FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk for humans cannot be completely ruled out as the potential for local immunosuppression with the long-term use of pimecrolimus cream is unknown.
Danish: Risiko for mennesker kan ikke udelukkes fuldstændigt, da potentialet for lokal immunsuppression ved langtidsbrug af pimecrolimus ikke er kendt.
English: You should take care not to swallow it, or to accidentally transfer it into your mouth when for example it is applied to the hands.
Danish: Vær forsigtig med ikke at synke cremen eller ved et uheld få cremen ind i munden, når den f.eks. er smurt på hænderne.
English: Therefore, in patients with extensive disease, it is recommended to administer vaccinations during treatment-free intervals.
Danish: Det anbefales derfor at patienter med udbredt sygdom vaccineres i behandlingsfrie intervaller.
English: This could wash off the cream.
Danish: Cremen kan da blive skyllet af.
English: Half of the patients in the control group received topical corticosteroids for more than 95% of study days.
Danish: Halvdelen af patienterne i kontrolgruppen fik topikale kortikosteroider i mere end 95% af undersøgelsens forløb.
English: As a consequence, it blocks the synthesis of inflammatory cytokines in T cells.
Danish: Derved blokeres syntesen af inflammatoriske cytokiner i T-celler.
English: A 6-month randomized, double-blind, parallel group, vehicle-controlled study of similar design was performed in 192 adults with moderate to severe atopic dermatitis.
Danish: En 6-måneders randomiseret, dobbelt-blind, parallel, vehikelkontrolleret undersøgelse af tilsvarende design blev udført med 192 voksne med moderat til svær atopisk dermatitis.
English: • A statement reflecting the cases of malignancies reported in the post-marketing
Danish: • Oplysninger om tilfælde af maligniteter, der er blevet indberettet efter markedsføringen.
English: Data from clinical studies support intermittent treatment with <Invented Name> for up to 12 months.
Danish: Data fra kliniske undersøgelser støtter intermitterende behandling med {(Sær)navn} i op til 12 måneder.
English: Dermal application in embryo/fetal developmental studies in rats and rabbits and in carcinogenicity studies in mice and rats were negative.
Danish: Embryo/føtale udviklingsundersøgelser med dermal applikation til rotter og kaniner samt karcinogenicitetsundersøgelser med mus og rotter var negative.
English: There are no adequate data from the use of <Invented Name> in pregnant women.
Danish: Der er ikke tilstrækkelige data med henblik på anvendelse af {(Sær)navn} til gravide kvinder.
English: Cases of tumours and herpes zoster should be kept under review and regular updates should be provided in the PSURs.
Danish: Tilfælde af tumorer og herpes zoster bør overvåges løbende, og regelmæssige opdateringer bør tilvejebringes i PSUR'erne.
English: Absorption in adults
Danish: Absorption hos voksne
English: This helps to prevent progression to severe flare-ups.
Danish: Dette vil forhindre udbrud i at forværres til svær opblussen.
English: If you have any questions or are unsure about anything regarding your medicine please ask your doctor or pharmacist.
Danish: Hvis De har nogen spørgsmål eller er usikker på noget omkring Deres medicin, så kontakt lægen eller apoteket.
English: The MAHs should report on the results of all planned mechanistic studies, as part of the Risk Management Plan.
Danish: Indehaverne af markedsføringstilladelserne indberetter resultaterne af alle planlagte mekanistiske undersøgelser som del af risikostyringsplanen (Risk Management Plan).
English: Two double-blind studies of long-term management of atopic dermatitis were undertaken in 713 children and adolescents (2-17 years) and 251 infants (3-23 months).
Danish: Der er udført 2 dobbeltblinde undersøgelser med længerevarende behandling af atopisk dermatitis hos 713 børn og unge (2-17 år) og 251 små børn (3-23 måneder).
English: Some amendments of study designs have to be undertaken and further time is needed in order for pimecrolimus to be used by more subjects who can be observed for a sufficient length of time.
Danish: Der skal foretages visse ændringer i forsøgenes udformning, og der er behov for yderligere tid, så pimecrolimus kan blive anvendt af flere forsøgspersoner, som kan blive observeret over tilstrækkelig lang tid.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEERNE OG INDLÆGSSEDLERNE FREMLAGT AF EMEA
English: Also speak to your doctor before using <Invented Name> if you have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause.
Danish: De skal også kontakte lægen før brug af {(Sær)navn}, hvis De har ondartede svulster i huden (tumorer), eller hvis de har et svækket immunsystem (immunkompromiseret), uanset hvilken årsag.
English: Note: This Annex III (Summary of Product Characteristics, Labelling and Package Leaflet) is the one that was Annexed to the Commission Decision on this Article 31 referral for pimecrolimus containing medicinal products.
Danish: Bemærk: Dette bilag III (Produktresumé, Etikettering og Indlægsseddel) var bilag til Europa-Kommissionens beslutning angående denne artikel 31 arbitreringssag vedrørende lægemidler indeholdende pimekrolimus.
English: There was no increase in blood concentration over time in any patient during the 12 months of treatment.
Danish: Der var ingen stigning i blodkoncentrationen over tid hos nogen af patienterne igennem de 12 måneders behandling.
English: Absorption in children
Danish: Absorption hos børn
English: Novartis Pharma 2-4, rue Lionel Terray 92500 Rueil-Malmaison France
Danish: Novartis Pharma 2-4, rue Lionel Terray 92500 Rueil-Malmaison Frankrig
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of cream contains 10 mg of pimecrolimus.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 g creme indeholder 10 mg pimecrolimus.
English: The bioavailability of pimecrolimus in mini-pigs following a single dermal dose (applied for 22h under semi-occlusion) was 0.03%.
Danish: Biotilgængeligheden af pimecrolimus i mini-grise efter en enkelt dermal dosis (administreret i 22 timer under semi-okklusion) var 0,03%.
English: WHAT <INVENTED NAME> CREAM IS AND WHAT IT IS USED FOR
Danish: HVAD {(SÆR)NAVN} ER, OG HVAD DET ANVENDES TIL
English: Both <Invented Name> and topical corticosteroids were used without restrictions.
Danish: Både {(Sær)navn} og de topikale kortikosteroider blev anvendt uden restriktioner.
English: As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summaries of Product Characteristics and Package Leaflets are set out in Annex III.
Danish: Som følge heraf har CHMP anbefalet opretholdelse af markedsføringstilladelserne for de lægemidler, der henvises til i bilag I. Ændringerne til de relevante afsnit i produktresuméerne og indlægssedlerne er opstillet i bilag III.
English: Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AX15
Danish: Farmakoterapeutisk klassifikation: Dermatologiske midler, andre, ATC-kode: D11AX15
English: The CHMP agreed that these skin malignancies may mimic AD and that their diagnosis can be difficult.
Danish: CHMP var enig i, at disse hudmaligniteter kan ligne AD, og at de kan være svære at diagnosticere.
English: The timelines will depend on the scope of the re-analysis, which will be clarified with the RMS.
Danish: Tidsplanen vil afhænge af reanalysens omfang, hvilket vil blive yderligere afklaret i samarbejde med referencemedlemsstaterne.
English: Infants: A similar 6-week study was conducted in 186 patients aged 3-23 months.
Danish: Små børn: Der er udført lignende 6-ugers undersøgelse med 186 patienter i alderen 3-23 måneder.
English: Read the following information before you use <Invented Name> cream.
Danish: Læs følgende information, før De begynder at bruge {(Sær)navn} creme.
English: <Invented Name> has no photocarcinogenic potential in animals (see section 5.3.
Danish: {(Sær)navn} har intet fotocarcinogent potentiale hos dyr (se pkt.
English: Improvement 2
Danish: Forbedring2
English: The control group received <Invented Name> vehicle in order to maintain blinding.
Danish: Kontrolgruppen blev behandlet med {(Sær)navn} vehiklet for at opretholde blindingen.
English: The present data indicate that <Invented Name> can be used simultaneously with antibiotics, antihistamines and corticosteroids (oral/nasal/inhaled).
Danish: Nuværende data viser, at {(Sær)navn} kan anvendes samtidig med antibiotika, antihistaminer og kortikosteroider (orale/nasale/inhalerede).
English: • A statement that pimecrolimus cream should not be used in children under 2 years.
Danish: • Information om, at pimecrolimus creme ikke bør anvendes til børn under 2 år.
English: The systemic exposure at the LOAEL of 15mg/kg/day was 31 times the highest maximum exposure observed in a human (paediatric patient).
Danish: Den systemiske eksponering ved LOAEL på 15 mg/kg/dag var 31 gange højere end den højeste maksimale eskponering, som er set hos mennesker (pædiatrisk patient).
English: Systemic exposure to pimecrolimus was investigated in 58 paediatric patients aged 3 months to 14 years.
Danish: Systemisk optagelse af pimecrolimus blev undersøgt hos 58 pædiatriske patienter i alderen 3 måneder til 14 år.
English: The DSMB will be composed of independent physicians with expertise in Dermatology, Pediatric Medicine, Immunology, Epidemiology and Oncology.
Danish: DSMB sammensættes af uafhængige læger med ekspertise i dermatologi, pædiatrisk medicin, immunologi, epidemiologi og onkologi.
English: If you are using <Invented Name> , do not cover the treated skin with bandages, dressings or wraps.
Danish: Hvis De bruger {(Sær)navn}, må De ikke tildække den behandlede hud med bandager og forbindinger.
English: Surrey GUI6 7SR, United Kingdom
Danish: Surrey GUI6 7SR, Storbritannien
English: Following this request, the CHMP reviewed data on efficacy and the available data on the mentioned safety issue, including post-marketing reports, data from non-clinical studies, clinical trials and epidemiological studies.
Danish: Efter denne anmodning har CHMP gennemgået effektdata og tilgængelige data vedrørende det nævnte sikkerhedsspørgsmål, inklusive indberetninger efter markedsføringen, data fra ikke-kliniske forsøg, kliniske forsøg samt epidemiologiske undersøgelser.
English: Animal studies on milk excretion after topical application were not conducted and the use of <Invented Name> in breastfeeding women has not been studied.
Danish: Der er ikke udført dyrestudier vedrørende udskillelse i mælk efter topikal applikation, og brug af {(Sær)navn} til ammende kvinder er ikke undersøgt.
English: • Open the tube (the first time you use the tube you will need to break the seal using the spike in the top of the cap).
Danish: (Første gang De bruger tuben, skal De bryde forseglingen ved at bruge spidsen i toppen af hætten)
English: At the present stage, the CHMP considered that the data produced from reported epidemiological studies do not allow conclusions to be drawn regarding the potential risk of malignacies.
Danish: På nuværende tidspunkt vurderer CHMP, at dataene fra de indberettede epidemiologiske undersøgelser ikke gør det muligt at drage konklusioner vedrørende den potentielle risiko for maligniteter.
English: If you forget to use <Invented Name>
Danish: Hvis De glemmer at anvende {(Sær)navn}
English: The Committee also concluded that the product information should include warnings regarding the potential risk of malignancies and reflect the second line use.
Danish: Komitéen konkluderede endvidere, at produktinformationen bør indeholde advarsler vedrørende den potentielle risiko for maligniteter, og at den bør informere om brugen som sekundær behandling.
English: In view of the available data (including pre-clinical, clinical and epidemiological) the CHMP concluded that a potential association with the use of pimecrolimus cannot be ruled out and therefore further data are needed to ensure an acceptable long term safety profile.
Danish: Under hensyntagen til de tilgængelige data (inklusive prækliniske, kliniske og epidemiologiske data) konkluderede CHMP, at en potentiel forbindelse til brugen af pimecrolimus ikke kan udelukkes, og at yderligere data derfor er nødvendige for at sikre en acceptabel profil for langtidssikkerheden.
English: It is not known whether pimecrolimus is excreted in the milk after topical application.
Danish: Det vides ikke, om pimecrolimus udskilles i mælken efter topikal applikation.
English: Pharmacological/Mechanistic Studies
Danish: Farmakologiske/virkningsmekanistiske undersøgelser
English: Therefore pimecrolimus metabolism could not be determined after topical administration.
Danish: Pimecrolimus' metabolisme efter topikal administration kan derfor ikke fastlægges.
English: Children and adolescents: Two 6-week, vehicle-controlled trials were conducted including a total of 403 paediatric patients aged 2 to 17 years.
Danish: Børn og unge: Der er udført to 6-ugers, vehikelkontrollerede undersøgelser, inkluderende ialt 403 pædiatriske patienter i alderen 2-17 år.
English: Pimecrolimus had no genotoxic, antigenic, phototoxic, photoallergenic or photocarcinogenic potential.
Danish: Pimecrolimus havde intet genotoksisk, antigent, fototoksisk, fotoallergent eller fotokarcinogent potentiale.
English: • A statement to highlight that pimecrolimus should not be applied to lesions, which are considered to be potentially malignant or pre-malignant.
Danish: • En erklæring, der fremhæver, at pimecrolimus ikke bør påsmøres læsioner, der betragtes som værende potentielt maligne eller præmaligne.
English: A total of 50.0% of the patients treated with <Invented Name> did not experience any flare compared with 24.0% of the patients randomized to the control group.
Danish: Ialt 50,0% af patienterne behandlet med {(Sær)navn} oplevede ingen opblussen sammenlignet med 24,0% af patienterne randomiseret til kontrolgruppen.
English: After single oral administration of radiolabeled pimecrolimus in healthy subjects, unchanged pimecrolimus was the major active substance-related component in blood and there were numerous minor metabolites of moderate polarity that appeared to be products of O-demethylations and oxygenation.
Danish: Efter enkelt oral administration af radiomærket pimecrolimus til raske frivillige, udgjorde uomdannet pimecrolimus den største aktiv substansrelaterede bestanddel i blodet, og der var flere mindre metabolitter af moderat polaritet, som synes at være produkter af O-demethyleringer og oxydering.
English: <Invented Name> cream should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that causes immunosuppression.
Danish: {(Sær)navn} creme bør ikke bruges hos patienter med medfødte eller erhvervede immundefekter eller hos patienter, der er i en behandling, som kan give immunsuppression.
English: The MAHs should implement a comprehensive non-promotional communication plan designed to reach both prescribers and patients in order to highlight the correct use of pimecrolimus according to the approved indication; to provide guidance when to start and to stop and how to administer the cream in relation to the disease extent; and further to discourage off-label use (with regard to age groups and non-approved high risk groups).
Danish: Indehaverne af markedsføringstilladelserne implementerer en omfattende ikke-reklamerende kommunikationsplan, som er beregnet til at nå ud til både ordinerende læger og patienter med henblik på at fremhæve den korrekte brug af pimecrolimus ifølge den godkendte indikation; med henblik på at give vejledning i, hvornår man bør påbegynde og standse behandlingen med samt anvende cremen i forhold til sygdommens omfang; samt for yderligere at fraråde off labelbrug (med hensyn til aldersgrupper og ikke-godkendte højrisikogrupper).
English: Pimecrolimus blood concentrations were consistently low regardless of the extent of lesions treated or duration of therapy.
Danish: Pimecrolimus-blodkoncentrationerne var vedvarende lave, uanset graden af den behandlede læsion og varighed af behandlingen.
English: After first opening the container: 12 months.
Danish: Efter anbrud: 12 måneder.
English: Non-clinical pharmacology
Danish: Non-klinisk farmakologi
English: Pimecrolimus is a calcineurin inhibitor approved as cream formulation at a 1% concentration.
Danish: Pimecrolimus er en calcineurin-inhibitor, der er godkendt som cremeformulering med en koncentration på 1 %.
English: Do not use for other skin conditions.
Danish: Brug ikke cremen til andre hudsygdomme.
English: Tell your doctor before starting treatment with <Invented Name> if you are pregnant or think that you may be pregnant.
Danish: Inden De starter behandling med {(Sær)navn}, skal De fortælle lægen, hvis De er gravid, eller tror De måske kunne være gravid.
English: The CHMP also considered the available data from clinical trials and epidemiological studies.
Danish: CHMP tog også de tilgængelige data fra kliniske og epidemiologiske undersøgelser med i overvejelserne.
English: The use of <Invented Name> in patients under 2 years of age is not recommended until further data become available.
Danish: Børn Anvendelse af {(Sær)navn} til børn under 2 år kan ikke anbefales før der foreligger yderligere data.
English: • The treatment should be intermittent and not continuous.
Danish: • Behandlingen bør være intermitterende og ikke-kontinuerlig.
English: Please check with your doctor or pharmacist if you have any questions.
Danish: - Kontakt Deres læge eller apotek, hvis De har yderligere spørgsmål.
English: AUC ranges observed in patients with <40% BSA affected at baseline were comparable to those in patients with ≥40% BSA.
Danish: AUC-værdier hos patienter med <40% afficeret BSA ved baseline var sammenlignelige med værdier hos patienter med ≥40% BSA.
English: The efficacy and safety profile of <Invented Name> has been evaluated in more than 2,000 patients including infants (≥3 months), children, adolescents, and adults enrolled in phase II and III studies.
Danish: Kliniske data {(Sær)navn}s effekt og sikkerhedsprofil er vurderet hos mere end 2000 patienter, omfattende små børn (≥3 måneder), børn, unge og voksne, i fase II og III undersøgelser.
English: Dose-dependent increases in the incidence of lymphomas were observed at all doses in a 39 week monkey oral toxicity study.
Danish: Der observeredes en dosisafhængig øgning i forekomst af lymfomer ved alle dosistrin i et 39 ugers oralt toxicitetsstudie på aber.
English: There has been no experience of overdose with <Invented Name>.
Danish: Der er ingen erfaring med overdosering af {(Sær)navn}.
English: Atopic dermatitis (eczema) is rarely observed in patients aged 65 and over.
Danish: Atopisk dermatitis (eksem) ses sjældent hos patienter over 65 år.
English: Vehicle (N=63)
Danish: Vehikel (N=63)
English: These reactions are usually mild and last only for a short time.
Danish: Disse reaktioner er normalt milde og varer kun et kort stykke tid.
English: The MAHs should re-run the lymphoma study in 2009 and report the results to the RMS.
Danish: Indehaverne af markedsføringstilladelserne gennemfører undersøgelsen af lymfomer igen i 2009 og indberetter resultaterne til referencemedlemsstaterne.
English: Tolerability studies demonstrated that <Invented Name> has not shown contact sensitising, phototoxic or photosensitising potential, nor did they show any cumulative irritation.
Danish: Specialundersøgelser {(Sær)navn} har i tolerabilitetsundersøgelser ikke vist kontaktsensitiverende, fototoksisk eller fotosensitiverende potentiale eller nogen kumulativ irritation.
English: Topical corticosteroid medication was used on 14.2 ± 24.2% of the days of the 24-week treatment period in <Invented Name> group and on 37.2 ± 34.6% of the days in the control group (p<0.001).
Danish: I den 24-ugers behandlingsperiode anvendte {(Sær)navn}gruppen topikalt kortikosteroid i 14,2 ± 24,2% af dagene og kontrolgruppen i 37,2 ± 34,6% af dagene (p<0,001).
English: If you forget an application of the cream, apply it as soon as possible and then continue your normal dosing routine.
Danish: Hvis De glemmer en påsmøring af cremen, skal De anvende den så hurtigt som muligt og så ellers forsætte med behandlingen som hidtil.
English: The maximum body surface area treated was 92% in clinical pharmacology studies and up to 100% in Phase III trials.
Danish: Det maksimale BSA behandlet i farmakologiske undersøgelser var 92%, og op til 100% i fase III undersøgelser.
English: Vehicle (N=136)
Danish: Vehikel (N=136)
English: The MAHs should provide, if available, the immune status and serology data when reporting individual tumours to Regulatory Authorities and in the regular PSURs.
Danish: Indehaverne af markedsføringstilladelserne fremlægger, hvis sådanne er tilgængelige, immunstatus og serologidata i forbindelse med indberetning af individuelle tumorer til de lovgivende myndigheder og i de regelmæssige PSUR'er.
English: Systemic exposure is limited with the topical use of pimecrolimus.
Danish: Systemisk eksponering er begrænset med den topiske brug af pimecrolimus.
English: Use of <Invented Name> may cause mild and transient reactions at the site of application, such as a feeling of warmth and/or burning sensation.
Danish: Anvendelse af {(Sær)navn} kan forårsage milde og forbigående reaktioner på applikationsstedet, så som varm og/eller brændende fornemmelse.
English: However, <Invented Name> should not be used during pregnancy.
Danish: {(Sær)navn} bør dog ikke anvendes under graviditet.
English: <Invented Name> contains cetyl alcohol and stearyl alcohol which may cause local skin reactions.
Danish: {(Sær)navn} indeholder cetylalkohol og stearylalkohol, som kan forårsage lokale hudreaktioner.
English: <Invented Name> Cream is for use only after other prescription medicines or emollients have not worked for you or if your Doctor recommends that other prescription medicines should not be used.
Danish: {(Sær)navn} må kun bruges, hvis anden receptpligtig medicin eller fugtighedscremer ikke har virket, eller hvis Deres læge anbefaler, at anden receptpligtig medicin ikke må bruges.
English: Via Umberto Boccioni, 1 21040 Origgio, Varese Italy
Danish: Via Umberto Boccioni, 1 21040 Origgio, Varese Italien
English: Due to the potential for increased systemic absorption of pimecrolimus, <Invented Name> is not recommended in patients with Netherton's syndrome.
Danish: På grund af risiko for øget systemisk absorption af pimecrolimus, kan {(Sær)navn} ikke anbefales til patienter med Nethertons syndrom.
English: More patients treated with <Invented Name> completed 6 months [children (61% <Invented Name> vs 34% control), infants (70% <Invented Name> vs 33% control)] and 12 months with no flare [children (51% <Invented Name> vs 28% control), infants (57% <Invented Name> vs 28% control)].
Danish: Flere patienter behandlet med {(Sær)navn} gennemførte 6 måneders (børn [61% {(Sær)navn} vs 34% kontrol]; små børn [70% {(Sær)navn} vs 33% kontrol]) og 12 måneders behandling uden opblussen (børn [51% {(Sær)navn} vs 28% kontrol]; små børn [57% {(Sær)navn} vs 28% kontrol]).
English: Hypersensitivity to pimecrolimus, other macrolactams or to any of the excipients.
Danish: Hypersensitivitet over for pimecrolimus, andre makrolaktamer eller et eller flere af hjælpestofferne.
English: You can use <Invented Name> on all skin areas, including the head, face and neck and in the folds of the skin.
Danish: De kan bruge {(Sær)navn} på alle hudoverflader, inklusive hoved, ansigt, hals og i hudfolder.
English: Patients were treated twice daily with <Invented Name>.
Danish: Patienterne blev behandlet 2 gange daglig med {(Sær)navn}.
English: If you apply more cream to your skin than you needed to, just wipe it off.
Danish: Hvis De anvender mere {(Sær)navn}, end De bør Hvis De kommer til at anvende mere creme på huden, end De skulle, kan De blot tørre det af.
English: They were in a range similar to that measured in adult patients.
Danish: Blodkoncentrationerne lå inden for et område der svarede til det, der blev målt hos voksne patienter.