FrancophonIA/ELRC3.0 huggingface dataset:
English: In pigs, it is used to treat or for metaphylaxis of a number of infectious diseases that are caused by bacteria that affect the lungs (i.e. swine enzootic pneumonia) or the intestinal tract (swine dysentery or porcine proliferative enteropathy).
Croatian: U svinja se koristi za liječenje ili metafilaksu brojnih infektivnih bolesti uzrokovanih bakterijom koje zahvaćaju pluća (primjerice svinjska enzootska pneumonija) ili probavni sustav (svinjska dizenterija ili svinjska proliferativna enteropatija).
English: The treatment success with Aivlosin was similar to the effectiveness of other medicines of the same class authorised for such diseases in pigs.
Croatian: Uspjeh liječenja VMP-om Aivlosin bio je sličan djelotvornosti drugih lijekova iste skupine koji su odobreni za liječenje takvih bolesti u svinja.
English: These included a dose confirmation study in turkey poults (young turkeys) artificially infected with a lung virus (avian pneumovirus) and Ornithobacterium rhinotracheale, to simulate a complicated infection.
Croatian: Ona su obuhvaćala ispitivanje potvrde doze kod mladih purana koji su umjetno zaraženi plućnim virusom (pneumovirus ptičje gripe) i bakterijom Ornithobacterium rhinotracheale radi oponašanja komplicirane infekcije.
English: The main measure of effectiveness was damage to lungs and air sacs, which was less for the Aivlosin-treated turkeys than for the untreated group.
Croatian: Glavno mjerilo djelotvornosti bilo je oštećenje pluća i zračnih vrećica, koje je bilo manje izraženo u peradi liječene VMP-om Aivlosin nego u skupini koja nije liječena.
English: Skin that has been in contact with Aivlosin or medicated feed or drinking water should be washed.
Croatian: Kožu koja je bila u doticaju s VMP-o Aivlosin ili ljekovitom hranom treba isprati vodom.
English: The medicine is not authorised for use in turkeys producing eggs for human consumption.
Croatian: VMP nije odobren za primjenu u pura koje nose jaja za ljudsku prehranu.
English: In turkeys, it is used to treat lung infections caused by a bacterium, Ornithobacterium rhinotracheale, which can cause illness when it is complicated by other viral and bacterial infections.
Croatian: U purana se koristi za liječenje infekcija pluća uzrokovanih bakterijom Ornithobacterium rhinotracheale koja može uzrokovati bolest ako dođe i do drugih virusnih ili bakterijskih infekcija.
English: The studies showed that pigs treated with Aivlosin showed less severe signs of disease than untreated animals.
Croatian: Ispitivanja su pokazala da su kod svinja liječenih VMP-om Aivlosin znakovi bolesti bili manje ozbiljni nego kod životinja koje nisu bile liječene.
English: The oral powder is mixed into pig feed by the pig owner and is used to treat individual pigs.
Croatian: Vlasnik svinje miješa oralni prašak u hranu za svinje te se on koristi za liječenje pojedinih svinja.
English: The withdrawal period for eggs from chickens treated with Aivlosin is zero days.
Croatian: Razdoblje karencije za jaja kokoši liječenih VMP-om Aivlosin iznosi nula dana.
English: Chickens and pheasants treated with Aivlosin showed less severe signs of disease than untreated animals.
Croatian: Pilići i fazani liječeni VMP-om Aivlosin imali su manje ozbiljne znakove bolesti nego oni koji nisu bili liječeni.
English: How is Aivlosin used?
Croatian: Kako se Aivlosin koristi?
English: The withdrawal period for meat from chickens, turkeys and pheasants treated with Aivlosin given via drinking water is two days.
Croatian: Razdoblje karencije za meso pilića, purana i fazana liječenih VMP-om Aivlosin u vodi za piće je dva dana.
English: How does Aivlosin work?
Croatian: Kako djeluje Aivlosin?
English: The withdrawal period for meat from pigs treated with Aivlosin given in the feed is two days and one day with Aivlosin given via drinking water.
Croatian: Razdoblje karencije za meso svinja liječenih VMP-om Aivlosin u hrani je dva dana, te jedan dan nakon primjene VMP-a Aivlosin u vodi za piće.
English: For practical information about using Aivlosin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Aivlosin vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For more information about treatment with Aivlosin animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Aivlosin vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: What benefits of Aivlosin have been shown in studies?
Croatian: Koje su koristi VMP-a Aivlosin utvrđene u ispitivanjima?
English: The effectiveness of Aivlosin was similar to that of other medicines of the same class already authorised for this disease in chickens.
Croatian: Uspjeh liječenja VMP-om Aivlosin bio je sličan djelotvornosti drugih lijekova iste skupine koji su odobreni za liječenje takvih bolesti u pilića.
English: Poults either received treatment with Aivlosin or no treatment three days later.
Croatian: Nakon tri dana perad je liječena VMP-om Aivlosin ili nije primala nikakvo liječenje.
English: This later diagnosis is not any more listed in the DSM-IV-TR.
Croatian: Ova kasnija dijagnoza nije više navedena u DSM-IV-TR.
English: The number of patients could be considered sufficient in 4 studies (146, 203, 155 and 324 patients) and small in 2 studies (50 and 49 patients).
Croatian: Broj pacijenata trebao bi biti dostatan u 4 ispitivanja (146, 203, 155 i 324 bolesnika) te mali u dva ispitivanja (50 i 49 bolesnika).
English: The duration of these studies was short (2 or 3 months) considering the chronic indication approved.
Croatian: Trajanje ovih ispitivanja bilo je kratko (2 ili 3 mjeseca) s obzirom na kroničnu indikaciju za koju su odobreni.
English: Patients included in most of these studies presented various very different symptoms without standardised diagnosis.
Croatian: Pacijenti uključeni u većinu ovih ispitivanja iskazivali su vrlo različite simptome bez standardizirane dijagnoze.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Croatian: Naznačena je ozbiljnost takvih štetnih događaja i njihov mogući smrtni ishod.
English: Only one study (Vinckier study) mentioned a small group of patients suffering from associated systemic disease.
Croatian: Samo je jedno ispitivanje (Ispitivanje Vinckier) spomenulo malu skupinu bolesnika koji su patili od dodatne sistemske bolesti.
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC the CHMP recommends:
Croatian: Direktive 2001/83/EZ CHMP preporučuje:
English: • The Committee considered the overall submitted data provided by the MAHs and the outcome of the scientific advisory group.
Croatian: • Povjerenstvo je uzelo u obzir ukupne podatke koje su podnijeli nositelji odobrenja i ishod vijećanja znanstvene savjetodavne skupine.
English: There seemed to be a benefit of treatment in approximately 5575% of patients but the CHMP concluded that these results are in fact difficult to interpret from a clinical point of view and not reliable due to the methodological limitations of the studies.
Croatian: Čini se da postoji dobrobit od liječenja od približno 55-75 % u bolesnika, ali CHMP je zaključio da je te rezultate zapravo teško protumačiti s kliničkog stajališta te da nisu pouzdani zbog metodoloških ograničenja u samim ispitivanjima.
English: In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the product outweigh the risk.
Croatian: Kako bi se ukinula suspenzija nositelji odobrenja moraju identificirati specifičnu populaciju bolesnika za koje dobrobiti premašuju rizik.
English: The studies included young and old patients (1878 years old) with idiopathic acrosyndrome.
Croatian: Ispitivanja su uključivala mlade i starije bolesnike (u dobi od 18 do 78 godina) s idiopatskim akrosindromom.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications.
Croatian: • Povjerenstvo je uzelo u obzir postupak u skladu s člankom 31 Direktive 2001/83/EZ za lijekove koji sadrže derivate ergota u dotičnim indikacijama.
English: The absence of such reports claimed from the MAH, raised questions to the CHMP with regard to the way that the data collection was performed.
Croatian: Nedostatak takvih izvješća koji su zatraženi od nositelja odobrenja podiglo je pitanja CHMP u vezi načina prikupljanja podataka.
English: As a note, one of the above mentioned three cases of fibrosis was reported in 2009 (i.e. after finalisation of the previous referral) which shows that the risk minimisation measures that were imposed at that point in time are not sufficient to exclude the risk.
Croatian: Valja spomenuti da je jedan od tri prethodno spomenuta slučaja prijavljen 2009. godine (tj. nakon dovršetka prethodne procjene) što ukazuje da je su mjere minimizacije rizika uspostavljene u to vrijeme bile nedostatne za isključivanje rizika.
English: • The Committee considered that a potential causal association between fibrotic reactions or ergotism and dihydroergocryptine/caffeine cannot be excluded.
Croatian: • Povjerenstvo je smatralo da se moguća uzročna povezanost između fibrotičkih reakcija ili ergotizma i dihidroergokriptina/kofeina ne može isključiti.
English: • The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergocryptine/caffeine in the currently assessed indications is very limited, and therefore the potential benefit for patients in these indications is outweighed by the above identified risk.
Croatian: • Povjerenstvo smatra da su dokazi značajne kliničke djelotvornosti dihidroergokriptina/kofeina u trenutno procijenjenim indikacijama vrlo ograničeni i da je stoga moguća dobrobit za bolesnike u ovim indikacijama nadmašena prethodno navedenim rizikom.
English: The CHMP considered the MAHs proposals for risk minimisation measures.
Croatian: CHMP je razmotrio prijedloge nositelja odobrenja za mjere minimizacije rizika.
English: The clinical efficacy endpoints were numerous and heterogeneous with no defined primary efficacy endpoint.
Croatian: Ishodi kliničke djelotvornosti bili su brojni i raznoliki bez definiranog primarnog ishoda djelotvornosti.
English: In rats, dihydroergocryptine showed to activate antioxidant enzymatic systems physiologically alterated during aging.
Croatian: Kod štakora je dokazano je da dihidroergokriptin aktivira antioksidative enzimatske sustave koji se fiziološki mijenjaju tijekom starenja.
English: Following a national pharmacovigilance review held in 2011 new spontaneous notifications reported with some of those products identified serious cases of fibrosis and ergotism and France considered that this safety concern is not outweighed by the limited evidence of efficacy.
Croatian: Nakon državne farmakovigilancijske procjene koja je održana 2011. godine nova spontana izvješća za neke od ovih lijekova identificirala su ozbiljne slučajeve fibroze i ergotizma te je Francuska smatrala da ova sigurnosna briga nije nadmašena ograničenim dokazima o djelotvornosti.
English: A review of all other available data (i.e. literature data, pre-clinical data, and other clinical data including epidemiological studies) that were relevant to evaluate the risk of fibrosis was provided where possible.
Croatian: Pregled svih drugih dostupnih podataka (primjerice podataka iz literature, nekliničkih podataka i drugih kliničkih podataka uključujući podatke iz epidemioloških ispitivanja) koji su bili relevantni za procjenu rizika od fibroze prikazan je tamo gdje je bilo moguće.
English: Under-reporting can also be suspected because the substance is marketed for a long time as well as because fibrosis is already mentioned as an adverse drug reaction in the product information.
Croatian: Može se sumnjati i na nedovoljno prijavljivanje jer je djelatna tvar dugo vremena na tržištu ali i zbog toga jer je fibroza već navedena kao nuspojava u informacijama o proizvodu.
English: The marketing authorisation holders (MAHs) submitted all available efficacy data from clinical trials and observational studies, including data that became available since the granting of the initial marketing authorisation.
Croatian: Nositelji odobrenja za stavljanje lijeka u promet (MAHs) predali su sve dostupne podatke o djelotvornosti iz kliničkih i opservacijskih ispitivanja uključujući podatke koji su postali dostupni od dobivanja početnog odobrenja za stavljanje lijeka u promet.
English: Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis.
Croatian: Derivati ergota prepoznati su kao oni koji su u stanju potaknuti fibrozu, posebice fibrozu srčanog zalistka.
English: The group highlighted that the claimed indication is not used anymore in the clinical practice and that from a clinical viewpoint there is no evidence at present that there is a therapeutic need for this active substance in the treatment of cognitive and neurosensorial impairment in the elderly.
Croatian: Skupina je istaknula da se tražena indikacija više ne upotrebljava u kliničkoj praksi i da s kliničkog stajališta nema aktualnog dokaza da postoji terapijska potreba za ovu djelatnu tvar u liječenju kognitivnog i neurosenzorskog oštećenja u starijih.
English: In general the CHMP was of the opinion that the methodological flaws and the absence of primary efficacy endpoint do not allow to draw conclusions on clinical efficacy or to support an indication with standardised diagnosis.
Croatian: CHMP je općenito smatrao da se metodološki nedostaci i odsutnost primarnog ishoda djelotvornosti ne omogućavaju donošenje zaključaka o kliničkoj djelotvornosti ili kao potpora indikaciji sa standardiziranom dijagnozom.
English: Although some of the proposed measures could help identify patients with preexisting fibrosis, relevant concomitant medication and increased risk, the Committee pointed out that they are insufficient to avoid that some patients develop fibrosis and ergotism during treatment.
Croatian: Iako neke od predloženih mjera mogu pomoći u identifikaciji bolesnika s postojećom fibrozom, relevantnih konkomitantnih lijekova i povećanog rizika, Povjerenstvo je istaknulo da nisu dostatne da bi pojedini bolesnici izbjegli fobrozu i ergotizam tijekom liječenja.
English: On 18 January 2012, France triggered a referral under Article 31 of Directive 2001/83/EC for the following ergot derivatives containing medicinal products: dihydroergocryptine/caffeine, dihydroergocristine, dihydroergotamine, dihydroergotoxine and nicergoline.
Croatian: Na dan 18. siječnja 2012. godine Francuska je pokrenula pitanje procjene u skladu s člankom 31. Direktive 2001/83/EZ za sljedeće lijekove koji sadrže derivate ergota: dihidroergokriptin/kofein, dihidroergokristin, dihidrergotamin, dihidriergotoksin i nikergolin.
English: The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocryptine/caffeine.
Croatian: CHMP je uzeo u obzir ukupne dostupne podatke o sigurnosti i djelotvornosti dihidroergokriptina/kofeina.
English: Considering the several reported cases of vasoconstriction and the pharmacological structure of this ergot alkaloid derivative product, ergotism cannot be ruled out.
Croatian: Uzimajući u obzir nekoliko prijavljenih slučajeva vazokonstrikcije i farmakološku strukturu ovog derivata ergot alkaloida, ne može se isključiti ergotizam.
English: Results were heterogeneous and there was no consistency across studies.
Croatian: Rezultati su bili raznoliki i nije bilo dosljednosti kroz ispitivanja.
English: The MAHs also submitted their own overviews and critical summaries of all spontaneous reports of fibrotic reactions (cardiac with or without pulmonary arterial hypertension, pulmonary, pleural, peritoneal, retroperitoneal, etc) and ergotism with their ergot derivatives-containing medicinal products.
Croatian: Nositelji odobrenja predali su također vlastite preglede i kritičke sažetke svih spontanih izvješća o fibrotičkim reakcijama (srčana s ili bez hipertenzije plućne arterije, pulmonalna, pleuralna, peritonealna, retroperitonealna itd.) i ergotizam za svoje lijekove koji sadrže derivate ergota.
English: The studies mainly assessed functional symptoms, capillaroscopic parameters and plethysmographic parameters whose clinical relevance was considered questionable by the CHMP.
Croatian: Ispitivanja su uglavnom procjenjivala funkcionalne simptome, kapilaroskopske parametre čiji je klinički značaj CHMP-a smatrao upitnim.
English: • The suspension of the marketing authorisation for dihydroergocryptine /caffeine containing medicinal products referred to in Annex I in the event that no other indications are approved as part of their marketing authorisation.
Croatian: • Suspenzija odobrenja za stavljanje lijeka u promet za lijekove koji sadrže dihidroergokriptin/kofein navedenih u Prilogu I. u slučaju da nisu odobrene nikakve dodatne indikacije kao dio njihovog odobrenja za stavljanje u promet.
English: Based on these data and based on the pharmacological plausibility, dihydroergocryptine is considered to be associated with fibrotic reactions.
Croatian: Na temelju ovih podataka i farmakološke vjerojatnosti, dihidroergokriptin se smatra povezanim s fibrotičkim reakcijama.
English: The reliability and the clinical relevance of the study results was therefore questionable and preclude any conclusion on the efficacy of the product.
Croatian: Pouzdanost i klinički značaj rezultata ispitivanja stoga je bio upitan i unaprijed je isključio bilo kakav zaključak o djelotvornosti lijeka.
English: The data from the reported cases of fibrosis (n=3) are limited in order to draw any firm conclusions, however, the risk cannot be excluded considering the improvement observed when dihydroergocryptine/caffeine was discontinued in one of the three reported cases of pulmonary fibrosis occurring with recommended daily dose.
Croatian: Podaci iz prijavljenih slučajeva fibroze (n=3) su ograničeni da bi se iz njih mogli izvući čvrste zaključke međutim, nije moguće isključiti rizik uzimajući u obzir poboljšanja uočena prilikom prekida liječenja dihidroergokriptinom/kofeinom u jednom od tri prijavljena slučaja plućne fibroze koja su se dogodila s preporučenom dnevnom dozom.
English: In fact, dihydroergocryptine being part of the class of ergot derivatives containing medicinal products covered by this procedure is only approved in the above mentioned indications in France and only in combination with caffeine since 1979.
Croatian: Zapravo je dihidroergokriptin kao dio klase lijekova koji sadrži derivate ergot alkaloida pokrivenih ovim postupkom odobren je samo za prethodno navedene indikacije u Francuskoj te samo u kombinaciji s kofeinom od 1979. godine.
English: It is available in combination with caffeine that may improve the digestive absorption of this ergot alkaloid.
Croatian: Dostupan je u kombinaciji s kofeinom koji može poboljšati apsorpciju ovog alkaloida ergota u probavnom sustavu.
English: Regarding ergotism, there were several cases reported in the French Pharmacovigilance database where dihydroergocryptine/caffeine was the suspected drug for symptoms related to ergotism.
Croatian: Što se tiče samog ergotizma, zabilježeno je nekoliko slučajeva u francuskoj farmakovigilancijskoj bazi podataka gdje je postojala sumnja da je dihidrergokriptin/kofein suspektni lijek za simptome povezane s ergotizmom.
English: Grounds for the variation/suspension to the terms of the marketing authorisations
Croatian: Temelji za izmjenu/suspenziju uvjeta odobrenja za stavljanje lijeka u promet
English: Dihydroergocryptine only containing products are approved in other EU Member States but their indications were not in the scope of this referral procedure (e.g. Parkinson's disease) and were excluded from this review.
Croatian: Lijekovi koji sadrže samo dihidroergokriptin odobreni su u drugim državama članicama ali njihove indikacije ne spadaju pod djelokrug ovog postupka procjene (primjerice Parkinsonova bolest) te su bile isključene iz ove procjene.
English: Overall, for the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”, the MAHs provided 6 publications (dated from 1983 to 1998) with an adequate design (randomised, double-blind, placebo controlled) to support the claim for efficacy, plus one study in vascular cognitive impairment which wasnot further discussed.
Croatian: Ukupno gledano za indikaciju „simptomatsko liječenje kroničnog patološkog, kognitivnog i neurosenzornog oštećenja u starijih (isključujući Alzheimerovu bolest i druge demencije) ”, nositelji odobrenja predali su 6 publikacija (u razdoblju od 1983. do 1998. godine) s odgovarajućim dizajnom (randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje) kako bi se podržao zahtjev za ispitivanjem djelotvornosti te dodatnim ispitivanjem o vaskularnom kognitivnom oštećenju koje do sada nije raspravljeno.
English: Is not favourable for ancillary treatment of Raynaud's syndrome.
Croatian: Nije povoljan za pomoćno liječenje Raynaudova sindroma.
English: • Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease
Croatian: • Pomoćno liječenje intermitentne klaudikacije u simptomatskoj perifernoj bolesti okluzije arterija
English: The CHMP was therefore requested to give its opinion on whether the marketing authorisations for ergot derivatives containing medicinal products should be maintained, varied, suspended or withdrawn in relation to the below mentioned indications:
Croatian: Od CHMP-a se stoga zahtijevalo da izrazi svoje mišljenje o tome treba li održati odobrenje za stavljanje u promet lijekova koji sadrže derivate ergota, promijeniti ga ili suspendirati, a povezano s indikacijama navedenim u nastavku:
English: Data provided during a referral under Article 31 in 2007-2008 (EMEA/H/A-31/881) including dihydroergocryptine showed that several cases of fibrosis either pulmonary or cardiac or retroperitoneal were suspected to be associated to the treatment with dihydroergocryptine use for Parkinson's disease treatment (involving dosage five times higher).
Croatian: Podaci dobiveni tijekom postupka procjene u skladu s člankom 31. u postupku 2007.-2008. (EMA/H/A31/881) uključujući dihidroergokriptin pokazali su da se sumnja da je nekoliko slučajeva fibroze bilo plućne, srčane ili retroperitonealne bilo povezano s liječenjem dihidrergokriptinom kod Parkinsonove bolesti (uključujući i doze pet puta više od propisanih).
English: In 2 studies patients presented a clinical diagnosis of mild organic brain syndrome (stage 2-3 on the Global Deterioration Scale) (Scarzella study) and an early stage senile cerebral deterioration without dementia or major dependence with respect to the environment, based on DSM-III criteria (Babeau study).
Croatian: U dva ispitivanja bolesnici su se prezentirali s kliničkom dijagnozom blagog organskog sindroma mozga (stupanj 2-3 na Općoj ljestvici pogoršanja) (ispitivanje Szarcella) te ranim stadijem senilnog cerebralnog pogoršanja bez demencije ili velike ovisnosti s obzirom na okoliš, a na temelju kriterija DSM-III (ispitivanje Babeau).
English: From the approved indications of the dihydroergocryptine containing medicinal products the ones that are in the scope of this referral procedure and are approved in at least one Member State are the following (specific wording of the indication may vary from product to product):
Croatian: Iz odobrenih indikacija za lijekove koji sadrže dihidroergokriptin oni koji spadaju pod djelokrug ove procjene te su odobreni barem u jednoj državi članici su sljedeće (specifične riječi za indikaciju mogu varirati od lijeka do lijeka):
English: The relationship between fibrosis and serotoninergic receptor activation, particularly 5-HT2B receptors by ergot derivatives is extensively described in the literature.
Croatian: Odnos između fibroze i aktivacije serotoninergičnih receptora, posebice receptora 5-HT2B izazvane derivatima ergota detaljno je opisan u literaturi.