FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving binimetinib in combination with encorafenib should undergo a head and neck examination, chest/abdomen computerised tomography (CT) scan, anal and pelvic examinations (for women) and complete blood cell counts prior to initiation, during and at the end of treatment as clinically appropriate.
Danish: Hos patienter, der får binimetinib i kombination med encorafenib, bør der gennemføres en hoved- og halsundersøgelse, CT-scanning af brystet/abdomen, undersøgelse af endetarmen og underlivet (hos kvinder) og komplette blodtællinger inden opstart af behandlingen og under og efter behandlingen efter klinisk behov.
English: Binimetinib inhibits growth of BRAF V600 mutant melanoma cell lines and demonstrates anti-tumour effects in BRAF V600 mutant melanoma animal models.
Danish: Binimetinib hæmmer væksten af BRAF V600-muterede melanomcellelinjer og udviser antitumoreffekt på melanomer med BRAF V600-mutationer i dyremodeller.
English: The confirmed ORR per BIRC was 65.9 % (95 % CI: 59.8, 71.7) for Combo 300, and 50.4 % (95 % CI 44.3, 56.4) for Enco 300 (Parts 1 and 2).
Danish: Den bekræftede ORR ifølge BIRC var 65.9 % (95 % CI: 59,8, 71,7) for Combo 300 og 50,4 % (95 % CI: 44,3, 56,4) for Enco 300 (del 1 og 2).
English: Effect of CYP enzymes on binimetinib
Danish: CYP-enzymers indvirkning på binimetinib
English: Contents of the pack and other information What Mektovi contains
Danish: Pakningsstørrelser og yderligere oplysninger Mektovi indeholder:
English: • Muscle problems: Mektovi can cause breakdown of muscle (rhabdomyolysis).
Danish: • Muskelproblemer: Mektovi kan forårsage nedbrydning af muskler (rabdomyolyse).
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 ansigsmuskler - betændelse i bugspytkirtlen (pancreatitis) med svære mavesmerter til følge
English: Depending on the severity of symptoms, degree of CK elevation or creatinine elevation, dose reduction, dose interruption or permanent discontinuation of binimetinib may be required (see Table 1 in section 4.2).
Danish: Afhængigt af symptomernes sværhedsgrad, graden af CK-stigning eller kreatininstigning kan det være nødvendigt at reducere eller pausere doseringen eller seponere binimetinib permanent (se tabel 1 i pkt.
English: This increase expends to three fold in both moderate and severe hepatic impairment when considering unbound binimetinib exposure (see section 4.2).
Danish: Denne stigning er op til trefoldig ved både moderat og svært nedsat leverfunktion, når eksponeringen for ubunden binimetinib tages i betragtning (se pkt.
English: Eye problems: Mektovi can cause fluid to leak under the retina in the eye, leading to detachment of different layers in the eye (retinal pigment epithelial detachment) which could lead to:
Danish: Øjenproblemer: Mektovi kan være årsag til, at væske siver ud under nethinden i øjet, hvilket kan føre til løsning af forskellige lag i øjet (løsning af retinalt pigmentepitel) eller blokering af en vene i øjet (retinal veneokklusion), hvilket kan forårsage:
English: • muscle pain, cramps, stiffness or spasm
Danish: • muskelsmerter, -kramper, -stivhed eller -sammentrækninger
English: Genital examinations (for women) and anal examinations are also recommended before the initiation and at the end of your treatment.
Danish: Der bør desuden gennemføres gynækologiske undersøgelser (hos kvinder) og undersøgelser af endetarmen før og efter behandlingen.
English: Liver laboratory values should be monitored before initiation of binimetinib and encorafenib and at least monthly during the 6 first months of treatment, and then as clinically indicated.
Danish: Levertallene bør kontrolleres inden opstart af binimetinib og encorafenib og mindst en gang om måneden i de første 6 måneder af behandlingen og herefter som klinisk indiceret.
English: What you need to know before you take Mektovi
Danish: Det skal du vide, før du begynder at tage Mektovi
English: Hepatic impairment No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh A).
Danish: Nedsat leverfunktion Det er ikke nødvendigt at justere dosis hos patienter med let nedsat leverfunktion (Child-Pugh A).
English: When encorafenib was used at a dose of 300 mg once daily in combination with binimetinib 45 mg twice daily (Combo 300) in study CMEK162B2301-Part 2, the frequency category was lower compared to the pooled Combo 450 population for the following adverse reactions: anemia, peripheral neuropathy, haemorrhage, hypertension, pruritus (common) and colitis, increased amylase and increased lipase (uncommon).
Danish: Når encorafenib blev anvendt i en dosis på 300 mg én gang dagligt i kombination med binimetinib 45 mg to gange dagligt (Combo 300) i studiet CMEK162B2301-del 2, var frekvenskategorien lavere sammenlignet med den samlede Combo 450-population for følgende bivirkninger: anæmi, perifer neuropati, blødning, hypertension, pruritus (almindelig); og colitis, øget amylase og øget lipase (ikke almindelig).
English: RPED was Grade 1 (asymptomatic) in 21.2 % (58/274) of patients, Grade 2 in 6.6 % (18/274) of patients and Grade 3 in 1.8 % (5/274) of patients.
Danish: RPED var af grad 1 (asymptomatisk) hos 21,2 % (58/274) af patienterne, grad 2 hos 6,6 % (18/274) og grad 3 hos 1,8 % (5/274).
English: Diarrhoea*
Danish: Diarré*
English: Effect of UGT1A1 inducers or inhibitors on binimetinib Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation.
Danish: Indvirkningen af UGT1A1-induktorer og -hæmmere på binimetinib Binimetinib metaboliseres primært via UGT1A1-medieret glukuronidering.
English: Additionally, the combination of encorafenib and binimetinib prevented the emergence of treatment resistance in BRAF V600E mutant human melanoma xenografts in vivo.
Danish: Derudover forhindrede kombinationen af encorafenib og binimetinib fremkomst af behandlingsresistens i xenografter af humane melanomer med BRAF V600-mutation in vivo.
English: Diarrhoea led to dose discontinuation in 0.4 % of patients and to dose interruption or dose modification in 4.4 % of patients.
Danish: Diarré førte til seponering hos 0,4 % af patienterne og til pausering eller dosisjustering hos 4,4 % af patienterne.
English: Your doctor will check that your heart is working properly before and during your treatment with this medicine.
Danish: Lægen vil undersøge dit hjerte før og under behandlingen med dette lægemiddel for at sikre, at det fungerer korrekt.
English: Grade 3 events occurred in 1.1 % (3/274) of patients.
Danish: Hændelser af grad 3 forekom hos 1,1 % (3/274) af patienterne.
English: Hyperkeratosis *
Danish: Hyperkeratose*
English: LVD led to treatment discontinuation in 0.4% (1/274) of patients and led to dose interruptions or dose reductions in 6.6 % (18/274) of patients.
Danish: LVD førte til seponering hos 0,4 % (1/274) af patienterne og medførte pausering eller reduktion af doseringen hos 6,6 % (18/274) af patienterne.
English: Talk to your doctor immediately if you have any symptoms of bleeding problems such as coughing up of blood, blood clots, vomit containing blood or that looks like “coffee grounds”, red or black stools that look like tar, passing blood in the urine, stomach (abdominal) pain, unusual vaginal bleeding.
Danish: Kontakt omgående lægen, hvis du får tegn på blødningsproblemer som f.eks. at du hoster blod op eller får blodpropper, har opkast, der er blodig eller ligner ”kaffegrums”, har røde eller sorte afføringer, der ligner tjære, har blod i urinen, mavesmerter, usædvanlig blødning fra skeden.
English: Following a single oral dose of 45 mg [14C] binimetinib in healthy subjects, at least 50 % of the binimetinib dose was absorbed.
Danish: Efter en enkelt oral dosis af 45 mg [14C]-binimetinib hos raske forsøgsdeltagere blev mindst 50 % af binimetinib-dosen absorberet.
English: • Skin changes: Mektovi, when taken with encorafenib, may cause other types of skin cancer such as cutaneous squamous cell carcinoma.
Danish: • Hudforandringer: Når Mektovi anvendes sammen med encorafenib, kan det forårsage andre typer af hudkræft, såsom kutant planocellulært karcinom.
English: Uveitis including iridocyclitis and iritis have been reported in patients treated with binimetinib in combination with encorafenib (see section 4.8).
Danish: Der er rapporteret om uveitis, herunder iridocyclitis og iritis, hos patienter, der blev behandlet med binimetinib i kombination med encorafenib (se pkt.
English: As encorafenib is not recommended in patients with moderate (Child Pugh B) or severe hepatic impairment (Child-Pugh C), administration of binimetinib is not recommended in these patients.
Danish: Da encorafenib ikke anbefales til patienter med moderat (Child Pugh B) eller svært nedsat nyrefunktion (Child-Pugh C), anbefales administration af binimetinib ikke til disse patienter (se pkt.
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 (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: Median DOR for confirmed responses per BIRC was 12.7 months [95% CI: 9.3, 15.1] for Combo 300 and 12.9 months [95 % CI: 8.9, 15.5] for Enco 300.
Danish: Median DOR for bekræftet respons ifølge BIRC var 12,7 måneder [95 % CI: 9,3, 15,1] for Combo 300 og 12,9 måneder [95 % CI: 8,9, 15,5] for Enco 300.
English: Binimetinib is to be given in combination with encorafenib.
Danish: Binimetinib skal gives i kombination med encorafenib.
English: Binimetinib should be used with caution in patients who are at risk for, or who have a history of VTE.
Danish: Binimetinib bør anvendes med forsigtighed hos patienter med risiko for VTE eller med VTE i anamnesen.
English: The recommended dose of binimetinib is 45 mg (three 15 mg tablets) twice daily, corresponding to a total daily dose of 90 mg approximately 12 hours apart.
Danish: Den anbefalede dosis af binimetinib er 45 mg (tre 15 mg tabletter) to gange dagligt med cirka 12 timers mellemrum, svarende til en total daglig dosis på 90 mg.
English: Binimetinib should be withheld until improved to Grade 0 or 1 and resumed at the same dose if first occurrence or resumed at a reduced dose if recurrent Grade 3.
Danish: Binimetinib skal pauseres indtil bedring til grad 0 eller 1, og herefter genoptages i samme dosis, hvis det var første forekomst, eller i reduceret dosis, hvis det var tilbagevendende grad 3.
English: The median time to onset of the first event of RPED (all grades) was 1.5 month (range 0.03 to 17.5 months).
Danish: Mediantiden til indtræden af første RPED-hændelse (alle grader) var 1,5 måneder (område 0,03 til 17,5 måneder).
English: Binimetinib in combination with encorafenib in patients with brain metastases
Danish: Binimetinib i kombination med encorafenib hos patienter med hjernemetastaser
English: • First occurrence of Grade 3 (AST or ALT > 5x ULN and blood bilirubin > 2x ULN)
Danish: • Første forekomst af grad 3 (ASAT eller ALAT > 5x ULN og blodbilirubin > 2x ULN)
English: Following a single oral dose of 45 mg [14C] binimetinib in healthy subjects, the apparent volume of distribution (Vz/F) of binimetinib is 374 L.
Danish: Efter en enkelt oral dosis af 45 mg [14C]-binimetinib hos raske forsøgsdeltagere var det tilsyneladende distributionsvolumen (Vz/F) af binimetinib 374 l.
English: Cutaneous malignancies such as cutaneous squamous cell carcinoma (cuSCC) including kerathoacanthoma has been observed in patients treated with binimetinib when used in combination with encorafenib.
Danish: Der er set kutane maligniteter, såsom kutant planocellulært karcinom (cuSCC), herunder keratoakantom, hos patienter i behandling med binimetinib i kombination med encorafenib.
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 reaction.
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: It is recommended that LVEF is assessed by echocardiogram or multi-gated acquisition (MUGA) scan before initiation of binimetinib, 1 month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment.
Danish: Det anbefales at måle LVEF ved hjælp af ekkokardiogram eller MUGA-scanning inden opstart af binimetinib, 1 måned efter behandlingsopstart og cirka hver 3. måned under behandlingen, eller hyppigere hvis klinisk relevant.
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 section 5.1 of encorafenib SmPC).
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: Tell your doctor immediately if you get severe headache, feel dizzy or lightheaded or if your blood pressure measured on a home blood pressure device is much higher than usual.
Danish: Kontakt straks lægen, hvis du får kraftig hovedpine, føler dig svimmel eller omtumlet, eller hvis dit blodtryk, målt på et blodtryksapparat derhjemme, er meget højere end sædvanligt.
English: Based on a population pharmacokinetic (PK) analysis, the PK of binimetinib were similar in males as compared with females.
Danish: Baseret på en populationsfarmakokinetisk analyse var binimetinibs farmakokinetik ensartet hos mænd og kvinder.
English: Women of childbearing potential must use effective contraception during treatment with binimetinib and for at least 1 month following the last dose.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i mindst 1 måned efter sidste dosis.
English: Binimetinib in combination with encorafenib in patients who have progressed on a BRAF inhibitor
Danish: Binimetinib i kombination med encorafenib hos patienter, der er progredieret under behandling med en BRAF-hæmmer
English: Each film-coated tablet contains 133.5 mg of lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 133,5 mg lactosemonohydrat.
English: CK elevation/rhabdomyolysis
Danish: CK-stigning/rabdomyolyse
English: Photosensitivity*
Danish: Lysfølsomhed*
English: Following a single oral dose of 45 mg [14C] binimetinib in healthy subjects, a mean of 62.3 % of the radioactivity was eliminated in the feces while 31.4 % was eliminated in the urine.
Danish: Efter en enkelt oral dosis af 45 mg [14C]-binimetinib hos raske forsøgsdeltagere blev gennemsnitligt 62,3 % af radioaktiviteten elimineret via fæces og 31,4 % via urinen.
English: BRAF V600 mutant unresectable or metastatic melanoma The safety and efficacy of binimetinib in combination with encorafenib were evaluated in a 2-part Phase III, randomised (1:1:1) active-controlled, open-label, multicenter 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 binimetinib i kombination med encorafenib blev vurderet i et randomiseret (1:1:1), aktivt kontrolleret fase III-multicenterstudie 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: Mektovi 15 mg tablets binimetinib
Danish: Mektovi 15 mg tabletter binimetinib
English: Lactose monohydrate Cellulose microcrystalline (E460i) Silica colloidal anhydrous (E551) Croscarmellose sodium (E468) Magnesium stearate (E470b)
Danish: Lactosemonohydrat Cellulose, mikrokrystallinsk (E460i) Silica, kolloid vandfri (E551) Croscarmellosenatrium (E468) Magnesiumstearat (E470b)
English: There are limited data for use of the combination of binimetinib with encorafenib in patients who have progressed on a prior BRAF inhibitor given for the treatment of unresectable or metastatic melanoma with BRAF V600 mutation.
Danish: Der er begrænsede data for brug af kombinationsbehandling med binimetinib og encorafenib hos patienter, som er progredieret under tidligere BRAF-hæmmerbehandling, som er givet til behandling af inoperabel eller metastatisk melanom med BRAF V600-mutation.
English: Gamma-glutamyl transferase increased*
Danish: Forhøjet gamma-glutamyltransferase* Meget almindelig Forhøjet kreatinin i blodet*
English: There are no data on the effect on fertility in humans for binimetinib.
Danish: Der foreligger ingen data vedrørende binimetinibs indvirkning på fertiliteten hos mennesker.
English: Dose interruption or dose modification was reported in 0.4 % (1/274) of patients.
Danish: Pausering eller dosisændring blev rapporteret hos 0,4 % (1/274) af patienterne.
English: Common (may affect up to 1 in 10 people) - some types of skin tumours such as skin papilloma and basal cell carcinoma - allergic reaction that may include swelling of the face and difficulty breathing - changes in the way things taste - inflammation of the eye (uveitis) - inflammation of the colon (colitis) - redness, chapping or cracking of the skin - inflammation of the fatty layer under the skin, symptoms include tender skin nodules - skin rash with a flat discoloured area or raised bumps like acne (dermatitis acneiform) - redness, skin peeling or blisters on hand and feet (palmar plantar erythrodysesthesia or hand and foot syndrome) - kidney failure - abnormal kidney test results (creatinine elevations) - abnormal blood test results for liver function (blood alkaline phosphatase) - abnormal blood test results for pancreas function (amylase, lipase) - increased skin sensitivity to sunlight
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - visse typer af tumorer i huden, såsom hudpapillom og basalcellekarcinom - allergisk reaktion, som kan omfatte hævelse af ansigtet og vejrtrækningsbesvær - ændringer i smagssansen - betændelse i øjet (uveitis) - betændelse i tyktarmen (colitis) - rødme, revner eller sprækker i huden - betændelse i fedtlaget under huden; symptomerne omfatter ømme knuder i huden - hududslæt med et fladt misfarvet område eller hævede knuder ligesom akne (akneiform dermatitis) - rødme, hudafskalning eller blæredannelse på hænder og fødder (palmo-plantar erythrodysæstesi eller hånd-fod-syndrom) - nyresvigt - uregelmæssige resultater af nyrefunktionstest (stigning i kreatinin) - uregelmæssige blodprøveresultater for leverfunktionen (basisk fosfatase i blodet) - uregelmæssige blodprøveresultater af bugspytkirtelfunktionen (amylase, lipase) - øget følsomhed i huden over for sollys
English: • sudden shortness of breath or trouble breathing
Danish: • pludselig indtræden af stakåndethed eller vejrtrækningsbesvær
English: In patients treated with Combo 450, dermatitis acneiform occurred in 4.4 % (12/274) of patients, was Grade 1 and 2 and no event led to treatment discontinuation.
Danish: Akneiform dermatitis forekom hos 4,4 % (12/274) af de patienter, der fik behandling med Combo 450, var af grad 1 og 2, og ingen hændelser førte til seponering af behandlingen.
English: • swelling in the legs
Danish: • hævelse i benene
English: Overall response rate, n (%) (95 % CI)
Danish: Samlet responsrate, n (%) (95 % CI)
English: Dose modification was reported in 0.7 % (2/274) of patients.
Danish: Der blev rapporteret om dosisændringer hos 0,7 % (2/274) af patienterne.
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, LVD was reported in 8.4 % (23/274) of patients.
Danish: I den samlede Combo 450-population blev der rapporteret om LVD hos 8,4 % (23/274) af patienterne.
English: In the pooled Combo 450 population, RPED was reported in 29.6 % (81/274) of patients.
Danish: I den samlede Combo 450-population blev der rapporteret om RPED hos 29,6 % (81/274) af patienterne.
English: Blood clots: Mektovi may cause blood clots (venous thromboembolism including pulmonary embolism); signs and symptoms can include:
Danish: Blodpropper: Mektovi kan forårsage blodpropper (venøs tromboemboli, herunder lungeemboli); tegn og symptomer herpå kan omfatte:
English: • red or black stools that look like tar
Danish: • rød afføring eller sort, tjærelignende afføring
English: • Tablet core: lactose monohydrate, cellulose microcrystalline (E460i), silica colloidal anhydrous (E551), croscarmellose sodium (E468) and magnesium stearate (E470b).
Danish: • Tabletkerne: lactosemonohydrat, cellulose, mikrokrystallinsk (E460i), silica, kolloid vandfri (E551), croscarmellosenatrium (E468) og magnesiumstearat (E470b).
English: In the safety analysis of pooled studies of encorafenib 450 mg once daily in combination with 45 mg binimetinib twice daily (Combo 450), 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 af encorafenib 450 mg én gang dagligt i kombination med 45 mg binimetinib to gange dagligt (Combo 450) 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: 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: Study CMEK162B2301, Part 1: Kaplan-Meier plot of progression-free survival by independent central review (cut-off date 19 May 2016)
Danish: Studie CMEK162B2301, Del 1: Kaplan-Meier-kurve over progressionsfri overlevelse i henhold til uafhængig central gennemgang (skæringsdato 19. maj 2016)
English: In part 1, patients in the study were randomised to receive binimetinib 45 mg orally twice daily plus encorafenib 450 mg orally daily (Combo 450, n = 192), encorafenib 300 mg orally daily (hereafter referred to as 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 binimetinib 45 mg oralt to gange dagligt plus encorafenib 450 mg oralt dagligt (Combo 450, n=192), encorafenib 300 mg oralt dagligt (herefter benævnt Enco 300, n=194) eller vemurafenib 960 mg oralt to gange dagligt (herefter benævnt Vem, n=191).
English: How to store Mektovi 6.
Danish: Sådan skal du tage Mektovi 4.
English: Binimetinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity.
Danish: Binimetinib hæmmer aktiveringen af MEK via BRAF og hæmmer MEK-kinaseaktiviteten.
English: Mektovi contains lactose
Danish: Mektovi indeholder lactose
English: Vomiting occurred in 15.2% (39/257) of patients with Grade 3 reported in 0.4% (1/257) of patients.
Danish: Opkastning forekom hos 15,2 % (39/257) af patienterne med grad 3 rapporteret hos 0,4 % (1/257) af patienterne.