natgillin/translations-raw huggingface dataset:
Patientvejledningen vedrørende TOOKAD bør indeholde følgende vigtige elementer:
The Patient information guide about TOOKAD should contain the following key elements:
Dette kan være tegn på infektion i urinvejene, prostatakirtlen eller kønsorganerne.
These may be signs of infection in the urinary tract, the prostate or the genital system.
Der er ikke udført karcinogenicitets- og reproduktionstoksicitetsstudier med padeliporfin.
Carcinogenicity and reproductive toxicity studies have not been conducted with padeliporfin.
Patienterne bør undgå eksponering for direkte sollys (herunder gennem vinduer) og alle kraftige lyskilder både indendørs og udendørs.
Patients should avoid exposure to direct sunlight (including through windows) and all bright light sources, both indoors and outdoors.
To tilfælde af omfattende ekstraprostatisk nekrose sås som følge af forkert laserkalibrering, uden kliniske sequelae.
Two cases of excessive extraprostatic necrosis occurred due to incorrect laser calibration without clinical sequelae.
Dette forstærkes af RNS-induceret endotelcelle-apoptose og initiering af selvudløst tumorcellenekrose ved peroxidering af cellemembranen.
This is enhanced by RNS-induced endothelial cell apoptosis and initiation of self-propagated tumour cells necrosis through peroxidation of their membrane.
• Forklaring af, hvad VTP-proceduren går ud på, herunder nødvendigheden af at træffe forholdsregler for at beskytte patienten mod lys i 48 timer efter proceduren på grund af TOOKAD's fotosensibiliserende virkning samt af at udlevere et eksemplar af indlægssedlen for TOOKAD til patienterne inden VTP-proceduren
• Explain what the VTP procedure involves, including the need to follow the rules to protect the Patient against light after the procedure for 48 hours, due to the photosensitising effect of TOOKAD and provide a copy of the TOOKAD Package Leaflet to the Patient ahead of the VTP procedure
• Forklaring af proceduren samt relevante data vedrørende TOOKAD's virkning og sikkerhed ved hjælp af enkle grafiske fremstillinger i patientvejledningen.
• Explain the procedure as well as relevant efficacy and safety results of TOOKAD with simple graphics included in the Patient Information Guide.
I in vitro-test af genotoksicitet udviste padeliporfin et svagt potentiale for at inducere klastogenicitet ved eksponering for ultraviolet lys (UV); dette korrelerer med virkningsmekanismen (dannelse af reaktive oxygener).
In vitro genotoxicity testing identified padeliporfin as having weak potential to induce clastogenicity when illuminated by ultraviolet (UV); this correlates with the mechanism of action (formation of reactive oxygen species).
TOOKAD's farmakokinetiske egenskaber er undersøgt hos 42 raske mænd (uden lysaktivering) og hos 70 patienter med lokaliseret prostatacancer (efter lysaktivering).
The pharmacokinetic properties of TOOKAD were studied in 42 healthy human male subjects (without photoactivation) and in 70 patients with localised prostate cancer (after photoactivation).
En forlænget fotosensibilisering er dog mulig, og beskyttelsesforanstaltningerne mod lyseksponering bør opretholdes i yderligere 24 timer (se pkt.
However, a prolongation of photosensitisation is possible and precautions against light exposure should be maintained for an additional 24 hours (see section 4.4).
Medicinske tilstande, der udelukker anvendelse af fuld narkose eller invasive procedurer.
Any medical condition that precludes the administration of a general anaesthetic or invasive procedures.
Der anvendes hule nåle til at indsætte fibre det rigtige sted i din prostata.
Hollow needles are used to insert the fibres into the right place in the prostate.
Du må gerne se fjernsyn i en afstand af 2 meter, og fra 6 timer efter proceduren må du gerne bruge elektroniske apparater som smartphones, tablets og computere.
You may watch television at a distance of 2 metres and, from 6 hours after the procedure, you may use electronic devices such as smartphones, tablets and computers.
Den mediane varighed var 21 dage (4-197).
The median duration was 21 days (4-197).
Under behandlingsforhold svarende til LDI ≥ 1 i fase II-undersøgelser sås et gennemsnitligt nekroseomfang i målzonen dag 7 på 89 % ± 20,75 ved unilateral behandling.
In Phase II studies, treatment conditions corresponding to an LDI ≥ 1 were associated with a mean rate of necrosis of the targeted zone at day 7 of 89 % ± 20.75 for unilateral treatment.
Hvis patienten har seksuelt samkvem med fødedygtige kvinder, skal han og/eller hans partner anvende sikker prævention for at undgå graviditet i en periode på 90 dage efter VTP-proceduren.
If the patient is sexually active with women who are capable of getting pregnant, he and/or his partner should use an effective form of birth control to prevent getting pregnant during a period of 90 days after the VTP procedure.
TOOKAD indeholder: - Aktivt stof: padeliporfin.
What TOOKAD contains - The active substance is padeliporfin.
I dagene umiddelbart efter VTP-proceduren kan nogle patienter have vandladningsbesvær (dårligt flow på grund af forsnævring af urinrøret), eller de kan slet ikke lade vandet.
In the few days after the VTP procedure some patients may have difficulties (poor stream due to urethral narrowing) or inability to pass urine.
Advarsler og forsigtighedsregler TOOKAD må kun anvendes af personale, der er oplært i VTP-proceduren.
Warnings and precautions TOOKAD should only be used by personnel trained in the VTP procedure.
Patienternes legemsvægt (interval 60-120 kg) udviste en mindre indvirkning på TOOKAD's farmakokinetiske parametre ved doser op til 5 mg/kg padeliporfindikalium.
The body weight of patients (range 60-120 kg) presented a minor impact on the TOOKAD pharmacokinetic parameters for doses up to 5 mg/kg of padeliporfin di-potassium.
Da de fibre, hvorigennem lyset sendes, indføres på en sådan måde, at hele prostatakirtlens lap bliver eksponeret, er det muligt, at der opstår en skade uden for prostatakirtlen.
Because the fibres that carry the light have to be inserted in such a way that the whole of the lobe of the prostate gland gets exposed, it is possible that some damage may occur outside of the prostate.
Genbehandling af lapper, der var cancerpositive ved kontrolbesøget efter 12 måneder, var tilladt.
Retreatment of lobes found positive for cancer at 12-months follow-up was allowed.
Undersøgelsen havde to co-primære endepunkter for TOOKAD-VTP sammenholdt med AS: - A: Fravær af manifest cancer baseret på histologi efter 24 måneder - B: Forskelle i forekomst af behandlingssvigt i forbindelse med observeret sygdomsprogression fra prostatacancer af lav risiko til prostatacancer af moderat eller højere risiko.
The study had two co-primary endpoints for TOOKAD-VTP in comparison to AS: - A: The rate of absence of definite cancer based on histology at 24 months, - B: The difference in rate of treatment failure associated with observed progression of disease from low to moderate or higher risk prostate cancer.
TOOKAD må kun anvendes på hospital.
TOOKAD is restricted to hospital use only.
Problemer med at få og holde en rejsning
Difficulties in getting or maintaining an erection
De vigtigste eksklusionskriterier var tidligere eller nuværende behandling for prostatacancer, operation for godartet prostatahypertrofi, forventet levetid under 10 år, medicinske tilstande, der udelukker brug af fuld narkose.
The main exclusion criteria were any prior or current treatment for prostate cancer, any surgical intervention for benign prostatic hypertrophy, life expectancy less than 10 years, medical conditions which preclude the use of general anaesthesia.
I den europæiske fase III-hovedundersøgelse sås moderat eller svær uretrastenose hos 2 patienter (1,0 %) 5-6 måneder efter proceduren.
In the pivotal Phase III European study, moderate or severe urethral stenosis developed in 2 (1.0 %) patients 5 to 6 months post-procedure.
I kliniske undersøgelser var samtidig behandling af begge prostatalapper forbundet med et dårligere resultat og bør ikke finde sted.
Simultaneous treatment of both prostate lobes was associated with an inferior outcome in clinical trials and should not be performed.
Nogle lægemidler (især lægemidler, der fremkalder lysfølsomhed, eller som påvirker blodstørkningen) kan interagere med TOOKAD og bør stoppes inden behandling med TOOKAD.
Some medicines (in particular any medicines that are photosensitising or that affect blood clotting) may interact with TOOKAD and should be stopped before using TOOKAD.
Ud af de 121 patienter i AS-gruppen, der oplevede progression, gennemgik 54 radikal behandling, og 67 havde ikke fået nogen aktiv behandling ved undersøgelsens afslutning.
Of 121 patients that progressed in the AS arm, 54 underwent radical therapy and 67 had not received any active treatment at the end of the study.
Negativ biopsi i den behandlede lap*, n (%)
Negative biopsy in the treated lobe*, n (%)
Patienter på kaliumkontrolleret diæt
Use in patients on a controlled potassium diet
Den mediane varighed var 10 dage (1-344).
The median duration was 10 days (1-344).
En vis grad af erektil dysfunktion kan forekomme kort efter proceduren og vare i mere end 6 måneder (se pkt.
Some degree of erectile dysfunction is possible soon after the procedure and may last for more than 6 months (see section 4.8).
Indehaveren af markedsføringstilladelsen skal sikre, at alle sundhedspersoner og alle patienter/omsorgspersoner, der forventes at skulle ordinere og bruge TOOKAD, i alle de medlemsstater, hvor TOOKAD markedsføres, har adgang til eller får udleveret følgende informationsmateriale:
The MAH shall ensure that in each Member State where TOOKAD is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use TOOKAD have access to/are provided with the following educational package:
I vurderingen af den overordnede tolerabilitet efter 24 måneder blev inkluderede patienter, der gennemgik radikal behandling, også talt med i scoringen af prostatasymptomer og erektil funktion.
In assessing overall tolerability by Month 24, post enrolment patients who underwent a radical therapy were also counted in the scoring of prostate symptoms and erectile function.
Dagen før og lige inden VTP-proceduren forberedes og renses endetarmen.
The day before and at the beginning of the VTP procedure, a rectal preparation is performed in order to clean the rectum.
Profylaktisk antibiotika og alfa-blokkere kan ordineres, hvis lægen skønner det nødvendigt.
Prophylactic antibiotics and alpha-blockers may be prescribed at the physician's discretion.
LDI ≥ 1 var forbundet med et større nekroseomfang ved MR-scanningen dag 7 og en større andel af patienter med negativ biopsi efter 6 måneder sammenholdt med LDI < 1 (se pkt.
An LDI ≥ 1 appeared to be associated with a greater volume of necrosis on Day 7 MRI and greater share of patients with negative biopsy at 6 months compared with an LDI < 1 (see section 4.2).
PSA bør testes hver 3. måned i de første 2 år efter VTP og derefter hver 6. måned for at vurdere PSAdynamikken (PSA-fordoblingstid og PSA-velocitet).
PSA should be tested every 3 months for first 2 years post VTP and every 6-months thereafter in order to assess PSA dynamics (PSA Doubling Time (DT), PSA velocity).
Ud af de 58 patienter i TOOKAD-VTP-gruppen, der oplevede progression, var der kun 11, der gennemgik radikal behandling; 18 patienter gennemgik endnu en VTP-procedure, og 29 havde ikke fået yderligere behandling ved undersøgelsens afslutning.
Of 58 patients that progressed in the TOOKAD-VTP arm, only 11 underwent radical therapy, 18 patients underwent a second VTP procedure and 29 had not received further treatment at the end of the study.
Denne medicin indeholder kalium, og normalt vil dosen (3,66 mg/kg) være mindre end 1 mmol (39 mg), dvs. i det væsentlige "kaliumfri".
This medicinal product contains potassium and in general the dose (3.66 mg/kg) will be less than 1 mmol (39 mg) i.e. essentially ‘potassium free'.
Dette giver forbigående arterieudvidelse, der fører til frigivelse af vasokonstriktoren endotelin-1.
This results in transient arterial vasodilatation that triggers the release of the vasoconstrictor, endothelin-1.
Inden TOOKAD lanceres i de enkelte medlemsstater, skal indehaveren af markedsføringstilladelsen indgå en aftale med den nationale kompetente myndighed om indholdet og formatet af informationsmaterialet, herunder kommunikationsmedier, distributionsmåder og lignende.
Prior to launch of TOOKAD in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
I den europæiske fase III-hovedundersøgelse af 24 måneders varighed var der ingen af patienterne, der fik radikal strålebehandling efter TOOKAD-VTP.
In the 24 months of the pivotal European Phase III study, no patients underwent radical radiotherapy post TOOKAD-VTP.
Du skal fortsat opholde dig i dæmpet lys uden at eksponere din hud og dine øjne for dagslys.
You must remain under reduced light conditions, without exposing your skin and your eyes to daylight.
Risikoen for lukkemuskelskade kan minimeres ved omhyggelig planlægning af fiberplaceringen ved brug af guide-softwaren.
The risk of sphincter damage can be minimised by careful planning of the fibre placement using the treatment guidance software.
Problem forbundet med urinrøret
Problem associated with the urethra
En overdosering af laserlys kan øge risikoen for uønsket ekstraprostatisk nekrose (se pkt.
An overdose of the laser light may increase the risk of undesirable extraprostatic necrosis (see section 4.4).
TOOKAD bør anvendes med forsigtighed hos patienter med svært nedsat leverfunktion.
TOOKAD should be used with caution in patients with severe hepatic impairment.
Du må gerne gå udendørs i dagtimerne, men kun i skyggefulde områder eller i overskyet vejr.
You may go outdoors during daylight hours but only in shaded areas or when it is overcast.
Iltradikalernes hurtige forbrug af •NO-radikalerne fører til dannelse af reaktive nitrogener (RNS) (f.eks. peroxynitrit) parallelt med arteriekonstriktion.
Rapid consumption of the •NO radicals, by oxygen radicals, leads to the formation of reactive nitrogen species (RNS) (e.g. peroxynitrite), in parallel to arterial constriction.
Der var ingen signifikant korrelation mellem procentandelen af prostatanekrose ved MR-scanningen dag 7 og sandsynligheden for negativ prostatabiopsi ved opfølgningen.
There was no significant correlation between the percentage of prostate necrosis on Day 7 MRI and the likelihood of a negative prostate biopsy at follow-up.
Desuden menes nedsat deformabilitet at forstærke erytrocytternes aggregationsevne, og dannelsen af blodkoageler i grænsefladen mellem arterieforsyningen (tilførende arterier) og tumorens mikrokredsløb fører til okklusion af tumorkarrene.
In addition, impaired deformability is thought to enhance erythrocyte aggregability and formation of blood clots at the interface of the arterial supply (feeding arteries) and tumour microcirculation, results in occlusion of the tumour vasculature.
Den endelige opløsning indeholder 9,15 mg/ml.
The final solution concentration is 9.15 mg/mL.
2 ), som forårsager lokal hypoksi, der igen inducerer frigivelse af nitrogenoxid (•NO)-radikaler.
causing local hypoxia that induces the release of nitric oxide (•NO) radicals.
Efter proceduren skal du bære beskyttelses-solbriller og holdes under lægetilsyn i mindst 6 timer i et rum med dæmpet lys.
After the procedure, you should wear protective goggles and will be kept under medical surveillance for at least 6 hours in a room with reduced light.
Hvis du oplever en eller flere af nedenstående bivirkninger, skal du straks sige det til lægen: - Urinretention (du kan ikke lade vandet).
If you get any of the side effects below, tell your doctor immediately: - Urinary retention (not able to pass urine).
Gentaget behandling af den samme prostatalap eller sekventiel behandling af den kontralaterale lap anbefales ikke (se pkt.
Retreatment of the same lobe or sequential treatment of the contralateral lobe of the prostate are not recommended (see section 4.4).
4 Levertoksicitet (forhøjet alaninaminotransferase, forhøjet aspartataminotransferase).
Hepatotoxicity (alanine aminotransferase increased, aspartate aminotransferase increased).
Interaktionens omfang er ikke undersøgt klinisk, men en forbigående stigning i plasmakoncentrationen af samtidigt administrerede substrater for OATP1B1 og OATP1B3 kan ikke udelukkes.
The magnitude of interaction has not been investigated clinically but a transient increase in the plasma concentration of co-administered substrates of OATP1B1 and OATP1B3 cannot be ruled out.
Patienten må gerne se fjernsyn i en afstand af 2 meter, og efter 6 timer må han gerne bruge elektroniske apparater som smartphones, tablets og computere.
The patient may watch television from a distance of 2 metres and, from 6 hours onwards, may use electronic devices such as smartphones, tablets and computers.
Hvis du oplever ubehag i huden eller øjnene, mens du er på hospitalet, skal du fortælle det til lægen eller sygeplejersken, så lyset kan dæmpes, og der kan tages ekstra forholdsregler for at beskytte dig mod kunstigt og naturligt lys.
If you feel skin or eye discomfort while in hospital, you must tell your doctor or nurse so the level of lighting can be reduced and extra care can be taken to protect you from artificial and natural light.
Disse lægemidler bør stoppes fra mindst 10 dage før TOOKAD-proceduren til mindst 3 dage efter proceduren eller bør udskiftes med andre behandlinger, der ikke fremkalder lysfølsomhed.
These medicines 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 photosensitising properties.
Det må kun anvendes af personale, der er oplært i VTPproceduren.
It should only be used by personnel trained in the VTP procedure.
Antallet af patienter, der har gennemgået gentagen behandling af den ipsilaterale lap eller sekventiel behandling af den kontralaterale lap, er utilstrækkeligt til at bestemme virkningen ved og sikkerheden af en fornyet TOOKAD-VTP-procedure.
Insufficient patients underwent retreatment of the ipsilateral lobe or sequential treatment of the contralateral lobe to determine the efficacy and safety of a second TOOKAD-VTP procedure.
Meget almindelig Urinretention Hæmaturi
Very common Urinary retention Haematuria
Eksponering for stærkt lys kan medføre hudreaktioner og ubehag i øjnene, mens TOOKAD er i blodbanen.
Photosensitivity Strong light may cause skin reactions and eye discomfort while TOOKAD is in the blood stream.
Drej hætteglasset forsigtigt rundt i 2 minutter.
Swirl the vial gently for 2 minutes.
Dette omfatter solarier, kraftige computerskærme og lys i medicinsk udstyr som f.eks. oftalmoskoper, otoskoper og endoskopiapparater (gælder i 48 timer efter VTP-proceduren).
This includes sunbeds, bright computer monitor screens and medical examination lights, such as ophthalmoscopes, otoscopes and endoscopy equipment, for 48 hours following the VTP procedure.
AS (Active Surveillance) omfattede serielle målinger af absolut PSA og ultralydsguidet prostatabiospi efter 12 og 24 måneder.
AS involved serial absolute PSA measurements and ultrasound-guided prostatic biospy at 12 and 24 months.
Antal forsøgspersoner med
Number of subjects with
LISTE OVER HJÆLPESTOFFER Hjælpestof: Mannitol
LIST OF EXCIPIENTS Excipient: Mannitol
Det må kun anvendes af personale, der er oplært i Vascular-Targeted Photodynamic (VTP)-proceduren.
It should only be used by personnel trained in the Vascular-Targeted Photodynamic therapy (VTP) procedure.
Efter TOOKAD-VTP bør patienterne gennemgå digital rektalundersøgelse (DRE) og have overvåget deres serum-PSA samt have vurderet deres PSA-dynamik (PSA-fordoblingstid og PSA-velocitet).
Following TOOKAD VTP, patients should undergo digital rectal examination (DRE) and have their serum PSA monitored, including an assessment of PSA dynamics (PSA doubling time and PSA velocity).
VTP-proceduren udføres under fuld bedøvelse efter forberedelse af endetarmen.
The VTP procedure is performed under general anaesthetic after rectal preparation.
En blærefistel er set i ét tilfælde på grund af forkert fiberplacering.
A urinary fistula has occurred in one case due to incorrect fibre placement.
Der kan opstå bivirkninger ved brug af TOOKAD og i forbindelse med VTP-proceduren.
Possible side effects can occur with TOOKAD and VTP procedure.
De første 12 timer efter VTP-proceduren
First 12 hours after VTP procedure
Patienten må gerne gå udendørs i dagtimerne, men kun i skyggefulde områder eller i overskyet vejr.
The patient may go outdoors during daylight hours but only in shaded areas or when it is overcast.
53 (26,9 %) patienter oplevede erektil dysfunktion i over 6 måneder; hos 34 (17,3 %) af disse havde den erektile dysfunktion ikke fortaget sig ved undersøgelsens afslutning.
53 (26.9 %) patients experienced erectile dysfunction for more than 6 months, including 34 (17.3 %) patients in whom the erectile dysfunction had not resolved at the end of the study.
Der er ingen relevante indikationer for brug af TOOKAD i den pædiatriske population ved behandling af lokaliseret prostatacancer i lavrisikokategorien.
There is no relevant use of TOOKAD in the paediatric population in the treatment of low-risk localised prostate cancer.
Det skal du vide, før du får TOOKAD
What you need to know before TOOKAD is used
Det er påvist, at padeliporfin er cytotoksisk ved tilstedeværelse af UVA-stråler (in vitro), og padeliporfin vurderes at være fototoksisk hos marsvin (in vivo).
Padeliporfin was shown to be cytotoxic in the presence of UVA irradiation (in vitro) and considered phototoxic in the guinea pig (in vivo).
Tilstanden fortog sig og efterlod en lille defekt i synsfeltet.
This resolved with a small defect in the visual field.
Rekonstitution af TOOKAD-pulver til injektionsvæske, opløsning Opløsningen skal forberedes i omgivelser med dæmpet lys på grund af lægemidlets fotosensibiliserende egenskaber.
Reconstitution of the TOOKAD powder for solution for injection The solution must be prepared in a dimmed-light environment due to the photosensitizing properties of the medicine.
Patienten skal bære beskyttelses-solbriller og holdes under lægetilsyn i mindst 6 timer i et rum med dæmpet lys.
The patient should wear protective goggles and be kept under medical surveillance for at least 6 hours in a room with dimmed light.
Den mediane tid til debut af urogenitale infektioner var 22,5 dage (4-360).
The median time to onset of genito-urinary infections was 22.5 days (4-360).
Svær langsigtet urininkontinens er set hos en patient, der tidligere har fået foretaget transuretral prostatektomi (TURP).
Severe long-term urinary incontinence was observed in a patient who underwent a previous transurethral prostatectomy (TURP).
Hvis det ikke er muligt at stoppe et lægemiddel, der kan fremkalde lysfølsomhed (f.eks. amiodaron), kan der opstå øget følsomhed; du kan være nødt til at beskytte dig mod eksponering for direkte lys i en længere periode.
If it is not possible to stop a photosensitising medicine (such as amiodarone), increased sensitivity may occur, you may need to protect yourself from direct light exposure for a longer period.
Det kan være, at lægen vil bede dig om at afbryde behandlingen med følgende typer lægemidler midlertidigt:
The following types of medicines may be ones that your doctor will advise you to stop temporarily:
Raske forsøgspersoner er blevet eksponeret for doser på op til 15 mg/kg padeliporfindikalium (svarende til 13,73 mg/kg padeliporfin) uden lysaktivering, og 23 patients er blevet behandlet med 6 mg/kg padeliporfindikalium (svarende til 5,49 mg/kg padeliporfin) uden signifikante sikkerhedsproblemer.
Healthy subjects have been exposed to doses up to 15 mg/kg of padeliporfin di-potassium (corresponding to 13.73 mg/kg of padeliporfin) without light activation and 23 patients have been treated with 6 mg/kg of padeliporfin di-potassium (corresponding to 5.49 mg/kg of padeliporfin) without significant safety issues.