natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
In the laBCC cohort, tumour response was assessed based on visual assessment of external tumour and ulceration, tumour imaging (where appropriate), and tumour biopsy.
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. 
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.
Det kan derfor muligvis udelukkes, at vismodegib hæmmer CYP-enzymer in vivo. 
Thus inhibition of CYP enzymes by vismodegib in vivo may be excluded.
Det vides ikke, om Erivedge udskilles i mælk og kan skade barnet. 
It is not known if Erivedge can pass into your breast milk and harm your baby.
Hypogeusi 
Hypogeusia
Erivedges sikkerhed er evalueret i kliniske forsøg med 138 patienter behandlet for fremskredent basalcellekarcinom, som inkluderer både metastatisk basalcellekarcinom og lokalt fremskredent basalcellekarcinom. 
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).
• hun skal være i stand til at overholde de forholdsregler, der er forbundet med svangerskabsforebyggelse 
• She must be able to comply with effective contraceptive measures,
• tab af smagssans 
• loss of taste,
95% konfidensinterval for overordnet respons Fuldstændigt respons 0 Delvist respons Stabil sygdom 20 Progressiv sygdom‡ 1 Median varighed af respons (måneder) 
Complete Response 0 Partial Response Stable disease Progressive disease ‡ 1
Resultater fra et post-marketing studie 
Post approval study results
Kvinder, der tager Erivedge: 
For women taking Erivedge
Hos mennesker inkluderer vismodegibs metaboliseringsveje oxidation, glukuronidering og en sjælden spaltning af pyridinringen. 
Metabolic pathways of vismodegib in humans include oxidation, glucuronidation, and an uncommon pyridine ring cleavage.
Et lægemiddelinteraktionsstudie med kræftpatienter har vist, at den systemiske eksponering af ethinylestradiol og norethindron ikke ændres ved administration sammen med vismodegib. 
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.
Lyserød, uigennemsigtig hoveddel mærket “150 mg” og en grå, uigennemsigtig hætte mærket “VISMO” med sort blæk. 
Pink coloured opaque body marked “150 mg” and a grey opaque cap marked “VISMO” with black ink.
• Samtidig indtagelse af perikon (Hypericum perforatum) (se pkt. 
• Coadministration of St John's wort (Hypericum perforatum) (see section 4.5).
MARKEDSFØRINGSTILLADELSESNUMMER EU/1/13/848/001 
EU/1/13/848/001
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. 
In the dedicated 26-week vismodegib rat fertility study, significantly increased absolute weights of seminal vesicles and reduced absolute weights of prostate were observed.
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. 
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.
• At patienten skal informere en sundhedsperson om alle bivirkninger 
• That the patient should tell the healthcare professional about any adverse event
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. 
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).
• Udbredt udslæt, feber og hævede lymfeknuder (DRESS-syndrom eller lægemiddel overfølsomhedssyndrom). 
• Widespread rash, fever, and enlarged lymph nodes (DRESS-syndrome or drug hypersensitivity syndrome).
Når vismodegib administreres samtidig med CYP-induktorer (rifampicin, carbamazepin, phenytoin, perikon), kan eksponeringen af vismodegib mindskes (se pkt. 
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).
• Graviditetstest indenfor maksimum 7 dage inden behandlingsstart samt månedligt under behandlingen, superviseret af sundhedspersonale 
• Pregnancy test within a maximum of 7 days prior to treatment initiation, and monthly medically supervised pregnancy tests during treatment
• manglende appetit og vægttab 
• loss of appetite and weight loss,
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. 
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).
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. 
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.
• mavebesvær eller fordøjelsesbesvær 
• upset stomach or indigestion,
Der forventes ikke nedsat fertilitet hos mænd (se pkt. 
Fertility impairment in human males is not expected (see Section 5.3).
Resultater fra et klinisk studie viste ingen klinisk signifikant farmakokinetisk interaktion mellem vismodegib og itraconazol (en stærk P-gp hæmmer) hos raske forsøgspersoner. 
Results from a clinical study demonstrated no clinically significant PK interaction between vismodegib and itraconazole (a strong P-glycoprotein inhibitor) in healthy volunteers.
• 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. 
• 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.
• Nødvendigheden af at sikre, at alle patienter udfylder og underskriver et Erivedge-skema til verifikation af rådgivning. 
• 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
Komplet respons blev opnået af 4,8% af patienter i metastatiske basalcelle karcinom-kohorten og 33,4% af patienter i lokalt fremskredent basalcellekarcinomkohorten. 
Complete response was achieved in 4.8% patients in the mBCC cohort and 33.4% in the laBCC cohort.
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. 
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.
Før patienterne deltog i studiet, blev basalcellekarcinom diagnosen bekræftet ved histologi. 
Prior to study enrolment, diagnosis of BCC was confirmed by histology.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hård kapsel indeholder 150 mg vismodegib. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of vismodegib.
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. 
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.
• Patientvejledning 
• Patient Brochure
Tabel 1 Bivirkninger hos patienter behandlet med Erivedge MedDRAsystemorganklasser 
Table 1 ADRs occurring in patients treated with Erivedge MedDRA SOC Very common
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. 
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.
Delvist respons blev opnået af 32,1% af patienterne i metastatiske basalcellekarcinomkohorten og 35,1% af patienter i lokalt fremskredent basalcellekarcinom kohorten. 
Partial response was achieved in 32.1% patients in the mBCC cohort and 35.1% in the laBCC cohort.
Patienter med fremskredent basalcellekarcinom har øget risiko for at udvikle kutant planocellulært karcinom. 
Patients with advanced BCC have an increased risk of developing cuSCC.
Indehaveren af markedsføringstilladelsen skal ved lancering af produktet distribuere en direkte meddelelse til læger og sundhedspersoner, som indeholder følgende information: 
The MAH shall distribute a Direct Healthcare Professional Communication letter at launch of the product, which should contain the following:
Resultater fra et klinisk studie viste en stigning på 57% i koncentrationerne af ubundet vismodigib på dag 7 efter samtidig behandling med 400 mg fluconazol dagligt (en moderat CYP2C9hæmmer). 
Results from a clinical study demonstrated a 57% increase in vismodegib unbound drug concentrations on day 7 after co-treatment with 400 mg fluconazole (a moderate CYP2C9 inhibitor) daily, but this interaction is not expected to be clinically significant.
Kontakt apoteket eller lægen for at få oplysninger om aflevering af medicinen. 
Talk to your pharmacist or doctor regarding where to return the medicine.
• Må ikke opbevares ved temperaturer over 30°C. 
• Do not store above 30 °C.
Der er i dyreforsøg med dette lægemiddel set problemer med udvoksende tænder og knoglevækst. 
Problems with growing teeth and bones were seen in animal studies with this medicine.
Følg rådene i denne indlægsseddel vedrørende brug af prævention. 
You must follow the contraception advice described in this leaflet.
† Ikke evaluérbare/manglende data omfattede 1 patient med metastatisk basalcellekarcinom og 4 patienter med lokalt fremskredent basalcellekarcinom. 
† Unevaluable/missing data included 1 mBCC and 4 laBCC patients.
Der sås deformationer, inklusive kraniofaciale anomalier, åben perineum og manglende og/eller sammenvoksede fingre/tæer, hos fostre hos hundyr, der havde fået doser svarende til 20% af den typiske steady-state-eksponering hos patienter. 
Malformations, including craniofacial anomalies, open perineum, and absent and/or fused digits, were observed in foetuses of dams at a dose which corresponded to 20 % of the typical steady-state exposure in patients, and a 100 % incidence of embryolethality was observed at higher doses.
Eliminationen af vismodegib involverer hovedsageligt metabolisme i leveren og galde/intestinal sekretion. 
The major elimination pathways of vismodegib involve hepatic metabolism and biliary/intestinal secretion.
Patienterne blev behandlet med en daglig oral dose på 150 mg Erivedge. 
Patients were treated with oral daily dosing of Erivedge at 150 mg.
• hun skal kontakte sin læge, hvis én eller flere af følgende situationer forekommer under behandlingen eller inden for 24 måneder efter sidste dosis: 
• She must tell her healthcare provider if any of the following occur during treatment and for 24 months after her final dose:
Kapselhætte Jernoxid, sort (E172) Jernoxid, rød (E172) Titandioxid (E171) Gelatine 
Capsule shell Iron oxide black (E172) Iron oxide red (E172) Titanium dioxide (E171) Gelatine
5.1), som vismodegib, er vist at være embryotoksiske og/eller teratogene hos flere dyrearter og kan forårsage svære misdannelser, inklusive kraniofaciale anomalier, midtlinjedefekter og ekstremitetsdefekter (se pkt. 
Hedgehog pathway inhibitors, (see section 5.1) such as vismodegib, have been demonstrated to be embryotoxic and/or teratogenic in multiple animal species and can cause severe malformations, including craniofacial anomalies, midline defects and limb defects (see section 5.3).
Erivedge kan forårsage embryo-føtal død eller svære medfødte misdannelser, hvis det administreres til en gravid kvinde (se pkt. 
Erivedge may cause embryo-foetal death or severe birth defects when administered to a pregnant woman (see section 4.4).
Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis, men genoptag behandlingen næste gang, det er tid til at tage en dosis. 
If you forget to take Erivedge Do not take a double dose to make up for a forgotten dose, but resume with the next scheduled dose.
Sikkerheden blev yderligere vurderet i et post-marketing studie, der inkluderede 1215 evaluerbare patienter med fremskredent basalcellekarcinom. 
Additionally, safety was assessed in a post approval study that included 1215 aBCC patients evaluable for safety and treated with 150 mg.
• Oplysninger om lokal kontakt, hvortil mistanke om graviditet skal rapporteres 
• Local contact details for reporting of any suspected pregnancy
• Alvorlige hudreaktioner: 
• Liver injury Serious skin reactions:
• Vejledning om at seponere Erivedge ved mistanke om graviditet 
• Instructions to stop Erivedge upon suspicion of pregnancy
• Nødvendigheden af tilstrækkelig prævention (selv om kvinden oplever amenoré) under behandling og i 24 måneder efter Erivedge-behandling 
• The need for adequate contraceptive measures (even if the woman has amenorrhoea) during treatment and for 24 months after Erivedge treatment
Det frarådes at bruge Erivedge til børn og teenagere under 18 år, da det ikke vides, om det er sikkert eller effektivt til denne aldersgruppe. 
This is because it is not known if it is safe or effective in this age group.
Andre lægemidlers effekt på vismodegib ved samtidig behandling 
Effects of vismodegib on concomitant medicinal products
• Nødvendigheden af at anvende kondom ved samleje med en kvindelig partner under behandling og i 2 måneder efter Erivedge-behandling 
• The need to use condoms when having sex with a female partner during treatment and for 2 months after Erivedge treatment
Data vedrørende ældre patienter er begrænset. 
There are limited data in older people.
Vismodegib og dets metabolitter elimineres primært via leveren. 
Vismodegib and associated metabolic products are eliminated primarily by the hepatic route.
Fertile kvinder skal have foretaget en lægeligt superviseret graviditetstest, udført af sundhedspersonale, inden for syv dage, inden behandlingen påbegyndes og herefter en gang om måneden under behandlingen. 
In a WCBP, a medically supervised pregnancy test, conducted by a heath care provider, should be performed within 7 days prior to initiating treatment and monthly during treatment.
For at undgå utilsigtet eksponering hos patienter og sundhedspersonale må kapslerne ikke åbnes. 
The capsules must not be opened, to avoid unintended exposure to patients and health care providers.
• du har mistanke om, at præventionen har svigtet 
• you think your contraception has failed for any reason,
• Nødvendigheden af at fortælle patienter, at de straks skal rapportere enhver mistanke om graviditet hos en kvindelig patient eller hos en kvindelig partner til en mandlig patient til den behandlende læge 
• The need to tell patients to report immediately to the treating healthcare professional if pregnancy is suspected in a female patient, or in a female partner of a male patient
Blandt de patienter, der opnåede tumorreduktion, var mediantiden til maksimal tumorreduktion 5,6 og 5,5 måneder for patienter med henholdsvis lokalt fremskredent basalkarcinom og metastatisk basalkarcinom baseret på vurdering af uafhængig part. 
Among patients who achieved tumour reduction, the median time to maximum tumour reduction occurred in 5.6 and 5.5 months for laBCC and mBCC patients respectively, based on the IRF assessment.
• Nødvendigheden af straks at kontakte lægen ved mistanke om graviditet under behandling og i 24 måneder efter behandling 
• The need to contact the healthcare professional immediately if a pregnancy is suspected during treatment or in the 24 months following treatment
Du skal aflevere ikke anvendte kapsler efter behandlingens afslutning. 
You should return unused capsules at the end of your treatment.
Baseret på investigators vurdering var mediantid til maksimal tumorreduktion 6,7 og 5,5 måneder for patienter med henholdsvis lokalt fremskredent basalkarcinom og metastatisk basalkarcinom. 
According to investigator assessment, the median time to maximum tumour reduction occurred in 6.7 and 5.5 months for laBCC and mBCC patients respectively.
Erivedge er kontraindiceret hos fertile kvinder, der ikke overholder Erivedge-programmet for svangerskabsforebyggelse. 
Erivedge is contraindicated in WCBP who do not comply with the Erivedge Pregnancy Prevention Programme.
Det vides ikke, om kutant planocelluært karcinom er relateret til behandling med Erivedge. 
It is not known if SCC is related to treatment with Erivedge.
Erivedge 150 mg hårde kapsler vismodegib 
Erivedge 150 mg hard capsules vismodegib
• Kapselskal: jernoxid, rød (E172), jernoxid, sort (E172), titandioxid, gelatine. 
• Capsule shell: iron oxide red (E172), iron oxide black (E172), titanium dioxide, gelatine,
Ud af i alt 138 patienter i de fire kliniske studier med Erivedge ved fremskredent basalcellekarcinom var ca. 40% af patienterne ≥65 år. 
Of a total number of 138 patients in 4 clinical trials of Erivedge in advanced basal cell carcinoma, approximately 40 % of patients were ≥ 65 years old and no overall differences in safety and efficacy were observed between these patients and younger patients.
LÆGEMIDLETS NAVN Erivedge 150 mg hårde kapsler 
NAME OF THE MEDICINAL PRODUCT Erivedge 150 mg hard capsules
• hun bliver gravid eller har mistanke om, at hun er gravid 
• If she becomes pregnant or think for any reason that she may be pregnant,
Almindelig (≥1/100 til <1/10) 
Common ( ≥ 1/100 to < 1/10)
Patienten skal umiddelbart efter behandlingens afslutning bortskaffe ikke anvendt lægemiddel i henhold til de lokale retningslinjer (fx. ved at aflevere kapslerne på apoteket eller til lægen). 
Any unused medicinal product at the end of treatment must immediately be disposed of by the patient in accordance with local requirements (if applicable, e.g. by returning the capsules to the pharmacist or physician).
Sjælden (≥1/10.000 til <1/1.000) 
Rare ( ≥ 1/10,000 to < 1/1,000)
• Opbevar beholderen tæt tillukket for at beskytte mod fugt. 
• Keep the bottle tightly closed in order to protect from moisture.
Det er ikke fastslået, om kutant planocellulært karcinom er relateret til behandlingen med Erivedge. 
It has not been determined whether cuSCC is related to Erivedge treatment.
Hver hård kapsel indeholder 150 mg vismodegib. 
Each hard capsule contains 150 mg of vismodegib.
Lokalt fremskredent basalcellekarcinom ** (n = 63) 
laBCC** (n = 63)
Fertile kvinder med uregelmæssige eller udeblevne menstruationer skal følge forholdsreglerne for effektiv svangerskabsforebyggelse. 
WCBP, whose periods are irregular or stopped, must follow all the advice on effective contraception.
Lokalt fremskredent basalcellekarcinom var defineret som forandringer i huden, der var uegnet til kirurgi (inoperabel, eller hvor operation ville resultere i deformitet) og hvor strålebehandling var mislykket eller kontraindikeret. 
LaBCC was defined as cutaneous lesions that were inappropriate for surgery (inoperable, or for whom surgery would result in substantial deformity) and for which radiotherapy was unsuccessful or contraindicated.
Patienterne blev behandlet med en daglig, oral dosis Erivedge på 150 mg. 
Patients were treated with oral daily dosing of Erivedge at 150mg.
Metastatisk basalcellekarcinom (n = 33) 
Investigator-Assessed mBCC (n = 33)
Generelt var den observerede sikkerhedsprofil, som angivet nedenfor, ensartet for patienter med metastatisk basalcellekarcinom og lokalt fremskredent basalcellekarcinom, samt på tværs af studier. 
In general the safety profile observed was consistent in both mBCC and laBCC patients and across studies as described below.
Mikrokrystallinsk cellulose Lactosemonohydrat Natriumlaurilsulfat Povidon (K29/32) Natriumstivelsesglycolat (Type A) Talcum 
Sodium lauril sulfate Povidone (K29/32) Sodium starch glycolate (Type A) Talc
• Printblæk: shellac-glasur og jernoxid, sort (E172). 
• Printing ink: shellac glaze and iron oxide black (E172).
Brug altid kondom (med sæddræbende creme, hvis det er tilgængeligt), når du har samleje med en kvindelig partner, også selvom du er steriliseret. 
Always use a condom (with spermicide, if available) even after a vasectomy, when you have sex with a female partner.
Vismodegib findes hovedsageligt i plasma i koncentrationer, der udgør mere end 98% af de totale cirkulerende koncentrationer (inklusive relaterede metabolitter). 
Vismodegib is predominant in plasma, with concentrations representing greater than 98 %
• sulfasalazin - bruges til bestemte betændelsestilstande, 
• sulfasalazine - used for certain inflammatory disorders, and especially,
• hun skal have foretaget en graviditetstest hos sundhedspersonalet inden for syv dage inden behandlingen med Erivedge påbegyndes, og testen skal være negativ 
• She must have a negative pregnancy test, conducted by a health care provider within 7 days before starting Erivedge treatment,
• din menstruation udebliver 
• your periods stop,
• Nødvendigheden af at opbevare Erivedge kapsler utilgængeligt for børn 
• The need to keep Erivedge capsules out of sight and reach of children
Erivedge-kapsler indeholder lactosemonohydrat og bør ikke anvendes til patienter med arvelig galactoseintolerans, Lapp Lactase deficiency eller glucose/galactosemalabsorption. 
Patients with a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
• der skal udføres graviditetstest hver måned under behandlingen, selvom hun oplever amenoré, og prøven skal være negativ 
• She must have a negative pregnancy test monthly during treatment, even if she has become amenorrhoeic,