FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor straight away if your partner becomes pregnant while you are taking Odomzo and for 6 months after your treatment has finished.
Danish: Fortæl det straks til lægen, hvis din partner bliver gravid, mens du tager Odomzo og i 6 måneder efter, din behandling er afsluttet.
English: • severe itching of the skin, with a red rash or raised bumps.
Danish: • alvorlig hudkløe med rødt udslæt eller knopper.
English: Blood glucose increased
Danish: Forhøjet blodglukose
English: You must also use one barrier method, such as:
Danish: Du skal også bruge en barrieremetode, som fx:
English: Each capsule contains 200 mg sonidegib.
Danish: Hver kapsel indeholder 200 mg sonidegib.
English: Do not stop taking Odomzo without talking to your doctor first.
Danish: Hvis du holder op med at tage Odomzo Du må ikke holde op med at tage Odomzo uden først at tale med din læge.
English: Studies in animals have shown teratogenicity and foetotoxicity (see section 5.3).
Danish: Dyreforsøg har påvist teratogenicitet og føtotoksicitet (se pkt.
English: Clinically relevant laboratory abnormalities
Danish: Klinisk relevante laboratorieabnormaliteter
English: If clinically notable elevation of CK is detected, renal function should be assessed (see section 4.2).
Danish: Hvis der måles klinisk betydende forhøjet CK, skal nyrefunktionen vurderes (se pkt.
English: Based on the mechanism of action, in animal studies, sonidegib has been shown to be teratogenic and foetotoxic.
Danish: Baseret på virkningsmekanismen har sonidegib i dyreforsøg vist sig at være teratogent og føtotoksisk.
English: Odomzo is used to treat adults with a type of skin cancer called basal cell carcinoma.
Danish: Odomzo bruges til at behandle voksne med en type hudkræft, der hedder basalcellecarcinom.
English: The pregnancy status of women of child-bearing potential must be established within 7 days prior to the initiation of Odomzo treatment and monthly during treatment by means of a test performed by a healthcare professional.
Danish: Fertile kvinder skal have deres graviditetsstatus klarlagt inden for 7 dage før initiering af behandling med Odomzo og månedligt under behandlingen ved hjælp af en test, der udføres af sundhedspersonale.
English: If you take more Odomzo than you should, or if someone else accidentally takes your medicine, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har taget for meget Odomzo, eller hvis en anden ved et uheld tager din medicin, skal du straks kontakte en læge eller tage på hospitalet.
English: When dose interruption is required, consider resuming Odomzo at the same dose after resolution of the adverse reaction to ≤ grade 1.
Danish: Når dosisafbrydelse er nødvendigt, skal det overvejes at genoptage Odomzo-behandlingen ved den samme dosis efter forbedring af bivirkningen til ≤ grad 1.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvenskategori er bivirkningerne opstillet efter faldende alvorlighedsgrad.
English: Cutaneous squamous cell carcinoma (cuSCC)
Danish: Kutant pladecellecarcinom (cuSCC)
English: Figures 1 shows the best change in target lesion size for each patient with laBCC at the dose of 200 mg per central review.
Danish: Figur 1 viser den bedste ændring i mållæsionens størrelse hos hver enkelt patient med laBCC ved en dosis på 200 mg ifølge central vurdering.
English: One death occurred while on treatment or within 30 days of the last dose taken in either metastatic BCC or locally advanced BCC patients taking Odomzo 200 mg.
Danish: Der forekom ét dødsfald under behandlingen eller inden for 30 dage efter den sidst indtagne dosis hos patienter med enten BCC eller lokalt fremskredet BCC, som tog Odomzo 200 mg.
English: • difficulty breathing or swallowing
Danish: • problemer med at trække vejret eller synke
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 sonidegib cannot be excluded (see also section 4.5).
Danish: Samtidig behandling med CYP-induktorer (fx rifampicin, carbamazepin eller phenytoin) bør undgås, da risiko for nedsat plasmakoncentration og nedsat effekt af sonidegib ikke kan udelukkes (se også pkt.
English: The secondary endpoints included duration of response, time to tumour response and progression free survival (PFS) according to mRECIST in patients with laBCC and RECIST 1.1 in patients with mBCC as determined by central review.
Danish: De sekundære endepunkter omfattede responsvarighed, tid til tumorrespons og progressionsfri overlevelse (PFS) ifølge mRECIST hos patienter med laBCC og RECIST 1.1 hos patienter med mBCC bestemt ved central vurdering.
English: • if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Odomzo Pregnancy Prevention Programme.
Danish: • hvis du kan blive gravid, men ikke kan eller ikke vil tage de nødvendige forholdsregler mod graviditet,
English: There was reduced fertility at low exposure in female rats.
Danish: Der var nedsat fertilitet ved lave eksponeringer hos hunrotter.
English: Very common * Of the 79 patients receiving Odomzo 200 mg, 5 were women of childbearing age.
Danish: Meget almindelig * 5 ud af 79 patienter, der fik Odomzo 200 mg var fertile kvinder.
English: This will help you to remember when to take your medicine.
Danish: hvornår du skal tage din medicin.
English: If the same adverse drug reaction occurs following the switch to alternate daily dosing and does not improve, consider discontinuing treatment with Odomzo.
Danish: Hvis den samme bivirkning optræder efter skiftet til dosering hver anden dag og ikke bedres, skal seponering af behandlingen med Odomzo overvejes.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the following with the National Competent Authority:
Danish: Inden lancering skal indehaveren af markedsføringstilladelsen komme til enighed med den nationale lægemiddelmyndighed i hvert medlemsland om:
English: • you must use 2 methods of contraception, one highly effective method and one barrier method (see the examples below) while you are taking Odomzo,
Danish: • Du skal anvende to præventionsmetoder; en yderst effektiv metode og en barrieremetode (se eksemplerne herunder), så længe du tager Odomzo.
English: Do not take Odomzo:
Danish: Tag ikke Odomzo:
English: Skin and subcutaneous tissue disorders Alopecia
Danish: Hud og subkutane væv Alopeci
English: The median duration of exposure to sonidegib during Study X2104 was 97 days (range 34 to 511 days) for adult patients and 55 days (range 2 to 289 days) for paediatric patients.
Danish: Den mediane varighed af eksponering for sonidegib under studie X2104 var 97 dage (område 34 til 511 dage) for voksne patienter og 55 dage (område 2 til 289 dage) for pædiatriske patienter.
English: Sonidegib binding to Smo will inhibit Hh signalling and consequently block signal transduction.
Danish: Sonidegibs binding til Smo vil hæmme Hh-signalering og dermed blokere transduktion.
English: Aberrant Hh signalling has been linked to the pathogenesis of several types of cancer, including basal cell carcinoma (BCC).
Danish: Atypisk Hh-signalering er blevet koblet til flere cancertypers patogenese, herunder basalcellecarcinom (BCC).
English: These tests will check the health of your muscles by measuring the levels of an enzyme in your blood called creatine phosphokinase.
Danish: Blodprøverne bruges til at kontrollere dine musklers sundhedstilstand ved at måle indholdet af enzymet kreatinkinase i dit blod.
English: Study CLDE225X2104 was a Phase I/II study of sonidegib in paediatric patients with recurrent or refractory medulloblastoma or other tumours potentially dependent on the Hedgehog (Hh) signalling pathway and adult patients with recurrent or refractory medulloblastoma.
Danish: Studie CLDE225X2104 var et fase I/II-studie af sonidegib hos pædiatriske patienter med recidiverende eller refraktær medulloblastoma eller andre tumorer, som er potentielt afhængige af hedgehog-signaleringsvej (Hh) og voksne patienter med recidiverende eller refraktær medulloblastoma.
English: Study CLDE225C2301 was a Phase II, multi-centre, open-label, single-arm study of the efficacy and safety of oral sonidegib in patients with Hh-activated relapsed medulloblastoma.
Danish: Studie CLDE225C2301 var et fase II, multicenter, ikke-blindet, enarmet studie af effektiviteten og sikkerheden aforal sonidegib hos patienter med Hh-aktiveret recidiveret medulloblastoma.
English: Patients should be closely monitored for muscle-related symptoms if Odomzo is used in combination with certain medicinal products that may increase the potential risk of developing muscle toxicity (e.g. CYP3A4 inhibitors, chloroquine, hydroxychloroquine, fibric acid derivatives, penicillamine, zidovudine, niacin and HMG-CoA reductase inhibitors) (see section 4.5).
Danish: Patienterne skal monitoreres nøje for muskelrelaterede symptomer, hvis Odomzo anvendes i kombination med visse lægemidler, der kan øge den potentielle risiko for at udvikle muskeltoksicitet (fx CYP3A4hæmmere, chloroquin, hydroxychloroquin, fibrinsyrederivativer, penicillamin, zidovudin, niacin og HMGCoA-reduktasehæmmere) (se pkt.
English: No patient taking HMG-CoA reductase inhibitors experienced grade 3/4 CK elevations, as opposed to 6 (9.0%) patients not taking HMG-CoA reductase inhibitors.
Danish: Ingen af de patienter, der tog HMG-CoA-reduktasehæmmere, oplevede forhøjet CK i grad 3/4, i modsætning til 6 patienter (9,0 %), der ikke tog HMG-CoA-reduktasehæmmere.
English: One patient receiving Odomzo 200 mg experienced muscle symptoms and CK elevations above 10x ULN and required intravenous fluids, compared to 6 patients receiving Odomzo 800 mg.
Danish: En af de patienter, der fik Odomzo 200 mg, oplevede muskelsymptomer og CK-stigninger over 10x ULN og havde behov for intravenøs væske sammenlignet med 6 patienter, der fik Odomzo 800 mg.
English: Grade 3/4 increase in blood CK was reported in 8% of patients taking Odomzo 200 mg.
Danish: Grad 3/4 stigninger i blod-CK blev indberettet hos 8 % af de patienter, der tog Odomzo 200 mg.
English: For most patients, muscle symptoms and CK elevations resolved with appropriate management.
Danish: Hos de fleste patienter bedredes muskelsymptomerne og CK-stigningerne med relevant behandling.
English: • a medicine called nefazodone used to treat depression
Danish: • medicin, som hedder nefazodon mod depression
English: • If symptoms re-occur, interrupt treatment until resolution to baseline.
Danish: • Hvis symptomerne vender tilbage, afbrydes behandlingen indtil bedring til baseline.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000
Danish: Derudover er den tilsvarende frekvenskategori for hver bivirkning baseret på følgende konvention (CIOMS III): meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Partial response Disease stabilisation Disease progression Unknown Time to tumour response (months) Median 95% CI Duration of response No. of events* No. censored Median (months) 95% CI
Danish: Partielt respons Stabil sygdom Sygdomsprogression Ukendt Tid til tumorrespons (måneder) Median 95 % CI Responsvarighed Antal hændelser* Antal censureret Median (måneder) 95 % CI
English: If you forget to take Odomzo If you forget to take a dose of Odomzo, take it as soon you realise.
Danish: Hvis du glemmer at tage en dosis af Odomzo, skal du tage den, så snart du kommer i tanke om det.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Risk of severe birth defects.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Risiko for alvorlige fostermisdannelser.
English: Myopathy [muscular fatigue and muscular weakness]
Danish: Myopati [muskeltræthed og muskelsvækkelse]
English: Women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 months after ending treatment.
Danish: Kvinder, der tager Odomzo, må ikke være eller blive gravide under behandlingen og i 20 måneder efter endt behandling.
English: They must use two methods of recommended contraception, including one highly effective method and a barrier method, during Odomzo therapy and for 20 months after the final dose.
Danish: De skal anvende to anbefalede præventionsmetoder, herunder en yderst effektiv metode og en barrieremetode, under behandlingen med Odomzo og i 20 måneder efter den sidste dosis.
English: Table 1 Recommended dose modifications and management for symptomatic CK elevations and muscle-related adverse events
Danish: Tabel 1 Anbefalede dosisjusteringer og håndtering ved symptomatisk forhøjet CK og muskelrelaterede bivirkninger
English: Population pharmacokinetic analyses showed that there are no clinically relevant effects of age (range tested from 20-93 years, mean 61 years), body weight (range tested 42-181 kg, mean 77 kg), gender, or creatinine clearance (range tested 27.3-290 ml/min, mean 92.9 ml/min) on the systemic exposure of sonidegib.
Danish: Farmakokinetiske populationsanalyser viste, at alder (testet interval 20-93 år, middelværdi 61 år), kropsvægt (testet interval 42-181 kg, middelværdi 77 kg), køn eller kreatininclearance (testet interval 27,3-290 ml/min, middelværdi 92,9 ml/min) ikke har nogen klinisk relevant påvirkning af den systemiske eksponering for sonidegib.
English: Table 1 summarises recommendations for dose interruption and/or dose reduction of Odomzo therapy in the management of symptomatic CK elevations and muscle-related adverse events (such as myalgia, myopathy, and/or spasm).
Danish: Tabel 1 opsummerer anbefalingerne for dosisafbrydelse og/eller dosisreduktion af Odomzo-behandling ved håndtering af symptomatisk forhøjet CK og muskelrelaterede bivirkninger (såsom myalgi, myopati og/eller spasmer).
English: Since sonidegib is not renally excreted, no change in systemic exposure is anticipated in patients with renal impairment.
Danish: Da sonidegib ikke udskilles via nyrerne, forventes ingen ændring af den systemiske eksponering hos patienter med nedsat nyrefunktion.
English: At exposures well above the clinical exposure, an additional target organ was the kidney.
Danish: Ved eksponering et godt stykke over den kliniske eksponering var nyren et yderligere målorgan.
English: • diarrhoea or heartburn
Danish: • diarré eller halsbrand
English: It is not known whether SCC can be related to treatment with Odomzo.
Danish: Det vides ikke, om der kan være en sammenhæng mellem SCC og behandling med Odomzo.
English: Abnormal hair growth
Danish: Abnorm hårvækst
English: Co-administration of sonidegib with strong CYP3A inducers decreases sonidegib plasma concentration.
Danish: Samtidig administration af sonidegib og stærke CYP3A-inducere nedsætter plasmakoncentrationen af sonidegib.
English: Upon resolution, resume treatment at the same dose level and measure CK monthly thereafter.
Danish: Når der er opnået bedring, genoptages behandlingen ved samme dosisniveau, og CK måles månedligt derefter.
English: • a herbal medicine called St. John's wort (also known as Hypericum perforatum) used to treat depression.
Danish: • et naturlægemiddel, som hedder perikon (kaldes også Hypericum perforatum) mod depression.
English: Grade 1 [CK elevation >ULN - 2.5 x ULN]
Danish: Grad 1 [Forhøjet CK >ULN - 2,5 x ULN]
English: The sonidegib-related toxicity reported in paediatric patients was similar to the results reported in adults, with the exceptions of a reduced incidence of muscle toxicity (e.g. CK elevations observed in 16.7% of paediatric patients compared with 50% of adults in study X2104) and the observation of post-natal development effect particularly with prolonged exposure (reported as cases of epiphyseal plate of phalanx disorder, knee subchondral condensation of area of growth plate, physeal distal femur disorder, chondropathy, and chipped tooth).
Danish: Den indberettede sonidegib-relaterede toksicitet hos pædiatriske patienter var lig med de indberettede resultaterhos voksne med undtagelse af en reduceret hyppighed af muskeltoksicitet (f.eks. CKstigninger observeret hos 16,7 % af pædiatriske patienter sammenlignet med 50 % af voksne i studie X2104) og observationen af post-natal udviklingsmæssig virkning især med forlænget eksponering (indberettet som tilfælde af epifyseskive i forbindelse med phalanxlidelse, knæ subchondral kondensering af epifyseskiveområdet, physeal distal lårbenslidelse, chondropati og krakeleret tand).
English: In the phase II pivotal trial, 12 (15.2%) patients treated with Odomzo 200 mg took concomitant HMG-CoA reductase inhibitors (9 took pravastatin, 3 took non-pravastatin HMG-CoA reductase inhibitors including rosuvastatin and simvastatin).
Danish: I fase II-hovedforsøget tog 12 (15,2 %) af de patienter, der blev behandlet med Odomzo 200 mg, samtidig HMG-CoA-reduktasehæmmere (9 tog pravastatin, 3 tog non-pravastatin-HMG-CoA-reduktasehæmmere, herunder rosuvastatin og simvastatin).
English: You must use one highly effective method, such as:
Danish: Du skal bruge én yderst effektiv metode, som fx:
English: INFORMATION IN BRAILLE Odomzo 200 mg
Danish: INFORMATION I BRAILLESKRIFT Odomzo 200 mg
English: The most common adverse drug reactions occurring in ≥10% of patients treated with Odomzo 200 mg were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhoea, weight decreased, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting and pruritus.
Danish: De mest almindelige bivirkninger, som forekom hos ≥10 % af de patienter, der blev behandlet med Odomzo 200 mg, var muskelspasmer, alopeci, dysgeusi, træthed, kvalme, muskel-, led- og knoglesmerter, diarré, nedsat vægt, nedsat appetit, myalgi, mavesmerter, hovedpine, smerter, opkastning og pruritus.
English: • That the patient should tell the healthcare professional about any adverse event
Danish: • At patienten skal informere lægen om en hvilken som helst bivirkning
English: It is not known whether Odomzo can pass into your breast milk and cause harm to your baby.
Danish: Det vides ikke, om Odomzo bliver udskilt i brystmælk og dermed kan skade barnet.
English: Strong CYP3A inhibitors include, but are not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole and nefazodone.
Danish: Stærke CYP3A-hæmmere inkluderer, men er ikke begrænset til, ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol og nefazodon.
English: Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Danish: Den optimale behandlingsvarighed kan variere for hver enkelt patient.
English: Adverse drug reactions for the recommended dose from the phase II pivotal clinical study (Table 2) are listed by Medical Dictionary for Regulatory Activities (MedDRA) version 18 system organ class.
Danish: Bivirkningerne for den anbefalede dosis fra fase II-hovedforsøget (tabel 2) er opstillet efter MedDRAsystemorganklasse version 18.
English: • absence of menstrual periods
Danish: • udebleven menstruation
English: If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking Odomzo.
Danish: Hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl, skal du tale med lægen eller apotekspersonalet, før du tager Odomzo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg sonidegib (as phosphate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hård kapsel indeholder 200 mg sonidegib (som fosfat).
English: • Inform patients that they should not donate blood during treatment with Odomzo and for at least
Danish: • Informere patienter om, at de ikke må donere blod under behandling med Odomzo og i mindst
English: A woman of childbearing potential is defined in the Odomzo Pregnancy Prevention Programme as a sexually mature female who
Danish: En fertil kvinde defineres i Odomzo-programmet for svangerskabsforebyggelse som en kønsmoden kvinde, der
English: The median duration of exposure to sonidegib during Study C2301 was 2.8 months (range 0.4 to 33.2 months) for adult patients and 3.5 months (range 1.3 to 5.7 months) for paediatric patients.
Danish: Den mediane varighed af eksponering for sonidegib under studie C2301 var 2,8 måneder (område 0,4 til 33,2 måneder) for voksne patienter og 3,5 måneder (område 1,3 til 5,7 måneder) for pædiatriske patienter.
English: In particular tell your doctor or pharmacist if you are taking any of the following:
Danish: Fortæl det især til lægen eller apotekspersonalet, hvis du tager en eller flere af følgende:
English: Gastro-oesophageal reflux disorder
Danish: Gastro-øsofageal reflukssygdom
English: Tell your doctor or pharmacist immediately if your muscles hurt or you have unexplained muscle cramps or weakness during treatment with Odomzo.
Danish: Fortæl det straks til lægen eller apotekspersonalet, hvis du får ondt i musklerne, eller hvis du får uforklarlige muskelkramper eller muskelsvækkelse under behandling med Odomzo.
English: Figure 1 Best change from baseline in the target lesions of laBCC patients per central review assessment by FAS
Danish: Figur 1 Bedste ændring fra baseline af mållæsioner hos laBCC-patienter ifølge vurdering ved central vurdering efter FAS
English: General toxicology
Danish: Generel toksicitet
English: Tell your doctor or pharmacist straight away if you notice any of the following:
Danish: Fortæl det straks til lægen eller apotekspersonalet, hvis du bemærker en eller flere af følgende:
English: If you are not sure, talk to your doctor or pharmacist before taking Odomzo.
Danish: Hvis du er i tvivl, skal du tale med din læge eller apotekspersonalet, inden du tager Odomzo.
English: You should return unused capsules at the end of your treatment.
Danish: Du skal returnere ubrugte kapsler efter endt behandling.
English: • Obligations of the health care professional in relation to the prescribing of Odomzo
Danish: • Lægers forpligtelser i relation til at udskrive Odomzo
English: • muscle cramps, muscle pain, pain in the bones, ligaments and tendons
Danish: • muskelkramper, muskelsmerter, smerter i knogler, ledbånd eller sener
English: • If renal function is not impaired and CK resolves to baseline, consider resuming treatment at 200 mg every other day.
Danish: • Ved ikke-nedsat nyrefunktion, og hvis CK bedres til baseline, skal genoptagelse af behandlingen med 200 mg hver anden dag overvejes.
English: If vomiting occurs during the course of the treatment, then no re-dosing of the patient is allowed before the next scheduled dose.
Danish: Hvis patienten kaster op under behandlingen, må patienten ikke tage en ny dosis før den næste planlagte dosis.
English: You should not donate semen during your treatment and for 6 months after your treatment has finished.
Danish: Du må ikke donere sæd under din behandling og i 6 måneder efter, at din behandling er afsluttet.
English: • He will tell his healthcare provider if his female partner becomes pregnant while he is taking Odomzo or during the 6 months after his final dose.
Danish: • Han skal fortælle sin læge det, hvis hans kvindelige partner bliver gravid, mens han tager Odomzo eller i de første 6 måneder efter sidste dosis.
English: It is unknown whether sonidegib is contained in semen.
Danish: Det vides ikke om sonidegib udskilles i sæd.
English: Odomzo contains lactose (milk sugar).
Danish: Odomzo indeholder lactose (mælkesukker).
English: While you are taking Odomzo, always use a condom (with spermicide, if available) when you have sex with a female partner, even if you have had a vasectomy.
Danish: Mens du tager Odomzo, skal du altid bruge kondom (så vidt muligt med sæddræbende creme), når du har samleje med en kvindelig partner; også selvom du er steriliseret.