natgillin/translations-raw huggingface dataset:
Let og moderat nedsat nyrefunktion forventes ikke at påvirke eliminationen af vismodegib, dosisjustering er derfor ikke nødvendig. 
Mild and moderate renal impairment is not expected to impact the elimination of vismodegib and no dose adjustment is needed.
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. 
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.
Dette kan få hudkræften til at skrumpe. 
As a result, your skin cancer may shrink.
Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for vismodegib er CHMP nået frem til følgende videnskabelige konklusioner: 
Taking into account the PRAC Assessment Report on the PSUR(s) for vismodegib, the scientific conclusions of the CHMP are as follows:
Nogle kvinder, der har taget Erivedge, er holdt op med at menstruere. 
Some women taking Erivedge have stopped having periods.
I metastatisk basalcellekarcinom-kohorten vurderedes tumorrespons i overensstemmelse med Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0. 
In the mBCC cohort, tumour response was assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0.
Erivedge indeholder en slags sukker, der kaldes lactose. 
Erivedge contains a type of sugar called lactose.
Sundhedspersonalet skal informere patienterne på en sådan måde, at de forstår og erkender alle betingelserne i Erivedge-programmet for svangerskabsforebyggelse. 
HCPs must educate the patients so they understand and acknowledge all the conditions of the Erivedge Pregnancy Prevention Programme.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/848/001 
MARKETING AUTHORISATION NUMBER(S) EU/1/13/848/001
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. 
The median age of the efficacy evaluable population was 62 years (46 % were at least 65 years old), 61 % male and 100 % White.
Erivedge kan derfor tages uafhængigt af måltider. 
Therefore, Erivedge may be taken without regard to meals.
• carbamazepin, phenytoin - bruges til epilepsi, 
• carbamazepine, phenytoin - used for epilepsy,
Hvis patienten får nogle af disse bivirkninger ved behandling med vismodegib, må behandling med vismodegib hos denne patient ikke genoptages på noget tidspunkt. 
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.
Vismodegib bindes til både humant serum-albumin og surt alfa1-glykoprotein (AAG). 
Vismodegib binds to both human serum albumin and alpha-1-acid glycoprotein (AAG).
For at undgå risiko for føtal eksponering under graviditet, skal alle mandlige patienter forstå, at: 
To avoid potential foetal exposure during pregnancy, a male patient must understand that:
Patienter med Gorlins syndrom, som havde mindst én fremskreden basalcellekarcinom-læsion og opfyldte inklusionskriterierne, kunne deltage i studiet. 
Patients with Gorlin syndrome who had at least one aBCC lesion and met inclusion criteria were eligible to participate in the study.
PD = progressiv sygdom, SD = stabil sygdom, PR = delvist respons. 
PD = progressive disease, SD = stable disease, PR = partial response.
Tag altid Erivedge nøjagtigt efter lægens anvisning. 
Always take Erivedge exactly as your doctor has told you.
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. 
Vismodegib concentrations are strongly correlated with AAG levels, showing parallel fluctuations of AAG and total vismodegib over time and consistently low unbound vismodegib levels.
I kliniske forsøg blev patienterne behandlet med Erivedge indtil sygdomsprogression eller uacceptabel toksicitet. 
In clinical trials, treatment with Erivedge was continued until disease progression or until unacceptable toxicity.
• Sikring af, at patienterne er i stand til at følge kravene for sikker anvendelse af Erivedge 
• To ensure that patients are capable of complying with the requirements for the safe use of Erivedge
Vismodegib hæmmer UGT2B7 in vitro, og det kan ikke udelukkes, at hæmning kan finde sted i tarmen in vivo. 
Vismodegib inhibits UGT2B7 in vitro and it may not be excluded that inhibition can take place in vivo in the intestine.
• Formatet og indholdet af materialet til sundhedspersoner og patienter 
• The format and content of the Healthcare professional and patient material
• ændringer i blodprøver, herunder forhøjede levertal eller forhøjet kreatinin fosfokinase (et protein hovedsageligt fra muskler). 
• changes in blood tests, which include increased values in liver tests or increased values in creatine phosphokinase (a protein mainly from muscle).
• du er nødt til at ændre præventionsmiddel. 
• you need to change contraception.
Påvirkning af post-natal udvikling 
Effects on post-natal development
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. 
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.
Nogle lægemidler kan påvirke virkningen af Erivedge eller øge risikoen for, at du får bivirkninger. 
Some medicines may affect how Erivedge works, or make it more likely that you will have side effects.
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. 
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.
Der er ikke gennemført studier specifikt til evaluering af vismodegibs potentiale til at påvirke den post-natale udvikling. 
Dedicated studies to assess the potential of vismodegib to affect post-natal development have not been performed.
Det gælder også håndkøbslægemidler, vitaminer og naturlægemidler. 
This also includes non-prescription medicines, vitamins and herbal medicines.
In vitro-studier indikerer, at vismodegib har potentiale til at være en hæmmer af brystkræft-resistent protein (BCRP). 
In vitro studies indicate that vismodegib has the potential to act as an inhibitor of breast cancer resistance protein (BCRP).
Baseret på farmakokinetiske populationsanalyser af kombinerede data fra 121 mænd og 104 kvinder, påvirkes vismodegibs farmakokinetik ikke af køn. 
Based on population pharmacokinetic analysis of combined data from 121 males and 104 females, gender did not appear to affect the pharmacokinetics of vismodegib.
• Lægen skal vurdere graviditetsstatus, rådgive patienten om den teratogene risiko og henvise patienten til en specialist for rådgivning 
• The healthcare professional should assess the pregnancy status, counsel the patient on teratogenicity risk and refer the patient to a specialised physician for counselling
Vismodegibs tilsyneladende halveringstid ved steady-state er estimeret til at være 4 dage ved kontinuerlig daglig dosering. 
The apparent half-life of vismodegib at steady-state is estimated to be 4 days with continuous daily dosing.
• rifampicin - bruges til bakterieinfektioner, 
• rifampicin - used for bacterial infections,
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 28 kapsler 
PHARMACEUTICAL FORM AND CONTENTS 28 capsules
CYP2C9 synes til dels at bidrage til vismodegibs metabolisme in vivo. 
CYP2C9 appears to contribute in part to vismodegib metabolism in vivo.
Desuden blev forholdet mellem organvægt versus terminal kropsvægt signifikant øget for bitestikler, cauda epididymis, testikler og sædblærer. 
In addition, the ratio of organ weight to terminal body weight was significantly increased for epididymis, cauda epididymis, testes and seminal vesicles.
4.4 og 5.3) bør dette lægemiddel ikke anvendes til børn og teenagere under 18 år. 
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.
• Synk kapslen hel, sammen med vand. 
• Swallow the capsule whole with a drink of water.
Blandt disse kvinder blev der observeret amenoré hos tre (30%). 
Amongst these women, amenorrhoea was observed in 3 patients (30 %).
• oplever amenoré på grund af kræftbehandling, herunder behandling med Erivedge. 
• becomes amenorrhoeic following cancer therapy, including treatment with Erivedge.
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. 
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.
• ikke er hysterektomeret eller bilateralt ooforektomeret eller har verificeret permanent, præmaturt ovariesvigt, 
• has not undergone a hysterectomy or a bilateral oophorectomy, or who does not have medically-confirmed permanent premature ovarian failure,
Lægen vil teste, om du er gravid: 
Your doctor will make sure to test you for pregnancy:
Det kan ikke udelukkes, at vismodegib kan øge eksponeringen af OATP1B1-substrater, fx bosentan, ezetimibe, glibenclamid, repaglinid, valsartan og statiner. 
It cannot be excluded that vismodegib may increase the exposure to substrates of OATP1B1, e.g. bosentan, ezetimibe, glibenclamide, repaglinide, valsartan and statins.
Det vides ikke, i hvilket omfang vismodegib udskilles i mælk. 
The extent to which vismodegib is excreted in breast milk is not known.
Ved kontinuerlig daglig dosering er der 3 gange så stor akkumulering af vismodegibs totale plasmakoncentration. 
Upon continuous daily dosing, there is a 3 fold accumulation of vismodegib total plasma concentrations.
Metastatisk basalcellekarcinom var defineret som histologisk bekræftet fjernmetastase. 
Metastatic BCC was defined as histologically confirmed distant metastasis.
Dosisjustering er ikke nødvendig hos patienter ≥65 år (se pkt. 
No dose adjustment is required in patients ≥ 65years of age (see section 5.2).
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Kapslen må ikke knuses, åbnes eller tygges Læs indlægssedlen inden brug Oral anvendelse 
METHOD AND ROUTE(S) OF ADMINISTRATION Do not crush, open or chew the capsule Read the package leaflet before use Oral use
• ikke har en XY-genotype, Turners syndrom eller uterusagenesi 
• does not have a XY genotype, Turner's syndrome, or uterine agenesis,
Hvis du har taget for meget Erivedge Hvis du har taget mere Erivedge, end du skulle, skal du kontakte lægen. 
If you take more Erivedge than you should If you take more Erivedge than you should, talk to your doctor.
Erivedge er et lægemiddel mod kræft og indeholder det aktive stof vismodegib. 
What Erivedge is Erivedge is an anti-cancer medicine and contains the active substance vismodegib.
• ændret smagsopfattelse eller fuldstændigt tab af smagssans 
• a change in the way things taste or the complete loss of taste,
Kapslerne skal synkes hele med vand, med eller uden mad (se pkt. 
Erivedge is for oral use.The capsules must be swallowed whole with water, with or without food (see section 5.2).
CYP2C8 var in vitro den mest sensitive CYP-isoform for vismodegibhæmning. 
In vitro, CYP2C8 was the most sensitive CYP isoform for vismodegib inhibition.
Farmakokinetiske populationsanalyser tyder på, at alder ikke havde klinisk signifikant virkning på steady state-koncentrationen af vismodegib. 
Population pharmacokinetic analyses suggest that age did not have a clinically significant impact on steady-state concentration of vismodegib.
• Kort baggrundsbeskrivelse om Erivedge, de godkendte indikationer og dosering 
• Brief background on Erivedge, its licensed indication and posology
• kirugisk sterilisation. 
• surgical sterilisation.
SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30°C 
SPECIAL STORAGE CONDITIONS Do not store above 30 °C
Det kan ikke udelukkes, at vismodegib kan øge eksponeringen af lægemidler, der transporteres af dette protein, fx rosuvastatin, topotecan og sulfasalazin. 
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.
• Nødvendigheden af at give patienterne omfattende vejledning og rådgivning 
• The need to provide comprehensive advice and counselling to patients
Efter vedvarende daglig dosering synes vismodegibs farmakokinetik at være non-lineær på grund af mættet absorption og mættet proteinbinding. 
After continuous once-daily dosing, the pharmacokinetics of vismodegib appears to be nonlinear due to saturable absorption and saturable protein binding.
Hvis du holder op med at tage Erivedge 
If you stop taking Erivedge
• Nødvendigheden af tilstrækkelig prævention og definition på tilstrækkelig prævention 
• The need for adequate contraception and definition of adequate contraception
Graviditetstest 
Pregnancy testing
Meget sjælden (<1/10.000) 
Very rare ( < 1/10,000)
Vismodegib har efter en enkelt oral dosis en halveringstid på ca. 12 dage. 
After a single oral dose, vismodegib has a terminal half-life of ca. 12 days.
• Beskrivelse af programmet for svangerskabsforebyggelse 
• Description of the pregnancy prevention programme
• Tjekliste til sundhedspersoner for at sikre, at patienter får tilstrækkelig rådgivning 
• Check list for healthcare professional ensuring that patients receive the appropriate counselling
• Nationale eller andre specifikke måder til ordination og dispensering af Erivedge 
• National or other applicable specific arrangements for a prescription for Erivedge to be dispensed
PD = progressiv sygdom, SD = stabil sygdom, R = respons, * = fuldstændig opheling af ulceration(er). 
PD = progressive disease, SD = stable disease, R = response, * = complete resolution of ulceration(s).
Erivedges sikkerhed og virkning hos børn og teenagere under 18 år er ikke klarlagt. 
The safety and efficacy of Erivedge in children and adolescents aged below 18 years have not been established.
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%). 
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%).
Hvis lægen har fortalt dig, at du ikke kan tåle visse sukkerarter, skal du kontakte lægen, inden du tager medicinen. 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• Nødvendigheden af at henvise patienten til en specialist 
• The need to refer the patient to a specialist physician
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. 
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.
Læs og følg vejledningen i patientfolderen og på huskekortet til patienter, som lægen har givet dig. 
Read carefully and follow the instructions of the patient brochure and reminder card given to you by your doctor.
Dette kan også ske efter Erivedge-behandlingen er stoppet. 
This can happen even after stopping Erivedge.
INFORMATION I BRAILLESKRIFT erivedge 
INFORMATION IN BRAILLE erivedge
• ezetimibe og statiner, såsom atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin - bruges ved forhøjet kolesterol, 
• ezetimibe and statins , such as atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin used for high cholesterol,
Madarose Abnorm hårvækst 
Madarosis Abnormal hair growth
Den absolutte biotilgængelighed af en enkeltdosis Erivedge (variationskoefficient %) er gennemsnitligt 31,8 (14,5)%. 
The single dose mean (CV %) absolute bioavailability of Erivedge is 31.8 (14.5) %.
Tag ikke Erivedge: 
Do not take Erivedge
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. 
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.
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. 
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.
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. 
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.
Derfor er det usandsynligt at let og moderat nedsat nyrefunktion vil have en klinisk signifikant effekt på farmakokinetikken af vismodegib. 
Therefore, mild and moderate renal impairment is unlikely to have a clinically significant effect on the pharmacokinetics of vismodegib.
**54% af patienterne med lokalt fremskredent basalcellekarcinom havde ingen histopatologiske tegn på basalcellekarcinom ved uge 24. 
**54 % of laBCC patients had no histopathologic evidence of BCC at 24 weeks.
• Rødt, skællende udbredt udslæt med buler på huden og blærer ledsaget af feber i starten af behandlingen (akut generaliseret eksantematøs pustulose). 
• Red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
• At Erivedge ikke må videregives til andre personer 
• Not to give Erivedge to any other person
• Erivedge udgør en teratogen risiko for det ufødte barn, hvis han har ubeskyttet samleje med en gravid kvinde 
• Erivedge exposes a teratogenic risk to the unborn child if he engages in unprotected sexual activity with a pregnant woman,
Under klinisk relevante omstændigheder (steady state) påvirkes vismodegibs farmakokinetik ikke af føde. 
Under clinically relevant conditions (steady state), the PK of vismodegib is not affected by food.
Vedvarende udebleven menstruation under behandling med Erivedge skal antages at skyldes graviditet, indtil klinisk evaluering og bekræftelse. 
Persistent lack of menses during treatment with Erivedge should be assumed to indicate pregnancy until medical evaluation and confirmation.
I et embryo-føtalt udviklingsstudie, hvor drægtige rotter fik vismodegib dagligt under organogenesen, passerede vismodegib placenta og var svært toksisk for fosteranlægget. 
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.
Erivedge bruges til at behandle voksne med en type hudkræft, som kaldes fremskredent basalcellekarcinom. 
Erivedge is used to treat adults with a type of skin cancer called advanced basal cell carcinoma.
HDPE-beholder med børnesikret låg indeholdende 28 hårde kapsler. 
HDPE bottle with a child-resistant closure containing 28 hard capsules.
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. 
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.
FertilitetFertiliteten hos kvinder kan kompromitteres ved behandling med Erivedge (se pkt. 
Human female fertility may be compromised by treatment with Erivedge (see section 5.3).
• Nødvendigheden af at bruge kondom under samleje med kvindelig partner 
• The need to use condoms when having sex with a female partner
Erivedge er et kræftmiddel, der virker ved at kontrollere ét af de vigtigste proteiner, som er involveret i basalcellekarcinom. 
Erivedge is an anti-cancer medicine that works by controlling one of the key proteins involved in basal cell carcinoma.
Meget almindelig (≥1/10) 
Very common ( ≥ 1/10)
Det primære endepunkt var objektiv responsrate, vurderet af en uafhængig part, som angivet i Tabel 2. 
The primary endpoint was objective response rate (ORR) as assessed by an independent review facility (IRF) as summarised in Table 2.
Absorptionen er mættet, vist ved den manglende dosisproportionale stigning i eksponering efter en enkeltdosis på henholdsvis 270 mg og 540 mg Erivedge. 
Absorption is saturable as evidenced by the lack of dose proportional increase in exposure after a single dose of 270 mg and
Inden du begynder at tage medicinen, skal du spørge lægen, om du er i stand til at blive gravid. 
Before starting the treatment, ask your doctor if you are able to become pregnant.
Bivirkninger præsenteres i tabel 1 nedenfor, opstillet efter systemorganklasse og absolut frekvens. 
ADRs are presented in table 1 below by system organ class (SOC) and absolute frequency.
• han altid skal anvende anbefalet prævention (se afsnittet ”Prævention” nedenfor og pkt. 
• He must always use the recommended contraception (see the ‘Contraception' section below and section 4.6),
Alle patienter bør derfor monitoreres rutinemæssigt under behandling med Erivedge og kutant planocellulært karcinom behandles i overensstemmelse med standardpraksis. 
Therefore, all patients should be monitored routinely while taking Erivedge, and cuSCC should be treated according to the standard of care.
Specifikke vejledninger (Erivedge-programmet om svangerskabsforebyggelse), som lægen har givet dig, indeholder information specielt om, hvordan Erivedge påvirker et foster. 
Specific instructions (the Erivedge Pregnancy Prevention Programme), given to you by your doctor contain information particularly on the effects of Erivedge on unborn babies.
• Beskrivelse af programmet for svangerskabsforebyggelse samt kategorisering af patienter baseret på køn og fertilitet 
• Description of the pregnancy prevention programme and categorisation of patients based on sex and childbearing potential
Kontakt lægen eller apoteket for information om, hvor du kan aflevere kapslerne. 
Talk to your doctor or pharmacist regarding where to return the capsules.
Der er ikke rapporteretbenigne tumorer i hårsække i kliniske forsøg med Erivedge, og relevansen af dette fund i forhold til mennesker er usikker. 
Benign hair follicle tumors have not been reported in clinical trials with Erivedge, and the relevance of this finding to humans is uncertain.
Toksicitet ved gentagen dosering 
Repeat-dose toxicity
Erivedge indeholder lactose og natrium 
Erivedge contains lactose and sodium