FrancophonIA/ELRC3.0 huggingface dataset:
English: Liver laboratory abnormalities, specifically increases in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP), have been observed in patients treated with Cotellic plus vemurafenib (see section 4.8).
Danish: Der er observeret abnorme leverværdier, særligt stigning i alaninaminotransferase (ALAT), aspartataminotransferase (ASAT) og alkalisk fosfatase (ALP), hos patienter behandlet med Cotellic og vemurafenib (se pkt.
English: Dose modification advice for Cotellic when used with vemurafenib Liver laboratory abnormalities
Danish: Vejledning i dosisændringer for Cotellic, når det bruges sammen med vemurafenib Abnorme leverværdier
English: The majority of events were reported as chorioretinopathy or retinal detachment.
Danish: Størstedelen af bivirkningerne er indrapporteret som korioretinopati eller nethindeløsning.
English: Depending on the severity of symptoms or CPK elevation; treatment interruption, dose reduction or treatment discontinuation may be required (see section 4.2).
Danish: Afhængig af sværhedsgraden af symptomer eller stigning i kreatinkinase; behandling afbrydes, reducering af dosis eller seponering af behandling kan være påkrævet (se pkt.
English: Cotellic treatment should be permanently discontinued for haemorrhage events attributed to Cotellic.
Danish: Cotellic-behandling skal seponeres permanent hvis blødninger tilskrives Cotellic.
English: Mild CYP3A inhibitors: Cobimetinib can be co-administered with mild inhibitors of CYP3A without dose adjustment.
Danish: Svage CYP3A-hæmmere: Cobimetinib kan administreres samtidig med svage CYP3A-hæmmere uden dosisjustering.
English: Uncommon ≥ 1/1,000 to < 1/100
Danish: Ikke almindelig ≥ 1/1000 til < 1/100
English: Grade 2 (intolerable) or Grade ≥3 photosensitivity: Cotellic and vemurafenib should be interrupted until resolution to Grade ≤1.
Danish: Ved lysfølsomhedsreaktion grad 2 (intolerabel) eller grad ≥ 3: Behandling med Cotellic og vemurafenib afbrydes, indtil bivirkningen er reduceret til grad ≤ 1.
English: Vemurafenib dosing may be either temporarily interrupted and/or reduced, please refer to its SmPC for further information.
Danish: Vemurafenibbehandlingen kan afbrydes midlertidigt og/eller dosis reduceres, se produktresuméet for vemurafenib for yderligere information.
English: For strong CYP3A inhibitors used short-term (7 days or less), consider interrupting cobimetinib therapy during the duration of inhibitor use.
Danish: Ved kort tids brug (7 dage eller mindre) af potente CYP3A-hæmmere, bør det overvejes at afbryde behandlingen med cobimetinib, mens behandlingen med CYP3A-hæmmeren foregår.
English: LVEF value following treatment break
Danish: LVEF efter behandlingspause
English: How Cotellic works
Danish: Hvordan virker Cotellic?
English: Caution should be exercised if a moderate CYP3A inhibitor is co-administered with Cotellic.
Danish: Der skal udvises forsigtighed, hvis moderate CYP3A-hæmmere administreres samtidig med Cotellic.
English: Liver laboratory abnormalities
Danish: Abnorme laboratorieværdier
English: Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Danish: Cotellic er, i kombination med vemurafenib, indiceret til behandling af voksne patienter med ikkeoperabelt eller metastatisk melanom med BRAF-V600-mutation (se pkt.
English: If rhabdomyolysis is diagnosed, Cotellic treatment should be interrupted and CPK levels and other symptoms monitored until resolution.
Danish: Hvis rabdomyolyse diagnosticeres, bør behandling med Cotellic afbrydes samt kreatinkinaseniveauer og andre symptomer overvåges indtil bivirkningen reduceres.
English: Other medicines and Cotellic
Danish: Brug af anden medicin sammen med Cotellic
English: · Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller skraldespanden.
English: ADRs are based on results from a multi-centre, randomised, double-blind, placebo-controlled, Phase III Study (GO28141) that evaluated the safety and efficacy of Cotellic in combination with vemurafenib as compared to vemurafenib alone in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced (Stage IIIc) or metastatic melanoma (Stage IV).
Danish: Bivirkningerne er indsamlet i et randomiseret, dobbeltblindet, placebokontrolleret, fase IIImulticenterstudie (GO28141), der evaluerede sikkerheden og virkningen af Cotellic i kombination med vemurafenib sammenlignet med vemurafenib alene hos tidligere ubehandlede BRAF-V600mutationspositive patienter med ikke-operabelt, lokalt fremskredent (stadie IIIc) eller metastatisk melanom (stadie IV).
English: Gender does not have an effect on the exposure of cobimetinib, based on a population pharmacokinetic analysis including 210 women and 277 men.
Danish: Baseret på en farmakokinetisk populationsanalyse med 210 kvinder og 277 mænd påvirker køn ikke eksponeringen af cobimetinib.
English: Common (may affect up to 1 in 10 people) · some types of skin cancer such as basal cell carcinoma, cutaneous squamous cell carcinoma and keratoacanthoma · dehydration, when your body does not have enough fluid · decreased levels of phosphate or sodium (shown in blood tests) · increased sugar level (shown in blood tests) · increased liver pigment (called “bilirubin”) in the blood.
Danish: · visse former for hudkræft såsom basalcellekræft, pladecellekræft og keratoakantom · dehydrering, hvor kroppen mangler væske · fald i fosfat- eller natriumværdier (ses ved blodprøve) · forhøjede sukkerværdier (ses ved blodprøve) · forhøjet bilirubin (leverpigment) i blodet.
English: Moderate CYP3A inhibitors (see section 4.4.
Danish: Moderate CYP3A-hæmmere (se pkt.
English: · Bleeding
Danish: · Blødning
English: For patients reporting new or worsening visual disturbances, an ophthalmologic examination is recommended.
Danish: Patienter med nye eller forværrede synsforstyrrelser skal have foretaget oftalmologisk undersøgelse.
English: · Keep this medicine out of the sight and reach of children.
Danish: · Opbevar lægemidlet utilgængeligt for børn.
English: ): Caution should be exercised if cobimetinib is coadministered with moderate CYP3A inhibitors.
Danish: 4.4): Der skal udvises forsigtighed, hvis cobimetinib administreres samtidig med moderate CYP3A-hæmmere.
English: The mean apparent CL following oral dosing of 60 mg in cancer patients was 13.8 L/hr.
Danish: Den gennemsnitlige tilsyneladende plasmaclearance efter en oral dosis på 60 mg til kræftpatienter var
English: No dose adjustment is recommended in patients with hepatic impairment.
Danish: Dosisjustering anbefales ikke til patienter med nedsat leverfunktion.
English: Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib.
Danish: Hver filmovertrukken tablet indeholder cobimetinibhemifumarat svarende til 20 mg cobimetinib.
English: ): Avoid concurrent use of strong CYP3A inhibitors during treatment with cobimetinib.
Danish: 4.4): Undgå samtidig administration af potente CYP3A-hæmmere under behandling med cobimetinib.
English: Liver laboratory abnormalities can occur when Cotellic is used in combination with vemurafenib and with vemurafenib as a single agent (please refer to its SmPC).
Danish: Abnorme leverværdier kan forekomme, når Cotellic anvendes i kombination med vemurafenib og med vemurafenib i enkeltstofbehandling (se produktresuméet for vemurafenib).
English: NAME OF THE MEDICINAL PRODUCT Cotellic 20 mg film-coated tablets cobimetinib
Danish: LÆGEMIDLETS NAVN Cotellic 20 mg filmovertrukne tabletter cobimetinib
English: Liver laboratory abnormalities, specifically ALT, AST, and ALP have been observed in patients treated with Cotellic in combination with vemurafenib (see section 4.4).
Danish: Der er observeret abnorme leverværdier, specifikt ALAT, ASAT og ALP, hos patienter behandlet med Cotellic i kombination med vemurafenib (se pkt.
English: If liver laboratory abnormalities improve to Grade ≤1 within 4 weeks, Cotellic should be restarted at a dose reduced by 20 mg and vemurafenib at a clinically appropriate dose, per its SmPC.
Danish: Hvis leverværdierne bedres til grad ≤ 1 inden for 4 uger, genoptages Cotellic i en reduceret dosis på 20 mg og vemurafenib i en klinisk hensigtsmæssigt dosis i overensstemmelse med dets produktresumé.
English: Grade 3 liver laboratory abnormalities should be managed with vemurafenib treatment interruption or dose reduction.
Danish: Ved grad 3 abnorme leverværdier skal vemurafenibbehandlingen afbrydes eller vemurafenibdosis reduceres.
English: Avoid taking Cotellic with grapefruit juice.
Danish: Brug af Cotellic sammen med mad og drikke Undgå at drikke grapefrugtjuice, så længe du tager Cotellic.
English: Age does not have an effect on the exposure of cobimetinib, based on a population pharmacokinetic analysis including 133 patients ≥ 65 years of age.
Danish: Baseret på en farmakokinetisk populationsanalyse med 133 patienter ≥ 65 år påvirker alder ikke eksponeringen af cobimetinib.
English: Heart problems (common: may affect up to 1 in 10 people) Cotellic can lower the amount of blood pumped by your heart.
Danish: Hjerteproblemer (almindelige: kan optræde hos op til 1 ud af 10 patienter) Cotellic kan nedsætte hjertets pumpeevne.
English: Grade ≥3 photosensitivity events in the Cotellic plus vemurafenib arm were treated with primary topical medicinal products in conjunction with dose interruptions of both cobimetinib and vemurafenib (see section 4.2).
Danish: I Cotellic-plusvemurafenib-armen blev lysfølsomhedsreaktion grad ≥ 3 primært behandlet med topikale lægemidler sammen med behandlingsafbrydelse af såvel cobimetinib som vemurafenib (se pkt.
English: Rash events may occur with either Cotellic or vemurafenib treatment.
Danish: Der kan forekomme udslæt i forbindelse med behandling med såvel Cotellic som vemurafenib.
English: Liver laboratory tests should be monitored before initiation of combination treatment and monthly during treatment, or more frequently if clinically indicated (see section 4.2).
Danish: Leverværdier bør kontrolleres inden påbegyndelse af kombinationsbehandling samt månedligt under behandling eller hyppigere, hvis klinisk indiceret (se pkt.
English: What you need to know before you take Cotellic 3.
Danish: Det skal du vide, før du begynder at tage Cotellic Sådan skal du tage Cotellic Bivirkninger
English: How to take Cotellic
Danish: Sådan skal du tage Cotellic
English: Vemurafenib dosing can be continued when Cotellic treatment is modified (if clinically indicated).
Danish: Vemurafenibbehandlingen kan fortsættes uden dosisændring, når dosis af Cotellic er ændret (hvis dette er klinisk indiceret).
English: Serous retinopathy can be managed with treatment interruption, dose reduction or with treatment discontinuation (see Table 1 in section 4.2).
Danish: Serøs retinopati kan håndteres med behandlingsafbrydelse, dosisreduktion eller seponering (se tabel 1 i pkt.
English: Unbound cobimetinib exposures were similar between subjects with mild and moderate hepatic impairment compared to subjects with normal hepatic function while subjects with severe hepatic impairment had approximately 2-fold higher exposures (see section 4.2).
Danish: Eksponeringen af frit cobimetinib var sammenlignelig hos forsøgspersoner med let og moderat nedsat leverfunktion og forsøgspersoner med normal leverfunktion, men forsøgspersoner med svært nedsat leverfunktion havde ca. 2 gange højere eksponering (se pkt.
English: Serous retinopathy (fluid accumulation within the layers of the retina) has been observed in patients treated with MEK-inhibitors, including Cotellic (see section 4.8).
Danish: Der er observeret serøs retinopati (væskeansamling i retina-lagene) hos patienter behandlet med MEKhæmmere, inklusive Cotellic (se pkt.
English: Includes both chorioretinopathy and retinal detachment events indicative of serous retinopathy (see section 4.4) b Combined figure includes reports of photosensitivity reaction, sunburn, solar dermatitis, actinic elastosis
Danish: 4.4) b Kombinerede tal inkluderer indberetninger af lysfølsomhedsreaktioner, solskoldning, soleksem og aktinisk elastose
English: During this 7 day break in Cotellic treatment, you should keep taking vemurafenib as told by your doctor.
Danish: Cotellic, skal du fortsætte behandlingen med vemurafenib som foreskrevet af lægen.
English: Assessed and confirmed by the investigator (INV) using RECIST v1.1 b Stratified analysis by geographic region and metastasis classification (disease stage)
Danish: Vurderet og bekræftet af investigator ved hjælp af RECIST v1.1
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 20 November 2015
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Manage Grade 4 liver laboratory abnormalities with treatment interruption, dose reduction or with treatment discontinuation of both Cotellic and vemurafenib (see section 4.2).
Danish: Abnorme leverværdier af grad 4 skal håndteres med behandlingsafbrydelse, dosisreduktion eller seponering af såvel Cotellic som vemurafenib (se pkt.
English: Before starting this treatment, patients must have BRAF V600 mutation-positive melanoma tumour status confirmed by a validated test (see sections 4.4 and 5.1).
Danish: Inden behandlingen påbegyndes, skal det bekræftes ved en valideret test, at patientens melanom er BRAF-V600-mutationspositivt (se pkt.
English: Within each frequency grouping, ADRs are presented in order of decreasing severity and were reported according to NCICTCAE v 4.0 (common toxicity criteria) for assessment of toxicity in Study GO28141.
Danish: I studie GO28141 er bivirkningernes toksicitet vurderet i henhold til NCI-CTCAE v 4.0 (almene toksicitetskriterier).
English: Strong CYP3A inhibitors (see section 4.4.
Danish: Potente CYP3A-hæmmere (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Cotellic 20 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Cotellic 20 mg filmovertrukne tabletter.
English: Grade ≤3: After rhabdomyolysis has been ruled out, Cotellic dosing does not need to be modified.
Danish: Grad ≤ 3: Cotellic-dosis ændres ikke, hvis rabdomyolyse er udelukket.
English: In patients who had progressed on BRAF inhibitor therapy, the median overall survival was 8.4 months (95% CI 6.7-11.1).
Danish: For patienter med progression under behandling med BRAF-hæmmer var den mediane samlede overlevelse 8,4 måneder (95% konfidensinterval
English: Bleeding events have been reported more frequently in the Cotellic plus vemurafenib arm than in the placebo plus vemurafenib arm (all types and Grades: 13% vs 7%).
Danish: Blødninger sås hyppigere i Cotellic-plus-vemurafenib-armen end i placebo-plus-vemurafenib-armen (alle typer og grader: 13% versus 7%).
English: Cutaneous squamous cell carcinoma, keratoacanthoma and hyperkeratosis
Danish: Kutant pladecellekarcinom, keratoakantom og hyperkeratose
English: Cases of serous retinopathy have been reported in patients treated with Cotellic (see section 4.4.)
Danish: Der er indberettet tilfælde af serøs retinopati hos patienter behandlet med Cotellic (se pkt.
English: Duration of Response (DoR) Median DoR (months) (95% CI) for median NE = Not evaluable a
Danish: Responsvarighed Median responsvarighed (måneder) (95% konfidensinterval) for median
English: Always take Cotellic exactly as your doctor or pharmacist has told you.
Danish: Tag altid Cotellic præcist, som lægen foreskriver.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Anæmi Metabolisme og ernæring
English: This is available without prescription.
Danish: Kræver ikke recept.
English: Recommended Cotellic dose modification
Danish: Anbefalet ændring i Cotellic-dosis
English: Cotellic in combination with vemurafenib in patients who have progressed on a BRAF inhibitor There are limited data in patients taking the combination of Cotellic with vemurafenib who have progressed on a prior BRAF inhibitor.
Danish: Cotellic i kombination med vemurafenib hos patienter, som har progredieret under behandling med en BRAF-inhibitor.
English: Recommended Cotellic dose
Danish: Anbefalet Cotellic-dosis
English: Cotellic targets a protein called “MEK” that is important in controlling cancer cell growth.
Danish: Cotellic virker på et protein, der kaldes MEK.
English: If during treatment the QTc exceeds 500 msec, please refer to the vemurafenib SmPC sections 4.2 and
Danish: Hvis QTc overstiger 500 msek under behandlingen, se produktresuméet for vemurafenib (pkt.
English: Progression-Free Survival (PFS) Median (months) (95 % CI)
Danish: Progressionsfri overlevelse Median (måneder) 95 % konfidensinterval Hazard ratio (95% konfidensinterval)b
English: If Grade ≥3 diarrhoea recurs, the dose of Cotellic and vemurafenib should be reduced (see section 4.2).
Danish: Dosis af Cotellic og vemurafenib skal nedsættes, hvis grad ≥3 diarré opstår igen (se pkt.
English: Diarrhoea, Nausea, Vomiting
Danish: Mave-tarm-kanalen Diarré, kvalme, opkastning
English: · Liver problems
Danish: · Leverproblemer
English: Mild to moderate renal impairment does not influence cobimetinib exposure based on the population pharmacokinetic analysis.
Danish: Baseret på den farmakokinetiske populationsanalyse påvirker let til moderat nedsat nyrefunktion ikke eksponeringen af cobimetinib.
English: Increased ALT
Danish: Ældre
English: Depending on the severity of rhabdomyolysis, dose reduction or treatment discontinuation may be required (see section 4.2).
Danish: Afhængig af sværhedsgraden af rabdomyolyse, kan dosisreducering eller afbrydelse af behandling kræves (se pkt.
English: Decrease in LVEF from baseline can be managed using treatment interruption, dose reduction or with treatment discontinuation (see section 4.2).
Danish: Fald i LVEF i forhold til baseline kan håndteres med behandlingsafbrydelse, dosisreduktion eller seponering (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder cobimetinibhemifumarat svarende til 20 mg cobimetinib.
English: No studies have been conducted to investigate the pharmacokinetics of cobimetinib in paediatric patients.
Danish: Cotellics farmakokinetik er ikke undersøgt hos pædiatriske patienter.
English: Photosensitivity has been observed with a higher frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm (47% vs 35%).
Danish: Forekomsten af lysfølsomhedsreaktioner var højere i Cotellic-plus-vemurafenib-armen end i placeboplus-vemurafenib-armen (47% versus 35%).
English: If rhabdomyolysis or symptomatic CPK elevations do not improve within 4 weeks, Cotellic treatment should be permanently discontinued.
Danish: Cortellic-behandling skal seponeres permanent hvis ikke rabdomyolyse eller symptomatiske stigninger i kreatinkinase forbedres indenfor 4 uger.
English: Liver value abnormalities should be monitored by liver laboratory tests before initiation of combination treatment and monthly during treatment, or more frequently as clinically indicated (see section 4.2).
Danish: Der skal monitoreres for abnorme leverværdier inden påbegyndelse af behandlingen samt månedligt under behandlingen eller oftere, hvis klinisk indiceret (se pkt.
English: Patients with rare hereditary problems of galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption should consult with their physician and discuss whether the benefits outweigh the risks on an individual basis.
Danish: Lægen bør individuelt diskutere, om fordelene ved behandlingen opvejer risiciene med patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactose-malabsorption.
English: The majority of events were Grades 1 or 2, with Grade ≥3 events occurring in 4% of patients in the Cotellic plus vemurafenib arm vs 0% in the placebo plus vemurafenib arm.
Danish: 4% af patienterne i Cotellic-plus-vemurafenib-armen oplevede bivirkninger af grad ≥ 3 versus 0% i placeboplus-vemurafenib-armen.
English: Asymptomatic CPK elevations
Danish: Asymptomatiske stigninger i kreatinkinase
English: If haemorrhage occurs, treat as clinically indicated (see section 4.2 and 4.4).
Danish: Hvis blødninger opstår, skal de behandles som klinisk indiceret (se pkt.
English: België/Belgique/Belgien N.V. Roche S.A.
Danish: België/Belgique/Belgien
English: Serum CPK and creatinine levels should be measured before initiation of treatment, to establish baseline values, and then monitored monthly during treatment, or as clinically indicated.
Danish: Serum kreatinkinase- og kreatininniveauer bør monitoreres inden behandlingen startes for at etablere en værdi for baseline.
English: Dose modification advice for haemorrhage
Danish: Vejledning i dosisændringer ved blødning
English: These measures will help to protect the environment.
Danish: Dette protein har stor betydning for kontrollen af kræftcellernes vækst.
English: Using Clopper-Pearson method d Using Hauck-Anderson method e
Danish: Analyse stratificeret i forhold til geografisk region og metastase-klassifikation (sygdomsstadie) c Ved hjælp af Clopper-Pearsons metode d
English: If CPK improves to Grade ≤3 within 4 weeks, Cotellic could be restarted, if clinically indicated, at a dose reduced by 20 mg and the patient should be closely monitored.
Danish: Hvis kreatinkinase forbedres til grad ≤ 3 inden for 4 uger, kan Cotellic-behandling genoptages ved en dosis reduceret med 20 mg, hvis det er klinisk indiceret.
English: Cotellic treatment and vemurafenib treatment should be interrupted.
Danish: Grad 4: Behandling med Cotellic og vemurafenib afbrydes.
English: Clinical judgment should be applied when considering restarting Cotellic treatment.
Danish: Genoptagelse af Cotellic-behandling skal baseres på klinisk vurdering.
English: Increased AST
Danish: Forhøjet ASAT
English: Hyperkeratosis has been reported with a lower frequency in the Cotellic plus vemurafenib vs placebo plus vemurafenib arm (all Grade: 11% vs 30%).
Danish: Der blev indberettet færre tilfælde af hyperkeratose i Cotellic-plusvemurafenib-armen end i placebo-plus-vemurafenib-armen (alle grader: 11% versus 30%).
English: The median time to first onset was 6.1 months in the Cotellic plus vemurafenib arm.
Danish: I Cotellic-plus-vemurafenib-armen var median tiden 6.1 måned før første blødning.
English: Renal impairment
Danish: Serøs retinopati
English: Following confirmation of a BRAF V600 mutation, using the cobas® 4800 BRAF V600 mutation test,
Danish: 495 tidligere ubehandlede patienter med ikke-operabelt, lokalt fremskredent eller metastatisk melanom blev, efter BRAF-V600-mutation var verificeret ved hjælp af cobas® 4800 BRAF-V600-mutationstest,
English: Respiratory, thoracic and mediastinal disorders
Danish: Vaskulære sygdomme Hypertension, blødning* Luftveje, thorax og mediastinum
English: Decrease in LVEF from baseline has been reported in patients receiving Cotellic (see section 4.4).
Danish: Der er indberettet fald i LVEF i forhold til baseline hos patienter behandlet med Cotellic (se pkt.
English: Please refer to the vemurafenib SmPC.
Danish: Se produktresuméet for vemurafenib.
English: The OS p-value (0.0050) crossed the pre-specified boundary (p value <0.0499) f The data cut-off date for this updated PFS analysis and the secondary endpoints of ORR, BOR and DoR is 16 January 2015.
Danish: Hauck-Anderson metode er anvendt e p-værdi for den samlede overlevelse (0,0050) krydsede den tidligere specificerede grænse (p værdi <0,0499)
English: Keratoacanthoma has been reported with a lower frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm (all Grade: 2% vs 9%).
Danish: Der blev indberettet færre tilfælde af keratoakantom i Cotellic-plus-vemurafenib-armen end i placebo-plus-vemurafenib-armen (alle grader: 2% versus 9%).
English: Muscle problems (uncommon: may affect up to 1 in 100 people) Cotellic can result in the breakdown of muscle (rhabdomyolysis), symptoms may include: · muscle aches · muscle spasms and weakness · dark- or red-coloured urine.
Danish: Muskelproblemer (ikke almindelige: kan optræde hos op til 1 ud af 100 patienter) Cotellic kan forårsage muskelbeskadigelse (rabdomyolyse).