FrancophonIA/ELRC3.0 huggingface dataset:
English: In the safety analysis of pooled studies, the incidence of new QTc prolongation >500 ms was 0.7% (2/268) in the encorafenib 450 mg plus binimetinib group, and 2.5% (5/203) in the encorafenib single agent group.
Danish: I sikkerhedsanalysen af de samlede studier var forekomsten af ny QTc-forlængelse >500 ms 0,7 % (2/268) i gruppen, der fik encorafenib 450 mg plus binimetinib, og 2,5 % (5/203) i gruppen, der fik encorafenib som monoterapi.
English: Cellulose microcrystalline (E460i) Succinic acid (E363) Crospovidone (E1202) Silica colloidal anhydrous (E551) Magnesium stearate (E470b)
Danish: Cellulose, mikrokrystallinsk (E460i) Succinsyre (E363) Crospovidon (E1202) Silica, kolloid vandfri (E551) Magnesiumstearat (E470b)
English: Dysgeusia*
Danish: Dysgeusi
English: • Recurrent Grade 3 (AST or ALT > 5x ULN and blood bilirubin > 2x ULN)
Danish: • Tilbagevendende grad 3 (ASAT eller ALAT > 5x ULN og blodbilirubin > 2x ULN)
English: The Functional Assessment of Cancer Therapy-Melanoma (FACT-M), the European Organisation for Research and Treatment of Cancer's core quality of life questionnaire (EORTC QLQ-C30) and the EuroQoL-5 Dimension-5 Level examination (EQ-5D-5L) were used to explore patient-reported outcomes (PRO) measures of health-related Quality of Life, functioning, melanoma symptoms, and treatment-related adverse reactions.
Danish: Patientrapporterede oplysninger (PRO) vedrørende helbredsrelateret livskvalitet, funktionsstatus, melanomsymptomer og behandlingsrelaterede bivirkninger blev indsamlet ved hjælp af FACT-M (Functional Assessment of Cancer Therapy-Melanoma), EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer's core quality of life questionnaire) og EQ-5D-5L (EuroQoL-5 Dimension-5 Level examination).
English: Muscle problems: Braftovi, when taken with binimetinib, can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include: - muscle pain, cramps, stiffness or spasm - dark urine
Danish: Muskelproblemer: Braftovi i kombination med binimetinib kan forårsage muskelnedbrydning (rabdomyolyse), som kan forårsage nyreskade og være dødelig; tegn og symptomer herpå kan omfatte: - muskelsmerter, -kramper, -stivhed eller -sammentrækninger - mørkfarvet urin
English: - The active substance is encorafenib.
Danish: - Aktivt stof: encorafenib.
English: Permanent discontinuation of encorafenib should be considered.
Danish: En permanent seponering af encorafenib skal overvejes.
English: The PFS for encorafenib 300 mg orally daily used in combination with binimetinib 45 mg orally twice daily (Combo 300, n = 258) was compared to the PFS for Enco 300 (n = 280, including 194 patients from Part 1 and 86 patients from Part 2).
Danish: PFS for encorafenib 300 mg oralt 1 gang dagligt taget i kombination med binimetinib 45 mg oralt 2 gange dagligt (herefter benævnt Combo 300, n = 258) blev sammenlignet med PFS for Enco 300 (n = 280, herunder 194 patienter fra Del 1 og 86 patienter fra Del 2).
English: In Part 1, patients in the study were randomised to receive encorafenib 450 mg orally daily and binimetinib 45 mg orally twice daily (Combo 450, n = 192), encorafenib 300 mg orally daily (Enco 300, n = 194), or vemurafenib 960 mg orally twice daily (hereafter referred to as Vem, n = 191).
Danish: I Del 1 blev patienterne i studiet randomiseret til behandling med encorafenib 450 mg oralt dagligt og binimetinib 45 mg oralt to gange dagligt (Combo 450, n=192), encorafenib 300 mg oralt dagligt (Enco 300, n=194) eller vemurafenib 960 mg oralt to gange dagligt (herefter benævnt Vem, n=191).
English: Your doctor will run blood tests to check your liver before and during treatment.
Danish: Din læge vil tage nogle blodprøver før og under behandlingen for at kontrollere din lever.
English: Encorafenib is an inhibitor of UGT1A1.
Danish: Encorafenib hæmmer UGT1A1.
English: New melanomas may also occur while taking Braftovi.
Danish: Der kan også komme nye melanomer under behandlingen med Braftovi.
English: • Increased GGT: 14.6% (40/274) overall - Grade 3-4: 8.4% (23/274)
Danish: • Forhøjet GGT: 14,6 % (40/274) samlet - grad 3-4: 8,4 % (23/274)
English: The pharmacokinetics of encorafenib were studied in healthy subjects and patients with solid tumours, including advanced and unresectable or metastatic cutaneous melanoma harbouring a BRAF-V600E or K mutation.
Danish: Encorafenibs farmakokinetik er blevet undersøgt hos raske forsøgsdeltagere og hos patienter med solide tumorer, herunder fremskredent og inoperabelt eller metastatisk kutant melanom med BRAF-V600E eller K-mutation.
English: If encorafenib is temporarily interrupted (see Table 2), binimetinib should be interrupted.
Danish: Hvis encorafenib pauseres (se tabel 2), skal binimetinib pauseres.
English: In the pooled Combo 450 population, mild, mostly Grade 1, asymptomatic blood creatinine elevation was noted in 6.2% (17/274) of patients treated with the Combo 450 mg.
Danish: I den samlede Combo 450-population blev der rapporteret om let stigning i blodkreatinin, oftest asymptomatisk af grad 1, hos 6,2 % (17/274) af de patienter, der blev behandlet med Combo 450 mg.
English: Encorafenib was phototoxic in an in vitro 3T3 Neutral Red Uptake Test. Encorafenib was not a sensitiser in the in vivo mouse sensitization assay.
Danish: Encorafenib var fototoksisk i en 3T3 Neutral Red Uptake (NRU)-analyse udført in vitro.
English: Skin papilloma* Melanocytic nevus
Danish: Hudpapillom Melanocytnævus
English: There are no clinical data with encorafenib in patients with severe renal impairment.
Danish: Der foreligger ingen kliniske data vedrørende encorafenib hos patienter med svært nedsat nyrefunktion.
English: In vitro experiments indicate encorafenib is a relatively potent reversible inhibitor of UGT1A1, CYP2B6, CYP2C9 and CYP3A4/5, as well as a time-dependent inhibitor of CYP3A4.
Danish: In vitro-undersøgelser viser, at encorafenib er en relativt potent reversibel hæmmer af UGT1A1, CYP2B6, CYP2C9 og CYP3A4/5 og en tidsafhængig hæmmer af CYP3A4.
English: • First occurrence of Grade 4 (AST or ALT >20 ULN)
Danish: • Første forekomst af grad 4 ((ASAT eller ALAT > 20 ULN)
English: In the pooled Combo 450 population, photosensitivity was observed in 4.0% (11/274) of patients.
Danish: I den samlede Combo 450-population blev lysfølsomhed observeret hos 4,0 % (11/274) af patienterne.
English: Side effects of Braftovi such as nausea, vomiting, dehydration and blurred vision may appear or worsen.
Danish: Du kan få nye eller forværrede bivirkninger ved Braftovi, såsom kvalme, opkastning, dehydrering og sløret syn.
English: Study CMEK162B2301, Part 1: Overall survival interim results (cut-off date: 7 November 2017)
Danish: Studie CMEK162B2301, Del 1: Interimresultater for samlet overlevelse (skæringsdato: 7. november 2017)
English: Most events were mild-moderate: Grade 1 in 12.4% (27/217) of patients, Grade 2 in 26.7% (58/217) and Grade 3 in 12.4% (27/217) of patients.
Danish: De fleste hændelser var milde til moderate: grad 1 hos 12,4 % (27/217) af patienterne, grad 2 hos 26,7 % (58/217) og grad 3 hos 12,4 % (27/217) af patienterne.
English: Pancreatitis was reported in 0.7% (2/274) of patients.
Danish: Pancreatitis blev indberettet som bivirkning hos 0,7 % (2/274) af patienterne.
English: Encorafenib should be used with caution in patients with severe renal impairment.
Danish: Encorafenib bør anvendes med forsigtighed hos patienter med svært nedsat nyrefunktion.
English: If binimetinib is permanently discontinued, encorafenib should be discontinued.
Danish: Hvis binimetinib bliver seponeret permanent, skal encorafenib seponeres.
English: Encorafenib should be resumed at same dose level or at a reduced dose level when improved to Grade 0 or 1.
Danish: • Encorafenib skal genoptages med samme dosisniveau eller et reduceret dosisniveau ved bedring til grad 0 eller 1.
English: Encorafenib single agent 300 mg (n = 217)
Danish: Monoterapi med encorafenib 300 mg (n=217)
English: Heart problems: Braftovi when taken with binimetinib can affect how well your heart works (left ventricular ejection fraction decrease); signs and symptoms can include: - feeling dizzy, tired or lightheaded - shortness of breath - feeling like your heart is pounding, racing or beating irregularly - swelling in the legs
Danish: Hjerteproblemer: Braftovi i kombination med binimetinib kan påvirke hjertets virkning (nedsat ejektionsfraktion i venstre ventrikel); tegn og symptomer herpå kan omfatte: - svimmelhed, træthed eller omtumlethed - stakåndethed - følelse af, at hjertet hamrer, galoperer eller slår uregelmæssigt - hævelse i benene
English: PPES led to discontinuation in 4.1% (9/217) of patients and to dose interruption or dose modification in 23.0% (50/217) of patients.
Danish: PPES førte til seponering hos 4,1 % (9/217) af patienterne og til pausering af behandlingen eller dosisjustering hos 23,0 % (50/217) af patienterne.
English: BRAF V600 Mutant Unresectable or Metastatic Melanoma The safety and efficacy of encorafenib in combination with binimetinib were evaluated in a 2-part Phase III, randomised (1:1:1) active-controlled, open-label, multicentre study in patients with unresectable or metastatic BRAF V600 E or K mutant melanoma (Study CMEK162B2301), as detected using a BRAF assay.
Danish: Inoperabelt eller metastatisk melanom med BRAF V600-mutation Sikkerheden og virkningen af encorafenib i kombination med binimetinib blev vurderet i et randomiseret (1:1:1), aktivt kontrolleret fase III-multicenterforsøg med åben behandling af patienter med inoperabelt eller metastatisk melanom med BRAF V600 E eller K-mutation (studie CMEK162B2301), der blev påvist ved brug af en BRAF-analyse.
English: Constipation occurred in 24.1% (66/274) of patients and was Grade 1 or 2.
Danish: Obstipation forekom hos 24,1 % (66/274) af patienterne og var af grad 1 eller 2.
English: If uveitis is Grade 1 and it improves to Grade 0, then treatment should be resumed at the same dose.
Danish: • Hvis uveitis er af grad 1 og bedres til grad 0, skal behandlingen genoptages med samme dosis.
English: It is recommended that an electrocardiogram (ECG) is assessed before initiation of encorafenib, one month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment.
Danish: Det anbefales at tage et ekkokardiogram (ekg) inden opstart af encorafenib, 1 måned efter behandlingsopstart og cirka hver 3. måned under behandlingen, eller hyppigere hvis klinisk indiceret.
English: Effect of encorafenib on binimetinib
Danish: Encorafenibs indvirkning på binimetinib
English: What you need to know before you take Braftovi
Danish: Det skal du vide, før du begynder at tage Braftovi
English: Agents that are CYP3A4 substrates should be co-administered with caution.
Danish: Samtidig administration af stoffer, som er CYP3A4-substrater, bør ske med forsigtighed.
English: Vomiting* Constipation Abdominal pain* Diarrhoea*
Danish: Kvalme Opkastning* Obstipation Mavesmerter* Diarré*
English: QTc prolongation of >60 ms compared to pre-treatment values was observed in 4.9% (13/268) patients in the encorafenib plus binimetinib group, and in 3.4% (7/204) in the encorafenib single agent group (see Sections 4.2 and 4.4).
Danish: Der blev set QTc-forlængelse > 60 ms i forhold til værdien inden behandling hos 4,9 % (13/268) af patienterne i gruppen, der fik encorafenib plus binimetinib, og hos 3,4 % (7/204) i gruppen, der fik encorafenib som monoterapi (se pkt.
English: Encorafenib should be permanently discontinued (see monitoring in section 4.4).
Danish: Encorafenib skal seponeres permanent (se kontrol i pkt.
English: In the absence of clinical data, encorafenib is not recommended in patients with moderate or severe hepatic impairment.
Danish: Ved fraværet af kliniske data frarådes det at anvende encorafenib hos patienter med moderat eller svært nedsat leverfunktion.
English: In the pooled encorafenib 300 population, new primary melanoma events occurred in 4.1% of patients (9 /217) and was reported as Grade 1 in 1.4% (3/217) of patients, Grade 2 in 2.1% (4/217) of patients, Grade 3 in 0.5% (1/217) of patients and Grade 4 in 0.5% (1/217) of patients.
Danish: I den samlede encorafenib 300-population forekom hændelser med nyt primært melanom hos 4,1 % af patienterne (9/217) og blev rapporteret som grad 1 hos 1,4 % (3/217) af patienterne, grad 2 hos 2,1 % (4/217) af patienterne, grad 3 hos 0,5 % (1/217) af patienterne og grad 4 hos 0,5 % (1/217) af patienterne.
English: This is a precaution in case a squamous cell carcinoma develops inside your body.
Danish: Dette gøres som forholdsregel for at kontrollere for udvikling af et planocellulært karcinom i kroppen.
English: Muscular disorders/Myalgial Pain in extremity Back pain
Danish: Muskelforstyrrelser/myalgi1 Ekstremitetssmerter Rygsmerter
English: In the pooled encorafenib 300 population, cuSCC was reported in 7.4% (16/217) patients.
Danish: I den samlede encorafenib 300-population blev der rapporteret om cuSCC hos 7,4 % (16/217) af patienterne.
English: Most events were mild-moderate: Grade 1 in 2.3% (5/217); Grade 2 in 3.7% (8/217) and Grade 3 in 1.4% (3/217) of patients.
Danish: De fleste hændelser var milde til moderate: grad 1 hos 2,3 % (5/217); grad 2 hos 3,7 % (8/217) og grad 3 hos 1,4 % (3/217) af patienterne.
English: New primary malignancies, cutaneous and non-cutaneous, have been observed in patients treated with BRAF inhibitors and can occur when encorafenib is administered (see section 4.8).
Danish: Der er set nye primære maligniteter, både kutane og ikke-kutane, hos patienter i behandling med BRAF-hæmmere, og sådanne maligniteter kan forekomme ved administration af encorafenib (se pkt.
English: Visual impairment* RPED *
Danish: Nedsat syn* RPED*
English: • Recurrent Grade 4 (AST or ALT > 20 ULN)
Danish: • Tilbagevendende grad 4 (ASAT eller ALAT > 20 ULN)
English: It is recommended that left ventricular ejection fraction (LVEF) is assessed by echocardiogram or multi-gated acquisition (MUGA) scan before initiation of encorafenib and binimetinib, one month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment.
Danish: Det anbefales at måle ejektionsfraktionen i venstre ventrikel (LVEF) ved hjælp af ekkokardiogram eller MUGA-scanning inden opstart af encorafenib og binimetinib, 1 måned efter behandlingsopstart og cirka hver 3. måned under behandlingen, eller hyppigere hvis klinisk relevant.
English: Dermatitis acneiform* Skin exfoliationf Photosensitivity*
Danish: Akneiform dermatitis* Hudafstødningf Lysfølsomhed*
English: Ocular events
Danish: Okulære hændelser
English: Avoid driving or using machines if you have any problems with your vision, or have any other side effects that can affect your ability to drive or use machines (see section 4), while taking Braftovi.
Danish: Undlad at føre motorkøretøj og betjene maskiner, hvis du får synsproblemer eller andre bivirkninger, som kan påvirke denne evne (se afsnit 4).
English: Additionally, in the 13-week rat toxicity study, reversible clinical pathology changes were noted at doses ≥ 100 mg/kg/d.
Danish: Derudover blev der set reversible kliniske patologiske forandringer ved doser ≤ 100 mg/kg/d i det 13-ugers toksicitetsstudie hos rotter.
English: • Increased transaminases: 15.7% (43/274) overall - Grade 3-4: 5.5% (15/274)
Danish: • Forhøjede transaminaser: 15,7 % (43//274) samlet - grad 3-4: 5,5 % (15/274)
English: Overall, results suggest that single agent encorafenib has the potential to cause mild increases in heart rate.
Danish: Samlet set tyder resultaterne på, at encorafenib som monoterapi potentielt kan forårsage let forøget hjertefrekvens.
English: This could affect the ability to father a child. Talk to your doctor if this is a concern for you.
Danish: Drøft dette med lægen, hvis det er et problem for dig.
English: A drug interaction study in healthy subjects indicated the extent of encorafenib exposure was not altered in the presence of a gastric pH-altering agent (rabeprazole).
Danish: Et interaktionsstudie hos raske forsøgsdeltagere viste, at tilstedeværelse af et pH-ændrende stof (rabeprazol) ikke påvirkede eksponeringsgraden.
English: The safety of encorafenib (450 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 274 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the pooled Combo 450 population), based on two Phase II studies (CMEK162X2110 and CLGX818X2109) and one Phase III study (CMEK162B2301, Part 1).
Danish: Sikkerheden af encorafenib (450 mg oralt én gang dagligt) i kombination med binimetinib (45 mg oralt to gange dagligt) er blevet evalueret hos 274 patienter med inoperabelt eller metastatisk melanom med BRAF V600-mutation (herefter benævnt samlet Combo 450-population) på baggrund af to fase II-studier (CMEK162X2110 og CLGX818X2109) og ét fase III-studie (CMEK162B2301, del 1).
English: As Braftovi is to be used in combination with binimetinib, read the binimetinib leaflet carefully as well as this leaflet.
Danish: Eftersom Braftovi skal anvendes i kombination med binimetinib, bør du også læse indlægssedlen for binimetinib grundigt.
English: Nausea occurred in 41.6% (114/274) with Grade 3 or 4 observed in 2.6% (7/274) of patients.
Danish: Kvalme forekom hos 41,6 % (114/274) med grad 3 eller 4 hos 2,6 % (7/274) af patienterne.
English: Encorafenib in combination with binimetinib in patients with brain metastases There are limited efficacy data with the combination of encorafenib and binimetinib in patients with a BRAF V600 mutant melanoma which have metastasised to the brain (see section 5.1).
Danish: Encorafenib i kombination med binimetinib hos patienter med hjernemetastaser Der er begrænsede virkningsdata fra kombinationsbehandling med encorafenib og binimetinib hos patienter med melanomer med BRAF V600-mutation, der er metastaseret til hjernen (se pkt.
English: Most events were mild, with Grade 3 or 4 events reported in 0.7% (2/274) of patients.
Danish: De fleste af hændelserne var milde; hændelser af grad 3 eller 4 blev indberettet hos 0,7 % (2/274) af patienterne.
English: Uncommon (may affect up to 1 in 100 people) - weakness and paralysis of face muscles - inflammation of the pancreas (pancreatitis) causing severe abdominal pain
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): - svaghed og lammelse af ansigtsmuskler - betændelse i bugspytkirtlen (pancreatitis) med svære mavesmerter til følge
English: - Bleeding problems: Braftovi may cause serious bleeding problems.
Danish: - Blødningsproblemer: Braftovi kan forårsage alvorlige blødningsproblemer.
English: Recommended dose modifications for encorafenib (when used in combination with binimetinib)
Danish: Anbefalede dosisjusteringer for encorafenib (ved brug i kombination med binimetinib)
English: Side effects when Braftovi and binimetinib are taken together
Danish: Andre bivirkninger ved samtidig brug af Braftovi og binimetinib
English: Survival at 24 months (95% CI)
Danish: Overlevelse efter 24 måneder (95 % CI)
English: Your doctor will run blood tests to monitor your kidneys before and during treatment.
Danish: Din læge vil tage nogle blodprøver før og under behandlingen for at kontrollere dine nyrer.
English: • Increased GGT: 14.0% (36/257) overall - Grade 3-4: 4.7% (12/257)
Danish: • Forhøjet GGT: 14,0 % (36/257) samlet - grad 3-4: 4,7 % (12/257)
English: Diarrhoea occurred in 28.4% (73/257) of patients with Grade 3 reported in 1.6% (4/257) of patients.
Danish: Diarré forekom hos 28,4 % (73/257) af patienterne med grad 3 rapporteret hos 1,6 % (4/257) af patienterne.
English: If no improvement within 4 weeks, encorafenib should be withheld until improved to Grade 0 or 1 or to pretreatment/baseline levels and then resumed at the same dose.
Danish: • Ved manglende bedring i løbet af 4 uger skal encorafenib pauseres indtil bedring til grad 0 eller 1 eller til niveauet inden behandling/ved baseline, hvorefter samme dosis genoptages.
English: Amylase increased *composite terms which included more than one preferred term a includes keratoacanthoma, squamous cell carcinoma, lip squamous cell carcinoma and squamous cell carcinoma of skin b includes angioedema, drug hypersensitivity, hypersensitivity, hypersensitivity vasculitis and urticaria c includes facial nerve disorder, facial paralysis, facial paresis d includes extrasystoles, sinus tachycardia, supraventricular extrasystoles, tachyarrhythmia, tachycardia e includes erythema, generalised erythema, plantar erythema f includes dermatitis exfoliative, skin exfoliation, exfoliative rash g includes myalgia, muscle fatigue, muscle injury, muscle spasm, muscle weakness h includes left ventricular dysfunction, ejection fraction decreased, cardiac failure and ejection fraction abnormal i includes haemorrhage at various sites including cerebral haemorrhage j includes pulmonary embolism, deep vein thrombosis, embolism, thrombophlebitis, thrombophlebitis superficial and thrombosis k includes colitis, colitis ulcerative, enterocolitis and proctitis l includes myalgia, muscular weakness, muscle spasm, muscle injury, myopathy, myositis m includes fluid retention, peripheral oedema, localised oedema
Danish: overfølsomhedsvaskulitis og nældefeber c Omfatter facialisnerveforstyrrelser, facialisparalyse, facialisparese d omfatter ekstrasystoler, sinustakykardi, supraventrikulære ekstrasystoler, takyarytmi, takykardi e omfatter erytem, generaliseret erytem, plantart erytem f omfatter eksfoliativ dermatitis, hudafstødning, eksfoliativt udslæt g omfatter myalgi, muskeltræthed, muskelskade, muskelsammentrækninger, muskelsvaghed h Omfatter dysfunktion af venstre ventrikel, nedsat ejektionsfraktion, hjertesvigt og abnorm ejektionsfraktion i Omfatter blødning på forskellige steder, herunder cerebral blødning j Omfatter lungeemboli, dyb venetrombose, emboli, tromboflebitis, overfladisk tromboflebitis og trombose k Omfatter colitis, ulcerøs colitis, enterocolitis og proctitis l Omfatter myalgi, muskelsvaghed, muskelsammentrækninger, muskelskade, myopati, myositis m Omfatter væskeretention, perifert ødem, lokalt ødem
English: Study CMEK162B2301, Part 1: Kaplan-Meier plot of interim overall survival (cut-off date: 7 November 2017)
Danish: Studie CMEK162B2301, Del 1: Kaplan-Meier plot af foreløbig samlet overlevelse (skæringsdato: 7. november 2017)
English: As encorafenib is primarily metabolised and eliminated via the liver, patients with mild to severe hepatic impairment may have increased encorafenib exposure over the range of inter-subject variability exposure (see section 5.2).
Danish: Eftersom encorafenib primært metaboliseres og elimineres via leveren, kan eksponeringen for encorafenib være forøget til et niveau, der ligger over intervallet for interindividuel eksponeringsvariabilitet, hos patienter med let til svært nedsat leverfunktion (se pkt.
English: HRa (95% CI) (vs Vem) Nominal p-value
Danish: HRa (95 % CI) (vs. Vem) Nominel p-værdi
English: Survival at 12 months (95% CI)
Danish: Overlevelse efter 12 måneder (95 % CI)
English: If, uveitis including iridocyclitis and iritis occurs during treatment, see section 4.2.
Danish: 4.2, hvis der opstår uveitis, herunder iridocyclitis og iritis, under behandlingen.
English: Call your doctor right away if you get these symptoms of eye problems: - blurred vision, loss of vision, or other vision changes (such as coloured dots in your vision) - halo (seeing blurred outline around objects) - eye pain, swellling or redness
Danish: Kontakt omgående lægen, hvis du får disse symptomer på øjenproblemer: - sløret syn, synstab eller andre synsforstyrrelser (såsom farvede prikker i synsfeltet) - haloer (du ser uskarpe konturer omkring ting) - smerter, hævelse eller rødme i øjet
English: If uveitis is Grade 2 or 3 and it improves to Grade 0 or 1, then treatment should be resumed at a reduced dose.
Danish: • Hvis uveitis er af grad 2 eller 3 og bedres til grad 0 eller 1, så skal behandlingen genoptages med reduceret dosis.