FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne ordnet efter hyppighed med de hyppigste bivirkninger først.
English: AUCinf of sonidegib was 40%, 22% and 8% lower, respectively.
Danish: Sonidegibs AUCinf var henholdsvis 40 %, 22 % og 8 % lavere.
English: • does not have a XY genotype, Turner's syndrome or uterine agenesis,
Danish: • ikke har en XY-genotype, Turners syndrom eller uterin agenese,
English: Progression-free survival probability (%), (95% CI)
Danish: Sandsynlighed for progressionsfri overlevelse (%), (95 % CI)
English: This was also true for grade 3/4 adverse reactions, except fatigue.
Danish: Dette gjaldt også grad 3/4 bivirkninger bortset fra træthed.
English: Management of severe or intolerable adverse reactions may require temporary dose interruption (with or without a subsequent dose reduction) or discontinuation.
Danish: For håndtering af alvorlige eller uacceptable bivirkninger kan det være nødvendigt med midlertidig afbrydelse af doseringen (med eller uden efterfølgende dosisreduktion) eller seponering.
English: Unchanged sonidegib in faeces represented 88.7% of the administered dose and was not detectable in urine.
Danish: Ikke omdannet sonidegib i fæces udgjorde 88,7 % af den administrerede dosis og kunne ikke måles i urinen.
English: • you must take precautions so that you do not become pregnant while taking Odomzo,
Danish: • Du skal tage nogle forholdsregler, så du ikke bliver gravid, mens du tager Odomzo.
English: Foetotoxicity in rabbits was also seen at very low maternal exposure.
Danish: Føtotoksicitet hos kaniner blev også set ved meget lav maternel eksponering.
English: In case of pregnancy or missed menstrual periods
Danish: Ved graviditet eller udeblevet menstruation
English: Frequency all grades 200 mg
Danish: Hyppighed, alle grader 200 mg
English: If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
Danish: Hvis du tager et eller flere af dem, vil din læge måske ordinere et andet lægemiddel til dig.
English: Your doctor will test you for pregnancy:
Danish: Din læge vil undersøge om du er gravid:
English: Talk to your doctor if you are unsure.
Danish: Tal med din læge, hvis du er i tvivl.
English: Management of high-grade CK elevation using supportive therapy, including proper hydration, should be considered according to local standards of medical practice and treatment guidelines.
Danish: Det skal overvejes at håndtere svære grader af forhøjet CK med understøttende behandling, herunder korrekt hydrering, i overensstemmelse med lokale standarder for lægelig praksis og behandlingsretningslinjer.
English: The capsules must not be opened due to risk of teratogenicity (see section 5.3).
Danish: Kapslerne må ikke åbnes på grund af risiko for teratogenicitet (se pkt.
English: Odomzo is provided in perforated unit-dose blisters containing 10 x 1 capsule.
Danish: Odomzo fås i perforerede enkeltdosis blistere, der indeholder 10 x 1 kapsel.
English: The majority of adverse effects of sonidegib can be attributed to its pharmacological mechanism of action on developmental pathways and effects in rats and dogs were similar.
Danish: Hovedparten af sonidegibs bivirkninger kan tilskrives dets farmakologiske virkningsmekanisme på udviklingssignalvejene, og virkningerne var tilsvarende hos rotter og hunde.
English: For patients with laBCC, the Independent Review Committee (IRC) Composite Overall Response was integrated from centrally evaluated MRI scans, digital clinical photographs and histopathology according to mRECIST.
Danish: For patienter med laBCC blev den uafhængige bedømmelseskomités (IRC) samlede overordnede respons integreret ud fra centralt evaluerede MRI-scanninger, kliniske digitalbilleder og histopatologi ifølge mRECIST.
English: Carcinogenicity studies have not been performed with sonidegib, but sonidegib was not genotoxic in studies conducted in vitro and in vivo.
Danish: Der er ikke udført karcinogenicitetsstudier med sonidegib, men sonidegib var ikke genotoksisk i studier udført in vitro og in vivo..
English: • She must not take Odomzo if she is pregnant or plans to become pregnant.
Danish: • Hun må ikke tage Odomzo, hvis hun er gravid eller planlægger at blive gravid.
English: • She must be able to comply with effective contraceptive measures.
Danish: • Hun skal konsekvent kunne anvende effektiv prævention.
English: Odomzo works by blocking this process, stopping cancer cells from growing and making new cells.
Danish: Odomzo virker ved at blokere denne proces, og dermed forhindre kræftceller i at vokse og dele sig.
English: Sonidegib is a competitive inhibitor of CYP2B6 and CYP2C9 in vitro.
Danish: Sonidegib er en kompetitiv hæmmer af CYP2B6 og CYP2C9 in vitro.
English: • She must tell her healthcare provider if any of the following occur during treatment and during the 20 months after her final dose: o she becomes pregnant or thinks for any reason that she may be pregnant, o she misses her expected menstrual period, o she stops using contraception unless she commits to not having sexual intercourse (abstinence), o she needs to change contraception.
Danish: • Hun skal fortælle sin læge, hvis en eller flere af følgende forekommer under behandlingen og i 20 måneder efter den sidste dosis: o hun bliver gravid eller har grund til at tro, at hun kan være gravid, o hendes forventede menstruation udebliver, o hun holder op med at bruge prævention, medmindre hun forpligter sig til ikke at have samleje (afholdenhed), o hun får behov for at skifte præventionsmetode.
English: Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity develops.
Danish: Behandlingen skal fortsættes, så længe der observeres en klinisk gavnlig virkning, eller indtil der opstår uacceptabel toksicitet.
English: Nervous system disorders Dysgeusia
Danish: Nervesystemet Dysgeusi
English: Odomzo 200 mg capsules are pink and opaque.
Danish: Odomzo 200 mg kapsler er lyserøde og uigennemsigtige.
English: 10 x 1 hard capsule in PCTFE/PVC/Alu perforated unit-dose blisters.
Danish: 10 x 1 hård kapsel i PCTFE/PVC/Alu perforerede enkeltdosis blistere.
English: This dose of sonidegib is predicted to adjust the AUC to the range observed without inducers based on pharmacokinetic data when the concomitant treatment with the inducer is no longer than 14 days.
Danish: Denne dosis sonidegib forventes at justere AUC til det område, der ses uden inducere, baseret på farmakokinetiske data, når den samtidige behandling med induktoren ikke er længere end 14 dage.
English: The evaluation of safety in the paediatric population is based on data from 16 adult and 60 paediatric patients from Study CLDE225X2104 and 16 adult and 2 paediatric patients from Study CLDE225C2301.
Danish: Evalueringen af sikkerhed hos den pædiatriske population er baseret på data fra 16 voksne og 60 pædiatriske patienter fra studie CLDE225X2104 og 16 voksne og 2 pædiatriske patienter fra studie CLDE225C2301.
English: Additional information on the above points can be found in the sections “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men”.
Danish: Du kan finde flere oplysninger om ovenstående punkter under overskrifterne “Graviditet”, ”Amning”, ”Frugtbarhed” og “Prævention til kvinder og mænd”.
English: Odomzo may have an impact on fertility in men and women.
Danish: Odomzo kan påvirke mænds og kvinders frugtbarhed.
English: The elimination half-life (t1/2) of sonidegib estimated from population pharmacokinetic modeling was approximately 28 days.
Danish: Sonidegibs halveringstid (t1/2), estimeret ud fra farmakokinetisk populationsmodellering, var ca. 28 dage.
English: These could be signs of a problem called rhabdomyolysis, which involves the breakdown of muscle tissue.
Danish: Dette kan være tegn på en lidelse kaldet rhabdomyolyse, som medfører nedbrydning af muskelvæv.
English: Keep taking Odomzo for as long as your doctor tells you.
Danish: Fortsæt med at tage Odomzo, så længe din læge siger, at du skal gøre det.
English: • The need to ensure all patients complete and sign the Odomzo Verification of Counselling Form which is to be present in the healthcare professional educational material
Danish: • Nødvendigheden af at sikre, at alle patienter udfylder og underskriver Odomzos formularen for verificering af rådgivning, som skal være tilgængelig i uddannelsesmaterialet til læger
English: Patient-reported outcomes were evaluated as an exploratory endpoint using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its associated head and neck cancer specific module (H&N35).
Danish: Patientindberettede resultater blev evalueret som et eksplorativt endepunkt ved hjælp af spørgeskemaet European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) og dets tilknyttede specifikke modul for cancer i hoved og hals (H&N35).
English: 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: Hvis patienten bliver gravid, en menstruation udebliver, eller på anden måde mistænker, at hun kan være gravid, skal hun kontakte behandlende læge med det samme.
English: If dose reduction is required, then the dose should be reduced to 200 mg every other day.
Danish: Hvis dosisreduktion er nødvendig, skal dosis nedsættes til 200 mg hver anden dag.
English: If you have questions about how long to take Odomzo, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvor længe du skal tage Odomzo, skal du tale med din læge eller apotekspersonalet.
English: Your doctor may need to change your dose, or stop your treatment temporarily or permanently.
Danish: Din læge vil måske ændre din dosis eller midlertidigt stoppe eller helt afbryde din behandling.
English: In order to help healthcare providers and patients avoid embryonic and foetal exposure to Odomzo, the Marketing Authorisation Holder will provide educational materials (Odomzo Pregnancy Prevention Programme) to reinforce the potential risks associated with use of the medicinal product.
Danish: For at hjælpe sundhedspersonale og patienter med at undgå at embryoer og fostre eksponeres for Odomzo, vil indehaveren af markedsføringstilladelsen stille uddannelsesmateriale til rådighed (Odomzo-programmet for svangerskabsforebyggelse) for at understrege de potentielle risici, der er forbundet med brug af lægemidlet.
English: Longer concomitant treatment with inducer is not recommended because sonidegib exposure will be decreased and this may compromise efficacy.
Danish: Længere tids samtidig behandling med inducere anbefales ikke, da sonidegibs eksponering vil nedsættes og dette kan kompromittere effekten.
English: Healthcare professionals must educate patients so they understand and acknowledge all the conditions of the Odomzo Pregnancy Prevention Programme.
Danish: Sundhedspersonalet skal informere patienterne, så de forstår og er indforståede med alle betingelserne i Odomzo-programmet for svangerskabsforebyggelse.
English: Biochemistry parameters Serum creatinine increased
Danish: Biokemiske parametre Forhøjet serumkreatinin
English: In patients with basal cell carcinoma, changes occur to genes controlling a part of this process known as the “hedgehog pathway”.
Danish: Hos patienter med basalcellecarcinom opstår der forandringer i genet, der kontrollerer en del af denne proces kaldet ”hedgehogvejen”.
English: • you need to change contraception
Danish: • du får behov for at skifte prævention.
English: • Check list for healthcare professional ensuring that patients receive the appropriate counselling
Danish: • Lægers tjekliste for at sikre, at patienter får tilstrækkelig rådgivning
English: Based on in vitro data, sonidegib is not a substrate of P-gp, BCRP or multi-resistance protein 2 (MRP2).
Danish: Baseret på in vitro-data er sonidegib ikke et substrat for P-gp, BCRP eller multi-resistensprotein 2 (MRP2).
English: Food interaction
Danish: Interaktion med mad
English: However, one reported case in a patient treated with Odomzo 800 mg in a non-pivotal study was confirmed.
Danish: Et indberettet tilfælde hos en patient, der blev behandlet med Odomzo 800 mg i et ikke-hovedforsøg blev dog bekræftet.
English: b Using only negative histology to define CR among patients who have at least a PR from other modalities (MRI or photography) resulted in a CR rate of 21.2%.
Danish: b Ved brug af negativ histologi alene til at definere komplet respons iblandt patienter, der havde mindst partielt respons fra andre modaliteter (MRI eller fotografi), resulterede i en komplet respons-rate på 21,2 %.
English: Table 2 Adverse drug reactions observed in the phase II pivotal study Primary system organ class Preferred term
Danish: Tabel 2 Bivirkninger observeret i fase II-hovedforsøget Primær systemorganklasse Foretrukken betegnelse
English: • if you are allergic to sonidegib or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for sonidegib eller et af de øvrige indholdsstoffer i Odomzo (angivet i punkt 6).
English: • Methodology to collect information on the use of Odomzo and the compliance with the pregnancy pharmacovigilance programme and its effectiveness
Danish: • Metoden for indsamling af information om brug af Odomzo og overholdelse af graviditetsprogrammet og dets effektivitet som en del af lægemiddelovervågning
English: The phase II pivotal study evaluated the safety of Odomzo in a total of 229 adult patients with locally advanced or metastatic BCC.
Danish: Fase II-hovedforsøget evaluerede Odomzos sikkerhed hos i alt 229 voksne patienter med lokalt fremskredent eller metastatisk BCC.
English: Steady-state level of sonidegib in the skin was 6-fold higher than in plasma.
Danish: I steady state var sonidegib-koncentrationen i huden 6 gange højere end i plasma.
English: Table 3 Laboratory abnormalities*
Danish: Tabel 3 Laboratorieabnormaliteter*
English: Reproductive system and breast disorders Amenorrhoea*
Danish: Det reproduktive system og mammae Amenorré*
English: All patients starting therapy with Odomzo must be informed of the risk of muscle-related adverse events, including the possibility of rhabdomyolysis.
Danish: Alle patienter, der påbegynder behandling med Odomzo, skal informeres om risikoen for muskelrelaterede bivirkninger, herunder risikoen for rhabdomyolyse.
English: Further, sonidegib plasma concentrations above those achieved with the therapeutic doses were not associated with life-threatening arrhythmias or torsades de pointes.
Danish: Endvidere var sonidegib-plasmakoncentrationer, der var højere end dem, der opnås med de terapeutiske doser, ikke forbundet med livstruende arytmier eller torsades de pointes.
English: Sonidegib is also a breast cancer resistance protein (BCRP) inhibitor (IC50 ~1.5µM).
Danish: Sonidegib er også en hæmmer af brystcancer-resistent protein (BCRP) (IC50 ~1,5 µM).
English: Dose modification or interruption guidelines should be followed (see section 4.2).
Danish: Retningslinjerne for dosisjustering eller -afbrydelse skal følges (se pkt.
English: A moderate meal taken 1 hour after the administration of Odomzo 200 mg provided similar exposures compared to the fasted state.
Danish: Et moderat måltid indtaget 1 time efter administration af Odomzo 200 mg gav samme eksponering som ved fastende tilstand.
English: Educational material
Danish: Uddannelsesmateriale
English: Unchanged sonidegib represented 36% of circulating radioactivity and the major circulating metabolite (45% of parent exposure) identified in plasma is the hydrolysis product of sonidegib and is pharmacologically inactive.
Danish: Uforandret sonidegib repræsenterede 36 % af den cirkulerende radioaktivitet, og den cirkulerende hovedmetabolit (45 % af eksponeringen for moderstoffet), som kan identificeres i plasma, er hydrolyseproduktet af sonidegib og er farmakologisk inaktiv.
English: For healthcare professionals
Danish: Til sundhedspersonale
English: In clinical trials, treatment with Odomzo was continued until disease progression or until unacceptable toxicity.
Danish: I kliniske studier forsatte behandlingen med Odomzo indtil sygdomsprogression eller indtil uacceptabel toksicitet.
English: In the pivotal study, 29.1% of patients discontinued due to adverse events, which were mostly mild or moderate (see section 4.8).
Danish: I hovedstudiet afbrød 29,1 % af patienterne behandlingen pga. bivirkninger, der hovedsagelig var lette eller moderate (se pkt.
English: Response by digital clinical photograph was evaluated by World Health Organization (WHO) adapted criteria [partial response (PR): ≥50% decrease in the sum of the product of perpendicular diameters (SPD) of a lesion; complete response (CR): disappearance of all lesions; progressive disease: ≥25% increase in the SPD of lesions].
Danish: Respons ifølge kliniske digitalbilleder blev evalueret efter Verdenssundhedsorganisationens (WHO) tilpassede kriterier [partielt respons (PR): ≥50 % fald i summen af de lodrette diametres produkt (SPD) for en læsion; komplet respons (KR): alle læsioner forsvundet; progressiv sygdom: ≥25 % stigning i læsioners SPD].
English: Patients concomitantly using substrates of BCRP transporters should be carefully monitored for adverse drug reactions.
Danish: Patienter, der samtidig bruger substrater for BCRP-transportere, skal monitoreres nøje for bivirkninger.
English: CK levels should be measured weekly for 2 months after re-administration of sonidegib and monthly thereafter.
Danish: CK-værdierne skal måles ugentligt i 2 måneder efter genoptaget administration af sonidegib og derefter månedligt.
English: Sonidegib did not inhibit apical efflux transporters, P-gp or MRP2, hepatic uptake transporters OATP1B1 or OATP1B3, renal organic anion uptake transporters OAT1 and OAT3, or the organic cation uptake transporters OCT1 or OCT2 at clinically relevant concentrations.
Danish: Sonidegib hæmmede ikke de apikale effluxtransportere P-gp eller MRP2, hepatiske optagstransportere OATP1B1 eller OATP1B3, renale organiske anion-optagstransportere OAT1 og OAT3 eller organiske kation-optagstransportere OCT1 eller OCT2 i klinisk relevante koncentrationer.
English: During your treatment with Odomzo, you should also tell your doctor or pharmacist if you are prescribed another medicine that you were not taking before.
Danish: Under din behandling med Odomzo skal du også fortælle det til lægen eller apotekspersonalet, hvis du får ordineret andre lægemidler, som du ikke tog i forvejen.
English: Cases of cuSCC have been reported in advanced BCC patients treated with Odomzo.
Danish: Tilfælde af cuSCC er blevet indberettet hos patienter med fremskredent BCC, der blev behandlet med Odomzo.
English: Safety and efficacy data in patients aged 65 years and older do not suggest that a dosage adjustment is required in these patients (see section 5.2).
Danish: Data om sikkerhed og virkning hos patienter i alderen 65 år og derover tyder ikke på, at dosisjustering er nødvendig hos disse patienter (se pkt.
English: In dose escalation studies, Odomzo was administered at doses up to 3000 mg orally once daily.
Danish: I dosiseskaleringsforsøg blev Odomzo administreret i doser på op til 3.000 mg oralt én gang dagligt.
English: Sonidegib was highly bound to human plasma proteins (human serum albumin and alpha-1 acid glycoprotein) in vitro (>97%), and binding was not concentration-dependent from 1 ng/ml to 2500 ng/ml.
Danish: Sonidegib var i høj grad bundet til humane plasmaproteiner (human serumalbumin og alpha-1-syreglycoprotein) in vitro (>97 %), og bindingen var ikke koncentrationsafhængig fra 1 ng/ml til 2.500 ng/ml.
English: • Safety advice for men
Danish: • Råd om sikkerhed til mænd
English: • Description of the pregnancy prevention programme and categorisation of patients based on sex and childbearing potential
Danish: • Beskrivelse af programmet for svangerskabsforebyggelse og klassificering af patienter baseret på køn og fertil potentiale
English: Muscle-related events including CK elevation
Danish: Muskelrelaterede bivirkninger, herunder forhøjet CK
English: Blood donation
Danish: Bloddonation
English: It binds to Smoothened (Smo), a G protein-coupled receptor-like molecule that positively regulates the Hh pathway and eventually activates and releases glioma-associated oncogene (GLI) transcription factors which induces the transcription of Hh target genes involved in proliferation, differentiation and survival.
Danish: Det binder til Smoothened (Smo), et G protein-koblet receptorlignende molekyle, der positivt regulerer Hh-signalvejen og endelig aktiverer og frigiver gliom-associerede onkogene (GLI) transkriptionsfaktorer, hvilket inducerer transskriberingen af Hhmålgenorne, der er involverede i proliferation, differenciering og overlevelse.
English: Patients should be carefully monitored for adverse events if one of these agents is used together with sonidegib.
Danish: Patienter skal monitoreres omhyggeligt for bivirkninger, hvis et af disse stoffer anvendes sammen med sonidegib.
English: The key efficacy results per central review and local investigator assessment are presented in Table 4.
Danish: De vigtigste effektresultater ifølge central bedømmelse og lokale investigatorers vurdering er vist i tabel 4.
English: The median age of all patients receiving Odomzo 200 mg was 67 years (59.5% were >65 years of age), 60.8% were male and 89.9% Caucasian.
Danish: Den mediane alder for alle patienter, der fik Odomzo 200 mg, var 67 år (59,5 % var >65 år gamle), 60,8 % var mænd og 89,9 % kaukasiere.
English: - Your doctor will check your skin regularly for another type of cancer called cutaneous squamous cell carcinoma (SCC).
Danish: - Din læge vil kontrollere din hud regelmæssigt for en anden type kræft, der hedder pladecellecarcinom (SCC).
English: The recommended dose is 200 mg sonidegib taken orally once daily at least two hours after a meal and at least one hour before the following meal, at the same time each day.
Danish: Den anbefalede dosis er 200 mg sonidegib indtaget oralt én gang dagligt, mindst to timer efter et måltid og mindst en time før det næste måltid, på samme tid hver dag.
English: Grade 2, 3 or 4 with renal impairment (serum Cr > ULN)
Danish: Grad 2, 3 eller 4 med nedsat nyrefunktion (serum-Cr > ULN)
English: Following the administration of a single dose of Odomzo (100 mg to 3000 mg) without food in patients with cancer, the median time-to-peak concentration (Tmax) was 2 to 4 hours.
Danish: Efter administration af en enkelt dosis Odomzo (100 mg til 3.000 mg) uden indtagelse af mad hos patienter med cancer, var den mediane tid til maksimal koncentration (Tmax) 2 til 4 timer.
English: The median duration of treatment was 11.0 months for patients treated with Odomzo at the recommended dose of 200 mg (range 1.3 to 41.3 months).
Danish: Behandlingens mediane varighed var 11,0 måneder for patienter, der blev behandlet med Odomzo med den anbefalede dosis på 200 mg (interval 1,3 til 41,3 måneder).
English: Any capsules that remain unused at the end of treatment should immediately be disposed of by the patient in accordance with local requirements (e.g. by returning the capsules to their pharmacist or physician).
Danish: Ubrugte kapsler efter endt behandling skal med det samme bortskaffes af patienten i henhold til lokale retningslinjer (fx ved at returnere kapslerne til apoteket eller deres læge).
English: Patients should be monitored closely for adverse events and given appropriate supportive measures in all cases of overdose.
Danish: Patienter skal monitoreres nøje for bivirkninger og have relevant understøttende pleje i alle tilfælde af overdosering.
English: Patients should be closely monitored and dose adjustments should be considered if muscle symptoms develop.
Danish: Patienterne skal monitoreres nøje, og dosisjustering skal overvejes, hvis der opstår muskelsymptomer.
English: Sonidegib is an orally bioavailable inhibitor of the Hh signalling pathway.
Danish: Sonidegib er en oral biotilgængelig hæmmer af Hh-signalvejen.