natgillin/translations-raw huggingface dataset:
Patienter over 75 år har muligvis en højere risiko for respirationsrelaterede bivirkninger som pleuraekssudat og dyspnø.
5 Patients older than 75 years may be at a higher risk of respiratory related adverse events such as pleural effusion and dyspnoea.
Lunge - og hjertesygdomme Patienter med pulmonal eller kardial medicinsk sygdom eller en anamnese med en sådan sygdom skal behandles med forsigtighed.
Pulmonary or cardiac disorders Patients with pulmonary or cardiac medical illness or a history of such illness should be treated with caution.
4. 8).
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).
5 Alle patienter, der modtager PhotoBarr, vil blive lysfølsomme og skal tage forholdsregler til at undgå at udsætte hud og øjne for direkte sollys eller stærkt indendørs lys (fra undersøgelseslamper inklusive tandlægelamper, operationslamper, uafskærmede lyspærer tæt ved, neonlys osv.) i mindst 90 dage efter behandling, da visse patienter kan forblive lysfølsomme i indtil 90 dage eller mere.
Photosensitivity All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid exposure of skin and eyes to direct sunlight or bright indoor light (from examination lamps, including dental lamps, operating room lamps, unshaded light bulbs at close proximity, neon lights, etc.) for at least 90 days after treatment, as some patients may remain photosensitive for up to 90 days or more.
I denne periode bør patienterne bruge solbriller, der har en gennemsnitlig transmissionsfaktor for hvidt lys på < 4%, når de er udendørs.
During this period, patients should wear dark sunglasses, which have an average white light transmittance of < 4% when outdoors.
Hvis der ikke forekommer nogen lysfølsomhedsreaktion (erythem, ødem, blisterdannelse) inden for 24 timer, kan patienten gradvist genoptage normale udendørs aktiviteter, idet han/ hun i begyndelsen fortsætter med at udvise forsigtighed og gradvist tillader stigende eksposition.
If no photosensitivity reaction (erythema, oedema, blistering) occurs within 24 hours, the patient can gradually resume normal outdoor activities, initially continuing to exercise caution and gradually allowing increased exposure.
Nedsat leverfunktion Der er ingen tilgængelige farmakokinetiske data og sikkerhedsdata for patienter med leverfunktionsnedsættelse.
Hepatic impairment No pharmacokinetic and safety data in patients with hepatic impairment are available.
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.
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.
Som resultat af PDT- behandling kan patienterne klage over substernale brystsmerter på grund af inflammatorisk respons i det behandlede område.
As a result of PDT treatment, patients may complain of substernal chest pain because of inflammatory responses within the area of treatment.
Hvis indtagelse af mad og/ eller drikke bliver umulig, eller der kommer gentagne opkastninger, skal patienten tilrådes at vende tilbage til klinikken for evaluering og for, om nødvendigt, at få intravenøs væske.
If intake of food and/ or drink becomes impossible or repeated vomiting occurs, patients should be advised to return to the clinic for evaluation and to receive intravenous fluids if needed.
Hvis PDT skal anvendes før eller efter radioterapi, skal der være tilstrækkelig tid mellem terapierne til at sikre, at inflammationsreaktionen, der er fremkaldt af den første behandling, er svundet, inden den nye behandling påbegyndes.
6 If PDT is to be used before or after radiotherapy, sufficient time should be allowed between the therapies to ensure that the inflammatory reaction produced by the first treatment has subsided prior to commencement of the second treatment.
5. 1).
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 5.1).
Det er muligt, at samtidig anvendelse af andre fotosensibiliserende midler (f. eks. tetracycliner, sulfonamider, phenothiaziner, hypoglykæmika af sulfonylurea- typen, thiazid- diuretika, griseofulvin og fluoroquinoloner) kan øge fotosensibiliseringsreaktionen.
It is possible that concomitant use of other photosensitising agents (e. g., tetracyclines, sulphonamides, phenothiazines, sulphonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin and fluoroquinolones) could increase the photosensitivity reaction.
PhotoBarr PDT forårsager direkte intracellulær beskadigelse ved at initiere radikalkæde- reaktioner, der beskadiger intracellulære membraner og mitokondrier.
PhotoBarr PDT causes direct intracellular damage by initiating radical chain reactions that damage intracellular membranes and mitochondria.
Forbindelser, der undertrykker aktive oxygenspecies eller bortskaffer radikaler såsom dimethylsulfoxid, β- caroten, ætanol, formiat og mannitol ville forventes at mindske PDT - aktivitet.
Compounds that quench active oxygen species or scavenge radicals, such as dimethyl sulphoxide, b-carotene, ethanol, formate and mannitol would be expected to decrease PDT activity.
Lægemidler der reducerer koagulation, vasokonstriktion eller blodpladeaggregation, f. eks thromboxan A2 inhibitorer, kan mindske effektiviteten af PDT.
Medicinal products that decrease clotting, vasoconstriction or platelet aggregation, e. g., thromboxane A2 inhibitors, could decrease the efficacy of PDT.
Graviditet Der er ingen erfaring med anvendelse af natriumporfimer til gravide.
Pregnancy There are no clinical data on exposed pregnancies available for porfimer sodium.
5. 3).
Animal studies are insufficient with respect to effects on pregnancy, embryo/ foetal development, parturition and postnatal development (see section 5.3).
Amning Det vides ikke, om natriumporfimer udskilles i human brystmælk.
Lactation It is not known whether porfimer sodium is excreted into human breast milk.
Til PDT - proceduren kan sedation være nødvendig, hvorfor der skal udvises forsigtighed.
7 For the PDT procedure, sedation may be required, and consequently caution should be taken.
I en open- label farmakokinetisk studie oplevede alle 24 raske personer lysfølsomhedsreaktioner, der var karakteristisk repræsenteret ved erythematøst udslet og ødem og var af mild til moderat intensitet.
In an open label pharmacokinetic study, all 24 healthy subjects experienced photosensitivity reactions, which were characteristically represented by erythematous rash and oedema and were mild to moderate in intensity.
Andre, mindre almindelige, hudmanifestationer blev rapporteret, hvor lysfølsomhedsreaktioner var forekommet som for eksempel øget hårvækst, misfarvning af huden,
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.
Disse manifestationer kan muligvis skyldes en pseudoporfyri- tilstand (forbigående lægemiddelinduceret kutan porfyri).
These manifestations may be attributable to a pseudoporphyria state (temporary medicinal product-induced cutaneous porphyria).
PhotoBarr PDT plus omeprazol (PDT + OM) - behandling blev sammenlignet med en gruppe behandlet med omeprazol alene (OM alene), i det BO med HGD kontrollede kliniske forsøg.
PhotoBarr PDT plus omeprazole (PDT + OM) treatment was compared to a group treated with omeprazole alone (OM only), in the BO with HGD controlled clinical trial.
De mest hyppigt rapporterede bivirkninger var lysfølsomhedsreaktioner (69%), øsofagusstenose (40%), opkastning (32%), brystsmerter af ikke - kardial oprindelse (20%), pyreksi (20%), dysfagi (19%), obstipation (13%), dehydrering (12%) og kvalme (11%).
The most frequently reported adverse reactions were photosensitivity reactions (69%), oesophageal stenosis (40%), vomiting (32%), chest pain of non-cardiac origin (20%), pyrexia (20%), dysphagia (19%), constipation (13%), dehydration (12%) and nausea (11%).
Rapporterede bivirkninger er opført på liste nedenfor i Tabel 5 efter organklasse og hyppighed.
Adverse reactions reported are listed below in Table 5 by organ class and frequency.
Hyppigheder er defineret som: meget almindelig (> 1/ 10); almindelig (> 1/ 100 < 1/ 10); ikke almindelig (> 1/ 1. 000, < 1/ 100).
Frequencies are defined as: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100).
Inden for hver enkelt frekvensgruppe, skal bivirkningerne opstilles efter, hvor alvorlige de er.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Oversigt over bivirkninger med natriumporfimer hos patienter med HGD og BO Infektioner og parasitære sygdomme Ikke almindelig:
Neoplasms benign,
Bronchitis, neglesvampeinfektion, sinusitis, hudinfektion Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper) Ikke almindelig:
Bronchitis, nail fungal infection, sinusitis, skin infection malignant and unspecified (incl cysts and polyps)
Basalcellekarcinom, lentigo Blod og lymfesystem Ikke almindelig:
Basal cell carcinoma, lentigo
Leukocytose Metabolisme og ernæring Meget almindelig:
Blood and lymphatic system disorders Uncommon:
Dehydrering Almindelig:
Metabolism and nutrition disorders Very common:
Appetitnedsættelse, elektrolytforstyrrelse
Appetite decreased, electrolyte imbalance Hypokalaemia
Ængstelse, søvnløshed
Anxiety, insomnia Restlessness
Rastløshed Nervesystemet Almindelig:
Eye disorders
Hovedpine, paræstesier, smagsforstyrrelser
Headache, paraesthesia, dysgeusia Dizziness, hypoaesthesia, tremor
Svimmelhed, hypæstesi, tremor Øjne Ikke almindelig:
Eye irritation, eye oedema
Øjenirritation, øjenødem Øre - og labyrint Ikke almindelig:
8 Ear and labyrinth disorders Uncommon:
Døvhed, tinnitus, forværring af tinnitus Hjerte Almindelig:
Cardiac disorders
Takykardi, brystsmerter
Deafness, tinnitus, tinnitus aggravated
Angina pectoris, atrieflimren, atrieflagren, ubehag i brystet Vaskulære sygdomme Ikke almindelig:
Tachycardia, chest pain Angina pectoris, atrial fibrillation, atrial flutter, chest discomfort
Hypertension, hæmorrhagi, hedestigninger, hypotension, orthostatisk hypotension Luftveje, thorax og mediastinum Almindelig:
Hypertension, haemorrhage, hot flushes, hypotension, orthostatic hypotension
Pleuraekssudat, faryngitis, atelektase, dyspnø
Pleural effusion, pharyngitis, atelectasis, dyspnoea
Kvælningsfornemmelse, funktionsdyspnø, hæmoptyse, hypoxi, tæt næse, aspirationspneumoni, produktiv hoste, respirationsdepression, respirationsvejskongestion, hvæsen
Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion, pneumonia aspiration, productive cough, respiratory depression, respiratory tract congestion, wheezing
8 Mave- tarm- kanalen Meget almindelig:
Gastrointestinal disorders Very common:
Erhvervet øsofagusstenose, opkastning, dysfagi, obstipation, kvalme Almindelig:
Oesophageal stenosis acquired, vomiting, dysphagia, constipation, nausea Common:
Hikke, odynofagi, diarre, dyspepsi, øsofagusulcus, øvre abdominalsmerter, abdominalsmerter, haematemese, øsofagussmerter, ructus, melæna (haematocheznia), forstyrrelser i øsophagus, føderegurgitation, abdominal défence, øsofagusspasmer, øsofagitis.
Hiccups, odynophagia, diarrhoea, dyspepsia, oesophageal ulcer, abdominal pain upper, abdominal pain, haematemesis, oesophageal pain, eructation, melaena (haematocheznia), oesophageal disorder, regurgitation of food, abdominal rigidity, oesophageal spasm, oesophagitis.
Løs afføring, ulcerøs øsofagitis, abdominalt ubehag, abdominal distension, nedre abdominalsmerter, erhvervet pylorusstenose, sprukne læber, colitis, flatulens, gastritis, gastrointestinal blødning, dårlig ånde, øsofagusblødning, øsofagusperforation.
Loose stools, oesophagitis ulcerative, abdominal discomfort, abdominal distension, abdominal pain lower, acquired pylori stenosis, chapped lips, colitis, flatulence, gastritis, gastrointestinal haemorrhage, halitosis, oesophageal haemorrhage, oesophageal perforation.
Lysfølsomhedsreaktion Almindelig:
Photosensitivity reaction Common:
Pruritus, udslet, hudskørhed, misfarvning af huden, hudsår, eksfoliativ dermatitis, tør hud, varmeknopper, maculo- papuløst udslæt, papuløst udslæt, ardannelse, hyperpigmentering af huden, hudlæsion, hudnoduli, urticaria
Pruritus, rash, skin fragility, skin discolouration, skin ulcer, dermatitis exfoliative, dry skin, milia, rash maculo-papular, rash papular, scar, skin hyperpigmentation, skin lesion, skin nodule, urticaria
Koldsved, dermatitis, abnorm hårvækst, øget tendens til blå mærker, keloid- ar, nattesved, lysfølsomt udslæt, maculøst udslæt, skællende udslæt, skorpedannelse, cikatricesmerter, vitiligo.
Cold sweat, dermatitis, hair growth abnormal, increased tendency to bruise, keloid scar, night sweats, photosensitive rash, rash macular, rash scaly, scab, scar pain, vitiligo.
Knogler, led, muskler og bindevæv Almindelig:
Uncommon:
Rygsmerter, ekstremitetssmerter
Back pain, pain in the limb Joint contracture, joint range of motion decreased, musculoskeletal chest pain, plantar fascitis
Ikke almindelig:
Urinary retention
Urinretention Det reproduktive system og mammae Ikke almindelig:
Reproductive system and breast disorders Uncommon:
Gynækomasti Medfødte, familiære og genetiske sygdomme Ikke almindelig:
Congenital, and familial and genetic disorders Uncommon:
Pyreksi Almindelig:
General disorders
Kulderystelser, træthed
Pigmented naevus and administration site conditions
Varmefølelse, erythem på injektionsstedet, somnolens, utilpashed, perifert ødem, smerter, fingertryksødem, temperaturintolerans, svaghed Undersøgelser Almindelig:
Investigations
Nedsat vægt, forhøjet legemstemperatur
Rigors, fatigue Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, pitting oedema, temperature intolerance, weakness
Nedsat blodalbumin, forhøjet blodklorid, forhøjet blodurea, nedsat hæmatokrit, nedsat hæmoglobin, nedsat oxygenmætning, nedsat totalprotein Traumer, forgiftninger og behandlingskomplikationer Almindelig:
Weight decreased, body temperature increased Blood albumin decreased, blood chloride increased, blood urea increased, haematocrit decreased, haemoglobin decreased, oxygen saturation decreased, protein total decreased
Smerter efter proceduren, afskrabning
9 Injury poisoning, and procedural complications Common:
Blisterdannelse, blødning efter proceduren
Post procedural pain, abrasion Blister, post procedural haemorrhage
Af de alvorlige bivirkninger (SAEs) i PhotoBarr PDT + OM- gruppen blev de 44 (23, 1%) betragtet som forbundet med behandlingen.
Of the serious adverse events (SAEs) in the PhotoBarr PDT + OM group, 44 (23.1%) were considered associated with the treatment.
Hovedparten af behandlingsassocieret øsofagusstenose (som omfatter øsofagusforsnævring og øsofagusstrikturer) rapporteret i PhotoBarr PDT + OM- gruppen var af mild eller moderat intensitet (92%).
The majority of treatment-associated oesophageal stenosis (which includes oesophageal narrowing and oesophageal strictures) reported in the PhotoBarr PDT + OM group were of mild or moderate intensity (92%).
Forekomstfrekvensen steg til 32%, da der blev givet en ny behandlingskur, især hvor den ny behandlingskur overlappede den første, og beløb sig til 10% for dem, der modtog en tredje
The occurrence rate rose to 32% when a second course of therapy was given, especially in the areas where second treatment overlaps the first and amounted to 10% for those who received a third treatment course.
Hovedparten af disse var milde til moderate i intensitet og kunne behandles ved hjælp af 1- 2 dilatationer.
The majority of these was mild to moderate in intensity and could be managed through 1-2 dilatations.
Otte procent var alvorlige og krævede multiple (6 - > 10) dilatationer.
Eight percent were severe, requiring multiple (6 - > 10) dilatations.
Ét tilfælde af mulig kataraktudfældning er rapporteret.
One case of possible precipitation of cataracts has been reported.
En 51- årig adipøs mand blev behandlet med PhotoBarr PDT for HGD i BO, off- label.
A 51 year-old obese man was treated with PhotoBarr PDT for HGD in BO, off-label.
PhotoBarr Der er ikke rapporteret tilfælde af overdosering af PhotoBarr.
PhotoBarr There is no information on overdose of PhotoBarr.
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.
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.
4. 4).
At this time, patients should test for residual photosensitivity (see section 4.4).
Laserlys Lysdoser på to til tre gange den anbefalede dosis har været administreret til nogle få patienter med superficielle endobronchiale tumorer.
Laser light Light doses of two to three times the recommended dose have been administered to a few patients with superficial endobronchial tumours.
Sensibilisatorer til fotodynamisk/ stråle- terapi, ATC- kode:
Sensitizers used in photodynamic/ radiation therapy, ATC code:
De cytotoksiske virkninger af natriumporfimer er lys - og oxygenafhængige.
Mechanism of action Porfimer sodium is a mixture of porphyrin units, which are linked together in chains of two to eight units The cytotoxic actions of porfimer sodium are light and oxygen-dependent.
Fotodynamisk terapi med PhotoBarr er en 2- trinsproces.
Photodynamic therapy with PhotoBarr is a 2-stage process.
Clearance fra forskellige væv foregår i løbet af 40- 72 timer, men tumorer, hud og organer i det retikuloendoteliale system (inklusive lever og milt) tilbageholder natriumporfimer i længere tid.
10 Clearance from a variety of tissues occurs over 40-72 hours, but tumours, skin, and organs of the reticuloendothelial system (including liver and spleen) retain porfimer sodium for a longer period.
Tumor - og dysplasivævs selektivitet i behandlingen kan til dels opstå gennem selektiv retention af natriumporfimer, men hovedsageligt gennem en selektiv tildeling af lys.
Tumour and dysplastic tissue selectivity in treatment may occur partly through selective retention of porfimer sodium but mainly through a selective delivery of light.
Cellebeskadigelsen forårsaget af natriumporfimer PDT er en følge af formeringen af frie radikal- reaktioner.
Cellular damage caused by porfimer sodium PDT is a consequence of the propagation of free radical reactions.
Spin- overførsel fra natriumporfimer til molekylært oxygen kan derpå generere singlet oxygen.
Spin transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen.
Efterfølgende kan frie radikal- reaktioner danne superoxid og hydroxylradikaler.
Subsequent free radical reactions can form superoxide and hydroxyl radicals.
Tumorcelledød opstår også via iskæmisk nekrose sekundært til vaskulær okklusion, der viser sig at være delvist medieret af thromboxan A2 - frigørelse.
Tumour cell death also occurs through ischaemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release.
Klinisk virkning I et kontrolleret klinisk forsøg blev en PhotoBarr PDT + OM (omeprazol) - patientgruppe (n=183) sammenlignet med en gruppe patienter, der kun fik OM (n=70).
Clinical efficacy In a controlled clinical trial, a PhotoBarr PDT + OM (omeprazole) patient group (n=183)was compared to a group of patients receiving OM only (n=70).
Patienter, der indgik i denne studie, skulle have biopsi- verificeret HGD i Barretts øsofagus (BO).
Eligible patients for this study were to have biopsy-proven HGD in Barrett's oesophagus (BO).
Patienter blev udelukket fra undersøgelsen, hvis der forekom invasiv øsofaguscancer, hvis de havde cancer i sygehistorien udover ikke- melanomisk hudcancer, eller hvis de tidligere havde fået PDT på øsofagus.
Patients were excluded from the study if there was a presence of invasive oesophageal cancer, if they had a history of cancer other than non- melanoma skin cancer or if they had received prior PDT to the oesophagus.
10 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.
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.
En eller 2 laserlysbehandlinger blev givet efter PhotoBarr- injektion.
One or 2 laser light treatments were administered following PhotoBarr injection.
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.
The first laser light session occurred 40-50 hours after injection and a second session, if indicated, occurred 96-120 hours after injection.
Samtidig administration af omeprazol (20 mg BID) begyndte mindst 2 dage før PhotoBarr- injektion.
Co-administration of omeprazole (20 mg BID) began at least 2 days before PhotoBarr injection.
Ved den endelige analyse, udført ved et minimum på 24 måneders opfølgning, fremviste en statistisk signifikant procentdel af patienterne (77%) i PhotoBarr PDT + OM- gruppen fuldstændig fjernelse af HGD sammenlignet med 39% af patienterne i gruppen med OM alene (p < 0, 0001).
At final analysis, performed at a minimum of 24 months follow-up, a statistically significant percentage of patients (77%) in the PhotoBarr PDT + OM group demonstrated complete HGD ablation compared to 39% of patients in the OM alone group (p < 0.0001).
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).
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).
Disse resultater bekræfter dem, der er observeret efter et minimum på 6 måneders opfølgning, der viste fjernelse af HGD hos 72% af patienterne i PhotoBarr PDT + OM- gruppen sammenlignet med 31% i OM alene gruppen.
These results confirm those observed after a minimum of 6 months follow-up which showed HGD ablation in 72% of patients in the PhotoBarr PDT + OM group compared to 31% in the OM only group.
Ved slutningen af den minimale opfølgning på to år var 13% i PhotoBarr PDT + OM- gruppen progredieret til cancer sammenlignet med 28% i OM alene gruppen i behandlingsintensions( ITT) - populationen.
By the end of the minimum follow-up of two years, 13% in the PhotoBarr PDT + OM group had progressed to cancer compared to 28% in the OM only group in the intent-to-treat (ITT) population.
Andelen af patienter, der progredierede til cancer i PhotoBarr PDT + OM- gruppen var statistisk lavere end i OM alene gruppen (p=0, 0060).
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).
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.
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.