FrancophonIA/ELRC3.0 huggingface dataset:
English: Hedgehog pathway signalling through the Smoothened transmembrane protein (SMO) leads to the activation and nuclear localisation of Glioma-Associated Oncogene (GLI) transcription factors and induction of
Danish: Hedgehogsignalering gennem smoothened (SMO) transmembranprotein medfører aktivering og nuklear lokalisering af glioma-associeret onkogen (GLI)-transkriptionsfaktorer og induktion af Hedgehog target-gener.
English: If you do become pregnant during the treatment with Erivedge, you must stop the treatment and inform your doctor immediately.
Danish: Hvis du bliver gravid under behandling med Erivedge, skal du straks stoppe med at tage medicinen og kontakte lægen.
English: • Methodology to collect information on the use of Erivedge and the compliance with the pregnancy pharmacovigilance programme and its effectiveness
Danish: • En metode til indsamling af oplysninger om brugen af Erivedge og overholdelse af programmet for svangerskabsforebyggelse (lægemiddelovervågning) samt effektiviteten heraf
English: You must stop treatment and inform your doctor straight away if: you miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
Danish: Du skal stoppe med behandlingen og straks kontakte lægen, hvis du ikke får din menstruation eller tror, din menstruation måske er udeblevet, din menstruation er anderledes, end den plejer at være, eller du har mistanke om, at du er gravid.
English: Renal excretion of orally administered vismodegib is low.
Danish: Udskillelse af oralt administreret vismodegib gennem nyrerne er lav.
English: • if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Erivedge Pregnancy Prevention Programme,
Danish: • hvis du kan blive gravid, og ikke ønsker eller ikke er i stand til at tage de nødvendige forholdsregler for at undgå at blive gravid.
English: You must also use one barrier method, such as:
Danish: Du skal også bruge en barrieremetode, fx:
English: No dose adjustment is required in patients with mild, moderate or severe hepatic impairment defined based on National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG)- criteria for hepatic impairment:
Danish: Nedsat leverfunktion Dosisjustering er ikke nødvendig hos patienter med let, moderat eller svært nedsat leverfunktion defineret ud fra National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG)-kriterier for nedsat leverfunktion:
English: Erivedge or during the 2 months after his final dose.
Danish: Erivedge eller i to måneder efter sidste dosis.
English: If a dose is missed, patients should be instructed not to take the missed dose but to resume with the next scheduled dose.
Danish: Patienterne bør informeres om, at hvis de glemmer en dosis, skal de ikke tage den glemte dosis, men blot genoptage behandlingen med næste planlagte dosis.
English: *Of the 138 patients with advanced BCC, 10 were WCBP.
Danish: *Af de 138 patienter med fremskredent basalcellekarcinom var 10 fertile kvinder.
English: In clinical trials with aBCC, approximately 40 % of patients were of geriatric age (≥ 65 years).
Danish: I kliniske studier med fremskredent basalcellekarcinom var ca. 40% af patienterne ældre (≥65 år).
English: • Do not throw away any medicines via wastewater or household waste.
Danish: • Du må ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Additional findings at clinically relevant exposures included faecal changes; skeletal muscle twitching or tremors; alopecia; swelling, follicular hyperkeratosis, and inflammation in paw pads; and increased LDL and HDL cholesterol.
Danish: Yderligere fund ved klinisk relevant eksponering inkluderede fæcesforandringer, trækninger eller tremor i skeletmuskler, alopeci, hævelser, follikulær hyperkeratose og inflammation i trædepuderne samt forhøjet LDL- og HDL-kolesterol.
English: Increased number of degenerating germ cells and hypospermia in sexually immature dogs observed at ≥ 50 mg/kg/day in the 4-week general toxicity study was of undetermined relationship to vismodegib.
Danish: Det øgede antal degenererende kimceller og hypospermi, som blev observeret hos ikke-kønsmodne hunde ved ≥ 50 mg/kg/dag i det 4ugers generelle tokscitetsstudie, kunne ikke relateres til vismodegib.
English: Among patients in the efficacy-evaluable population with measurable and histologically confirmed disease, 68.5% and 36.9% responded to treatment in the laBCC and mBCC cohorts, respectively, by RECIST v1.1.
Danish: Blandt patienterne, i den effekt evaluerbare population med målbar og histologisk bekræftet sygdom, reagerede 68,5% og 36,9% af henholdsvis i lokalt fremskredent basalcellekarcinom-kohorten og i metastatiske basalcellekarcinom-kohorten på behandlingen i forhold til RECIST v1.1.
English: In the same study there were no histopathological findings in male reproductive organs and no effects on male fertility endpoints, including percent motile sperm, observed at 100 mg/kg/day at the end of dosing or recovery phase (corresponding to 1.3-fold of the steady-state AUC0-24h at the recommended human dose).
Danish: I samme studie blev der ikke observeret histopatologiske fund i hannernes kønsorganer, og der var ingen påvirkning af fertilitetsendepunkter, herunder procent bevægelige sædceller, ved 100 mg/kg/dag ved slutningen af doserings- eller restitutionsperioden (svarende til 1,3 gange AUC0-24t ved steady state ved den anbefalede dosis til mennesker).
English: Abdominal pain upper Abdominal pain
Danish: Smerter i øvre abdomen Abdominalsmerter
English: In the dedicated 26-week vismodegib rat fertility study, vismodegib-related effects on female reproductive organs were observed at 100 mg/kg/day immediately after treatment discontinuation, including decreased implantations, increased percent preimplantation loss, and decreased number of dams with viable embryos.
Danish: I det 26-ugers specifikke fertilitetsstudie med vismodegib hos rotter blev vismodegib-relaterede virkninger på hunners kønsorganer observeret ved 100 mg/kg/dag umiddelbart efter behandlingsophør, herunder fald i implantationer, øget procent af præimplantationstab og nedsat antal hunner med levedygtige fostre.
English: • Women who are pregnant or breast-feeding (see sections 4.4 and 4.6).
Danish: • Kvinder, der er gravide eller ammer (se pkt.
English: Results from a clinical study demonstrated a 33% decrease in vismodegib unbound drug concentrations after 7 days co-treatment with 20 mg rabeprazole (a proton pump inhibitor) given 2 h before each vismodegib administration.
Danish: Resultater fra et klinisk studie viste et fald på 33% i koncentrationerne af ubundet vismodigib efter 7 dages samtidig behandling med 20 mg rabeprazol (en protonpumpehæmmer) der blev givet 2 timer før hver vismodegib administration.
English: A post-approval, open-label, non-comparative, multicenter, phase II clinical trial (MO25616) was conducted in 1232 patients with advanced BCC, of whom 1215 patients were evaluable for efficacy and safety with laBCC (n = 1119) or mBCC (n = 96).
Danish: I et post-marketing, åbent, non-komparativ, multicenter fase II klinisk studie (MO25616) udført blandt 1232 patienter med fremskredent basalcellekarcinom var effekten og sikkerheden evaluerbar hos 1215 patienter med lokalt fremskredent basalcellekarcinom (n=1119) eller metastatisk basalcellekarcinom (n=96).
English: In a clinical study in patients with hepatic impairment (degree of impairment based on subject's AST and total bilirubin levels) following multiple doses of vismodegib, it was shown that in patients with mild (NCI-ODWG criteria, n=8), moderate (NCI-ODWG criteria, n=6), and severe (NCI-ODWG criteria, n=3) hepatic impairment, the pharmacokinetic profile of vismodegib was comparable to that of subjects with normal hepatic function (n=9) (see section 4.2).
Danish: I et klinisk studie med patienter med nedsat leverfuktion (graden af nedsat leverfunktion var baseret på patientens ASAT og total-bilirubin) blev det vist, at efter flere doser vismodegib hos patienter med let (NCI-ODWG kriterium, n=8), moderat (NCI-ODWG kriterium, n=6) eller svær (NCI-ODWG kriterium, n=3) nedsat leverfunktion var den farmakokinetiske profil af vismodegib sammenlignelig med profilen hos forsøgspersoner med normal leverfunktion (n=9) (se pkt 4.2).
English: In case of pregnancy in a woman treated with Erivedge, treatment must be stopped immediately.
Danish: Hvis en kvinde, der behandles med Erivedge, bliver gravid, skal behandlingen straks seponeres.
English: • If she misses her expected menstrual period,
Danish: • en forventet menstruationsperiode udebliver
English: • Periodic Safety Update Reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Erivedge may cause severe birth defects.
Danish: Erivedge kan forårsage svære medfødte misdannelser.
English: Of patients who had a confirmed response (partial or complete), the median Duration of Response was 23.0 months (95% CI: 20.4, 26.7) in the laBCC cohort and 13.9 months (95% CI: 9.2, NE) in the mBCC cohort.
Danish: Blandt patienterne, der havde en bekræftet respons (delvist eller komplet) var den mediane varighed af respons 23,0 måneder (95% konfidensinterval: 20,4;26,7) i lokalt fremskredent basalcellekarcinomkohorten og 13,9 måneder (95% konfidensinterval: 9,2;NE) i metastatiske basalcellekarcinom-kohorten.
English: Nervous system disorder
Danish: Nervesystemet
English: • Vasectomy,
Danish: • Vasektomi,
English: Itraconazole (a strong CYP3A4 inhibitor) 200 mg daily did not influence vismodegib AUC0-24h after 7 days co-treament in healthy volunteers.
Danish: 200 mg Itraconazol dagligt (en stærk CYP3A4-hæmmer) påvirkede ikke AUC0-24 timer efter 7 dages samtidig behandling af raske forsøgspersoner.
English: • Serious skin reactions have been reported in association with Erivedge treatment.
Danish: • Der er set alvorlige hudreaktioner ved behandling med Erivedge.
English: The bottle cap material is Polypropylene.
Danish: Beholderens låg er lavet af polypropylen.
English: Vismodegib binds to and inhibits the SMO protein thereby blocking Hedgehog signal transduction.
Danish: Vismodegib bindes til og hæmmer SMO-proteinet og blokerer derved transduktion af Hedgehogsignaler.
English: Carcinogenic potential was identified in rats only and was limited to benign hair follicle tumors, including pilomatricomas and keratoacanthomas respectively at ≥ 0.1-fold and ≥0.6-fold of the steady-state AUC(0-24h) of the recommended human dose.
Danish: Potentialet for karcinogenicitet blevr kun identificeret hos rotter og var begrænset til benigne tumorer i hårsækkene, herunder pilomatrikomer og keratoakantomer ved henholdsvis ≥ 0,1 gange og ≥0, 6 gange den anbefalede humane dosis ved steady-state AUC(0-24timer).
English: Amenorrhoea*
Danish: Amenoré*
English: • He will tell his healthcare provider if his female partner becomes pregnant while he is taking
Danish: • han skal kontakte lægen, hvis hans kvindelige partner bliver gravid, mens han er i behandling med
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller et eller flere hjælpestoffer anført i pkt.
English: Drug induced liver injury*****
Danish: Lægemiddelinduceret leverskade*****
English: Due to the risk of embryo-foetal death or severe birth defects caused by vismodegib, women taking Erivedge must not be pregnant or become pregnant during treatment and for 24 months after the final dose (see sections 4.3 and 4.4).
Danish: På grund af risiko for embryo-føtal død eller svære medfødte misdannelser forårsaget af vismodegib må kvinder, der tager Erivedge, ikke være gravide eller blive gravide under behandlingen og i 24 måneder efter sidste dosis (se pkt.
English: There are limited data in non-Caucasian patients.
Danish: Der er begrænsede data fra patienter af anden etnicitet end kaukasisk.
English: The median duration of treatment for all patients was 8.6 months (range 0 to
Danish: Median behandlingsvarighed for alle patienter var 8,6 måneder (mellem 0 til 44,1 måned).
English: What Erivedge is used for
Danish: Hvad bruges Erivedge til?
English: In animal species, vismodegib has been shown to cause severe irreversible changes in growing teeth (degeneration/necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and haemorrhage) and closure of the epiphyseal growth plate.
Danish: Vismodegib er hos flere dyrearter vist at forårsage svære, irreversible forandringer på tænder i vækst (degeneration/nekrose af odontoblaster, dannelse af væskefyldte cyster i tandpulpen, ossificering af rodkanalen og blødning) samt epifyseskivelukning.
English: In the laBCC cohort, tumour response was assessed based on visual assessment of external tumour and ulceration, tumour imaging (where appropriate), and tumour biopsy.
Danish: I lokalt fremskredent basalcellekarcinom-kohorten blev tumorrespons vurderet på baggrund af visuel vurdering af udvendig tumor og ulceration, tumorskanning (hvis dette var relevant) og tumorbiopsi.
English: However, results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of rosiglitazone (a CYP2C8 substrate) is not altered when co-administered with vismodegib.
Danish: Resultater fra et lægemiddelinteraktionsstudie med cancerpatienter har dog vist, at den systemiske eksponering af rosiglitazon (et CYP2C8-substrat) ikke ændres ved samtidig administration af vismodegib.
English: Thus inhibition of CYP enzymes by vismodegib in vivo may be excluded.
Danish: Det kan derfor muligvis udelukkes, at vismodegib hæmmer CYP-enzymer in vivo.
English: It is not known if Erivedge can pass into your breast milk and harm your baby.
Danish: Det vides ikke, om Erivedge udskilles i mælk og kan skade barnet.
English: Hypogeusia
Danish: Hypogeusi
English: The safety of Erivedge has been evaluated in clinical trials with 138 patients treated for advanced basal cell carcinoma (aBCC), which includes both metastatic BCC (mBCC) and locally advanced BCC (laBCC).
Danish: Erivedges sikkerhed er evalueret i kliniske forsøg med 138 patienter behandlet for fremskredent basalcellekarcinom, som inkluderer både metastatisk basalcellekarcinom og lokalt fremskredent basalcellekarcinom.
English: • She must be able to comply with effective contraceptive measures,
Danish: • hun skal være i stand til at overholde de forholdsregler, der er forbundet med svangerskabsforebyggelse
English: • loss of taste,
Danish: • tab af smagssans
English: Complete Response 0 Partial Response Stable disease Progressive disease ‡ 1
Danish: 95% konfidensinterval for overordnet respons Fuldstændigt respons 0 Delvist respons Stabil sygdom 20 Progressiv sygdom‡ 1 Median varighed af respons (måneder)
English: Post approval study results
Danish: Resultater fra et post-marketing studie
English: For women taking Erivedge
Danish: Kvinder, der tager Erivedge:
English: Metabolic pathways of vismodegib in humans include oxidation, glucuronidation, and an uncommon pyridine ring cleavage.
Danish: Hos mennesker inkluderer vismodegibs metaboliseringsveje oxidation, glukuronidering og en sjælden spaltning af pyridinringen.
English: Results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of ethinyl estradiol and norethindrone is not altered when co-administered with vismodegib.
Danish: Et lægemiddelinteraktionsstudie med kræftpatienter har vist, at den systemiske eksponering af ethinylestradiol og norethindron ikke ændres ved administration sammen med vismodegib.
English: Pink coloured opaque body marked “150 mg” and a grey opaque cap marked “VISMO” with black ink.
Danish: Lyserød, uigennemsigtig hoveddel mærket “150 mg” og en grå, uigennemsigtig hætte mærket “VISMO” med sort blæk.
English: • Coadministration of St John's wort (Hypericum perforatum) (see section 4.5).
Danish: • Samtidig indtagelse af perikon (Hypericum perforatum) (se pkt.
English: EU/1/13/848/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/13/848/001
English: In the dedicated 26-week vismodegib rat fertility study, significantly increased absolute weights of seminal vesicles and reduced absolute weights of prostate were observed.
Danish: I et 26-ugers specifikt fertilitetsstudie med vismodegib hos rotter blev der observeret signifikant stigning i den absolutte vægt af sædblærer og nedsættelse af den absolutte vægt af blærehalskirtlen.
English: To avoid potential foetal exposure during pregnancy, male patients must always use a condom (with spermicide, if available), even after a vasectomy, when having sex with a female partner while taking Erivedge and for 2 months after the final dose.
Danish: For at undgå risiko for føtal eksponering under graviditet skal mandlige patienter altid bruge kondom (om muligt med sæddræbende creme), selv efter vasektomi, når han har samleje med en kvindelig partner, mens han er i behandling med Erivedge og i to måneder efter sidste dosis.
English: • That the patient should tell the healthcare professional about any adverse event
Danish: • At patienten skal informere en sundhedsperson om alle bivirkninger
English: Due to its potential to cause serious developmental defects women must not breast-feed while taking Erivedge and for 24 months after the final dose (see sections 4.3 and 5.3).
Danish: På grund af dets potentiale til at forårsage alvorlige udviklingsdefekter må kvinder ikke amme, mens de behandles med Erivedge og i 24 måneder efter sidste dosis (se pkt.
English: • Widespread rash, fever, and enlarged lymph nodes (DRESS-syndrome or drug hypersensitivity syndrome).
Danish: • Udbredt udslæt, feber og hævede lymfeknuder (DRESS-syndrom eller lægemiddel overfølsomhedssyndrom).
English: When vismodegib is administered with CYP inducers (rifampicin, carbamazepine, phenytoin, St. John´s wort), exposure to vismodegib may be decreased (see sections 4.3 and 4.4).
Danish: Når vismodegib administreres samtidig med CYP-induktorer (rifampicin, carbamazepin, phenytoin, perikon), kan eksponeringen af vismodegib mindskes (se pkt.
English: • Pregnancy test within a maximum of 7 days prior to treatment initiation, and monthly medically supervised pregnancy tests during treatment
Danish: • Graviditetstest indenfor maksimum 7 dage inden behandlingsstart samt månedligt under behandlingen, superviseret af sundhedspersonale
English: • loss of appetite and weight loss,
Danish: • manglende appetit og vægttab
English: Female patients must use two methods of recommended contraception including one highly effective method and a barrier method during Erivedge therapy and for 24 months after the final dose (see section 4.6).
Danish: Kvindelige patienter skal anvende to former for anbefalet prævention, herunder én højeffektiv metode og én barrieremetode, under behandlingen med Erivedge og i 24 måneder efter sidste dosis (se pkt.
English: There was no evidence of genotoxicity in in vitro assays (reverse bacterial mutagenesis [Ames] and human lymphocyte chromosome aberration assays) or in the in vivo rat bone marrow micronucleus assay.
Danish: Der sås ingen tegn på genotoksicitet i in vitro-test (Ames-test og kromosomaberrationstest i humane lymfocytter) eller in vivo ved mikronukleus-test i rotters knoglemarv.
English: • upset stomach or indigestion,
Danish: • mavebesvær eller fordøjelsesbesvær
English: Fertility impairment in human males is not expected (see Section 5.3).
Danish: Der forventes ikke nedsat fertilitet hos mænd (se pkt.
English: Results from a clinical study demonstrated no clinically significant PK interaction between vismodegib and itraconazole (a strong P-glycoprotein inhibitor) in healthy volunteers.
Danish: Resultater fra et klinisk studie viste ingen klinisk signifikant farmakokinetisk interaktion mellem vismodegib og itraconazol (en stærk P-gp hæmmer) hos raske forsøgspersoner.
English: • if you are pregnant, think you may be pregnant, or are planning to become pregnant during the course of treatment or during the 24 months after your final dose of this medicine.
Danish: • hvis du er gravid, tror, du måske er gravid, eller planlægger at blive gravid under behandlingen og inden for 24 måneder efter sidste dosis af medicinen.
English: • The need to ensure all patients complete and sign the Erivedge Verification of Counselling Form which is to be present in the healthcare professional educational material
Danish: • Nødvendigheden af at sikre, at alle patienter udfylder og underskriver et Erivedge-skema til verifikation af rådgivning.
English: Complete response was achieved in 4.8% patients in the mBCC cohort and 33.4% in the laBCC cohort.
Danish: Komplet respons blev opnået af 4,8% af patienter i metastatiske basalcelle karcinom-kohorten og 33,4% af patienter i lokalt fremskredent basalcellekarcinomkohorten.
English: Do not take Erivedge if you are pregnant, think you may be pregnant, or are planning to become pregnant during the course of treatment or during the 24 months after your final dose of this medicine.
Danish: Du må ikke tage Erivedge, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid i løbet af behandlingen eller inden for 24 måneder efter, du har fået den sidste dosis af medicinen.
English: Prior to study enrolment, diagnosis of BCC was confirmed by histology.
Danish: Før patienterne deltog i studiet, blev basalcellekarcinom diagnosen bekræftet ved histologi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of vismodegib.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hård kapsel indeholder 150 mg vismodegib.
English: LaBCC patients had cutaneous lesions that were inappropriate for surgery (inoperable, multiply recurrent where curative resection deemed to be unlikely or for whom surgery would result in substantial deformity or morbidity) and for which radiotherapy was unsuccessful or contraindicated or inappropriate.
Danish: Patienter med lokalt fremskredent basalcellekarcinom havde kutane læsioner, hvor operation ikke var hensigtsmæssig (inoperabel, gentagne recidiver, hvor kurativ resektion ikke skønnes sandsynlig, eller hvor operation ville medføre betydelig deformitet eller morbiditet), og hvor stråleterapi var uden virkning, kontraindiceret eller uhensigtsmæssig.
English: • Patient Brochure
Danish: • Patientvejledning
English: Table 1 ADRs occurring in patients treated with Erivedge MedDRA SOC Very common
Danish: Tabel 1 Bivirkninger hos patienter behandlet med Erivedge MedDRAsystemorganklasser
English: At least one case of Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN), 2 cases of Drug reaction with eosinophilia and systemic symptoms (DRESS) and one case of acute generalised exanthematous pustulosis (AGEP) are causally related to the treatment, based on clinical and pathological features, and the compatible temporal relationship.
Danish: Mindst et tilfælde af Stevens-Johnsons syndrom/toksisk epidermal nekrolyse, to tilfælde af lægemiddelreaktion med eosinofili og systemiske symptomer og et tilfælde af akut generaliseret eksantematøs pustulose er relateret til behandlingen, baseret på kliniske og patologiske træk og det tidsmæssige forhold.
English: Partial response was achieved in 32.1% patients in the mBCC cohort and 35.1% in the laBCC cohort.
Danish: Delvist respons blev opnået af 32,1% af patienterne i metastatiske basalcellekarcinomkohorten og 35,1% af patienter i lokalt fremskredent basalcellekarcinom kohorten.
English: Patients with advanced BCC have an increased risk of developing cuSCC.
Danish: Patienter med fremskredent basalcellekarcinom har øget risiko for at udvikle kutant planocellulært karcinom.