FrancophonIA/ELRC3.0 huggingface dataset:
English: • Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary.
Danish: • Patienter, der modtager sirolimus, nifedipin eller itraconazol i kombination med Mycamine skal overvåges for sirolimus-, nifedipin- eller itraconazoltoksicitet, og sirolimus-, nifedipineller itraconazoldoseringen skal om nødvendigt reduceres.
English: • Caution must be demonstrated if the patient: - has severe liver function impairment - has chronic liver diseases known to represent preneoplastic conditions (e.g. advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects) - is receiving a concomitant therapy including hepatotoxic and/or genotoxic properties - is receiving concomitant therapy with amphotericin B desoxycholate - has history of haemolysis, haemolytic anaemia or renal impairment.
Danish: • Der skal udvises forsigtighed, hvis patienten: - har alvorligt forringet leverfunktion - har kronisk leversygdom, der udviser kendte præneoplastiske tilstande (fx. fremskreden leverfibrose, cirrose, viral hepatitis, neonatal leversygdom eller kongenitte enzymdefekter) - modtager samtidig behandling, der omfatter hepatotoksiske og/eller genotoksiske egenskaber - modtager samtidig behandling med amphotericin B-deoxycholat - har anamnestisk hæmolyse, hæmolytisk anæmi eller nedsat nyrefunktion.
English: • Mycamine is contra-indicated if the patient has a history of hypersensitivity to micafungin, other echinocandins or excipients.
Danish: • Mycamine er kontraindiceret, hvis patienten har kendt hypersensitivitet over for micafungin, andre echinocandiner eller hjælpestofferne.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET SKAL IMPLEMENTERES AF MEDLEMSLANDENE
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below i.e. the details of a prescription checklist are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller begrænsninger mht. sikker og effektiv anvendelse af nedenstående beskrevne lægemidler d.v.s. om udlevering og brug implementeres:
English: The study started on the 1st of June 2009 and results are expected to be available in 2013.
Danish: Undersøgelsen begyndte den 1. juni 2009, og resultaterne ventes at foreligge i 2013.
English: This information was circulated in a rapid alert triggering a procedure under Article 107 of Directive 2001/83/EC, as amended.
Danish: Disse oplysninger blev udsendt som en hurtig varsling, der udløste en procedure i henhold til artikel 107 i direktiv 2001/83/EF, som ændret.
English: All 10,330 patients were assigned to three risk categories for long-term mortality based on the clinical condition.
Danish: Alle 10 330 patienter blev tilordnet til tre risikokategorier for langsigtet mortalitet på grundlag af deres kliniske tilstand.
English: Overall summary of the scientific evaluation of somatropin-containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler indeholdende somatropin (se bilag I)
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended for somatropin-containing medicinal products;
Danish: • Udvalget behandlede proceduren i henhold til artikel 107 i direktiv 2001/83/EF, som ændret, for lægemidler indeholdende somatropin.
English: Overall mortality risk was small, with an excess of 23 deaths over the 70 expected.
Danish: Den samlede mortalitetsrisiko var lille med en overdødelighed på 23 dødsfald i forhold til de forventede 70.
English: However, this study presents significant methodological limitations that preclude these results to be regarded as robust.
Danish: Undersøgelsen har imidlertid væsentlige metodologiske begrænsninger, som udelukker, at disse resultater kan anses for holdbare.
English: Finally, data from the patient group that died due to diseases of the circulatory system showed that all but one had been treated for a diagnosis of growth hormone deficiency.
Danish: Endelig viste data fra den gruppe patienter, som døde på grund af kredsløbssygdomme, at alle undtagen én var blevet behandlet for diagnosen væksthormonmangel.
English: Therefore, limited information on long-term safety of somatropin treatment is currently available.
Danish: På nuværende tidspunkt foreligger således kun begrænsede oplysninger om den langsigtede sikkerhed af somatropinbehandling.
English: This long-term surveillance study collected data from all patients that were treated with rhGH in the period from 1985 to 1996 and who were older than 18 years of age at the time of data collection in 2007.
Danish: I denne langsigtede overvågningsundersøgelse blev der indsamlet data fra alle patienter, der blev behandlet med rhGH i perioden fra 1985 til 1996, og som var over 18 år på tidspunktet for dataindsamlingen i 2007.
English: A large epidemiological study based on data from the Association France-Hypophyse registry was ongoing since 2007 - the French Santé Adulte GH Enfant (SAGHE) study.
Danish: En stor epidemiologisk undersøgelse baseret på registerdata fra Association France-Hypophyse har været i gang siden 2007 - den franske Santé Adulte GH Enfant (SAGHE) undersøgelse.
English: • The Committee agreed that the French SAGHE study has significant methodological limitations (e.g. general population used as reference for the calculation of mortality).
Danish: • Udvalget fandt, at den franske SAGHE-undersøgelse havde væsentlige metodologiske begrænsninger (f.eks. at den almindelige befolkning blev anvendt som reference for beregningen af mortalitet).
English: This information is very limited not allowing a conclusion with regards the cardiovascular risks.
Danish: Der er således tale om meget begrænsede oplysninger, som ikke gør det muligt at drage en konklusion om de kardiovaskulære risici.
English: The SAGHE study in Europe is part of the FP7 Health work programme and approximatelly the sample size is of 30,000 patients will be included in the 8 involved countries (France, Belgium, United Kingdom, Netherlands, Switzerland, Italy, Germany and Sweden).
Danish: SAGHE-undersøgelsen i Europa er en del af arbejdsprogrammet FP7 Health og har en stikprøvestørrelse på ca. 30 000 patienter, som vil blive inkluderet i de otte involverede lande (Frankrig, Belgien, Det Forenede Kongerige, Nederlandene, Schweiz, Italien, Tyskland og Sverige).
English: The primary objective of the study was to evaluate the overall and cancer-related mortality and morbidity risks in comparison with risks in the general population.
Danish: Undersøgelsens primære formål var at vurdere den totale og cancerrelaterede mortalitets- og morbiditetsrisiko i forhold til risikoen i den almindelige befolkning.
English: The suggested increased risk with the higher doses is only statistically significant in the group treated with mean doses above 50 µg/kg/day (n=281).
Danish: Den formodede øgede risiko ved de højere doser er kun statistisk signifikant i den gruppe, der blev behandlet med en gennemsnitsdosis over 50 µg/kg/dag (n = 281).
English: Namely, the general population used as reference group for the calculation of the standard mortality ratios leading to unmeasurable confounding.
Danish: At anvende den almindelige befolkning som referencegruppe til beregning af standardmortalitetsrater medfører således en ubestemmelig konfundering.
English: J Clin Endocrinol Metab 2006;91:3494-3498
Danish: J Clin Oncol 2006;91:3494-3498
English: • The Committee agreed however, that the results of the French SAGHE study are regarded as potential safety signal.
Danish: • Udvalget fandt dog, at resultaterne af den franske SAGHE-undersøgelse bør anses for et potentielt sikkerhedssignal.
English: In addition the risk increased with short duration of treatment, nevertheless a sub-analysis by cumulative doses did not confirm this finding.
Danish: Derudover øges risikoen ved kort behandlingstid, men en underanalyse baseret på kumulative doser bekræftede ikke dette resultat.
English: No information on the presence of cardiovascular risk factors was available for 3 out of 9 patients.
Danish: Hos 3 ud af 9 patienter forelå ingen oplysninger om tilstedeværelse af kardiovaskulære risikofaktorer.
English: On 9 December 2010, the French National Competent Authority (AFSSAPS) informed the European Commission, the European Medicines Agency and all Member States of unpublished results of the SAGHE study that showed an all-cause mortality significantly higher in children treated with rhGH (standard mortality ratio - SMR of 1.33, 95% CI 1.08;1.64).
Danish: Den 9. december 2010 underrettede de kompetente franske myndigheder (AFSSAPS) EuropaKommissionen, Det Europæiske Lægemiddelagentur og alle medlemsstaterne om de upublicerede resultater af SAGHE-undersøgelsen, der viste signifikant forhøjet dødelighed af alle årsager hos børn behandlet med rhGH (standardmortalitetsrate (SMR) 1,33, 95 % SI 1,08;1,64).
English: However, the results of the French SAGHE study are regarded as potential safety signal to be further considered in light of long term safety data that will become available in 2 years time, namely the results of the European SAGHE consortium study.
Danish: Resultaterne af den franske SAGHE-undersøgelse anses dog for at være et potentielt sikkerhedssignal, som bør vurderes nærmere på baggrund af de langsigtede sikkerhedsdata, der bliver tilgængelige om to år, nemlig resultaterne af den fælleseuropæiske SAGHE-undersøgelse.
English: Some indications are not approved for all somatropin containing medicines.
Danish: Visse indikationer er ikke godkendt til alle lægemidler indeholdende somatropin.
English: The safety of growth hormone therapy has been mainly based on large samples of patients followed in post-marketing databases during or not for long after treatment.
Danish: Sikkerheden af væksthormonbehandling har hovedsagelig været baseret på store stikprøver af patienter, der efter markedsføringen via databaser blev fulgt op under behandlingen eller efterfølgende i kortere tid.
English: Somatropin (rhGH) products have been available in Europe since the late 1980's for the treatment of several conditions associated with growth hormone deficiency and/or short stature.
Danish: Produkter indeholdende somatropin (rhGH) har været på markedet i Europa siden slutningen af 1980'erne til behandling af en række sygdomme knyttet til væksthormonmangel og/eller kort statur.
English: No data on the occurrence of non-fatal neoplasms in patients of the SAGHE study is, at the moment, available and the morbidity results are still is on-going.
Danish: På nuværende tidspunkt er oplysninger om forekomsten af ikke-fatale neoplasmer hos patienter i SAGHE-undersøgelsen ikke tilgængelige, og indsamlingen af resultater om morbiditet er fortsat i gang.
English: In children with inadequate endogenous growth hormone, somatropin stimulates linear growth and increases growth rate.
Danish: Hos børn med insufficient endogent væksthormon stimulerer somatropin den lineære vækst og øger væksthastigheden.
English: It is noted that in this group, 225 (80%) patients were part of a company-sponsored study conducted in children born short for gestational age (SGA) and overall this is considered a very small subpopulation for a clear association of the suggested risk with the dose.
Danish: Det bemærkedes, at i denne gruppe indgik 225 (80 %) af patienterne i en virksomhedssponsoreret undersøgelse hos børn, der var små ved fødslen i forhold til fosteralderen (SGA), hvilket overordnet må anses for at være en meget lille underpopulation som grundlag for at fastslå en klar sammenhæng mellem den formodede risiko og dosis.
English: Somatropin is a recombinant human growth hormone (rhGH) acting on the metabolism of lipids, carbohydrates and proteins.
Danish: Somatropin er et rekombinant humant væksthormon (rhGH) med virkning på metabolismen af lipider, kulhydrater og proteiner.
English: Of the 93 allcause mortality cases, 21 classified as resulting from “ill-defined conditions” are of unknown cause.
Danish: At de 93 dødsfald af alle årsager er årsagen ukendt til de 21, der blev klassificeret som forårsaget af ”ikke nærmere bestemte tilstande”.
English: Also, the characteristics of the treated patients that per se may be associated with increased mortality, even if in a low risk group (i.e. treated for isolated GHD, ISS and SGA).
Danish: Desuden kan de behandlede patienters karakteristika i sig selv være forbundet med øget mortalitet, selv i en lavrisikogruppe (dvs. en gruppe, der behandles for isoleret GHD, ISS og SGA).
English: Currently there are nine approved somatropin-medicinal products in the Union: Genotropin, Humatrope, Maxomat, Norditropin, Saizen, Zomacton approved via Mutual Recognition procedure (MRP) or Nationally (NAP) and Omnitrope, NutropinAq and Valtropin approved centrally (CAP).
Danish: På nuværende tidspunkt er ni somatropinprodukter godkendt i EU: Genotropin, Humatrope, Maxomat, Norditropin, Saizen, Zomacton, der er godkendt via den gensidige anerkendelsesprocedure (MRP) eller ved en national godkendelse (NAP), samt Omnitrope, NutropinAq og Valtropin, der er centralt godkendt (CAP).
English: Finally, to address the potential signal of an increased risk with increased dose as suggested by the results of the French SAGHE study, it was agreed to emphasize in the product information of all somatropin-containing medicinal products that the maximum recommended daily dose should not be exceeded.
Danish: Som reaktion på det potentielle signal om øget risiko ved stigende dosis, som resultaterne af den franske SAGHE-undersøgelse giver anledning til, blev det vedtaget, at det i produktinformationen for alle produkter indeholdende somatropin skal fremhæves, at den maksimale anbefalede dagsdosis ikke bør overskrides.
English: In adults, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by mobilisation of body fat.
Danish: Hos voksne opretholder somatropin den normale kropssammensætning ved at øge kvælstofoptagelsen og stimulere væksten af skeletmuskulaturen samt ved at mobilisere kropsfedtet.
English: All other data reviewed by the CHMP did not corroborate the results of the SAGHE study or did provide new or additional safety concerns.
Danish: Ingen øvrige data, som er gennemgået af CHMP, har bekræftet resultaterne af SAGHE-undersøgelsen eller givet anledning til nye eller yderligere sikkerhedsmæssige betænkeligheder.
English: This potential risk should also be reflected in the Risk Management Plan for all somatropin products as well as the potential risk of subarachnoid or intracerebral haemorrhage.
Danish: Denne potentielle risiko bør ligeledes afspejles i risikohåndteringsplanen for alle produkter indeholdende somatropin, foruden den potentielle risiko for subaraknoidal eller intracerebral blødning.
English: Grounds for amendment of the summaries of product characteristics and Package Leaflets
Danish: Begrundelse for ændringen af produktresuméerne og indlægssedlerne
English: Somatropin-treatment has been associated with tumour-promoting potential and this is currently reflected in the product information of all somatropin-containing medicinal products.
Danish: Behandling med somatropin er blevet tillagt tumorigent potentiale, hvilket afspejles i den nuværende produktinformation for alle lægemidler indeholdende somatropin.
English: Scientific conclusions and grounds for the amendment of the summaries of product characteristics and package leaflets presented by the EMA
Danish: Bilag II Videnskabelige konklusioner og begrundelse for ændringen af produktresuméerne og indlægssedlerne fremlagt af EMA
English: Considering previously published data and information already included in the Product Information for some somatropins, the Committee considered that it is justified to harmonise existing contraindications for all somatropin containing medicines when there is any evidence of activity of a tumour.
Danish: På baggrund af tidligere offentliggjorte data og oplysninger, som allerede indgår i produktinformationen for nogle somatropiner, anså udvalget det for berettiget at harmonisere de eksisterende kontraindikationer for alle produkter indeholdende somatropin ved tegn på tumoraktivitet.
English: • The Committee considered the results of the French SAGHE study and all available data submitted from clinical trials, registries, cohorts and safety databases in relation to the cardiovascular risk and risk of neoplasm associated with somatropin-treatment.
Danish: • Udvalget gennemgik data fra den franske SAGHE-undersøgelse og alle data, der var forelagt fra kliniske undersøgelser, registre, kohorter og sikkerhedsdatabaser vedrørende den kardiovaskulære risiko og risikoen for neoplasmer knyttet til behandling med somatropin.
English: 1 Swerdlow AJ, Higgins CD, Adlard P, et al. Risk of cancer in patients treated with pituitary growth hormone in the UK, 195985: a cohort study.
Danish: 1 Swerdlow AJ, Higgins CD, Adlard P, et al. Risk of cancer in patients treated with pituitary growth hormone in the UK, 1959-85: an epidemiological cohort study.
English: Results of the French SAGHE study, a long-term surveillance study in a high number of patients and with a mean follow up of 17 years suggested an overall increase of mortality in patients treated with somatropin for isolated growth hormone deficiency (GDH), idiopathic short stature (ISS) and short for gestational age (SGA) compared to the general population.
Danish: Resultaterne af den franske SAGHE-undersøgelse, en langtidsovervågningsundersøgelse hos et stort antal patienter med en gennemsnitlig opfølgningsperiode på 17 år, viste forhøjet total dødelighed hos patienter behandlet med somatropin for isoleret væksthormonmangel (GDH), idiopatisk kort statur (ISS) og lille størrelse i forhold til fosteralderen (SGA) i forhold til den almindelige befolkning.
English: The low risk population defined as treatment for idiopathic growth hormone deficiency, idiopathic short stature, short stature in children born short for gestational age, or isolated growth hormone deficiency was included in the mortality analysis (n=6,892 patients corresponding to 116,403 person-years of observation).
Danish: Lavrisikopopulationen, der var defineret som populationen behandlet for idiopatisk væksthormonmangel, idiopatisk kort statur, kort statur hos børn, der er små ved fødslen i forhold til fosteralderen, eller isoleret væksthormonmangel, indgik i mortalitetsanalysen (n = 6 892 patienter, svarende til 116 403 personårs observation).
English: There were concerns on the impact of the results of this study on the benefit-risk balance of somatropin-containing medicinal products.
Danish: Resultaterne af denne undersøgelse gav anledning til betænkelighed vedrørende risk/benefit-forholdet for lægemidler indeholdende somatropin.
English: The CHMP reviewed all data submitted including data from the French SAGHE study and from clinical trials, registries, cohorts and safety databases (pharmacovigilance) as well as data available in the literature relating to the cardiovascular risk and risk of neoplasm associated with somatropin-treatment.
Danish: CHMP gennemgik alle forelagte data, herunder data fra den franske SAGHE-undersøgelse og fra kliniske undersøgelser, registre, kohorter og sikkerhedsdatabaser (lægemiddelovervågning) samt foreliggende litteraturdata vedrørende den kardiovaskulære risiko og risikoen for neoplasmer ved behandling med somatropin.
English: In the Union, somatropin is approved to be used in children for growth hormone deficiency (including idiopathic growth hormone deficiency), growth failure in patients with Turner syndrome, chronic renal insufficiency or short stature homebox-containing gene (SHOX) deficiency, PraderWilli syndrome and in patients born small for gestational age (SGA).
Danish: I EU er somatropin godkendt til anvendelse til børn ved væksthormonmangel (herunder idiopatisk væksthormonmangel), væksthæmning hos patienter med Turners syndrom, kronisk nyreinsufficiens eller manglende short stature homebox-gen (SHOX) samt til patienter, der er små ved fødslen i forhold til fosteralderen (SGA).
English: The specific wording to be include in section 4.3 of the SmPCs and reflected in the package leaflets of all somatropin-containing medicinal products was agreed (see Annex II).
Danish: Udvalget fastlagde den nærmere ordlyd heraf, som vil indgå i punkt 4.3 af produktresuméerne og afspejles i indlægssedlerne for alle produkter indeholdende somatropin (se bilag II).
English: • Other data reviewed did not corroborate the results of the SAGHE study, or provided additional safety concerns.
Danish: • De øvrige data, som CHMP har gennemgået, kan ikke bekræfte resultaterne af SAGHEundersøgelsen og giver ikke anledning til yderligere betænkeligheder vedrørende sikkerheden.
English: In view of all the above discussed, the Committee considered justified to harmonise or include , as appropriate, contraindications for all somatropin containing medicinal products with regards the potential for tumour-promoting associated with treatment.
Danish: På baggrund af ovenstående analyse anså udvalget det for berettiget i nødvendigt omfang at indsætte kontraindikationer for alle produkter indeholdende somatropin hvad angår behandlingens tumorigene potentiale.
English: Overall, in view of the limitations of the French SAGHE study the findings of an apparent increased risk of mortality in children treated with somatropin (increased risk with higher doses and relating to subarachnoid or intracerebral haemorrhage and bone tumours) cannot be regarded as robust data.
Danish: På baggrund af den franske SAGHE-undersøgelses begrænsninger kan en tilsyneladende øget mortalitetsrisiko hos børn behandlet med somatropin (stigende risiko med højere doser som følge af subaraknoidal eller intracerebral blødning og knogletumorer) ikke anses for at være et holdbart resultat.
English: These results suggested an increased mortality with higher doses and due to diseases of the circulatory system (subarachnoid or intracerebral haemorrhage) and bone tumours.
Danish: Ifølge disse resultater var der tale om stigende dødelighed med stigende dosis som følge af kredsløbssygdomme (subaraknoidal eller intracerebral blødning) og knogletumorer.
English: Increased mortality was apparent when higher doses were used and due to subarachnoid or intracerebral haemorrhage and bone tumours.
Danish: Den stigende dødelighed ved stigende dosis skyldtes subaraknoidal og intracerebral blødning og knogletumorer.
English: In view of the above, the CHMP has recommended the variation to the terms of the Marketing Authorisations for somatropin-containing medicinal products (see Annex I), for which the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III and subject to the conditions set out in Annex IV of this Opinion.
Danish: Dette bør ligeledes afspejles i risikohåndteringsplanerne og den potentielle risiko for subaraknoidal eller intracerebral blødning, og derudover fandt udvalget, at det i produktinformationen (punkt 4.4) bør fremhæves, at den maksimale anbefalede dosis ikke bør overskridesanbefalede CHMP ændring af betingelserne for markedsføringstilladelserne for lægemidler indeholdende somatropin (se bilag I), for hvilke de relevante afsnit af produktresuméet og indlægssedlen fremgår af bilag III, under betingelserne i bilag IV til denne udtalelse.