FrancophonIA/ELRC3.0 huggingface dataset:
English: On 6 November 2008 Denmark asked the CHMP, under Article 31 of Directive 2001/83/EC, to give its opinion on whether the marketing authorisations for GdCAs should be varied in relation to its use in special patient's population more at risk to develop nephrogenic systemic fibrosis (NSF).
Danish: I henhold til artikel 31 i direktiv 2001/83/EF anmodede Danmark den 6. november 2008 CHMP om at afgive udtalelse om, hvorvidt markedsføringstilladelserne for gadoliniumholdige kontraststoffer skulle ændres i forbindelse med anvendelsen hos en særlig patientgruppe, der er mere udsat for at udvikle nefrogen systemisk fibrose (NSF).
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 Summary of Product Characteristics and Package Leaflet are set out in Annex III and in accordance to the conditions set out in Annex IV.
Danish: Som følge heraf anbefalede CHMP at opretholde markedsføringstilladelserne for de lægemidler, der henvises til i bilag I, for hvilke ændringerne til de relevante afsnit i produktresuméet og indlægssedlen er anført i bilag III og i overensstemmelse med betingelserne i bilag IV.
English: Having considered the detailed grounds for re-examination provided by the MAH in writing, the CHMP agrees that medical history could identify some patients with possible renal dysfunction.
Danish: Efter at have vurderet de detaljerede begrundelser for revurdering, som MAH har fremsendte i skriftlig form, er CHMP enig i, at anamnesen kunne identificere nogle patienter, som muligvis lider af nyreinsufficiens.
English: However, screening should only require laboratory testing following evaluation of the patient's medical history and the minimisation measure should be the same for all GdCAs.
Danish: Men screening bør kun kræve laboratorieprøver efter en vurdering af patientens anamnese, og minimeringsforanstaltningerne bør være de samme for alle gadoliniumholdige kontraststoffer.
English: Based on the above, the CHMP concluded that its Opinion of 19 November 2009 should be maintained with the recommended amendments to relevant sections of the Summary of Product Characteristics and Package Leaflet as set out in Annex III to the opinion.
Danish: På grundlag af ovenstående konkluderede CHMP, at dets udtalelse af 19. november 2009 skal fastholdes med de anbefalede ændringer af de relevante afsnit i produktresuméerne og indlægssedlerne som anført i bilag III til udtalelsen.
English: The estimated relative risk for NSF calculated based on the number of unconfounded cases and GdCA is higher for gadodiamide (100%), gadoversetamide (94%), and gadopentetic acid (10%) and <1% for gadoteridol and gadoteric acid.
Danish: Den vurderede relative risiko for NSF beregnet på grundlag af antallet af ikke-forstyrrende tilfælde og anvendelsen af gadoliniumholdige kontraststoffer er højere for gadodiamid (100 %), gadoversetamid (94 %) og gadopentetinsyre (10 %) og <1 % for gadoteridol og gadoterinsyre.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF GADOLINIUMCONTAINING CONTRAST AGENTS (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF KONTRASTSTOFFER, DER INDEHOLDER GADOLINIUM (se bilag I)
English: In order to have a harmonised traceability method across Europe for the effective monitoring of the use of GdCAs the National Competent Authorities, coordinated by the Reference Member State (where applicable) should ensure the implementation by the MAHs of detachable (“sticky”) labels on the vials and syringes of the GdCAs.
Danish: For at have en harmoniseret sporbarhedsmetode i hele Europa til effektiv overvågning af anvendelsen af gadoliniumholdige kontraststoffer bør de nationale kompetente myndigheder, koordineret af referencemedlemsstaten (hvis relevant) sikre, at indehaverne af markedsføringstilladelsen gennemfører anvendelsen af aftagelige (”klister-”)mærker på hætteglas og injektionssprøjter med gadoliniumholdige kontraststoffer.
English: The following information is intended for medical or healthcare professionals only: [Use currently approved text with the addition of information on NSF] Prior to administration of {Invented name}, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale: [Anvend nuværende godkendt tekst og yderligere information om NSF] Inden administration af {Produktnavn} anbefales det, at alle patienter bliver screenet for nedsat nyrefunktion ved hjælp af laboratorieprøver.
English: - The Committee considered all the available data submitted on the safety of the gadolinium containing contrast agents, in relation to the risk of NSF.
Danish: - Udvalget gennemgik alle tilgængelige indsendte data vedrørende sikkerheden ved gadoliniumholdige kontraststoffer i forhold til risikoen for NSF.
English: However as the risk with gadopentetic acid remains substantially higher than the NSF risk with the other lower risk contrast agents, the CHMP recommended that gadopentetic acid should be retained in the high risk group and be subject to the same risk minimisation measures.
Danish: Da risikoen ved gadopentetinsyre dog stadig er betydeligt højere end risikoen for NSF ved de andre kontraststoffer med lavere risiko, anbefalede CHMP, at gadopentetinsyre skulle bibeholdes i højrisikogruppen og underkastes de samme risikominimeringstiltag.
English: At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut.
Danish: Der forventes ingen virkning på spædbarnet ved kliniske doser på grund af de små mængder, der udskilles i mælken og den lave absorption fra tarmen.
English: Animal studies have shown reproductive toxicity at repeated high doses (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet ved gentagne høje doser (se pkt.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ OG INDLÆGSSEDLER FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: - The CHMP concluded that the Product Information of all GdCAs should include safety information to minimise the risk of NSF and therefore recommended the amendments to the relevant sections of the Summaries of Product Characteristics and Package Leaflets in accordance to the risk category.
Danish: - CHMP konkluderede, at produktinformationen for alle gadoliniumholdige kontraststoffer bør indeholde sikkerhedsoplysninger for at minimere risikoen for NSF, og anbefalede derfor, at de relevante afsnit i produktresuméerne og indlægssedlerne ændres i overensstemmelse med risikokategorien.
English: No relative risk was estimated for the other GdCAs as their usage is too low.
Danish: Den relative risiko i forbindelse med de andre gadoliniumholdige kontraststoffer blev ikke vurderet, da anvendelsen af disse er for lav.
English: - The Committee, concluded that gadolinium contrast agents are associated with NSF and that the risk is increased in renal impaired patients, liver transplant patients, the paediatric population, during pregnancy and lactation and in the elderly.
Danish: - Udvalget konkluderede, at gadoliniumholdige kontraststoffer er forbundet med NSF, og at risikoen øges for patienter med nedsat nyrefunktion, levertransplantationspatienter, børn, under graviditet og amning samt hos ældre.
English: Use during pregnancy is not recommended for any GdCA due to the possibility of gadolinium accumulation in human tissues.
Danish: Anvendelse under graviditet anbefales ikke for noget gadoliniumholdigt kontraststof på grund af muligheden for ophobning af gadolinium i humant væv.
English: You should not be given {Invented name} if you suffer from severe kidney problems, or if you are a patient who is about to have or has recently had a liver transplant, as use of {Invented name} in patients with these conditions has been associated with a disease called nephrogenic systemic fibrosis (NSF).
Danish: Du må ikke få {Særnavn}, hvis du har alvorlige problemer med nyrerne, eller hvis du inden længe skal have eller har fået en levertransplantation, da brugen af {Særnavn} til patienter med disse tilstande er blevet forbundet med en sygdom, som kaldes nefrogen systemisk fibrose (NSF).
English: Your doctor will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive {Invented name}.
Danish: Lægen vil drøfte med dig, hvorvidt du bør fortsætte amning eller afbryde amning i 24 timer, efter du har fået {Produktnavn}.
English: GE Healthcare Via Galeno 36, 20126 Milano
Danish: GE Healthcare Via Galeno 36, 20126 Milano Italy
English: The gadolinium-containing contrast agents (GdCAs) - gadoversetamide, gadodiamide, gadopentetic acid, gadobenic acid, gadofosveset, gadoxetic acid, gadoteridol, gadobutrol and gadoteric acid - are intravenous agents used for contrast enhancement with magnetic resonance imaging (MRI) and with magnetic resonance angiography (MRA).
Danish: De gadoliniumholdige kontraststoffer - gadoversetamid, gadodiamid, gadopentetinsyre, gadobensyre, gadofosveset, gadoxetinsyre, gadoteridol, gadobutrol og gadoterinsyre - er intravenøse stoffer, der anvendes til kontrastforstærkning med magnetisk resonansscanning (MRI) og med magnetisk resonans-angiografi (MRA).
English: All GdCAs are chelate complexes containing Gd3+, the highly toxic gadolinium ion, which potentially may be released through transmetallation in vivo.
Danish: Alle gadoliniumholdige kontraststoffer er chelatkomplekser, der indeholder Gd3+, den yderst giftige gadoliniumion, som potentielt kan frigives via transmetallisering in vivo.
English: The extent of transmetallation differs significantly between the complexes with the linear chelates more likely to release Gd3+ than the cyclical chelates where the gadolinium ion is caged in a cavity.
Danish: Omfanget af transmetallisering varierer meget mellem de forskellige komplekser, idet der er større sandsynlighed for, at der frigives Gd3+ fra de lineære chelater end fra de cykliske chelater, hvor gadoliniumionen er fanget i et hulrum.
English: In order to minimise the recognised risk associated with GdCAs and the development of NSF, the CHMP agreed on the following measures for the following at risk patient groups:
Danish: For at minimere den anerkendte risiko, der er forbundet med gadoliniumholdige kontraststoffer og udviklingen af NSF, vedtog CHMP følgende tiltag for følgende udsatte patientgrupper:
English: The MAHs should provide to the CHMP an annual cumulative review on nephrogenic systemic fibrosis (NSF) cases commencing one year after Commission Decision and for 3 consecutive years.
Danish: Indehaverne af markedsføringstilladelsen bør indsende en samlet årlig gennemgang af tilfældene af nefrogen systemisk fibrose (NSF) til CHMP med start ét år efter kommissionens beslutning og i 3 efterfølgende år.
English: b) Linear ionic chelate: gadopentetic acid (Magnevist, Gado-MRT-ratiopharm, Magnegita).
Danish: b) Ionisk lineært chelat: gadopentetinsyre (Magnevist, Gado-MRT-ratiopharm, Magnegita).
English: The MAH for Omniscan (gadodiamide) disagreed with the proposed labelling warnings with respect to screening patients for renal dysfunction and requested a re-examination of the opinion.
Danish: Indehaverne af markedsføringstilladelsen for Omniscan (gadodiamid) var uenige i de foreslåede advarsler på klistermærker med henblik på screening af patienter med nyreinsufficiens og anmodede om en revurdering af udtalelsen.
English: The CHMP also recognised that according to their risk for NSF, GdCAs can be classified in 3 risk categories: high, medium and low risk.
Danish: CHMP erkendte ligeledes, at gadoliniumholdige kontraststoffer kan klassificeres i tre risikokategorier alt efter deres risiko for NSF: høj, middelhøj og lav risiko.
English: The CHMP recognises that within the high risk group the risk of NSF with gadodiamide and gadoversetamide appears higher than with gadopentetic acid based on physicochemical properties, studies in animals and the number of cases of NSF reported.
Danish: CHMP erkender, at risikoen for NSF ved gadodiamid og gadoversetamid virker højere inden for højrisikogruppen end ved gadopentetinsyre på grundlag af fysisk-kemiske egenskaber, dyreforsøg og antallet af indberettede tilfælde af NSF.
English: There is insufficient information on the excretion of {active substance} in animal milk.
Danish: Der er ikke tilstrækkelige oplysninger om udskillelsen af {aktivt stof} i mælken hos dyr.
English: In addition to the minimisation measures included in the product information, the CHMP having considered the evidence that toxic free gadolinium ions are retained in human tissues concluded that studies evaluating the potential for long-term retention of gadolinium in bone are needed.
Danish: Foruden minimeringstiltagene i produktinformationen konkluderede CHMP efter at have overvejet dokumentationen for, at de giftige frie gadoliniumioner ophobes i humant væv, at der er behov for undersøgelser til at vurdere potentialet for langsigtet ophobning af gadolinium i knoglerne.
English: Use during pregnancy and lactation
Danish: Anvendelse under graviditet og amning
English: Based on the above the CHMP recognised that there are different categories of NSF-risk for GdCAs:
Danish: Baseret på ovenstående anerkendte CHMP, at der er forskellige kategorier af NSF-risici for gadoliniumholdige kontraststoffer:
English: NSF is a disease involving thickening of the skin and connective tissues.
Danish: NSF er en sygdom, som viser sig ved fortykkelse af hud og bindevæv.
English: The use of “sticky labels” detachable from the vials and syringes are considered an appropriate method to be implemented for all GdCAs.
Danish: Anvendelsen af "klistermærker", som kan tages af hætteglas og injektionssprøjter, betragtes som en passende metode, der bør gennemføres for alle gadoliniumholdige kontraststoffer.
English: This risk minimisation was applied in accordance with the three different categories of NSF-risk for GdCAs recognised by the CHMP based on their thermodynamic and kinetic properties.
Danish: Denne risikominimering blev anvendt i overensstemmelse med de tre forskellige kategorier af risiko for NSF i forbindelse med gadoliniumholdige kontraststoffer baseret på deres termodynamiske og kinetiske egenskaber.
English: Macrocyclic chelates including gadoteric acid (Dotarem), gadoteridol (ProHance) and gadobutrol (Gadovist).
Danish: Makrocykliske chelater, herunder gadoterinsyre (Dotarem), gadoteridol (ProHance) og gadobutrol (Gadovist).
English: Therefore the use of high-risk GdCAs is contraindicated in this population.
Danish: Derfor er anvendelsen af gadoliniumholdige kontraststoffer med høj risiko kontraindiceret for denne population.
English: Before you receive {Invented name}, you will need to have a blood test to check how well your kidneys are working.
Danish: Før du får {Særnavn}, skal du have taget en blodprøve for at kontrollere, hvor godt dine nyrer fungerer.
English: DE - Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Danish: Tyskland ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: High risk: a) Linear non-ionic chelates including gadoversetamide (OptiMARK) and gadodiamide (Omniscan).
Danish: Høj risiko: a) Ikkeioniske lineære chelater, herunder gadoversetamid (OptiMARK) og gadodiamid (Omniscan).
English: {Invented name} should not be used during pregnancy unless the clinical condition of the woman requires use of {active substance}.
Danish: {Produktnavn} bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver anvendelse af {aktivt stof}.
English: Therefore, the MAHs are requested to submit to the CHMP protocols and timelines for the studies of gadolinium accumulation in human bone within 3 months of the decision on this referral procedure.
Danish: Derfor anmodes indehaverne af markedsføringstilladelsen om at indsende protokoller og tidsplaner for undersøgelser af gadoliniumophobning i humane knogler til CHMP senest 3 måneder efter beslutningen om denne procedure for henvisning af sager.
English: Co-factors that may increase the risk of NSF such as serum calcium and phosphate levels at the time of administration of a GdCA should be studied and biomarkers evaluated.
Danish: Kofaktorer, der kan øge risikoen for NSF, såsom serumcalcium og fosfatniveauer på tidspunktet for indgivelsen af et gadoliniumholdigt kontraststof, bør undersøges, og biomarkører bør evalueres.
English: Guerbet Nederland B.V. Avelingen-West 3A 4202 MS GORINCHEM Netherlands
Danish: Avelingen-West 3A 4202 MS GORINCHEM Netherlands
English: GdCAs were first associated with nephrogenic systemic fibrosis (NSF) in January 2006 when five end-stage renal failure patients undergoing MRA developed signs of NSF two to four weeks after GdCAs administration.
Danish: Gadoliniumholdige kontraststoffer blev første gang sat i forbindelse med nefrogen systemisk fibrose (NSF) i januar 2006, da fem patienter i slutstadiet af nyresvigt, der gennemgik MRA-scanning, udviklede tegn på NSF to til fire uger efter indgivelsen af de gadoliniumholdige kontraststoffer.
English: Gadolinium containing contrast agents are excreted into breast milk in very small amounts (see section 5.3).
Danish: Gadoliniumholdige kontrastmidler udskilles i human mælk i meget små mængder (se pkt.
English: In addition, the MAHs should submit a cumulative review on NSF cases annually for 3 consecutive years commencing one year after the decision on this referral procedure.
Danish: Desuden bør indehaverne af markedsføringstilladelsen indsende en samlet gennemgang af NSFtilfældene om året i 3 på hinanden følgende år med start ét år efter beslutningen om denne procedure for henvisning af sager.
English: You must tell your doctor if you think you are or might become pregnant as {Invented name} should not be used during pregnancy unless strictly necessary.
Danish: Fortæl det til din læge, hvis du tror, du er gravid eller måske kan blive gravid, da {Særnavn} ikke må bruges under graviditet, medmindre det er strengt nødvendigt.
English: Available data in animals have shown excretion of {active substance} in milk (for details see section 5.3).
Danish: Tilgængelige oplysninger fra dyr har vist, at {aktivt stof} udskilles i mælken (for yderligere oplysninger se pkt.
English: This screening is recommended for all patients who will receive medium and low NSF-risk GdCAs.
Danish: Denne screening anbefales for alle patienter, som skal have indgivet gadoliniumholdige kontraststoffer med middelhøj og lav risiko for NSF.
English: DE - Germany be imaging GmbH Dr.-Rudolf-Eberle-Str. 8-10 D-76534 Baden-Baden Germany
Danish: Tyskland be imaging GmbH Dr.-Rudolf-Eberle-Str. 8-10 D-76534 Baden-Baden Germany
English: The testing of bone samples from patients undergoing hip and knee replacement surgery is recommended.
Danish: Det anbefales, at der tages knogleprøver fra patienter, som gennemgår kirurgiske indgreb såsom udskiftning af hofter og knæ.
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for gadolinium containing contrast agents (GdCAs) initiated by Denmark.
Danish: - Udvalget behandlede den sag, der var indbragt af Danmark i henhold til artikel 31 i Rådets direktiv 2001/83/EF, med senere ændringer, for gadoliniumholdige kontraststoffer.
English: Pregnancy [Amend currently approved text for data in pregnant women and animal studies in line with the CHMP Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling (24 July 2008)]
Danish: Graviditet [den nuværende godkendte tekst vedrørende data for gravide kvinder og dyreforsøg ændres i overensstemmelse med CHMP Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling (24 July 2008)]
English: Patients undergoing liver transplantation are at particular risk of NSF if exposed to GdCAs particularly to the high-risk GdCAs.
Danish: Patienter, der gennemgår levertransplantationer, har en særlig risiko for at udvikle NSF, hvis de udsættes for gadoliniumholdige kontraststoffer, særlig de gadoliniumholdige kontraststoffer med høj risiko.
English: However, if use is necessary then dose restrictions to a minimum dose during one scan with a minimum 7 day interval between administrations are recommended.
Danish: Men hvis anvendelsen er nødvendig, anbefales en begrænsning af dosis til et minimum under én scanning med mindst syv dages interval mellem indgivelserne.
English: The MAHs should submit to the CHMP protocols and timelines for studies evaluating the potential for long-term accumulation of gadolinium in human bone.
Danish: Indehaverne af markedsføringstilladelsen bør indsende protokoller og tidsplaner for undersøgelser til vurdering af muligheden for langsigtet ophobning af gadolinium i humane knogler til CHMP.
English: No dose adjustments are recommended but screening of 65 years and older patients for renal dysfunction is of particular importance prior to the administration of GdCAs.
Danish: Der anbefales ingen dosisjusteringer, men screening af patienter over 65 år for nyreinsufficiens er særlig vigtigt inden indgivelsen af gadoliniumholdige kontraststoffer.
English: • your kidneys do not work properly • you have recently had, or soon expect to have, a liver transplant
Danish: • dine nyrer ikke fungerer ordentligt • hvis du for nylig har fået eller snart skal have en levertransplantation
English: GdCAs have been associated with nephrogenic systemic fibrosis (NSF), a rare, serious and lifethreatening syndrome involving fibrosis of the skin, joints and internal organs in patients with severe renal impairment.
Danish: Gadoliniumholdige kontraststoffer er blevet sat i forbindelse med nefrogen systemisk fibrose (NSF), et sjældent, alvorligt og livstruende syndrom, der medfører fibrose i hud, led og indre organer hos patienter med alvorlig nedsat nyrefunktion.
English: It is not necessary to adjust your dose if you are 65 years of age or older but you may have a blood test to check how well your kidneys are working.
Danish: Det er ikke nødvendigt at ændre dosis, hvis du er 65 år eller ældre, men måske skal du have foretaget en blodprøve for at kontrollere, om dine nyrer fungerer korrekt.
English: Use for whole body MRI is not recommended in children less than 6 months of age.
Danish: Anvendelse til MR-scanning af hele kroppen frarådes til børn under 6 måneder.
English: Liver transplant patients
Danish: Levertransplantationspatienter
English: Continuing or discontinuing breast feeding for a period of 24 hours after administration of {Invented name}, should be at the discretion of the doctor and lactating mother.
Danish: Om amning skal fortsætte eller ophøre i en 24-timers periode efter administration af {Produktnavn} bør afhænge af lægens og den ammende moders vurdering.
English: For all patients to whom high NSF risk GdCAs will be administered, mandatory screening for renal dysfunction by laboratory tests is required.
Danish: For alle patienter, som skal have indgivet gadoliniumholdige kontraststoffer med høj risiko for NSF, skal der obligatorisk foretages screening for nyreinsufficiens ved hjælp af laboratorieprøver.
English: It is not necessary to adjust your dose if you are 65 years of age or older but you will have a blood test to check how well your kidneys are working.
Danish: Det er ikke nødvendigt at ændre dosis, hvis du er 65 år eller derover, men du skal have taget en blodprøve for at kontrollere, hvor godt dine nyrer fungerer.
English: Although only small amounts of gadolinium are excreted into human breast milk, the immaturity of foetal kidneys could delay the excretion of gadolinium leading to the possibility of long-term accumulation of gadolinium in tissues.
Danish: Selv om der kun udskilles små mængder gadolinium i modermælken, er der risiko for, at fosterets endnu uudviklede nyrer kan forsinke udskillelsen af gadolinium og muligvis føre til en ophobning af gadolinium i vævet på længere sigt.