natgillin/translations-raw huggingface dataset:
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.
Ta bakterija povzroča okužbe pri ptičih, predvsem v pljučih in „zračnih mešičkih“, tj. posebnih vrečkah v telesu ptičev, v katerih se shranjuje zrak med dihanjem.
MS-H Vaccine, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Cepivo MS-H kot vsa druga cepiva deluje tako, da imunski sistem (naravni obrambni mehanizem telesa) „nauči“, kako naj se brani pred boleznijo.
Other information about MS-H Vaccine:
Druge informacije o cepivu MS-H:
MS-H Vaccine is given as one eye drop into one eye.
Cepivo MS-H se daje kot ena kapljica v eno oko.
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.
Cepivo MS-H se uporablja pri mladih piščancih, namenjenih za vzrejo brojlerjev (za meso) in nesnic (za proizvodnjo jajc), za zmanjševanje poškodb na zračnih mešičkih in zniževanje števila jajc z nenormalno oblikovano lupino.
When MS-H Vaccine is given to chickens the immune system recognises the weakened strain as ‘foreign' and makes defences against it.
Po cepljenju piščancev s cepivom MS-H imunski sistem prepozna oslabljeni sev kot „tujek“ in proti njemu vzpostavi obrambo.
Infection with Mycoplasma synoviae may result in difficulty breathing and is also associated with poor quality of the eggshell.
Okužbe z bakterijo Mycoplasma synoviae lahko privedejo do oteženega dihanja, povezane pa so tudi s slabo kakovostjo jajčnih lupin.
What is MS-H Vaccine and what is it used for?
Kaj je cepivo MS-H in za kaj se uporablja?
What are the risks associated with MS-H Vaccine?
Kakšna tveganja so povezana s cepivom MS-H?
MS-H Vaccine is available as eye drops and can only be obtained with a prescription.
Cepivo MS-H je na voljo v obliki kapljic za oko in se izdaja le na recept.
MS-H Vaccine
Cepivo MS-H
The laboratory studies showed that MS-H Vaccine reduces damage to the air sacs and reduces the number of eggs with shell abnormalities.
Laboratorijske študije so pokazale, da cepivo MS-H zmanjšuje poškodbe zračnih mešičkov in znižuje število jajc z nenormalno oblikovano lupino.
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.
Laboratorijske študije so vključevale tudi provokacijski model okužbe z bakterijo Mycoplasma synoviae in študijo, s katero so proučevali učinek cepljenja na nenormalno oblikovane jajčne lupine.
What benefits of MS-H Vaccine have been shown in studies?
Kakšne koristi je cepivo MS-H izkazalo v študijah?
For practical information about using MS-H Vaccine, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi cepiva MS-H naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with MS-H Vaccine, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju s cepivom MS-H naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Mycoplasma synoviae strain MS-H vaccine (live attenuated)
cepivo proti sevu bakterije Mycoplasma synoviae MS-H (živo, oslabljeno)
MS-H Vaccine is a vaccine used in chickens from five weeks of age to protect them against Mycoplasma synoviae.
Cepivo MS-H se uporablja pri piščancih, starih pet tednov in več, za zaščito pred bakterijo Mycoplasma synoviae.
Why is MS-H Vaccine approved?
Zakaj je bilo cepivo MS-H odobreno?
Any accidental splashing to the face and eyes should be thoroughly washed with water.
Če cepivo nenamerno oškropi oči ali obraz osebe, ki daje zdravilo, je treba oči in obraz temeljito sprati z vodo.
The field study looked at how vaccinated chickens fared when moved to flocks with a history of Mycoplasma synoviae infection.
S terensko študijo so proučevali, kako so se cepljeni piščanci odzvali, ko so jih preselili v jato, pri kateri so se v preteklosti pojavljale okužbe z bakterijo Mycoplasma synoviae.
MS-H Vaccine contains a live, attenuated strain of Mycoplasma synoviae.
Cepivo MS-H vsebuje živ oslabljen sev bakterije Mycoplasma synoviae.
The withdrawal period for MS-H vaccine for meat and eggs is zero days.
Karenca za meso in jajca po cepljenju s cepivom MS-H je nič dni.
It is not intended to provide practical advice on how to use MS-H Vaccine.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How is MS-H Vaccine used?
Kako se cepivo MS-H uporablja?
How does MS-H Vaccine work?
Kako cepivo MS-H deluje?
Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/114)
Izid postopka v skladu s členom 34 Direktive 2001/82/ES (EMEA/V/A/114)
14 July 2017
14. julij 2017
The European Commission issued a decision on 14 July 2017.
Evropska komisija je sklep izdala 14. julija 2017.
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.
Zdravilo Denagard 45% (in povezana imena, kot so Tiamutin 45%, Denagard 450 mg/g in Denagard vet 450 mg/g) se trži v Avstriji, Belgiji, na Češkem, Finskem, v Nemčiji, Grčiji, na Madžarskem, v Italiji, Latviji, Litvi, na Nizozemskem, Poljskem, Portugalskem, v Romuniji, na Slovaškem in v Španiji.
Denagard 45% is authorised in the EU via national procedures.
Zdravilo Denagard 45% je bilo v EU odobreno po nacionalnih postopkih.
Tiamulin is a semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and works by inhibiting bacterial protein synthesis.
Tiamulin je polsintetični antibiotik, ki spada v skupino plevromutilinskih antibiotikov in zavira sintezo bakterijskih beljakovin.
On 12 April 2017, the European Medicines Agency (the Agency) completed a review of Denagard 45%.
Evropska agencija za zdravila (agencija) je 12. aprila 2017 zaključila pregled zdravila Denagard 45%.
Questions and answers on Denagard 45% and its associated names
Vprašanja in odgovori v zvezi z zdravilom Denagard 45% in povezanimi imeni
Questions and answers on Denagard 45% and its associated names EMA/275123/2017
Vprašanja in odgovori v zvezi z zdravilom Denagard 45% in povezanimi imeni EMA/491902/2017
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.
Zdravilo Denagard 45% je zdravilo za uporabo v veterinarski medicini, na voljo v obliki zrnc za uporabo v pitni vodi, ki vsebuje 450 mg tiamulinijevega hidrogenfumarata na gram zdravila.
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.
Zdravilo Denagard 45% je indicirano za zdravljenje prašičje dizenterije, kolitisa, ileitisa, enzootske pljučnice in plevropnevmonije pri prašičih, kronične respiratorne bolezni pri piščancih ter infekcijskega sinusitisa in vnetja zračnih vrečk pri puranih.
Why was Denagard 45% reviewed?
Zakaj je bilo zdravilo Denagard 45% pregledano?
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.
Nemčija je opozorila, da med državami članicami obstajajo razlike v načinu, kako se zdravilo za uporabo v veterinarski medicini lahko uporablja, kar se odraža v razlikah med povzetki glavnih značilnosti zdravila v državah, kjer se zdravilo Denagard 45% trži.
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.
Odbor CVMP je na podlagi vrednotenja trenutno razpoložljivih podatkov zaključil, da je treba informacije o zdravilu za zdravilo Denagard 45% in povezana imena uskladiti po vsej EU.
What is Denagard 45%?
Kaj je zdravilo Denagard 45%?
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).
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je treba uskladiti informacije o zdravilu (povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo) za zdravilo Denagard 45% v Evropski uniji (EU).
The amended product information is available on the 'All documents' tab.
Popravljene informacije o zdravilu so na voljo pod zavihkom
On 24 August 2016, Germany referred the matter to the CVMP in order to harmonise the product information for Denagard 45% (and associated names) in the EU.
Nemčija je za uskladitev informacij o zdravilu za zdravilo Denagard 45% (in povezana imena) 24. avgusta 2016 zadevo napotila na odbor CVMP.
In addition, the EC requested the Agency to give its opinion, as to whether provisional measures were necessary to protect public health.
Poleg tega je Evropska komisija agencijo zaprosila za mnenje, ali so potrebni začasni ukrepi za zaščito javnega zdravja.
The adequacy of these provisional measures will be reviewed as part of the ongoing Article 20.
Presoja ustreznosti teh začasnih ukrepov bo opravljena kot dela potekajočega postopka iz člena 20.
Therefore, monitoring of serum transaminases levels should continue to be performed at least monthly and more frequently as clinically indicated, further, bilirubin levels should also be tested.
Zato je treba še dalje spremljati ravni transaminaz v serumu najmanj mesečno oziroma pogosteje, v kolikor za to obstajajo klinične indikacije, poleg tega pa je treba preverjati tudi ravni bilirubina.
The current recommendation relates only to provisional measures recommended by the PRAC for daclizumab based on the preliminary data available at this time.
Trenutno priporočilo se nanaša zgolj na ukrepe, katere za daklizumab priporoča odbor PRAC na osnovi predhodnih podatkov, ki so ob tem času na voljo.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, in particular regarding the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004 for Zinbryta (daclizumab).
• Odbor PRAC je upošteval postopek iz člena 20 Uredbe (ES) št. 726/2004, ki je bil sprožen na podlagi farmakovigilančnih podatkov, zlasti zaradi potrebe po uvedbi začasnih ukrepov v skladu s členom 20(3) Uredbe (ES) št. 726/2004 za zdravilo Zinbryta (daklizumab).
While liver function monitoring continues to be an important measure to detect liver injury, and likely reduce the incidence of severe cases, it is unclear at this stage whether any alternative monitoring regimen would necessarily prevent further severe cases.
Čeprav spremljanje funkcije jeter še dalje ostaja pomemben ukrep za odkrivanje morebitne poškodbe jeter in je verjetno, da bo zmanjšalo število resnih primerov, ni povsem jasno, ali je na tej stopnji potrebno uvesti še kakšen drug režim spremljanja za namen preprečevanja nadaljnjih resnih primerov.
On 9 June 2017 the EC therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Zinbryta (daclizumab) and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Zato je Evropska komisija 9. junija 2016 na podlagi farmakovigilančnih podatkov sprožila postopek v skladu z členom 20 Uredbe (ES) št. 726/2004 in odbor PRAC zaprosila, naj oceni vpliv zgoraj navedenih pomislekov na razmerje med tveganji in koristmi zdravila Zinbryta (daklizumab) ter izda priporočilo o tem, ali naj se ustrezna dovoljenja za promet z zdravilom ohranijo, spremenijo, začasno umaknejo ali ukinejo.
The threshold of transaminases elevation for patients not included in clinical trials, and therefore in which treatment initiation is not recommended, should be corrected from above two times the upper normal limit to above or equal to two times that limit.
Prag dviga vrednosti transaminaz pri bolnikih, ki niso vključeni v klinična preskušanja, in zato pri njih uvedba zdravljenja ni priporočena, je treba popraviti z več kot dvakratne vrednosti zgornje normalne meje na več ali enako dvakratni vrednosti te meje.
Since the initial marketing authorisation further serious cases of liver injury have been reported, including a fatal case despite an attempted liver transplant.
Od izdaje prvotnega dovoljenja za promet so bili zabeleženi nadaljnji primeri resne poškodbe jeter, vključno s smrtnim primerom, ki se je zgodil kljub poskusu presaditve jeter.
In the fatal case under review, the finding of normal serum transaminases levels prior to the dose of daclizumab did not prevent the occurrence of liver failure.
Pri smrtnem primeru, ki je sedaj v preiskavi, ugotovitev normalnih ravni transaminaz v serumu pred dajanjem odmerka daklizumaba ni preprečila pojava odpovedi jeter.
Analyses performed in the clinical development program to assess potential interactions of daclizumab with potentially hepatotoxic medications showed no clear evidence of increased risk of liver injury with concomitant hepatotoxic medications.
Analize, ki so bile izvedene v okviru programa za klinični razvoj zdravila, za oceno morebitnega medsebojnega delovanja med daklizumabom in potencialno hepatotoksičnimi zdravili, niso dale nobenih jasnih dokazov o povečanem tveganju poškodbe jeter zaradi sočasnega jemanja hepatotoksičnih zdravil.
Caution should also be used when medicinal products of known hepatotoxic potential are used concomitantly.
Prav tako je potrebna previdnost pri sočasnem jemanju zdravil s hepatotoksičnim potencialom.
Patients exhibiting signs and symptoms suggestive of liver injury should be promptly referred to a hepatologist.
Bolniki, ki kažejo znake in simptome, ki kažejo na poškodbe jeter, morajo biti nemudoma napoteni k hepatologu.
On 7 June 2017, the European Commission (EC) was informed of a fatal case of fulminant liver failure in a patient treated with daclizumab in an ongoing observational study, despite monthly liver function testing performed in accordance with recommendations in the product information.
Evropska komisija je 7. junija 2017 prejela obvestilo o smrtnem primeru zaradi fulminantne odpovedi jeter pri bolniku, zdravljenim z daklizumabom v okviru tekoče opazovalne študije, kljub mesečnim pregledom delovanja jeter v skladu s priporočili in informacijami o izdelku.
In addition, consideration should be given to discontinue treatment if an adequate therapeutic response is not achieved.
Poleg tega je treba razmisliti o prenehanju zdravljenja pri bolnikih, pri katerih ni bil dosežen ustrezen terapevtski odziv.
The PRAC also considered that daclizumab should be contraindicated in patients with pre-existing hepatic disease or impairment.
Odbor PRAC prav tako meni, da je treba daklizumab kontraindicirati pri bolnikih s predhodno obstoječo boleznijo ali okvaro jeter.
In view of this and while the magnitude and nature of the risk of liver injury is being further investigated, the PRAC considered that provisional measures are needed to limit the use of daclizumab.
Glede na navedeno in medtem ko je preiskava obsega in narave tveganja za poškodbe jeter še vedno v teku, odbor PRAC meni, da je treba uvesti začasne ukrepe za omejitev uporabe daklizumaba.
This was also noted in serious cases that occurred since the marketing authorisation, including the fatal case, therefore while the role of concomitant hepatotoxic medication is not fully elucidated, concomitant use with daclizumab should be cautious.
To je bilo opaženo tudi pri resnih primerih, ki so se pripetili po izdaji dovoljenja za promet, vključno s smrtnim primerom, zato je kljub temu, da vloga sočasnega jemanja hepatotoksičnih zdravil ni povsem jasna, potrebna posebna previdnost pri sočasnem zdravljenju z daklizumabom.
In view of the above, the Committee considers that the benefit-risk balance of Zinbryta (daclizumab) remains favourable subject to the agreed provisional amendments to the product information.
Odbor je glede na zgoraj navedeno menil, da je razmerje med tveganji in koristmi zdravila Zinbryta (daclizumab) še naprej ugodno, če se upoštevajo dogovorjene začasne spremembe informacij o zdravilu.
• The PRAC noted that a fatal case of fulminant liver failure occurred despite adherence to the terms of the marketing authorisation and the risk minimisation measures recommended, including the liver function monitoring.
• Odbor PRAC je menil, da se je smrtni primer fulminantne odpovedi jeter zgodil kljub upoštevanju pogojev dovoljenja za promet in izvajanju priporočenih ukrepov za zmanjševanje tveganja, vključno s spremljanjem funkcije jeter.
Transaminases elevations and serious hepatic injury are known risks associated to treatment with Zinbryta (daclizumab) and several risk minimisation measures (RMMs) were implemented in this regard, including monthly liver function monitoring.
Dvig ravni transaminaz in resne poškodbe jeter so znana tveganja pri zdravljenju z zdravilom Zinbryta (daklizumab), zaradi česar so bili uvedeni številni ukrepi za zmanjševanje teh tveganj (RMM), vključno z mesečnim spremljanjem delovanja jeter.
Further, the PRAC took into consideration that interrupting treatment in patients whose disease is well-controlled with daclizumab may induce relapses.
Upošteval je tudi, da lahko prekinitev zdravljenja pri bolnikih, pri katerih je bolezen s pomočjo daklizumaba dobro nadzorovana, povzroči ponovitev bolezni.
The PRAC took under consideration the alternative treatment options for the different stages or manifestations of RMS and that limiting access to daclizumab may deny some patients a treatment option for this disease.
Odbor PRAC je proučil alternativne možnosti zdravljenja za različne stopnje ali manifestacije multiple skleroze ter pri tem upošteval dejstvo, da omejitev dostopa do daklizumaba nekaterim bolnikom odvzema možnost zdravljenja njihove bolezni.
The efficacy of daclizumab was demonstrated in two pivotal studies in subjects with relapsing remitting multiple sclerosis that led to the indication in relapsing multiple sclerosis.
Učinkovitost daklizumaba je bila dokazana v dveh ključnih študijah na subjektih z recidivno-remitentno multiplo sklerozo, kar je vodilo v sprejetje indikacije za zdravljenje recidivne multiple skleroze.
• The PRAC reviewed the preliminary data provided by the marketing authorisation holder on cases of serious liver injury reported since the initial marketing authorisation, in the context of available safety data from clinical trials submitted in support of the initial marketing authorisation in relation to the overall risk of liver injury with daclizumab.
• Odbor PRAC je pregledal predhodne podatke, ki jih je posredoval imetnik dovoljenja za promet z zdravilom glede primerov resne poškodbe jeter, ki so bili zabeleženi po izdaji dovoljenja za promet, v kontekstu podatkov o varnosti iz kliničnega preskušanja, ki so bili predloženi v podporo prvotnemu dovoljenju za promet v zvezi z celokupnim tveganjem poškodbe jeter z daklizumabom.
Zinbryta (daclizumab) is a centrally authorised medicinal product indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
Zinbryta (daclizumab) je zdravilo, odobreno po centraliziranem postopku, namenjeno za zdravljenje recidivnih oblik multiple skleroze pri odraslih bolnikih.
The RMMs implemented, in particular the monthly liver testing, have not been effective to prevent the fatal case of fulminant hepatic failure.
Uvedeni ukrepi za zmanjšanje tveganja, zlasti mesečno testiranje funkcije jeter, niso bili dovolj učinkoviti za preprečitev smrtnega primera fulminantne odpovedi jeter.
Cases of serious liver injury occurred at any time point between early after treatment initiation to several month after discontinuation and no window of susceptibility to could be defined from cases observed in clinical trials.
Primeri resnih poškodb jeter so se zgodili v obdobju med zgodnjo fazo po uvedbi zdravljenja in nekaj mesecev po prekinitvi zdravljenja, vendar na osnovi primerov, opazovanih v okviru kliničnega preskušanja, ni bilo mogoče določiti okna občutljivosti.
The above provisional measures should be reflected in the product information of daclizumab and communicated to HCPs via a dedicated letter.
Zgoraj navedeni začasni ukrepi se morajo odražati tudi v informacijah o zdravilu za daklizumab, sporočiti pa jih je treba tudi zdravstvenim delavcem v obliki dopisa na to temo.
Finally, physicians should consider discontinuing daclizumab treatment if an adequate therapeutic response has not been achieved.
Zdravniki morajo razmisliti o prekinitvi zdravljenja z daklizumabom v primerih, pri katerih ni dosežen ustrezen terapevtski odziv.
The PRAC noted that the hepatic findings observed during the clinical development program had led at time of the initial marketing authorisation to the inclusion of a warning in the product information that treatment of patients with pre-existing severe hepatic impairment is not appropriate and that those with pre-existing mild or moderate hepatic impairment should be monitored.
Odbor PRAC je menil tudi, da so izsledki glede spremljanja jeter, ugotovljeni v okviru programa kliničnega razvoja zdravila, v času prvotnega dovoljenja za promet privedli do vključitve opozorila v informacije o zdravilu, da zdravilo ni primerno za bolnike s prej obstoječo resno okvaro jeter ter, da je treba bolnike s predhodno blago ali zmerno okvaro jeter redno spremljati.
Considering the lack of clinical data in patients with pre-existent significant hepatic diseases as these were excluded from clinical trials, the new serious hepatic cases, and that a mild elevation of serum transaminases was reported prior to treatment initiation in the patient who died of fulminant liver failure, the PRAC recommended as a provisional measure that daclizumab should be contraindicated in all patients with pre-existing hepatic disease or hepatic impairment, while the pattern of hepatotoxicity and possible mechanism of action is further investigated.
Glede na pomanjkanje kliničnih podatkov pri bolnikih s predhodno obstoječimi resnimi boleznimi jeter, saj so bili ti izključeni iz kliničnih preizkusov, nove resne primere jetrnih obolenj ter dejstva, da je bil pri bolniku, ki je umrl zaradi fulminantne odpovedi jeter, pred začetkom zdravljenja ugotovljen blag dvig ravni transaminaz v serumu, odbor PRAC kot začasen ukrep priporoča kontraindikacijo daklizumaba pri vseh bolnikih s predhodno obstoječim obolenjem jeter ali okvaro jeter, medtem pa je treba vzorec hepatotoksičnosti in možen mehanizem delovanja nadalje raziskati.