FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall distribute a Direct Healthcare Professional Communication letter at launch of the product, which should contain the following:
Danish: Indehaveren af markedsføringstilladelsen skal ved lancering af produktet distribuere en direkte meddelelse til læger og sundhedspersoner, som indeholder følgende information:
English: 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.
Danish: 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).
English: Talk to your pharmacist or doctor regarding where to return the medicine.
Danish: Kontakt apoteket eller lægen for at få oplysninger om aflevering af medicinen.
English: • Do not store above 30 °C.
Danish: • Må ikke opbevares ved temperaturer over 30°C.
English: Problems with growing teeth and bones were seen in animal studies with this medicine.
Danish: Der er i dyreforsøg med dette lægemiddel set problemer med udvoksende tænder og knoglevækst.
English: You must follow the contraception advice described in this leaflet.
Danish: Følg rådene i denne indlægsseddel vedrørende brug af prævention.
English: † Unevaluable/missing data included 1 mBCC and 4 laBCC patients.
Danish: † Ikke evaluérbare/manglende data omfattede 1 patient med metastatisk basalcellekarcinom og 4 patienter med lokalt fremskredent basalcellekarcinom.
English: 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.
Danish: 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.
English: The major elimination pathways of vismodegib involve hepatic metabolism and biliary/intestinal secretion.
Danish: Eliminationen af vismodegib involverer hovedsageligt metabolisme i leveren og galde/intestinal sekretion.
English: Patients were treated with oral daily dosing of Erivedge at 150 mg.
Danish: Patienterne blev behandlet med en daglig oral dose på 150 mg Erivedge.
English: • She must tell her healthcare provider if any of the following occur during treatment and for 24 months after her final dose:
Danish: • hun skal kontakte sin læge, hvis én eller flere af følgende situationer forekommer under behandlingen eller inden for 24 måneder efter sidste dosis:
English: Capsule shell Iron oxide black (E172) Iron oxide red (E172) Titanium dioxide (E171) Gelatine
Danish: Kapselhætte Jernoxid, sort (E172) Jernoxid, rød (E172) Titandioxid (E171) Gelatine
English: 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).
Danish: 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.
English: Erivedge may cause embryo-foetal death or severe birth defects when administered to a pregnant woman (see section 4.4).
Danish: Erivedge kan forårsage embryo-føtal død eller svære medfødte misdannelser, hvis det administreres til en gravid kvinde (se pkt.
English: 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.
Danish: 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.
English: Additionally, safety was assessed in a post approval study that included 1215 aBCC patients evaluable for safety and treated with 150 mg.
Danish: Sikkerheden blev yderligere vurderet i et post-marketing studie, der inkluderede 1215 evaluerbare patienter med fremskredent basalcellekarcinom.
English: • Local contact details for reporting of any suspected pregnancy
Danish: • Oplysninger om lokal kontakt, hvortil mistanke om graviditet skal rapporteres
English: • Liver injury Serious skin reactions:
Danish: • Alvorlige hudreaktioner:
English: • Instructions to stop Erivedge upon suspicion of pregnancy
Danish: • Vejledning om at seponere Erivedge ved mistanke om graviditet
English: • The need for adequate contraceptive measures (even if the woman has amenorrhoea) during treatment and for 24 months after Erivedge treatment
Danish: • Nødvendigheden af tilstrækkelig prævention (selv om kvinden oplever amenoré) under behandling og i 24 måneder efter Erivedge-behandling
English: This is because it is not known if it is safe or effective in this age group.
Danish: 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.
English: Effects of vismodegib on concomitant medicinal products
Danish: Andre lægemidlers effekt på vismodegib ved samtidig behandling
English: • The need to use condoms when having sex with a female partner during treatment and for 2 months after Erivedge treatment
Danish: • Nødvendigheden af at anvende kondom ved samleje med en kvindelig partner under behandling og i 2 måneder efter Erivedge-behandling
English: There are limited data in older people.
Danish: Data vedrørende ældre patienter er begrænset.
English: Vismodegib and associated metabolic products are eliminated primarily by the hepatic route.
Danish: Vismodegib og dets metabolitter elimineres primært via leveren.
English: 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.
Danish: 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.
English: The capsules must not be opened, to avoid unintended exposure to patients and health care providers.
Danish: For at undgå utilsigtet eksponering hos patienter og sundhedspersonale må kapslerne ikke åbnes.
English: • you think your contraception has failed for any reason,
Danish: • du har mistanke om, at præventionen har svigtet
English: • 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
Danish: • 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
English: 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.
Danish: 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.
English: • The need to contact the healthcare professional immediately if a pregnancy is suspected during treatment or in the 24 months following treatment
Danish: • Nødvendigheden af straks at kontakte lægen ved mistanke om graviditet under behandling og i 24 måneder efter behandling
English: You should return unused capsules at the end of your treatment.
Danish: Du skal aflevere ikke anvendte kapsler efter behandlingens afslutning.
English: 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.
Danish: 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.
English: Erivedge is contraindicated in WCBP who do not comply with the Erivedge Pregnancy Prevention Programme.
Danish: Erivedge er kontraindiceret hos fertile kvinder, der ikke overholder Erivedge-programmet for svangerskabsforebyggelse.
English: It is not known if SCC is related to treatment with Erivedge.
Danish: Det vides ikke, om kutant planocelluært karcinom er relateret til behandling med Erivedge.
English: Erivedge 150 mg hard capsules vismodegib
Danish: Erivedge 150 mg hårde kapsler vismodegib
English: • Capsule shell: iron oxide red (E172), iron oxide black (E172), titanium dioxide, gelatine,
Danish: • Kapselskal: jernoxid, rød (E172), jernoxid, sort (E172), titandioxid, gelatine.
English: 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.
Danish: Ud af i alt 138 patienter i de fire kliniske studier med Erivedge ved fremskredent basalcellekarcinom var ca. 40% af patienterne ≥65 år.
English: NAME OF THE MEDICINAL PRODUCT Erivedge 150 mg hard capsules
Danish: LÆGEMIDLETS NAVN Erivedge 150 mg hårde kapsler
English: • If she becomes pregnant or think for any reason that she may be pregnant,
Danish: • hun bliver gravid eller har mistanke om, at hun er gravid
English: Common ( ≥ 1/100 to < 1/10)
Danish: Almindelig (≥1/100 til <1/10)
English: 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).
Danish: 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).
English: Rare ( ≥ 1/10,000 to < 1/1,000)
Danish: Sjælden (≥1/10.000 til <1/1.000)
English: • Keep the bottle tightly closed in order to protect from moisture.
Danish: • Opbevar beholderen tæt tillukket for at beskytte mod fugt.
English: It has not been determined whether cuSCC is related to Erivedge treatment.
Danish: Det er ikke fastslået, om kutant planocellulært karcinom er relateret til behandlingen med Erivedge.
English: Each hard capsule contains 150 mg of vismodegib.
Danish: Hver hård kapsel indeholder 150 mg vismodegib.
English: laBCC** (n = 63)
Danish: Lokalt fremskredent basalcellekarcinom ** (n = 63)
English: WCBP, whose periods are irregular or stopped, must follow all the advice on effective contraception.
Danish: Fertile kvinder med uregelmæssige eller udeblevne menstruationer skal følge forholdsreglerne for effektiv svangerskabsforebyggelse.
English: 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.
Danish: 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.
English: Patients were treated with oral daily dosing of Erivedge at 150mg.
Danish: Patienterne blev behandlet med en daglig, oral dosis Erivedge på 150 mg.
English: Investigator-Assessed mBCC (n = 33)
Danish: Metastatisk basalcellekarcinom (n = 33)
English: In general the safety profile observed was consistent in both mBCC and laBCC patients and across studies as described below.
Danish: Generelt var den observerede sikkerhedsprofil, som angivet nedenfor, ensartet for patienter med metastatisk basalcellekarcinom og lokalt fremskredent basalcellekarcinom, samt på tværs af studier.
English: Sodium lauril sulfate Povidone (K29/32) Sodium starch glycolate (Type A) Talc
Danish: Mikrokrystallinsk cellulose Lactosemonohydrat Natriumlaurilsulfat Povidon (K29/32) Natriumstivelsesglycolat (Type A) Talcum
English: • Printing ink: shellac glaze and iron oxide black (E172).
Danish: • Printblæk: shellac-glasur og jernoxid, sort (E172).
English: Always use a condom (with spermicide, if available) even after a vasectomy, when you have sex with a female partner.
Danish: Brug altid kondom (med sæddræbende creme, hvis det er tilgængeligt), når du har samleje med en kvindelig partner, også selvom du er steriliseret.
English: Vismodegib is predominant in plasma, with concentrations representing greater than 98 %
Danish: Vismodegib findes hovedsageligt i plasma i koncentrationer, der udgør mere end 98% af de totale cirkulerende koncentrationer (inklusive relaterede metabolitter).
English: • sulfasalazine - used for certain inflammatory disorders, and especially,
Danish: • sulfasalazin - bruges til bestemte betændelsestilstande,
English: • She must have a negative pregnancy test, conducted by a health care provider within 7 days before starting Erivedge treatment,
Danish: • hun skal have foretaget en graviditetstest hos sundhedspersonalet inden for syv dage inden behandlingen med Erivedge påbegyndes, og testen skal være negativ
English: • your periods stop,
Danish: • din menstruation udebliver
English: • The need to keep Erivedge capsules out of sight and reach of children
Danish: • Nødvendigheden af at opbevare Erivedge kapsler utilgængeligt for børn
English: Patients with a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Erivedge-kapsler indeholder lactosemonohydrat og bør ikke anvendes til patienter med arvelig galactoseintolerans, Lapp Lactase deficiency eller glucose/galactosemalabsorption.
English: • She must have a negative pregnancy test monthly during treatment, even if she has become amenorrhoeic,
Danish: • der skal udføres graviditetstest hver måned under behandlingen, selvom hun oplever amenoré, og prøven skal være negativ
English: 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 (see section 4.6).
Danish: Mandlige patienter skal altid anvende kondom (om muligt med sæddræbende creme), selv efter vasektomi, når de har samleje med en kvindelig partner under behandlingen med Erivedge og i to måneder efter sidste dosis (se pkt.
English: • The need for the patient to report immediately to the treating healthcare professional if his partner becomes pregnant whilst he is taking Erivedge or shortly after he has stopped taking Erivedge
Danish: • Nødvendigheden af at patienten straks rapporterer til den behandlende læge, hvis partneren bliver gravid, mens manden tager Erivedge eller kort til efter, at manden er stoppet med at tage Erivedge
English: What Erivedge looks like and contents of the pack The capsules have a pink opaque coloured body marked “150 mg” and a grey cap marked "VISMO” in black edible ink.
Danish: Kapslerne består af en lyserød, uigennemsigtig hoveddel, mærket “150 mg”, og en grå hætte, mærket "VISMO” med sort, spiselig blæk.
English: Epiphyses premature fusion****
Danish: Præmatur lukning af epifyse****
English: Criteria for a woman of childbearing potential (WCBP) A WCBP is defined in the Erivedge Pregnancy Prevention Programme as:
Danish: Forholdsregler for fertile kvinder En fertil kvinde defineres i Erivedge-programmet for svangerskabsforebyggelse som
English: • abnormal hair growth,
Danish: • unormal hårvækst
English: Precocious puberty****
Danish: For tidlig indtræden af pubertet****
English: • If you are male, you should not donate semen at any time during treatment and for 2 months after the final dose.
Danish: • Hvis du er en mand, må du ikke være sæddonor under behandlingen eller 2 måneder efter sidste dosis.
English: Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Acute Generalised Exanthematous Pustulosis (AGEP)******
Danish: Stevens-Johnsons syndrom / toksisk epidermal nekrolyse, lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS) og akut generaliseret eksantematøs pustulose ******
English: WCBP must be able to comply with effective contraceptive measures.
Danish: Fertile kvinder skal kunne overholde de forholdsregler, der er forbundet med brug af prævention.
English: The patient educational material for Erivedge should contain the following key elements:
Danish: Erivedge uddannelsesmateriale til patienter skal indeholde følgende hovedpunkter:
English: Median Progression Free survival (months) (95 % CI)
Danish: konfidensinterval) Median progressionsfri overlevelse (måneder)
English: • The need to stop Erivedge immediately upon suspicion of pregnancy
Danish: • Nødvendigheden af at straks stoppe med at tage Erivedge, hvis der er mistanke om graviditet
English: Any unused capsules at the end of treatment should immediately be disposed of by the patient in accordance with local requirements (if applicable, e.g. by returning the capsules to their pharmacist or physician).
Danish: Patienten skal umiddelbart efter behandlingens afslutning bortskaffe ikke anvendte kapsler i henhold til de lokale retningslinjer (fx ved at aflevere kapslerne på apoteket eller til lægen).
English: Additionally, amenorrhoea has been observed in clinical trials in WCBP (see section 4.8).
Danish: Derudover er der set amenoré i kliniske forsøg med fertile kvinder (se pkt.
English: In vitro, vismodegib is an inhibitor of OATP1B1.
Danish: Vismodegib hæmmer OATP1B1 in vitro.
English: A WCBP must understand that:
Danish: Enhver fertil kvinde skal forstå, at:
English: Dysgeusia Ageusia
Danish: Dysgeusi Ageusi
English: In addition, in the vismodegib general toxicity studies up to 26-week in sexually mature rats and dogs, no effects on male reproductive organs were observed.
Danish: Desuden blev der ikke observeret påvirkning på hannernes kønsorganer i de generelle toksicitetsstudier af vismodegib af op til 26 ugers varighed hos kønsmodne rotter og hunde.
English: In four open label phase 1 and 2 clinical trials patients were treated with at least one dose of Erivedge monotherapy at doses ≥ 150 mg. Doses > 150 mg did not result in higher plasma concentrations in clinical trials and patients on doses > 150 mg have been included in the analysis.
Danish: Doser >150 mg har ikke medført højere plasmakoncentrationer i kliniske forsøg, og patienter i behandling med doser >150 mg er inkluderet i analysen.
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 150 mg of vismodegib.
Danish: ANGIVELSE AF AKTIVT STOF Hver kapsel indeholder 150 mg vismodegib.
English: For the metastatic cohort, the majority of patients had prior therapies, including surgery (91%), radiotherapy (62%) and systemic therapy (16%).
Danish: For den metastatiske kohort havde majoriteten tidligere været i behandling, der inkluderede kirurgi (91%), strålebehandling (62%) og systemisk behandling (16%).
English: Semen donation Male patients should not donate semen while taking Erivedge and for 2 months after the final dose.
Danish: Mandlige patienter må ikke være sæddonorer, mens de behandles med Erivedge og i to måneder efter sidste dosis.
English: Keep the bottle tightly closed in order to protect from moisture
Danish: Opbevar beholderen tæt tillukket for at beskytte mod fugt
English: Do this during treatment and for 2 months after your final dose of this medicine.
Danish: Fortsæt med det gennem hele behandlingen og i to måneder efter, du har fået den sidste dosis af medicinen.
English: • Any male condom (with spermicide, if available),
Danish: • Alle former for kondomer til mænd (om muligt med sæddræbende creme),
English: • if you are breast-feeding or plan to breast-feed during the course of treatment or during the 24 months after your final dose of this medicine.
Danish: • hvis du ammer eller planlægger at amme under behandlingen eller i 24 måneder efter sidste dosis af medicinen.
English: Tell your doctor in case you notice any changes in your skin.• Never give this medicine to anyone else.
Danish: Fortæl din læge, hvis du lægger mærke til forandringer i din hud.
English: Uncommon ( ≥ 1/1,000 to < 1/100)
Danish: Ikke almindelig (≥1/1.000 til <1/100)
English: • The need to provide patients with the patient educational material and patient reminder cards
Danish: • Nødvendigheden af at udlevere uddannelsesmateriale og huskekort til patienterne
English: • Pregnancy reporting form
Danish: • Skema til rapportering af graviditet
English: • The need to use condoms if his sexual partner is pregnant or a women of childbearing potential (even if the man has had a vasectomy) during treatment and for 2 months after Erivedge treatment
Danish: • Nødvendigheden af at bruge kondom, hvis mandens partner er en gravid eller fertil kvinde (også hvis manden er blevet vasektomeret) under behandling og 2 måneder efter Erivedge-behandling
English: • The need for adequate contraceptive measures during treatment and for 24 months after Erivedge treatment
Danish: • Nødvendigheden af tilstrækkelig prævention under behandling og i 24 måneder efter Erivedge-behandling
English: Musculoskeletal chest pain
Danish: Flankesmerter Muskuloskeletale smerter
English: NAME OF THE MEDICINAL PRODUCT Erivedge 150 mg hard capsules vismodegib
Danish: LÆGEMIDLETS NAVN Erivedge 150 mg hårde kapsler vismodegib
English: • Safety advice for women of childbearing potential
Danish: • Sikkerhedsrådgivning til fertile kvinder
English: Not known (cannot be estimated from the available data).
Danish: Ukendt (kan ikke estimeres fra den tilgængelige data) Inden for de enkelte frekvenskategorier angives bivirkningerne i rækkefølge efter faldende alvorlighedsgrad.
English: Keep the bottle tightly closed in order to protect from moisture.
Danish: Opbevar beholderen tæt tillukket for at beskytte mod fugt.
English: Seven cases of severe cutaneous adverse reactions (SCARs) have been reported in association with vismodegib cumulatively.
Danish: Der er samlet set rapporteret 7 tilfælde af svære kutane bivirkninger i forbindelse med behandling med vismodegib.
English: • The need for the patient to report a suspected pregnancy immediately to the treating healthcare professional
Danish: • Nødvendigheden af at patienten ved mistanke om graviditet straks kontakter den behandlende læge
English: For the locally advanced cohort, the majority of patients had prior therapies, including surgery (85%), radiotherapy (28%) and systemic therapy (7%).
Danish: For lokalt fremskredent-kohorten havde majoriteten tidligere været i behandling, der inkluderede kirurgi (85%), strålebehandling (28%) og systemisk behandling (7%).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 July 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: • mild:total bilirubin (TB) ≤ upper limit of normal (ULN), aspartate aminotransferase
Danish: • Let: total-bilirubin ≤ øvre normalgrænse, aspartat-aminotransferase (ASAT) > øvre normalgrænse eller øvre normalgrænse < total-bilirubin ≤ 1,5 × øvre normalgrænse, alle værdier af ASAT
English: • To return unused capsules at the end of the treatment (disposal will depend on local requirements)
Danish: • Aflevering af ikke anvendte kapsler efter behandlingens afslutning (bortskaffelse af de lokale retningslinjer) Telefonnumre i nødstilfælde
English: Clinically significant PK interactions between vismodegib and CYP450 substrates are not expected.
Danish: Klinisk signifikante farmakokinetiske interaktioner mellem vismodegib og CYP450-substrater forventes ikke.
English: Premature fusion of the epiphyses and precocious puberty have been reported in paediatric patients exposed to Erivedge.
Danish: Hos pædiatriske patienter der har indtaget Erivedge, er der rapporteret præmatur lukning af epifyse og for tidlig indtræden af pubertet.