natgillin/translations-raw huggingface dataset:
b) history of severe head trauma that required hospitalization, intracranial or intraspinal surgery, or haemorrhagic stroke within the previous 3 months, or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesion; patients with an epidural catheter or who are anticipated to receive an c) history of congenital bleeding diatheses d) gastrointestinal bleeding within the last 6 weeks that has required medical intervention unless definitive surgery has been performed e) trauma patients at increased risk of bleeding
• Bolniki s povečanim tveganjem za krvavitev (na primer): a) kakršenkoli večji operacijski poseg, opredeljen kot operacijski poseg, ki zahteva splošno ali spinalno anestezijo, opravljen v 12-urnem obdobju neposredno pred infuzijo zdravila, ali katerikoli bolnik po operaciji, ki kaže znake aktivne krvavitve, ali katerikoli bolnik z načrtovanim ali pričakovanim operacijskim posegom v obdobju infuzije zdravila b) huda poškodba glave, ki je zahtevala hospitalizacijo, intrakranialni ali intraspinalni operacijski poseg ali hemoragični cerebrovaskularni insult v prejšnjih 3 mesecih, kakršnekoli intracerebralne arteriovenske malformacije, možganska anevrizma ali ekspanzivni proces osrednjega živčevja kadarkoli v preteklosti; bolniki z epiduralnim katetrom ali bolniki pri katerih se pričakuje, da jim bodo med infuzijo vstavili epiduralni c) prirojena nagnjenost h krvavitvam v anamnezi d) krvavitev v prebavila v zadnjih 6 tednih, ki je zahtevala medicinsko posredovanje, z izjemo krvavitev, ki so bile dokončno ozdravljene s kirurškim posegom e) bolniki po poškodbah s povečanim tveganjem za krvavitev
Please read all of this leaflet carefully.
Pred uporabo natančno preberite navodilo!
Each Xigris vial contains 5 mg of drotrecogin alfa (activated).
Vsaka viala zdravila Xigris vsebuje 5 mg drotrekogina alfa (aktiviranega).
After reconstitution with 10 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Po pripravi (rekonstituciji) z 10 ml vode za injekcije vsak ml vsebuje 2 mg drotrekogina alfa (aktiviranega).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 20 mg of Drotrecogin alfa (activated).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 20 mg drotrekogina alfa (aktiviranega).
A vial contains 20 mg of drotrecogin alfa (activated).
Viala vsebuje 20 mg drotrekogina alfa (aktiviranega).
Xigris 20 mg powder for solution for infusion Drotrecogin alfa (activated)
Xigris 20 mg prašek za raztopino za infundiranje drotrekogin alfa (aktiviran)
Sodium citrate Citric acid Hydrochloric acid Sodium hydroxide
6.1 Seznam pomožnih snovi saharoza natrijev klorid natrijev citrat citronska kislina klorovodikova kislina natrijev hidroksid
Xigris 5 mg powder for solution for infusion Drotrecogin alfa (activated)
Xigris 5 mg prašek za raztopino za infundiranje Drotrekogin alfa (aktiviran)
Prior to administration, 20 mg vials of Xigris must be reconstituted with 10 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ml drotrecogin alfa (activated).
Pred dajanjem je treba 20 mg viale zdravila Xigris pripraviti z 10 ml vode za injekcije, kar da raztopino s koncentracijo približno 2 mg/ml drotrekogina alfa (aktiviranega).
The incidence of CNS bleeds during the 28-day study period was 0.2% and 0.1% for drotrecogin alfa (activated)treated and placebo-treated patients, respectively.
Incidenca krvavitev v osrednje živčevje v 28-dnevnem trajanju študije je bila 0,2 % oziroma 0,1 % pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), oziroma bolnikih, ki so prejemali placebo.
Over the infusion period (study days 0-6) the number of patients experiencing CNS bleeding was 5 versus 1 (2.1% versus 0.4%) for the overall population (drotrecogin alfa (activated) versus placebo), with 4 of the 5 events in the drotrecogin alfa (activated) group occurring in patients ≤ 60 days old or ≤ 3.5 kg bodyweight.
Med infundiranjem (dnevi študije 0-6) je bilo za celotno populacijo število bolnikov s krvavitvijo v osrednje živčevje 5 proti 1 (2,1 % proti 0,4 % za drotrekogin alfa (aktivirani) proti placebu), s pojavnostjo 4 od 5 dogodkov v skupini z drotrekoginom alfa (aktiviranim) pri bolnikih, starih ≤ 60 dni oz. s telesno maso ≤ 3,5 kg. Pojavnost krvavitev v osrednje živčevje, ki so povzročile smrt, hudih krvavitev (med infundiranjem in v 28-dnevnem obdobju trajanja študije), resnih neželenih učinkov in obsežnejših amputacij je bila v skupini z drotrekoginom alfa (aktiviranim) podobna kot v skupini s placebom.
3 In ENHANCE six patients experienced multiple serious bleeding events during the study drug infusion period
3V študiji ENHANCE je šest bolnikov izkusilo več resnih krvavitev v času infundiranja preiskovanega zdravila (94 krvavitev pri 85 bolnikih).
However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15ºC - 30ºC).
Sicer lahko pripravljeno (rekonstituirano) raztopino hranimo do 3 ure v viali pri sobni temperaturi (15 ºC - 30 ºC).
Prior to administration, 5 mg vials of Xigris must be reconstituted with 2.5 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ml drotrecogin
Pred dajanjem je treba 5 mg viale zdravila Xigris pripraviti z 2,5 ml vode za injekcije, kar da raztopino s koncentracijo približno 2 mg/ml drotrekogina alfa (aktiviranega).
The solution of reconstituted Xigris should be diluted into an infusion bag containing sterile 0.9% Sodium Chloride Injection to a final concentration of between
Raztopino pripravljenega zdravila Xigris moramo razredčiti s sterilno 0,9 % raztopino natrijevega klorida v infuzijski vrečki do končne koncentracije med 100 μg/ml
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Xigris 5 mg powder for infusion
IME ZDRAVILA IN POT(I) UPORABE Xigris 5 mg prašek za infundiranje Za intravensko infuzijo po pripravi in redčenju.
However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15 to 30ºC).
Sicer lahko hranite pripravljeno (rekonstituirano) raztopino v viali do 3 ure pri sobni temperaturi (med 15 in 30 ºC).
a) you have had surgery within the last twelve hours before you receive Xigris, or you are bleeding from a previous surgery, or you might have surgery while you receive Xigris b) you have been in hospital with a severe injury to your head, or you have had surgery on your brain or spine, or you have had a bleed in your brain (haemorrhagic stroke) within the past three months, or you have abnormal blood vessels in your brain, or a mass in your head; you have an epidural catheter (a tube in your spine) c) you have been born with bleeding tendencies d) you have bled from your bowels within the last six weeks, unless treated adequately e) you have had a major accident and are at increased risk of bleeding
(hemoragično kap), če imate nenormalne krvne žile v možganih ali tvorbo v glavi; če imate epiduralni kateter (cevko v hrbtenici) c) če ste od rojstva nagnjeni h krvavitvam d) če ste v zadnjih šestih tednih krvaveli iz prebavil, razen če so bile krvavitve uspešno pozdravljene e) če ste imeli hudo nezgodo in imate povečano tveganje za krvavitev
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Xigris 20 mg powder for infusion
IME ZDRAVILA IN POT(I) UPORABE Xigris 20 mg prašek za infundiranje Za intravensko infuzijo po pripravi in redčenju.
Serious bleeding events during the 28-day study period In PROWESS, the incidence of serious bleeding events during the 28-day study period was 3.5% and 2.0% in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively.
V študiji PROWESS je bila incidenca resnih krvavitev v 28-dnevnem trajanju študije 3,5 % oziroma 2,0 % pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), oziroma bolnikih, ki so prejemali placebo.
A total of 2378 adult patients with severe sepsis received drotrecogin alfa (activated) in a Phase 3b, international, single-arm, open-label clinical trial (ENHANCE).
V mednarodnem kliničnem preskušanju faze 3b (ENHANCE) z enim krakom in znanim zdravilom je drotrekogin alfa (aktiviran) prejemalo skupno 2378 odraslih bolnikov s hudo sepso.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 20 mg of Drotrecogin alfa (activated).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka viala vsebuje 20 mg drotrekogina alfa (aktiviranega).
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 5 mg of Drotrecogin alfa (activated).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka viala vsebuje 5 mg drotrekogina alfa (aktiviranega).
Intra-abdominal
Prebavila Intraabdominalno Intratorakalno Retroperitonealno Osrednje živčevje1
There are no risks for the user, the consumer or the environment.
Ni tveganja za uporabnika, potrošnika ali okolje.
Such very virulent field strains have occurred since the late 1980's in Europe
Taki zelo virulentni terenski sevi so se začeli pojavljati proti koncu 80. let prejšnjega stoletja v Evropi
• The field study supports the safety of the vaccine.
• Terenska študija podpira varnost cepiva.
• There is no risk for the consumer of vaccinated chickens, nor is there any risk for the user of the vaccine or the environment.
• Ni tveganja niti za potrošnika cepljenih piščancev niti za uporabnika cepiva ali okolje.
GROUNDS FOR RECOMMENDATION OF THE GRANTING OF MARKETING AUTHORISATIONS
PODLAGA ZA PRIPOROČILO ODOBRITVE DOVOLJENJ ZA PROMET Z ZDRAVILOM
• Product Safety Update Reports in the UK, where the product has been authorised since 1998, have not indicated a problem with immunosuppression.
• Redna posodobljena poročila o varnosti zdravila v Združenem kraljestvu, kjer je cepivo odobreno od leta 1998, ne kažejo težav z imunosupresijo.
THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, RECOMMENDED DOSE, WITHDRAWAL PERIOD, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
IMENA, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKA VRSTA, POT UPORABE ZDRAVILA, PRIPOROČENI ODMEREK, KARENCA, PREDLAGATELJ/IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
• A study to assess the potential immunosuppression linked to administration of the vaccine was carried out according to the recommendations of the Ph. Eur.
• Opravljena je bila študija vrednotenja potencialne imunosupresije, povezane z uporabo cepiva, v skladu s priporočili Ph. Eur.
Belgium argued that the study conducted by the Applicant according to Ph. Eur.
Argument Belgije je bil, da je študija, ki jo je predlagatelj opravil skladno z monografijo Ph. Eur.
Layer chicks are clinically more sensitive than broilers
Kokoši nesnice so klinično občutljivejše od pitovnih piščancev
The valid Summary of Product Characteristics, Labelling and Package Leaflet are the final versions achieved during the Coordination group procedure.
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku Koordinacijske skupine.
There are sufficient recommendations and warnings provided to ensure that the veterinarian can determine whether the product is appropriate for use in an outbreak of vvIBD.
Obstaja dovolj priporočil in opozoril, da lahko veterinar ugotovi, ali je cepivo primerno za uporabo v primeru izbruha vvIBD.
• The vaccine strain is able to spread to incontact chickens, but is very unlikely to increase in virulence.
• Cepilni sev se lahko širi med kokošmi v stiku, vendar je zelo malo verjetno, da bi prišlo do povečanja virulence.
Although the oral route is recommended, some safety studies have been carried out using the intraocular route.
Čeprav se priporoča peroralna pot uporabe, so v nekaterih študijah varnosti cepili intraokularno.
• Since the product has been authorised, the reported incidence of adverse reactions is zero which indicates that the safety profile is acceptable.
• Od odobritve cepiva je bila pojavnost prijavljenih neželenih učinkov nič, kar pomeni, da je varnostni profil sprejemljiv.
Having considered all the overall submitted data in writing the CVMP concluded that:
CVMP je ob upoštevanju vseh predloženih pisnih podatkov zaključil naslednje:
The Marketing Authorisation Holder (MAH) provided 5 pivotal studies, 7 supportive studies and 3 field studies in order to assess safety of the vaccine.
Imetnik dovoljenja za promet z zdravilom je za vrednotenje varnosti cepiva predložil 5 ključnih študij, 7 podpornih študij in 3 terenske študije.
Prevention of mortality and reduction of bursal lesions were demonstrated.
Dokazano je bilo preprečevanje smrtnosti in zmanjšanje burzalnih lezij.
In addition the intrinsic immunosuppressive nature of the vaccine strain is further evidenced in another study.
Intrinzično imunosupresivno naravo cepilnega seva pa dodatno dokazuje še ena študija.
o The safety and efficacy data provided by the applicant were sufficient to consider that the overall benefit-risk balance for the product is positive.
o Podatki o varnosti in učinkovitosti, ki jih je predložil predlagatelj, so bili zadostni, da se skupno razmerje med koristmi in tveganji cepiva šteje za pozitivno.
From the studies that were presented in the safety part of the dossier, the following conclusions can be drawn:
Na podlagi študij, predloženih v delu dokumentacije o varnosti, lahko naredimo naslednje zaključke:
The MAH provided 2 pivotal studies, 7 supportive studies and 4 field studies.
Imetnik dovoljenja za promet z zdravilom je predložil 2 ključni študiji, 7 podpornih študij in 4 terenske študije.
The benefit/risk balance for the product is considered positive.
Razmerje med koristmi in tveganji za cepivo se šteje za pozitivno.
Therefore, the benefits of the product have been adequately demonstrated and that any risks associated with residual virulence is a recognised risk associated with this type of product, which is only recommended for use in an environment contaminated with vvIBD.
Zato so bile koristi učinka cepiva zadostno dokazane, vsa tveganja, povezana z rezidualno virulenco, pa so znana tveganja, povezana s tovrstnimi cepivi, ki se priporočajo za uporabo le v okoljih, okuženih z vvIBD.
Therefore, the CVMP recommended the granting of the Marketing Authorisations for Poulvac Bursa Plus for which the Summary of Product Characteristics, Labelling and Package Leaflet set out in Annex III of the CVMP Opinion.
CVMP je zato priporočil odobritev dovoljenj za promet z zdravilom Poulvac Bursa Plus, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III mnenja CVMP.
Poulvac Bursa Plus is a live vaccine against Infectious Bursal Disease Virus (IBDV), also known as Gumboro disease.
Zdravilo Poulvac Bursa Plus je živo cepivo proti virusu Gumborske bolezni (IBDV), znane tudi kot bolezen Gumboro.
monograph 01/2008:0587 showed that this vaccine strain causes significant damages to the Bursa of Fabricius, which in turn result in immunosuppression.
01/2008:0587, pokazala, da cepilni sev povzroči pomembne poškodbe Fabricijeve burze, kar povzroči imunosupresijo.
However, the monograph is only intended for classical strains and bursal damage is expected to be associated with intermediate plus vaccine strains.
Vendar je monografija namenjena le za klasične seve, poškodbe burze pa se pričakujejo le pri „vmesnih plus“ cepilnih sevih.
From the studies that were provided in the efficacy part of the dossier, the following conclusions can be drawn:
Na podlagi študij, predloženih v delu dokumentacije o učinkovitosti, lahko naredimo naslednje zaključke:
The potential advantage of using “intermediate plus” or “hot” strains, such as the one contained in Poulvac Bursa Plus is that they could break through higher maternally derived antibodies (MDA) levels than milder strains can do.
Potencialna prednost uporabe „vmesnih plus“ ali „vročih“ sevov, kakršen je v cepivu Poulvac Bursa Plus, je, da lahko premagajo visoke ravni od matere pridobljenih protiteles (MDA), ki jih bolj oslabljeni sevi ne morejo.
For Poulvac Bursa Plus, the optimum day of vaccination recommended in the Summary of Product Characteristics (SPC) needs to be calculated using the Kouwenhoven's formula; the target maximum MDA levels at the time of vaccination is 500 ELISA Units using a commercially available kit, but whatever the vaccination day calculation reaches, it is contra-indicated to vaccinate chickens less than 10 days of age.
Optimalni cepilni dan za cepivo Poulvac Bursa Plus, priporočen v povzetku glavnih značilnosti zdravila, se izračuna s Kouwenhovnovo formulo; ciljna najvišja raven protiteles, pridobljenih od matere, ob cepljenju je 500 ELISA enot, določena s komercialno dostopnim kompletom, vendar je ne glede na izračun cepilnega dne kontraindicirano cepiti piščance, mlajše od 10 dni.
The vaccine is to be specifically used in case of outbreaks caused by very virulent IBDV (vvIBDV) strains.
Cepivo se lahko zlasti uporablja v primerih izbruhov, ki jih povzročijo zelo virulentni sevi virusa Gumborske bolezni (vvIBDV).
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF POULVAC BURSA PLUS
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA POULVAC BURSA PLUS
An onset and duration of protection of respectively 14 and 32 days were demonstrated.
Dokazali so nastop zaščite 14 dni po cepljenju in trajanje zaščite 32 dni.
The risk of bursal damage and limited immunosuppression are clearly stated on the SPC (as is the need to restrict the use of the product to case of outbreaks of very virulent IBDV strains) and form part of the risk benefit assessment conducted by the veterinarian when deciding to use this product.
Tveganje poškodb burze in omejena imunosupresija sta jasno navedena v povzetku glavnih značilnosti zdravila (saj je treba omejiti uporabo cepiva na izbruhe zelo virulentnih sevov virusa Gumborske bolezni) in tvorita del ocene koristi in tveganj, ki jo opravi veterinar pri odločanju o uporabi tega cepiva.
Withdrawal period (meat)
Karenca (meso)
Benefit/risk balance
Razmerje med koristmi in tveganji
• Although no compatibility is claimed, serological data have been provided to support an absence of a negative interaction between Poulvac Bursa Plus and other vaccines.
• Čeprav se združljivost ne zahteva, so bili predloženi serološki podatki v podporo odsotnosti negativne interakcije med cepivom Poulvac Bursa Plus in drugimi cepivi.
Maximum doses of virus, at minimum passage level, were used in almost all the pivotal safety studies (4 out of 5).
V skoraj vseh ključnih študijah varnosti (4 od 5) so uporabili največje odmerke virusa z najmanjšo ravnjo prehoda.
The level of bursal lesions seen in independent confirmatory testing of Poulvac Bursa Plus is in line with those seen following vaccination with similar products which are already authorised in several Member States and used within the EU.
Ravni burzalnih lezij, ugotovljenih v neodvisnem potrjevalnem preskušanju cepiva Poulvac Bursa Plus, so skladne s tistimi po cepljenju s podobnimi cepivi, ki so že odobrena v več državah članicah in se uporabljajo v EU.
monograph (01/2008:0587) for classical IBDV vaccines, in that there was bursal damage and an interference on the serological response to NDV, it was acknowledged that there was no requirement to comply with this monograph because the product was classified as an intermediate plus strain.
(01/2008:0587) za klasična cepiva proti Gumborski bolezni, saj povzroča burzalne poškodbe in moti serološki odziv na virus atipične kokošje kuge, je bilo potrjeno, da ni zahtev za skladnost z omenjeno monografijo, ker je cepivo uvrščeno kot vmesni plus sev.
However, one of the problems to assess the efficacy of vaccination in commercial broilers (with MDA) under laboratory conditions is that they are usually not clinically affected by a vvIBDV challenge, as Specific Pathogen Free (SPF) chickens are.
Vendar je ena od težav pri ocenjevanju učinkovitosti cepljenja pri komercialnih pitovnih piščancih (s protitelesi, pridobljenimi od matere) v laboratorijskih pogojih, da se izziv z vvIBDV po navadi ne izrazi klinično kot pri piščancih brez specifičnih patogenov (SPF).
• The SPC reflects the results of the various safety studies.
• V povzetku glavnih značilnosti zdravila so navedeni rezultati več študij o varnosti.
The vaccine is indicated for the active immunisation of chickens with maternal antibody levels of ≤ 500 ELISA units, to reduce mortality and bursal lesions of Gumboro disease.
Cepivo je indicirano za aktivno imunizacijo piščancev z ravnmi materinskih protiteles ≤ 500 ELISA enot za zmanjšanje smrtnosti in burzalne lezije zaradi Gumborske bolezni.
During the mutual recognition procedure concerns were raised by Belgium that the benefit/risk balance of Poulvac Bursa Plus might be considered unfavourable.
Med postopkom z medsebojnim priznavanjem je Belgija izrazila zadržke, da je morda razmerje med koristmi in tveganji cepiva Poulvac Bursa Plus neugodno.
Field data confirm the benefits of vaccination under practical conditions on sites which have experienced ongoing problems with vvIBD where intermediate products have not been successful at controlling the vvIBD problem.
Terenski podatki potrjujejo koristi cepljenja v praktičnih razmerah na mestih, kjer obstajajo izkušnje s stalnimi težavami z zelo virulentnimi sevi virusa Gumborske bolezni in kjer vmesna cepiva niso bila uspešna pri obvladovanju vvIBD.
Given its residual pathogenicity, the vaccine strain, V877, is classified as “intermediate plus” and also known as a “hot” strain.
Cepilni sev V877 je zaradi rezidualne patogenosti uvrščen med „vmesne plus“ seve in znan kot „vroč“ sev.
• With respect to the level of bursal damage seen in SPF birds vaccinated with Poulvac Bursa Plus it is noted that the results of independent confirmatory testing of Poulvac Bursa Plus conducted by Germany and presented during the current procedure indicate that the level of bursal lesions seen are in line with those seen following vaccination with similar products which are already authorised in many Member States and therefore used widely within the European Union.
• V zvezi z ravnmi poškodb burze pri piščancih brez specifičnih patogenov, cepljenih s cepivom Poulvac Bursa Plus, je treba opozoriti, da rezultati neodvisnega potrjevalnega testiranja cepiva Poulvac Bursa Plus, opravljenega v Nemčiji in predstavljenega med tem postopkom, kažejo, da so ravni lezij burze v skladu s tistimi poškodbami, opazenimi po cepljenju s podobnimi zdravili, ki so že odobrena v več državah članicah in posledično v širši uporabi v Evropski uniji.
o Although the product did not comply with Ph. Eur.
o Čeprav cepivo ni bilo skladno z monografijo Ph. Eur.
• These types of product are for use in specific cases where there is evidence of vvIBD and where the level of bursal damage incurred is a necessary risk to achieve the protection provided against vvIBD.
• Tovrstna zdravila se uporabljajo v posebnih primerih, ko so dokazani zelo virulentni sevi virusa Gumborske bolezni in ko je raven nastalih poškodb burze nujno tveganje, da se zagotovi zaščita pred zelo virulentnimi sevi virusa Gumborske bolezni.
In view of the fact that no compatibility statement is claimed it is considered that sufficient information has been provided to support an absence of a negative interaction between Poulvac Bursa Plus and other vaccines.
Ker se združljivost ne zahteva, se šteje, da so bile predložene zadostne informacije v podporo odsotnosti negativnega medsebojnega vplivanja med cepivom Poulvac Bursa Plus in drugimi cepivi.
• Efficacy of the vaccine in the presence of a range of MDA titres (mean titre of around 500 ELISA Units as recommended) was also shown under laboratory conditions: significant reduction of the bursal lesions was shown at 14 and 32 days post challenge.
• V laboratorijskih pogojih je bila dokazana učinkovitost cepiva v prisotnosti razpona titrov protiteles, pridobljenih od matere (povprečni titer približno 500 ELISA enot, kakor je priporočeno): pomembno zmanjšanje burzalnih lezij so dokazali 14. in 32. dan po izzivnem preskusu.