FrancophonIA/ELRC3.0 huggingface dataset:
English: Some cases of hepatotoxicity (1.5 %), such as elevation of transaminases, were also reported.
Danish: Der sås også tilfælde af levertoksicitet (1,5 %), f.eks. forhøjede transaminaser.
English: The targeted zone corresponds to the lobe containing the positive biopsies.
Danish: Målzonen svarer til lappen med de positive biopsier.
English: Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: L01XD07
Danish: Farmakoterapeutisk klassifikation: Sensibilatorer til fotodynamisk/stråle-terapi, ATC-kode: L01XD07
English: When 48 hours have passed after the procedure, you can resume your normal activities and you can be exposed to direct sunlight.
Danish: 48 timer efter proceduren kan du genoptage dine normale aktiviteter, og du må gerne blive eksponeret for sollys.
English: Taking into account its molecular mass and the very low urinary excretion of the molecule, faecal elimination is the most probable route of elimination in human.
Danish: I betragtning af den molekylære masse og den meget lave urinudskillelse af molekylet er fækal elimination den mest sandsynlige eliminationsvej hos mennesker.
English: Patients in the AS arm were not offered subsequent VTP.
Danish: Patienterne i AS-gruppen fik ikke tilbudt efterfølgende VTP.
English: Normally this is just the fat around the prostate and is not important but nearby organs such as the bladder and rectum may potentially be affected.
Danish: Normalt drejer dette sig kun om fedtlaget omkring prostata og betyder ikke noget, men nærved liggende organer som blæren og endetarmen kan potentielt blive skadet.
English: The treatment is carried out under general anaesthetic (medicines that send you to sleep to prevent pain and discomfort).
Danish: Behandlingen udføres under fuld bedøvelse (ved hjælp af lægemidler, der får dig til at sove, så du ikke mærker smerter og ubehag).
English: In this case, you should contact your doctor as you may need further blood or urine analysis and antibiotics treatment.
Danish: I dette tilfælde bør du kontakte lægen, da det kan være nødvendigt at undersøge dit blod eller din urin yderligere og give dig antibiotika.
English: In consequence there is a potential risk of damage to adjacent structures, such as the bladder and/or rectum, and development of a recto-urethral or external fistula.
Danish: Der er således en potentiel risiko for skade i de tilstødende strukturer, f.eks. blæren og/eller endetarmen, og for udvikling af rekto-uretrale eller udvendige fistler.
English: TOOKAD is administered as part of focal VTP.
Danish: TOOKAD administreres som led i fokal VTP.
English: Padeliporfin di-potassium is highly bound to human plasma proteins (99 %).
Danish: Padeliporfindikalium har en høj bindingsgrad til humane plasmaproteiner (99 %).
English: However, patients weighing more than 115 kg will receive more than 1 mmol potassium.
Danish: Patienter med en kropsvægt over 115 kg vil dog få mere end 1 mmol kalium.
English: Padeliporfin has not been tested for reproductive toxicity and fertility.
Danish: Padeliporfin er ikke testet for reproduktions- og fertilitetstoksicitet.
English: Your medical team will decide if you can leave hospital on the evening of your treatment.
Danish: Hospitalspersonalet vil vurdere, om du kan udskrives om aftenen efter behandlingen.
English: Pregnancy and breast-feeding TOOKAD is not indicated for the treatment of women.
Danish: Graviditet og amning TOOKAD er ikke indiceret til behandling af kvinder.
English: • Patient information guide • Physician guideline
Danish: • Patientvejledning • Retningslinjer for læger
English: Exposure to padeliporfin is expected to be increased and/or prolonged in patients with hepatic impairment.
Danish: Eksponeringen for padeliporfin forventes at være større og/eller vare længere hos patienter med nedsat leverfunktion.
English: For instructions on reconstitution of TOOKAD before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af TOOKAD før administration, se pkt.
English: This is normally avoidable by careful planning but should it occur there is a risk of an abnormal connection forming between the rectum and the bladder or skin.
Danish: Dette kan normalt undgås ved omhyggelig planlægning, men sker det, er der risiko for, at der opstår en unormal forbindelse mellem endetarmen og blæren eller huden.
English: A secondary objective was to determine the difference between the two arms with regard to the rate of subsequent radical therapy for prostate cancer.
Danish: Et andet formål var at bestemme forskellen på de to grupper, hvad angår hyppigheden af efterfølgende radikal behandling for prostatacancer.
English: Urinary excretion of padeliporfin in healthy human subjects was very low (< 0.2 % of the dose).
Danish: Urinudskillelsen af padeliporfin hos raske forsøgspersoner var meget lav (< 0,2 % af dosen).
English: Longer follow-up will be required to determine whether TOOKAD-VTP will be curative in a proportion of patients.
Danish: Længere tids opfølgning vil være nødvendigt for at klarlægge, om TOOKAD-VTP virker kurativt hos en given andel af patienterne.
English: It is important that all patients follow the light precautions below for 48 hours post-procedure to minimize the risk of damage to the skin and eyes.
Danish: Det er vigtigt, at alle patienter i 48 timer efter proceduren følger nedenstående forholdsregler, hvad angår lys, for at minimere risikoen for skader på hud og øjne.
English: In other cases, urethral stenosis may have been a late consequence of TOOKAD-VTP induced necrosis.
Danish: I andre tilfælde kan uretrastenose have været en sen konsekvens af TOOKAD-VTP-induceret nekrose.
English: You will be given a general anaesthetic to send you to sleep before the VTP procedure.
Danish: Du vil få et bedøvelsesmiddel, der får dig til at sove før VTP-proceduren.
English: - The other ingredient is mannitol.
Danish: - Øvrige indholdsstoffer: mannitol.
English: At present TOOKAD-VTP has been shown to defer the need for radical therapy and its associated toxicity.
Danish: Det er påvist, at TOOKAD-VTP udskyder behovet for radikal behandling og den dermed forbundne toksicitet.
English: The most common infections are orchitis, epididymitis and urinary tract infections including cystitis.
Danish: De hyppigste infektioner er orchitis, epididymitis og urinvejsinfektioner, herunder cystitis.
English: The safety and efficacy of subsequent radical therapy (surgery or radiotherapy) is uncertain.
Danish: Sikkerheden ved og virkningen af efterfølgende radikal behandling (kirurgi eller strålebehandling) kendes ikke til bunds.
English: Only 1 (0.5 %) patient had a severe (Grade 3) urinary incontinence.
Danish: Kun 1 patient (0,5 %) havde svær urininkontinens (grad 3).
English: Talk to your doctor or nurse if: - You feel any irritation of the skin or problems with vision or eye irritation after the
Danish: Tal med lægen eller sygeplejersken: - hvis din hud er irriteret, hvis du har problemer med at se, eller hvis dine øjne er irriterede efter
English: An injection filter of 0.22 µm and an opaque tubing should be used to administer the medicinal product to the patient.
Danish: Et injektionsfilter på 0,22 µm og en uigennemsigtig slange skal anvendes ved administrationen af lægemidlet til patienten.
English: In vitro studies indicate that TOOKAD is unlikely to be an inhibitor of CYP450 enzymes.
Danish: In vitro-undersøgelser tyder på, at TOOKAD sandsynligvis ikke er en hæmmer af CYP450-enzymer.
English: In some cases pain relief was required for perineal pain or anorectal discomfort.
Danish: I nogle tilfælde var smertelindring nødvendigt ved smerter i perineum eller anorektalt ubehag.
English: A: Rate of absence of definite cancer based on histology at 24 months Negative biopsy, n (%)
Danish: A: Fravær af manifest cancer baseret på histologi efter 24 måneder Negativ biopsi, n (%)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Residual tumour has been found on follow-up biopsy of the treated lobe at 12 and 24 months, usually outside of the treated volume, but occasionally within the area of necrosis.
Danish: Ved kontrolbesøg er der fundet residualtumor ved biopsi af den behandlede lap efter 12 og 24 måneder, typisk uden for det behandlede område, men indimellem i nekroseområdet.
English: If you do require further treatment, at the moment, there is limited information on whether TOOKAD-VTP affects the efficacy and safety results of other treatments (such as surgery to remove the prostate or radiotherapy).
Danish: Hvis du har behov for yderligere behandling, findes der indtil videre kun begrænsede oplysninger om, hvorvidt TOOKAD-VTP påvirker effekten og sikkerheden ved andre behandlinger (f.eks. kirurgisk fjernelse af prostata eller strålebehandling).
English: Minimal metabolism of padeliporfin was observed in in vitro metabolism studies in human liver microsomes and S9 fractions.
Danish: Der er set minimal metabolisering af padeliporfin i metabolismeundersøgelser af humane levermikrosomer og S9-fraktioner in vitro.
English: Those results were improved at Month 3 and back to baseline values at Month 6, with further improvement until Month 24.
Danish: Der sås en bedring efter 3 måneder, idet værdierne var vendt tilbage til baseline-niveauet efter 6 måneder, og der sås yderligere bedring frem til måned 24.
English: This may also cause bruising, blood in the urine and/or local pain.
Danish: Dette kan også forårsage blå mærker, blod i urinen og/eller lokale smerter.
English: In certain cases, the bulbar location suggested that the stenosis was caused by urinary catheterisation.
Danish: I visse tilfælde tydede den bulbære placering på, at stenosen skyldtes anlæggelse af urinkateter.
English: mpMRI may be used to improve the decision making but not, at present, to replace biopsy.
Danish: Multiparametrisk MR (mpMR) kan benyttes som hjælp i beslutningsprocessen, men ikke som erstatning for biopsi på nuværende tidspunkt.
English: Before treatment, the tumour must be accurately located and confirmed as unilateral using high-resolution biopsy strategies based on current best practice, such as multi-parametric MRI-based strategies or template-based biopsy procedures.
Danish: Inden behandling skal tumoren lokaliseres nøjagtigt og bekræftes som unilateral ved brug af biopsi taget ved højopløsningsteknik baseret på nugældende bedste praksis, f.eks. MR-baserede multiparameterteknikker eller template-baserede biopsiprocedurer.
English: In the Active Surveillance arm, the IPSS score slightly worsened over time until Month 24.
Danish: I AS-gruppen blev IPSS-scoren en smule ringere over tid frem til måned 24.
English: There is limited data on long-term outcomes and on potential consequences of post-TOOKAD local scarring in case of disease progression.
Danish: Der foreligger kun begrænsede data om de langsigtede virkninger og om potentielle konsekvenser af lokal ardannelse efter TOOKAD-behandling i tilfælde af sygdomsprogression.
English: The patient may be discharged in the evening of the same day at the physician's discretion.
Danish: Patienten kan udskrives om aftenen samme dag, hvis lægen skønner det forsvarligt.
English: One serious adverse event of prostatic abscess which was considered severe was reported in the study performed in Latin America in a patient who had a unilateral VTP procedure.
Danish: Der er rapporteret om ét alvorligt tilfælde af svær prostata-absces i en undersøgelse foretaget i Latinamerika hos en patient, der fik foretaget en unilateral VTP-procedure.
English: Very few patients aged over 75 years were enrolled into studies where pharmacokinetic measurements were taken so it is not known if there is a difference in these older patients compared to patients less than 75 years of age (see sections 4.2 and 5.1).
Danish: Det er kun meget få patienter over 75 år, der har deltaget i undersøgelser, hvor der er foretaget farmakokinetiske målinger, så det vides ikke, om der er en forskel mellem ældre patienter og patienter under 75 år (se pkt.
English: There is limited clinical information on overdose involving TOOKAD.
Danish: Der foreligger kun begrænsede kliniske oplysninger om overdosering af TOOKAD.
English: Risk of damage near the prostate gland
Danish: Risiko for skade nær prostatakirtlen
English: The reconstituted solution is dark.
Danish: Den rekonstituerede opløsning er mørk.
English: There is limited biopsy data beyond 2 years after TOOKAD treatment, so long-term efficacy has not been determined.
Danish: Der foreligger kun begrænsede biopsidata ud over 2 år efter TOOKAD-behandling, så den langsigtede virkning er ikke klarlagt.
English: Effects of covariates on pharmacokinetic properties The effects of age, weight and race were investigated in healthy volunteers and patients.
Danish: Kovariaters indvirkning på farmakokinetiske egenskaber Indvirkningen af alder, vægt og etnisk oprindelse er undersøgt hos raske forsøgspersoner og patienter.
English: 12-48 hours after VTP procedure
Danish: 12-48 timer efter VTP-proceduren
English: The results of the population PK study showed that age, race, health status and markers of hepatic function were unlikely to have a substantial and biologically significant impact on the pharmacokinetics of TOOKAD.
Danish: Resultaterne af den farmakokinetiske populationsanalyse viste, at alder, etnisk oprindelse, helbredsstatus og leverfunktionsmarkører sandsynligvis ikke har en væsentlig eller biologisk signifikant indvirkning på TOOKAD's farmakokinetik.
English: The equipment should be carefully calibrated and use the treatment guidance software to reduce the risk of clinically significant extraprostatic necrosis.
Danish: Udstyret skal kalibreres omhyggeligt, og guide-softwaren skal anvendes for at reducere risikoen for klinisk signifikant ekstraprostatisk nekrose.
English: To date information beyond two years after VTP procedure is limited and so, at this time, data are currently not available to know whether the benefit of TOOKAD-VTP is long-lasting.
Danish: Der foreligger kun begrænsede data ud over to år efter VTP-proceduren, og derfor er der p.t. ingen tilgængelige oplysninger om, hvorvidt fordelen ved TOOKAD-VTP er langvarig.
English: This includes sunbeds, bright computer monitor screens (see precautions below), and examination lights from medical equipment.
Danish: Dette omfatter solarier, kraftigt lys fra computerskærme (se forsigtighedsreglerne nedenfor) og undersøgelseslamper fra medicinsk udstyr.
English: Prostatitis occurred in 7 (3.6 %) patients in the controlled Phase III European study.
Danish: Prostatitis sås hos 7 patienter (3,6 %) i den kontrollerede europæiske fase III-undersøgelse.
English: The reconstituted solution for infusion is dark.
Danish: Den rekonstituerede infusionsopløsning er mørk.
English: TOOKAD is a medicine that contains padeliporfin (as potassium salt).
Danish: TOOKAD er et lægemiddel, der indeholder padeliporfin (som kaliumsalt).
English: Sunscreen creams do not protect you against the type of light (near infra-red) that can cause problems after the procedure.
Danish: Solcreme beskytter dig ikke mod den type lys, der kan medføre problemer efter proceduren (såkaldt nær-infrarødt lys).
English: The LDI corresponds to the ratio of the cumulative length of illuminated fibre tips (cm) to the volume (cc) of the targeted zone to be treated.
Danish: Lysdensitetsindekset (LDI) svarer til forholdet mellem den kumulative længde af de belyste fiberspidser (cm) og volumenet (cc) af den målzone, der skal behandles.
English: In case of unilateral disease, focal treatment of one lobe was to be applied.
Danish: Ved unilateral sygdom blev der givet fokal behandling af én lap.
English: All of them were mild in intensity.
Danish: Alle tilfælde var milde.
English: Some difficulties in getting or maintaining an erection is possible soon after the procedure and may last for more than 6 months.
Danish: Det kan være vanskeligt at få eller holde en rejsning straks efter proceduren, og dette kan vare i mere end 6 måneder.
English: Additional adverse reactions in the Phase II prostate cancer studies and Special Authorization Extraprostatic necrosis
Danish: Yderligere bivirkninger i fase II-undersøgelserne af prostatacancer - særlig tilladelse Ekstraprostatisk nekrose
English: The Physician guideline about TOOKAD should contain the following key elements:
Danish: Retningslinjerne til læger om TOOKAD bør indeholde følgende vigtige elementer:
English: You or your partner or both should use an effective form of birth control to prevent your partner getting pregnant for 90 days after the VTP procedure.
Danish: Du og/eller din partner skal bruge sikker prævention for at forhindre, at din partner bliver gravid i 90 dage efter VTP-proceduren.
English: The powder is a dark lyophilisate.
Danish: Pulveret er et mørkt lyofilisat.
English: This event was not considered to be related to a faulty procedure but rather the pre-existing damage to the internal urethral sphincter from the TURP.
Danish: Denne hændelse vurderes ikke at være forbundet med en fejlbehæftet procedure, men derimod en eksisterende skade på uretras indre lukkemuskel som følge af TURP-proceduren.
English: For the 48 hours after the procedure you should avoid exposure to direct sunlight (including through windows) and all bright light sources, both indoors and outdoors.
Danish: Du bør i 48 timer efter proceduren undgå eksponering for direkte sollys (herunder gennem vinduer) og alle kraftige lyskilder både indendørs og udendørs.
English: TOOKAD is for intravenous use.
Danish: TOOKAD er til intravenøs anvendelse.
English: Limited information is available regarding the safety and efficacy of radical prostatectomy after TOOKAD-VTP.
Danish: Der foreligger kun begrænsede data om sikkerheden ved og virkningen af radikal prostatektomi efter TOOKAD-VTP.
English: In each table are also presented the results of patients meeting the indication criteria (patients with unilateral low-risk localised prostate cancer excluded the very low-risk)
Danish: Tabellerne viser også resultaterne fra patienter, der opfylder indikationskriterierne (patienter med unilateral lokaliseret prostatacancer i lavrisikokategorien udelukkede prostatacancer af meget lav risiko)
English: Place a 0.22 μm injection filter on the syringe.
Danish: Sæt et 0,22 μm-injektionsfilter på sprøjten.
English: Medicinal products that prevent or reduce platelet aggregation should not be started for at least 3 days after the procedure.
Danish: Lægemidler, der hæmmer eller reducerer blodpladeaggregationen, bør ikke påbegyndes i mindst 3 dage efter proceduren.
English: Table 1: Summary of adverse reactions considered related to TOOKAD and/or the study device and/or the study procedure in the pooled safety analysis (N=398)
Danish: Tabel 1: Oversigt over bivirkninger, der vurderes at være forbundet med TOOKAD og/eller det medicinske udstyr og/eller undersøgelsesprocedurerne i den samlede sikkerhedsanalyse (N = 398)
English: Connect an opaque tube to the filter.
Danish: Kobl en uigennemsigtig slange til filteret.
English: Due to the photosensitising properties of TOOKAD, the content of the vial should then be transferred into an opaque syringe that should be held in an upright position for 3 minutes to ensure any foam disappears.
Danish: På grund af TOOKAD's fotosensibiliserende egenskaber skal hætteglassets indhold derefter overføres til en uigennemsigtig sprøjte, der skal holdes i lodret position i 3 minutter for at sikre, at eventuelt skum forsvinder.
English: The Patient information guide about TOOKAD should contain the following key elements:
Danish: Patientvejledningen vedrørende TOOKAD bør indeholde følgende vigtige elementer:
English: These may be signs of infection in the urinary tract, the prostate or the genital system.
Danish: Dette kan være tegn på infektion i urinvejene, prostatakirtlen eller kønsorganerne.
English: Carcinogenicity and reproductive toxicity studies have not been conducted with padeliporfin.
Danish: Der er ikke udført karcinogenicitets- og reproduktionstoksicitetsstudier med padeliporfin.
English: Patients should avoid exposure to direct sunlight (including through windows) and all bright light sources, both indoors and outdoors.
Danish: Patienterne bør undgå eksponering for direkte sollys (herunder gennem vinduer) og alle kraftige lyskilder både indendørs og udendørs.
English: Two cases of excessive extraprostatic necrosis occurred due to incorrect laser calibration without clinical sequelae.
Danish: To tilfælde af omfattende ekstraprostatisk nekrose sås som følge af forkert laserkalibrering, uden kliniske sequelae.
English: This is enhanced by RNS-induced endothelial cell apoptosis and initiation of self-propagated tumour cells necrosis through peroxidation of their membrane.
Danish: Dette forstærkes af RNS-induceret endotelcelle-apoptose og initiering af selvudløst tumorcellenekrose ved peroxidering af cellemembranen.
English: • 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
Danish: • 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
English: • Explain the procedure as well as relevant efficacy and safety results of TOOKAD with simple graphics included in the Patient Information Guide.
Danish: • Forklaring af proceduren samt relevante data vedrørende TOOKAD's virkning og sikkerhed ved hjælp af enkle grafiske fremstillinger i patientvejledningen.
English: 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).
Danish: 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).
English: 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).
Danish: TOOKAD's farmakokinetiske egenskaber er undersøgt hos 42 raske mænd (uden lysaktivering) og hos 70 patienter med lokaliseret prostatacancer (efter lysaktivering).
English: However, a prolongation of photosensitisation is possible and precautions against light exposure should be maintained for an additional 24 hours (see section 4.4).
Danish: En forlænget fotosensibilisering er dog mulig, og beskyttelsesforanstaltningerne mod lyseksponering bør opretholdes i yderligere 24 timer (se pkt.
English: Any medical condition that precludes the administration of a general anaesthetic or invasive procedures.
Danish: Medicinske tilstande, der udelukker anvendelse af fuld narkose eller invasive procedurer.
English: Hollow needles are used to insert the fibres into the right place in the prostate.
Danish: Der anvendes hule nåle til at indsætte fibre det rigtige sted i din prostata.
English: 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.
Danish: 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.