FrancophonIA/ELRC3.0 huggingface dataset:
English: Protopic is a dermatological medicinal product that contains the calcineurin inhibitor tacrolimus at a 0.1% and 0.03% concentration.
Danish: Protopic er et dermatologisk lægemiddel, som indeholder calcineurin-hæmmeren tacrolimus i styrkerne 0,1 % og 0,03 %.
English: However, having reviewed the available data, the CHMP concluded that not all cases could be considered to be cases of pre-existing malignancy disease, and an association with tacrolimus could not be excluded in some of the cases.
Danish: Efter at have gennemgået de foreliggende oplysninger konkluderede CHMP imidlertid, at ikke alle tilfældene kan anses for at være forud eksisterende malign sygdom, og at en sammenhæng med tacrolimus i nogle af tilfældene ikke kan udelukkes.
English: After reviewing the available data the CHMP concluded that the balance of risks and benefits for Protopic is considered favourable.
Danish: Efter at have gennemgået de foreliggende oplysninger konkluderede CHMP, at balancen mellem risici og fordele ved Protopic bør anses for gunstig.
English: Therefore the CHMP requested that the MAH should take the appropriate measures in order to ensure that Protopic is not used in this age group.
Danish: CHMP forlangte derfor, at indehaveren af markedsføringstilladelsen tager passende skridt til at sikre, at Protopic ikke anvendes i denne aldersgruppe.
English: • Protopic should not be used in immunocompromised adults or children.
Danish: • Protopic bør ikke anvendes hos voksne eller børn med nedsat immunforsvar
English: - The Committee, as a consequence, concluded that the following information should be included in the Summary of Product Characteristics and relevant sections of the Package Leaflet of Protopic:
Danish: - Som konsekvens heraf konkluderede udvalget, at følgende oplysninger skal indgå i produktresuméet og i de pågældende afsnit af indlægssedlen til Protopic:
English: The CHMP also concluded that the potential role of tacrolimus in the pathogenesis of CTCL should be further investigated through mechanistic studies.
Danish: CHMP konkluderede yderligere, at den potentielle rolle af tacrolimus i patogenesen af CTCL bør undersøges nærmere ved mekanistiske forsøg.
English: In addition, the CHMP concluded that further data are required to better elicit the long-term safety of Protopic in respect of its association with malignancies.
Danish: Desuden konkluderede CHMP, at der er brug for flere oplysninger for bedre at få belyst den langsigtede sikkerhed af Protopic hvad angår sammenhængen med ondartede lidelser.
English: Case reports of malignancies (including skin cancer, cutaneous T-Cell lymphoma (CTCL), NonHodking lymphoma (NHL) and systemic malignancies) have been received during the clinical development and post-marketing experience in association with the use of Protopic.
Danish: Der er indkommet case-rapporter om maligne lidelser i forbindelse med brug af Protopic (bestående i hudkræft, kutant T-celle lymfom (CTCL), non-Hodgkin lymfom (NHL) og systemiske maligne sygdomme) under den kliniske udvikling og efter markedsføring.
English: In order to address the safety concerns in relation to the cases of malignancies the CHMP concluded that warnings reflecting the cases of malignancies and the need for monitoring of patients treated with Protopic should be included in the product information.
Danish: Hvad angår de sikkerhedsmæssige betænkeligheder omkring tilfældene af maligne lidelser konkluderede CHMP, at der i produktoplysningerne bør indsættes advarsler, der afspejler tilfældene af maligne lidelser og nødvendigheden af at overvåge patienter, der behandles med Protopic.
English: Protopic 0.1% is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults who are not adequately responsive to or are intolerant of conventional therapies and Protopic 0.03% is indicated for the treatment of moderate to severe AD in adults or children (2 years of age and above) who failed to respond adequately to conventional therapies.
Danish: Protopic 0,03 % er indiceret til behandling af moderat til svær atopisk dermatitis hos voksne og børn (fra 2-års alderen), der ikke har reageret tilfredsstillende på traditionelle behandlingsformer.
English: In order to reduce the likelihood of mis-diagnosis and in order to better ensure the appropriate use of the medicinal product, the CHMP emphasised that the product information should reflect that the initial diagnosis and initial prescription should be undertaken by physicians with experience in the treatment of AD. Additionally, the CHMP concluded that Protopic should not be used in immunocompromised adults or children and that Protopic should not be applied to lesions that are considered to be potentially malignant or pre-malignant and that lymphadenopathy present at initiation of therapy should be investigated and kept under review.
Danish: For at begrænse sandsynligheden for fejldiagnose og sikre hensigtsmæssig brug af lægemidlet lagde CHMP vægt på, at det af produktoplysningerne fremgår, at indledende diagnose og første ordination bør foretages af læger med erfaring i behandling af atopisk dermatitis.
English: In view of the available data (including pre-clinical, clinical and epidemiological) the CHMP concluded that a potential association with the use of Protopic cannot be ruled out and therefore further data are needed to ensure an acceptable long-term safety profile.
Danish: BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN Ud fra følgende betragtninger: - Udvalget behandlede proceduren i henhold til artikel 20 af forordning (EF) nr. 726/2004 for Protopic - Udvalget tog til efterretning, at der er indberettet tilfælde af maligne lidelser (hudkræft og lymfom) hos patienter behandlet med Protopic På grundlag af de foreliggende oplysninger (prækliniske, kliniske og epidemiologiske) konkluderede CHMP, at man ikke kan udelukke en mulig sammenhæng med brug af Protopic, hvorfor der er brug for flere oplysninger for at sikre, at den langsigtede sikkerhedsprofil er acceptabel.