FrancophonIA/ELRC3.0 huggingface dataset:
English: − Healthcare professionals should be aware of side effects that may arise during or shortly after treatment, and how to treat them.
Danish: − Sundhedspersoner skal kende de bivirkninger, der kan forekomme under eller kort efter behandling, og de skal vide, hvordan disse behandles.
English: During this period, patients should wear dark sunglasses, which have an average white light transmittance of < 4% when outdoors.
Danish: I denne periode bør patienterne bruge solbriller, der har en gennemsnitlig transmissionsfaktor for hvidt lys på <4%, når de er udendørs.
English: Photodynamic therapy with PhotoBarr is a 2-stage process.
Danish: Fotodynamisk terapi med PhotoBarr er en 2-trinsproces.
English: Patients who received one course of PDT had a greater risk of progression to cancer than patients who received two or three courses of PDT (50% vs. 39% and 11% respectively)
Danish: Patienter, der fik én PDTkur havde en større risiko for progression til cancer end patienter, som fik to eller tre PDT-kure (50% mod henholdsvis 39% og.
English: PhotoBarr should not be used during pregnancy unless clearly necessary.
Danish: PhotoBarr bør ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
English: Spills of PhotoBarr should be wiped up with a damp cloth.
Danish: Spildt PhotoBarr skal tørres op med en fugtig klud.
English: For 90 days following your PhotoBarr injection, you must take precautions to avoid exposure of skin and eyes to light.
Danish: I 90 dage efter Deres PhotoBarr-injektion skal De være forsigtig og undgå at eksponere hud og øjne for lys.
English: Of the serious adverse events (SAEs) in the PhotoBarr PDT + OM group, 44 (23.1%) were considered associated with the treatment.
Danish: Af de alvorlige bivirkninger (SAEs) i PhotoBarr PDT + OM-gruppen blev de 44 (23,1%) betragtet som forbundet med behandlingen.
English: Photodynamic therapy with PhotoBarr should be performed only by, or under the supervision of, a physician with experience in endoscopic laser procedures.
Danish: Fotodynamisk terapi med PhotoBarr må kun udføres af, eller under supervision af, en læge med erfaring i endoskopiske laserprocedurer.
English: Approximately 40-50 hours after PhotoBarr administration, light should be delivered by a fibre optic diffuser passed through the central channel of a centring balloon.
Danish: Cirka 40-50 timer efter administration af PhotoBarr skal der afgives lys ved hjælp af en fiberoptikdiffusor ledt gennem den centrale kanal af en centreringsballon.
English: The choice of fibre optic/balloon diffuser combination will depend on the length of oesophagus to be treated (Table 1).
Danish: Valget af fiberoptik/ballonsprederkombinationen vil afhænge af længden af øsofagus, der skal behandles (Tabel 1).
English: The first laser light session occurred 40-50 hours after injection and a second session, if indicated, occurred 96-120 hours after injection.
Danish: Den første laserlys-session fandt sted 40-50 timer efter injektion, og den anden session, hvis den var indiceret, fandt sted 96-120 timer efter injektion.
English: Acute hypersensitivity reactions including anaphylaxis have been reported.
Danish: Der er blevet rapporteret om akutte overfølsomhedsreaktioner, herunder anafylaksi.
English: Elderly patients(≥ 65 years old) Dose modification based upon age is not required.
Danish: Ældre patienter (≥ 65 år) Dosisændring baseret på alder er ikke nødvendig.
English: PhotoBarr should not be used in children and adolescents below 18 years of age, due to lack of experience.
Danish: PhotoBarr bør ikke bruges til børn og unge under 18 år på grund af manglende erfaring.
English: Illumination of the target area with 630 nm wavelength laser light constitutes the second stage of therapy.
Danish: Behandling af målområdet med laserlys af en bølgelængde på 630 nm udgør det andet trin i terapien.
English: Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development (see section 5.3).
Danish: Erfaringsgrundlaget fra dyreforsøg er utilstrækkeligt med hensyn til virkningerne på drægtigheden, den embryonale/føtale udvikling, fødslen og den postnatale udvikling (se pkt.
English: Healthcare professionals administration and monitoring guide
Danish: Administrations- og monitoreringsvejledning til sundhedspersoner
English: Before exposing any area of skin to direct sunlight or bright indoor light, the patient should test it for residual photosensitivity.
Danish: Inden udsættelse af noget område af huden for direkte sollys eller stærkt indendørs lys bør patienten teste det for residual lysfølsomhed.
English: A PhotoBarr 15 mg vial will be needed for every additional 7.5 kg body weight.
Danish: Et PhotoBarr 15 mg hætteglas vil være nødvendigt pr. 7,5 kg yderligere legemsvægt.
English: To increase your response rate, you may need up to three PDT courses, separated by at least 90 days.
Danish: For at øge Deres responsrate kan De have behov for at få tre PDT-kure med mindst 90 dages mellemrum.
English: − Record the patient's skin type and the date of injection on the patient alert card
Danish: − Registrere patientens hudtype og dato for injektion på alarmkortet.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The effects of an overdose on the duration of photosensitivity are unknown.
Danish: Virkningerne af en overdosering på lysfølsomhedens varighed er ukendte.
English: If you go out during daylight hours (even on cloudy days and while travelling in a vehicle), you should take the following precautions: cover as much skin as possible by wearing a long-sleeved shirt, trousers, socks, shoes, gloves and a wide brimmed hat protect your eyes with dark sunglasses.
Danish: Hvis De går ud om dagen (selv på overskyede dage og under rejse i et køretøj), skal De tage følgende forholdsregler: Tildæk så meget af huden som muligt ved at bruge bluse med lange ærmer, lange bukser, sokker, sko, handsker og bredskygget hat.
English: Based on preclinical studies, acceptable light intensity for the balloon/diffuser combination ranges from 175-270 mW/cm of diffuser.
Danish: Baseret på prækliniske studier strækker acceptabel lysintensitet for ballon/diffusor kombination sig fra 175 til 270 mW/cm fra diffusoren.
English: − Area in card for physician to record skin type and date of injection.
Danish: − Plads på kortet til lægens registrering af hudtype og dato for injektion.
English: PhotoBarr PDT + OM was effective in eliminating HGD in patients with BO.
Danish: PhotoBarr PDT + OM var effektivt til eliminering af HGD hos patienter med BO.
English: Direct sunlight:
Danish: Direkte sollys
English: Radical initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state.
Danish: Radikal initiering kan opstå, når natriumporfimer absorberer lys og danner en porfyrinstimuleret tilstand.
English: Photodynamic therapy with PhotoBarr should be applied by physicians trained in endoscopic use of PDT and only in those facilities properly equipped for the procedure.
Danish: Fotodynamisk terapi med PhotoBarr bør gives af læger, der er uddannet i endoskopisk brug af PDT og kun på afdelinger, der er korrekt udstyret til proceduren.
English: PhotoBarr is a light-activated medicine used photodynamic therapy (PDT)in combination with a non-burning, red laser light.
Danish: PhotoBarr er en lysaktiveret medicin, der bruges i fotodynamisk terapi (PDT) i kombination med et ikke-brændende, rødt laserlys.
English: 6.6 Special precautions for disposal and other handling Instructions for reconstitution
Danish: 6.6 Regler for destruktion og anden håndtering Instruktioner til rekonstitution
English: High-grade dysplasia in Barrett's oesophagus of < 7 cm
Danish: Højt differentieret dysplasi i Barretts øsofagus på < 7 cm
English: The recommended 2 mg/kg dose, instead of the recommended single administration, was given twice two days apart (10 patients) and three times within two weeks (1 patient), without any notable adverse reactions being reported.
Danish: Den anbefalede dosis på to 2 mg/kg i stedet for den anbefalede enkeltdosis blev givet to gange med to dages mellemrum (10 patienter) og tre gange inden for to uger (1 patient), uden at der blev rapporteret nogen betydende bivirkninger.
English: However, because of its potential to induce photosensitivity, PhotoBarr might be an eye and/or skin irritant in the presence of bright light.
Danish: Da PhotoBarr kan inducere lysfølsomhed, kan det dog irritere øjne og/eller hud i nærvær af stærkt lys.
English: Patients should be advised to consult their ophthalmologist if they notice any vision changes after treatment with PhotoBarr PDT.
Danish: Patienterne skal opfordres til at konsultere deres øjenlæge, hvis de bemærker synsændringer efter behandling med PhotoBarr PDT.
English: Expose a small area of skin to sunlight for 10 minutes.
Danish: Eksponér et lille hudområde for sollys i 10 minutter.
English: The mean elimination half-life (t1/2) was 21.5 days (CV 26 %, range 264-672) in patients and 17 days in volunteers.
Danish: Den gennemsnitlige halveringstid (t½) var 21,5 dage (CV 26%, område 264-672) hos patienter og 17 dage hos frivillige forsøgspersoner.
English: The second stage of therapy is illumination with laser light 40-50 hours following injection with PhotoBarr.
Danish: Det andet terapitrin er belysning med laserlys 40-50 timer efter injektionen med PhotoBarr.
English: Since PhotoBarr is activated by the red part of light, sunscreens for UV (ultraviolet) light will not protect you against photosensitivity reactions.
Danish: Da PhotoBarr aktiveres af den røde del af lyset, beskytter solafskærmninger, der beskytter mod UV-lys (ultraviolet lys), ikke mod lysfølsomhedsreaktioner.
English: The first stage is the intravenous injection of PhotoBarr.
Danish: Første trin er den intravenøse injektion af PhotoBarr.
English: PhotoBarr is contraindicated in patients with severe hepatic impairment.
Danish: PhotoBarr er kontraindiceret til patienter med kraftig leverfunktionsnedsættelse.
English: Comparison between the survival curves of the two treatment arms using the log rank test showed a statistically significant difference between the curves of the two groups in the ITT population (p=0.0014), indicating a significant delay in the progression to cancer.
Danish: Sammenligning mellem overlevelseskurverne for de to behandlingsformer ved hjælp af log rank test viste en statistisk signifikant forskel mellem kurverne for de to grupper i ITT-populationen (p=0,0014), hvilket viser en signifikant forsinkelse i progressionen til cancer.
English: The proportion of patients who progressed to cancer in the PhotoBarr PDT + OM group was statistically lower than in the OM only group (p=0.0060).
Danish: Andelen af patienter, der progredierede til cancer i PhotoBarr PDT + OM-gruppen var statistisk lavere end i OM alene gruppen (p=0,0060).
English: Breastfeeding should be terminated prior to treatment.
Danish: Amning skal afsluttes inden behandlingen.
English: The cytotoxic actions of porfimer sodium are light and oxygen-dependent.
Danish: De cytotoksiske virkninger af natriumporfimer er lys- og oxygenafhængige.
English: The first stage of PDT is the slow intravenous injection of PhotoBarr.
Danish: Det første trin i PDT er en langsom intravenøs injektion af PhotoBarr.
English: General disorders and administration site conditions Very common: Pyrexia
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: Pyreksi
English: A small area of skin should be exposed to sunlight for 10 minutes.
Danish: Et lille hudområde skal eksponeres for sollys i 10 minutter.
English: Patients older than 75 years may be at a higher risk of respiratory related adverse events such as pleural effusion and dyspnoea.
Danish: Patienter over 75 år har muligvis en højere risiko for respirationsrelaterede bivirkninger som pleuraeffusion og dyspnø.
English: There may be an increase in the risk of thrombo-embolic events especially in patients with prolonged immobilization, post major surgery and other thromboembolic risk factors.
Danish: Der kan være en øget risiko for tromboemboliske hændelser særligt hos patienter, som har været immobiliseret i længere tid, som har gennemgået større operationer, eller som har andre tromboemboliske risikofaktorer.
English: There is no information on overdose of PhotoBarr.
Danish: Der er ikke rapporteret tilfælde af overdosering af PhotoBarr.
English: PhotoBarr PDT regularly causes dysphagia, odynophagia, nausea and vomiting.
Danish: PhotoBarr PDT giver regelmæssigt dysfagi, odynofagi, kvalme og opkastning.
English: During your light treatment you may receive sedation.
Danish: Under lysbehandlingen får De muligvis beroligende medicin.
English: Fibre optic diffuser/balloon combinationa
Danish: Fiberoptik-diffusor/ballon kombination
English: A maximum of 7 cm of Barrett's mucosa is treated at the first light session using an appropriate size of centering balloon and fibre optic diffuser (Table 1).
Danish: Maksimalt 7 cm af Barretts mucosa behandles ved den første lyssession ved hjælp af en centreringsballon og fiberoptik-diffusor af passende størrelse (Tabel 1).
English: Sufficient vials of PhotoBarr should be reconstituted to provide the patient with a dose of 2 mg/kg.
Danish: Der skal rekonstitueres et tilstrækkeligt antal hætteglas til at forsyne patienten med en dosis på 2 mg/kg.
English: Metabolism and nutrition disorders Very common: Dehydration* Common:
Danish: Metabolisme og ernæring Meget almindelig: Dehydrering* Almindelig:
English: How to prevent a photosensitivity reaction
Danish: Hvordan lysfølsomhedsreaktioner forebygges
English: One or 2 laser light treatments were administered following PhotoBarr injection.
Danish: En eller 2 laserlysbehandlinger blev givet efter PhotoBarr-injektion.
English: You will be given a sedative along with a local anaesthetic to minimise discomfort.
Danish: De vil få et beroligende middel sammen med en lokalbedøvelse for at minimere ubehag.
English: Oesophageal or gastric varices or patients with oesophageal ulcers >1 cm in diameter.
Danish: Øsofagus- eller ventrikelvaricer eller patienter med øsofagusulcera >1 cm i diameter.
English: Laser light treatment: Your doctor will apply the red laser light (not a burning laser) to the involved area using an endoscope (a device used to see inside certain parts of the body).
Danish: Laserlysbehandling: Lægen vil rette det røde laserlys (ikke en brændende laser) mod det involverede område ved hjælp af et endoskop (et instrument, der bruges til at se indvendig i visse dele af kroppen).
English: Porphyria.
Danish: Porfyri.
English: Based on evidence for a primarily hepatic/biliary elimination of photoactive substances, severity of phototoxic reactions and duration of the period of photosensitivity in patients with any grade of hepatic impairment may be increased.
Danish: Baseret på beviser på primært lever-/galdeblæreeliminering af lysfølsomme stoffer kan omfanget af forbrændingsreaktioner samt længden af perioden med lysfølsomhed for patienter med en hvilken som helst grad af leverfunktionsnedsættelse blive forøget.
English: Indoor light:
Danish: Indendørs lys:
English: Patients may receive a second laser light application 96-120 hours after administration.
Danish: Patienterne kan modtage en ny laserlysbestråling 96-120 timer efter administration.
English: You will be given a sedative along with a local anaesthetic, to minimise discomfort
Danish: De vil få et beroligende middel sammen med en lokalbedøvelse for at minimere ubehag
English: Patient guide − Brief background and introduction to Barrett's oesophagus and high grade
Danish: − Kort baggrundsbeskrivelse og introduktion af Barrets øsofagus og højt
English: You should stop breast-feeding before using PhotoBarr.
Danish: Du skal holde op med at amme, før du bruger PhotoBarr.
English: Laser light
Danish: Laserlys
English: − At the request of the EMEA
Danish: − på anmodning fra det Europæiske Lægemiddelagentur
English: A dark red to reddish brown lyophilised powder or cake.
Danish: Et mørkerødt eller rødbrunt, frysetørret pulver eller kage.
English: Required power output from diffuser a
Danish: Nødvendigt effektoutput fra diffusor a
English: o Patients should be instructed to seek medical advice if signs/symptoms suggestive of photosensitivity occur during or after therapy with porfimer.
Danish: o Patienterne skal have besked på at søge læge, hvis der opstår tegn/symptomer, der tyder på lysfølsomhed, under eller efter terapi med porfimer.
English: Patients randomised to treatment with PDT received PhotoBarr at a dose of 2 mg/kg body weight through slow intravenous injection over 3 to 5 minutes.
Danish: Patienter randomiseret til behandling med PDT fik PhotoBarr i en dosis på 2 mg/kg legemsvægt ved langsom intravenøs injektion over 3 til 5 minutter.
English: cover as much skin as possible by wearing a long-sleeved shirt, trousers, socks, shoes, gloves and a wide brimmed hat protect your eyes with dark sunglasses.
Danish: Tildæk så meget af huden som muligt ved at bruge bluse med lange ærmer, lange bukser, sokker, sko, handsker og bredskygget hat.
English: − Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection
Danish: − Lysfølsomhed kan kun forebygges ved at undgå udsættelse for sol i 90 dage efter at
English: Other less common skin manifestations were reported in areas where photosensitivity reactions had occurred, such as increased hair growth, skin discolouration, skin nodules, skin wrinkling and skin fragility.
Danish: Andre, mindre almindelige, hudmanifestationer blev rapporteret, hvor lysfølsomhedsreaktioner var forekommet som for eksempel øget hårvækst, misfarvning af huden, hudnoduli, rynkedannelse og skørhed af huden.
English: The pharmacokinetics of porfimer sodium have been studied in 12 patients with endobronchial cancer and 23 healthy subjects (11 men and 12 women), given 2 mg/kg porfimer sodium through slow intravenous injection.
Danish: Natriumporfimers farmakokinetik er blevet undersøgt hos 12 patienter med endobronchial cancer og 23 raske forsøgspersoner (11 mænd og 12 kvinder), som fik indgivet 2 mg/kg natriumporfimer ved langsom intravenøs injektion.
English: PhotoBarr should be administered as a single slow intravenous injection over 3 to 5 minutes.
Danish: PhotoBarr skal administreres som en enkelt, langsom, intravenøs injektion over 3 til 5 minutter.
English: PDT specifically targets and destroys abnormal cells.
Danish: PDT er en behandling, der er designet til specifikt at opsøge og tilintetgøre unormale celler.
English: Injury, poisoning, and procedural complications Common:
Danish: Traumer, forgiftninger og behandlingskomplikationer Almindelig:
English: PhotoBarr is neither a primary ocular irritant nor a primary dermal irritant.
Danish: PhotoBarr er hverken et primært øjenirriterende middel eller et primært hudirriterende middel.
English: Preclinical data also suggest that tissue ischaemia, allopurinol, calcium channel blockers and some prostaglandin synthesis inhibitors could interfere with PhotoBarr PDT.
Danish: Prækliniske data tyder også på, at vævsiskæmi, allopurinol, kalciumkanalblokkere og visse prostaglandinsyntesehæmmere kan interferere med PhotoBarr PDT.
English: a Whenever possible, the BO segment selected for treatment should include normal tissue margins of a few millimetres at the proximal and distal ends.
Danish: Når det er muligt, skal det BO-segment, der er valgt til behandling, indbefatte normale vævskanter på nogle få millimeter i proksimale og distale ende.
English: A second laser light application may be given to a previously treated segment that shows a 'skip' area, (i.e., an area that does not show sufficient mucosal response) using a short < 2.5 cm fibre optic diffuser at the light dose of 50 J/cm of diffuser length (see Table 3).
Danish: En ny behandling med laserlys kan gives mod et tidligere behandlet segment, der fremviser et 'oversprings' område, (dvs. et område, der ikke viser tilstrækkelig mucosa-respons) ved hjælp af en kort, < 2,5 cm, fiberoptik-diffusor ved lysdosis på 50 J/cm af diffusorlængden (se Tabel 3).
English: Fifty-two percent of patients in the PDT + OM group showed normal squamous cell epithelium while 59% had absence of dysplasia compared to 7% and 14% in the OM alone group, respectively (p<0.0001).
Danish: Tooghalvtreds procent af patienterne i PDT + OM-gruppen viste normalt pladeepitel, mens 59% havde fravær af dysplasi sammenlignet med henholdsvis 7% og 14% i OM alene gruppen (p<0,0001).
English: In the clinical studies with PhotoBarr, follow-up surveillance was done every three months, or every six months after four consecutive biopsy results had shown no more high-grade dysplasia (see section
Danish: I de kliniske studier med PhotoBarr blev der foretaget opfølgning hver tredje eller hver sjette måned, efter at fire konsekutive biopsiresultater havde vist, at der ikke mere var højtdifferentieret dysplasi (se pkt.
English: The light dose administered will be 130 Joules/cm (J/cm) of diffuser length using a centring balloon.
Danish: Den administrerede lysdosis vil være 130 Joules/cm (J/cm) af diffusorlængden ved hjælp af en centreringsballon.
English: The survival curves indicated that, by the end of the entire follow-up period, patients in the PhotoBarr PDT + OM group had a 83% chance of being cancer-free as compared to a 53% chance for patients in the OM only group.
Danish: Overlevelseskurverne viste, at patienterne i PhotoBarr PDT + OM-gruppen ved slutningen af hele opfølgningsperioden havde en 83% chance for at blive cancer-frie sammenlignet med en 53% chance for patienterne i OM alene gruppen.
English: Tracheo-oesophageal or broncho-oesophageal fistula.
Danish: Tracheo-øsofageal eller broncho-øsofageal fistel.
English: PhotoBarr is used to remove high-grade dysplasia (cells with atypical changes that increase the risk of developing cancer) in patients with Barrett's oesophagus (gullet).
Danish: PhotoBarr bruges til at fjerne højt differentieret dysplasi (celler med atypiske forandringer, der øger risikoen for at udvikle cancer) hos patienter med Barretts øsofagus (spiserør).
English: if you are not able to swallow at all or repeated vomiting occurs
Danish: hvis De slet ikke kan synke, eller der forekommer gentagen opkastning.
English: These patients may be at higher risk for the development of cardiac and pulmonary related adverse events such as heart rhythm disorders, angina pectoris, dyspnoea, cough, pleural effusion, pharyngitis, atelectasis and events like dehydration (see also section 4.8).
Danish: Disse patienter kan have en højere risiko for at udvikle kardialt og pulmonalt relaterede bivirkninger såsom hjerterytmeforstyrrelser, angina pectoris, dyspnø, hoste, pleuraekssudat, faryngitis, atelektase og hændelser som dehydrering (se også pkt.
English: Tracheo-oesophageal fistula, Gastrointestinal necrosis Skin and subcutaneous tissue disorders
Danish: Trakeo-øsofageal fistel, gastrointestinal nekrose Hud og subkutane væv
English: Before you use PhotoBarr 3.
Danish: Det skal De vide, før De begynder at bruge PhotoBarr 3.
English: With light activation, porfimer sodium was mutagenic in some in-vitro tests.
Danish: Med lysaktivering var natriumporfimer mutagent i visse in-vitro tests.
English: The light dose (J/cm)= power output from diffuser (W) x treatment time (sec)
Danish: Lysdosis (J/cm)= effekt-output fra diffusor (W) x behandlingstid (sek)
English: After reconstitution, PhotoBarr is a dark red to reddish brown, opaque solution.
Danish: Efter rekonstitution er PhotoBarr en mørkerød eller rødbrun, uigennemsigtig opløsning.
English: Very common: Photosensitivity reaction Common:
Danish: Meget almindelig: Lysfølsomhedsreaktion
English: After it has been reconstituted, PhotoBarr should be used immediately (within 3 hours) and protected from light.
Danish: Efter rekonstitution skal PhotoBarr bruges straks (inden for 3 timer) og beskyttes mod lys.