FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee recognised the limited available information on testosterone therapy for age-related hypogonadism and also the lack of reference.
Croatian: Odbor je priznalo ograničene dostupne informacije u vezi s terapijom testosterona za hipogonadizam povezan s dobi, kao i manjak referenci.
English: • 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.
Croatian: • je PRAC zaključio da na temelju cjelokupnih trenutno dostupnih podataka, navedeni rizik od kardiovaskularnih događaja povezanih s terapijom testosteronom ostaje slabi signal.
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.
Croatian: • je Odbor suglasan kako je u informaciji o lijeku za sve lijekove koji sadrže testosteron potrebno navesti aktualna saznanja o kardiovaskularnim rizicima povezanim s terapijom testosteronom i preporučio je izmjene u dijelu 4.1. (terapijske indikacije), dijelu 4.4. (upozorenja i mjere opreza) i dijelu 4.8. (nuspojave) sažetka opisa svojstava lijeka.
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.
Croatian: Očekuje se da će nositelji odobrenja za stavljanje lijeka u promet nastaviti pratiti kardiovaskularne događaje kao i da će nalazi ispitivanja u tijeku biti prikazani u periodičkim izvješćima o neškodljivosti lijeka (PSUR-ovima) nakon što postanu dostupni.
English: 4 Vigen et al. “Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.” JAMA.
Croatian: “Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.”
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.
Croatian: Općenito, PRAC je zaključio da nalazi u literaturi ne potvrđuju konzistentno povećanje rizika kardiovaskularnih događaja i ne potvrđuju signal povišenog rizika od kardiovaskularnih događaja povezan s terapijom testosteronom.
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.
Croatian: Od nositelja odobrenja za stavljanje lijeka u promet zatraženo je da pri sljedećem PSUR-u istraži i prijavi primjenu tih lijekova u navedenoj populaciji bolesnika, te da razmotri je li uzorak nuspojava usporediv s drugim dobnim skupinama.
English: • The Committee noted that the available data does not consistently show an increased risk of cardiovascular events during testosterone therapy.
Croatian: • je Odbor napomenuo da dostupni podaci ne ukazuju konzistentno na povišeni rizik od kardiovaskularnih događaja tijekom terapije testosteronom.
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.
Croatian: Rezultati ukazuju na stope raka prostate i kardiovaskularne događaje unutar okvira očekivanog raspona, bez dokaza povećanog rizika u liječenih u odnosu na neliječene bolesnike.
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).
Croatian: Simptomi su manje specifični ako se hipogonadizam razvije nakon puberteta, te su okarakterizirani primjerice smanjenom seksualnom funkcijom, neplodnošću, smanjenom energijom, depresivnim raspoloženjem, blagom anemijom, smanjenom mišićnom masom i snagom, povećanim masnim tkivom i BMI-om (smjernica endokrinog društva).
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.
Croatian: Glavni cilj terapije testosteronom (TT) jest postići normalne fiziološke razine testosterona kako bi se ublažili simptomi hipogonadizma poput smanjenje seksualne funkcije, neplodnosti, smanjene energije, depresivnog raspoloženja, blage anemije, smanjene mišićne mase i snage, povećanog masnog tkiva i indeksa tjelesne mase (BMI-a), te psihološkog oštećenja.
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.
Croatian: PRAC je pregledao podatke dostupne iz kliničkih ispitivanja, opservacijskih ispitivanja, meta analiza, podatke dostupne nakon stavljanja lijeka u promet i sve daljnje objavljene podatke o kardiovaskularnim rizicima povezanima s terapijom testosteronom.
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.
Croatian: PRAC je napomenuo kako nalazi nekoliko opservacijskih ispitivanja, kliničkih ispitivanja i meta analize randomiziranih kliničkih ispitivanja ne pružaju dovoljno dokaza o vezi između testosterona i kardiovaskularnog događaja.
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.
Croatian: Hipogonadizam je klasificiran kao primarno testikularno zatajenje uslijed problema s testisima i kao sekundarno zatajenje testisa uslijed problema u hipotalamusu ili hipofizi.
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
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet koja su podložna uvjetima i detaljnom pojašnjenju znanstvenih razloga za razlike u odnosu na preporuku PRAC-a
English: The PRAC acknowledged that some studies show an increased risk of cardiovascular events in men treated with testosterone.
Croatian: PRAC je potvrdio kako je u pojedinim ispitivanjima utvrđen povišeni rizik od kardiovaskularnih događaja u muškaraca liječenih testosteronom.
English: 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.
Croatian: U svjetlu prethodno navedenog, PRAC je preporučio izmjenu uvjeta odobrenja za stavljanje u promet lijekova koji sadrže testosteron (vidjeti Dodatak I.), za koje su relevantni dijelovi sažetka opisa svojstava lijeka i uputa o lijeku navedeni u Dodatku III. i podložni su uvjetima navedenim u Dodatku IV. preporuke PRAC-a.
English: Ediburgh: Churchill Livingstone, 1991; T20-1
Croatian: Ediburgh: Churchill Livingstone, 1991; T20-1 2 Buvat J, Maggi M, Guay A, Torres LO.
English: • The Committee recognised the limited available information on testosterone therapy for agerelated hypogonadism and also the lack of reference values.
Croatian: • je Odbor prepoznao ograničene dostupne informacije o terapiji testosteronom za hipogonadizam povezan s dobi, kao i manjak referentnih vrijednosti.
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.
Croatian: 6 Baillargeon J, Urban RJ, Kuo Y-F, Ottenbacher KJ, Raji MA, Du F, Lin Y-l, Goodwin JS.
English: All testosterone-containing medicinal products approved in the European Union were included in this review performed by the PRAC.
Croatian: Ovim pregledom koji je proveo PRAC obuhvaćeni su svi lijekovi koji sadrže testosteron odobreni u Europskoj uniji.
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.
Croatian: Uzimajući u obzir trenutno raspoloživa saznanja, PRAC je preporučio da nositelji odobrenja za stavljanje lijeka u promet trebaju dodatno istražiti mogući mehanizam povezanosti između kardiovaskularnih/venskih tromboembolijskih događaja i razine testosterona i prijaviti ih u sljedećem PSUR-u.
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.
Croatian: Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.
English: 2001/83/EC was therefore initiated, to review the benefit-risk balance of testosterone containing medicinal products.
Croatian: Stoga je pokrenut postupak upućivanja u skladu s člankom 31. Direktive 2001/83/EZ s ciljem pregleda omjera koristi i rizika lijekova koji sadrže testosteron.
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.
Croatian: Stoga je Odbor zaključio da omjer koristi i rizika za lijekove koji sadrže testosteron ostaje povoljan, te da podliježe uvjetima odobrenja za stavljanje lijeka u promet, uzimajući u obzir preporučene dopune informacija o lijeku.
English: Exp Opin Drug Safety 2014 (Posted online on August 19, 2014.
Croatian: Exp Opin Drug Safety 2014 (Posted online on August 19, 2014. (doi:10.1517/14740338.2014.950653)
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.
Croatian: oblicima: otopina za intramišićnu injekciju, oralne kapsule, gel koji se nanosi na kožu, otopina koja se nanosi na kožu i transdermalni flaster.
English: 2013 Nov 6;310(17):1829-36.
Croatian: 2013 Nov 6;310(17):1829-36. 5 Xu L, Freeman G, Cowling BJ,Schooling CM.
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.
Croatian: 7 Corona G, Maseroli E, Rastrelli G, Isidori A, Mannucci E, Maggi M.
English: The field study did not bring additional information.
Croatian: Terensko ispitivanje nije pružilo dodatne informacije.
English: This summary was last updated in March 2016
Croatian: Sažetak je posljednji put ažuriran u 03.2016.
English: Protection starts four weeks after vaccination.
Croatian: Zaštita počinje četiri tjedna nakon cijepljenja.
English: The company presented data from laboratory studies and from one field trial.
Croatian: Tvrtka je predočila podatke iz laboratorijskih ispitivanja i jednog terenskog ispitivanja.
English: It should not be used in birds in lay or within five weeks of the start of the laying period.
Croatian: Ne smije se primjenjivati na pticama koje nesu niti unutar pet tjedana prije početka perioda nesenja.
English: Protection against damage to air sacs lasts for 40 weeks, but the duration of protection against abnormal shells forming is not known.
Croatian: Zaštita od oštećenja zračnih vrećica traje 40 tjedana, ali trajanje zaštite od abnormalnog formiranja ljuske nije poznato.
English: Any accidental splashing to the face and eyes should be thoroughly washed with water.
Croatian: U slučaju nehotičnog prskanja, lice i oči treba temeljito isprati vodom.
English: In the future, if the animals are exposed to Mycoplasma synoviae, the immune system will be able to respond more quickly.
Croatian: Ako životinje u budućnosti budu izložene bakteriji Mycoplasma synoviae, imunosni sustav moći će brže reagirati.
English: 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.
Croatian: Osoba koja primjenjuje cjepivo treba nositi zaštitnu opremu koja se sastoji od zaštitnih rukavica i naočala kako bi se izbjegle ozljede kože i očiju, do kojih može doći prilikom rukovanja s bočicom cjepiva koja je smrznuta.
English: 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.
Croatian: Ova bakterija uzrokuje infekcije u ptica, uglavnom infekcije pluća i „zračnih vrećica”, specijaliziranih vrećica unutar tijela ptice gdje se čuva zrak tijekom disanja.
English: MS-H Vaccine, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Croatian: Kao i sva cjepiva, MS-H Cjepivo djeluje „učeći” imunosni sustav (prirodnu obranu tijela) kako se obraniti protiv bolesti.
English: MS-H Vaccine
Croatian: MS-H Cjepivo
English: The whole flock should be vaccinated at the same time.
Croatian: Treba cijepiti istovremeno sve ptice u jatu.
English: Mycoplasma synoviae strain MS-H vaccine (live attenuated)
Croatian: Mycoplasma synoviae soj MS-H Cjepivo (živo, atenuirano)
English: It is not intended to provide practical advice on how to use MS-H Vaccine.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju VMP-a MS-H Cjepivo.
English: What is MS-H Vaccine and what is it used for?
Croatian: Što je MS-H Cjepivo i za što se koristi?
English: This is a summary of the European public assessment report (EPAR) for MS-H Vaccine.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o veterinarsko-medicinskom proizvodu MS-H Cjepivo.
English: 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.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a MS-H Cjepivo nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The vaccine has no known side effects.
Croatian: Nema poznatih nuspojava u primjeni cjepiva.
English: The withdrawal period for MS-H vaccine for meat and eggs is zero days.
Croatian: Razdoblje karencije za meso i jaja za VMP MS-H Cjepivo iznosi nula dana.
English: When MS-H Vaccine is given to chickens the immune system recognises the weakened strain as ‘foreign' and makes defences against it.
Croatian: Kada se MS-H Cjepivo daje pilićima imunosni sustav prepoznaje oslabljeni soj kao „strano tijelo” i stvara obrambeni mehanizam protiv njega.
English: Infection with Mycoplasma synoviae may result in difficulty breathing and is also associated with poor quality of the eggshell.
Croatian: Infekcija bakterijom Mycoplasma synoviae može rezultirati otežanim disanjem, a također je povezana s ljuskom jajeta loše kvalitete.
English: MS-H Vaccine is used in young chickens intended to produce eggs for broilers (for meat) and layers (for egg production) to reduce the damage to air sacs and reduce the number of eggs with abnormal shells.
Croatian: MS-H Cjepivo primjenjuje se na pilićima namijenjenim za proizvodnju jaja za buduće brojlere (uzgajane za meso) i roditelje/nesilice (uzgajane za jaja) kako bi se smanjila oštećenja zračnih vrećica i smanjio broj jaja s abnormalnom ljuskom.
English: MS-H Vaccine is given as one eye drop into one eye.
Croatian: VMP MS-H Cjepivo primjenjuje se tako da se jedna kap ukapa u jedno oko.
English: Why is MS-H Vaccine approved?
Croatian: Zašto je MS-H Cjepivo odobreno?
English: The laboratory studies showed that MS-H Vaccine reduces damage to the air sacs and reduces the number of eggs with shell abnormalities.
Croatian: Laboratorijska su ispitivanja pokazala da VMP MS-H Cjepivo smanjuje oštećenja zračnih vrećica i smanjuje broj jaja s abnormalnom ljuskom.
English: What are the risks associated with MS-H Vaccine?
Croatian: Koji su rizici povezani s VMP-om MS-H Cjepivo?
English: For practical information about using MS-H Vaccine, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a MS-H Cjepivo vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: The laboratory studies included a challenge model of Mycoplasma synoviae infection as well as a study looking at the effect of vaccination on eggshell abnormalities.
Croatian: Laboratorijska ispitivanja uključivala su probni model infekcije bakterijom Mycoplasma synoviae, kao i ispitivanje učinka cijepljenja na abnormalnosti ljuski jaja.
English: MS-H Vaccine is a vaccine used in chickens from five weeks of age to protect them against Mycoplasma synoviae.
Croatian: MS-H Cjepivo jest cjepivo koje se primjenjuje na pilićima starima pet tjedana i starijima od te dobi radi zaštite od bakterije Mycoplasma synoviae.
English: Other information about MS-H Vaccine:
Croatian: Ostale informacije o VMP-u MS-H Cjepivo
English: MS-H Vaccine is available as eye drops and can only be obtained with a prescription.
Croatian: VMP MS-H Cjepivo dostupan je u obliku kapi za oči i izdaje se samo na veterinarski recept.
English: The field study looked at how vaccinated chickens fared when moved to flocks with a history of Mycoplasma synoviae infection.
Croatian: Terensko ispitivanje istraživalo je što se događalo s cijepljenim pilićima koji su premješteni u jata koja su prethodno bila zaražena bakterijom Mycoplasma synoviae.
English: What benefits of MS-H Vaccine have been shown in studies?
Croatian: Koje su koristi VMP-a MS-H Cjepivo utvrđene u ispitivanjima?
English: How is MS-H Vaccine used?
Croatian: Kako se MS-H Cjepivo koristi?
English: How does MS-H Vaccine work?
Croatian: Kako djeluje MS-H Cjepivo?
English: 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.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP MS-H Cjepivo na snazi u Europskoj uniji od 14. lipnja 2011. Cjeloviti EPAR za VMP MS-H Cjepivo nalazi se na internetskim stranicama Agencije: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/vet_epar_search.jsp Za dodatne informacije o terapiji VMP-om MS-H Cjepivo vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: ‘Attenuated' means that the strain has first been weakened so that it does not cause disease.
Croatian: VMP MS-H Cjepivo sadrži živi, atenuirani soj Mycoplasma synoviae. „Atenuirani” znači da je soj prvo oslabljen tako da ne izaziva bolest.
English: Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/114)
Croatian: Ishod postupka u skladu s člankom 34. Direktive 2001/82/EZ (EMEA/V/A/114)
English: The European Commission issued a decision on 14 July 2017.
Croatian: Europska komisija donijela je odluku 14. srpnja 2017.
English: The amended product information is available on the 'All documents' tab.
Croatian: Izmijenjene informacije o lijeku dostupne su u kartici „All documents”.
English: Denagard 45% (and associated names such as Tiamutin 45%, Denagard 450 mg/g and Denagard vet 450 mg/g) is marketed in Austria, Belgium, Czech Republic, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovak Republic and Spain.
Croatian: Denagard 45 % (i pridružena imena kao što su Tiamutin 45 %, Denagard 450 mg/g i Denagard vet 450 mg/g) stavljen je u promet u Austriji, Belgiji, Češkoj Republici, Finskoj, Grčkoj, Italiji, Latviji, Litvi, Mađarskoj, Nizozemskoj, Njemačkoj, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj Republici i Španjolskoj.
English: 14 July 2017
Croatian: 14. srpnja 2017.
English: Denagard 45% is authorised in the EU via national procedures.
Croatian: Denagard 45 % odobren je u EU-u u okviru nacionalnih postupaka.
English: What is Denagard 45%?
Croatian: Što je Denagard 45 %?
English: Tiamulin is a semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and works by inhibiting bacterial protein synthesis.
Croatian: Tiamulin je polusintetički antibiotik koji pripada pleuromutilinskoj skupini antibiotika i djeluje na način da onemogućuje sintezu proteina u bakterijama.
English: Germany noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Denagard 45% is marketed.
Croatian: Njemačka je primijetila da u državama članicama postoje odstupanja u načinu na koji se veterinarsko-medicinski proizvod može primjenjivati, kao što je uočeno u razlikama u informacijama o lijeku u zemljama u kojima je Denagard 45 % stavljen u promet.
English: Questions and answers on Denagard 45% and its associated names
Croatian: Pitanja i odgovori o VMP-u Denagard 45 % i pridruženim imenima
English: Denagard 45% is indicated for the treatment of swine dysentery, colitis, ileitis, enzootic pneumonia and pleuropneumonia in pigs; chronic respiratory disease in chickens and infectious sinusitis and airsacculitis in turkeys.
Croatian: Denagard 45 % indiciran je za liječenje svinjske dizenterije, kolitisa, ileitisa, enzootske pneumonije i pleuropneumonije u svinja; kronične respiratorne bolesti u pilića te infektivnog sinusitisa i bolesti zračnih vrećica u purana.
English: Denagard 45% is a veterinary medicinal product available as granules for use in drinking water and contains 450 mg tiamulin hydrogen fumarate per gram product.
Croatian: Denagard 45 % je veterinarsko-medicinski proizvod u obliku granula za primjenu u vodi za piće i sadržava 450 mg tiamulin hidrogenfumarata po gramu VMP-a.
English: Questions and answers on Denagard 45% and its associated names EMA/275123/2017
Croatian: Pitanja i odgovori o VMP-u Denagard 45 % i pridruženim imenima EMA/491891/2017
English: Why was Denagard 45% reviewed?
Croatian: Zašto je Denagard 45 % ponovno ocjenjivan?
English: Based on the evaluation of the currently-available data, the CVMP concluded that the product information for Denagard 45% and its associated names should be harmonised across the EU.
Croatian: CVMP je na temelju evaluacije trenutačno dostupnih podataka zaključio da se informacije o lijeku za Denagard 45 % i pridružena imena moraju uskladiti na razini EU-a.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information (summary of product characteristics (SPC), labelling and package leaflet) for Denagard 45% in the European Union (EU).
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija o lijeku (sažetka opisa svojstava lijeka, označivanja i uputa o lijeku) za VMP Denagard 45 % u Europskoj uniji (EU).