natgillin/translations-raw huggingface dataset:
A TSE Declaration of Compliance and revised supporting TSE compliance tables should be provided to address - a) the issues raised in Point 8, above, and b) the out of date information and certification which have been provided for the sources of gelatine.
Predlagatelj mora predložiti dokazilo, da je država izvora jate, ki služi kot vir, Španija in da države izvora ne bo spreminjal (in ne bo spreminjal ukrepov za zatiranje bolezni pri jatah), ne da bi obvestil CVMP.
Results should be provided from in-process tests on three batches of H5N6 antigen, to demonstrate batch consistency.
Ni navedeno preskušanje WSV za podtip H5N6 in predlagatelj se mora obvezati, da bo predložil informacije o preskušanjih za vsako serijo WSV.
It is assumed that in-process tests are conducted at each of the proposed sites of antigen manufacture.
Nenavajanje držav izvora krav, od katerih je pridobljeno mleko, in nenavajanje dobaviteljev triptoze in NZ- aminov je nesprejemljivo.
No information has been provided on the steps taken to ensure the equivalence of results obtained from tests conducted at the three sites of antigen manufacture e. g. for the virus titration and associated HA tests.
Navedeni morajo biti posodobljeni podatki o državah izvora za živali, ki služijo kot vir mleka za pripravo triptoze iz BD Biosciences in za pripravo kazeina ter laktoze, kadar je primerno, za izdelavo NZ- aminov, kupljenih pri Quest/ Kerry.
Reassurances should be provided on the equivalence of tests and test results from the different sites.
Predlagatelj mora soglašati, da bo podrobno navedel NZ- amin( e), ki jih bo uporabil v proizvodnji in kot vir za triptozo in podrobno naveden( e) NZ - amin( e) uporabljal samo podjetja, za katera so v dokumentaciji primerne 'izjave o mleku' in podrobni podatki o državah izvora živali, ki služijo kot vir.
CONTROL TESTS ON THE FINISHED PRODUCT
KONTROLNI PRESKUSI MED IZDELAVO
II. E.2 Identification and assay of active ingredients
Manjkajo podatki o ukrepih za zagotavljanje ekvivalentnosti rezultatov preskušanj, ki so bila izvedena na treh mestih izdelave antigena, na primer za titracijo virusa in z njo povezane teste HA.
The Applicant should provide the SOP and further details on the conduct of the batch potency test for Nobilis Influenza H5N6.
Predlagatelj mora predložiti SOP in dodatne podatke o izvajanju testa učinkovitosti serije za Nobilis Influenza H5N6.
It should be clarified what route of vaccination is used, how the sera are tested (in a pool or individually), whether all chickens have to develop a titre of 6.0 log2 or if this is a mean titre.
Pojasniti je treba, kakšna je pot cepljenja, kako je preskušen serum (zbirni serum ali posamično), ali se mora pri vseh piščancih razviti titer 6, 0 log2 ali je to srednji titer.
It should be indicated what reference antigen is used in the HI test and details should be provided on the standards included in the test.
Navedeno mora biti, kateri referenčni antigen je uporabljen pri preskusu HI in podani podatki o standardih v preskusu.
Test for identification:
Preskus istovetnosti:
A final product batch test should be introduced to identify the neuraminidase component and confirm that the vaccine has the correct composition.
Vpeljati je treba končni preskus serije izdelka za istovetnost sestavine nevraminidaze in potrditev, da ima cepivo pravilno sestavo.
9 II. E.9 Batch to batch consistency
II. E. 9 Konsistentnost serij 14.
No information has been provided on the steps taken to ensure the equivalence of results obtained from tests on the final product, conducted at Boxmeer and Salamanca, (e. g. for the batch potency tests and HI and HA tests) and reassurances should be provided on the equivalence of tests and test results from the two sites.
Manjkajo podatki o ukrepih za zagotovitev ekvivalentnosti rezultatov preskusov končnega izdelka, izvedenih v Boxmeeru in Salamanci (na primer za preskušanje učinkovitosti serij ter preskusov HI in HA); podati je treba zagotovila o ekvivalentnosti preskusov in rezultatov preskusov z obeh mest.
II. F.
9 II.
II. F.1
F.
Stability of the bulk antigen
STABILNOST II. F. 1 Stabilnost nepakiranega antigena 16.
The antigen should be stored for no longer than 12 months at 2-8ºC pending the provision of data supporting a longer period of storage.
Antigena se ne sme shranjevati dlje kot 12 mesecev pri temperaturi 2– 8 ºC, dokler ne bo na voljo nadaljnjih podatkov, na podlagi katerih bo možno daljše obdobje shranjevanja.
II. F.1 Stability of the final product
II. F. 1 Stabilnost končnega izdelka 17.
Although a shelf life of 2 years can be accepted for vaccine filled into PET containers of both sizes, the shelf life should be no longer than 12 months at 2-8ºC for vaccine filled into glass containers, pending the provision of further information in support of a longer period of storage in the glass containers.
Čeprav je za cepivo, polnjeno v vsebnike iz PET obeh velikosti, 2- letni rok uporabnosti sprejemljiv, rok uporabnosti za cepivo, polnjeno v vsebnike iz stekla ne sme biti daljši od 12 mesecev pri temperaturi 2– 8 ºC, dokler ne bo na voljo nadaljnjih podatkov, na podlagi katerih bo možen daljši rok uporabnosti.
The Applicant is required to submit 3-montly Periodic Update Safety reports for the first 2 years following the initial use in the field and is additionally required to present a protocol that would ensure adequate recording and reporting of field data in relation to suspected adverse reactions including suspected lack of efficacy.
Predlagatelj mora predložiti 3- mesečna periodična poročila o varnosti za prvi 2 leti po prvi uporabi na terenu in protokol, ki zagotavlja ustrezno zapisovanje podatkov in poročanje o podatkih s terena o sumu na neželene učinke, tudi sumu na odsotnost učinkovitosti.
Serology results for the efficacy study carried out in chickens by Katsma et al. should be provided.
Predložiti je treba serološke rezultate študije učinkovitosti, ki so jo pri piščancih izvedli Katsma et. al.
Intramuscular or subcutaneous injection of 0.25 or 0.5 ml, depending on the age.
Intramuskularno ali subkutano odmerek po 0, 25 ali 0, 5 ml, glede na starost.
< EXP {month/year} > Once broached, use within 8 hours.
EXP {mesec/ leto} Načeto zdravilo uporabite v 8 urah.
14 MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
14 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Intramuscular or subcutaneous injection Read the package leaflet before use.
Intramuskularno ali subkutano Pred uporabo preberite navodilo za uporabo.
16 PACKAGE LEAFLET FOR:
16 NAVODILO ZA UPORABO ZA:
Nobilis Influenza H5N6 emulsion for injection
Nobilis Influenza H5N6 emulzija za injiciranje
Liquid paraffin
Adjuvans: redko tekoči parafin
Studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Pokazalo se je, da trajajo pri piščancih zaščitne ravni protiteles v serumu najmanj 7 mesecev, študije z drugimi cepnimi sevi pa so pokazale, da bi bila pri piščancih po dveh odmerkih cepiva protitelesa v serumu predvidoma prisotna najmanj 12 mesecev.
Chickens From 8-14 days old:
0, 25 ml subkutano
0.25 or 0.5ml subcutaneously or intramuscularly 6 weeks and older:
0, 5 ml subkutano ali intramuskularno
0.5ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination No information is available on vaccination in the presence of maternally derived antibodies.
Pri bodočih nesnicah in matičnih jatah moramo cepljenje ponoviti 4 do 6 tednov po prvem cepljenju.
Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
Cepivo ogrejte na 15 °C– 25 °C in ga pred uporabo dobro pretresite.
Do not freeze.
Shranjujte pri temperaturi 2 °C do 8 °C.
The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
Če ga uporabljamo pri drugih vrstah ptic, za katere menimo, da je pri njih povečano tveganje okužbe, ga moramo uporabljati previdno, pred množičnim cepljenjem pa ga je priporočljivo preskusiti na majhnem številu ptic.
18 No information is available on the safety of this vaccine for birds in lay.
Ni podatkov o varnosti cepiva pri pticah v obdobju nesnosti.
19
19 Velikosti pakiranja:
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Nobilis Influenza H7N1 been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Nobilis Influenza H7N1 raziskano?
When compared, the subcutaneous and intramuscular routes were shown to produce the same responses. • The vaccine has been shown to reduce clinical signs and mortality and reduce virus shedding in infected chickens. • The vaccine has been shown reduce virus shedding in infected ducks. • The vaccine is able to induce antibodies in a wide range of birds. • If the circulating avian influenza field virus has a different N component to the N1 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Ob primerjavi subkutanega in intramuskularnega načina dajanja zdravila se je izkazalo, da so bili odzivi enaki. • Dokazano je bilo, da cepivo zmanjša klinične znake in umrljivost ter zmanjšuje izločanje virusa pri okuženih piščancih. • Dokazano je bilo tudi, da cepivo zmanjša izločanje virusa pri okuženih racah. • Cepivo spodbudi nastajanje protiteles pri številnih vrstah ptic. • Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N1 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
The person who injects the vaccine should be careful to avoid accidental self injection.
Oseba, ki daje cepivo, mora paziti, da si zdravila po nesreči ne samo - injicira.
Nobilis Influenza H7N1 has been authorised under “ Exceptional Circumstances”.
Zdravilo Nobilis Influenza H7N1 je bilo odobreno v „ izjemnih okoliščinah “.
Page 2/ 3 ©EMEA 2007 Other information about Nobilis Influenza H7N1:
Stran 2/ 3 ©EMEA 2007 Druge informacije o zdravilu Nobilis Influenza H7N1:
The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H7N1 to Intervet International BV on 14/ 05/ 2007.
Evropska komisija je dovoljenje za promet z zdravilom Nobilis Influenza H7N1, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 14/ 05/ 2007
This summary was last updated in May 2007.
Ta povzetek je bil nazadnje posodobljen 05/ 2007.
Package Withdrawal size Period
Velikost pakiranja
HI titre ≥ Emulsion for 6.0 log2 per injection dose
titer HI ≥ 6. 0 log2 v odmerku
Chickens and ducks
piščanci in race
Intramuscular Glass bottles or (hydrolytical class subcutaneous II) with rubber stopper and aluminium cap
stekleničke (steklo tipa II) z gumijastimi zamaški in aluminijasto zaporko
1 bottle Zero days
1 steklenička
Intramuscular PET bottles with or rubber stopper and subcutaneous aluminium cap
plastenke iz PET z gumijastimi zamaški in aluminijasto zaporko
1 bottle Zero days
1 plastenka
Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/ CK/ Italy/ 473/ 99), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Inaktivirani antigen podtipa virusa aviarne influence H7N1 (sev, A/ CK/ Italija/ 473/ 99), ki vzbudi titer HI ≥ 6, 0 log2 pri preizkusu učinkovitosti.
For a list of excipients see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals. -In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination. -In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.
Učinkovitost je ocenjena na podlagi začetnih rezultatov pri piščancih in rdečehrbtnih racah. - Pri piščancih so se klinični znaki, umrljivost, izločanje in prenos virusa po provokaciji zmanjšali v dveh tednih po cepljenju z enim odmerkom. - Pri racah sta se izločanje in prenos virusa po provokaciji zmanjšala v dveh tednih po cepljenju z enim odmerkom.
2 4.4 Special warnings for each target species
4. 4 Posebna opozorila za vsako ciljno živalsko vrsto
3 Chickens
Piščanci
From 8 to 14 days old:
Od 8 do 14 dni starosti:
0.25 or 0.5 ml subcutaneously or intramuscularly
0, 25 ali 0, 5 ml subkutano ali intramuskularno
6 weeks and older:
Stari 6 tednov in starejši:
0.5 ml subcutaneously or intramuscularly
0, 5 ml subkutano ali intramuskularno
Ducks
3 Race
From 2 to 6 weeks:
Od 2 do 6 tednov starosti:
Laying and breeder stock should get a second vaccination 6-10 weeks after the first vaccination.
0, 5 ml subkutano ali intramuskularno Nesnice in plemenske živali moramo ponovno cepiti 6– 10 tednov po prvem cepljenju.
QI01AA23
Farmakoterapevtska skupina: inaktivirano cepivo, oznaka ATC vet:
The vaccine stimulates active immunity against Avian Influenza virus type A, subtype H7N1.
QI01AA23 Cepivo vzbudi aktivno imunost proti virusu aviarne influence tipa A, podtip H7N1.
If the circulating avian influenza field virus has a different H and/ or N component to the H7N1 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect haemagglutinin and/ or neuraminidase antibodies.
Če ima divji virus aviarne influence sestavino H ali N, ki se razlikuje od sestavin H7N1 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti hemaglutininu ali nevraminidazi.
1 year
2 leti Steklene viale:
After broaching use within 8 hours, provided the product is not subject to extreme temperatures or contaminated.
1 leto Načeto zdravilo porabite v 8 urah, če izdelek ni bil izpostavljen zelo visoki temperaturi ali kontaminiran.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
4 6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
The import, sale, supply and/ or use of Nobilis Influenza H7N1 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ ali uporaba Nobilisa Influenza H7N1 je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/ or use Nobilis Influenza H7N1 must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati Nobilis Influenza H7N1, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ ali uporabo.
5 The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena samo v posebnih razmerah, ki so opredeljene v zakonodaji Evropske skupnosti za nadzor nad aviarno influenco.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu /
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na območju skoraj ni prisotna.
Pharmacologically active substance Light liquid paraffin Polysorbate 80 Sorbitan mono oleate (E494) Glycine
Farmakološko aktivna snov lahki tekoči parafin polisorbat 80 sorbitan monooleat (E494) glicin
STARTING MATERIALS II. C.2
VHODNE SNOVI
Not listed in a Pharmacopoeia
II. C. 2 Niso navedene v farmakopeji
The Applicant should provide a list of any changes to the source countries for the pigs used as a source of the porcine starting material in tryptose.
Posebni ukrepi, ki se nanašajo na preprečitev prenosa živalske spongiformne encefalopatije
A revised supporting TSE compliance table should be provided with deletion of the words ‘ or equivalent ’ after the source companies for the tryptose and NZ-Amines and ‘ e. g.’ before the corresponding lists of source countries.
Predložiti je treba revidirano tabelo o skladnosti za transmisivno spongiformno encefalopatijo, v kateri je treba izbrisati besedi 'ali enakovredna' za podjetji izvora za triptozo in NZ- amini ter 'npr.' pred ustreznimi seznami držav izvora.
An up-to-date certificate of suitability should be provided for Rousselot Acid hide gelatin (European origin) II. E.
Predložiti je treba veljaven certifikat o ustreznosti za Rousselot Acid hide gelatin (evropski izvor)
CONTROL TESTS ON THE FINISHED PRODUCT II. E.2
KONTROLA KAKOVOSTI KONČNEGA IZDELKA
Identification and assay of active ingredients
II. E. 2 Istovetnost in vsebnost zdravilnih učinkovin
A clear justification should be given in support of the proposed pass level of an HI serum titre of 6.0 log2.
Podana mora biti jasna utemeljitev predlagane mejne vrednosti titra HI v serumu 6, 0 log2.
STABILITY
STABILNOST
Stability of the bulk antigen
II. F. 1 Stabilnost nepakiranega antigena 5.
SAFETY ASPECTS 6.
VARNOSTNI VIDIKI 6.
The report of the overdose safety studies in ducks with Nobilis Influenza H7N1 administered by both s. c. and i. m. routes should be provided as soon as it is available
Poročila študij o varnosti enkratnega odmerka in prevelikega odmerka cepiva Nobilis Influenza H7N1 pri racah po s. c. in i. m. dajanju je treba predložiti takoj, ko bodo na voljo.
9 PHARMACOVIGILANCE ASPECTS
8 FARMAKOVIGILANČNI VIDIKI
The applicant is required to submit 3-montly Periodic Update Safety reports for the first 2 years following the initial use in the field and is additionally required to present a protocol that would ensure adequate recording and reporting of field data in relation to suspected adverse reactions including suspected lack of efficacy.
Predlagatelj mora predložiti 3- mesečna periodična poročila o varnosti za prvi 2 leti po prvi uporabi na terenu in protokol, ki zagotavlja ustrezno zapisovanje podatkov in poročanje o podatkih s terena o sumu na neželene učinke, tudi sumu na odsotnost učinkovitosti.
EFFICACY ASPECTS 8.
8.
I. M. or S. C. injection of 0.25, 0.5 ml or 1 ml, depending on the age and species.
i. m. ali s. c. odmerek po 0, 25, 0, 5 ml ali 1 ml, glede na starost in živalsko vrsto.
14 MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
13 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
I. M. or S. C. injection Read the package leaflet before use.
Pred uporabo preberite navodilo za uporabo.
8.
< EXP {mesec/ leto} > Načeto/ odprto zdravilo uporabite v 8 urah.
Nobilis Influenza H7N1 emulsion for injection
Nobilis Influenza H7N1 emulzija za injiciranje
Liquid paraffin
Tekoči lahki parafin
17 5.
17 6.
Chickens From 8 to 14 days old:
Piščanci Od 8 do 14 dni starosti:
From 2 to 6 weeks:
Race Od 2 do 6 tednov starosti:
Do not freeze.
Shranjujte in prevažajte pri temperaturi 2 °C do 8 °C.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
19 Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena le v določenih razmerah, opredeljenih v zakonodaji Evropske skupnosti o nadzoru nad aviarno influenco.
Nobilis OR Inac is a vaccine that contains a suspension of the bacterium Ornithobacterium rhinotracheale serotype A, strain B3263/ 91.
Zdravilo Nobilis OR Inac je cepivo, ki vsebuje suspenzijo bakterije Ornithobacterium rhinotracheale, serotip A, sev B3263/ 91.
Nobilis OR Inac is used to vaccinate female chickens that are being used for breeding broilers (chickens bred for meat) against the bacterium O. rhinotracheale serotype A.
Zdravilo Nobilis OR Inac se uporablja za cepljenje piščancev ženskega spola, ki se uporabljajo za vzrejo brojlerjev (piščancev, ki se redijo za meso) proti bakteriji O. rhinotracheale, serotipa A.
This immunity is then passed on to the chickens’ offspring, so that the broilers are protected against infection with the same type of bacteria.
Ta imunost se nato prenese na potomce cepljenih piščancev (kokoši), tako da so brojlerji zaščiteni pred okužbo z enako vrsto bakterije.
Nobilis OR Inac is given as two 0.25-ml injections, either under the skin in the neck or into the breast muscle.
Zdravilo Nobilis OR Inac se daje v obliki dveh 0, 25 ml injekcij pod kožo na vratu ali v prsno mišico.
Immunity is transferred to the chicken’ s offspring for a period of 43 weeks after the last vaccination.
Imunost se prenaša na potomce kokoši 43 tednov po zadnjem cepljenju.
Nobilis OR Inac contains small amounts of a killed bacterium called O. rhinotracheale serotype A, strain B3263/ 91.
Zdravilo Nobilis OR Inac vsebuje majhne količine ubite bakterije, imenovane O. rhinotracheale, serotip A, sev B3263/ 91.
The vaccine also contains an ‘ adjuvant’ (liquid paraffin) to stimulate a better response.
Cepivo vsebuje tudi adjuvans (tekoči parafin) za stimulacijo boljšega odziva.
When a breeder is given the vaccine, the immune system recognises the killed bacteria as ‘ foreign’ and makes antibodies against them.
Ko kokoš matične jate prejme cepivo, imunski sistem prepozna ubite bakterije kot tujke in proti njim razvije protitelesa.
These antibodies are then passed on to the breeder’ s offspring through the eggs.
Ta protitelesa se nato prenesejo na potomce teh kokoši prek jajc.
Reproduction is authorised provided the source is acknowledged How has Nobilis OR Inac been studied?
Reproduction is authorised provided the source is acknowledged Kako je bilo zdravilo Nobilis OR Inac raziskano?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobilis OR Inac exceed the risks for passive immunistaion of broilers induced by active immunisation of female broiler breeders to reduce infection with O. rhinotracheale serotype A when this agent is involved, and recommended that Nobilis OR Inac be given a marketing authorisation.
Zato je priporočil, da se za zdravilo Nobilis OR Inac odobri dovoljenje za promet.
This summary was last updated on 10.01.2008.
Povzetek je bil nazadnje posodobljen 10. 01. 2008
Withdrawal period
Velikost pakiranja
1 x 107 cells per 0.25 ml dose
1 x 107 celic v
Emulsion for injection
subkutana ali
Chickens
odmerku po