natgillin/translations-raw huggingface dataset:
Der er udført karcinogenicitetsstudier med mus og rotter.
Carcinogenicity studies were performed in mice and rats.
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).
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).
Basalcellekarcinom udvikles, når DNA i normale hudceller bliver beskadiget, og kroppen ikke kan reparere skaden.
Basal cell carcinoma develops when DNA in normal skin cells becomes damaged and the body cannot repair the damage.
Der foreligger ingen in vivo-interaktionsdata.
In vivo interaction data is not available.
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.
Four patients were excluded from the figure: 3 patients with stable disease were assessed by non-target lesions only and 1 patient was unevaluable.
Vismodegib er til stede i sæd.
Vismodegib is present in semen.
Fire patienter havde ingen læsionsmålinger og er ikke inkluderet i diagrammet.
Four patients did not have lesion measurements and were not included in the plot.
• Information til mænd
• Information for men
Reversibiliteten af nedsat fertilitet er ukendt.
Reversibility of fertility impairment is unknown.
Kontakt lægen eller apotekspersonalet, før du tager Erivedge, hvis du har spørgsmål til informationen i dette afsnit:
Talk to your doctor or pharmacist before taking Erivedge if you have questions on the information in this section:
Følgende højeffektive metoder anbefales:
The following are recommended forms of highly effective methods:
Tag ikke medicinen, hvis én eller flere af ovenstående punkter passer på dig.
Do not take this medicine if any of the above apply to you.
Der blev ikke identificeret maligne tumorer hos disse undersøgte arter.
No malignant tumors were identified in either species tested.
***Observeret i patienter under et post-marketing studie med 1215 sikkerhedsevaluerbarer patienter.
*** Observed in patients during a post-approval study with 1215 safety evaluable patients.
Erivedge er et stof med høj permeabilitet og lav vandopløselighed (BCS-klasse II).
Erivedge is a highly permeable compound with low aqueous solubility (BCS Class 2).
Erivedge kan også påvirke virkningen af andre lægemidler.
Erivedge can also affect how some other medicines work.
Som del af Erivedge-programmet for svangerskabsforebyggelse vil alle patienter modtage:
As part of the Erivedge Pregnancy Prevention Programme, all patients will receive a:
• hun ikke må tage Erivedge, hvis hun er gravid eller planlægger at blive gravid
• She must not take Erivedge if she is pregnant or plans to become pregnant,
• hvis hun er nødt til at ændre præventionsmidler under behandlingen
• If she needs to change contraception during treatment,
Prævention - til mænd og kvinder
Contraception - for men and women
• har spredt sig til andre dele af kroppen (det kaldes “metastatisk” basalcellekarcinom)
• has spread to other parts of the body (called “metastatic” basal cell carcinoma)
Det pivotale studie ERIVANCE BCC (SHH4476g) var et internationalt, enkeltarm, multicenter, 2kohorte-studie.
The pivotal trial, ERIVANCE BCC (SHH4476g), was an international, single-arm, multi-centre, 2-cohort study.
• Brug ikke lægemidlet efter den udløbsdato, der står på beholderen og pakningen efter EXP.
• Do not use this medicine after the expiry date, which is stated on the bottle and carton after EXP.
Erivedge bør kun ordineres af eller under supervision af en speciallæge med erfaring i behandling af de sygdomme, der fremgår af den godkendte indikation.
Erivedge should only be prescribed by or under the supervision of a specialist physician experienced in the management of the approved indication.
Fordelene ved fortsat behandling skal løbende vurderes, idet den optimale behandlingsvarighed er forskellig fra patient til patient.
Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
• smerter i bryst, ryg eller i siden
• pain in your chest, back or side,
Anbefalede præventionsmetoder: Tal med lægen om, hvilke to metoder, der er bedst for dig.
Method of recommended contraception: Talk to your doctor about the best two contraception methods for you.
In vitro-binding til AAG er mættet ved klinisk relevante koncentrationer.
In vitro binding to AAG is saturable at clinically relevant concentrations.
• bosentan, glibenclamid, repaglinid, valsartan
• bosentan, glibenclamide, repaglinide, valsartan,
4.1 Terapeutiske indikationer
4.1 Therapeutic indication
Før lancering af lægemidlet i de enkelte medlemslande skal indehaveren af markedsføringstilladelsen aftale følgende med den relevante nationale myndighed:
Prior to launch in each Member State, the Marketing Authorisation Holder (MAH) shall agree the following with the National Competent Authority:
Du kan finde flere oplysninger om dette i afsnittene ”Graviditet, amning og fertilitet” samt ”Prævention - til mænd og kvinder”.
More information on the issues above is found in the sections “Pregnancy, breast-feeding and fertility” and “Contraception - for men and women”.
Det er særligt vigtigt at fortælle lægen, hvis du tager ét eller flere af følgende lægemidler:
In particular, tell your doctor if you take any of the following medicines:
Den prækliniske sikkerhedsprofil for Erivedge er blevet vurderet hos mus, rotter og hunde.
The preclinical safety profile of Erivedge was assessed in mice, rats, and dogs.
• Sikkerhedsrådgivning til mænd
• Safety advice for men
Følgende barrieremetoder anbefales:
The following are recommended forms of barrier methods:
Det kan også forårsage, at det ufødte barn dør.
It may also lead to the death of the unborn baby.
Interaktionsstudiet varede dog kun 7 dage, og derfor kan det ikke udelukkes, at vismodegib ved længere varende behandling inducerer enzymer, der metaboliserer antikonceptive steroider.
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.
• du holder op med at anvende prævention
• you stop using contraception,
• topotecan - bruges til bestemte kræftformer,
• topotecan - used for certain types of cancer,
• Nødvendigheden af månedlige graviditetstest
• The need for monthly pregnancy tests
Meget almindelig (kan påvirke mere end 1 ud af 10 patienter):
Very common (may affect more than 1 in 10 people):
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.
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.
Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske midler, ATC-kode: L01XX43.
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX43.
Hvis du ønsker yderligere oplysninger om dette lægemiddel, kan du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Den mediane behandlingsvarighed var 12,9 måneder (0,747,8 måneder).
The median duration of treatment was 12.9 months (range 0.7 to 47.8 months).
• hvis du er allergisk over for vismodegib eller ét af de øvrige indholdsstoffer (angivet i afsnit 6)
• if you are allergic to vismodegib or any of the other ingredients of this medicine (listed in section 6).
Alle bivirkninger er gradvurderet i overensstemmelse med National Cancer Institute - Common Terminology Criteria for Adverse Events v 3.0, medmindre andet er angivet.
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.
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.