natgillin/translations-raw huggingface dataset:
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.
Tudi v študiji RHYME, opazovalni registrski študiji, izvedeni v 6 evropskih državah, v kateri so ocenjevali povezavo med zdravljenjem s testosteronom (v obdobju dveh let) in izidom glede zdravja prostate pri moških s hipogonadizmom, so proučili zdravstvene izide kot sekundarne opazovane dogodke.
Further studies will be needed to provide relevant safety and efficacy data in this patient population.
Potrebne bodo dodatne študije, s katerimi bodo pridobili podatke o varnosti in učinkovitosti za to skupino bolnikov.
Abstract Book of the 2014 Annual Meeting of the American Association of Clinical Endocrinologists (AACE), pg 238, abstract # 1353; available at: https://www.aace.com/files/late-breaking-abstracts-2014.pdf 9 Hildreth KL, Barry DW, Moreau KL, Vande Griend J, Meacham RB, Nakamura T, Wolfe P, Kohrt WM, Ruscin JM, Kittelson J, Cress
Abstract Book of the 2014 Annual Meeting of the American Association of Clinical Endocrinologists (AACE), pg 238, abstract # 1353; available at: https://www.aace.com/files/late-breaking-abstracts-2014.pdf 9 Hildreth KL, Barry DW, Moreau KL, Vande Griend J, Meacham RB, Nakamura T, Wolfe P, Kohrt WM, Ruscin JM, Kittelson J, Cress ME, Ballard R, Schwartz RS.
• The PRAC considered the procedure under Article 31 of directive 2001/83/EC for testosteronecontaining medicinal products.
• odbor PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo testosteron;
The next PSUR, will have the common DLP to all testosterone-containing medicinal products of 31 December 2015.
Zaključek vnosa podatkov za naslednje poročilo PSUR za vsa zdravila, ki vsebujejo testosteron, bo 31. decembra 2015.
Testosterone is an androgenic hormone secreted by the Leydig cells in the testis.
Testosteron je androgeni hormon, ki ga izločajo Leydigove celice v modih.
On the other hand, testosterone stimulates red blood proliferation, which theoretically could increase the risk of thromboembolic events.
Po drugi strani testosteron spodbuja proliferacijo eritrocitov, kar lahko teoretično poveča tveganje trombemboličnih dogodkov.
The clinical symptoms depend on the age of onset androgen deficiency.
Klinični simptomi so odvisni od starosti pri prvem pojavu pomanjkanja androgenov.
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.
Pričakuje se, da bodo imetniki dovoljenj za promet z zdravilom še naprej spremljali kardiovaskularne dogodke in da se bodo ugotovitve potekajočih študij vključile v redno posodobljena poročila o varnosti zdravila (PSUR), ko bodo na voljo.
Testosterone therapy is not associated with higher risk of myocardial infarction or stroke: The low T
Testosterone therapy is not associated with higher risk of myocardial infarction or stroke: The low T experience.
The CMDh considered the below PRAC recommendation with regard to testosterone containing medicinal products:
Skupina CMDh je proučila spodnje priporočilo odbora PRAC v zvezi z zdravili, ki vsebujejo testosteron:
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.
Če se hipogonadizem razvije pred puberteto, npr. kot del genetske bolezni, bo imel moški evnuhoidne zunanje znake, zapoznel razvoj sekundarnih spolnih značilnosti in visok glas.
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.
Odbor PRAC je prav tako upošteval, da ima lahko testosteron neposreden in posreden učinek na srčnožilni sistem: nizka raven testosterona poveča tveganje metabolnega sindroma, ki lahko poveča tveganje za pojav neželenih kardiovaskularnih dogodkov.
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.
CMDh je na podlagi preučitve priporočila, ki ga je dne 9. oktobra 2014 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES podal PRAC, sprejela sporazum o spremembi dovoljenj za promet z zdravili, ki vsebujejo testosteron , skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III, in pod pogoji, določenimi v Prilogi IV.
• 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.
• odbor se je strinjal, da je treba v informacije o zdravilu za vsa zdravila, ki vsebujejo testosteron, vključiti trenutno vedenje o kardiovaskularnih tveganjih, povezanih z zdravljenjem s testosteronom, in priporočil spremembe v poglavjih 4.1 (terapevtske indikacije), 4.4 (opozorila in previdnostni ukrepi) in 4.8 (neželeni učinki) v povzetku glavnih značilnosti zdravila;
The wording was amended accordingly in section 2 of the Package Leaflet as set out in Annex III.
Skladno s tem se je spremenilo besedilo v poglavju 2 navodila za uporabo, kot je določeno v Prilogi III.
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.
Podatki glede bolnikov, starejših od 65 let, so omejeni, kar bo vključeno v poglavje z opozorili v informacijah o zdravilu za vsa zdravila, ki vsebujejo testosteron.
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.
Imetniki dovoljenj za promet z zdravilom morajo raziskati uporabo teh zdravil pri tej skupini bolnikov in o njih poročati v naslednjem poročilu PSUR, prav tako pa morajo pretehtati, ali je vzorec neželenih dogodkov primerljiv z drugimi starostnimi skupinami.
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.
Testosteron in druge androgene ter anabolne steroide je treba uporabljati previdno pri bolnikih s kardiovaskularnimi motnjami, ledvično ali jetrno okvaro, epilepsijo, migreno, sladkorno boleznijo ali drugimi stanji, ki jih lahko poslabša morebitna retencija tekočine ali posledični edem.
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.
Na podlagi zgornje razprave je odbor PRAC menil, da je treba v informacije o zdravilu za vsa zdravila, ki vsebujejo testosteron in so odobrena v Evropski uniji, vključiti, da mora predpisovanje testosterona pri hipogonadizmu temeljiti na potrditvi kliničnih značilnosti in biokemijskih preiskavah.
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).
Je esencialni hormon za razvoj moških reproduktivnih tkiv, kot so moda in prostata, ter za spodbujanje sekundarnih spolnih značilnosti, kot so povečana mišična masa, kostna masa in rast dlak po telesu (Dollery in sod.
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.
Odbor PRAC je posledično zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo testosteron, še naprej ugodno pod pogojem, da se upoštevajo pogoji dovoljenj za promet z zdravili ter priporočene spremembe informacij o zdravilu.
• 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.
• odbor je upošteval študije, ki so povečale pomisleke glede povečanega tveganja kardiovaskularnih dogodkov, povezanih z zdravljenjem s testosteronom, in razpoložljive podatke iz kliničnih preskušanj, opazovalnih študij, metaanaliz, podatke iz obdobja trženja ter dodatno objavljene podatke;
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.
Rezultati kažejo, da so bili deleži raka prostate in kardiovaskularnih dogodkov znotraj pričakovanega razpona, pri čemer ni bilo dokazov o povečanem tveganju pri zdravljenih bolnikih v primerjavi z nezdravljenimi.
The PRAC acknowledged that some studies show an increased risk of cardiovascular events in men treated with testosterone.
Odbor PRAC je potrdil, da nekatere študije kažejo povečano tveganje kardiovaskularnih dogodkov pri moških, zdravljenih s testosteronom.
• 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.
• odbor PRAC je prav tako sklenil, da morajo vsi imetniki dovoljenja za promet z zdravilom skrbno spremljati kardiovaskularno tveganje in ugotovitve, vključno z venskimi trombemboličnimi dogodki, morebitnim(i) mehanizmom(i), vzorcem uporabe in neželenimi dogodki pri bolnikih, starejših od 65 let, opisati v naslednjem poročilu PSUR.
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.
Odbor PRAC je izpostavil, da ugotovitve mnogih drugih opazovalnih študij, kliničnih preskušanj in metaanaliz randomiziranih kliničnih preskušanj ne dokazujejo povezave med testosteronom in kardiovaskularnimi dogodki.
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.
Znano je, da lahko zdravljenje s testosteronom pri bolnikih s hudo srčno, jetrno ali ledvično insuficienco ali ishemično srčno boleznijo povzroči hude zaplete, za katere je značilen edem s kongestivnim srčnim popuščanjem ali brez njega.
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).
Hipogonadizem pri moških je kongenitalni ali pridobljeni sindrom, pri katerem moda ne proizvajajo fizioloških ravni testosterona in semenčic, saj pride do motnje na osi hipotalamus-hipofiza-moda (HHM).
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.
Odbor PRAC je pregledal vse razpoložljive podatke iz kliničnih preskušanj, opazovalnih študij, metaanaliz, podatke iz obdobja trženja in dodatne objavljene podatke o kardiovaskularnem tveganju, povezanem z zdravljenjem s testosteronom.
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.
Ko je odbor upošteval celotne podatke, je presodil, da so dokazi glede povečanega kardiovaskularnega tveganja, povezanega z uporabo testosterona, še vedno šibki in neprepričljivi.
The Committee recognised the limited available information on testosterone therapy for age-related hypogonadism and also the lack of reference.
Odbor je upošteval omejene razpoložljive podatke o zdravljenju s testosteronom pri hipogonadizmu, povezanem s starostjo, in pomanjkanje referenc.
2001/83/EC was therefore initiated, to review the benefit-risk balance of testosterone containing medicinal products.
Zaradi tega je bil v skladu s členom 31 Direktive 2001/83/ES sprožen napotitveni postopek za pregled razmerja med tveganji in koristmi zdravil, ki vsebujejo testosteron.
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.
V informacije o zdravilu je treba vključiti podatke o kardiovaskularni varnosti in dobro dokumentiranih neželenih učinkih na krvni sistem, ki lahko prispevajo h kardiovaskularnemu tveganju.
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
Priloga II Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom pod določenimi pogoji ter podrobna obrazložitev znanstvene podlage za odstopanja od priporočila odbora PRAC
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.
Na splošno je odbor PRAC sklenil, da so ugotovitve v literaturi glede povečanega tveganja kardiovaskularnih dogodkov nedosledne in ne podpirajo poročanja o povečanem tveganju kardiovaskularnih dogodkov, povezanih z zdravljenjem s testosteronom.
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.
Glavni cilj zdravljenja s testosteronom je doseči normalne fiziološke ravni testosterona, s čimer se olajšajo simptomi hipogonadizma, kot so zmanjšana spolna funkcija, neplodnost, zmanjšana energija, depresivno razpoloženje, blaga anemija, zmanjšana mišična masa in moč, povečana telesna maščoba ter indeks telesne mase (ITM) in poslabšanje duševne funkcije.
2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
2 - Podrobna obrazložitev znanstvenih razlogov za odstopanja od priporočila PRAC
In view of the above, the PRAC has recommended the variation to the terms of the Marketing Authorisations for testosterone-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 the PRAC recommendation.
Na podlagi zgornje razprave je odbor PRAC priporočil spremembe pogojev dovoljenj za promet z zdravili, ki vsebujejo testosteron (glejte Prilogo I), ki so za ustrezna poglavja povzetka glavnih značilnosti zdravila ter navodila za uporabo navedene v Prilogi III in so predmet pogojev, določenih v Prilogi IV priporočila odbora PRAC.
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.
Ravni testosterona je treba spremljati ob izhodišču in v rednih presledkih med zdravljenjem, da se zagotovi zadostnost uporabljenega odmerka.
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.
Hipogonadizem je razvrščen kot primarna testikularna odpoved zaradi težave v modih in sekundarna testikularna odpoved zaradi težav v hipotalamusu ali hipofizi.
All testosterone-containing medicinal products approved in the European Union were included in this review performed by the PRAC.
V ta pregled, ki ga je opravil odbor PRAC, so bila vključena vsa zdravila, ki vsebujejo testosteron in so odobrena v Evropski uniji.
• The Committee recognised the limited available information on testosterone therapy for agerelated hypogonadism and also the lack of reference values.
• odbor je upošteval omejene razpoložljive podatke o zdravljenju s testosteronom pri hipogonadizmu, povezanem s starostjo, in pomanjkanje referenčnih vrednosti.
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.
Na podlagi trenutnega znanja je odbor PRAC priporočil, da morajo imetniki dovoljenj za promet z zdravilom dodatno raziskati morebitne mehanizme glede povezave med kardiovaskularnimi/venskimi trombemboličnimi dogodki in ravnijo testosterona in o njih poročati v naslednjem poročilu PSUR.
• 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.
• odbor PRAC je sklenil, da na podlagi celotnih trenutno razpoložljivih podatkov zadevno tveganje kardiovaskularnih neželenih dogodkov, povezanih z zdravljenjem s testosteronom, ostaja šibek pomislek.
3 Finkle et al. “Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” PLoS One.
J Sex Med 2013;10:245-284. 3 Finkle et al. “Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” PLoS One.
All were authorised nationally and are available in different pharmaceutical forms: solution for intramuscular injection, oral capsules, cutaneous gel, cutaneous solution and transdermal patch.
farmacevtskih oblikah: raztopina za intramuskularno injiciranje, peroralne kapsule, dermalni gel, dermalna raztopina in transdermalni obliž.
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.
2013 Nov 6;310(17):1829-36. 5 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.
• The Committee noted that the available data does not consistently show an increased risk of cardiovascular events during testosterone therapy.
• odbor je ugotovil, da razpoložljivi podatki o povečanem tveganju kardiovaskularnih dogodkov med zdravljenjem s testosteronom niso dosledni;
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).
Za tako vrsto hipogonadizma so na primer značilni zmanjšana spolna funkcija, neplodnost, zmanjšana energija, depresivno razpoloženje, blaga anemija, zmanjšana mišična masa in moč, povečana telesna maščoba in ITM (smernica Združenja za endokrinologijo).
There are no treatment alternatives to testosterone for male hypogonadism (Buvat et al. 20132)
Pri zdravljenju moškega hipogonadizma razen testosterona ne obstajajo nobene druge oblike zdravljenja (Buvat in sod.
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).
Pojavili so se pomisleki glede morebitnega povečanega tveganja kardiovaskularnih dogodkov, predvsem miokardnega infarkta, pri moških s srčno boleznijo, zdravljenih s testosteronom (Finkle in sod.
This summary was last updated in March 2016
Povzetek je bil nazadnje posodobljen marca 2016.
Protection starts four weeks after vaccination.
Zaščita se vzpostavi štiri tedne po cepljenju.
‘Attenuated' means that the strain has first been weakened so that it does not cause disease.
„Oslabljen“ pomeni, da je bil sev najprej oslabljen, tako da ne povzroča bolezni.
The company presented data from laboratory studies and from one field trial.
Družba je predstavila podatke iz laboratorijskih študij in enega terenskega preskušanja.
The field study did not bring additional information.
S terenskimi študijami niso pridobili nobenih novih informacij.
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.
Celotno evropsko javno poročilo o oceni cepiva MS-H je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The whole flock should be vaccinated at the same time.
Vse ptice v jati morajo biti cepljene hkrati.
This is a summary of the European public assessment report (EPAR) for MS-H Vaccine.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za cepivo MS-H.
Protection against damage to air sacs lasts for 40 weeks, but the duration of protection against abnormal shells forming is not known.
Zaščita pred poškodbami zračnih mešičkov traja 40 tednov, trajanje zaščite pred nenormalno oblikovano lupino pa ni znano.
The European Commission granted a marketing authorisation valid throughout the European Union, for MS-H vaccine on 14 June 2011.
Evropska komisija je dovoljenje za promet s cepivom MS-H, veljavno po vsej Evropski uniji, izdala 14. junija 2011.
It should not be used in birds in lay or within five weeks of the start of the laying period.
Ne sme se uporabljati pri pticah v obdobju nesnosti ali pet tednov pred začetkom obdobja nesnosti.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that MS-H Vaccine's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi cepiva MS-H večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The vaccine has no known side effects.
Za cepivo niso znani nobeni neželeni učinki.
In the future, if the animals are exposed to Mycoplasma synoviae, the immune system will be able to respond more quickly.
Če bo žival v prihodnosti ponovno izpostavljena bakteriji Mycoplasma synoviae, se bo imunski sistem lahko tako hitreje odzval.
The person administering the vaccine should wear protective equipment, consisting of gloves and safety glasses to avoid skin and eye injuries which may occur by manipulating the vaccine bottle which is frozen.
Oseba, ki daje zdravilo, mora nositi zaščitno opremo, ki vključuje zaščitne rokavice in očala, ki preprečujejo poškodbe kože in oči, do katerih lahko pride pri rokovanju z zamrznjeno stekleničko cepiva.