natgillin/translations-raw huggingface dataset:
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.
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.
Ordlyden af indlægssedlens afsnit 2 blev ændret i henhold hertil, som det fremgår af bilag III.
The wording was amended accordingly in section 2 of the Package Leaflet as set out in Annex III.
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.
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.
testosteron Deficiency in Men: Systematic Review and Standard Operating Procedures for
Testosterone Deficiency in Men: Systematic Review and Standard Operating Procedures for Diagnosis and Treatment.
Der er ingen behandlingsalternativer til testosteron for hypogonadisme hos mænd (Buvat et al., 20132)
There are no treatment alternatives to testosterone for male hypogonadism (Buvat et al. 20132)
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.
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.
3 Finkle et al. “Increased risk of non-fatal myocardial infarction following testosteron therapy prescription in men.” PLoS One.
3 Finkle et al. “Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” PLoS One.
De kliniske symptomer afhænger af alderen ved androgenmanglens indsætten.
The clinical symptoms depend on the age of onset androgen deficiency.
Yderligere undersøgelser er nødvendige for at tilvejebringe de relevante data om sikkerhed og virkning hos denne patientgruppe.
Further studies will be needed to provide relevant safety and efficacy data in this patient population.
De er alle godkendt nationalt og findes som forskellige lægemiddelformer: injektionsvæske til intramuskulær brug, orale kapsler, gel, kutanopløsning og depotplastre.
All were authorised nationally and are available in different pharmaceutical forms: solution for intramuscular injection, oral capsules, cutaneous gel, cutaneous solution and transdermal patch.
4 Vigen et al. “Association of testosteron therapy with mortality, myocardial infarction, and stroke in men with low testosteron levels.” JAMA.
4 Vigen et al. “Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.” JAMA.
I den næste PSUR for alle lægemidler indeholdende testosteron skal den 31. december 2015 være fælles dataafskæringspunkt.
The next PSUR, will have the common DLP to all testosterone-containing medicinal products of 31 December 2015.
De begrænsede data om ældre patienter over 65 år skal ligeledes nævnes i advarselsdelen af produktinformationen for alle lægemidler indeholdende testosteron.
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.
På den anden side stimulerer testosteron erytrocytproliferationen, hvilket i teorien kan øge risikoen for tromboemboliske hændelser.
On the other hand, testosterone stimulates red blood proliferation, which theoretically could increase the risk of thromboembolic events.
• 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
• 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.
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.
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.
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.
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.
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.
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.
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
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.
Når samtlige data tages i betragtning, vurderes signalet om en øget kardiovaskulær risiko ved anvendelse af testosteron til fortsat at være svagt og inkonklusivt.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
• 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
• 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.
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.
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.
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.
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.
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.
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.
PRAC vedgik, at visse undersøgelser viser øget risiko for kardiovaskulære hændelser hos mænd, der behandles med testosteron.
The PRAC acknowledged that some studies show an increased risk of cardiovascular events in men treated with testosterone.
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.
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.
medfør af artikel 31 i direktiv 2000/83/EF med henblik på gennemgang af benefit/risk-forholdet for lægemidler indeholdende testosteron.
2001/83/EC was therefore initiated, to review the benefit-risk balance of testosterone containing medicinal products.
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.
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.
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.
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.
Hypogonadisme inddeles i primært testikulært svigt forårsaget af problemer i testiklerne og sekundært svigt forårsaget af problemer i hypothalamus eller hypofysen.
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.
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.
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.
Produktinformationen skal indeholde oplysninger om den kardiovaskulære sikkerhed og om veldokumenterede bivirkninger fra blodsystemet, som kan bidrage til den kardiovaskulære risiko.
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.
Udvalget noterede sig de begrænsede foreliggende oplysninger om behandling af aldersrelateret hypogonadisme med testosteron og manglende referencer.
The Committee recognised the limited available information on testosterone therapy for age-related hypogonadism and also the lack of reference.
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).
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).
Videnskabelige konklusioner samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra PRAC's anbefaling
Scientific conclusions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
• udvalget bemærkede, at de foreliggende data ikke samstemmende viser øget risiko for kardiovaskulære hændelser under behandling med testosteron
• The Committee noted that the available data does not consistently show an increased risk of cardiovascular events during testosterone therapy.
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.
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.
• udvalget noterede sig de begrænsede foreliggende oplysninger om behandling med testosteron ved aldersrelateret hypogonadisme foruden manglende referenceværdier.
• The Committee recognised the limited available information on testosterone therapy for agerelated hypogonadism and also the lack of reference values.
Videnskabelige konklusioner og begrundelse for ændring af markedsføringstilladelserne på visse betingelser samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra PRAC's anbefaling
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
Ediburgh: Churchill Livingstone, 1991; T20-1 2 Buvat J, Maggi M, Guay A, Torres LO.
Ediburgh: Churchill Livingstone, 1991; T20-1
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.
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.
CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) har gennemgået nedenstående anbefaling fra PRAC (Udvalget for Risikovurdering inden for Lægemiddelovervågning) om lægemidler indeholdende testosteron:
The CMDh considered the below PRAC recommendation with regard to testosterone containing medicinal products:
• PRAC konkluderede, at den formodede risiko for kardiovaskulære hændelser ved behandling med testosteron fortsat er et svagt signal, når alle foreliggende data tages i betragtning.
• The PRAC concluded that based on the overall currently available data, the suggested risk for cardiovascular events associated with the testosterone therapy remains a weak signal.
• PRAC konkluderede, at var nødvendigt, at alle indehavere af markedsføringstilladelserne overvåger den kardiovaskulære risiko og i den næste PSUR drøfter resultaterne heraf, herunder venøse tromboemboliske hændelser og mulig(e) mekanisme(r) herfor samt anvendelsesmønster og bivirkninger hos patienter over 65 år anbefalede PRAC på ovennævnte baggrund ændring af betingelserne for markedsføringstilladelserne for lægemidler indeholdende testosteron (se bilag I), for hvilke de relevante afsnit af produktresuméet og indlægssedlen fremgår af bilag III, og betingelserne af bilag IV til PRAC's anbefaling.
• The PRAC also concluded that there was the need for all MAHs to closely monitor cardiovascular risk and discuss the findings including venous thromboembolic events and possible mechanism(s) and usage pattern and adverse events in patients older than 65 years in the next PSUR.
Dette sammendrag blev sidst ajourført i marts 2016.
This summary was last updated in March 2016
Hele flokken bør vaccineres samtidig.
The whole flock should be vaccinated at the same time.
Beskyttelsen starter fire uger efter vaccinationen.
Protection starts four weeks after vaccination.
Vaccinen har ingen kendte bivirkninger.
The vaccine has no known side effects.
Feltundersøgelsen gav ingen yderligere information.
The field study did not bring additional information.
Den må ikke bruges til æglæggende fugle eller inden for fem uger efter æglægningsperiodens start.
It should not be used in birds in lay or within five weeks of the start of the laying period.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for MS-H Vaccine den 14. juni 2011.
The European Commission granted a marketing authorisation valid throughout the European Union, for MS-H vaccine on 14 June 2011.
Virksomheden fremlagde data fra laboratorieundersøgelser og fra en feltundersøgelse.
The company presented data from laboratory studies and from one field trial.
Beskyttelsen mod skader på luftsækkene varer i 40 uger, men varigheden af beskyttelsen mod dannelse af unormal skal kendes ikke.
Protection against damage to air sacs lasts for 40 weeks, but the duration of protection against abnormal shells forming is not known.
Den fuldstændige EPAR for MS-H Vaccine findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The full EPAR for MS-H Vaccine can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Tilbageholdelsestiden for MS-H Vaccine for kød og æg er nul dage.
The withdrawal period for MS-H vaccine for meat and eggs is zero days.
"Svækket" betyder, at stammen først er blevet svækket, så den ikke er sygdomsfremkaldende.
‘Attenuated' means that the strain has first been weakened so that it does not cause disease.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for MS-H Vaccine.
This is a summary of the European public assessment report (EPAR) for MS-H Vaccine.
Denne bakterie forårsager infektion hos fugle, almindeligvis i lungerne og i "luftsækkene", som er de særlige sække i fuglens krop, hvor luften opbevares under vejrtrækningen.
This bacterium causes infections in birds, generally in the lungs and the ‘air sacs', the specialised bags within the bird's body where air is stored during breathing.
Ligesom alle andre vacciner virker MS-H Vaccine ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal beskytte sig mod en sygdom.
MS-H Vaccine, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Hvis dyrene senere udsættes for Mycoplasma synoviae, vil immunsystemet hurtigere kunne reagere.
In the future, if the animals are exposed to Mycoplasma synoviae, the immune system will be able to respond more quickly.