FrancophonIA/ELRC3.0 huggingface dataset:
English: • The need for adequate contraception and definition of adequate contraception
Danish: • Nødvendigheden af tilstrækkelig prævention og definition på tilstrækkelig prævention
English: Pregnancy testing
Danish: Graviditetstest
English: Very rare ( < 1/10,000)
Danish: Meget sjælden (<1/10.000)
English: After a single oral dose, vismodegib has a terminal half-life of ca. 12 days.
Danish: Vismodegib har efter en enkelt oral dosis en halveringstid på ca. 12 dage.
English: • Description of the pregnancy prevention programme
Danish: • Beskrivelse af programmet for svangerskabsforebyggelse
English: • Check list for healthcare professional ensuring that patients receive the appropriate counselling
Danish: • Tjekliste til sundhedspersoner for at sikre, at patienter får tilstrækkelig rådgivning
English: • National or other applicable specific arrangements for a prescription for Erivedge to be dispensed
Danish: • Nationale eller andre specifikke måder til ordination og dispensering af Erivedge
English: PD = progressive disease, SD = stable disease, R = response, * = complete resolution of ulceration(s).
Danish: PD = progressiv sygdom, SD = stabil sygdom, R = respons, * = fuldstændig opheling af ulceration(er).
English: The safety and efficacy of Erivedge in children and adolescents aged below 18 years have not been established.
Danish: Erivedges sikkerhed og virkning hos børn og teenagere under 18 år er ikke klarlagt.
English: The most common adverse drug reactions (ADR) occurring in ≥ 30 % of patients, were muscle spasms (74.6 %), alopecia (65.9%), dysgeusia (58.7%), weight decreased (50.0%), fatigue (47.1%), nausea (34.8 %) and diarrhea (33.3%).
Danish: De hyppigst forekommende bivirkninger, der forekom hos ≥30% af patienterne, var muskelspasmer (74,6%), alopeci (65,9%), dysgeusi (58,7%), vægttab (50,0%), træthed (47,1%), kvalme (34,8%) og diarré (33,3%).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du ikke kan tåle visse sukkerarter, skal du kontakte lægen, inden du tager medicinen.
English: • The need to refer the patient to a specialist physician
Danish: • Nødvendigheden af at henvise patienten til en specialist
English: Decreased haematocrit or platelet count were observed in some dogs at clinically relevant exposures; however, there was no evidence of a primary effect on bone marrow in affected animals.
Danish: Fald i hæmatokrit og trombocyttal sås hos nogle hunde ved klinisk relevant eksponering; der var dog ingen tegn på primæreffekt på knoglemarven hos de påvirkede dyr.
English: Read carefully and follow the instructions of the patient brochure and reminder card given to you by your doctor.
Danish: Læs og følg vejledningen i patientfolderen og på huskekortet til patienter, som lægen har givet dig.
English: This can happen even after stopping Erivedge.
Danish: Dette kan også ske efter Erivedge-behandlingen er stoppet.
English: INFORMATION IN BRAILLE erivedge
Danish: INFORMATION I BRAILLESKRIFT erivedge
English: • ezetimibe and statins , such as atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin used for high cholesterol,
Danish: • ezetimibe og statiner, såsom atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin - bruges ved forhøjet kolesterol,
English: Madarosis Abnormal hair growth
Danish: Madarose Abnorm hårvækst
English: The single dose mean (CV %) absolute bioavailability of Erivedge is 31.8 (14.5) %.
Danish: Den absolutte biotilgængelighed af en enkeltdosis Erivedge (variationskoefficient %) er gennemsnitligt 31,8 (14,5)%.
English: Do not take Erivedge
Danish: Tag ikke Erivedge:
English: As shown in the waterfall plots in figures 1 and 2, which chart maximum reduction in target lesion(s) size for each patient, the majority of patients in both cohorts experienced tumour shrinkage as assessed by the IRF.
Danish: Som vist i waterfall-diagrammer i figur 1og 2, som angiver maksimal reduktion i størrelsen af targetlæsion(er) for hver patient, var tumor skrumpet hos størstedelen af patienterne i begge kohorter, vurderet af uafhængig part.
English: However, irreversible defects in growing teeth and premature closure of the femoral epiphyseal plate, observed in rat toxicity studies at clinically relevant exposures, represent risks to post-natal development.
Danish: Irreversible defekter i tænder i vækst og præmatur lukning af den femorale epifyseskive, set i toksicitetsstudier med rotter ved klinisk relevante koncentrationer, udgør dog en risiko for den post-natale udvikling.
English: NE = not estimable * Efficacy-evaluable patient population is defined as all enrolled patients who received any amount of Erivedge and for whom the independent pathologist's interpretation of archival tissue or baseline biopsy was consistent with BCC.
Danish: NE = kan ikke estimeres * Effekt-evaluérbar patientpopulation defineres som alle inkluderede patienter, som har fået Erivedge, og hvor uafhængig patolog vurderede, at opbevaret væv eller baseline-biopsi var i overensstemmelse med basalcellekarcinom.
English: Therefore, mild and moderate renal impairment is unlikely to have a clinically significant effect on the pharmacokinetics of vismodegib.
Danish: Derfor er det usandsynligt at let og moderat nedsat nyrefunktion vil have en klinisk signifikant effekt på farmakokinetikken af vismodegib.
English: **54 % of laBCC patients had no histopathologic evidence of BCC at 24 weeks.
Danish: **54% af patienterne med lokalt fremskredent basalcellekarcinom havde ingen histopatologiske tegn på basalcellekarcinom ved uge 24.
English: • Red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
Danish: • Rødt, skællende udbredt udslæt med buler på huden og blærer ledsaget af feber i starten af behandlingen (akut generaliseret eksantematøs pustulose).
English: • Not to give Erivedge to any other person
Danish: • At Erivedge ikke må videregives til andre personer
English: • Erivedge exposes a teratogenic risk to the unborn child if he engages in unprotected sexual activity with a pregnant woman,
Danish: • Erivedge udgør en teratogen risiko for det ufødte barn, hvis han har ubeskyttet samleje med en gravid kvinde
English: Under clinically relevant conditions (steady state), the PK of vismodegib is not affected by food.
Danish: Under klinisk relevante omstændigheder (steady state) påvirkes vismodegibs farmakokinetik ikke af føde.
English: Persistent lack of menses during treatment with Erivedge should be assumed to indicate pregnancy until medical evaluation and confirmation.
Danish: Vedvarende udebleven menstruation under behandling med Erivedge skal antages at skyldes graviditet, indtil klinisk evaluering og bekræftelse.
English: In an embryo-foetal development study in which pregnant rats were administered vismodegib daily during organogenesis, vismodegib crossed the placenta and was severely toxic to the conceptus.
Danish: I et embryo-føtalt udviklingsstudie, hvor drægtige rotter fik vismodegib dagligt under organogenesen, passerede vismodegib placenta og var svært toksisk for fosteranlægget.
English: Erivedge is used to treat adults with a type of skin cancer called advanced basal cell carcinoma.
Danish: Erivedge bruges til at behandle voksne med en type hudkræft, som kaldes fremskredent basalcellekarcinom.
English: HDPE bottle with a child-resistant closure containing 28 hard capsules.
Danish: HDPE-beholder med børnesikret låg indeholdende 28 hårde kapsler.
English: In case of pregnancy or missed menstrual periods If the patient does become pregnant, misses a menstrual period, or suspects for any reason that she may be pregnant, she must notify her treating physician immediately.
Danish: I tilfælde af graviditet eller udebleven menstruation Hvis patienten alligevel bliver gravid, oplever en udebleven menstruation eller har mistanke om graviditet, skal hun straks kontakte den behandlende læge.
English: Human female fertility may be compromised by treatment with Erivedge (see section 5.3).
Danish: FertilitetFertiliteten hos kvinder kan kompromitteres ved behandling med Erivedge (se pkt.
English: • The need to use condoms when having sex with a female partner
Danish: • Nødvendigheden af at bruge kondom under samleje med kvindelig partner
English: Erivedge is an anti-cancer medicine that works by controlling one of the key proteins involved in basal cell carcinoma.
Danish: Erivedge er et kræftmiddel, der virker ved at kontrollere ét af de vigtigste proteiner, som er involveret i basalcellekarcinom.
English: Very common ( ≥ 1/10)
Danish: Meget almindelig (≥1/10)
English: The primary endpoint was objective response rate (ORR) as assessed by an independent review facility (IRF) as summarised in Table 2.
Danish: Det primære endepunkt var objektiv responsrate, vurderet af en uafhængig part, som angivet i Tabel 2.
English: Absorption is saturable as evidenced by the lack of dose proportional increase in exposure after a single dose of 270 mg and
Danish: Absorptionen er mættet, vist ved den manglende dosisproportionale stigning i eksponering efter en enkeltdosis på henholdsvis 270 mg og 540 mg Erivedge.
English: Before starting the treatment, ask your doctor if you are able to become pregnant.
Danish: Inden du begynder at tage medicinen, skal du spørge lægen, om du er i stand til at blive gravid.
English: ADRs are presented in table 1 below by system organ class (SOC) and absolute frequency.
Danish: Bivirkninger præsenteres i tabel 1 nedenfor, opstillet efter systemorganklasse og absolut frekvens.
English: • He must always use the recommended contraception (see the ‘Contraception' section below and section 4.6),
Danish: • han altid skal anvende anbefalet prævention (se afsnittet ”Prævention” nedenfor og pkt.
English: Therefore, all patients should be monitored routinely while taking Erivedge, and cuSCC should be treated according to the standard of care.
Danish: Alle patienter bør derfor monitoreres rutinemæssigt under behandling med Erivedge og kutant planocellulært karcinom behandles i overensstemmelse med standardpraksis.
English: Specific instructions (the Erivedge Pregnancy Prevention Programme), given to you by your doctor contain information particularly on the effects of Erivedge on unborn babies.
Danish: Specifikke vejledninger (Erivedge-programmet om svangerskabsforebyggelse), som lægen har givet dig, indeholder information specielt om, hvordan Erivedge påvirker et foster.
English: • Description of the pregnancy prevention programme and categorisation of patients based on sex and childbearing potential
Danish: • Beskrivelse af programmet for svangerskabsforebyggelse samt kategorisering af patienter baseret på køn og fertilitet
English: Talk to your doctor or pharmacist regarding where to return the capsules.
Danish: Kontakt lægen eller apoteket for information om, hvor du kan aflevere kapslerne.
English: Benign hair follicle tumors have not been reported in clinical trials with Erivedge, and the relevance of this finding to humans is uncertain.
Danish: Der er ikke rapporteretbenigne tumorer i hårsække i kliniske forsøg med Erivedge, og relevansen af dette fund i forhold til mennesker er usikker.
English: Repeat-dose toxicity
Danish: Toksicitet ved gentagen dosering
English: Erivedge contains lactose and sodium
Danish: Erivedge indeholder lactose og natrium
English: See leaflet for further information
Danish: Se indlægsseddel for yderligere information
English: Paediatric population There are insufficient pharmacokinetic data in paediatric patients.
Danish: Pædiatriske patienter Farmakokinetiske data vedrørende pædiatriske patienter er utilstrækkelige.
English: • use 2 methods of contraception, one highly effective method and one barrier method (please see the examples below)
Danish: • skal du anvende to former for prævention, én meget sikker metode og én barrieremetode (se eksempler nedenfor)
English: Fertility preservation strategies should be discussed with WCBP prior to starting treatment with Erivedge.
Danish: Strategi for bevarelse af fertilitet bør diskuteres med fertile kvinder, inden behandling med Erivedge påbegyndes.
English: The skin reactions are often preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Danish: Hudreaktionerne kommer ofte efter forudgående feber og influenzalignende symptomer (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse).
English: In a thorough QTc study in 60 healthy subjects, there was no effect of therapeutic doses of Erivedge on the QTc interval.
Danish: I et omfattende QTc-studie med 60 raske individer påvirkede terapeutiske doser af Erivedge ikke QTcintervallet.
English: Posology The recommended dose is one 150 mg capsule taken once daily.
Danish: Dosering Den anbefalede dosis er én 150 mg kapsel én gang dagligt.
English: Concomitant treatment with strong CYP inducers (e.g. rifampicin, carbamazepine or phenytoin) should be avoided, as a risk for decreased plasma concentrations and decreased efficacy of vismodegib cannot be excluded (see also section 4.5).
Danish: Samtidig behandling med potente CYP-induktorer (fx rifampicin, carbamazepin eller phenytoin) bør undgås, da risiko for nedsat plasmakoncentration og nedsat effekt af vismodegib ikke kan udelukkes (se også pkt.
English: 39 months follow-up after last patient enrolled): efficacy-evaluable patients*,†
Danish: Erivedge-effektresultater (opfølgning i 21 måneder af uafhængig part og i 39 måneder af investigator efter den sidste patient er inkluderet): effekt-evaluérbare patienter*† Vurderet af uafhængig part
English: It may also lead to the death of a baby before it is born or shortly after being born.
Danish: Det kan også medføre, at barnet dør inden fødslen eller kort efter fødslen.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan påvirke op til 1 ud af 10 patienter):
English: • Erivedge exposes a teratogenic risk to the unborn child,
Danish: • Erivedge udgør en teratogen risiko for det ufødte barn
English: • lack of energy or weakness (asthenia),
Danish: • manglende energi eller følelse af svaghed
English: Metastatic BCC was defined as BCC that had spread beyond the skin to other parts of the body, including the lymph nodes, lung, bones and/or internal organs.
Danish: Metastatisk basalcellekarcinom blev defineret som basalcellekarcinom, der havde spredt sig fra huden til andre dele af kroppen, inklusive lymfekirtler, lunger, knogler og/eller indre organer.
English: **Includes preferred terms: liver function test abnormal, blood bilirubin increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, alkaline phosphatase increased, liver hepatic enzyme increased.
Danish: **Inkluderer de foretrukne termer: unormal leverfunktionstest, forhøjet bilirubin i blodet, forhøjet gammaglutamyltransferase, forhøjet aspartat-aminotransferase, forhøjet basisk fosfatase, forhøjede leverenzymer.
English: ****Individual cases have been reported in patients with medulloblastoma during post-marketing use (see section
Danish: ****Individuelle tilfælde er rapporteret hos patienter med medulloblastoma efter markedsføring af lægemidlet (se pkt.
English: • The need for monthly pregnancy tests even if the patient has amenorrhoea
Danish: • Nødvendigheden af månedlige graviditetstest, selvom patienten oplever amenoré
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er næsten ”natriumfrit”.
English: If you are not sure, talk to your doctor or pharmacist before taking Erivedge.
Danish: Hvis du er i tvivl, skal du kontakte lægen eller apoteket, før du tager Erivedge.
English: Unused capsules should be returned at the end of treatment
Danish: Ikke anvendte kapsler skal afleveres ved behandlingens afslutning
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included>
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: The majority of patients were male (57%); 8% had mBCC whereas 92% had laBCC.
Danish: Majoriteten af patienterne var mænd (57%); 8% havde metastatisk basalcellekarcinom, hvorimod 92% havde lokalt basalcellekarcinom.
English: • If she stops using contraception unless she commits to not having sexual intercourse (abstinence),
Danish: • hvis hun holder op med at anvende præventionsmidler, medmindre hun forpligter sig til ikke at være seksuelt aktiv
English: Patients who present with amenorrhoea during treatment with Erivedge should continue monthly pregnancy testing while on treatment.
Danish: Patienter, der oplever amenoré under behandling med Erivedge, skal fortsat testes for graviditet en gang om måneden under behandlingen.
English: ***** Cases of drug induced liver injury have been reported in patients during post-marketing use.
Danish: *****Tilfælde af lægemiddelinduceret leverskade er rapporteret hos patienter efter markedsføring af lægemidlet.
English: It may lead to the death of a baby before it is born or shortly after being born.
Danish: Det kan medføre, at barnet dør inden fødslen eller kort efter fødslen.
English: The exposure in female rats at 100 mg/kg corresponds to 1.2-fold of the steady-state AUC0-24h at the recommended human dose.
Danish: Eksponeringen hos hunrotter ved 100 mg/kg svarede til 1,2 gange AUC0-24t ved steady state ved den anbefalede dosis til mennesker.
English: A patient was considered a responder in the laBCC cohort if at least one of the following criteria was met and the patient did not experience progression: (1) ≥ 30 % reduction in lesion size [sum of the longest diameter (SLD)], from baseline in target lesions by radiography; (2) ≥ 30 % reduction in SLD from baseline in externally visible dimension of target lesions; (3) Complete resolution of ulceration in all target lesions.
Danish: Patienten blev vurderet som responderende i lokalt fremskredent basalcellekarcinom-kohorten, hvis mindst ét af følgende kriterier var opfyldt, og patienten ikke oplevede progression: (1) ≥30% reduktion i læsionstørrelse [sum af længste dimension (SLD)] fra baseline i target-læsioner ved radiografi; (2) ≥30% reduktion i SLD fra baseline i dimensionerne af udvendigt synlige target-læsioner; (3) Fuldstændig opheling af ulceration i alle target-læsioner.
English: • Your doctor should check your skin regularly for a type of cancer called “cutaneous squamous cell carcinoma' (SCC).
Danish: • Lægen skal undersøge din hud regelmæssig for kræfttypen kutant planocellulært karcinom.
English: Alopecia Pruritus Rash
Danish: Alopeci Pruritus Udslæt
English: What Erivedge contains
Danish: Erivedge indeholder
English: Erivedge can pass into semen.
Danish: Erivedge kan overføres til sæden.
English: Vismodegib is an orally available small-molecule inhibitor of the Hedgehog pathway.
Danish: Vismodegib er et oralt tilgængeligt lille molekyle, som hæmmer Hedgehog-signalvejen.
English: Even if your periods have stopped, it is essential to ask your doctor if there is any risk that you could become pregnant.
Danish: Selvom du er holdt op med at menstruere, er det vigtigt, at du får afklaret med lægen, om der er nogen som helst risiko for, at du kan blive gravid.
English: Very limited data is available in patients with severe renal impairment.
Danish: Meget begrænset data er tilgængelig hos patienter med svært nedsat nyrefunktion.
English: Roche Products Ltd.
Danish: United Kingdom Roche Products Ltd.
English: • Obligations of the health care professional in relation to the prescribing of Erivedge
Danish: • Lægens pligter i forbindelse med ordination af Erivedge
English: • if you are also taking St John's wort (Hypericum perforatum) - a herbal medicine used for depression (see “Other medicines and Erivedge”).
Danish: • hvis du også tager perikon (Hypericum perforatum) - et naturlægemiddel anvendt mod depression (se ”Brug af anden medicin sammen med Erivedge”).
English: Vismodegib is slowly eliminated by a combination of metabolism and excretion of parent drug substance.
Danish: Vismodegib nedbrydes langsomt ved en kombination af metabolisme og udskillelse af moderstoffet.
English: The findings of premature fusion of the epiphyses indicate a potential risk for short stature and tooth deformities to infants and children (see section 5.3).
Danish: Fund af præmatur lukning af epifyse indikerer en mulig risiko for væksthæmning og tanddeformiteter hos spædbørn og børn (se pkt.
English: • Remind patients to return unused capsules at the end of the treatment (disposal will depend on local requirements)
Danish: • Påminde patienterne om at returnere ikke anvendte kapsler ved behandlingens afslutning, (bortskaffelse efter lokale retningslinjer)
English: Musculoskeletal pain Blood creatine phosphokinase increased***
Danish: Forhøjet blod kreatinin fosfokinase***
English: The initial prescription and dispensing of Erivedge should occur within a maximum of 7 days of a negative pregnancy test (day of pregnancy test = day 1).
Danish: Ordination til og udleveringsrestriktioner for fertile kvinder Den første ordination og udlevering af Erivedge skal finde sted inden for maksimum syv dage, efter der er udført en negativ graviditetstest (dagen hvor graviditetstesten er udført = dag 1).
English: • Information on the methodology, agreed with the National Competent Authority, to collect information on the use of Erivedge and the compliance with the pregnancy pharmacovigilance programme and its effectiveness.
Danish: • Information om metoden, godkendt af den relevante nationale myndighed, til indsamling af information om anvendelse af Erivedge og overholdelse af programmet for svangerskabsforebyggelse (lægemiddelovervågning) samt effektiviteten heraf
English: Read the specific instructions given to you by your doctor, particularly on the effects of Erivedge on unborn babies.
Danish: Læs de specifikke vejledninger, som lægen har udleveret til dig, særligt om hvordan Erivedge kan påvirke et foster.
English: Erivedge has no or negligible influence on the ability to drive and use machines.
Danish: Erivedge påvirker ikke, eller kun i ubetydelig grad, evnen til at føre motorkøretøj eller betjene maskiner.
English: • The need for adequate contraceptive measures
Danish: • Nødvendigheden af tilstrækkelig prævention
English: Erivedge is unlikely to affect your ability to drive, use any tools or machines.
Danish: Erivedge vil sandsynligvis ikke påvirke din evne til at føre motorkøretøj eller anvende maskiner.
English: What you need to know before you take Erivedge
Danish: Det skal du vide, før du begynder at tage Erivedge
English: • you must take precautions so that you do not become pregnant while taking Erivedge
Danish: • skal du tage forholdsregler for at sikre, at du ikke bliver gravid under behandlingen med Erivedge
English: Programme (see sections 4.4 and 4.6).
Danish: 4.4. og 4.6).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Erivedge in all subsets of the paediatric population with basal cell carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Erivedge i alle undergrupper af den pædiatriske population med basalcellekarcinom (se pkt.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially ‘sodium free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per kapsel, dvs. stort set natriumfrit.
English: Note: Tumour size is based on sum of longest dimensions of target lesions.
Danish: NB: Tumorstørrelse beregnes på baggrund af summen af target-læsionernes længste dimensioner.
English: • Requirements in the event of pregnancy
Danish: • Krav ved graviditet
English: She 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.
Danish: De 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.