FrancophonIA/ELRC3.0 huggingface dataset:
English: The company is also required to analyse available tumour material from patients whose cancer worsened despite treatment, in order to determine why the treatment did not work.
Danish: Virksomheden skal også analysere tilgængeligt tumormateriale fra patienter, hvis cancer forværredes trods behandling, for at afgøre, hvorfor behandlingen ikke virkede.
English: By attaching to this protein, sonidegib blocks the Hedgehog signalling pathway and thereby reduces the growth and spread of cancer cells.
Danish: Ved at binde sig til dette protein blokerer sonidegib Hedgehog-signaleringsvejen og reducerer derved væksten og spredningen af kræftceller.
English: Other information about Odomzo
Danish: Andre oplysninger om Odomzo
English: Patients were started on two different doses of Odomzo: 200 or 800 mg once a day.
Danish: Patienter blev startet på to forskellige doser af Odomzo: 200 eller 800 mg én gang dagligt.
English: Furthermore, the company is to supply further analysis from its main study on the effectiveness and safety of Odomzo, including its effectiveness in rapidly growing and slow-growing basal cell carcinoma.
Danish: Endvidere skal virksomheden levere yderligere analyse fra sin hovedundersøgelse om Odomzos effektivitet og sikkerhed, herunder dets effektivitet over for hastigt voksende og langsomtvoksende basalcellekarcinom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Odomzo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Odomzo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It should only be prescribed by a specialist doctor experienced in the treatment of advanced basal cell carcinoma or under the supervision of such a doctor.
Danish: Det bør kun ordineres af en speciallæge med erfaring i behandling af avanceret basalcellekarcinom eller under opsyn af en sådan læge.
English: It will also supply educational material to doctors and to patients, including a reminder card about the risks of the medicine and, in particular, the possibility of serious harm to the unborn baby if Odomzo is taken during pregnancy.
Danish: Virksomheden vil også levere uddannelsesmateriale til læger og til patienter, herunder et oplysningskort om risiciene ved lægemidlet og især muligheden for alvorlig skade på det ufødte barn, hvis Odomzo tages under en graviditet.
English: Odomzo contains the active substance sonidegib.
Danish: Odomzo indeholder det aktive stof sonidegib.
English: Of those with locally advanced basal cell carcinoma, around 56% (37 of 66 patients) on the 200-mg dose and 45% (58 of 128 patients) started on the 800-mg dose responded to treatment.
Danish: Ud af dem med lokalt fremskredent basalcellekarcinom reagerede ca. 56 % (37 ud af 66 patienter) på en dosis af 200 mg, og 45 % (58 ud af 128 patienter), der blev startet på en dosis af 800 mg, på behandlingen.
English: This pathway normally controls a number of cell activities including cell growth and how cells develop correctly to make up different body organs in unborn babies.
Danish: Denne signaleringsvej kontrollerer normalt et antal celleaktiviteter, herunder cellevækst og hvordan celler udvikler sig korrekt til at blive til forskellige kropsorganer hos fostre.
English: What measures are being taken to ensure the safe and effective use of Odomzo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Odomzo?
English: Women who could potentially become pregnant must not take Odomzo unless they comply with the Odomzo pregnancy prevention programme.
Danish: Kvinder, som potentielt kan blive gravide, må ikke tage Odomzo, medmindre de følger Odomzos præventionsprogram mod graviditet.
English: Women who are pregnant or who are breastfeeding must not take Odomzo.
Danish: Kvinder, der er gravide, eller som ammer, må ikke tage Odomzo.
English: Some cancers, including basal cell carcinoma, result from overactivity of a specific set of cell processes called the Hedgehog signalling pathway.
Danish: Visse kræftformer, herunder basalcellekarcinom, stammer fra overaktivitet i et specifikt sæt celleprocesser, der kaldes Hedgehog-signaleringsvejen.
English: Response rates were less than 20% in patients with metastatic cancer started on either 200 or 800 mg Odomzo and the company withdrew its application for use in metastatic basal cell carcinoma.
Danish: Responsrater var mindre end 20 % hos patienter med metastatisk kræft, der blev startet på enten 200 eller 800 mg Odomzo, og virksomheden trak sin ansøgning for anvendelse ved metastatisk basalcellekarcinom tilbage.
English: Odomzo can only be obtained with a prescription.
Danish: Odomzo udleveres kun efter recept.
English: Sonidegib, the active substance in Odomzo, attaches to a protein that controls the Hedgehog signalling pathway.
Danish: Sonidegib, det aktive stof i Odomzo, bindes til et protein, der kontrollerer Hedgehog-signaleringsvejen.
English: Odomzo is a cancer medicine used to treat adults with basal cell carcinoma (a type of skin cancer) which is locally advanced (has started to spread nearby) and which cannot be treated either by surgery or by radiotherapy (treatment with radiation).
Danish: Odomzo er et kræftlægemiddel, der anvendes til behandling af voksne med basalcellekarcinom (en type hudkræft), som er lokalt fremskredent (er begyndt at sprede sig lokalt), og som ikke kan behandles enten ved operation eller ved stråleterapi (behandling med stråling).
English: Odomzo was studied in one main study involving 230 patients with basal cell carcinoma which was either locally advanced or metastatic (spread to other parts of the body).
Danish: Odomzo blev undersøgt i en hovedundersøgelse, der involverede 230 patienter med basalcellekarcinom, som enten var lokalt fremskredent eller metastatisk (spredt til andre dele af kroppen).
English: It is not intended to provide practical advice on how to use Odomzo.
Danish: Det er ikke en praktisk vejledning i, hvordan Odomzo bør anvendes.
English: What is Odomzo and what is it used for?
Danish: Hvad er Odomzo, og hvad anvendes det til?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Odomzo, including the precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Odomzo, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: For more information about treatment with Odomzo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Odomzo, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why is Odomzo approved?
Danish: Hvorfor blev Odomzo godkendt?
English: What are the risks associated with Odomzo?
Danish: Hvilke risici er der forbundet med Odomzo?
English: The main measure of effectiveness was the response to treatment, based on a reduction in tumour size and improvement in other signs of cancer; treatment was considered sufficiently effective if the response rate was at least 30%.
Danish: Hovedmålet for effektivitet var responsen på behandlingen, baseret på en reduktion i tumorstørrelse og forbedring af andre tegn på cancer.
English: For the full list of all side effects reported with Odomzo, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Odomzo fremgår af indlægssedlen.
English: For practical information about using Odomzo, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Odomzo, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Therefore, women taking Odomzo must take effective measures to prevent pregnancy during treatment and for 20 months after stopping it. Men taking Odomzo must always use condoms for sex with female partners and for 6 months after stopping treatment.
Danish: Mænd, der tager Odomzo, skal altid anvende kondom ved sex med kvinder og i 6 måneder efter behandlingens afslutning.
English: What benefits of Odomzo have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Odomzo?
English: How is Odomzo used?
Danish: Hvordan anvendes Odomzo?
English: How does Odomzo work?
Danish: Hvordan virker Odomzo?
English: Subcutaneos use
Danish: Subkutan anvendelse
English: 1 vial
Danish: 1 hætteglas Ikke relevant
English: 1 bottle + 1 oral syringe + 1 press-in bottle adapter
Danish: 1 flaske + 1 oral sprøjte + 1 adapter til flasken
English: Clear or almost clear 1
Danish: Klar eller næsten klar 1
English: However, you can still wear normal clothing.
Danish: De kan dog have Deres almindelige tøj på.
English: However, this interaction has not been studied.
Danish: Denne interaktion er dog ikke undersøgt.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Danish: {Navn og adresse} <{tlf}> <{fax}> <{email}>
English: It may harm them, even if their symptoms are the same as yours
Danish: Det kunne skade dem, selvom deres symptomer er de samme som Deres egne.
English: • Wash and dry your hands.
Danish: • Vask og tør hænderne
English: In these three 6-week studies, the efficacy results at endpoint were as follows:
Danish: I disse tre 6-ugers undersøgelser var effektresultaterne ved endpoint som følger:
English: 59.9% 33% not done
Danish: 59,9% 33% ikke udført
English: Keep the tube tightly closed.
Danish: Hold tuben helt lukket.
English: Therefore it should not be used in this age group.
Danish: Derfor bør den ikke bruges til denne aldersgruppe.
English: Your doctor will be able to tell you if this is necessary.
Danish: Deres læge vil fortælle Dem, hvis det er nødvendigt.
English: The data of both studies were pooled.
Danish: Data fra begge undersøgelser blev poolet.
English: This will be re-evaluated on a regular basis.
Danish: Dette vil regelmæssigt blive taget op til fornyet vurdering.
English: The first report will be provided in 2007 and this requirement will be reevaluated on a regular basis.
Danish: Den første rapport vil blive udsendt i 2007, og dette krav vil blive revurderet regelmæssigt.
English: 2Improvement=lower IGA than at baseline
Danish: 2: Forbedring=lavere IGA end ved baseline
English: It does not contain any steroids.
Danish: Den indeholder ikke nogen steroider.
English: In general, these data are not conclusive and the studies have weaknesses which limit their interpretation.
Danish: Generelt er disse data ikke fuldgyldige, og undersøgelserne har svagheder, hvilket begrænser fortolkningen af dataene.
English: Once opened, the tube should be used within 12 months.
Danish: Efter åbning bør tuben bruges inden 12 måneder.
English: 68% 40% Not done
Danish: 68% 40% ikke udført
English: Populations with potentially higher risk of systemic exposure.
Danish: Populationer med potentielt højere risiko for systemisk eksponering.
English: The malignancies reported were very diverse in their origin and location.
Danish: De indberettede maligniteter var meget forskelligartede med hensyn til deres oprindelse og lokalisering.
English: Do not use it in your nose, eyes or mouth.
Danish: Brug ikke cremen i næsen, øjnene eller munden.
English: If you have a weakened immune system (you are immuno-compromised)
Danish: - hvis De har et svækket immunsystem (De er immunkompromiseret).
English: Registry Study (C2311)
Danish: Registerundersøgelse (C2311)
English: Do not use after the expiry date shown on the carton and tube.
Danish: Anvend ikke efter udløbsdatoen, som er angivet på karton og tube.
English: Independent DSMB
Danish: Uafhængig DSMB
English: You may need to read it again.
Danish: De får muligvis behov før at læse den igen.
English: 1: p-value based on CMH test stratified by centre
Danish: 1: p-værdi baseret på CMH test stratificeret af centret
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING PIMECROLIMUS (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE PIMECROLIMUS (se bilag I)
English: However a local immunosuppressive effect in the skin cannot be excluded.
Danish: Imidlertid kan en lokal immunosuppressiv virkning i huden ikke udelukkes.
English: Study C2308
Danish: Undersøgelse C2308
English: If signs and symptoms return you should start treatment again.
Danish: Hvis tegn og symptomer kommer igen, skal De genoptage behandlingen.
English: This is reflected by the findings from the fertility study.
Danish: Dette afspejles i fundene i fertilitetsundersøgelsen.
English: Long-term clinical trials were 1 year in duration.
Danish: Længerevarende kliniske undersøgelser varede 1 år.
English: You may find it helpful to write the date you opened the tube in the space provided on the carton.
Danish: Det kan være en hjælp at skrive datoen, hvor De åbnede tuben, i feltet på kartonen.
English: The cream should be applied twice daily, for instance once in the morning and once in the evening.
Danish: {(Sær)navn} bør anvendes 2 gange daglig, for eksempel 1 gang om morgenen og 1 gang om aftenen.
English: A Dear Healthcare professional letter should be sent to relevant Healthcare professionals on 3 April
Danish: Der sendes et brev til relevante fagfolk inden for sundhedssektoren den 3. april 2006.
English: If the application site reaction is severe, the risk-benefit of treatment should be re-evaluated.
Danish: Hvis reaktionen på applikationsstedet er af svær grad, bør risk-benefit ved behandlingen revurderes.
English: Pimecrolimus is exclusively metabolised by CYP 450 3A4.
Danish: Pimecrolimus metaboliseres udelukkende af CYP 450 3A4.
English: • Squeeze the cream onto your finger.
Danish: • Tryk cremen ud på en finger
English: National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: Nationale kompetente myndigheder koordineret af referencemedlemsstaterne skal sikre, at følgende forhold opfyldes af indehaverne af markedsføringstilladelserne.
English: Short-term (acute) treatment:
Danish: Korterevarende (akut) behandling:
English: In accordance with the “Guideline on risk management systems for medicinal products for human use (EMEA/CHMP/96268/2005)”, the MAHs should provide a full Risk Management Plan to the RMS.
Danish: I overensstemmelse med “Guideline on risk management systems for medicinal products for human use (EMEA/CHMP/96268/2005)”, indsender indehaverne af markedsføringstilladelserne en fyldestgørende risikostyringsplan til referencemedlemsstaterne.
English: very common: application site burning.
Danish: - Meget almindelig: brænden ved applikationsstedet.
English: These children were treated with <Invented Name> twice daily for 3 weeks and five out of them were treated for up to 1 year on a “as needed” basis.
Danish: Børnene blev behandlet med {(Sær)navn} 2 gange daglig i 3 uger, og 5 af dem blev behandlet i op til 1 år på ”efter behov” basis.
English: PHARMACEUTICAL FORM Cream.
Danish: LÆGEMIDDELFORM Creme.
English: Distribution, Metabolism, and Excretion
Danish: Fordeling, metabolisme og udskillelse
English: Clinical studies with <Invented Name> did not include a sufficient number of patients in this age range to determine whether they respond differently from younger patients.
Danish: Kliniske undersøgelser med {(Sær)navn} har ikke inkluderet et tilstrækkeligt antal patienter i denne aldersgruppe til at fastlægge, hvorvidt de skulle respondere anderledes end yngre patienter.
English: Frequency estimates: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000, including isolated reports).
Danish: Hyppighedsberegning: meget almindelig (≥1/10); almindelig (≥1/100, <1/10); usædvanlig (≥1/1000, <1/100); sjælden (≥1/10.000, <1/1000); meget sjælden (<1/10.000, herunder enkeltstående indberetninger).
English: Continue using the cream for as long as your doctor advises.
Danish: Fortsæt med at anvende cremen lige så længe, som lægen råder Dem til.
English: Overall (mean % change)3
Danish: Total (gennemsnitlig ændring i %)3
English: Signs of recovery and/or at least partial reversibility of the effects were noted upon cessation of dosages in a few animals.
Danish: Der blev set tegn på bedring og/eller i det mindste delvis reversibilitet af effekten ved ophør af indgift hos nogle få dyr.
English: This should encompass all age groups including those aged <2 years.
Danish: Dette bør omfatte alle aldersgrupper, inklusive børn under 2 år.
English: There is no clinical data beyond 1 year of treatment.
Danish: Der foreligger ingen kliniske data fra mere end 1 års behandling.
English: Frequency of application greater than twice daily has not been studied.
Danish: Applikationshyppighed over 2 gange daglig er ikke undersøgt.
English: Total mean recovery of radioactivity was 80.9%.
Danish: Gennemsnitlig genfunden radioaktivitet var totalt 80,9%.
English: Therefore the CHMP requested that the MAH should take the appropriate measures in order to ensure that Elidel is not used in this age group.
Danish: Derfor har CHMP anmodet om, at indehaveren af markedsføringstilladelsen tager passende forholdsregler for at sikre, at Elidel ikke anvendes i denne aldersgruppe.
English: Do not bath, shower or swim right after applying <Invented Name> .
Danish: Tag ikke bad, brusebad eller svøm lige efter påsmøring af {(Sær)navn}.
English: The main reasons include too short lengths of exposure, too short durations of follow-up and methodological shortcomings.
Danish: De vigtigste grunde hertil omfatter for korte perioder af eksponering for stoffet, for kort varighed af opfølgningen samt metodologiske mangelfuldheder.
English: Animal studies using dermal application do not indicate direct or indirect harmful effects with respect to embryonal/fetal development.
Danish: Dyrestudier med dermal applikation indikerer hverken direkte eller indirekte skadelig virkning med hensyn til embryo/føtal udvikling.
English: Active substance-related radioactivity was excreted principally via the faeces (78.4%) and only a small fraction (2.5%) was recovered in urine.
Danish: Aktiv substansrelateret radioaktivitet blev primært udskilt via fæces (78,4%) og kun en lille del (2,5%) blev genfundet i urinen.
English: Carefully follow all instructions given to you by your doctor.
Danish: Følg omhyggeligt alle lægens instruktioner.
English: The duration of the exposure to pimecrolimus cream until the diagnosis of malignancy was also different in all cases, and it was not possible to detect any specific trend.
Danish: Varigheden af eksponeringen for pimecrolimus creme indtil diagnosticeringen af malignitet var ligeledes forskellig i samtlige tilfælde, og det var ikke muligt at påvise nogen specifik tendens.
English: Tubes of 15, 30, 60 and 100 grams.
Danish: Tuber med 15, 30, 60 og 100 gram.
English: The CHMP also expressed concerns about the degree of use of topical pimecrolimus in children under the age of 2 (not approved) when the immune system is still developing.
Danish: CHMP udtrykte ligeledes bekymring over graden af brug af topisk pimecrolimus hos børn under 2 år (ikke godkendt), hvor immunsystemet stadig er under udvikling.
English: The affected BSA ranged from 10-92%.
Danish: Det afficerede BSA varierede fra 10-92%.
English: On the view of these results, the necessity for further studies should be rediscussed with the RMS.
Danish: Ud fra disse resultater skal nødvendigheden af yderligere undersøgelser igen drøftes med referencemedlemsstaterne.
English: The efficacy of <Invented Name> was maintained over time.
Danish: Effekten af {(Sær)navn} blev opretholdt over tid.
English: <Invented Name> should be used for as short period as possible during flares of disease.
Danish: {(Sær)navn} bør anvendes i så korte perioder som muligt ved opblussen af sygdommen.
English: Based on the minimal extent of absorption, a potential systemic interaction with vaccination is unlikely to occur.
Danish: Baseret på den minimale grad af absorption er det ikke sandsynligt, at der skulle forekomme systemisk interaktion med vaccinationer.
English: 3: p-value based on ANCOVA model of EASI at Day 43 endpoint, with centre and treatment as factors and baseline (Day 1) EASI a covariate;
Danish: 3: p-værdi baseret på ANCOVA modellen af EASI ved Dag 43 endpoint, med centret og behandlingen som faktorer og baseline (Dag 1) EASI et co-variat
English: Potential interactions between <Invented Name> and other medicinal products have not been systematically evaluated.
Danish: Potentielle interaktioner mellem {(Sær)navn} og andre lægemidler er ikke systematisk undersøgt.
English: Failure to derive a NOAEL precludes an assessment of the margin of safety between a non-carcinogenic concentration in the monkey and exposures in patients.
Danish: At det ikke lykkedes at opnå et NOAEL udelukker en vurdering af sikkerhedsmargin mellem en ikke-carcinogen koncentration hos aber og eksponering hos patienter.
English: Denmark requested the CHMP to give its opinion on the benefit/risk profile of pimecrolimus considering efficacy and safety concerns with regards to the potential risk of cancer.
Danish: Danmark anmodede CHMP om at give sin vurdering af benefit/risk-profilen af pimecrolimus, med hensyn til betragtninger vedrørende effekt og sikkerhed i forhold til den potentielle risiko for kræft.
English: Over 1,500 of these patients were treated with <Invented Name> and over 500 were treated with control treatment i.e. either <Invented Name> vehicle and/or topical corticosteroids.
Danish: Mere end 1500 af disse patienter blev behandlet med {(Sær)navn} og mere end 500 blev behandlet med kontrolbehandling, det vil sige enten {(Sær)navn} vehiklet og/eller topikale kortikosteroider.
English: Stop the treatment and consult your doctor if no improvement occurs after 6 weeks or if your eczema gets worse.
Danish: Stop behandlingen og rådfør Dem med lægen, hvis der ikke er sket en forbedring efter 6 uger, eller hvis eksemen forværres.
English: Patients HIV status, HTLV-1 for T-cell lymphomas and EVB status for B-cell lymphomas
Danish: Patienters HIV-status, HTLV-1 for T-celle lymfomer og EVB status for B-celle lymfomer
English: Occlusive dressings are not recommended.
Danish: Okklusive forbindinger anbefales ikke.
English: DK-2100 København Ø, Denmark
Danish: DK-2100 København Ø, Danmark
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing topical pimecrolimus.
Danish: - Komitéen har overvejet henvisningen under artikel 31 i direktiv 2001/83/EF, med senere ændringer, vedrørende lægemidler indeholdende topisk pimecrolimus.
English: Whitish and homogeneous.
Danish: Hvidlig og ensartet.
English: Please consult your doctor.
Danish: Spørg lægen.
English: The amount of active substance-related material in the skin at the application site (almost exclusively unchanged pimecrolimus) remained practically constant for 10 days.
Danish: Mængden af aktivt substansrelateret materiale i huden på applikationsstedet (næsten udelukkende uomdannet pimecrolimus) forblev næsten konstant i 10 dage.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORIZATION
Danish: BILAG IV BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Use of pimecrolimus in the EU vs US
Danish: Brugen af pimecrolimus i EU i forhold til i USA
English: • Pimecrolimus cream should not be used in immunocompromised adults or children.
Danish: • Pimecrolimus creme bør ikke anvendes til immunkompromitterede voksne eller børn.
English: The most common adverse events were application site reactions which were reported by approximately 19% of the patients treated with <Invented Name> and 16% of patients in the control groups.
Danish: De mest almindelige bivirkninger var reaktioner ved applikationsstedet, som blev indberettet hos ca. 19% af patienterne behandlet med {(Sær)navn} og 16% af patienterne i kontrolgrupperne.