FrancophonIA/ELRC3.0 huggingface dataset:
English: If this happens to you, it is not known if your periods will come back.
Danish: Hvis dette sker for dig, vides det ikke, om du begynder at menstruere igen.
English: • Hormonal depot injection,
Danish: • Hormon depot-injektion,
English: • The active substance is vismodegib.
Danish: • Det Aktive indholdsstof er vismodegib.
English: Educational material
Danish: Undervisningsmateriale
English: Like all medicines, Erivedge can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Carcinogenicity studies were performed in mice and rats.
Danish: Der er udført karcinogenicitetsstudier med mus og rotter.
English: Erivedge can cause bones to stop growing and lead to premature onset of puberty (before age 8 years in girls or age 9 years in boys).
Danish: Erivedge kan få knogler til at stoppe med at vokse og føre til for tidlig indtræden af pubertet (før 8 år hos piger eller 9 år hos drenge).
English: Basal cell carcinoma develops when DNA in normal skin cells becomes damaged and the body cannot repair the damage.
Danish: Basalcellekarcinom udvikles, når DNA i normale hudceller bliver beskadiget, og kroppen ikke kan reparere skaden.
English: In vivo interaction data is not available.
Danish: Der foreligger ingen in vivo-interaktionsdata.
English: Four patients were excluded from the figure: 3 patients with stable disease were assessed by non-target lesions only and 1 patient was unevaluable.
Danish: Fire patienter er ikke medtaget i figuren: tre patienter med stabil sygdom blev kun vurderet på non-target-læsioner, og én patient kunne ikke evalueres.
English: Vismodegib is present in semen.
Danish: Vismodegib er til stede i sæd.
English: Four patients did not have lesion measurements and were not included in the plot.
Danish: Fire patienter havde ingen læsionsmålinger og er ikke inkluderet i diagrammet.
English: • Information for men
Danish: • Information til mænd
English: Reversibility of fertility impairment is unknown.
Danish: Reversibiliteten af nedsat fertilitet er ukendt.
English: Talk to your doctor or pharmacist before taking Erivedge if you have questions on the information in this section:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Erivedge, hvis du har spørgsmål til informationen i dette afsnit:
English: The following are recommended forms of highly effective methods:
Danish: Følgende højeffektive metoder anbefales:
English: Do not take this medicine if any of the above apply to you.
Danish: Tag ikke medicinen, hvis én eller flere af ovenstående punkter passer på dig.
English: No malignant tumors were identified in either species tested.
Danish: Der blev ikke identificeret maligne tumorer hos disse undersøgte arter.
English: *** Observed in patients during a post-approval study with 1215 safety evaluable patients.
Danish: ***Observeret i patienter under et post-marketing studie med 1215 sikkerhedsevaluerbarer patienter.
English: Erivedge is a highly permeable compound with low aqueous solubility (BCS Class 2).
Danish: Erivedge er et stof med høj permeabilitet og lav vandopløselighed (BCS-klasse II).
English: Erivedge can also affect how some other medicines work.
Danish: Erivedge kan også påvirke virkningen af andre lægemidler.
English: As part of the Erivedge Pregnancy Prevention Programme, all patients will receive a:
Danish: Som del af Erivedge-programmet for svangerskabsforebyggelse vil alle patienter modtage:
English: • She must not take Erivedge if she is pregnant or plans to become pregnant,
Danish: • hun ikke må tage Erivedge, hvis hun er gravid eller planlægger at blive gravid
English: • If she needs to change contraception during treatment,
Danish: • hvis hun er nødt til at ændre præventionsmidler under behandlingen
English: Contraception - for men and women
Danish: Prævention - til mænd og kvinder
English: • has spread to other parts of the body (called “metastatic” basal cell carcinoma)
Danish: • har spredt sig til andre dele af kroppen (det kaldes “metastatisk” basalcellekarcinom)
English: The pivotal trial, ERIVANCE BCC (SHH4476g), was an international, single-arm, multi-centre, 2-cohort study.
Danish: Det pivotale studie ERIVANCE BCC (SHH4476g) var et internationalt, enkeltarm, multicenter, 2kohorte-studie.
English: • Do not use this medicine after the expiry date, which is stated on the bottle and carton after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på beholderen og pakningen efter EXP.
English: Erivedge should only be prescribed by or under the supervision of a specialist physician experienced in the management of the approved indication.
Danish: Erivedge bør kun ordineres af eller under supervision af en speciallæge med erfaring i behandling af de sygdomme, der fremgår af den godkendte indikation.
English: Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Danish: Fordelene ved fortsat behandling skal løbende vurderes, idet den optimale behandlingsvarighed er forskellig fra patient til patient.
English: • pain in your chest, back or side,
Danish: • smerter i bryst, ryg eller i siden
English: Method of recommended contraception: Talk to your doctor about the best two contraception methods for you.
Danish: Anbefalede præventionsmetoder: Tal med lægen om, hvilke to metoder, der er bedst for dig.
English: In vitro binding to AAG is saturable at clinically relevant concentrations.
Danish: In vitro-binding til AAG er mættet ved klinisk relevante koncentrationer.
English: • bosentan, glibenclamide, repaglinide, valsartan,
Danish: • bosentan, glibenclamid, repaglinid, valsartan
English: 4.1 Therapeutic indication
Danish: 4.1 Terapeutiske indikationer
English: Prior to launch in each Member State, the Marketing Authorisation Holder (MAH) shall agree the following with the National Competent Authority:
Danish: Før lancering af lægemidlet i de enkelte medlemslande skal indehaveren af markedsføringstilladelsen aftale følgende med den relevante nationale myndighed:
English: More information on the issues above is found in the sections “Pregnancy, breast-feeding and fertility” and “Contraception - for men and women”.
Danish: Du kan finde flere oplysninger om dette i afsnittene ”Graviditet, amning og fertilitet” samt ”Prævention - til mænd og kvinder”.
English: In particular, tell your doctor if you take any of the following medicines:
Danish: Det er særligt vigtigt at fortælle lægen, hvis du tager ét eller flere af følgende lægemidler:
English: The preclinical safety profile of Erivedge was assessed in mice, rats, and dogs.
Danish: Den prækliniske sikkerhedsprofil for Erivedge er blevet vurderet hos mus, rotter og hunde.
English: • Safety advice for men
Danish: • Sikkerhedsrådgivning til mænd
English: The following are recommended forms of barrier methods:
Danish: Følgende barrieremetoder anbefales:
English: It may also lead to the death of the unborn baby.
Danish: Det kan også forårsage, at det ufødte barn dør.
English: However, the interaction study was of only 7 days duration and it cannot be excluded that vismodegib upon longer treatment is an inducer of enzymes which metabolise contraceptive steroids.
Danish: Interaktionsstudiet varede dog kun 7 dage, og derfor kan det ikke udelukkes, at vismodegib ved længere varende behandling inducerer enzymer, der metaboliserer antikonceptive steroider.
English: • you stop using contraception,
Danish: • du holder op med at anvende prævention
English: • topotecan - used for certain types of cancer,
Danish: • topotecan - bruges til bestemte kræftformer,
English: • The need for monthly pregnancy tests
Danish: • Nødvendigheden af månedlige graviditetstest
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan påvirke mere end 1 ud af 10 patienter):
English: The volume of distribution for vismodegib is low, ranging from 16.4 to 26.6 L. In vitro binding of vismodegib to human plasma proteins is high (97 %) at clinically relevant concentrations.
Danish: Vismodegibs fordelingsvolumen er lavt, varierende fra 16,4 til 26,6 l. In vitro-binding af vismodegib til humane plasmaproteiner er høj (97%) ved klinisk relevante koncentrationer.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX43.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske midler, ATC-kode: L01XX43.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, kan du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: The median duration of treatment was 12.9 months (range 0.7 to 47.8 months).
Danish: Den mediane behandlingsvarighed var 12,9 måneder (0,747,8 måneder).
English: • if you are allergic to vismodegib or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for vismodegib eller ét af de øvrige indholdsstoffer (angivet i afsnit 6)
English: All reporting is based on ADRs of all grades using National Cancer Institute - Common Terminology Criteria for Adverse Events v 3.0 except where noted.
Danish: Alle bivirkninger er gradvurderet i overensstemmelse med National Cancer Institute - Common Terminology Criteria for Adverse Events v 3.0, medmindre andet er angivet.
English: Mild and moderate renal impairment is not expected to impact the elimination of vismodegib and no dose adjustment is needed.
Danish: Let og moderat nedsat nyrefunktion forventes ikke at påvirke eliminationen af vismodegib, dosisjustering er derfor ikke nødvendig.
English: In order to assist health care providers and patients to avoid embryonic and foetal exposure to Erivedge the Marketing Authorisation Holder will provide educational materials (Erivedge Pregnancy Prevention Programme) to reinforce the potential risks associated with the use of Erivedge.
Danish: For at bistå sundhedspersonalet og patienterne i at undgå embryo- og føtal eksponering for Erivedge vil indehaveren af markedsføringstilladelsen udlevere undervisningsmateriale (Erivedge-programmet for svangerskabsforebyggelse) for at understrege de potentielle risici forbundet med brug af Erivedge.
English: As a result, your skin cancer may shrink.
Danish: Dette kan få hudkræften til at skrumpe.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for vismodegib, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for vismodegib er CHMP nået frem til følgende videnskabelige konklusioner:
English: Some women taking Erivedge have stopped having periods.
Danish: Nogle kvinder, der har taget Erivedge, er holdt op med at menstruere.
English: In the mBCC cohort, tumour response was assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0.
Danish: I metastatisk basalcellekarcinom-kohorten vurderedes tumorrespons i overensstemmelse med Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0.
English: Erivedge contains a type of sugar called lactose.
Danish: Erivedge indeholder en slags sukker, der kaldes lactose.
English: HCPs must educate the patients so they understand and acknowledge all the conditions of the Erivedge Pregnancy Prevention Programme.
Danish: Sundhedspersonalet skal informere patienterne på en sådan måde, at de forstår og erkender alle betingelserne i Erivedge-programmet for svangerskabsforebyggelse.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/848/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/848/001
English: The median age of the efficacy evaluable population was 62 years (46 % were at least 65 years old), 61 % male and 100 % White.
Danish: Den mediane alder for populationen, hvor virkning kunne evalueres, var 62 år (46% var mindst 65 år gamle), 61% var mænd, og 100% var kaukasier.
English: Therefore, Erivedge may be taken without regard to meals.
Danish: Erivedge kan derfor tages uafhængigt af måltider.
English: • carbamazepine, phenytoin - used for epilepsy,
Danish: • carbamazepin, phenytoin - bruges til epilepsi,
English: If the patient has developed any of these reactions with the use of vismodegib, treatment with vismodegib must not be restarted in this patient at any time.
Danish: Hvis patienten får nogle af disse bivirkninger ved behandling med vismodegib, må behandling med vismodegib hos denne patient ikke genoptages på noget tidspunkt.
English: Vismodegib binds to both human serum albumin and alpha-1-acid glycoprotein (AAG).
Danish: Vismodegib bindes til både humant serum-albumin og surt alfa1-glykoprotein (AAG).
English: To avoid potential foetal exposure during pregnancy, a male patient must understand that:
Danish: For at undgå risiko for føtal eksponering under graviditet, skal alle mandlige patienter forstå, at:
English: Patients with Gorlin syndrome who had at least one aBCC lesion and met inclusion criteria were eligible to participate in the study.
Danish: Patienter med Gorlins syndrom, som havde mindst én fremskreden basalcellekarcinom-læsion og opfyldte inklusionskriterierne, kunne deltage i studiet.
English: PD = progressive disease, SD = stable disease, PR = partial response.
Danish: PD = progressiv sygdom, SD = stabil sygdom, PR = delvist respons.
English: Always take Erivedge exactly as your doctor has told you.
Danish: Tag altid Erivedge nøjagtigt efter lægens anvisning.
English: Vismodegib concentrations are strongly correlated with AAG levels, showing parallel fluctuations of AAG and total vismodegib over time and consistently low unbound vismodegib levels.
Danish: Vismodegibkoncentrationer er i høj grad korreleret med AAG-niveauer, vist ved parallelle fluktuationer af AAG og total-vismodegib over tid og vedvarende lave niveauer af ubundet vismodegib.
English: In clinical trials, treatment with Erivedge was continued until disease progression or until unacceptable toxicity.
Danish: I kliniske forsøg blev patienterne behandlet med Erivedge indtil sygdomsprogression eller uacceptabel toksicitet.
English: • To ensure that patients are capable of complying with the requirements for the safe use of Erivedge
Danish: • Sikring af, at patienterne er i stand til at følge kravene for sikker anvendelse af Erivedge
English: Vismodegib inhibits UGT2B7 in vitro and it may not be excluded that inhibition can take place in vivo in the intestine.
Danish: Vismodegib hæmmer UGT2B7 in vitro, og det kan ikke udelukkes, at hæmning kan finde sted i tarmen in vivo.
English: • The format and content of the Healthcare professional and patient material
Danish: • Formatet og indholdet af materialet til sundhedspersoner og patienter
English: • changes in blood tests, which include increased values in liver tests or increased values in creatine phosphokinase (a protein mainly from muscle).
Danish: • ændringer i blodprøver, herunder forhøjede levertal eller forhøjet kreatinin fosfokinase (et protein hovedsageligt fra muskler).
English: • you need to change contraception.
Danish: • du er nødt til at ændre præventionsmiddel.
English: Effects on post-natal development
Danish: Påvirkning af post-natal udvikling
English: Since the number of subjects who were not Caucasian comprised only < 3% of the total population (6 Black, 219 Caucasian), race was not evaluated as a covariate in the population pharmacokinetic analysis.
Danish: Da antallet af ikke-kaukasiske patienter udgjorde < 3% af den totale population (6 af afrikansk etnicitet, 219 af kaukasisk etnicitet), indgik race ikke som kovariat i den farmakokinetiske populationsanalyse.
English: Some medicines may affect how Erivedge works, or make it more likely that you will have side effects.
Danish: Nogle lægemidler kan påvirke virkningen af Erivedge eller øge risikoen for, at du får bivirkninger.
English: On the basis of the scientific conclusions for vismodegib the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vismodegib is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for vismodegib er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder vismodegib forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Dedicated studies to assess the potential of vismodegib to affect post-natal development have not been performed.
Danish: Der er ikke gennemført studier specifikt til evaluering af vismodegibs potentiale til at påvirke den post-natale udvikling.
English: This also includes non-prescription medicines, vitamins and herbal medicines.
Danish: Det gælder også håndkøbslægemidler, vitaminer og naturlægemidler.
English: In vitro studies indicate that vismodegib has the potential to act as an inhibitor of breast cancer resistance protein (BCRP).
Danish: In vitro-studier indikerer, at vismodegib har potentiale til at være en hæmmer af brystkræft-resistent protein (BCRP).
English: Based on population pharmacokinetic analysis of combined data from 121 males and 104 females, gender did not appear to affect the pharmacokinetics of vismodegib.
Danish: Baseret på farmakokinetiske populationsanalyser af kombinerede data fra 121 mænd og 104 kvinder, påvirkes vismodegibs farmakokinetik ikke af køn.
English: • The healthcare professional should assess the pregnancy status, counsel the patient on teratogenicity risk and refer the patient to a specialised physician for counselling
Danish: • Lægen skal vurdere graviditetsstatus, rådgive patienten om den teratogene risiko og henvise patienten til en specialist for rådgivning
English: The apparent half-life of vismodegib at steady-state is estimated to be 4 days with continuous daily dosing.
Danish: Vismodegibs tilsyneladende halveringstid ved steady-state er estimeret til at være 4 dage ved kontinuerlig daglig dosering.
English: • rifampicin - used for bacterial infections,
Danish: • rifampicin - bruges til bakterieinfektioner,
English: PHARMACEUTICAL FORM AND CONTENTS 28 capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 28 kapsler
English: CYP2C9 appears to contribute in part to vismodegib metabolism in vivo.
Danish: CYP2C9 synes til dels at bidrage til vismodegibs metabolisme in vivo.
English: In addition, the ratio of organ weight to terminal body weight was significantly increased for epididymis, cauda epididymis, testes and seminal vesicles.
Danish: Desuden blev forholdet mellem organvægt versus terminal kropsvægt signifikant øget for bitestikler, cauda epididymis, testikler og sædblærer.
English: Due to safety concerns (see sections 4.4 and 5.3), this medicinal product should not be used in children and adolescents aged below 18 years.
Danish: 4.4 og 5.3) bør dette lægemiddel ikke anvendes til børn og teenagere under 18 år.
English: • Swallow the capsule whole with a drink of water.
Danish: • Synk kapslen hel, sammen med vand.
English: Amongst these women, amenorrhoea was observed in 3 patients (30 %).
Danish: Blandt disse kvinder blev der observeret amenoré hos tre (30%).
English: • becomes amenorrhoeic following cancer therapy, including treatment with Erivedge.
Danish: • oplever amenoré på grund af kræftbehandling, herunder behandling med Erivedge.
English: In general, the tolerability of Erivedge in repeat-dose toxicity studies in rats and dogs was limited by nonspecific manifestations of toxicity including decreased body weight gain and food consumption.
Danish: Generelt var tolerabiliteten af Erivedge i toksicitetsstudier med gentagne doser til rotter og hunde begrænset af non-specifikke manifestationer af toksicitet, inklusive nedsat vægtøgning og fødeindtagelse.
English: • has not undergone a hysterectomy or a bilateral oophorectomy, or who does not have medically-confirmed permanent premature ovarian failure,
Danish: • ikke er hysterektomeret eller bilateralt ooforektomeret eller har verificeret permanent, præmaturt ovariesvigt,
English: Your doctor will make sure to test you for pregnancy:
Danish: Lægen vil teste, om du er gravid:
English: It cannot be excluded that vismodegib may increase the exposure to substrates of OATP1B1, e.g. bosentan, ezetimibe, glibenclamide, repaglinide, valsartan and statins.
Danish: Det kan ikke udelukkes, at vismodegib kan øge eksponeringen af OATP1B1-substrater, fx bosentan, ezetimibe, glibenclamid, repaglinid, valsartan og statiner.
English: The extent to which vismodegib is excreted in breast milk is not known.
Danish: Det vides ikke, i hvilket omfang vismodegib udskilles i mælk.
English: Upon continuous daily dosing, there is a 3 fold accumulation of vismodegib total plasma concentrations.
Danish: Ved kontinuerlig daglig dosering er der 3 gange så stor akkumulering af vismodegibs totale plasmakoncentration.
English: Metastatic BCC was defined as histologically confirmed distant metastasis.
Danish: Metastatisk basalcellekarcinom var defineret som histologisk bekræftet fjernmetastase.
English: No dose adjustment is required in patients ≥ 65years of age (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter ≥65 år (se pkt.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not crush, open or chew the capsule Read the package leaflet before use Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Kapslen må ikke knuses, åbnes eller tygges Læs indlægssedlen inden brug Oral anvendelse
English: • does not have a XY genotype, Turner's syndrome, or uterine agenesis,
Danish: • ikke har en XY-genotype, Turners syndrom eller uterusagenesi
English: If you take more Erivedge than you should If you take more Erivedge than you should, talk to your doctor.
Danish: Hvis du har taget for meget Erivedge Hvis du har taget mere Erivedge, end du skulle, skal du kontakte lægen.
English: What Erivedge is Erivedge is an anti-cancer medicine and contains the active substance vismodegib.
Danish: Erivedge er et lægemiddel mod kræft og indeholder det aktive stof vismodegib.
English: • a change in the way things taste or the complete loss of taste,
Danish: • ændret smagsopfattelse eller fuldstændigt tab af smagssans
English: Erivedge is for oral use.The capsules must be swallowed whole with water, with or without food (see section 5.2).
Danish: Kapslerne skal synkes hele med vand, med eller uden mad (se pkt.
English: In vitro, CYP2C8 was the most sensitive CYP isoform for vismodegib inhibition.
Danish: CYP2C8 var in vitro den mest sensitive CYP-isoform for vismodegibhæmning.
English: Population pharmacokinetic analyses suggest that age did not have a clinically significant impact on steady-state concentration of vismodegib.
Danish: Farmakokinetiske populationsanalyser tyder på, at alder ikke havde klinisk signifikant virkning på steady state-koncentrationen af vismodegib.
English: • Brief background on Erivedge, its licensed indication and posology
Danish: • Kort baggrundsbeskrivelse om Erivedge, de godkendte indikationer og dosering
English: • surgical sterilisation.
Danish: • kirugisk sterilisation.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30°C
English: It may not be excluded that vismodegib may give rise to increased exposure of medicinal products transported by this protein, such as rosuvastatin, topotecan, and sulfasalazin.
Danish: Det kan ikke udelukkes, at vismodegib kan øge eksponeringen af lægemidler, der transporteres af dette protein, fx rosuvastatin, topotecan og sulfasalazin.
English: • The need to provide comprehensive advice and counselling to patients
Danish: • Nødvendigheden af at give patienterne omfattende vejledning og rådgivning
English: After continuous once-daily dosing, the pharmacokinetics of vismodegib appears to be nonlinear due to saturable absorption and saturable protein binding.
Danish: Efter vedvarende daglig dosering synes vismodegibs farmakokinetik at være non-lineær på grund af mættet absorption og mættet proteinbinding.
English: If you stop taking Erivedge
Danish: Hvis du holder op med at tage Erivedge