natgillin/translations-raw huggingface dataset:
Further, the PRAC could not identify conditions which if fulfilled in the future would demonstrate a positive benefit-risk balance for these products in their current indication.
Odbor PRAC tudi ni mogel določiti pogojev, ki bi ob prihodnji izpolnitvi dokazali pozitivno razmerje med tveganji in koristmi za ta zdravila pri njihovi trenutni indikaciji.
Consequently, the PRAC recommend the revocation of the marketing authorisations for flupirtinecontaining medicinal products.
Zato odbor priporoča ukinitev dovoljenj za promet z zdravili, ki vsebujejo flupirtin.
PRAC considered that the newly available safety data, confirmed the known risk of unpredictable and potentially fatal liver injury.
Odbor PRAC je ocenil, da novo razpoložljivi podatki o varnosti potrjujejo že znano tveganje za nepredvidljivo in potencialno usodno poškodbo jeter.
In addition, cases of drug induced liver injury (DILI), including serious cases, continued to be received in EudraVigilance (EV) with flupirtine-containing medicinal products reported as suspected or interacting products.
Poleg tega so v sistem EudraVigilance (EV) še naprej prihajala poročila o primerih z zdravili povzročene poškodbe jeter, vključno z resnimi primeri, pri čemer so bila kot domnevni ali dejanski povzročitelji interakcije navedena zdravila, ki vsebujejo flupirtin.
In 2013, as a result of an urgent Union procedure under Article 107i of Directive 2001/83/EC (EMEA/H/A-107i/1363), the marketing authorisations (MAs) for flupirtine-containing medicinal products were varied to impose restrictions and risk minimisations measures implemented in view of the risk of liver injury.
Leta 2013 so bila kot rezultat nujnega postopka Unije v skladu s členom 107i Direktive 2001/83/ES (EMEA/H/A-107i/1363) spremenjena dovoljenja za promet z zdravilom za zdravila, ki vsebujejo flupirtin, da bi uvedli omejitev in ukrepe za zmanjšanje tveganja zaradi tveganja za poškodbo jeter.
Serious cases have also been received following the implementation of the related risk minimisation measures.
Tudi po uvedbi povezanih ukrepov za zmanjšanje tveganja so še naprej poročali o resnih primerih.
Therefore, in view of the impossibility to minimise sufficiently the risk of hepatotoxicity, the PRAC concluded that this risk outweighs the benefits of flupirtine in the treatment of acute pain, when treatment with other analgesics is contraindicated.
Odbor PRAC je zato na podlagi nezmožnosti zadostnega zmanjšanja tveganja za hepatotoksičnost zaključil, da to tveganje presega koristi flupirtina pri zdravljenju akutne bolečine, kadar je zdravljenje z drugimi analgetiki kontraindicirano.
• Furthermore, the PRAC could not identify any condition, the fulfilment of which would demonstrate a positive benefit-risk balance for flupirtine-containing medicinal products in their current indication.
• odbor PRAC poleg tega ni mogel določiti pogojev, ki bi ob prihodnji izpolnitvi dokazali pozitivno razmerje med tveganji in koristmi za ta zdravila pri njihovi trenutni indikaciji.
Cases of drug induced liver injury (DILI), including cases of acute liver failure, cases necessitating a liver transplant and cases with a fatal outcome have been received since the previous review.
Od predhodnega pregleda so še naprej poročali o primerih z zdravili povzročenih poškodb jeter, vključno s primeri akutne odpovedi jeter, primeri, pri katerih je bila potrebna presaditev jeter, in primeri s smrtnim izidom.
The CMDh, as a consequence, considers that flupirtine-containing medicinal products are harmful.
Skupina CMDh posledično meni, da so zdravila, ki vsebujejo flupirtin, škodljiva, in da njihovo razmerje med tveganji in koristmi ni ugodno.
• The PRAC discussed further risk minimisation proposals and concluded that no feasible measures would ensure effective minimisation of the hepatotoxicity risk to an acceptable level and that therefore this risk outweighs the benefits of flupirtine in the treatment of acute pain, when treatment with other analgesics is contraindicated.
da noben izvedljiv ukrep ne bi zagotovil učinkovitega zmanjšanja tveganja za hepatotoksičnost na sprejemljivo raven, kar pomeni, da to tveganje presega koristi flupirtina pri zdravljenju akutne bolečine, kadar je zdravljenje z drugimi analgetiki kontraindicirano;
The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on correct diagnosis and therapeutic managements of the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3Oxosteroid-5β-reductase deficiency and to inform on expected and potential risks associated with the treatment.
Preden imetnik dovoljenja za promet z zdravilom da zdravilo v promet, mora v dogovoru s pristojnimi organi držav članic izvesti izobraževalni program za zdravnike, katerega cilj je zagotoviti izobraževalno gradivo o pravilnem diagnosticiranju in izvajanju terapije pri zdravljenju prirojenih napak v sintezi primarne žolčne kisline zaradi pomanjkanja 3β-hidroksi-Δ5-C27-steroid-oksireduktaze ali pomanjkanja Δ4-3-oksosteroid-5β-reduktaze ter obvestiti zdravnike o pričakovanih in možnih tveganjih, povezanih z zdravljenjem.
• Prescription of a supratherapeutic dose (MedDRA term: drug toxicity)
• predpisovanje supraterapevtskega odmerka (izraz po MedDRA: toksičnost zdravila);
Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Pogoji ali omejitve v zvezi z varno in učinkovito rabo zdravila, ki jih morajo uvesti države članice
100 tablets (2 x 50)
100 tablet (2 X 50)
Invented name Strength Pharmaceutical Form
Številke EU Zaščiteno ime Jakosti Farmacevtske oblike
Package size
Velikosti pakiranj
bottle (HDPE) without outer carton 180 tablets
Plastenke iz polietilena visoke gostote brez zunanje ovojnine
This summary was last updated in April 2016.
Povzetek je bil nazadnje posodobljen 04-2016.
In turkeys only laboratory studies were performed.
Pri puranih so izvedli samo laboratorijske študije.
The European Commission granted a marketing authorisation valid throughout the EU for Aivlosin on 9 September 2004.
Evropska komisija je dovoljenje za promet z zdravilom Aivlosin, veljavno po vsej Evropski uniji, izdala 9. septembra 2004.
The main clinical studies on the effectiveness of Aivlosin were carried out on farms in a number of countries in Europe as well as outside the EU.
Glavne klinične študije učinkovitosti zdravila Aivlosin so bile izvedene na kmetijah v več evropskih državah in zunaj EU.
The full EPAR for Aivlosin 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 zdravila (EPAR) za zdravilo Aivlosin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Aivlosin.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aivlosin.
Aivlosin is an antibiotic.
Zdravilo Aivlosin je antibiotik.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Aivlosin's benefits are greater that 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 zdravila Aivlosin večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Metaphylaxis refers to the simultaneous treatment of both diseased animals and clinically healthy animals in close contact with them.
Metafilaksa se nanaša na sočasno zdravljenje obolelih in klinično zdravih živali, ki so v tesnem stiku z njimi.
The treatment did not completely eliminate all bacteria in the respiratory system and some birds still showed the disease; however, the number of affected animals was significantly smaller than in an untreated group of birds.
Zdravljenje ni popolnoma odpravilo vseh bakterij v dihalnem sistemu, saj so nekateri piščanci še vedno kazali znake bolezni; vendar pa je bilo število okuženih živali občutno manjše od skupine ptic, ki ni bila zdravljena.
Other information about Aivlosin:
Druge informacije o zdravilu Aivlosin:
The active substance of Aivlosin is tylvalosin (previous name: acetylisovaleryltylosin), an antibiotic of the macrolide group.
Zdravilna učinkovina zdravila Aivlosin je tilvalozin (prejšnje ime: acetilizovaleriltilozin), ki je antibiotik iz skupine makrolidov.
The oral powder cannot properly be mixed into pellets and should therefore not be used in pelleted pig feed.
Peroralnega praška ni mogoče ustrezno zmešati med pelete, zato se ne sme dodajati peletirani prašičji krmi.
The studies in pigs were carried out either in pigs already affected by the disease or in pigs who had been in contact with diseased animals on the same farm and were, therefore, likely to develop the disease as well.
V študije so bili vključeni prašiči, ki so bodisi že zboleli ali pa so bili v stiku z bolnimi živalmi na isti kmetiji, zato je obstajala verjetnost, da se bo bolezen razvila tudi pri njih.
What benefits of Aivlosin have been shown in studies?
Kakšne koristi je zdravilo Aivlosin izkazalo v študijah?
Skin that has been in contact with Aivlosin or medicated feed or drinking water should be washed.
Kožo, ki je prišla v stik z zdravilom Aivlosin oziroma medicinirano krmo ali pitno vodo, je treba umiti.
What is Aivlosin and what is it used for?
Kaj je zdravilo Aivlosin in za kaj se uporablja?
The antimicrobial effectiveness of tylvalosin against bacteria causing diseases was investigated in the laboratory.
Raziskave protimikrobne učinkovitosti tilvalozina proti bakterijam, ki povzročajo bolezni, so potekale v laboratoriju.
Aivlosin is available as a premix for medicated feeding stuff and as an oral powder for pigs, and as granules for use in drinking water for pigs, chickens, turkeys and pheasants.
Zdravilo Aivlosin je na voljo kot predmešanica za izdelavo medicinirane krme, kot peroralni prašek za prašiče in kot zrnca za uporabo v pitni vodi za prašiče, piščance, purane in fazane.
In chickens and pheasants, it is used for treatment or metaphylaxis of lung infections caused by a bacterium Mycoplasma gallisepticum.
Pri piščancih in fazanih se uporablja za zdravljenje ali metafilakso okužb pljuč, ki jih povzroča bakterija Mycoplasma gallisepticum.
The premix is mixed into pig feed by an authorised feed mill and the resulting “medicated feeding stuff” is then distributed to the farmer to treat a large number of pigs.
Predmešanico v prašičjo krmo vmeša pooblaščeni izvajalec, ki se ukvarja z mletjem živalske krme; tako pridobljeno „zdravilno krmo“ pa nato dobavijo kmetom za zdravljenje velikega števila prašičev.
Aivlosin should not be used in people.
Zdravilo Aivlosin ni namenjeno ljudem.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom prašičev sam. Zrnca se dodajo v sistem pitne vode, bodisi neposredno ali po razredčenju v osnovno raztopino.
What is the risk associated with Aivlosin?
Kakšna tveganja so povezana z zdravilom Aivlosin?
Aivlosin improves the health and weight of the animals, but may not eliminate completely the bacteria that caused lung infection.
Zdravilo Aivlosin pripomore k izboljšanju zdravstvenega stanja in povečanju telesne mase živali, vendar pa ne more v celoti odpraviti bakterij, ki so povzročile okužbo pljuč.
Why is Aivlosin approved?
Zakaj je bilo zdravilo Aivlosin odobreno?
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.
Te so vključevale študijo potrditve odmerka pri mladih puranih, ki so jih umetno okužili s pljučnim virusom (ptičjim pljučnim virusom) in bakterijo Ornithobacterium rhinotracheale, da bi tako izzvali zapleteno okužbo.
The medicine is not authorised for use in turkeys producing eggs for human consumption.
Zdravilo ni odobreno za uporabo pri puranih, katerih jajca so namenjena prehrani ljudi.
Since the composition of the pig feed might affect the effectiveness of Aivlosin, it should only be used in dry feed.
Ker lahko na učinkovitost zdravila Aivlosin vpliva tudi sestava krme za prašiče, se sme to zdravilo primešati izključno suhi krmi.
People who have had reactions when handling Aivlosin or similar products should avoid any contact with Aivlosin.
Ljudje, pri katerih so se v preteklosti med rokovanjem z zdravilom Aivlosin ali podobnimi zdravili pojavile reakcije, naj se izogibajo kakršnemu koli stiku s tem zdravilom.
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).
Pri prašičih se uporablja za zdravljenje ali metafilakso številnih infekcijskih bolezni, ki jih povzročajo bakterije in prizadenejo pljuča (tj. enzootska pljučnica pri prašičih) ali črevesni trakt živali (prašičja griža ali prašičja proliferativna enteropatija).
It works by blocking the bacteria's ribosomes, the parts of the cell where proteins are produced, and inhibits the growth of bacteria.
Deluje tako, da zavira ribosome bakterij (dele celice, na katerih poteka sinteza beljakovin) in preprečuje rast bakterij.
The studies showed that pigs treated with Aivlosin showed less severe signs of disease than untreated animals.
Študije so pokazale, da so prašiči, zdravljeni z zdravilom Aivlosin, kazali manj hude znake bolezni kot živali, ki niso bile zdravljene.
It should not, therefore, be used in laying turkeys nor for three weeks before turkeys are likely to start laying eggs for human consumption.
Zato se ne sme uporabljati pri puranih v obdobju nesnosti, vključno v obdobju treh tednov pred začetkom nesnosti pri purah, kadar se njihova jajca uporabljajo za prehrano ljudi.
The treatment success with Aivlosin was similar to the effectiveness of other medicines of the same class authorised for such diseases in pigs.
Uspešnost zdravljenja z zdravilom Aivlosin je bila primerljiva z učinkovitostjo drugih odobrenih zdravil iz iste skupine, ki se uporabljajo za zdravljenje tovrstnih bolezni pri prašičih.
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.
Pri puranih se uporablja za zdravljenje okužb pljuč, ki jih povzroča bakterija Ornithobacterium rhinotracheale, ki lahko povzroči bolezen pri zapletih zaradi drugih sočasnih virusnih in bakterijskih okužb.
However, if Aivlosin is accidentally consumed by a person, immediate medical advice should be sought and the package leaflet or label shown to the doctor.
Če človek zdravilo Aivlosin nenamerno zaužije, se mora nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali nalepko.
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.
Glavno merilo učinkovitosti je bila poškodba pljuč in pljučnih mešičkov, ki je bila manjša pri puranih, zdravljenih z zdravilom Aivlosin, kot pri tistih, ki niso bili zdravljeni.
A further set of studies investigated Aivlosin in diseased chickens and pheasants as well as in very young chicks that hatched from eggs, which came from flocks where the disease was present.
Zdravilo Aivlosin so nadalje raziskovali v številnih študijah pri obolelih piščancih in fazanih ter mladih piščetih, izvaljenih iz jajc, ki so prišla iz jat, pri katerih je bila prisotna bolezen.
Poults either received treatment with Aivlosin or no treatment three days later.
Mlade purane so tri dni kasneje bodisi zdravili z zdravilom Aivlosin bodisi jih niso zdravili.
Chickens and pheasants treated with Aivlosin showed less severe signs of disease than untreated animals.
Piščanci in fazani, zdravljeni z zdravilom Aivlosin, so kazali manj hude znake bolezni kot živali, ki niso bile zdravljene.
The effectiveness of Aivlosin was similar to that of other medicines of the same class already authorised for this disease in chickens.
Učinkovitost zdravila Aivlosin je bila podobna učinkovitosti drugih odobrenih zdravil iz iste skupine, ki se uporabljajo za zdravljenje te bolezni pri piščancih.
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.
Karenca za meso prašičev, zdravljenih z zdravilom Aivlosin, ki je bilo dano v krmo, je dva dni, in en dan, če je bilo zdravilo Aivlosin dano v pitno vodo.
For practical information about using Aivlosin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Aivlosin naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Aivlosin animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Aivlosin naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
The withdrawal period for meat from chickens, turkeys and pheasants treated with Aivlosin given via drinking water is two days.
Karenca za meso piščancev, puranov in fazanov, zdravljenih z zdravilom Aivlosin, ki je bilo dano v pitno vodo, je dva dni.
How does Aivlosin work?
Kako zdravilo Aivlosin deluje?
When mixing Aivlosin into feed or drinking water or handling the medicated feed or water, direct contact with eyes, skin and mouth should be avoided and protective equipment should be worn, e.g. overalls, gloves and face masks (respirator).
Pri mešanju zdravila Aivlosin v krmo ali pitno vodo oziroma pri rokovanju z medicinirano krmo ali vodo se je treba izogibati neposrednemu stiku z očmi, kožo in usti.
How is Aivlosin used?
Kako se zdravilo Aivlosin uporablja?
The withdrawal period for eggs from chickens treated with Aivlosin is zero days.
Karenca za jajca piščancev, zdravljenih z zdravilom Aivlosin, je nič dni.
The oral powder is mixed into pig feed by the pig owner and is used to treat individual pigs.
Peroralni prašek, ki se uporablja za zdravljenje posameznih prašičev, vmeša v prašičjo krmo lastnik
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).
Število bolnikov je bilo zadostno v 4 študijah (146, 203, 155 in 324 bolnikov) ter majhno v 2 študijah (50 in 49 bolnikov).
Only one study (Vinckier study) mentioned a small group of patients suffering from associated systemic disease.
Samo ena študija (študija Vinckier) je omenila majhno skupino bolnikov s povezano sistemsko boleznijo.
This later diagnosis is not any more listed in the DSM-IV-TR.
Slednja diagnoza ni več vključena v priročnik DSM-IV-TR.
Patients included in most of these studies presented various very different symptoms without standardised diagnosis.
Bolniki, vključeni v večino teh študij, so imeli raznovrstne in zelo različne simptome brez standardizirane diagnoze.
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.
Videti je, da je imelo korist od zdravljenja približno 55-75 % bolnikov, vendar je odbor CHMP zaključil, da je te rezultate težko interpretirati s kliničnega vidika in da niso zanesljivi zaradi metodoloških omejitev teh študij.
The studies included young and old patients (1878 years old) with idiopathic acrosyndrome.
Študije so vključevale mlade in stare bolnike (od 18 do 78 let) z idiopatičnim akrosindromom.
Results were heterogeneous and there was no consistency across studies.
Rezultati so bili heterogeni, med študijami pa je bila prisotna nedoslednost.
The reliability and the clinical relevance of the study results was therefore questionable and preclude any conclusion on the efficacy of the product.
Zanesljivost in klinična pomembnost rezultatov študij sta bili zato vprašljivi, kar onemogoča zaključke glede učinkovitosti zdravila.
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.
Opomba: o enem od zgoraj omenjenih primerov fibroze so poročali leta 2009 (tj. po koncu prejšnjega napotitvenega postopka), kar kaže, da takrat uvedeni ukrepi za zmanjševanje tveganja niso zadostni za izključitev tega tveganja.
• The Committee considered that a potential causal association between fibrotic reactions or ergotism and dihydroergocryptine/caffeine cannot be excluded.
• odbor je menil, da morebitne vzročne povezave med fibrotičnimi reakcijami ali ergotizmom in dihidroergokriptinom/kofeinom ni mogoče izključiti.
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.
Na splošno je odbor CHMP menil, da metodološke napake in odsotnost primarnega opazovanega dogodka za učinkovitost ne omogočajo zaključkov glede klinične učinkovitosti ali podpore indikacije s standardizirano diagnozo.
It is available in combination with caffeine that may improve the digestive absorption of this ergot alkaloid.
Na voljo je v kombinaciji s kofeinom, ki lahko izboljša prebavno absorpcijo tega ergot-alkaloida.
The studies mainly assessed functional symptoms, capillaroscopic parameters and plethysmographic parameters whose clinical relevance was considered questionable by the CHMP.
Študije so večinoma ocenjevale funkcionalne simptome, parametre kapilaroskopije in parametre pletizmografije, pri katerih je odbor CHMP menil, da je njihova klinična pomembnost vprašljiva.
The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocryptine/caffeine.
CHPM je upošteval vse razpoložljive podatke glede varnosti in učinkovitosti dihidroergokriptina/kofeina.
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.
Čeprav lahko nekatera od predlaganih meril pomagajo odkriti bolnike z obstoječo fibrozo, zadevna sočasna zdravila in povečano tveganje, je odbor izpostavil, da to ni zadostno za preprečevanje razvoja fibroze in ergotizma med zdravljenjem pri nekaterih bolnikih.
Overall summary of the scientific evaluation of dihydroergocryptine/caffeine containing medicinal products (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo dihidroergokriptin/kofein (glejte Prilogo I)
• 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.
• odbor meni, da so dokazi o klinično pomembni učinkovitosti dihidroergokriptina/kofeina v zvezi s trenutno ocenjenimi indikacijami izredno omejeni, zato je zgoraj omenjeno tveganje večje od morebitne koristi za bolnike v zvezi s temi indikacijami;
In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the product outweigh the risk.
Za preklic začasnega umika morajo imetniki dovoljenja za promet z zdravilom ugotoviti specifično populacijo bolnikov, pri kateri so koristi zdravila večje od tveganj.