natgillin/translations-raw huggingface dataset:
This will also facilitate the Agency's plans to provide access to safety and clinical trial-related information.
To bo olajšalo tudi pripravo načrtov agencije o dostopu do informacij o varnosti in kliničnih preskušanjih.
The EMEA, together with its partners, has developed and is implementing the European risk-management strategy (ERMS).
Agencija EMEA je skupaj s svojimi partnerji pripravila Evropsko strategijo za obvladovanje tveganja (ERMS).
The Agency will coordinate the activities of its scientific committees with those of the network, to ensure the production of sound, scientific risk assessments that take into account the use of antibiotics in both man and animals.
Agencija bo dejavnosti svojih znanstvenih odborov usklajevala s tistimi v mreži, da bi zagotovila pripravo utemeljenih znanstvenih ocen tveganj, v katerih se upošteva uporaba antibiotikov pri ljudeh in živalih.
The Agency operates in a global regulatory environment that is characterised, among other trends, by an increasing number of clinical trials conducted in countries where it is perceived that the application of good clinical practice does not yet have traditions as well established as those in the European Union, the US and other developed countries.
Agencija deluje v globalnem regulatornem okviru, ki ga med drugimi trendi zaznamuje naraščanje števila kliničnih preizkušanj, ki se izvajajo v državah, v katerih uvedba dobre klinične prakse še ni ustaljena oziroma ni tako dobro uveljavljena kot v državah EU, Združenih državah in drugih razvitih državah.
implementing and operating the new legislation on advanced-therapy medicinal products for human use, as well as other new legislation;
izvajanje in učinkovanje nove zakonodaje o zdravilih za napredno zdravljenje za uporabo v humani medicini kot tudi druge nove zakonodaje;
Some of these objectives include improving the planning of scientific resources, progressing initiatives in the field of training and competence development, and assuring effective communication within the network.
Nekateri izmed teh ciljev so izboljšanje načrtovanja znanstvenih virov, naprednih pobud s področja usposabljanja in sposobnosti razvoja ter zagotavljanje učinkovite izmenjave informacij v mreži.
At the same time, the EMEA has been allocating a significant part of its IT development and maintenance resources to the development and support of the EU Telematics systems.
Poleg tega je agencija EMEA namenjala velik delež sredstev za razvoj in vzdrževanje informacijske tehnologije za razvoj in podporo telematskih sistemov EU.
1 Benchmarking of European medicines agencies (BEMA).
1 Mreža za izvajanje primerjalnih analiz evropskih agencij za zdravila (BEMA).
This will have an effect on the workload in the field of inspections, both for the EMEA and for the national competent authorities, and will add a new dimension to the EMEA's international commitments.
To bo pomenilo večjo delovno obremenitev na področju inšpekcijskih pregledov za agencijo EMEA in nacionalne pristojne organe in dalo novo razsežnost mednarodnim obveznostim agencije EMEA.
Having established the necessary procedures for the evaluation of applications and for the provision of other specific advice related to advanced-therapy medicinal products, the Agency will operate these procedures and will develop riskmanagement and pharmacovigilance activities in this new field of responsibility.
Po vzpostavitvi potrebnih postopkov za ocenjevanje vlog in za specifično svetovanje, povezano z zdravili za napredno zdravljenje, jih bo agencija vodila in bo na tem novem področju pristojnosti pripravila dejavnosti za obvladovanje tveganja in farmakovigilanco.
These developments include recently adopted and upcoming legislation vesting the Agency with new responsibilities, including legislation on advanced-therapy medicinal products, a revised regulation on variations to marketing authorisations and revised legislation on safe limits for residues of veterinary medicines in food.
Te smernice vključujejo nedavno sprejeto in prihodnjo zakonodajo, ki nalaga agenciji nove odgovornosti, vključno s pripravo zakonodaje o zdravilih za napredno zdravljenje, pregledom uredbe o spremembah dovoljenj za promet z zdravilom ter pregledom zakonodaje o mejnih vrednostih ostankov veterinarskih zdravil v živilih.
Another important project is the strengthening of the methodology for assessment of the benefit-risk balance of human and veterinary medicines throughout their lifespan.
Drug pomemben projekt je krepitev metodologije za ocenjevanje razmerja med koristmi in tveganji v celotnem življenjskem krogu zdravil za uporabo v humani in veterinarski medicini.
The European medicines network is vital to the Agency's ability to deliver on its public-health mission and objectives.
Evropska mreža zdravil je ključna za uresničenje poslanstva in ciljev na področju javnega zdravja, ki jih je zastavila agencija.
The Agency is experiencing continuing growth in the volume of work across various areas of its activities, including scientific advice, medicines for paediatric use, authorisation of vaccines against epidemic diseases of animals, transparency and international commitments, to name but a few.
Obseg dela agencije na vseh področjih njenih dejavnosti neprestano narašča, vključno z znanstvenim svetovanjem, zdravili za pediatrično uporabo, dovoljenji za promet s cepivi proti nalezljivim boleznim živali, preglednostjo in mednarodnimi obveznostmi, če naštejemo le nekatere med njimi.
Significant effort is being made in the areas of communication, transparency and provision of information.
Precej prizadevanj je bilo na področju obveščanja, preglednosti in posredovanja informacij.
Second, the Agency will implement initiatives, in cooperation with the network, aimed at facilitating greater availability of veterinary medicines indicated for limited markets, including minor use/minor species, through the introduction of measures to assist companies at the time of authorisation.
Ob tem bo agencija v sodelovanju z mrežo izvajala pobude za večjo razpoložljivost veterinarskih zdravil, namenjenih za omejene trge, vključno z zdravili za manjšo uporabo in manj pomembne vrste, prek uvedbe ukrepov v pomoč podjetjem pri odobritvi dovoljenj.
As a result, the Agency will re-launch its website towards the end of 2009, and will begin work to ensure that all public-facing websites managed by the Agency are easy to use and access by external stakeholders.
Posledično bo agencija ob koncu leta 2009 prenovila svojo spletno stran in zunanjim uporabnikom omogočila enostaven dostop do vseh svojih javnih spletnih strani ter njihovo uporabo.
The Agency's priorities have been set considering these and other factors affecting the Agency in 2009, and will centre around:
Določene so bile prednostne naloge agencije, v okviru katerih so bili upoštevani ti in drugi dejavniki, ki bodo leta 2009 vplivali na agencijo.
contributing to improved availability of medicines for human and veterinary use;
prispevanje k večji razpoložljivosti zdravil za uporabo v humani in veterinarski medicini;
As scientists from European and other countries work in the area of biomarkers, translational medicine and nanotechnologies, the EMEA will provide scientific input into these novel fields of medicinal product development.
Vsi znanstveniki iz evropskih in drugih držav so dejavni na področju bioloških označevalev, sodobne medicine, ki vključuje dognanja drugih strok, in nanotehnnologij, zato bo agencija EMEA vključila znanstvene ugotovitve v ta nova področja priprave zdravil.
The EMEA is under increasing pressure to ensure that its online presence can meet the needs of external stakeholders by publishing information via the web that is easy to find and consume.
Pritisk na agencijo EMEA, da bi njena prisotnost na spletu z objavljanjem informacij, ki so enostavno dostopne in uporabne, zadovoljevala potrebe zunanjih interesnih skupin, narašča.
continuing to improve the safety-monitoring of medicines for human and veterinary use;
nadaljnje izboljšanje spremljanja varnosti zdravil za uporabo v humani in veterinarski medicini;
In order to encompass and consolidate all transparency-related activities, the Agency, after consultation with partners and stakeholders, will develop a transparency policy.
Agencija bo po posvetovanju s partnerji in interesnimi skupinami zagotovila politiko preglednosti, da bi zajela in utrdila dejavnosti, povezane s preglednostjo.
Third, the Agency will actively contribute to the work of the EU Commission, Community agencies and national competent authorities in relation to the assessment and, where appropriate, management of the potential risk to man arising from the use of antimicrobial agents as veterinary medicinal products.
Nazadnje bo agencije dejavno prispevala k delu Komisije EU, agencij Skupnosti in nacionalnih pristojnih organov v zvezi z vrednotenjem ter, po potrebi, k obvladovanju
The Agency will continue to focus on further streamlining these activities, including the development of a paediatric research network.
Agencija si bo z razvojem v mreži pediatričnih raziskav še naprej prizadevala poenostaviti te dejavnosti.
The use of veterinary medicinal products in food-producing animals may result in the presence of residues in foodstuffs obtained from treated animals.
morebitnih tveganj za ljudi, ki izhajajo iz uporabe protimikrobnih sredstev kot zdravil za uporabo v veterinarski medicini.
First, the Agency will work with stakeholders to promote and facilitate authorisation through the centralised procedure of vaccines against major epizootic diseases of animals, particularly avian influenza, bluetongue and foot-and-mouth disease.
Najprej bo agencija ob sodelovanju z interesnimi skupinami spodbujala in pospeševala izdajo dovoljenj za promet s cepivi proti večjim epizootskim boleznim živali, zlasti aviarni influenci, bolezni modrikastega jezika ter slinavki in parkljevki, s centraliziranim postopkom To bo bistveni del prispevka agencije k novi strategiji Skupnosti na področju zdravja živali „Bolje preprečiti kot zdraviti“.
ATCvet code: QI01AN01.
Oznaka ATC vet: QI01AN01.
Date of first authorisation: 05/02/2019
Datum pridobitve dovoljenja za promet: 05/02/2019
No data is available on protection of longer-lived birds such as future layers/breeders.
Na voljo ni podatkov o zaščiti ptic, ki živijo dlje časa, kot so bodoče nesnice/ matične jate.
Chickens must be strictly floor-reared in the first 3 weeks after vaccination.
Piščanci morajo biti strogo v talni reji v prvih 3 tednih po cepljenju.
Duration of immunity: 63 days post-vaccination in an environment that permits oocysts recycling.
Trajanje imunosti: 63 dni po cepljenju v okolju, ki dopušča recikliranje oocist.
Do not use in birds in lay or in breeding birds, or within 4 weeks before the start of the laying period.
Ne uporabite pri pticah v obdobju nesnosti ali matičnih jatah ali ali 4 tedne pred začetkom obdobja nesnosti.
This product is intended for the vaccination of short-lived chickens only.
To cepivo je predvideno samo za cepljenje kratkoživih piščancev.
After this time, place the chicks carefully into the litter and continue with regular management practices.
Po tem obdobju piščance previdno položite na steljo in nadaljujte z običajnimi načini upravljanja.
Store and transport refrigerated (2 ºC - 8 ºC).
Shranjujte in prevažajte v hladilniku (2°C - 8 °C).
* Number of sporulated oocysts derived from precocious attenuated lines of coccidia, according to in vitro procedures of the manufacturer at the time of blending.
*Število sporuliranih oocist, ki izhajajo iz zgodaj zrelih oslabljenih linij kokcidija, glede na postopke in vitro izdelovalca v času mešanja.
Onset of immunity: 14 days post-vaccination.
Nastop imunosti: 14 dni po cepljenju.
To improve the uniformity of the vaccination, maintain the chicks inside the transportation box for at least 1 hour in order to let them ingest all the vaccine droplets.
Za izboljšanje enovitosti cepljenja naj piščanci ostanejo v transportni škatli vsaj 1 uro, da zaužijejo vse kapljice cepiva.
The vaccine will not protect species other than chickens against coccidiosis and is only effective against the Eimeria species indicated.
Cepivo drugih živalskih vrst razen piščancev ne ščiti pred kokcidiozo in je učinkovito samo proti navedenim vrstam Eimeria.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC so bodisi dovoljene snovi za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
The active substances being principles of biological origin intended to produce active immunity are not within the scope of Regulation (EC) No 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina, ki je v osnovi biološkega izvora namenjena aktivne imunosti, ne spada v področje uporabe Uredbe(ES) št. 470/2009.
In order to reduce field infections, it is recommended that all litter should be removed and facilities and related equipment in contact with vaccinated chickens should be cleaned between production cycles.
Da bi zmanjšali okužbe iz okolja, je priporočeno odstranjevanje vseh odpadkov, objekte in povezano opremo, ki so v stiku s cepljenimi piščanci, pa je treba med proizvodnimi cikli očistiti.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in nalepki.
After the administration of a severe overdose (10-fold), mild, transient, clinical signs of coccidiosis were commonly observed without any consequences on the final performance.
Po dajanju prekomernega odmerka (10-kratnega) so bili najpogosteje opaženi blagi, prehodni klinični znaki kokcidioze brez kakršnih koli posledic na končno učinkovanje.
Additionally, the duration of immunity depends on an environment that permits recycling of oocysts, therefore a decision to use any anticoccidial substances in the period after 3 weeks postvaccination should be made taking into account the potential negative impact on the duration of immunity of this product.
Poleg tega je trajanje odpornosti odvisno od okolja, ki omogoča recikliranje oocist, zato je treba pri odločanju o uporabi morebitnih kokcidiostatikov v obdobju 3 tednov po cepljenju upoštevati morebiten negativni učinek na trajanje odpornosti, pridobljene z uporabo tega cepiva.
Before starting to prepare the spray solution, ensure there is a clean container with sufficient capacity for preparing the diluted vaccine suspension available.
Preden začnete s pripravo raztopine za pršenje, poskrbite, da boste imeli na voljo čist vsebnik z zadostno kapaciteto za pripravo razredčenega cepiva v suspenziji.
Maintain the diluted vaccine suspension in continuous homogenisation by using a magnetic stirrer while the vaccine is being administered via coarse spray to the chicks.
Razredčeno cepivo v suspenziji vzdržujte v stalni homogenizaciji tako, da uporabite magnetno mešalo, medtem ko se cepivo daje piščancem s pršenjem z večjimi kapljicami.
Dilute the vaccine with the relevant volumes of the solvent (HIPRAMUNE T) and water, as shown in the following table:
Cepivo razredčite z ustreznimi volumni vehikla (HIPRAMUNE T) in vode, kot je prikazano v naslednji preglednici:
No anticoccidial substances or other agents having anticoccidial activity via feed or water should be used for at least 3 weeks following the vaccination of chickens with this product otherwise the correct replication of the vaccine oocysts, and consequently the development of a solid immunity, could be hindered.
Prepovedana je uporaba vseh kokcidiostatikov ali drugih snovi s kokcidiostatičnimi učinki preko krme ali vode vsaj 3 tedne po cepljenju piščancev s tem cepivom, sicer je lahko ovirana pravilna replikacija oocist v cepivu in s tem tudi razvoj dobre odpornosti.
The method of administration is by coarse spray by using a suitable device (volume delivered: 28 ml/100 chicks, droplet size: 200 - 250 µm and working pressure: 1.5 to 3 bars).
Način uporabe zdravila je pršenje z večjimi kapljicami z uporabo primernega pripomočka (količina dovajanja: 28 ml/100 piščancev, velikost kapljic: 200-250 µm in delovni tlak: 1,5 do 3 bare).
1,000 doses 5,000 doses
1.000 odmerkov 5.000 odmerkov
Shake the vaccine (EVANT) vial and dilute the contents of it into the solvent and water solution.
Pretresite vialo s cepivom (EVANT) in razredčite vsebino v raztopino vehikla in vode.
10,000 doses
10.000 odmerkov
Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Sodium chloride
EVANT (cepivo): kalijev klorid natrijev hidrogenfosfat dodekahidrat kalijev dihidrogenfosfat natrijev klorid polisorbat 80
HIPRAMUNE T (solvent): Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
HIPRAMUNE T (vehikel): Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
Eimeria acervulina, strain 003 ..................................... 332 - 450* Eimeria maxima, strain 013 ......................................... 196 - 265* Eimeria mitis, strain 006 .............................................. 293 - 397* Eimeria praecox, strain 007 ......................................... 293 - 397* Eimeria tenella, strain 004 ........................................... 276 - 374*
Eimeria acervulina, sev 003 ........................................... 332-450* Eimeria maxima, sev 013 ............................................... 196-265* Eimeria mitis, sev 006 .................................................... 293-397* Eimeria praecox, sev 007 ............................................... 293-397* Eimeria tenella, sev 004 ................................................. 276-374*
Eimeria acervulina, strain 003 ....................................... 332 - 450 Eimeria maxima, strain 013 ........................................... 196 - 265 Eimeria mitis, strain 006 ................................................ 293 - 397 Eimeria praecox, strain 007 ........................................... 293 - 397 Eimeria tenella, strain 004 ............................................. 276 - 374
Eimeria acervulina, sev 003 ............................................. 332-450 Eimeria maxima, sev 013 ................................................. 196-265 Eimeria mitis, sev 006 ...................................................... 293-397 Eimeria praecox, sev 007 ................................................. 293-397 Eimeria tenella, sev 004 ................................................... 276-374
Name and address of the manufacturers of the biological active substances
Ime in naslov proizvajalca biološke učinkovine
Fill the reservoir of the spraying device with all the vaccine suspension prepared.
V rezervoar razpršilnika natočite vso pripravljeno količino cepiva v suspenziji.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKE (BIOLOŠKIH) UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
Vaccination schedule: One dose of vaccine (0.007 ml) from 1 day of age.
Shema cepljenja: Vsak odmerek cepiva (0,007 ml) od starosti 1 dneva.
Type I colourless glass vials containing 7 ml, 35 ml or 70 ml of suspension (1,000, 5,000 and 10,000 doses) closed with type I polymeric elastomer closures and aluminium caps.
Viale iz brezbarvnega stekla tipa I, ki vsebujejo 7 ml, 35 ml ali 70 ml suspenzije (1.000, 5.000 in 10.000 odmerkov), zaprte z zamaškom iz polimernega elastomera tipa I in aluminijasto zaporko.
Polypropylene vials containing 50 ml, 250 ml or 500 ml of solvent closed with type I polymeric elastomer closures and aluminium caps.
Polipropilenske viale, ki vsebujejo 50 ml, 250 ml ali 500 ml vehikla, zaprte z zamaškom iz polimernega elastomera tipa I in aluminijasto zaporko.
One dose of vaccine (0.007 ml) from 1 day of age.
Vsak odmerek cepiva (0,007 ml) od starosti 1 dneva.
Dilute the content of the vial with clean, room temperature water into an appropriate container.
V ustreznem vsebniku razredčite vsebino viale s čisto vodo s sobno temperaturo.
Shelf life of the veterinary medicinal product as packaged for sale: 10 months.
EVANT: Rok uporabnosti zdravila v pakiranju za prodajo: 10 mesecev
Suspension for oral spray.
Suspenzija za peroralno pršenje.
HIPRAMUNE T solvent for oral spray for chickens
HIPRAMUNE T, vehikel za peroralno pršilo za piščance.
Eimeria praecox and Eimeria tenella and to reduce clinical signs (diarrhoea) associated with Eimeria acervulina, Eimeria maxima and Eimeria tenella.
Eimeria praecox in Eimeria tenella, ter za zmanjšanje kliničnih znakov (diareje), povezanih s paraziti
Brilliant Blue (E133) Red AC (E129)
alurno rdeče AC (E129)
EVANT suspension and solvent for oral spray for chickens.
EVANT suspenzija in vehikel za peroralno pršilo za piščance.
To be mixed with HIPRAMUNE T (solvent).
Za mešanje s HIPRAMUNE T (vehikel).
EVANT suspension and solvent for oral spray for chickens
EVANT suspenzija in vehikel za peroralno pršilo za piščance
HIPRAMUNE T (solvent): Brilliant blue (E 133) Red AC (E 129) Vanillin
HIPRAMUNE T (vehikel): briljantno modro FCF (E133)
A purplish suspension is obtained after dilution.
Po redčenju dobite vijoličasto suspenzijo.
Water Vaccine HIPRAMUNE T (solvent)
Voda Cepivo HIPRAMUNE T (vehikel)
WATER VACCINE HIPRAMUNE T (solvent)
VODA CEPIVO HIPRAMUNE T (vehikel)
For the active immunisation of chicks from 1 day of age to reduce intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis,
Za aktivno imunizacijo piščancev od 1. dne starosti za zmanjšanje lezij v črevesju in tvorbe oocist,
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING Solvent vial of 50 ml, 250 ml or 500 ml
OVOJNINAH Viala z vehiklom s 50 ml, 250 ml ali 500 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes
PODATKI NA ZUNANJI OVOJNINI Škatle
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vaccine vial of 1,000 or 5,000 doses
Viala s cepivom s 1.000 ali 5.000 odmerki
Each dose (0.007 ml) of undiluted vaccine contains:
KOLIČINA UČINKOVIN(E) Vsak odmerek (0,007 ml) nerazredčenega cepiva vsebuje:
One vial of 35 ml (5,000 doses) of EVANT and one vial of 250 ml of HIPRAMUNE T (solvent).
Ena viala s 35 ml (5.000 odmerki) cepiva EVANT in ena viala s 250 ml HIPRAMUNE T (vehikel).
Cardboard box with one vial of EVANT containing 35 ml (5,000 doses) and one vial of HIPRAMUNE T containing 250 ml.
Škatla z eno vialo cepiva EVANT, ki vsebuje 35 ml (5.000 odmerkov), in eno vialo vehikla HIPRAMUNE T, ki vsebuje 250 ml.
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca(proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
To stimulate active immunity against coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella.
Eimeria maxima, Eimeria mitis, Eimeria praecox in Eimeria tenella.
Batch {number}
Lot {številka}
Cardboard box with one vial of EVANT containing 70 ml (10,000 doses) and one vial of HIPRAMUNE T containing 500 ml.
Škatla z eno vialo cepiva EVANT, ki vsebuje 70 ml (10.000 odmerkov), in eno vialo vehikla HIPRAMUNE T, ki vsebuje 500 ml.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vaccine vial of 10,000 doses
Viala s cepivom z 10.000 odmerki IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Cardboard box with one vial of EVANT containing 7 ml (1,000 doses) and one vial of HIPRAMUNE T containing 50 ml.
Škatla z eno vialo cepiva EVANT, ki vsebuje 7 ml (1.000 odmerkov), in eno vialo vehikla HIPRAMUNE T, ki vsebuje 50 ml.
One vial of 70 ml (10,000 doses) of EVANT and one vial of 500 ml of HIPRAMUNE T (solvent).
Ena viala s 70 ml (10.000 odmerki) cepiva EVANT in ena viala s 500 ml HIPRAMUNE T (vehikel).
One vial of 7 ml (1,000 doses) of EVANT and one vial of 50 ml of HIPRAMUNE T (solvent).
Ena viala s 7 ml (1.000 odmerki) cepiva EVANT in ena viala s 50 ml HIPRAMUNE T (vehikel).