FrancophonIA/ELRC3.0 huggingface dataset:
English: • Solid organ transplantation:
Danish: • Organtransplantation:
English: To achieve a harmonized SmPC, the MAH used the wording that is common to national SmPCs in the majority of MSs and the MAH's Core Data Sheet (CDS) for Sandimmun Neoral (dated 13 February 2012), as well as submitted legacy studies and literature references.
Danish: Til udarbejdelsen af et harmoniseret produktresumé anvendte indehaveren af markedsføringstilladelsen dels den ordlyd, der er fælles for de nationale produktresuméer i størstedelen af medlemsstaterne, dels virksomhedens centrale datablad (CDS) for Sandimmun Neoral (dateret den 13. februar 2012) foruden de oprindeligt indsendte undersøgelser og litteraturhenvisninger.
English: Whilst reviewing the MAH's proposal, in view of the SmPC guideline, the CHMP considered that the category “not known” should only be used in exceptional cases; the MAH was requested to adhere to the classification according to the CSP unless adequately justified.
Danish: Under gennemgang af forslaget fra indehaveren af markedsføringstilladelsen bemærkede CHMP, at kategorien “ikke kendt” kun bør benyttes undtagelsesvis i henhold til vejledningen om produktresuméer; indehaveren af markedsføringstilladelsen blev anmodet om at henholde sig til klassifikationen svarende til de centrale sikkerhedsoplysninger, medmindre det var tilstrækkeligt begrundet.
English: According to the EU guideline on the implementation of the outcome of a PSUR WS procedure, the 29 EU countries have submitted, within a 4 month timeframe after the release of the CSP, a variation to implement the agreed CSP.
Danish: Inden for en 4-måneders frist efter frigivelsen af de vedtagne centrale sikkerhedsoplysninger har de 29 EU-lande ved en ændringsansøgning søgt disse implementeret i henhold til EU-retningslinjerne for gennemførelse af udfaldet af en PSUR-arbejdsdelingsprocedure.
English: Posology:
Danish: Dosering:
English: The MAH addressed the points raised by the CHMP and proposed a final wording for this section on which the CHMP agreed.
Danish: Indehaveren af markedsføringstilladelsen imødekom de af CHMP rejste punkter og foreslog en endelig ordlyd til dette afsnit, som CHMP godkendte.
English: Sandimmun Neoral is available as Sandimmun Neoral soft gelatin capsules (10 mg, 25 mg, 50 mg and 100 mg) and Sandimmun Neoral oral solution, 100 mg/ml.
Danish: Sandimmun Neoral markedsføres som Sandimmun Neoral, bløde gelatinekapsler (10 mg, 25 mg, 50 mg og 100 mg) og Sandimmun Neoral, oral opløsning, 100 mg/ml.
English: In addition, the CHMP requested the MAH to specify in the SmPC whether Sandimmun/Sandimmun Neoral should be administered with or without food or if administration may be performed irrespective of concomitant food intake.
Danish: Desuden anmodede CHMP indehaveren af markedsføringstilladelsen om i produktresuméet at angive, om Sandimmun/Sandimmun Neoral bør administreres sammen med et måltid, mellem måltiderne eller uafhængigt af måltider.
English: • Nephrotic syndrome (NS)
Danish: • Nefrotisk syndrom
English: • Rheumatoid arthritis (RA)
Danish: • Reumatoid arthritis
English: The MAH's proposed indication wording for nephritic syndrome is approved in 16 EU countries.
Danish: Den af markedsføringstilladelsesindehaveren foreslåede ordlyd af indikationen nefrotisk syndrom er godkendt i 16 EU-lande.
English: After review of the dataset, the proposed posology in the bone marrow transplantation indication as approved in 16 EU MS was acceptable to the CHMP.
Danish: Efter gennemgang af datasættet kunne CHMP godtage den ansøgte dosering ved indikationen knoglemarvstransplantation, således som den var godkendt i 16 EU medlemsstater.
English: Sandimmun is available as Sandimmun soft gelatin capsules (25 mg, 50 mg and 100 mg), Sandimmun oral solution, 100 mg/ml and Sandimmum concentrate for solution for infusion, 50mg/ml.
Danish: Sandimmun markedsføres som Sandimmun, bløde gelatinekapsler (25 mg, 50 mg og 100 mg), Sandimmun, oral opløsning, samt Sandimmun, koncentrat til infusionsvæske, opløsning, 50 mg/ml.
English: The MAH proposed the wording related to the method of oral administration which is approved in 12 EU countries.
Danish: Vedrørende metoden til oral administration foreslog indehaveren af markedsføringstilladelsen en ordlyd, der er godkendt i 12 EU-lande.
English: With regards to the paragraphs concerning Medical supervision, Lymphomas and other malignancies, Geriatrics, Hyperkalaemia, Hypomagnesemia and Hyperuricaemia, Special excipients, the MAH proposed the CSP wording as the harmonised SmPC text.
Danish: Til afsnittene om Lægelig overvågning, Lymfomer og andre maligne sygdomme, Geriatri, Hyperkaliæmi, Hypomagnesiæmi og Hyperurikæmi og Særlige hjælpestoffer foreslog indehaveren af markedsføringstilladelsen, at ordlyden i de centrale sikkerhedsoplysninger blev anvendt i det harmoniserede produktresumé.
English: Based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon a harmonised wording of the section 4.2 accordingly for the special populations.
Danish: Efter vurdering af markedsføringstilladelsesindehaverens forslag, besvarelserne til LoQ og LoOI og drøftelserne i udvalget vedtog CHMP en harmoniseret ordlyd i overensstemmelse hermed af punkt 4.2 for særlige populationer.
English: However in view of the CHMP concerns the MAH revised and shortened the initially proposed text, leading for a final wording which was endorsed by the CHMP.
Danish: For at imødekomme CHMP's betænkeligheder reviderede og afkortede indehaveren af markedsføringstilladelsen dog den først foreslåede tekst, og CHMP godkendte den endelige ordlyd.
English: The MAH proposed a wording accordingly to include these recommendations, as requested by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen foreslog en tilsvarende ordlyd, der indeholdt disse anbefalinger som anmodet af CHMP.
English: Transplantation indications:
Danish: Transplantationsindikationer:
English: Regarding the sub-sections Doses/side effects, Infections and infestations and Neoplasms, Other ADRs from post-marketing experience, the MAH proposed align the harmonized SmPC text with the agreed CSP.
Danish: Vedrørende underafsnittene Doser/bivirkninger, Infektioner og parasitangreb, Neoplasmer og Andre bivirkninger fra erfaringerne efter markedsføring foreslog indehaveren af markedsføringstilladelsen at rette det harmoniserede produktresumé ind efter de vedtagne centrale sikkerhedsoplysninger.
English: The CHMP was concerned by the fact that different approaches in monitoring proposals for transplantation and non-transplantation populations were proposed by the MAH, ignoring blood levels measurements in non-transplant indications.
Danish: CHMP var betænkelig ved, at indehaveren af markedsføringstilladelsen foreslog forskellige tilgange til monitorering af transplantationspatienter og andre patienter og derved så bort fra blodkoncentrationsbestemmelse ved andre indikationer end transplantation.
English: • Solid organ transplantation
Danish: • Organtransplantation
English: In that context, a thorough comparison of the Feb 2011 agreed CSP information and the safety sections of the newly released CDSs was performed by the MAH.
Danish: I denne forbindelse foretog indehaveren af markedsføringstilladelsen en grundig gennemgang af de centrale sikkerhedsoplysninger, der var vedtaget i februar 2011, og af sikkerhedsafsnittene i de netop frigivne centrale datablade.
English: The MAH's proposed indication wording for rheumatoid arthritis is approved in 13 EU countries.
Danish: Den af markedsføringstilladelsesindehaveren foreslåede ordlyd af indikationen reumatoid arthritis er godkendt i 13 EU-lande.
English: The MAH agreed with the CHMP's opinion and a wording was agreed accordingly.
Danish: Indehaveren af markedsføringstilladelsen var enig i CHMP's opfattelse, og der blev vedtaget en ordlyd i henhold hertil.
English: The MAH provided the requested data and clarifications accordingly.
Danish: Indehaveren af markedsføringstilladelsen fremlagde de anmodede data og tilhørende præciseringer, og der blev vedtaget en ordlyd i overensstemmelse hermed.
English: The CHMP considered that the use of Hypericum perforatum (St. John's wort, SJW) products in the treatment of a mild depression was not considered to balance the potential risk of an acute organ rejection caused by SJW induction; the CHMP requested the introduction of a contraindication accordingly.
Danish: CHMP fandt ikke, at fordelene ved brug af produkter indeholdende Hypericum perforatum (prikbladet perikum) til behandling af let depression opvejede den potentielle risiko for akut organafstødning ved induktion fremkaldt af perikum.
English: Based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon a harmonised wording of the section 4.2 accordingly for the non-transplantations indications.
Danish: Efter vurdering af forslaget fra indehaveren af markedsføringstilladelsen, besvarelserne til LoQ, LoOI og drøftelserne i udvalget vedtog CHMP en harmoniseret ordlyd af punkt 4.2 i overensstemmelse hermed for andre indikationer end transplantation.
English: As stated above, the MAH proposed a following wording for the above-mentioned paragraph based on the wordings used in the CDS and CSP.
Danish: Som nævnt foreslog indehaveren af markedsføringstilladelsen følgende ordlyd til ovennævnte afsnit, baseret på ordlyden i det centrale datablad og de centrale sikkerhedsoplysninger.
English: In conclusion, based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon and adopted harmonised sets of PI documents for the various presentations of Sandimmun Neoral and associated names.
Danish: Efter vurderingen af forslaget fra markedsføringstilladelsesindehaveren, besvarelserne til LoQ og LoOI og drøftelserne i udvalget vedtog CHMP til sidst et harmoniseret sæt dokumenter til produktinformation for de forskellige pakningsstørrelser af Sandimmun Neoral og relaterede navne.
English: The efficacy of Sandimmun (oil based formulation of ciclosporin) has been demonstrated in 4 randomized controlled and 5 uncontrolled studies.The clinical results from these 9 clinical studies were analyzed using a pooling of data from all studies (controlled and uncontrolled).
Danish: De kliniske resultater af disse ni kliniske undersøgelser blev analyseret ved pooling af data fra alle undersøgelserne (kontrollerede og ukontrollerede).
English: Thus, the harmonized label for the safety section of the SmPC proposed by the MAH was based on the agreed CSP and enhanced with some newly added information from the full review of the MAH's labels (CDSs).
Danish: Markedsføringstilladelsesindehaverens forslag til harmoniserede produktoplysninger i produktresuméets sikkerhedsafsnit var således baseret på de vedtagne centrale sikkerhedsoplysninger, udvidet med visse nye oplysninger fra den fuldstændige gennemgang af markedsføringstilladelsesindehaverens produktoplysninger (centrale datablade).
English: The MAH agreed with the CHMP's opinion and hence revised the wording of the posology in the solid organ transplantation indication accordingly.
Danish: Indehaveren af markedsføringstilladelsen tilsluttede sig CHMP's opfattelse og reviderede ordlyden tilsvarende for doseringen ved indikationen organtransplantation.
English: Therefore, based on clinical data summary on atopic dermatitis and references provided by the MAH, the CHMP considers the argumentation made by the MAH acceptable and therefore agrees with the above mentioned wording.
Danish: Efter gennemgang af af den af markedsføringstilladelsesindehaveren forelagte komplette sammenfatning af kliniske data og litteraturhenvisninger vedrørende atopisk dermatitis kan CHMP godtage markedsføringstilladelsesindehaverens argumentation og tilslutter sig derfor ovenstående ordlyd.
English: The MAH agreed to include the above mentioned contraindication.
Danish: Indehaveren af markedsføringstilladelsen indvilligede i at indsætte denne kontraindikation.
English: Additional pharmacokinetics and pharmacodynamics studies, as well as non clinical trials were performed with Sandimmun Neoral medicinal product to support its registration.
Danish: Med henblik på registreringen af Sandimmun Neoral blev der udført supplerende farmakokinetiske og farmakodynamiske undersøgelser med dette produkt.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Sandimmum and associated names (see Annex I).
Danish: • det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaverne af markedsføringstilladelserne, blev vurderet på grundlag af den forelagte dokumentation og de videnskabelige drøftelser i udvalget,
English: The MAH agrees with the CHMP's view.
Danish: Indehaveren af markedsføringstilladelsen tilslutter sig CHMP's synspunkt.
English: Based on the comprehensive clinical data summary on psoriasis and references provided by the MAH, the CHMP considers the argumentation made by the MAH acceptable and therefore agrees with the wording proposed by the MAH.
Danish: Efter gennemgang af den komplette sammenfatning af kliniske data og litteraturhenvisninger vedrørende psoriasis, der er forelagt af indehaveren af markedsføringstilladelsen, kan CHMP godtage dennes argumentation og foreslåede ordlyd.
English: The CHMP agreed with the wording proposed by the MAH.
Danish: CHMP godkendte den foreslåede ordlyd.
English: The CHMP provided the MAH with a detailed suggestion of a clearer structure and proposed text revisions accordingly.
Danish: CHMP var ikke enig i markedsføringstilladelsesindehaverens forslag til ordlyden af dette afsnit, men fremlagde et detaljeret forslag for markedsføringstilladelsesindehaveren til en klarere struktur og tilsvarende revisioner af teksten.
English: The CHMP was of the view that the proposed text is relevant to include and therefore the CHMP agreed with the wordings as proposed by the MAH.
Danish: CHMP fandt den foreslåede tekst relevant og tilsluttede sig ordlyden som foreslået af markedsføringstilladelsesindehaveren.
English: Based on the most commonly approved wording in EU member states and the recent version of the company core data sheet (CDS) dated 13 February 2012, the MAH proposed a wording which is already approved in 13 EU MS.
Danish: Indehaveren af markedsføringstilladelsen forslog en ordlyd, der i forvejen er godkendt i 13 EUmedlemsstater og dermed tager udgangspunkt i den mest udbredte godkendte ordlyd i EU's medlemsstater og den nyeste version af virksomhedens centrale datablad (CDS) dateret 13. februar
English: Non-transplantation indications:
Danish: Andre indikationer end transplantation:
English: This point was addressed by the MAH and a wording was agreed.
Danish: Dette blev imødekommet af indehaveren af markedsføringstilladelsen, og der blev vedtaget en ordlyd.
English: The CHMP therefore agreed with the approach taken by the MAH.
Danish: CHMP tilsluttede sig derfor den tilgang, der var valgt af indehaveren af markedsføringstilladelsen.
English: • Bone marrow transplantation
Danish: • Knoglemarvstransplantation
English: The CHMP was in agreement with the approach taken by the MAH.
Danish: CHMP var enig i den tilgang, der var valgt af indehaveren af markedsføringstilladelsen.
English: A revised wording was proposed by the MAH accordingly and endorsed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen foreslog en tilsvarende revideret ordlyd, som CHMP godkendte.
English: The CHMP agreed with the addition proposed by the MAH.
Danish: CHMP godkendte tilføjelsen som foreslået af markedsføringstilladelsesindehaveren.
English: Non-transplantation indications
Danish: Andre indikationer end transplantationsindikationer
English: The CHMP was in agreement with this approach and related wordings as proposed by the MAH.
Danish: CHMP var enig heri og i den tilsvarende ordlyd, der blev foreslået af indehaveren af markedsføringstilladelsen.
English: The MAH accepted the proposal to amend the ADRs as highlighted by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen indvilligede i at rette bivirkningerne som foreslået af CHMP.
English: It is recommended that Sandimmun Neoral be administered on a consistent schedule with regard to time of day and relation to meals.
Danish: Det anbefales, at Sandimmun Neoral administreres på samme klokkeslæt og med samme relation til måltiderne fra dag til dag.” Denne ordlyd blev godkendt af CHMP.
English: The CHMP was in agreement with the MAH's proposal.
Danish: CHMP var enig i markedsføringstilladelsesindehaverens forslag.
English: The CHMP is in agreement with the MAH's position.
Danish: CHMP er enig i markedsføringstilladelsesindehaverens standpunkt.
English: The MAH proposed to harmonise the SmPC text along with the agreed CSP.
Danish: Indehaveren af markedsføringstilladelsen foreslog at harmonisere produktresuméets tekst i overensstemmelse med de vedtagne centrale sikkerhedsoplysninger.
English: The recommended dose is…
Danish: Den anbefalede dosis er...
English: Teva Ελλάς Α.Ε.
Danish: Ελλάδα Teva Ελλάς Α.Ε.
English: This can help to provide more information on the safety of medicines like this one.
Danish: Dette kan hjælpe med at fremskaffe mere information om sikkerheden af lægemidler som dette.
English: It needs to be treated at once.
Danish: Det skal omgående behandles.
English: Date of latest renewal: 26 August 2014.
Danish: Dato for seneste fornyelse: 26. august 2014
English: - Uncontrolled hypertension.
Danish: - Ukontrolleret hypertension.
English: Do not give this medicine to children and adolescents under 18 years of age because there are no data that show that this medicine is safe and works in this age group.
Danish: Giv ikke dette lægemiddel til børn og unge under 18 år, for der er ingen data der viser, at dette lægemiddel er sikkert og virker i denne aldersgruppe.
English: - if you have high blood pressure that cannot be controlled.
Danish: - hvis du har højt blodtryk, der ikke kan kontrolleres.
English: Date of first authorisation: 23 October 2009.
Danish: Dato for første markedsføringstilladelse: 23. oktober 2009.
English: This medicine may not be suitable for the following patients.
Danish: Dette lægemiddel er muligvis ikke egnet til følgende patienter.
English: Furthermore, deaths were more frequent in this patient group compared to younger patients.
Danish: Desuden sås flere dødsfald i denne patientgruppe end blandt yngre patienter.
English: Approximately 9% of patients can be expected to experience an adverse reaction.
Danish: Det kan forventes, at ca. 9 % af patienterne får en bivirkning.
English: Please discuss this with your doctor.
Danish: Tal med lægen om dette.
English: Proper treatment of your disease, however, requires close and constant co-operation with your doctor.
Danish: Den rette behandling af din sygdom opnår du dog kun gennem et tæt og løbende samarbejde med din læge.
English: End of 7 days period at room temperature: __/__/____
Danish: Sidste dag i perioden på 7 dage ved stuetemperatur: __/__/____
English: Your healthcare professional will always record the exact product you are using.
Danish: Dit sundhedspersonale vil altid registrere lige nøjagtigt det præparat, du anvender.
English: Do not warm Biopoin in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Opvarm ikke Biopoin på anden vis (den må for eksempel ikke varmes i mikrobølgeovn eller i varmt vand).
English: Your doctor will work out the right dose for you.
Danish: Din læge vil fastsætte den rigtige dosis til dig.
English: Your doctor or nurse will give you instructions on how to do this.
Danish: Din læge eller sygeplejerske kan vejlede dig i, hvordan du skal gøre.
English: *See subsection “Description of selected adverse reactions” below
Danish: *Se underpunktet ”Beskrivelse af udvalgte bivirkninger” nedenfor
English: - Severely elevated blood pressure:
Danish: - Alvorligt forhøjet blodtryk:
English: Treatment with Biopoin is divided into two stages: a) Correcting the anaemia
Danish: Behandling med Biopoin inddeles i to faser: a) Afhjælpning af anæmi
English: It works in exactly the same way as erythropoietin.
Danish: Det virker på nøjagtig samme måde som erytropoietin.
English: The extent of absorption (AUC) was slightly greater after injection in the abdomen in comparison to the other sites.
Danish: Absorptionsomfanget (AUC) var lidt større efter injektion i abdomen i forhold til de øvrige to steder.
English: It should be allowed to reach a comfortable temperature (15 °C - 25 °C) for injection.
Danish: Den skal have lov til at nå en behagelig temperatur (15 °C - 25 °C) til injektion.
English: Epoetins are not indicated for use in this patient population.
Danish: Epoetiner er ikke indiceret til anvendelse hos disse patientpopulationer.
English: Do not inject a double dose to make up for a forgotten dose.
Danish: Du må ikke indsprøjte en dobbeltdosis som erstatning for den glemte dosis.
English: In order to improve the traceability of epoetins, the name of the administered epoetin should be clearly recorded in the patient file.
Danish: For at forbedre epoetinernes sporbarhed, skal navnet på det administrerede epoetin registreres tydeligt i patientfilen.
English: Your treatment with this medicine is being initiated by a doctor who is experienced in the above-mentioned indications.
Danish: Din behandling med dette lægemiddel iværksættes af en læge med erfaring i ovennævnte indikationer.
English: It is unknown whether the active substance in this medicine passes over to the breast milk.
Danish: Det er ukendt, om det aktive stof i medicinen går over i modermælken.
English: Epoetin theta is a protein produced by biotechnology.
Danish: Epoetin theta er et protein, der fremstilles ved hjælp af bioteknologi.
English: Only clear, colourless solutions without particles should be used.
Danish: Kun klare, farveløse opløsninger uden synlige partikler må anvendes.
English: The safety and efficacy of Biopoin in children and adolescents aged up to 17 years have not yet been established.
Danish: Biopoins sikkerhed og virkning hos børn i alderen 0-17 år er endnu ikke klarlagt.
English: Anaemia occurs when your blood does not contain enough red blood cells.
Danish: Anæmi opstår, når dit blod ikke indeholder nok røde blodlegemer.
English: To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment.
Danish: For at sikre effektiv erytropoiese skal alle patienter screenes for jernstatus før og under behandlingen.
English: These symptoms could indicate that your treatment with this medicine is ineffective.
Danish: Disse symptomer kan være tegn på, at behandlingen med dette lægemiddel ikke virker.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of epoetin theta in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af epoetin theta til gravide kvinder.
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Danish: Erytropoietinreceptorer kan udtrykkes på overfladen af en række forskellige tumorceller.
English: Find a comfortable, well-lit place.
Danish: Find et behageligt sted med godt lys.
English: Average bioavailability of epoetin theta after subcutaneous administration is approximately 31% compared with intravenous administration.
Danish: Den gennemsnitlige biotilgængelighed for epoetin theta efter subkutan administration er ca. 31 % sammenlignet med intravenøs administration.
English: Anaemia in cancer patients
Danish: Anæmi hos kræftpatienter
English: Biopoin has not been tested in pregnant women.
Danish: Brug af Biopoin er ikke undersøgt hos gravide kvinder.
English: Hypertension can be treated with appropriate medicinal products (see section 4.4).
Danish: Hypertension kan behandles med passende lægemidler (se pkt.