveness of the TOOKAD-VTP treatment ; however, it is recommended that drugs that affect clotting are stopped prior to and for the immediate period following the VTP procedure (see section 4.5).
In vitro-undersøgelser tyder på, at TOOKAD sandsynligvis ikke er et substrat for de hepatiske uptaketransportere OATP1B1, OATP1B3, OCT1, OATP2B1, P-gp, BCRP, MRP2 og BSEP. 
In vitro studies indicate that TOOKAD is unlikely to be a substrate of OATP1B1, OATP1B3, OCT1, OATP2B1, P-gp, BCRP, MRP2 or BSEP hepatic uptake transporters.
Aktiv inflammatorisk tarmsygdom 
Active inflammatory bowel disease
Dosering Den anbefalede dosis TOOKAD er én enkeltdosis på 3,66 mg/kg padeliporfin. 
Posology The recommended posology of TOOKAD is one single dose of 3.66 mg/kg of padeliporfin.
Formålet med informationsmaterialet er at øge bevidstheden og informere om tegn og symptomer på en række vigtige identificerede risici ved padeliporfin, herunder lysfølsomhed, om de eksisterende terapeutiske tilgange (herunder VTP med TOOKAD) ved behandling af denne type prostatacancer samt om mulige fordele, risici og usikkerheder ved VTP med TOOKAD. 
The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of padeliporfin, including photosensitivity, and also information on the existing therapeutic approaches (including VTP with
Andre lægemidler, der kan interagere med TOOKAD Brug af lægemidler som f.eks. repaglinid, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan og glyburid bør undgås på dagen for TOOKAD-administration og i mindst 24 timer efter administrationen. 
The use of medicines such as repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide should be avoided on the day of TOOKAD administration and for at least 24 hours after administration.
Se også afsnittet "Brug af anden medicin sammen med TOOKAD" med hensyn til lægemidler, der fremkalder lysfølsomhed. 
See also under “Other medicines and TOOKAD” for photosensitizing medicines.
TOOKAD forberedes ved at rekonstituere pulveret til injektionsvæske med: - 20 ml glucoseopløsning 5 % for TOOKAD 183 mg - 40 ml glucoseopløsning 5 % for TOOKAD 366 mg. 
TOOKAD is prepared by reconstituting the powder for solution for injection with: - 20 mL of 5 % glucose solution for TOOKAD 183 mg,
Ét tilfælde af udvendige uretrafistler sås som følge af forkert fiberplacering (se pkt. 
One case of external urethral fistula occurred due to fibre misplacement (see section 4.4).
Radikal behandling efter VTP-procedure 
Radical therapy post VTP procedure
In vitro-undersøgelser tyder på, at TOOKAD ikke hæmmer P-gp, OAT1, OAT3, OCT2, OCT1, BCRP og BSEP, men at TOOKAD kan hæmme både OATP1B1- og OATP1B3-transportere (se pkt. 
In vitro studies indicate that TOOKAD does not inhibit P-gp, OAT1, OAT3, OCT2, OCT1, BCRP and BSEP but it could inhibit both OATP1B1 and OATP1B3 transporters (see section 4.5).
TOOKAD-VTP-proceduren er kontraindiceret hos patienter, der tidligere har fået foretaget indgreb i prostata, hvor den indre blæreringmuskel kan være blevet beskadiget, herunder transuretral resektion af prostata (TURP) ved godartet prostatahypertrofi (se pkt. 
The TOOKAD-VTP procedure is contraindicated in patients with any previous prostatic interventions where the internal urinary sphincter may have been damaged, including transurethral resection of the prostate (TURP) for benign prostatic hypertrophy (see section 4.3).
Ikke almindelig Gentaget kirurgisk indgreb Kontusion 
Surgical procedure repeated Contusion
Under proceduren udvælges de optiske fibre, og de placeres transperinealt i prostatakirtlen under ultralydsvejledning for at opnå et lystæthedsindeks på ≥ 1 i det ønskede væv. 
During the procedure, the optical fibres are selected and positioned transperineally into the prostate gland under ultrasound guidance to achieve a Light Density Index (LDI) ≥ 1 in the targeted tissue.
Et stort omfang af ekstraprostatisk nekrose er set efter forkert kalibrering af laseren eller ikke-korrekt placering af lysfibrene (se pkt. 
Excessive extraprostatic necrosis occurred as a result of incorrect calibration of the laser or placement of the light fibres (see section 4.8).
Antikoagulantia og trombocythæmmende midler 
Anticoagulants and antiplatelet agents
Hos raske mænd lå den gennemsnitlige fordelingsvolumen på 0,064-0,279 l/kg ved doseringer fra 1,25-15,0 mg/kg padeliporfindikalium, hvilket peger på fordeling i den ekstracellulære væske. 
In healthy human male subjects, the mean volume of distribution ranged from 0.064-0.279 L/kg, for posologies from 1.25 to 15 mg/kg of padeliporfin di-potassium indicating distribution into extracellular fluid.
Rutinemæssig biopsi anbefales efter 2-4 år samt efter 7 år efter VTP, med yderligere biopsier baseret på klinisk vurdering, herunder PSA-vurdering. 
Digital Rectal Examination (DRE) is recommended to be performed at least once a year and more often if clinically justified.Routine biopsy is recommended at 2-4 years and 7 years post VTP, with additional biopsies based on clinical/ PSA assessment.
Blodfortyndende midler (lægemidler, der nedsætter blodets størkningsevne) Disse lægemidler (f.eks. acenocumarol eller warfarin) bør stoppes mindst 10 dage før VTP-proceduren med TOOKAD. 
Anticoagulants (medicines that prevent the blood from clotting) These medicines (e.g. acenocoumarol, warfarin) should be stopped at least 10 days before the VTP procedure with TOOKAD.
Hvis du tidligere har haft en forsnævring af urinrøret eller problemer med urinflowet, kan TOOKADVTP-behandling øge risikoen for dårligt flow og urinretention (manglende vandladning). 
If you have a history of a narrowing of the urethra or urinary flow problems, treatment may increase the risk of poor flow and urinary retention.
En tilsvarende gennemsnitlig fordelingsvolumen sås hos patienter med lokaliseret prostatacancer, der var behandlet med 2 og 4 mg/kg padeliporfindikalium (0,09-0,10 l/kg). 
A similar mean distribution volume was seen in patients with localised prostate cancer treated with 2 and 4 mg/kg of padeliporfin di-potassium (0.09-0.10 L/kg respectively).
Straks herefter belyses prostata i 22 minutter og 15 sekunder med laserlys ved 753 nm afgivet via interstitielle optiske fibre fra et laserapparat med en effekt på 150 mW/cm fiber, der afgiver en energi på 200 J/cm. 
Then the prostate is illuminated immediately for 22 minutes 15 seconds by laser light at 753 nm delivered via interstitial optical fibres from a laser device at a power of 150 mW/cm of fibre, delivering an energy of 200 J/cm.
TOOKADVTP-gruppe N = 80 
TOOKAD-VTP arm N = 80
n Gennemsnitl ig score (SD) Baseline 179 7,6 (6,09) 185 6,6 (5,30) 71 6,7 (5,69) 73 6,0 (4,34) Dag 7 180 14,8 (8,64) 
n Mean score (SD) Baseline 179 7.6 (6.09) 185 6.6 (5.30) 71 6.7 (5.69) 73 6.0 (4.34) Day 7 180 14.8 (8.64)
Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) - svimmelhed, fald - hovedpine - føleforstyrrelser, myrekryb (følelse af, at der kravler insekter på eller under huden) - øjenirritation, lysfølsomhed - funktionsdyspnø (kraftig åndenød under eller efter motion) - humørforstyrrelser - vægttab. 
Uncommon side effects (may affect up to 1 in 100 people) - Dizziness, fall, - Headache, - Sensory disturbance, formication (sensation like crawling insects on or under the skin), - Eye irritation, photophobia (intolerance to light), - Dyspnoea exertional (excessive shortness of breath during or after exercise), - Mood disorder, - Weight decreased.
Hver ml opløsning indeholder herefter 9,15 mg padeliporfin. 
Each mL of the resulting solution will contain 9.15 mg of padeliporfin.
Gennemsnit (SD) Interval: min., maks. 
Range: min, max
11 Smerter i kønsdelene (smerter i penis, smerter i testiklerne, smerter i skrotum, ikke-infektiøs orchitis, inflammation i sædstrengen, genital kontusion). 
Genital pain (penile pain, testicular pain, scrotal pain, non-infective orchitis, spermatic cord inflammation, genital contusion).
Lad hætteglasset hvile i lodret position i 3 minutter uden yderligere bevægelser. 
Allow the vial to rest in a vertical position for 3 minutes without further shaking or moving.
8 Urininkontinens (urgeinkontinens, inkontinens, stressurininkontinens). 
Urinary incontinence (urge incontinence, incontinence, stress urinary incontinence).
Et tilsvarende gennemsnitligt clearance-interval sås hos patienter med lokaliseret prostatacancer, der var behandlet med 4 mg/kg og 2 mg/kg padeliporfindikalium (0,04-0,06 l/t/kg). 
A similar mean clearance range was seen in patients with localised prostate cancer treated with 4 mg/kg and 2 mg/kg of padeliporfin di-potassium (0.04-0.06 L/h/kg respectively).
Patienter med unormal blodkoagulation kan udvikle kraftig blødning ved indførelsen af de nåle, der bruges ved placering af lysfibrene. 
Patients with abnormal clotting may develop excessive bleeding due to the insertion of the needles required to position the light fibres.
Progression til Gleason ≥ 4 49 (23,8) 91 (44,0) 19 (23,8) Antal forsøgspersoner, hvor der sås sygdomsprogression i den behandlede lap efter 
Progression to Gleason ≥ 4 49 (23.8) Number of subjects progressed in the treated lobe* at Month 24, n (%)
ejakulationsforstyrrelser, hypospermi, smertefuld ejakulation, retrograd ejakulation, seksuel dysfunktion, nedsat sædvolumen). 
Male sexual dysfunction (erectile dysfunction, ejaculation failure, dyspareunia, ejaculation disorder, hypospermia, painful ejaculation, retrograde ejaculation, sexual dysfunction, semen volume decreased).
Da virkningen af TOOKAD-indgiften er kort, forventes risikoen for forstærket fototoksicitet imidlertid at være lav, forudsat at patienterne overholder forsigtighedsreglerne med hensyn til lyseksponering til punkt og prikke. 
However, the short duration of action of TOOKAD means that the risk of enhanced phototoxicity is expected to be low provided these patients strictly follow the precautions against light exposure.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING TOOKAD 183 mg pulver til injektionsvæske, opløsning Hvert hætteglas indeholder 183 mg padeliporfin (som dikaliumsalt). 
QUALITATIVE AND QUANTITATIVE COMPOSITION TOOKAD 183 mg powder for solution for injection Each vial contains 183 mg of padeliporfin (as di-potassium salt).
TOOKADVTP-gruppe N = 206 
TOOKAD-VTP arm N = 206
n Gennemsnitl ig score (SD) Baseline 184 18,6 (10,22) 188 20,6 (9,92) 74 18,4 (10,31) 74 20,8 (10,02) Dag 7 165 11,5 (10,96) 
n Mean score (SD) Baseline 184 18.6 (10.22) 188 20.6 (9.92) 74 18.4 (10.31) 74 20.8 (10.02) Day 7 165 11.5 (10.96)
Belysning med henblik på lysaktivering af TOOKAD TOOKAD aktiveres lokalt straks efter injektion ved hjælp af laserlys ved 753 nm sendt gennem interstitielle optiske fibre fra et laserapparat med en effekt på 150 mW/cm fiber, der afgiver en energi på 200 J/cm i 22 minutter og 15 sekunder. 
TOOKAD is locally activated immediately after injection by laser light at 753 nm delivered via interstitial optical fibres from a laser device at a power of 150 mW/cm of fibre, delivering an energy of 200 J/cm over 22 minutes 15 seconds.
Måned 3 171 14,7 (10,48) 182 21,0 (9,84) 69 14,3 (10,81) 70 21,7 (9,95) Måned 6 176 16,1 (9,98) 185 20,4 (9,83) 68 16,9 (9,78) 72 20,6 (9,85) Måned 12 170 15,1 (10,28) 167 19,9 (10,29) 70 16,7 (10,18) 65 20,4 (10,44) Måned 24* 159 15,0 (10,70) 152 16,8 (11,17) 62 15,4 (11,11) 54 16,4 (11,10) *Scorerne i måned 24 omfatter patienter, der gennemgik radikal behandling 
Month 3 171 14.7 (10.48) 182 21.0 (9.84) 69 14.3 (10.81) 70 21.7 (9.95) Month 6 176 16.1 (9.98) 185 20.4 (9.83) 68 16.9 (9.78) 72 20.6 (9.85) Month 12 170 15.1 (10.28) 167 19.9 (10.29) 70 16.7 (10.18) 65 20.4 (10.44) Month 24* 159 15.0 (10.70) 152 16.8 (11.17) 62 15.4 (11.11) 54 16.4 (11.10) *Scores at Month 24 include patients who underwent radical therapy
TOOKAD 366 mg pulver til injektionsvæske, opløsning Ravgult type I-hætteglas, forsynet med en gummiprop og aluminiumsforsegling samt en afrivelig hætte af hvid plast, indeholdende 366 mg padeliporfin. 
TOOKAD 366 mg powder for solution for injection Amber type I glass vial, sealed with a rubber stopper crimped with an aluminium seal and covered with a white plastic flip-off cap, containing 366 mg padeliporfin.
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - problemer med eller smerter ved vandladning (herunder smerter eller ubehag ved vandladning, blæresmerter, trang til at lade vandet akut eller hyppigere eller om natten, ufrivillig vandladning) - sex-problemer (herunder problem med at få eller holde en rejsning, manglende udløsning, tab af libido eller smerter ved samleje) - blod i urinen (hæmaturi) 
Very common side effects (may affect more than 1 in 10 people) - Problems with or pain on passing urine (including pain or discomfort on passing urine, bladder pain, the need to pass urine urgently or more frequently or at night; involuntary passing of urine), - Sexual problems (including difficulty in getting or maintaining an erection, ejaculation failure, loss of desire or pain on intercourse), - Blood in the urine (haematuria), - Perineal injury including bruising in the skin, bruising near where the needles are put into the prostate, pain and tenderness, - Genital pain and discomfort (inflammation of the testicles or the epididymis, pain due to inflammation or fibrosis of the prostate).
Måned 3 179 9,6 (6,86) 190 7,2 (5,75) 71 8,7 (5,72) 72 6,6 (5,11) Måned 6 182 7,5 (6,06) 189 6,8 (5,84) 74 6,4 (5,33) 73 6,3 (5,36) Måned 12 177 7,2 (5,85) 173 7,3 (5,95) 71 5,7 (5,01) 68 7,1 (5,75) Måned 24 165 6,6 (5,47) 154 8,2 (6,47) 66 5,5 (5,34) 55 8,6 (6,56) *Scorerne i måned 24 omfatter patienter, der gennemgik radikal behandling 
Month 3 179 9.6 (6.86) 190 7.2 (5.75) 71 8.7 (5.72) 72 6.6 (5.11) Month 6 182 7.5 (6.06) 189 6.8 (5.84) 74 6.4 (5.33) 73 6.3 (5.36) Month 12 177 7.2 (5.85) 173 7.3 (5.95) 71 5.7 (5.01) 68 7.1 (5.75) Month 24* 165 6.6 (5.47) 154 8.2 (6.47) 66 5.5 (5.34) 55 8.6 (6.56) *Scores at Month 24 include patients who underwent radical therapy
TOOKAD 183 mg pulver til injektionsvæske, opløsning Ravgult type I-hætteglas, forsynet med en gummiprop og aluminiumsforsegling samt en afrivelig hætte af blå plast, indeholdende 183 mg padeliporfin. 
TOOKAD 183 mg powder for solution for injection Amber type I glass vial, sealed with a rubber stopper crimped with an aluminium seal and covered with a blue plastic flip-off cap, containing 183 mg padeliporfin.
Da virkningen af TOOKAD 
How TOOKAD is used
Positiv biopsi i den behandlede lap*, n (%) aRisiko-ratio (95 %-KI) = 3,62 (2,50-5,26); p-værdi < 0,001 bRisiko-ratio (95 %-KI) = 3,24 (2,41-4,36); p-værdi < 0.001 cBlandt de 60 patienter, der fik radikal behandling, fik 5 foretaget biopsi efter 24 måneder dF.eks. 
Other reasons d, n (%) Positive biopsy, n (%) Positive biopsy in the treated lobe*, n (%) Risk Ratio (95% CI) = 3.62 (2.50 ; 5.26) ; p value < 0.001 Risk Ratio (95% CI) = 3.24 (2.41 ; 4.36) ; p value < 0.001 Among the 60 patients who had radical therapy, 5 patients had a Month 24 biopsy For example: study withdrawal, medical reason, subject refusal Risk Ratio (95% CI) = 4.39 (2.18 ; 8.83) ; p value < 0.001 Risk Ratio (95% CI) = 4.61 (2.60 ; 8.16) ; p value < 0.001 B: Difference in rate of treatment failure associated with observed progression of disease Number of subjects progressed at Month 24, n (%)
indgiften er kort, forventes risikoen for forstærket fototoksicitet imidlertid at være lav, forudsat at duoverholder forsigtighedsreglerne med hensyn til lyseksponering til punkt og prikke. 
However, the short duration of action of TOOKAD means that the risk of enhanced phototoxicity is expected to be low provided the precautions against light exposure are stricly followed.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til injektionsvæske, opløsning 
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection
Lysfølsomhed 
Photosensitisers
Hos raske mænd fremgik det, at Cmax var lineær fra 1,25-15,0 mg/kg padeliporfindikalium henover det terapeutiske interval. 
In healthy human male subjects, the Cmax was shown to be linear from 1.25 mg/kg to 15 mg/kg of padeliporfin di-potassium, covering the therapeutic range.
Tabel 5: PCM301 - Effekt på urinvejsmorbiditet (IPSS) - ITT-population og patienter, der opfylder indikationskriterierne 
Table 5: PCM301 - Effect on urinary morbidity (IPSS) - ITT population and patients meeting the indication criteria
Alt efter din tilstand, hvis du f.eks. ikke er kommet dig helt over bedøvelsen, kan det være, at du skal blive natten over. 
You may need to stay overnight if you have not fully recovered from the general anaesthetic and depending on your condition.
Hæmatom Hypertension 
Haematoma Hypertension
Tumorlokalisering 
Tumour localisation
Hvert hætteglas TOOKAD 366 mg indeholder 366 mg padeliporfin (som kaliumsalt). 
Each vial of TOOKAD 366 mg contains 366 mg of padeliporfin (as potassium salt).
Tabel 4: PCM301 - Antal forsøgspersoner, der har fået radikal behandling efter 24 månederITT-populationen og patienter, der opfylder indikationskriterierne Karakteristika 
Table 4: PCM301 - Number of subjects with radical treatment at 24 months - ITT population and patients meeting the indication criteria
Tabel 3: PCM301 - Co-primære effektmål - Hele prostata og behandlet lap/behandlede lapper* - ITT-population og patienter, der opfylder indikationskriterierne 
Table 3: PCM301 - Co-primary efficacy endpoints - Whole prostate gland and treated lobe(s)* - ITT population and patients meeting the indication criteria
I de kliniske undersøgelser var der ingen patienter med lysfølsom dermatitis, hudlidelser som f.eks. porfyri eller tidligere følsomhed over for sollys, som fik TOOKAD-behandling. 
No patients with photosensitive dermatitis, skin conditions such as porphyria or a history of sensitivity to sunlight have received TOOKAD in clinical studies.
Ikke almindelig Nedsat libido Emotionelle forstyrrelser Enkoprese 
Libido decreased Affective disorder Encopresis
Hver æske med TOOKAD 366 mg pulver til injektionsvæske, opløsning, indeholder et ravgult hætteglas med en hvid hætte. 
Each carton of TOOKAD 366 mg powder for solution for injection contains an amber glass vial with a white cap.
6 Dysuri (smerter i blæren, blærespasmer, hypertonisk blære, uretraspasmer, smerter i urinvejene). 
Dysuria (bladder pain, bladder spasm, hypertonic bladder, urethral spasm, urinary tract pain).
Antikoagulantia og trombocythæmmende midler (f.eks. acetylsalicylsyre) bør seponeres mindst 10 dage før TOOKAD-proceduren. 
Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD.
Selvom patienter med eksisterende stenose ikke indgik i de kliniske undersøgelser, vurderes det, at der er en potentiel risiko for stenose efter TOOKAD-VTP-proceduren hos sådanne patienter (se pkt. 
Although they were excluded from the clinical trials, there is a potential risk of increased stenosis post the TOOKAD-VTP procedure in patients with pre-existing stenosis (see section 4.8).