FrancophonIA/ELRC3.0 huggingface dataset:
English: In a compassionate use programme (study 1), 54 patients received 10 mg/m2/day dinutuximab beta given by continuous 10-day intravenous infusion in a 5-week treatment course, concurrently with subcutaneous IL-2 (6×106 IU/m²/day given on days 1-5 and 8-12 of each course) and followed by oral
Danish: I et compassionate use program (på udleveringstilladelse) (studie 1) fik 54 patienter dinutuximab beta 10 mg/m2/dag som kontinuerlig intravenøs infusion over 10 dage i en 5-ugers-behandlingsserie, samtidig med subkutan IL-2 (6x106 IE/m²/dag på dag 1-5 og 8-12 i hver serie) og efterfulgt af isotretinoin (13-cis-RA) (160 mg/m2/dag i 14 dage i hver serie).
English: Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25 °C (50 mL syringe) and for up to 7 days at 37 ºC (250 mL infusion bag), after cumulative storage in a refrigerator (2 °C - 8 °C) for 72 hours.
Danish: Der er vist kemisk og fysisk i-brug-stabilitet i op til 48 timer ved 25 °C (50 ml sprøjte) og i op til 7 dage ved 37 ºC (250 ml infusionspose) efter kumulativ opbevaring i køleskab (2 °C - 8 °C) i 72 timer (se pkt.
English: • With daily infusions of dinutuximab beta, morphine infusion should be continued at a decreased rate (e.g. 0.01 mg/kg/h) for 4 hours after the end of dinutuximab beta infusion.
Danish: • Ved daglig infusion af dinutuximab beta skal morfininfusionen fortsættes med nedsat hastighed (f.eks. 0,01 mg/kg/time) i 4 timer efter afslutning af dinutuximab beta-infusionen.
English: Refractory patients
Danish: Refraktære patienter
English: In order to evaluate the add-on effect of IL-2 in patients with relapsed refractory neuroblastoma, the MAH will submit the results of study APN311202v3.
Danish: For at vurdere effekten af tillæg af IL-2 hos patienter med recidiverende eller refraktært neuroblastom skal indehaveren af markedsføringstilladelsen indsende resultaterne af studie APN311-202v3.
English: For continuous infusions, the solution is administered at a rate of 2 mL per hour (48 mL per day) using an infusion pump.
Danish: Ved kontinuerlig infusion skal injektionsvæsken administreres med en hastighed på 2 ml pr. time (48 ml pr. dag) med en infusionspumpe.
English: • For continuous infusions, the solution for infusion can be prepared freshly on a daily basis, or sufficient for up to 5 days of continuous infusion.
Danish: • Ved kontinuerlig infusion kan infusionsvæsken fremstilles hver dag eller i en mængde, der er tilstrækkelig til op til 5 dages kontinuerlig infusion.
English: For continuous infusions, any medical device suitable for infusion at a rate of 2 mL per hour can be applied, e.g. syringe infusion pumps/infusors, electronic ambulatory infusion pumps.
Danish: Ved kontinuerlig infusion kan infusionsapparatur egnet til infusion ved en hastighed på 2 ml pr. time benyttes, f.eks. infusionspumpe/infusionsapparatur til sprøjte og elektronisk ambulant infusionspumpe.
English: Vascular disorders hypotension, capillary leak syndrome hypertension hypovolaemic shock, veno-occlusive disease
Danish: Vaskulære sygdomme hypotension, kapillærlækagesyndrom hypertension hypovolæmisk shock, venookklusiv sygdom
English: First 5-day treatment should start 7 days prior to first dinutuximab beta infusion.
Danish: Den første 5-dages-periode skal starte 7 dage før den første dinutuximab beta-infusion.
English: If IL-2 is combined with dinutuximab beta, it should be given as subcutaneous injections for 5 consecutive days twice during each course.
Danish: Hvis IL-2 kombineres med dinutuximab beta, skal IL-2 administreres som subkutan injektion 5 på hinanden følgende dage to gange i hver behandlingsserie.
English: • cardiac failure, fluid around the heart
Danish: • hjertesvigt, væske rundt om hjertet
English: What you need to know before you use Qarziba
Danish: Det skal du vide, før du får Qarziba
English: Table 2: Event-free survival (EFS) and overall survival (OS) rates [95% confidence interval] in patients without evidence of disease at baseline (complete response to initial treatment)
Danish: Tabel 2: Rater for hændelsesfri overlevelse (EFS) og samlet overlevelse (OS) [95 % konfidensinterval] hos patienter uden tegn på sygdom ved baseline (fuldstændigt respons på startbehandlingen)
English: When IL-2 is combined with Qarziba, it should be administered as subcutaneous injections of 6×106 IU/m2/day, for 2 periods of 5 consecutive days, resulting in an overall dose of 60×106 IU/m2 per course.
Danish: Når IL-2 kombineres med Qarziba, skal IL-2 administreres som subkutan injektion på 6×106 IE/m2/dag i 2 perioder af 5 på hinanden følgende dage, hvilket resulterer i en samlet dosis på 60×106 IE/m2 pr. behandlingsserie.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless liquid.
Danish: LÆGEMIDDELFORM Koncentrat til infusionsvæske, opløsning Klar, farveløs væske.
English: Other medicines and Qarziba
Danish: Brug af anden medicin sammen med Qarziba
English: LIST OF EXCIPIENTS Histidine, sucrose, polysorbate 20, water for injections, hydrochloric acid.
Danish: LISTE OVER HJÆLPESTOFFER Histidin, saccharose, polysorbat 20, vand til injektionsvæsker, saltsyre.
English: Grade 4 haematologic toxicities, improving to at least Grade 2 or baseline values by start of next treatment course, do not require dose modification.
Danish: Dosisjustering er ikke nødvendig ved grad 4 hæmatologisk toksicitet, der er bedret til mindst grad 2 eller baseline-niveau ved start af næste behandlingsserie .
English: For continuous infusions, the solution for infusion can be prepared freshly on a daily basis, or sufficient for up to 5 days of continuous infusion.
Danish: Ved kontinuerlig infusion kan infusionsvæsken fremstilles hver dag eller i en mængde, der er tilstrækkelig til op til 5 dages kontinuerlig infusion.
English: Table 3: Event-free survival (EFS) and overall survival (OS) rates [95% confidence interval] in patients with evidence of disease at baseline (no complete response to initial treatment)
Danish: Tabel 3: Rater for hændelsesfri overlevelse (EFS) og samlet overlevelse (OS) [95 % konfidensinterval] hos patienter med tegn på sygdom ved baseline (ikke fuldstændigt respons på startbehandlingen)
English: Qarziba should be diluted aseptically to the patient specific concentration/dose with sodium chloride 9 mg/mL (0.9%) solution for infusion containing 1% human albumin (e.g. 5 mL of human albumin 20% per 100 mL sodium chloride solution).
Danish: Qarziba skal fortyndes aseptisk til den patientspecifikke koncentration/dosis med 9 mg/ml (0,9 %) natriumchloridinfusionsvæske indeholdende 1 % humant albumin (f.eks. 5 ml humant albumin 20 % til 100 ml natriumchloridinfusionsvæske).
English: with IL-2 N=76
Danish: med IL-2 N=76
English: Haematologic toxicities
Danish: Hæmatologisk toksicitet
English: Second 5-day treatment with IL-2 should start concurrently with dinutuximab beta infusion (days 1 to 5 of each course).
Danish: Den anden 5-dages-periode med IL-2 skal starte samtidig med dinutuximab beta-infusionen (dag 1 til 5 i hver serie).
English: • low blood pressure, increased heartbeat
Danish: • lavt blodtryk (svimmelhed), hurtigere hjerteslag (puls)
English: Dinutuximab beta is a mouse-human chimeric monoclonal IgG1 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Danish: Dinutuximab beta er et humaniseret murint-humant monoklonalt IgG1-antistof fremstillet ved rekombinant DNA-teknologi i en pattedyrscellelinje (CHO).
English: Dose modification of dinutuximab beta
Danish: Dosisjustering af dinutuximab beta
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 behandlede):
English: • grade 3 peripheral neuropathy
Danish: • grad 3 perifer neuropati
English: with IL-2 N=107
Danish: med IL-2 N=107
English: • problems with your nerves You may notice numbness, tingling or burning in your hands, feet, legs or arms, reduced sensation or weakness with movement.
Danish: Du kan bemærke følelsesløshed, prikkende eller brændende fornemmelse i hænder, fødder, arme eller ben, og nedsat følsomhed eller svaghed i forbindelse med bevægelse.
English: The first 5-day course should start 7 days prior to the first infusion of dinutuximab beta and the second 5-day course should start concurrently with dinutuximab beta infusion (days 1 to 5 of each dinutuximab beta course).
Danish: Den første 5-dages-serie skal starte 7 dage inden den første infusion af dinutuximab beta, og den anden 5-dages-serie skal starte samtidig med dinutuximab betainfusionen (dag 1 til 5 i hver dinutuximab beta-serie).
English: Dinutuximab beta has been shown in vitro to bind to neuroblastoma cell lines known to express GD2 and to induce both complement dependent cytoxicity (CDC) and antibody dependent cell-mediated cytoxicity (ADCC).
Danish: Det er vist, at dinutuximab beta in vitro binder til neuroblastom-cellelinjer, der vides at eksprimere GD2, og inducerer både komplementafhængig cytotoksicitet (CDC) og antistofafhængig cellemedieret cytotoksicitet (ADCC).
English: Metabolism and nutrition disorders fluid retention decreased appetite, hypoalbuminaemia, hyponatraemia, hypokalaemia, hypophosphataemia, hypomagnesaemia, hypocalcaemia, dehydration
Danish: Metabolisme og ernæring væskeretention appetitløshed, hypoalbuminæmi, hyponatriæmi, hypokaliæmi, hypofosfatæmi, hypomagnesiæmi, hypokalcæmi, dehydrering
English: • nerve disorder in the arms and/or legs (with abnormal sensations or weakness), light headedness, trembling, muscle spasms
Danish: • nerveforstyrrelser i arme og/eller ben (med unormale fornemmelser eller svaghed), svimmelhed,
English: • paralysis of eye muscles, blurred vision, light sensitivity, swelling in the retina
Danish: • lammelse af øjenmuskler, sløret syn, lysfølsomhed, opsvulmning af nethinden
English: Interrupt infusion, After resolution, resume infusion at 50% rate
Danish: Afbryd infusionen Efter ophør genoptages infusionen med en hastighed på 50 %
English: Immune system disorders hypersensitivity , cytokine release syndrome anaphylactic reaction serum sickness
Danish: Immunsystemsygdom me overfølsomhed, cytokinfrigivelsessyndro m anafylaktisk reaktion serumsygdom
English: For repeated daily 8-hour infusions, the daily dose is 20 mg/m2 and the calculated dose should be diluted in 100 mL sodium chloride 9 mg/mL (0.9%) containing 1% human albumin.
Danish: Ved gentagne daglige 8-timers infusioner er den daglige dosis 20 mg/m2, og den beregnede dosis skal fortyndes med 100 ml 9 mg/ml (0,9 %) natriumchloridinfusionsvæske indeholdende 1 % humant albumin.
English: Blood and lymphatic system disorders anaemia,leukopenia, neutropenia, thrombocytopenia lymphopenia disseminated intravascular coagulation, eosinophilia
Danish: Blod og lymfesystem anæmi, leukopeni, neutropeni, trombocytopeni lymfopeni dissemineret intravaskulær koagulation, eosinofili
English: Dinutuximab beta is a chimeric monoclonal IgG1 antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells.
Danish: Dinutuximab beta er et humaniseret monoklonalt IgG1-antistof, der er specielt rettet mod kulhydratdelen af disialogangliosid 2 (GD2), som er overudtrykt på neuroblastom-celler.
English: Skin and subcutaneous tissue disorders pruritus , rash, urticaria dermatitis (including exfoliative) , erythema, dry skin, hyperhidrosis, petechiae, photosensitivity reaction
Danish: Sygdomme i hud og de subkutane væv kløe, hududslæt, urticaria dermatit (inklusive exfoliativ dermatit), erytem, tør hud, hyperhidrose, petekkier, lysfølsomhedsreaktion
English: Other intravenously co-administered agents should be delivered via a separate infusion line (see section 6.6).
Danish: Andre samtidigt administrerede intravenøse lægemidler skal indgives gennem en separat infusionsslange (se pkt.
English: Interrupt infusion and administer supportive measures, After resolution, resume infusion at original rate
Danish: Afbryd infusionen og administrer understøttende behandling Efter ophør genoptages infusionen med den oprindelige hastighed
English: Cardiac disorders tachycardia cardiac failure, left ventricular dysfunction, pericardial effusion
Danish: Hjerteforstyrrelser takykardi hjertesvigt, venstre ventrikeldysfunktion, perikardie-effusion
English: Interrupt infusion and administer supportive measures, Resume infusion at 50% rate if ADR resolves or improves to Grade 1 - 2, After resolution, increase to original rate
Danish: Afbryd infusionen og administrer understøttende behandling Genoptag infusionen med en hastighed på 50 %, når bivirkningen er ophørt eller bedret til grad 1-2 Efter ophør øges til den oprindelige hastighed
English: Breast-feeding should be discontinued during treatment with Qarziba and for 6 months after the last dose.
Danish: Amning skal ophøre under behandling med Qarziba og i 6 måneder efter den sidste dosis.
English: Diluted solution (solution for infusion)
Danish: Fortyndet koncentrat (infusionsvæske)
English: Hypersensitivity reaction e.g. hypotension
Danish: Overfølsomhedsreaktion, f.eks. hypotension
English: • decreased appetite, nausea, abdominal distension, accumulation of fluid in the abdominal cavity
Danish: • nedsat appetit, kvalme, udspiling af maven, ophobning af væske i bughulen
English: Discontinue infusion, Resume next day if ADR resolves
Danish: Genoptag infusionen næste dag, hvis bivirkningen er ophørt
English: Recurrent
Danish: Tilbagevendende
English: • injection-site reactions, skin problems such as reddening, dry skin, eczema, excessive sweating,
Danish: • reaktioner på injektionsstedet, hudproblemer såsom rødme, tør hud, eksem, overdreven svedproduktion, unormal reaktion på lys
English: Avoid vaccinations during treatment with Qarziba and for 10 weeks afterwards.
Danish: Undgå at blive vaccineret under behandlingen med Qarziba og i 10 uger efter, behandlinger er afsluttet.
English: Do not breast-feed during treatment with Qarziba and for 6 months after the last dose.
Danish: Undgå at amme under behandling med Qarziba og i 6 måneder efter den sidste dosis.
English: What Qarziba is and what it is used for What you need to know before you use Qarziba How to use Qarziba
Danish: Virkning og anvendelse Det skal du vide, før du får Qarziba Sådan får du Qarziba
English: ophthalmoplegia, papilloedema, accommodation disorder, blurred vision, photophobia
Danish: oftalmoplegi, papilødem, akkommodationsforstyrrels er, sløret syn, fotofobi
English: • For repeated daily infusions, the daily dose is 20 mg/m2 and the calculated dose should be diluted in 100 mL sodium chloride 9 mg/mL (0.9%) containing 1% human albumin.
Danish: • Ved gentagne daglige 8-timers infusioner er den daglige dosis 20 mg/m2, og den beregnede dosis skal fortyndes med 100 ml 9 mg/ml (0,9 %) natriumchloridinfusionsvæske indeholdende 1 % humant albumin
English: Interrupt infusion and administer supportive measures, Resume at 50% rate if ADR resolves or improves to Grade 1 - 2
Danish: Afbryd infusionen og administrer understøttende behandling Genoptag infusionen med en hastighed på 50 %, hvis bivirkningen er ophørt eller bedret til grad 1-2
English: • allergic reactions or other infusion-related reactions Tell your doctor or nurse if you have any kind of reaction during or after the infusion, such as: fever, shivering and/or low blood pressure difficulties in breathing skin rash, hives You will receive appropriate treatment to prevent these reactions and be closely monitored for these symptoms during infusion of Qarziba.
Danish: • Allergiske reaktioner og andre reaktioner på infusionen Fortæl din læge eller sundhedspersonalet, hvis du får en eller anden form for reaktion under eller efter infusionen, som f.eks.:
English: Study 1 N=15
Danish: Studie 1 (n=15)
English: Efficacy without IL-2 N=73
Danish: Virkning uden IL-2 N=73
English: Investigations increased weight , increased transaminases, increased gamma glutamyltransferase, increased blood bilirubin increased blood creatinine decreased weight, decreased glomerular filtration rate, hypertriglyceridaemia, prolonged activated partial thromboplastin time, prolonged prothrombin time, prolonged thrombin time
Danish: Undersøgelser vægtstigning, forhøjede aminotransferaser, forhøjet gamma glutamyltransferase, forhøjet blod-bilirubin vægttab, nedsat glomerulær filtrationshastighed, hypertriglyceridæmi, forlænget aktiveret partiel tromboplastintid, forlænget protrombintid, forlænget trombintid *inkluderer abdominalsmerter, ekstremitetssmerter, muskuloskeletale smerter, brystsmerter, artralgi
English: Efficacy without IL-2 N=104
Danish: Virkning uden IL-2 N=104
English: Nervous system disorders headache peripheral neuropathy, seizure, paraesthesia, dizziness, tremor intracranial pressure increased, posterior reversible encephalopathy syndrome
Danish: Psykiske forstyrrelser ophidselse, nervøsitet forstyrrelser af nervesystemet hovedpine perifer neuropati, epileptisk anfald, paræstesi, svimmelhed, tremor øget intrakranielt tryk, posteriort reversibelt encefalopatisyndro m
English: Respiratory, thoracic and mediastinal disorders hypoxia, cough bronchospasm , dyspnoea, respiratory failure, lung infiltration, pulmonary oedema, pleural effusion, tachypnoea, laryngospasm
Danish: Luftveje, thorax og mediastinum hypoxi, hoste bronkospasme, dyspnø, respirationsinsufficiens, lungeinfiltration, lungeødem, pleuraeffusion, takypnø, larynxspasme
English: Eye disorders mydriasis, pupillotonia, eye oedema (eyelid, periorbital)
Danish: Øjensygdomme mydriasis, pupillotoni, øjenødem (øjenlåg, periorbitalt)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of concentrate contains 4.5 mg dinutuximab beta.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml koncentrat indeholder 4,5 mg dinutuximab beta.
English: Recommended dose modifications for dinutuximab beta Adverse reaction Severity
Danish: Anbefalede dosisændringer for dinutuximab beta Bivirkning
English: Study 2 N=25
Danish: Studie 2 (n=25)
English: Intravenous immunoglobulin
Danish: Intravenøst immunglobulin
English: Study 1 N=29
Danish: Studie 1 (n=29)
English: Study 2 N=19
Danish: Studie 2 (n=19)
English: Gastrointestinal disorders vomiting , diarrhoea, constipation, stomatitis nausea, lip oedema, ascites, abdominal distension, ileus, dry lips enterocolitis
Danish: Mave-tarm-kanalen opkastning, diarré, obstipation, stomatitis kvalme, læbeødem, ascites, abdominal distension, ileus, tørre læber enterokolit
English: Tell your doctor if you are breast-feeding.
Danish: Sig det til lægen, hvis du ammer.
English: Each vial contains 20 mg dinutuximab beta in 4.5 mL.
Danish: Et hætteglas indeholder 20 mg dinutuximab beta i 4,5 ml.
English: NAME OF THE MEDICINAL PRODUCT Qarziba 4.5 mg/mL concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Qarziba 4,5 mg/ml koncentrat til infusionsvæske, opløsning
English: Dinutuximab beta was administered at a dose of 20 mg/m2/day on 5 consecutive days, given by 8-hour intravenous infusion in a 5-week treatment course, and was combined with 13-cis-RA and with or without additional subcutaneous IL-2 at the same posologies as in the previous studies.
Danish: Dinutuximab beta blev administreret i en dosis på 20 mg/m2/dag ved intravenøs infusion over 8 timer og givet 5 på hinanden følgende dage i en 5-ugers-behandlingsserie.
English: Decrease infusion rate to 50%, After resolution, resume infusion at original rate
Danish: Nedsæt infusionshastigheden til 50 Efter ophør genoptages infusionen med den oprindelige hastighed
English: Musculoskeletal and connective tissue disorders muscle spasms
Danish: Muskler, knogler og bindevæv muskelspasmer
English: 1 mL concentrate contains 4.5 mg dinutuximab beta.
Danish: 1 ml koncentrat indeholder 4,5 mg dinutuximab beta.
English: Tell your doctor or nurse immediately if you have any of the following:
Danish: Tal omgående med din læge eller sundhedspersonalet, hvis du bemærker noget af følgende: Meget almindelig (forekommer hos mere end 1 ud af 10 behandlede):
English: • fever, chills
Danish: • feber, kuldegysninger
English: • decreased weight, loss of fluids (dehydration)
Danish: • vægttab, væsketab (dehydrering)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Qarziba 4.5 mg/mL concentrate for solution for infusion dinutuximab beta
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ Qarziba 4,5 mg/ml koncentrat til infusionsvæske, opløsning dinutuximab beta
English: Qarziba 4.5 mg/mL concentrate for solution for infusion dinutuximab beta
Danish: Qarziba 4,5 mg/ml koncentrat til infusionsvæske, opløsning dinutuximab beta
English: STATEMENT OF ACTIVE SUBSTANCE 1 mL of concentrate contains 4.5 mg dinutuximab beta.
Danish: ANGIVELSE AF AKTIVT STOF 1 ml koncentrat indeholder 4,5 mg dinutuximab beta.
English: • have acute grade 3 or 4, or extensive long-lasting graft-versus-host disease This disease is a reaction in which cells of transplanted tissue attack cells of the recipient.
Danish: Graft versus host-sygdom er en reaktion, hvor cellerne i det transplanterede væv angriber kroppens celler.
English: Each 4.5 mL vial contains 20 mg dinutuximab beta.
Danish: Et 4,5 ml hætteglas indeholder 20 mg dinutuximab beta.
English: Preparation of the infusion
Danish: Fremstilling af infusionsvæske
English: Relapsed patients
Danish: Patienter med relaps
English: • oxygen deficiency
Danish: • iltmangel
English: Renal and urinary disorders oliguria, urinary retention, hyperphosphaturia, haematuria, proteinuria renal failure
Danish: nyresvigt urinvejssygdomme hyperfosfaturi, hæmaturi, proteinuri
English: • inflammation of the intestine, injury to the liver
Danish: • betændelse i tarmen, leverskade
English: Other side effects and their frequencies include: Very common (may affect more than 1 in 10 people):
Danish: Andre bivirkninger og deres hyppighed er:
English: General disorders and administration site conditions pyrexia, chills, pain*, peripheral oedema, face oedema injection site reaction
Danish: Almene symptomer og reaktioner på administrationsstedet feber, kuldegysninger, smerter*, perifert ødem, ansigtsødem reaktion på injektionsstedet
English: breathing difficulties, dizziness, hives, rapid or noticeable heartbeat, low blood pressure, hives,
Danish: feber, kulderystelser og/eller lavt blodtryk (bliver svimmel)
English: The information pack should contain the following:
Danish: Informationspakken skal indeholde følgende:
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY MEMBER STATES
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL INDFØRES AF MEDLEMSSTATERNE
English: The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on the correct prescription of Esbriet.
Danish: Indehaveren af markedsføringstilladelsen skal, i samråd med de kompetente myndigheder i medlemsstaterne, inden markedsføringen gennemføre et uddannelsesprogram for læger, der tager sigte på at udlevere informationsmateriale om korrekt ordinering af Esbriet.
English: • Patients are advised to avoid or reduce exposure to direct sunlight (including sunlamps).
Danish: • Patienter anbefales at undgå eller nedsætte eksponering for direkte sol (også solarier).
English: • There is a need to monitor liver function tests prior to initiation of treatment with Esbriet and at regular intervals thereafter.
Danish: • Det er nødvendigt at overvåge leverfunktionstest inden initiering af behandling med Esbriet og med regelmæssige mellemrum derefter.
English: • Elevations of serum transaminases can occur during treatment with Esbriet.
Danish: • Der kan forekomme forhøjelser af serumtransaminaser under behandling med Esbriet.
English: • Patients should be informed that Esbriet is known to be associated with photosensitivity reactions and that preventative measures have to be taken.
Danish: • Patienter skal oplyses om, at Esbriet er forbundet med lysfølsomhedsreaktioner, og at der skal træffes forebyggende foranstaltninger.