FrancophonIA/ELRC3.0 huggingface dataset:
English: In the phase II pivotal study muscle spasms were the most common “muscle-related” adverse events, and were reported in fewer patients in the Odomzo 200 mg group (54%) than in the Odomzo 800 mg group (69%).
Danish: I fase IIhovedforsøget var muskelspasmer de mest almindelige “muskelrelaterede” bivirkninger og blev indberettet hos færre patienter i gruppen, der fik Odomzo 200 mg (54 %), end i gruppen, der fik Odomzo 800 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1030/001 10 hard capsules
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1030/001 10 hårde kapsler
English: • Swallow the capsule whole.
Danish: • Kapslen skal synkes hel.
English: If concomitant use of a strong CYP3A inhibitor is required, the sonidegib dose should be reduced to 200 mg every other day.
Danish: Hvis samtidig brug af en stærk CYP3A-hæmmer er nødvendig, skal dosis af sonidegib reduceres til 200 mg hver anden dag.
English: A phase II, randomised double-blind study of two dose levels (200 mg or 800 mg once daily) of Odomzo was conducted in 230 patients with either locally advanced basal cell carcinoma (laBCC) (n=194) or metastatic basal cell carcinoma (mBCC) (n=36).
Danish: Et dobbeltblindet, randomiseret fase II-forsøg med Odomzo i to dosisniveauer (200 mg eller 800 mg én gang dagligt) blev udført med 230 patienter med enten lokalt fremskredent basalcellecarcinom (laBCC) (n=194) eller metastatisk basalcellecarcinom (mBCC) (n=36).
English: • Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171).
Danish: • Kapslen: gelatine, rød jernoxid (E172), titandioxid (E171).
English: • medicines such as ketoconazole (not including shampoos and creams), itraconazole, posaconazole or voriconazole used to treat fungal infections
Danish: • medicin, som fx ketoconazol (bortset fra shampoo og creme), itraconazol, posaconazol eller voriconazol mod svampeinfektioner
English: The majority of patients who had grade 2 or higher CK elevations developed muscle symptoms prior to the CK elevations.
Danish: Hovedparten af de patienter, der havde forhøjet CK af grad 2 eller derover, udviklede muskelsymptomer forud for CK-stigningerne.
English: Concomitant use of strong CYP3A inducers should be avoided; this includes, but is not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St John's Wort (Hypericum perforatum).
Danish: Samtidig brug af stærke CYP3Ainducere skal undgås, herunder, men ikke begrænset til, carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin og perikon (Hypericum perforatum).
English: A population pharmacokinetic analysis did not find significant influence of renal function (creatinine clearance >27 ml/min) on the apparent clearance (CL/F) of sonidegib suggesting that dose adjustment is not necessary in patients with renal impairment.
Danish: En farmakokinetisk populationsanalyse fandt ingen signifikant påvirkning af nyrefunktionen (kreatininclearance >27 ml/min) på sonidegibs tilsyneladende clearance (CL/F), hvilket tyder på, at dosisjustering ikke er nødvendig hos patienter med nedsat nyrefunktion.
English: To avoid potential foetal exposure during pregnancy, male patients, even those who have had a vasectomy, must always use a condom (with spermicide, if available) when having sex with a female partner while taking Odomzo and for 6 months after the final dose.
Danish: For at undgå potentiel føtal eksponering under graviditet, skal mandlige patienter altid anvende kondom (så vidt muligt med sæddræbende creme), selv efter vasektomi, når de har samleje med en kvindelig partner mens han tager Odomzo og i 6 måneder efter sidste dosis.
English: Additionally, amenorrhoea has been observed in clinical trials in women of childbearing potential (see section 4.8).
Danish: Amenorré er desuden blevet observeret i kliniske studier hos fertile kvinder (se pkt.
English: Other dose modifications
Danish: Andre dosisjusteringer
English: • medicines such as methotrexate, mitoxantrone, irinotecan, or topotecan used to treat certain types of cancers or other diseases such as severe joint problems (rheumatoid arthritis) and psoriasis
Danish: • medicin, som fx methotrexat, mitoxantron, irinotecan eller topotecan mod visse typer af kræft eller mod andre sygdomme som leddegigt (rheumatoid arthritis) og psoriasis
English: • Capsule contents: crospovidone, lactose monohydrate, magnesium stearate, poloxamer (188), silica, colloidal anhydrous (colloidal silicon dioxide), sodium laurilsulfate (sodium lauryl sulfate).
Danish: • Kapselindhold: crospovidon, lactosemonohydrat, magnesiumstearat, poloxamer (188), silica, kolloid vandfri (kolloid siliciumdioxid), natriumlaurilsulfat (natriumlaurylsulfat).
English: This is because it is not known whether Odomzo can pass into your breast milk and cause harm to your baby (see section “Breast-feeding”).
Danish: Dette skyldes, at det ikke vides, om Odomzo bliver udskilt i brystmælk og dermed kan skade barnet (se ”Amning”).
English: Cmax of sonidegib after a single oral 800 mg dose was 20%, 21% and 60% lower in mild, moderate and severe hepatic impairment, respectively, compared to normal hepatic function.
Danish: Efter en enkelt oral dosis på 800 mg var sonidegibs Cmax henholdsvis 20 %, 21 % og 60 % lavere ved let, moderat og svært nedsat leverfunktion sammenlignet med normal leverfunktion.
English: Criteria defining a woman of childbearing potential
Danish: Kriterier for definition af en fertil kvinde
English: You must follow the Odomzo Pregnancy Prevention Programme.
Danish: Odomzo-programmet om svangerskabsforebyggelse skal overholdes.
English: • medicines such as telithromycin, rifampicin or rifabutin used to treat bacterial infections
Danish: • medicin, som fx telithromycin, rifampicin eller rifabutin mod bakterieinfektioner
English: Odomzo capsules contain lactose monohydrate.
Danish: Odomzo-kapsler indeholder lactosemonohydrat.
English: The most commonly reported grade 3/4 laboratory abnormalities with an incidence of ≥5% occurring in patients treated with Odomzo 200 mg were lipase increase and blood CK increase (Table 3).
Danish: De hyppigst indberettede laboratorieabnormaliteter af grad 3/4 med en forekomst på ≥5 % hos patienter, der blev behandlet med Odomzo 200 mg, var forhøjet lipase og forhøjet CK i blodet (tabel 3).
English: Semen donation
Danish: Sæddonation
English: Women of childbearing potential must be able to comply with effective contraceptive measures.
Danish: Fertile kvinder skal konsekvent kunne anvende effektiv prævention.
English: Due to the risk of embryofoetal death or severe birth defects caused by sonidegib, women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 months after ending treatment (see section 4.4).
Danish: På grund af risikoen for embryoføtal død eller svære fødselsdefekter, som sonidegib forårsager, må kvinder, som tager Odomzo ikke være gravide eller blive gravide under behandling og i 20 måneder efter endt behandling (se pkt.
English: Due to the long half-life of sonidegib the full effect of a dose interruption or dose adjustment of sonidegib on several adverse events is expected to generally occur after a few weeks (see section 5.2).
Danish: Den fulde effekt af dosisafbrydelse eller dosisjustering af sonidegib på flere af bivirkningerne forventes generelt at ske efter nogle uger pga. sonidegibs lange halveringstid (se pkt.
English: What Odomzo is used for
Danish: Dette bruges Odomzo til
English: Among adverse drug reactions reported (Table 2), the frequency was greater in patients taking Odomzo 800 mg than in patients taking Odomzo 200 mg except for musculoskeletal pain, diarrhoea, abdominal pain, headache and pruritus.
Danish: Blandt de indberettede bivirkninger (tabel 2) var hyppigheden større hos patienter, der tog Odomzo 800 mg, end hos patienter, der tog Odomzo 200 mg, bortset fra muskel- og knoglesmerter, diarré, mavesmerter, hovedpine og pruritus.
English: If symptoms persist despite alternate-day dosing, consider discontinuing treatment.
Danish: Hvis symptomerne varer ved trods dosering hver anden dag, skal seponering af behandlingen overvejes.
English: In the phase II pivotal study, 2 (14.3%) out of 14 women of either child-bearing potential or of child-bearing age sterilised by tubal ligation developed amenorrhoea while on treatment with Odomzo 200 mg or 800 mg once daily.
Danish: I fase II-hovedforsøget opstod der amenorré hos 2 (14,3 %) ud af 14 fertile kvinder eller fertile kvinder, der var steriliseret ved tubal ligation under behandlingen med Odomzo 200 mg eller 800 mg én gang dagligt.
English: A population pharmacokinetic analysis found that mild or moderate renal impairment did not have a significant effect on the apparent clearance (CL/F) of sonidegib, suggesting that dose adjustment is not necessary in patients with renal impairment (see section 5.2).
Danish: En farmakokinetisk populationsanalyse viste, at let eller moderat nedsat nyrefunktion ikke havde en signifikant virkning på sonidegibs tilsyneladende clearance (CL/F), hvilket tyder på, at dosisjustering ikke er nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: moderate (Child-Pugh class B; n=8) or severe (Child-Pugh class C; n=9) hepatic impairment and in 8 healthy subjects with normal hepatic function.
Danish: Sonidegibs farmakokinetik blev undersøgt hos forsøgspersoner med let (Child-Pugh klasse A; n=8), moderat (Child-Pugh klasse B; n=8) eller svært (Child-Pugh klasse C; n=9) nedsat leverfunktion og hos 8 raske forsøgspersoner med normal leverfunktion.
English: If more than six hours have passed since the dose was due to be taken, skip the missed dose, then take the next dose at the scheduled time.
Danish: Hvis det er mere end seks timer efter, at du skulle have taget din dosis, skal du springe den glemte dosis over og tage den næste dosis som planlagt.
English: Patients with hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see section 5.2).
Danish: Patienter med nedsat leverfunktion Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: Dose modifications for creatine phosphokinase (CK) elevations and muscle-related adverse events Temporary dose interruption and/or dose reduction of Odomzo therapy may be required for CK elevations and muscle-related adverse events.
Danish: Dosisjusteringer ved forhøjet kreatinkinase (CK) og muskelrelaterede bivirkninger Midlertidig dosisafbrydelse og/eller dosisreduktion af Odomzo-behandlingen kan være nødvendig ved forhøjet CK og muskelrelaterede bivirkninger.
English: Odomzo may cause severe birth defects.
Danish: Odomzo kan give alvorlige fosterskader.
English: Results from a clinical study demonstrated a change in sonidegib exposure (32% and 38% decrease in AUC and Cmax) after co-administration of a single dose of Odomzo 200 mg with esomeprazole (a proton pump inhibitor) at 40 mg daily for 6 days in healthy subjects.
Danish: Resultater fra et klinisk studie viste en ændring i sonidegib-eksponering (32 % og 38 % fald i AUC og Cmax) efter samtidig administration af en enkelt dosis Odomzo på 200 mg og 40 mg esomeprazol (en protonpumpehæmmer) dagligt i 6 dage hos raske forsøgspersoner.
English: • medicines such as carbamazepine, phenytoin or phenobarbital used to treat acute seizures
Danish: • medicin, som fx carbamazepin, phenytoin eller phenobarbital mod akutte krampeanfald
English: • Printing ink: black iron oxide (E172), propylene glycol (E1520), shellac.
Danish: • Trykfarve: sort jernoxid (E172), propylenglycol (E1520), shellac.
English: The Cmax and AUCinf of sonidegib in Japanese healthy subjects were 1.56 and 1.68-fold higher, respectively, than those seen in Western healthy subjects for a single dose of 200 mg.
Danish: Sonidegibs Cmax og AUCinf hos raske japanske forsøgspersoner var henholdsvis 1,56 og 1,68 gange højere end hos raske vestlige forsøgspersoner ved en enkelt dosis på 200 mg.
English: Do not use while pregnant or breast-feeding.
Danish: Må ikke anvendes under graviditet eller amning.
English: • Patient educational material
Danish: • Uddannelsesmateriale til patienter
English: • medicines such as ritonavir, saquinavir or zidovudine used to treat AIDS or HIV
Danish: • medicin, som fx ritonavir, saquinavir eller zidovudin mod AIDS eller HIV
English: • medicines such as statins and fibric acid derivatives used to treat high cholesterol and lipids
Danish: • medicin, som fx statiner og fibrinsyrederivater mod forhøjet kolesterol og lipider
English: Monitor muscle symptoms for changes until resolution to baseline.
Danish: Monitorér muskelsymptomer for ændringer indtil bedring til baseline.
English: - You should not donate blood while on treatment with Odomzo and for 20 months after ending your treatment.
Danish: - Du må ikke give blod, så længe du er i behandling med Odomzo og i 20 måneder, efter at din behandling er afsluttet.
English: • severe muscle cramps, muscle pain or muscle weakness.
Danish: • kraftige muskelkramper, muskelsmerter eller muskelsvækkelse.
English: No dose adjustment is necessary in patients with hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion.
English: Muscle-related adverse events
Danish: Muskelrelaterede bivirkninger
English: • Continue treatment at the same dose and monitor CK levels weekly until resolution to baseline level and then monthly thereafter.
Danish: • Fortsæt behandlingen ved samme dosis og monitorér CK-værdier ugentligt indtil bedring til baseline-niveau og derefter månedligt.
English: Longer duration of concomitant use of CYP3A4 strong inhibitors (e.g. more than 14 days) will lead to a larger fold change in sonidegib exposure based on simulation.
Danish: Simulationer viser, at længere tids samtidig brug af stærke CYP3A4- inducere (fx mere end 14 dage) vil medføre en flere gange større ændring af eksponeringen for sonidegib.
English: Prescribing and dispensing restrictions for women of childbearing potential
Danish: Begrænsninger vedrørende ordination og udlevering til fertile kvinder
English: Aspartate amino transaminase (AST) increased
Danish: Forhøjet aspartataminotransaminase (ASAT)
English: • medicines such as chloroquine and hydroxychloroquine used to treat parasitic infections as well as other diseases such as rheumatoid arthritis or lupus erythematosus
Danish: • medicin, som fx chloroquin og hydroxychloroquin mod parasitære infektioner og mod andre sygdomme som leddegigt eller lupus erythematose
English: These effects observed at clinically relevant exposures include closure of bone growth plates, effects on growing teeth, effects on the male and female reproductive tract, atrophy of the hair follicles with alopecia, gastrointestinal toxicity with body weight loss and effects on lymph nodes.
Danish: Disse observerede kliniske relevante virkninger omfatter lukning af epifyseskiverne, virkninger på voksende tænder, virkninger på hanners og hunners reproduktionssystem samt atrofi af hårfollikler med alopeci.
English: For sonidegib-treated male rats, exposure at approx. 2-fold the clinical exposure did not impact male fertility.
Danish: Hos hanrotter, der blev behandlet med sonidegib, påvirkede en eksponering på ca. 2 gange den kliniske eksponering ikke den hanlige fertilitet.
English: Odomzo may cause severe birth defects, You must not become pregnant while taking this medicine (see “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men” in section 2 for more information).
Danish: Du må ikke blive gravid, mens du tager denne medicin (se flere oplysninger i “Graviditet”, ”Amning”, ”Frugtbarhed” og “Prævention til mænd og kvinder” i punkt 2).
English: The majority of patients treated with Odomzo 200 mg daily who had grade 2 or higher CK elevations developed muscle symptoms prior to the CK elevations.
Danish: Hovedparten af de patienter, der fik behandling med Odomzo 200 mg dagligt og som havde forhøjet CK af grad 2 eller derover, udviklede muskelsymptomer forud for CK-stigningerne.
English: Iron oxide red (E172) Titanium dioxide (E171)
Danish: Titandioxid (E171)
English: If a dose is missed, it should be taken as soon as this is realised, unless more than six hours have passed since it was scheduled to be taken; in this case, the patient should wait and take the next scheduled dose.
Danish: Hvis en dosis glemmes, skal den tages, så snart det opdages, medmindre der er gået mere end seks timer, siden den skulle have været taget.
English: The most common grade 3/4 adverse drug reactions occurring in ≥2% of patients treated with Odomzo 200 mg were fatigue, weight decreased and muscle spasms.
Danish: De mest almindelige grad 3/4 bivirkninger, som forekom hos ≥2 % af de patienter, der blev behandlet med Odomzo 200 mg, var træthed, nedsat vægt og muskelspasmer.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sun Pharmaceutical Industries Europe B.V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Sun Pharmaceutical Industries Europe B.V.
English: • Do not eat for 2 hours before taking Odomzo and for 1 hour afterwards.
Danish: • Du må ikke spise noget, 2 timer før du tager Odomzo og 1 time efter, at du har taget Odomzo.
English: Crospovidone (Type A) Lactose monohydrate Magnesium stearate Poloxamer (188) Silica, colloidal anhydrous Sodium lauryl sulfate
Danish: Crospovidon (Type A) Lactosemonohydrat Magnesiumstearat Poloxamer (188) Silica, kolloid vandfri
English: • Monitor muscle symptoms for changes until resolution to baseline.
Danish: • Monitorér muskelsymptomer for ændringer indtil bedring til baseline.
English: - If you are male, you should not donate semen at any time during treatment and for 6 months after the final dose.
Danish: - Som mand må du ikke være sæddonor på noget tidspunkt under behandlingen og i 6 måneder efter den sidste dosis.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg sonidegib (as phosphate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 200 mg sonidegib (som fosfat).
English: Other medicines and Odomzo
Danish: Brug af anden medicin sammen med Odomzo
English: • abnormal hair growth
Danish: • unormal hårvækst
English: Compared to the fasted state, the Cmax and AUC of Odomzo 200 mg increased 1.8- and 1.6-fold, respectively, when a moderate meal was taken 2 hours before the administration.
Danish: Sammenlignet med fastende tilstand steg Cmax og AUC for Odomzo 200 mg henholdsvis 1,8 og 1,6 gange, når et moderat måltid blev indtaget 2 timer før administration.
English: • She must not become pregnant while taking Odomzo and for 20 months after her final dose.
Danish: • Hun må ikke blive gravid, så længe hun tager Odomzo og i 20 måneder efter den sidste dosis.
English: Odomzo is contraindicated in woman of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (see section 4.3).
Danish: Odomzo er kontraindiceret til fertile kvinder, som ikke overholder Odomzos program for svangerskabsforbyggelse (se pkt.
English: • A requirement to inform patients of the teratogenic risks associated with Odomzo and the need to avoid foetal exposure
Danish: • Et krav om at informere patienter om den teratogene risiko forbundet med Odomzo og nødvendigheden af at undgå eksponering af fosteret
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator
English: • The need to tell patients to report immediately to the treating healthcare professional if pregnancy is suspected in a female patient, or in a female partner of a male patient
Danish: hvis graviditet mistænkes hos en kvindelig patient eller hos en kvindelig partner til en mandlig patient
English: Agents that may decrease sonidegib plasma concentration
Danish: Stoffer, der kan mindske plasmakoncentrationen af sonidegib
English: Agents that may increase sonidegib plasma concentration
Danish: Stoffer, der kan øge plasmakoncentrationen af sonidegib
English: • Safety advice for women of childbearing potential
Danish: • Råd om sikkerhed til kvinder i den fertile alder
English: Haematological parameters Haemoglobin decreased
Danish: Hæmatologiske parametre Nedsat hæmoglobin
English: Reproductive and developmental toxicity
Danish: Reproduktion og forstertoksisitet
English: The patient educational material for Odomzo should contain the following key elements:
Danish: Uddannelsesmaterialet for Odomzo til patienter skal indeholde følgende vigtige informationer:
English: • Vasectomy
Danish: • Vasektomi
English: [Grade 3 (CK elevation >5 x ULN - 10 x ULN)] [Grade 4 (CK elevation >10 x ULN)]
Danish: Grad 3 eller 4 uden nedsat nyrefunktion (serum-Cr ≤ ULN) [Grad 3 (forhøjet CK >5 x ULN - 10 x ULN)] [Grad 4 (forhøjet CK >10 x ULN)]
English: Compared to the fasted state, the Cmax and AUC of Odomzo 800 mg was increased 7.8- and 7.4-fold, respectively when the dose was given with a high-fat meal.
Danish: Sammenlignet med fastende tilstand steg Cmax og AUC for Odomzo 800 mg henholdsvis 7,8 og 7,4 gange, når dosis blev givet sammen med et fedtrigt måltid.
English: Women of child-bearing potential must use two methods of recommended contraception, including one highly effective method and a barrier method, while taking Odomzo and for 20 months after ending treatment (see section 4.6).
Danish: Fertile kvinder skal anvende to anbefalede præventionsmetoder, inklusive en yderst effektiv metode og en barrieremetode, så længe de tager Odomzo og i 20 måneder efter endt behandling (se pkt.
English: • Any male condom (with spermicide, if available)
Danish: • Enhver type kondom til mænd (så vidt muligt med spermicid)
English: • Information for women of childbearing potential
Danish: • Information til kvinder i den fertile alder
English: Sonidegib and its metabolites are eliminated primarily by the hepatic route with 93.4% of the administered dose recovered in the faeces and 1.95% recovered in urine.
Danish: 93,4 % af den administrerede dosis genfindes i fæces og 1,95 % i urinen.
English: Do not crush, open or chew the capsule.
Danish: Kapslen må ikke knuses, åbnes eller tygges.
English: For women of childbearing potential Odomzo is contraindicated in women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme.
Danish: Til fertile kvinder Odomzo er kontraindiceret til fertile kvinder, som ikke overholder Odomzos program for svangerskabsforbyggelse.
English: • Information for patients on the teratogenic risks associated with Odomzo and the need to avoid foetal exposure
Danish: • Information til patienter om den teratogene risiko forbundet med Odomzo og nødvendigheden af at undgå eksponering af fosteret
English: What Odomzo is
Danish: Hvad er Odomzo?
English: The healthcare professional educational material for Odomzo should contain the following key elements:
Danish: Uddannelsesmaterialet for Odomzo til læger skal indeholde følgende vigtige informationer:
English: Because of the potential for serious adverse drug reactions, such as serious developmental defects in breast-fed newborns/infants from sonidegib, women must not breast-feed while taking Odomzo or for 20 months after ending treatment (see section 5.3).
Danish: Da sonidegib potentielt kan forårsage alvorlige bivirkninger, som fx alvorlig udviklingsmæssige defekter hos ammede nyfødte/spædbørn, må kvinder ikke amme, mens de tager Odomzo og i 20 måneder efter endt behandling (se pkt.
English: Serum creatine phosphokinase (CK) increased
Danish: Forhøjet blodkreatinkinase (CK)
English: Male patients should not donate semen while taking Odomzo and for at least 6 months after ending treatment.
Danish: Mandlige patienter må ikke donere sæd, så længe de tager Odomzo og i mindst 6 måneder efter endt behandling.
English: Male patients, even those who have had a vasectomy, must always use a condom (with spermicide, if available) when having sex with a female partner while taking Odomzo and for 6 months after ending treatment (see sections 4.6 and 5.3).
Danish: Mandlige patienter skal altid anvende kondom (så vidt muligt med sæddræbende creme), selv efter vasektomi, når de har samleje med en kvindelig partner, så længe de tager Odomzo og i 6 måneder efter endt behandling (se pkt.
English: Alanine amino transaminase (ALT) increased
Danish: Forhøjet alaninaminotransaminase (ALAT)