FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Hårde kapsler
English: • high level of sugar in the blood (known as hyperglycaemia)
Danish: • højt blodsukker (kaldes også hyperglykæmi)
English: Specific instructions (the Odomzo Pregnancy Prevention Programme) given to you by your doctor contain information particularly on the effects of Odomzo on unborn babies.
Danish: Specifikke anvisninger (Odomzo's program for svangerskabsforebyggelse) givet til dig af din læge indeholder information særligt om virkningen af Odomzo på ufødte babyer.
English: In case of pregnancy occurring during treatment, Odomzo must be stopped immediately (see section 5.3).
Danish: Hvis der opstår graviditet under behandlingen, skal Odomzo omgående seponeres (se pkt.
English: • She must have a negative pregnancy test, conducted by a healthcare professional within 7 days before starting Odomzo treatment.
Danish: • Hun skal have en negativ graviditetstest, foretaget af sundhedspersonale inden for 7 dage før start på Odomzo-behandling.
English: Odomzo is not likely to affect your ability to drive or use any tools or machines.
Danish: Det er ikke sandsynligt, at Odomzo vil påvirke din evne til at køre bil eller betjene værktøj eller maskiner.
English: Some other medicines can also affect how Odomzo works, or make it more likely that you will have side effects.
Danish: Visse andre typer medicin kan også påvirke Odomzos virkning eller øge risikoen for, at du får bivirkninger.
English: • Emergency contact phone numbers
Danish: • Telefonnummer i tilfælde af nødsituation
English: • The format and content of the Healthcare professional and patient material
Danish: • Formatet og indholdet af uddannelsesmateriale til læger og patienter
English: In the phase II pivotal study, no reported cases of rhabdomyolysis were confirmed (defined as CK levels >10-fold above the pre-treatment or baseline level or >10x ULN if no baseline level reported plus a 1.5-fold increase in serum creatinine from the pre-treatment or baseline level).
Danish: I fase II-hovedforsøget blev ingen indberettede rhabdomyolysetilfælde bekræftet (defineret som CK-værdier >10 gange over niveauet før behandling eller ved baseline eller >10x ULN, hvis der ikke var indberettet et baseline-niveau, samt en 1,5 gange stigning i serumkreatinin fra niveauet før behandling eller ved baseline).
English: Agents that may increase muscle-related events
Danish: Stoffer, der kan øge muskelrelaterede hændelser
English: • Odomzo exposes a teratogenic risk to the unborn child.
Danish: • Odomzo udgør en teratogen risiko for det ufødte barn.
English: Blood tests during treatment with Odomzo
Danish: Blodprøver under behandling med Odomzo
English: The initial prescription and dispensing of Odomzo should occur within 7 days of a negative pregnancy test.
Danish: Den første ordination og udlevering af Odomzo skal finde sted inden for 7 dage efter en negativ graviditetstest.
English: However, results of a drug-drug interaction study in cancer patients demonstrate that the systemic exposure of bupropion (a CYP2B6 substrate) and warfarin (a CYP2C9 substrate) is not altered when co-administered with sonidegib.
Danish: Resultater fra et lægemiddelinteraktionsstudie hos cancerpatienter viser dog, at systemisk eksponering af bupropion (et CYP2B6-substrat) og warfarin (et CYP2C9-substrat) ikke er ændret, når de administreres sammen med sonidegib.
English: Based on a population pharmacokinetic analysis of 351 patients who received oral doses of Odomzo in the dose range of 100 mg to 3000 mg, the apparent steady-state volume of distribution (Vss/F) was 9170 litres.
Danish: Baseret på en farmakokinetisk populationsanalyse med 351 patienter, som fik en oral dosis Odomzo i dosisområdet 100 mg til 3.000 mg, var det tilsyneladende steady state fordelingsvolumen (Vss/F) 9.170 liter.
English: The majority of patients (laBCC 74%, mBCC 92%) had undergone prior therapies including surgery (laBCC 73%, mBCC 85%), radiotherapy (laBCC 18%, mBCC 54%) and antineoplastic therapies (laBCC 23%, mBCC 23%).
Danish: Hovedparten af patienterne (laBCC 74 %, mBCC 92 %) havde gennemgået tidligere behandlinger, herunder kirurgi (laBCC 73 %, mBCC 85 %), strålebehandling (laBCC 18 %, mBCC 54%) og antineoplastiske behandlinger (laBCC 23 %, mBCC 23 %).
English: As part of the Odomzo Pregnancy Prevention Programme, all patients will receive a:
Danish: Som led i programmet til forebyggelse af graviditet for patienter, der får Odomzo, vil alle patienter få udleveret:
English: Based on the available data, sonidegib elimination via the kidney is negligible.
Danish: Ifølge de tilgængelige data er elimination af sonidegib via nyrerne ubetydelig.
English: Odomzo may cause embryo-foetal death or severe birth defects when administered to pregnant women.
Danish: Odomzo kan forårsage embryoføtal død eller svære fødselsdefekter, når det administreres til gravide kvinder.
English: The safety and efficacy of Odomzo in children and adolescents aged below 18 years with basal cell carcinoma have not been established.
Danish: Odomzos sikkerhed og virkning hos børn og unge under 18 år med basalcellecarcinom er ikke klarlagt.
English: The average steady state Ctrough for 200 mg was 830 ng/ml (range 200 to 2400 ng/ml) in cancer patients.
Danish: Den gennemsnitlige steady state Ctrough for 200 mg var 830 ng/ml (interval 200 til 2.400 ng/ml) hos cancerpatienter.
English: Do not exceed the recommended dose prescribed by your doctor.
Danish: Den anbefalede dosis, som din læge har ordineret, må ikke overskrides.
English: Persistent lack of menses during treatment with Odomzo should be assumed to indicate pregnancy until medical evaluation and confirmation.
Danish: Vedvarende udeblivelse af menstruationen under behandling med Odomzo skal antages at indikere graviditet indtil der foreligger en medicinsk evaluering og bekræftelse.
English: • The active substance is sonidegib (as phosphate).
Danish: • Aktivt stof: sonidegib (som fosfat).
English: • high levels of the following enzymes: creatine phosphokinase (muscle function), lipase and/or amylase
Danish: • høje værdier af følgende enzymer: kreatinkinase (muskelfunktion), lipase og/eller amylase
English: • high level of creatinine (kidney function)
Danish: • høj kreatininværdi (nyrefunktion)
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX48
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, andre antineoplastiske stoffer, ATC-kode: L01XX48
English: • Do not use this medicine after the expiry date which is stated on the pack and the blister after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakning og blister efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Sonidegib has not been studied in a dedicated pharmacokinetic study in patients with renal impairment.
Danish: Sonidegib er ikke undersøgt i et dedikeret farmakokinetisk studie hos patienter med nedsat nyrefunktion.
English: The bioavailability of sonidegib is increased in the presence of food (see section 5.2).
Danish: Sonidegibs biotilgængelighed øges ved tilstedeværelse af mad (se pkt.
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Det gælder også medicin, som ikke er købt på recept samt naturlægemidler.
English: Odomzo has no or negligible influence on the ability to drive and use machines.
Danish: Odomzo påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Some medicines (e.g. medicines used to treat high cholesterol) might increase the risk for muscle problems.
Danish: Noget medicin (fx medicin mod forhøjet kolesterol) kan øge risikoen for muskelproblemer.
English: Sonidegib is primarily metabolised by CYP3A4.
Danish: Sonidegib metaboliseres primært af CYP3A4.
English: Odomzo must be taken at least two hours after a meal and at least one hour before the following meal to prevent increased risk of adverse events due to higher exposure of sonidegib when taken with a meal (see section 5.2).
Danish: Odomzo skal indtages mindst to timer efter et måltid og mindst en time før det næste måltid for at undgå en øget risiko for bivirkninger på grund af højere eksponering af sonidegib, når det tages i forbindelse med et måltid (se pkt.
English: It is unknown whether sonidegib is excreted in human milk.
Danish: Det er ukendt, om sonidegib udskilles i human mælk.
English: This is because Odomzo may cause harm or death to your unborn baby (see section “Pregnancy”).
Danish: Dette skyldes, at Odomzo kan medføre skade eller dødsfald for dit ufødte barn (se ”Graviditet”).
English: Patients were treated with Odomzo 200 mg daily (n=79) or with Odomzo 800 mg daily (n=150).
Danish: Patienterne blev behandlet med Odomzo 200 mg dagligt (n=79) eller med Odomzo 800 mg dagligt (n=150).
English: It has not been determined whether cuSCC is related to Odomzo treatment.
Danish: Det er ikke fastslået, hvorvidt cuSCC er relateret til Odomzo-behandling.
English: No efficacy and safety data are available in patients with severe renal impairment.
Danish: Der foreligger ingen data vedrørende virkning og sikkerhed hos patienter med svært nedsat nyrefunktion.
English: The toxicity of sonidegib as observed in studies C2301 and X2104 in adults was in line with the already known treatment related toxicity reported in adult patients with basal cell carcinoma.
Danish: Toksiciteten i forbindelse med sonidegib var, som observeret i studie C2301 og X2104 hos voksne, på linje med den allerede kendte, indberettede behandlingsrelaterede toksicitet hos voksne patienter med basalcellecarcinom.
English: Patients who present with amenorrhoea during treatment with Odomzo should continue monthly pregnancy testing while on treatment.
Danish: Patienter, som får amenorré under behandlingen med Odomzo skal fortsætte med månedlig graviditetstest mens behandlingen pågår.
English: CK levels should be checked prior to starting treatment and as clinically indicated thereafter, e.g. if muscle-related symptoms are reported.
Danish: CK-værdier skal kontrolleres før behandlingsstart og derefter som klinisk indiceret, fx hvis der indberettes muskelrelaterede symptomer.
English: • Patient Brochure
Danish: • En patientbrochure
English: You must stop taking Odomzo and talk to your doctor immediately if you become pregnant or suspect you could be pregnant.
Danish: Du skal straks holde op med at tage Odomzo og tale med din læge, hvis du bliver gravid eller tror, du kan være gravid.
English: • She must have a negative pregnancy test monthly during treatment, even if she has become amenorrhoeic.
Danish: • Hun skal hver måned have en negativ graviditetstest under behandlingen, også selvom hun oplever amenorré.
English: EU/1/15/1030/002 30 hard capsules
Danish: EU/1/15/1030/002 30 hårde kapsler
English: They must be instructed to report promptly any unexplained muscle pain, tenderness or weakness occurring during treatment with Odomzo or if symptoms persist after discontinuing treatment.
Danish: De skal opfordres til straks at indberette alle tilfælde af uforklarlig muskelsmerte, -ømhed eller -svækkelse, der forekommer under behandlingen med Odomzo, eller hvis symptomerne varer ved efter seponering af behandlingen.
English: Table 4 Efficacy overview per central review and local investigator assessment by FASa
Danish: Tabel 4 Oversigt over effekt ifølge central vurdering og lokal investigators vurdering efter FASa
English: • He must always use the recommended contraception (see the “Contraception” section below and section 4.6).
Danish: • Han skal altid anvende den anbefalede prævention (se punktet “Prævention” herunder og pkt.
English: • Remind patients to return unused capsules at the end of the treatment (disposal will depend on local requirements)
Danish: • Påmind patienter om at returnere ubrugte kapsler ved behandlingens afslutning (bortskaffelse vil afhænge af lokale retningslinjer)
English: Opaque pink hard capsule containing white to almost white powder with granules, with “NVR” imprinted in black ink on the cap and “SONIDEGIB 200MG” imprinted in black ink on the body.
Danish: Ugennemsigtig lyserød hård kapsel indeholdende hvidt til næsten hvidt pulver med granulat, der er præget med “NVR” med sort blæk på overdelen og “SONIDEGIB 200MG” med sort blæk på underdelen.
English: Adult (≥18 years of age) patients with laBCC or mBCC who were not candidates for radiotherapy, surgery or other local therapies, were randomised to receive Odomzo at either 200 mg or 800 mg daily until disease progression or unacceptable toxicity.
Danish: Voksne (≥18 år gamle) patienter med laBCC eller mBCC, som ikke var kandidater til strålebehandling, kirurgi eller andre lokale behandlinger, blev randomiseret til at få enten 200 mg eller 800 mg Odomzo dagligt indtil sygdomsprogression eller uacceptabel toksicitet.
English: 30 x 1 hard capsule
Danish: 30 x 1 hård kapsel
English: Odomzo must be taken at least two hours after a meal and at least one hour before the following meal.
Danish: Odomzo skal tages mindst to timer efter et måltid og mindst en time før det næste måltid.
English: Data from studies in rats and dogs indicate that male and female fertility may be irreversibly compromised by treatment with Odomzo (see section 5.3).
Danish: Data fra studier i rotter og hunde indikerer, at behandling med Odomzo kan skade den mandlige og kvindelige fertilitet irreversibelt (se pkt.
English: If a strong CYP3A4 inducer must be used concomitantly with sonidegib, consideration should be given to increasing the daily dose of sonidegib to 400-800 mg.
Danish: Hvis det er nødvendigt at anvende en stærk CYP3A4inducer samtidig med sonidegib, skal det overvejes at øge den daglige dosis af sonidegib trinvis til 400-800 mg.
English: Before starting Odomzo treatment, ask your doctor if you are able to become pregnant, even if your periods have stopped (menopause).
Danish: Før du begynder at tage Odomzo, skal du spørge din læge, om du kan blive gravid; også selvom dine menstruationer er stoppet (overgangsalder).
English: • thirst, not passing much urine, weight loss, dry flushed skin, irritability (possible symptoms of low level of fluids in the body, known as dehydration).
Danish: • tørst, udskiller lille mængde urin, vægttab, tør rød hud, irritabilitet (mulige tegn på for lidt væske i kroppen, kaldet dehydrering).
English: Unused capsules should be returned at the end of treatment.
Danish: Ubrugte kapsler skal afleveres ved behandlingens afslutning.
English: Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
Danish: Odomzo er indiceret til behandling af voksne patienter med lokalt fremskredent basalcellecarcinom (BCC), som ikke er egnet til kurativ operation eller strålebehandling.
English: Fertility preservation strategies should be discussed with women of childbearing potential prior to starting treatment with Odomzo.
Danish: Strategier for bevarelse af fertiliteten skal drøftes med fertile kvinder, før behandlingen med Odomzo påbegyndes.
English: If you vomit after you swallow the capsule, do not take any more capsules until your next scheduled dose.
Danish: Hvis du kaster op efter, at du har sunket kapslen, må du ikke tage flere kapsler førend din næste planlagte dosis.
English: • Not to give Odomzo to any other person as well as information on the disposal of unwanted medication and the need to keep Odomzo capsules out of sight and reach of children
Danish: • Ikke at give Odomzo til nogen andre personer så vel som information om bortskaffelse af ubrugt medicin og nødvendigheden af at opbevare Odomzo kapsler uden for børns syns- og rækkevidde
English: Muscle toxicity is the most clinically relevant side effect reported in patients receiving sonidegib therapy and is believed to be a class effect of inhibitors of the Hedgehog (Hh) signalling pathway.
Danish: Muskeltoksicitet er den mest klinisk relevante bivirkning, der indberettes hos patienter, der får behandling med sonidegib, og anses for at være en klasseeffekt for hæmmere af Hedgehog (Hh)-signalvejen.
English: • National or other applicable specific arrangements for a prescription for Odomzo to be dispensed
Danish: • Nationale eller andre specifikke gældende ordninger for at udskrive og udlevere Odomzo
English: Event-free probability (%), (95% CI) 6 months 9 months 12 months Progression-free survival No. of events* No. censored Median (months) 95% CI
Danish: Hændelsesfri sandsynlighed (%), (95 % CI) 6 måneder 9 måneder 12 måneder Progressionsfri overlevelse Antal hændelser* Antal censurerede Median (måneder) 95 % CI
English: 10 x 1 hard capsule
Danish: 10 x 1 hård kapsel
English: Tumour response was independent of Odomzo dose or plasma concentration in the dose range of 200 mg to 800 mg.
Danish: Tumorrespons var uafhængigt af Odomzo-dosis eller -plasmakoncentrationer i dosisområdet 200 mg til 800 mg.
English: In the phase II pivotal study, muscle spasms, myalgia, myopathy and cases of CK elevations were observed.
Danish: I fase II-hovedforsøget blev der observeret muskelspasmer, myalgi, myopati og tilfælde af forhøjet CK.
English: Patients with neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) must be closely monitored due to an increased risk of muscle toxicity.
Danish: Patienter med neuromuskulære lidelser (fx inflammatoriske myopatier, muskeldystrofi, amyotrofisk lateral sklerose, spinal muskelatrofi) skal monitoreres nøje på grund af øget risiko for muskeltoksicitet.
English: Due to overlapping toxicities, patients taking Odomzo who are also taking medicinal products known to increase the risk of muscle-related toxicity may be at increased risk of developing muscle-related adverse events.
Danish: På grund af overlappende toksicitet kan patienter, der tager Odomzo samtidig med lægemidler, der vides at øge risikoen for muskelrelateret toksicitet, have øget risiko for at udvikle muskelrelaterede bivirkninger.
English: For LaBCC, multiple punch biopsies were taken each time a response assessment was confounded by presence of lesion ulceration, cyst, and or scarring/fibrosis.
Danish: For LaBCC blev der taget flere stansebiopsier hver gang en responsvurdering blev påvirket af tilstedeværelse af læsionsblødning, cyster og/eller ardannelse/fibrose.
English: Of these patients, 7 (58.3%) had up to grade 1 muscle symptoms while 43 (64.1%) patients not taking HMG-CoA reductase inhibitors experienced up to grade 3 symptoms.
Danish: Af disse patienter havde 7 (58,3 %) muskelsymptomer op til grad 1, mens 43 patienter (64,1 %), der ikke tog HMG-CoA-reduktasehæmmere, oplevede symptomer op til grad 3.
English: In these patients, increases in laboratory values of CK to grade 2 and higher severity had a median time to onset of 12.9 weeks (range 2 to 39 weeks) after initiating Odomzo therapy and a median time to resolution (to normalisation or grade 1) of 12 days (95% CI 8 to 14 days).
Danish: Hos disse patienter havde stigninger i CK-laboratorieværdier til grad 2 eller højere sværhedsgrad en median tid til opståen på 12,9 uger (interval 2 til 39 uger) efter initiering af Odomzobehandling og en median tid til bedring (til normalisering eller grad 1) på 12 dage (95 % CI 8 til 14 dage).
English: Odomzo should only be prescribed by or under the supervision of a specialist physician experienced in the management of the approved indication.
Danish: Odomzo bør kun ordineres af en speciallæge med erfaring i behandling af den godkendte indikation eller under dennes tilsyn.
English: The MAH shall continuously ensure that all physicians who are expected to prescribe Odomzo are provided with the following:
Danish: Indehaveren af markedsføringstilladelsen skal vedvarende sikre, at alle læger, der forventes at udskrive Odomzo, forsynes med følgende:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Odomzo in all subsets of the paediatric population in basal cell carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Odomzo i alle undergrupper af den pædiatriske population ved basalcellecarcinom (se pkt.
English: Do not take Odomzo if you are pregnant, think you may be pregnant, or are planning to become pregnant during your treatment or during the 20 months after your treatment has finished.
Danish: Tag ikke Odomzo, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid under din behandling eller i de første 20 måneder efter, at din behandling er afsluttet.
English: Substances that are BCRP substrates with narrow therapeutic range (e.g. methotrexate, mitoxantrone, irinotecan, topotecan) should be avoided.
Danish: Stoffer, der er BCRP-substrater med snævre terapeutiske områder (fx methotrexat, mitoxantron, irinotecan, topotecan), skal undgås.
English: Sonidegib was shown to be foetotoxic in rabbits, as evidenced by abortion and/or complete resorption of foetuses and teratogenic resulting in severe malformations at very low exposure.
Danish: Det er påvist, at sonidegib er føtotoksisk hos kaniner, idet meget lave eksponeringer medførte abort og/eller fuldstændig resorption af fostre samt teratogene virkninger i form af alvorlige misdannelser.
English: Teratogenic effects included vertebral, distal limb and digit malformations, severe craniofacial malformations and other severe midline defects.
Danish: De teratogene virkninger omfattede misdannelser af rygsøjle, distale lemmer og digiti, svære kraniofaciale misdannelser og andre svære midtlinjedefekter.
English: • upset stomach or indigestion
Danish: • uro i maven eller fordøjelsesbesvær
English: • To return unused capsules at the end of the treatment (disposal will depend on local requirements)
Danish: • At returnere ubrugte kapsler ved behandlingens afslutning (bortskaffelse vil afhænge af lokale retningslinjer)
English: AUClast was 35% lower in mild hepatic impairment, 14% higher in moderate hepatic impairment and 23% lower in severe hepatic impairment.
Danish: AUClast var 35 % lavere ved let nedsat leverfunktion, 14 % højere ved moderat nedsat leverfunktion og 23 % lavere ved svært nedsat leverfunktion.
English: Of the 230 patients randomised, 79 patients were assigned to Odomzo 200 mg. Of these 79 patients, 66 (83.5%) were laBCC patients (37 [46.8%] with aggressive histology and 29 [36.7%] with non-aggressive histology) and 13 (16.5%) were mBCC patients.
Danish: 79 ud af de 230 randomiserede patienter fik tildelt Odomzo 200 mg. Af disse 79 var 66 (83,5 %) laBCCpatienter (37 [46,8 %] med aggressiv histologi og 29 [36,7 %] med ikke-aggressiv histologi) og 13 (16,5 %) var mBCC-patienter.
English: Other possible side effects If any of these side effects become severe, tell your doctor or pharmacist.
Danish: Andre bivirkninger Hvis en eller flere af disse bivirkninger bliver alvorlige, skal du fortælle det til lægen eller apotekspersonalet.
English: • Odomzo exposes a teratogenic risk to the unborn child if he engages in unprotected sexual activity with a pregnant woman.
Danish: • Odomzo udgør en teratogen risiko for det ufødte barn, hvis han har ubeskyttet samleje med en gravid kvinde.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1030/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1030/001
English: (pancreas function), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (liver function)
Danish: (bugspytkirtelfunktion), alaninaminotransferase (ALAT) og/eller aspartataminotransferase (ASAT)
English: Sonidegib undergoes metabolism primarily by CYP3A4, and concomitant administration of strong inhibitors or inducers of CYP3A4 can increase or decrease sonidegib concentrations significantly.
Danish: Sonidegib metaboliseres primært af CYP3A4, og samtidig administration af stærke hæmmere eller inducere af CYP3A4 kan øge eller nedsætte koncentrationen af sonidegib væsentligt.