FrancophonIA/ELRC3.0 huggingface dataset:
English: • Risk of serious haemolysis (in PNH) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations.
Danish: • risikoen for alvorlig hæmolyse (i PNH) efter afbrydelse/udsættelse af administration af eculizumab, tegn og symptomer forbundet hermed og anbefaling om at konsultere den ordinerende læge før afbrydelse/udsættelse af administration af eculizumab.
English: (≥1/10,000 to <1/1,000)
Danish: Sjælden (≥1/10.000 til
English: Discontinued treatment PRBC in previous 12 months (median (Q1,Q3))
Danish: Pakkede erytrocytter de foregående 12 måneder (median (Q1,Q3)) Middel-Hgb (g/dl) ved sætpunktet (standardafvigelse)
English: Renal impairment, Dysuria, Haematuria
Danish: Nyreinsufficiens, dysuri, hæmaturi
English: • Risk of severe thrombotic microangiopathic complications (in aHUS) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations.
Danish: • risikoen for alvorlige komplikationer som følge af trombotisk mikroangiopati (i aHUS) efter afbrydelse/udsættelse af administration af eculizumab, tegn og symptomer forbundet hermed og anbefaling om at konsultere den ordinerende læge før afbrydelse/udsættelse af administration af eculizumab.
English: • dyspnoea (difficulty breathing), nose bleed, stuffy nose (nasal congestion), throat irritation, runny nose
Danish: • vejrtrækningsbesvær (dyspnø), næseblod, tilstoppet næse, irritation i svælget, snue
English: Gently agitate the infusion bag containing the diluted solution to ensure thorough mixing of the product and diluent.
Danish: Infusionsposen med den fortyndede opløsning omrystes forsigtigt, så lægemidlet bliver grundigt opblandet i fortyndingsmidlet.
English: In PNH, chronic administration of Soliris resulted in a rapid and sustained reduction in complementmediated haemolytic activity.
Danish: Hos PNH-patienter resulterede kronisk administration af Soliris i en hurtig og vedvarende reduktion i den komplementmedierede hæmolytiske aktivitet.
English: Study C08-002A/B was a prospective, controlled, open-label study which accrued patients in the early phase of aHUS with evidence of clinical thrombotic microangiopathy manifestations with platelet count ≤
Danish: Studiet C08-002A/B var et prospektivt, kontrolleret, ikke-blindet studie, hvori der deltog patienter med aHUS i den tidlige fase med tegn på kliniske manifestationer af trombotisk mikroangiopati med et trombocyttal ≤ 150 x 109/l til trods for PE/PI-behandling, og serum-LDH og serum-kreatinin over øvre normalgrænse.
English: N=10 (%)
Danish: < 2 måneder N=10 (%)
English: The risks of stopping Soliris include an increase in the inflammation of your platelets, which may cause: - A significant fall in your platelets (thrombocytopenia), - A significant rise in destruction of your red blood cells, - Decreased urination (problems with your kidneys), - An increase in your serum creatinine level (problems with your kidneys), - Confusion or change in how alert you are, - Chest pain, or angina, - Shortness of breath, or - Thrombosis (blood clotting).
Danish: Det kan medføre følgende symptomer: et væsentligt fald i antallet af blodplader (trombocytopeni) en væsentlig øget nedbrydning af blodlegemer mindsket vandladning (problemer med nyrerne) øget indhold af kreatinin i blodet (problemer med nyrerne) forvirring eller ændret opmærksomhed og reaktionsevne brystsmerter åndenød eller blodpropdannelse (trombose).
English: Administration of Soliris may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis), though immune system disorders within 48 hours of Soliris administration did not differ from placebo treatment in PNH, aHUS, refractory gMG, NMOSD and other studies conducted with Soliris.
Danish: Der sås dog ingen forskel fra placebo i forekomsten af forstyrrelser i immunsystemet inden for 48 timer efter administration af Soliris i de PNH-studier, aHUS-studier, refraktær gMG-studier, NMOSD-studier og andre studier, hvor Soliris blev anvendt.
English: (n=62) (SEM)
Danish: Soliris (n=62) (SEM)
English: Time from aHUS diagnosis to first study dose (months), median ( min, max)
Danish: Tid fra aHUS-diagnose til første studiedosis (måneder), median (min., maks.)
English: If PNH patients discontinue treatment with Soliris they should be closely monitored for signs and symptoms of serious intravascular haemolysis.
Danish: Hvis Soliris-behandling afbrydes hos patienter med PNH, bør de monitoreres nøje for tegn og symptomer på alvorlig intravaskulær hæmolyse.
English: • severe infection (meningococcal infection), sepsis, septic shock, viral infection, , lower respiratory tract infection, stomach flu (gastrointestinal infection), cystitis
Danish: • alvorlig infektion (meningokok-infektion), sepsis (blodforgiftning), septisk shock, virusinfektion,
English: Patients who initiate Soliris treatment less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
Danish: Patienter, der påbegynder behandling med Soliris mindre end 2 uger efter, at de er blevet vaccineret mod meningokokinfektion, skal have passende profylaktisk antibiotisk behandling, indtil 2 uger efter vaccinationen.
English: Forty seven percent of patients had an identified complement regulatory factor mutation or auto-antibody.
Danish: 47% af patienterne havde en identificeret mutation i de gener, der koder for de proteiner, der er regulatorer af komplementsystemet eller auto-antistof.
English: • Maintenance phase: 900 mg of Soliris administered via a 25 - 45 minute intravenous infusion for the fifth week, followed by 900 mg of Soliris administered via a 25 - 45 minute intravenous infusion every 14 ± 2 days (see section 5.1).
Danish: • Vedligeholdelsesfase: 900 mg Soliris givet som intravenøs infusion over 25-45 minutter den 5. uge, efterfulgt af 900 mg Soliris givet som intravenøs infusion over 25-45 minutter hver 14.
English: Patients in aHUS study C08-003A/B received Soliris for a minimum of 26 weeks.
Danish: Patienter i aHUS-studiet C08-003A/B fik Soliris i mindst 26 uger.
English: Soliris administration should be interrupted in all patients experiencing severe infusion reactions and appropriate medical therapy administered.
Danish: Ved svære infusionsreaktioner skal administrationen af Soliris afbrydes og passende behandling gives.
English: Fifty percent of patients had an identified complement regulatory factor mutation or auto-antibody.
Danish: Halvtreds procent af patienterne havde en identificeret mutation i de gener, der koder for en af de faktorer (proteiner), der er regulatorer af komplementsystemet, eller autoantistof.
English: Treatment effect a
Danish: Virkning af behandlinga
English: Soliris is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Danish: Soliris anvendes til behandling af voksne og pædiatriske patienter med en særlig blodsygdom, der kaldes paroksystisk nokturn hæmoglobinuri (PNH).
English: Patients in aHUS Study C10-004 received Soliris for a minimum of 26 weeks.
Danish: Patienterne i aHUS-studie C10-004 fik Soliris i mindst 26 uger.
English: What Soliris contains
Danish: Soliris indeholder:
English: In all studies, the dose of Soliris in adult and adolescent aHUS patients was 900 mg every 7 ± 2 days for 4 weeks, followed by 1,200 mg 7 ± 2 days later, then 1,200 mg every 14 ± 2 days for the study duration.
Danish: I alle studier var Soliris-dosis hos voksne og unge aHUS-patienter 900 mg hver 7. dag ± 2 dage i 4 uger, efterfulgt af 1.200 mg 7 ± 2 dage senere og derefter 1.200 mg hver 14. dag ± 2 dage i den resterende del af studiet.
English: Interrupting or stopping treatment with Soliris may cause your gMG symptoms to come back.
Danish: Hvis du holder op med at bruge Soliris mod refraktær gMG Hvis du afbryder eller stopper behandlingen med Soliris, kan dine gMG-symptomer vende tilbage.
English: • swelling (edema), chest discomfort, feeling of weakness (asthenia), chest pain, infusion site pain, chills
Danish: • hævelse (væskeophobning), ubehag i brystet, svaghed, brystsmerter, smerter ved infusionsstedet,
English: Patients either received meningococcal vaccination at least 2 weeks prior to initiating treatment with Soliris or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Danish: Patienterne fik enten en meningokok-vaccination mindst 2 uger før de påbegyndte behandlingen med Soliris, eller de fik profylaktisk behandling med passende antibiotika indtil 2 uger efter vaccinationen.
English: Soliris is also used to treat adults and children patients with a certain type of disease affecting the blood system and kidney called atypical Haemolytic Uremic Syndrome (aHUS).
Danish: Soliris anvendes også til behandling af voksne og pædiatriske patienter med en særlig sygdom kaldet atypisk hæmolytisk uræmisk syndrom (aHUS), som påvirker blodet og nyrerne.
English: One vial of 30 ml contains 300 mg of eculizumab (10mg/ml) Eculizumab is a humanised monoclonal IgG2/4 k antibody produced in NS0 cell line by recombinant DNA technology.
Danish: Eculizumab er et humaniseret monoklonalt IgG2/4κ-antistof, der er produceret i en murin NS0-cellelinje ved rekombinant dna-teknologi.
English: • Initial phase: 600 mg of Soliris administered via a 25 - 45 minute intravenous infusion every week for the first 4 weeks.
Danish: • Startfase: 600 mg Soliris givet som intravenøs infusion over 25-45 minutter hver uge de første
English: In patients with PNH, their red blood cells can be destroyed which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots.
Danish: Det medfører lavt antal blodlegemer (anæmi) foruden træthed, nedsat funktionsevne, smerter, mørkfarvet urin, stakåndethed og blodstørkning.
English: Do not administer as an intravenous push or bolus injection.
Danish: Soliris må ikke gives som en intravenøs bolusinjektion.
English: The mean (±SD) platelet count increased from 88 ± 42 x109/L at baseline to 281 ± 123 x109/L by one week; this effect was maintained through 26 weeks (mean platelet count (±SD) at week 26: 293 ± 106 x109/L).
Danish: Det gennemsnitlige (±SD) trombocyttal steg fra 88 ± 42 x 109/l ved baseline til 281 ± 123 x 109/l efter 1 uge.
English: What Soliris is and what it is used for What you need to know before you use Soliris How to use Soliris
Danish: Det skal du vide, før du begynder at bruge Soliris Sådan skal du bruge Soliris Bivirkninger
English: (n=63) (SEM)
Danish: Placebo (n=63) (SEM)
English: < 2 months
Danish: Efter 2 år1
English: If you forget an appointment to receive Soliris
Danish: Hvis du har fået for meget Soliris
English: 2 Study C08-002: 3 patients received ESA which was discontinued after eculizumab initiation Study C08-003: 8 patients received ESA which was discontinued in 3 of them during eculizumab therapy aHUS Study C10-004 enrolled 41 patients who displayed signs of thrombotic microangiopathy (TMA).
Danish: 3 Studie C08-003: 8 patienter fik erytropoiese-stimulerende stoffer (ESA), som blev afbrudt hos 3 under behandlingen med eculizumab
English: How to use Soliris
Danish: Sådan skal du bruge Soliris
English: • Initial phase: 900 mg of Soliris administered via a 25 - 45 minute intravenous infusion every week for the first 4 weeks.
Danish: • Startfase: 900 mg Soliris givet som intravenøs infusion over 25-45 minutter hver uge de første
English: In aHUS Study C08-003A/B, the median duration of Soliris therapy was approximately 114 weeks
Danish: I aHUS-studiet C08-003A/B var den mediane varighed af Soliris-behandlingen ca. 114 uger (interval: 26 til 129 uger).
English: Patients in aHUS Study C08-002 A/B received Soliris for a minimum of 26 weeks.
Danish: Patienter, som deltog i aHUS-studiet C08-002A/B, fik Soliris i mindst 26 uger.
English: Complete TMA response, n (%) Median duration of complete TMA response, weeks (range) 1
Danish: Fuldstændig hæmatologisk normalisering, n (%) Medianvarigheden af fuldstændig hæmatologisk normalisering, uger (interval) Fuldstændigt TMA-respons, n (%) Medianvarigheden af fuldstændigt TMA-respons, uger (interval)1
English: Patients received meningococcal vaccination prior to initiating treatment with Soliris or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Danish: Patienterne fik en meningokok-vaccination, før de påbegyndte behandlingen med Soliris, eller de fik profylaktisk behandling med passende antibiotika indtil 2 uger efter vaccinationen.
English: • fever (pyrexia), feeling tired (fatigue), influenza like illness
Danish: • feber, kuldegysen, træthed, influenzalignende sygdom
English: Complete Hematologic Normalization, n (%)
Danish: Patienter med normalisering af trombocyttal, n (%)
English: 6.1 List of excipients Sodium phosphate, monobasic Sodium phosphate, dibasic Sodium chloride
Danish: Natriumphosphat, monobasisk Natriumphosphat, dibasisk Natriumchlorid Polysorbat 80
English: Interrupting or ending treatment with Soliris may cause your PNH symptoms to come back more severely soon.
Danish: Hvis du holder op med at bruge Soliris mod PNH Hvis du afbryder eller helt stopper behandlingen med Soliris, kan symptomerne på PNH komme igen og være mere alvorlige.
English: Daily TMA Intervention rate, median (range) Before eculizumab treatment, median On eculizumab treatment, median
Danish: Før behandling med eculizumab, median Under behandling med eculizumab, median
English: It should be taken into consideration by patients on a controlled sodium diet.
Danish: Hvis patienten får natriumfattig diæt, bør der tages hensyn hertil.
English: 1 month to <12 years
Danish: 1 måned til <12 år (N = 18) Efter 26 uger
English: N = 43 P - Value Soliris N = 97 P - Value
Danish: Soliris N = 97 P-værdi
English: Genitourinary tract gonococcal infection, Haemophilus influenzae infection,
Danish: Aspergillusinfektionc, bakteriel artritisc, urogenital gonokokinfektion, Haemophilus influenzaeinfektion, impetigo, gingivitis
English: N=5 (%)
Danish: > 2 måneder N=5 (%)
English: PNH Study M07-005, the safety profile appeared similar to that observed in adult PNH patients.
Danish: Sikkerhedsprofilen hos børn og unge patienter med PNH (i alderen 11 år til under 18 år), som blev inkluderet i det pædiatriske PNH-studie M07-005, var sammenlignelig med den sikkerhedsprofil, som var observeret hos voksne PNH-patienter.
English: Table 17: Baseline Characteristics of Paediatric and Adolescents Patients Enrolled in aHUS Study
Danish: Tabel 17: Baseline-karakteristika for pædiatriske og voksne patienter, der indgik i aHUS-studie C10-003
English: The risks of stopping Soliris include an increase in the destruction of your red blood cells, which may cause: - A significant fall in your red blood cell counts (anaemia), - Confusion or change in how alert you are, - Chest pain, or angina, - An increase in your serum creatinine level (problems with your kidneys), or - Thrombosis (blood clotting).
Danish: Det kan medføre følgende symptomer: et væsentligt fald i antallet af røde blodlegemer (anæmi) forvirring eller ændret opmærksomhed og reaktionsevne brystsmerter problemer med nyrefunktionen (stigning i serumkreatinin) eller blodpropdannelse (trombose).
English: At the last evaluation, 19 of 22 patients (86%) achieved eGFR
Danish: Ved den sidste evaluering havde 19 ud af 22 patienter (86 %) opnået eGFR-forbedring på ≥ 15 ml/min/1,73 m2 i forhold til baseline.
English: for Soliris and 68.3 for placebo, based on 125 study patients (p=0.0698).
Danish: Den primære analyse af MG-ADL var en Worst Rank ANCOVA med en gennemsnitlig rangering på 56,6 for Soliris og 68,3 for placebo, baseret på et studie med 125 patienter (p=0,0698).
English: Fifty-one percent of patients had an identified complement regulatory factor mutation or auto-antibody.
Danish: Enoghalvtreds procent af patienterne havde en identificeret mutation de gener, der koder for en af de faktorer (proteiner), der er regulatorer af komplementsystemet eller autoantistof.
English: Eculizumab binds to and inhibits a specific protein in the body that causes inflammation and so prevents your body's systems from attacking and destroying vulnerable blood cells, kidneys, muscles or eye nerves and spinal cord.
Danish: Herved forhindres kroppen i at angribe og ødelægge sårbare blodlegemer, nyrerne, musklerne eller øjets nerver og rygmarven.
English: • tingling in part of the body (paresthesia), shaking
Danish: • prikkende og snurrende fornemmelse i dele af kroppen (paræstesi), rysten
English: C08-003, C09-001r and C10-003, the safety profile appeared similar to that observed in adult aHUS patients.
Danish: Hos pædiatriske aHUS-patienter (fra 2 måneder til under 18 år) inkluderet i aHUS-studierne C08-002, C08-003, C09-001r og C10-003 forekom sikkerhedsprofilen at være sammenlignelig med den, som observeredes hos voksne aHUS-patienter.
English: Open Label Eculizumab
Danish: Under behandling med eculizumab
English: Withdraw the total amount of Soliris from the vial(s) using a sterile syringe.
Danish: Hele den pågældende Soliris-dosis trækkes op af hætteglasset eller -glassene med en steril sprøjte.
English: Complete TMA response, n (%) (95%
Danish: Komplet TMA-respons, n (%) (95% CI)
English: Number of patients with prior exacerbations since diagnosis, n (%)
Danish: Median ≥3 tidligere immunsupprimerende behandlinger* siden diagnose, n (%) Antal patienter med tidligere forværringer siden diagnose, n (%)
English: *One patient achieved eGFR improvement after renal transplant A total of 22 paediatric and adolescents patients (aged 5 months to 17 years) received Soliris in aHUS Study C10-003.
Danish: I alt 22 pædiatriske og unge patienter (i alderen 5 måneder til 17 år) fik Soliris i aHUS-studie C10
English: - polysorbate 80 (vegetable origin)
Danish: Baseline trombocyttal (× 10
English: NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion Eculizumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Soliris 300 mg koncentrat til infusionsvæske, opløsning Eculizumab
English: Soliris is indicated in adults for the treatment of: - Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor
Danish: Refraktær generaliseret myasthenia gravis (gMG) hos patienter, som er positive for antiacetylcholinreceptor (AChR)-antistoffer (se pkt.
English: Interrupting or ending treatment with Soliris may cause your aHUS symptoms to come back.
Danish: Hvis du holder op med at bruge Soliris mod aHUS Hvis du afbryder eller helt stopper behandlingen med Soliris, kan symptomerne på aHUS komme igen.
English: n (%) (95% CI) eGFR change mL/min/1.73 m2: median (range) eGFR improvement
Danish: Forbedring af kronisk nyreinsufficiens ≥ 1 stadie n (%) (95% CI) eGFR-ændring ml/min/1,73m2, median (interval) eGFR-forbedring ≥ 15 ml/min/1,73m2, n (%) (95% CI)
English: Cough, Oropharyngeal pain
Danish: Hoste, orofaryngeale smerter
English: Excipients
Danish: kulderystelser
English: (N = 96)
Danish: Eculizumab (N = 96)
English: Change from baseline at 12 weeks of PedsQLTM4.0 Generic Core scale (parents) Change from baseline at 12 weeks of PedsQLTM Multidimensional Fatigue (patients)
Danish: Ændring fra baseline efter 12 uger i PedsQLTM4.0 Generic Core-skala (forældre)
English: shortness of breath (dyspnoea), anaemia (haemoglobin <100 g/L), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction.
Danish: Disse patienter havde en høj sygdomsaktivitet, defineret som forhøjet hæmolyse (LDH ≥ 1,5 x ULN) og tilstedeværelse af et eller flere tilknyttede kliniske symptomer som træthed, hæmoglobinuri, abdominalsmerter, dyspnø, anæmi (hæmoglobin < 100 g/l), alvorlig vaskulær bivirkning (inklusive trombose), dysfagi eller erektil dysfunktion.
English: Daily TMA Intervention Rate, median (range) Before eculizumab On eculizumab treatment 1 Through data cut-off (September 4, 2012), with median duration of Soliris therapy of 50 weeks (range: 13
Danish: 1 Til og med data-afslutning (4. september 2012), med en median Soliris-behandlingsvarighed på 50 uger (interval: 13 uger til 86 uger).
English: Posology
Danish: Median
English: Eculizumab
Danish: Variabel
English: 20g/L, n (%) (95% CI)
Danish: Ændring i hæmoglobinniveau (Hgb) > 20 g/l, n (%) (95% CI)
English: Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s)
Danish: Der er påvist klinisk fordel for patienter med hæmolyse med et eller flere kliniske symptomer, der tyder på høj sygdomsaktivitet, uanset transfusionsanamnese (se pkt.
English: Mean (min, max) Female, n (%) Duration of MG (years), Mean (min, max)
Danish: Alder ved MG-diagnose (år), Gennemsnit (min, max)
English: Total
Danish: Hjerte
English: Baseline characteristics Baseline EDSS score Mean (SD) Median Min, Max
Danish: Baseline-karakteristika EDSS-score ved baseline
English: You should take into consideration if you are on a controlled sodium diet.
Danish: Hvis du får natriumattig diæt, skal du tage hensyn hertil.
English: Patients received meningococcal vaccination prior to receipt of Soliris or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Danish: Patienterne fik meningokokvaccination inden behandling med Soliris eller passende antibiotisk profylakse i 2 uger efter, de var blevet vaccineret.
English: • diarrhea, vomiting, nausea, abdominal pain, rash, hair loss (alopecia), itchy skin (pruritus)
Danish: • udslæt, hårtab (alopeci), hudkløe
English: Haematoma
Danish: Appetitløshed
English: • infection of the lung (pneumonia), common cold (nasopharyngitis), infection of the urinary system
Danish: • lungebetændelse, forkølelse, urinvejsinfektion
English: The proportion of clinical responders at Week 26 with no rescue therapy was 45.2%
Danish: Andelen af personer med klinisk respons ved uge 26 uden nogen nødbehandling var 45,2 % med Soliris sammenlignet med 19 % med placebo (p=0,0018).
English: Paroxysmal Nocturnal Haemoglobinuria
Danish: Paroksystisk nokturn hæmoglobinuri
English: Human IgG are known to cross the human placental barrier, and thus eculizumab may potentially cause terminal complement inhibition in the foetal circulation.
Danish: Eculizumab kan derfor tænkes at medføre terminal komplementhæmning i det føtale kredsløb.
English: • unusual backflow of food from stomach, gum pain
Danish: • sure opstød, smerter i tandkødet
English: stomach discomfort after meals (dyspepsia), abdominal distension
Danish: • bughindebetændelse, forstoppelse, mavegener efter måltider (dyspepsi), udspilet mave
English: Patients with platelet count normalization, n (%) Complete TMA response, n (%)
Danish: Patienter uden identificeret mutation, n (%)
English: Onbrez Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Danish: Onbrez Breezhaler må kun anvendes under graviditet, hvis de forventede fordele opvejer de mulige risici.
English: Children and adolescents Onbrez Breezhaler should not be given to children or adolescents below the age of 18 years.
Danish: Børn og unge Onbrez Breezhaler må ikke gives til børn eller unge under 18 år.
English: Paediatric population There is no relevant use of Onbrez Breezhaler in the paediatric population (under 18 years).
Danish: Pædiatrisk population Det er ikke relevant at anvende Onbrez Breezhaler hos den pædiatriske population (under 18 år).
English: Onbrez Breezhaler should be administered at the same time of the day each day.
Danish: Onbrez Breezhaler bør tages på samme tidspunkt hver dag.
English: An increase in the daily dose of Onbrez Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Danish: En forøgelse af den daglige dosis af Onbrez Breezhaler over den maksimale dosis på 300 mikrogram er ikke hensigtsmæssig.