FrancophonIA/ELRC3.0 huggingface dataset:
English: Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated) not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/3 strain (live, attenuated)
Danish: Fåresygevirus1 Jeryl Lynn stamme (levende, svækket (niveau B))
English: 1 vial + 1 pre-filled syringe without needle
Danish: 1 hætteglas + 1 fyldt injektionssprøjte uden nål
English: 1 vial + 1 pre-filled syringe with attached needle
Danish: 1 hætteglas + 1 fyldt injektionssprøjte med fastgjort nål
English: In such case, treatment must be stopped immediately.
Danish: I sådanne tilfælde skal behandlingen straks ophøre.
English: The timetable for the implementation of the agreement is set out in Annex V.
Danish: Tidsplanen for gennemførelse af aftalen fremgår af bilag V.
English: The studies and their limitations were considered together with the overall evidence available to date.
Danish: Undersøgelserne og deres begrænsninger blev taget i betragtning sammen med den samlede evidens, der til dato foreligger.
English: • The PRAC noted that some of the studies have methodological limitations.
Danish: • PRAC bemærkede, at nogle af undersøgelserne har metodologiske begrænsninger.
English: Some studies show an increased risk while others do not suggest a risk and therefore have not corroborated the signal.
Danish: Nogle undersøgelser viser øget risiko, mens andre ikke tyder på risiko og således ikke har kunnet bekræfte signalet
English: The PRAC noted that others studies will become available.
Danish: PRAC bemærkede, at der vil fremkomme andre undersøgelser
English: Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Danish: Efter at have gennemgået PRAC's anbefaling tilsluttede CMDh sig de overordnede videnskabelige konklusioner og begrundelsen for anbefalingen.
English: Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels.
Danish: Effects of testosteron and progressive resistance exercise in healthy, highly functioning older men with low-normal testosteron levels.
English: In addition, there is limited experience on the safety and efficacy of the use of testosterone in patients over 65 years of age.
Danish: Desuden er der kun begrænsede erfaringer om sikkerheden og virkningen af testosteron hos patienter over 65 år.
English: All testosterone-containing medicinal products approved in the European Union were included in this review performed by the PRAC.
Danish: Alle lægemidler, som indeholder testosteron, og som er godkendt i EU, var omfattet af denne gennemgang, der blev foretaget af PRAC.
English: Testosterone is an androgenic hormone secreted by the Leydig cells in the testis.
Danish: Testosteron er et androgent hormon, der udskilles af Leydig-cellerne i testis.
English: • The PRAC considered the procedure under Article 31 of directive 2001/83/EC for testosteronecontaining medicinal products.
Danish: • PRAC fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for lægemidler indeholdende testosteron
English: However, the CMDh considered that an amendment was required in the package leaflet to improve clarity for patients that should tell their doctor if they have high blood pressure but also if they are being treated for high blood pressure.
Danish: CMDh fandt dog, at der er behov for en ændring af indlægssedlen for at tydeliggøre det for patienterne, at de skal sige det til lægen, hvis de har forhøjet blodtryk eller er i behandling for forhøjet blodtryk.
English: Testosterone therapy is not associated with higher risk of myocardial infarction or stroke: The low T
Danish: testosteron therapy is not associated with higher risk of myocardial infarction or stroke: The low T
English: It is expected that the marketing authorisation holders continue to monitor cardiovascular events and it is expected that findings of ongoing studies will be reflected in periodic updated safety reports (PSURs) when available.
Danish: Det forventes, at indehaverne af markedsføringstilladelserne fortsat overvåger kardiovaskulære hændelser, og at resultaterne af de igangværende undersøgelser vil blive afspejlet i de periodiske opdaterede sikkerhedsrapporter (PSUR), når de foreligger.
English: The wording was amended accordingly in section 2 of the Package Leaflet as set out in Annex III.
Danish: Ordlyden af indlægssedlens afsnit 2 blev ændret i henhold hertil, som det fremgår af bilag III.
English: The marketing authorisation holders are requested to investigate and report in the next PSUR on the usage of these products in this patient population and to consider if the pattern of adverse events is comparable to other age groups.
Danish: Indehaverne af markedsføringstilladelserne anmodes om at undersøge og i den næste PSUR indberette om anvendelsen af disse lægemidler hos denne patientpopulation samt at tage stilling til, om bivirkningsmønsteret er sammenligneligt med andre aldersgruppers.
English: Testosterone Deficiency in Men: Systematic Review and Standard Operating Procedures for Diagnosis and Treatment.
Danish: testosteron Deficiency in Men: Systematic Review and Standard Operating Procedures for
English: There are no treatment alternatives to testosterone for male hypogonadism (Buvat et al. 20132)
Danish: Der er ingen behandlingsalternativer til testosteron for hypogonadisme hos mænd (Buvat et al., 20132)
English: Testosterone should be used with caution in men with hypertension and testosterone levels should be monitored both at baseline and at regular intervals during treatment to ensure the adequacy of the dose administered.
Danish: Testosteron bør anvendes med forsigtighed hos mænd med hypertension, og indholdet af testosteron bør under behandlingen overvåges både ved baseline og med regelmæssige intervaller for at sikre, at den administrerede dosis er passende.
English: 3 Finkle et al. “Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” PLoS One.
Danish: 3 Finkle et al. “Increased risk of non-fatal myocardial infarction following testosteron therapy prescription in men.” PLoS One.
English: The clinical symptoms depend on the age of onset androgen deficiency.
Danish: De kliniske symptomer afhænger af alderen ved androgenmanglens indsætten.
English: Further studies will be needed to provide relevant safety and efficacy data in this patient population.
Danish: Yderligere undersøgelser er nødvendige for at tilvejebringe de relevante data om sikkerhed og virkning hos denne patientgruppe.
English: All were authorised nationally and are available in different pharmaceutical forms: solution for intramuscular injection, oral capsules, cutaneous gel, cutaneous solution and transdermal patch.
Danish: De er alle godkendt nationalt og findes som forskellige lægemiddelformer: injektionsvæske til intramuskulær brug, orale kapsler, gel, kutanopløsning og depotplastre.
English: 4 Vigen et al. “Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.” JAMA.
Danish: 4 Vigen et al. “Association of testosteron therapy with mortality, myocardial infarction, and stroke in men with low testosteron levels.” JAMA.
English: The next PSUR, will have the common DLP to all testosterone-containing medicinal products of 31 December 2015.
Danish: I den næste PSUR for alle lægemidler indeholdende testosteron skal den 31. december 2015 være fælles dataafskæringspunkt.
English: Also, that there is limited data regarding elderly patients above the age of 65 and this will also be reflected in the warning section of the product information of all testosterone-containing medicinal products.
Danish: De begrænsede data om ældre patienter over 65 år skal ligeledes nævnes i advarselsdelen af produktinformationen for alle lægemidler indeholdende testosteron.
English: On the other hand, testosterone stimulates red blood proliferation, which theoretically could increase the risk of thromboembolic events.
Danish: På den anden side stimulerer testosteron erytrocytproliferationen, hvilket i teorien kan øge risikoen for tromboemboliske hændelser.
English: • The Committee agreed, that it is justified to reflect in the product information of all testosterone-containing medicinal products the current knowledge on cardiovascular risks associated with testosterone therapy and recommended changes in section 4.1 (therapeutic indications), section 4.4 (warnings and precautions for use) and section 4.8 (undesirable effects) of the Summary of Product Characteristics.
Danish: • udvalget fandt det berettiget, at produktinformationen for alle lægemidler indeholdende testosteron bør afspejle den nuværende viden om kardiovaskulære risici ved behandling med testosteron, og anbefalede ændringer i punkt 4.1 (Terapeutiske indikationer), punkt 4.4 (Advarsler og forsigtighedsregler vedrørende brugen) og punkt 4.8 (Bivirkninger) i produktresuméet
English: The CMDh, having considered the PRAC recommendation dated 9 October 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the variation of the marketing authorisations of testosterone containing medicinal products 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.
Danish: Efter gennemgang af PRAC's anbefaling af 9. oktober 2014 i henhold til artikel 107k, stk. 1 og 2, i direktiv 2000/83/EF vedtog CMDh ændring af markedsføringstilladelserne for lægemidler indeholdende testosteron, for hvilke de relevante afsnit af produktresuméet og indlægssedlen fremgår af bilag III, og under forudsætning af de betingelser, der er fastlagt i bilag IV.
English: 7 Corona G, Maseroli E, Rastrelli G, Isidori A, Mannucci E, Maggi M. Cardiovascular risk associated with testosterone boosting medications: a systematic review and metaanalysis.
Danish: 7 Corona G, Maseroli E, Rastrelli G, Isidori A, Mannucci E, Maggi M. Cardiovascular risk associated with testosteron boosting medications: a systematic review and metaanalysis.
English: Baillargeon J, Urban RJ, Kuo Y-F, Ottenbacher KJ, Raji MA, Du F, Lin Y-l, Goodwin JS. Risk of myocardial infarction in older men receiving testosterone therapy.
Danish: 6 Baillargeon J, Urban RJ, Kuo Y-F, Ottenbacher KJ, Raji MA, Du F, Lin Y-l, Goodwin JS. Risk of myocardial infarction in older men receiving testosteron therapy.
English: The PRAC also recognised that testosterone may have both direct and indirect effect on the cardiovascular systems: low testosterone increases the risk of the metabolic syndrome, which could potentially increase the risk of adverse cardiovascular events.
Danish: PRAC noterede sig også, at testosteron kan have både direkte og indirekte virkning på det kardiovaskulære system: Lavt testosteron øger risikoen for metabolisk syndrom, som potentielt kan øge risikoen for kardiovaskulære
English: Therefore, taking the totality of data into account it is judged that the signal for an increased cardiovascular risk associated with the use of testosterone remains weak and inconclusive.
Danish: Når samtlige data tages i betragtning, vurderes signalet om en øget kardiovaskulær risiko ved anvendelse af testosteron til fortsat at være svagt og inkonklusivt.
English: As an example, recently published studies (Baillargeon et al., 20146; Corona et al., 20147; Tan et al., 20148; Hildreth et al., 20139), with the objective to examine the risk of cardiovascular events with TT, did not report an increase in this risk.
Danish: Som eksempel herpå kan nævnes nyligt publicerede undersøgelser (Baillargeon et al., 20146; Corona et al., 20147; Tan et al., 20148; Hildreth et al., 20139), der havde til formål at undersøge risikoen for kardiovaskulære hændelser ved testosteronbehandling, og hvor der ikke fandtes øget risiko.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of testosterone-containing medicinal products remains favourable subject to the conditions to the marketing authorisations, and taking into account the amendments to the product information recommended.
Danish: PRAC konkluderede derfor, at benefit/risk-forholdet for lægemidler indeholdende testosteron fortsat er positivt under forudsætning af de anbefalede betingelser for markedsføringstilladelserne og ændringer i produktinformationen.
English: Based on all the above discussed, the PRAC considered justified to reflect in the product information of all testosterone containing medicinal products approved in the European Union that prescribing testosterone for hypogonadism should be based upon confirmation of both clinical features and biochemical testing.
Danish: På grundlag af det ovenfor drøftede fandt PRAC det berettiget, at det i produktinformationen for alle EU-godkendte lægemidler indeholdende testosteron angives, at ordination af testosteron ved hypogonadisme skal bygge på både det kliniske billede og biokemiske prøver.
English: Hypogonadism in men is a congenital or acquired syndrome, in which the testis fails to produce physiological levels of testosterone and spermatozoa, as there is a disruption in the hypothalamicpituitary-testicular axis (HPT).
Danish: Hypogonadisme hos mænd er en medfødt eller erhvervet syndrom, hvor testis ikke producerer fysiologiske mængder af testosteron og spermatozoer på grund af forstyrrelse i den hypotalamiskhypofysære-testikulære akse (HPT).
English: It is an essential hormone for the development of male reproductive tissues as the testis and the prostate and in promoting secondary sexual characteristics such as increased muscle, bone mass, and the growth of body hair (Dollery et al., 19911).
Danish: Dette hormon er essentielt for udviklingen af de mandlige reproduktive væv, såsom testis og prostata, og til udviklingen af sekundære seksuelle karakteristika, såsom øget muskel- og knoglemasse og vækst af kropsbehåring (Dollery et al., 19911).
English: Concerns were raised with regards to a potential increased risk of cardiovascular events, namely myocardial infarction, in men treated with testosterone and who have pre-existing heart disease (Finkle et al, 20143; Vigen et al, 20134 and Xu et al, 20135).
Danish: Der er udtrykt bekymring for potentiel forhøjet risiko for kardiovaskulære hændelser, navnlig myokardieinfarkt, hos mænd med præeksisterende hjertesygdom ved behandling med testosteron (Finkle et al, 20143; Vigen et al, 20134 og Xu et al, 20135).
English: Xu L, Freeman G, Cowling BJ,Schooling CM. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.
Danish: 5 Xu L, Freeman G, Cowling BJ,Schooling CM. testosteron therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.
English: Testosterone, as well as other androgens and anabolic steroids, should be used cautiously in patients with cardiovascular disorders, renal or hepatic impairment, epilepsy, migraine, diabetes mellitus or other conditions that may be aggravated by the possible fluid retention or oedema caused.
Danish: Testosteron bør ligesom andre androgener og anabolske steroider anvendes med forsigtighed hos patienter med kardiovaskulære sygdomme, nedsat nyre- eller leverfunktion, epilepsi, migræne, diabetes mellitus eller andre sygdomme, der kan forværres ved opståen af væskeretention eller ødem.
English: • The Committee considered the studies that heightened concerns about the increased risk of cardiovascular events associated with testosterone therapy and available data submitted from clinical trials, observational studies, meta-analyses, post-marketing data and further published data.
Danish: • udvalget gennemgik de undersøgelser, der bestyrkede betænkelighederne ved den øgede risiko for kardiovaskulære hændelser ved behandling med testosteron, samt de foreliggende data fra kliniske undersøgelser, observationsundersøgelser, metaanalyser, data efter markedsføring og andre publicerede data
English: If the hypogonadism develops before puberty e.g. as part of a genetic disease, the men will exhibit eunuchoid proportions, delayed of secondary sex characterises and high pitched voice.
Danish: Når hypogonadisme opstår før puberteten, f.eks. som følge af en arvelig sygdom, vil den pågældende mand få eunuklignende proportioner, forsinket udvikling af sekundære kønskarakteristika og skinger stemme.
English: The PRAC noted that the findings from several other observational studies, clinical trials and meta-analysis of randomised clinical trials do not provide evidence of an association between testosterone and cardiovascular events.
Danish: PRAC bemærkede, at resultaterne af flere andre observationsundersøgelser, kliniske undersøgelser og metaanalyser af randomiserede kliniske undersøgelser ikke giver evidens for en sammenhæng mellem testosteron og kardiovaskulære hændelser.
English: Results suggest that rates of prostate cancer and cardiovascular events were within the anticipated range, with no evidence of increased risk in treated versus untreated patients.
Danish: Resultaterne tyder på, at forekomsten af prostatacancer og kardiovaskulære hændelser lå inden for det forventede område uden tegn på højere risiko hos behandlede end hos ubehandlede patienter.
English: The PRAC acknowledged that some studies show an increased risk of cardiovascular events in men treated with testosterone.
Danish: PRAC vedgik, at visse undersøgelser viser øget risiko for kardiovaskulære hændelser hos mænd, der behandles med testosteron.
English: It is known that in patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.
Danish: Hos patienter med svært nedsat hjerte-, lever- eller nyrefunktion eller iskæmisk hjertesygdom vides testosteron at kunne medføre svære komplikationer kendetegnet af ødem med eller uden kongestiv hjerteinsufficiens.
English: 2001/83/EC was therefore initiated, to review the benefit-risk balance of testosterone containing medicinal products.
Danish: medfør af artikel 31 i direktiv 2000/83/EF med henblik på gennemgang af benefit/risk-forholdet for lægemidler indeholdende testosteron.
English: The PRAC reviewed all data available from clinical trials, observational studies, meta-analyses, postmarketing data and further published data on the cardiovascular risks associated with testosterone therapy.
Danish: PRAC gennemgik alle foreliggende data fra kliniske undersøgelser, observationsundersøgelser, metaanalyser, data efter markedsføring og yderligere publicerede data om de kardiovaskulære risici ved behandling med testosteron.
English: Overall the PRAC concluded that the findings in the literature do not consistently show an increased risk of cardiovascular events and do not corroborate the signal of an increased risk of cardiovascular events associated with testosterone therapy.
Danish: Overordnet konkluderede PRAC, at resultaterne fra litteraturen ikke samstemmende viser øget risiko for kardiovaskulære hændelser og ikke bekræfter signalet om en øget risiko for kardiovaskulære hændelser ved behandling med testosteron.
English: Hypogonadism is classified into primary testicular failure due to a problem in the testicles and secondary testicular failure, due to a problem in the hypothalamus or the pituitary gland.
Danish: Hypogonadisme inddeles i primært testikulært svigt forårsaget af problemer i testiklerne og sekundært svigt forårsaget af problemer i hypothalamus eller hypofysen.
English: Also, the RHYME study, an observational registry study performed in 6 European countries evaluating the association between TT (over two years) and prostate health outcome in men with hypogonadism also looked at health outcomes, as secondary endpoints.
Danish: Tilsvarende indgik helbredsmæssige udfald som sekundære endepunkter i RHYME, der var en observationsundersøgelse med registrering i seks europæiske lande til vurdering af sammenhængen mellem testosteronbehandling (af to års varighed) og udfaldet hvad angår prostatahelbred hos mænd med hypogonadisme.
English: Information on the cardiovascular safety and well-documented blood system adverse reactions, which may contribute to the cardiovascular risk should be included in the product information.
Danish: Produktinformationen skal indeholde oplysninger om den kardiovaskulære sikkerhed og om veldokumenterede bivirkninger fra blodsystemet, som kan bidrage til den kardiovaskulære risiko.
English: The Committee recognised the limited available information on testosterone therapy for age-related hypogonadism and also the lack of reference.
Danish: Udvalget noterede sig de begrænsede foreliggende oplysninger om behandling af aldersrelateret hypogonadisme med testosteron og manglende referencer.
English: The symptoms are less specific if the hypogonadism develops after puberty and are characterized by e.g. decreased sexual function, infertility, decreased energy, depressed mood, mild anaemia, reduced muscle bulk and strength, increase body fat and BMI (guideline of Endocrine Society).
Danish: Symptomerne er mindre specifikke ved hypogonadisme, der opstår efter puberteten, og karakteriseres af f.eks. nedsat seksuel funktion, infertilitet, nedsat energi, depression, let anæmi, nedsat muskelvolumen og -styrke, øget kropsvægt og legemsmasseindeks (BMI) (vejledningen fra Endocrine Society).
English: Scientific conclusions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra PRAC's anbefaling
English: • The Committee noted that the available data does not consistently show an increased risk of cardiovascular events during testosterone therapy.
Danish: • udvalget bemærkede, at de foreliggende data ikke samstemmende viser øget risiko for kardiovaskulære hændelser under behandling med testosteron
English: The major goal of testosterone therapy (TT) is to achieve normal physiological levels of testosterone levels to relieve symptoms of hypogonadism like decreased sexual function, infertility, decreased energy, depressed mood, mild anaemia, reduced muscle bulk and strength, increased body fat and body mass index (BMI) and psychological impairment.
Danish: Hovedformålet med behandlingen med testosteron er at opnå et normalt fysiologisk niveau af testosteron for at afhjælpe symptomer på hypogonadisme, såsom nedsat seksuel funktion, infertilitet, nedsat energi, depression, let anæmi, nedsat muskelvolumen og -styrke, øget kropsvægt og BMI samt nedsat psykisk funktion.
English: • The Committee recognised the limited available information on testosterone therapy for agerelated hypogonadism and also the lack of reference values.
Danish: • udvalget noterede sig de begrænsede foreliggende oplysninger om behandling med testosteron ved aldersrelateret hypogonadisme foruden manglende referenceværdier.
English: Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations subject to conditions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og begrundelse for ændring af markedsføringstilladelserne på visse betingelser samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra PRAC's anbefaling
English: Ediburgh: Churchill Livingstone, 1991; T20-1
Danish: Ediburgh: Churchill Livingstone, 1991; T20-1 2 Buvat J, Maggi M, Guay A, Torres LO.
English: knowledge to date, the PRAC recommended that the possible mechanism on the association between cardiovascular/venous thromboembolic events and the level of testosterone be further investigated by the marketing authorisation holders and reported at the next PSUR.
Danish: På baggrund af den nuværende viden anbefalede PRAC, at indehaverne af markedsføringstilladelserne nærmere undersøger den mulige mekanisme for sammenhæng mellem kardiovaskulære/venøse tromboemboliske hændelser og indholdet af testosteron, og at de indberetter dette i den næste PSUR.