natgillin/translations-raw huggingface dataset:
Udvalget anbefalede udstedelse af markedsføringstilladelse for Nobilis OR Inac.
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.
Side 2/ 3 ©EMEA 2008 Andre oplysninger om Nobilis OR Inac:
Other information about Nobilis OR Inac:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobilis OR Inac til Intervet International den 24. januar 2003.
The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis OR Inac to Intervet International on 24 January 2003.
Oplysningerne om udleveringsbestemmelserne for dette lægemiddel findes på etiketten/ den ydre emballage
Information on the prescription status of this product may be found on the label/ outer package.
Dette sammendrag blev sidst ajourført den 10. 01. 2008
This summary was last updated on 10.01.2008.
Indgivelsesvej
Target Species
Emballage Indhold
Route of administration
Paknings - størrelse
Packaging Content
1 x 107 celler per 0. 25 ml dosis
1 x 107 cells per 0.25 ml dose
Injektionsvæske, Kyllinger emulsion
Emulsion for injection
Subkutan eller intramuskulær anvendelse
Subcutaneous or intramuscular use
Hætteglas 250 ml (PET) (1000 doser)
250 ml (1000 doses)
Hætteglas 500 ml (PET) (2000 doser)
500 ml (2000 doses)
Pr. dosis af 0, 25 ml:
Per dose of 0.25 ml:
Aktivt stof (Aktive stoffer) Inaktiveret helcellesuspension af Ornithobacterium rhinotracheale serotype A, stamme B3263/ 91 1 x 107 celler *.
Active substance Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/ 91 1 x 107 cells *
* inducerer en gennemsnitstiter i kyllingerne fra potencytesten på mindst 11, 2 (log2).
* inducing a mean titre in the chickens of the potency test of at least 11.2 (log2).
Lys paraffinolie:
Adjuvant Light liquid paraffin:
Spor af formaldehyd
Excipients Traces of formaldehyde
Se afsnit 6. 1 for en fuldstændig fortegnelse over hjælpestoffer.
For a list of excipients, see section 6.1
2 4. 5 Særlige forsigtighedsregler vedrørende brugen
Special precautions for use in animals
Særlige forsigtighedsregler vedrørende brug til dyr Lad vaccinen opnå stuetemperatur (15- 25°C) inden brug.
Allow vaccine to reach room temperature (15-25°C) before using the vaccine.
Må ikke anvendes til fugle, der er i æglægning (se afsnit 4. 3).
Do not use in birds in lay (see section 4.3).
Vaccinationsprogrammet består af to injektioner med en dosis på 0, 25 ml, der gives subkutant i nakken eller intramuskulært i brystet.
The vaccination scheme consists of two injections with a dose of 0.25 ml, administered subcutaneously in the neck or intramuscularly in the breast.
Den første injektion kan gives ved 6- 12 ugers alderen.
The first injection can be administered at an age of 6 - 12 weeks.
Den anden injektion skal gives mindst 6 uger senere ved 14- 18 ugers alderen.
The second injection has to be administered at least 6 weeks later at an age of 14 - 18 weeks.
Lejlighedsvis ses små hårde lokale hævelser (0, 5 – 2, 0 cm), som forsvinder inden for 21 dage efter vaccination.
Occasionally hardened minor local swellings (0.5 – 2.0 cm) were observed which disappeared within 21 days after vaccination.
Inaktiveret bakteriel vaccine, ATCvet- kode:
Inactivated bacterial vaccine ATCvet code:
Phosphat buffer vandig opløsning.
Light liquid paraffin, Polysorbate 80, Sorbitan oleate, phosphate buffered aqueous solution
Må ikke blandes med andre vacciner eller immunologiske lægemidler.
Do not mix with any other vaccine/ immunological product.
15 måneder Opbevaringstid efter første åbning af beholderen:
15 months Shelf life after first opening:
Anvendes umiddelbart efter åbning.
Use immediately after opening
Opbevares og transporteres ved 2- 8°C.
Store and transport at 2 - 8°C.
Intervet International BV Wim de Körverstraat 35 NL- 5831 AN Boxmeer Holland
Intervet International Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Dette med henvisning til nationale dyresundhedsprogrammer.
The import, sale, supply and/ or use of the product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Enhver person, som har til hensigt at indføre, sælge, levere og/ eller anvende Nobilis OR inac, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden indførsel, salg, levering og/ eller anvendelse finder sted.
Any person intending to import, sell, supply and/ or use the product must consult the relevant Member States Competent Authority on the current vaccination policies prior to the import, sale, supply and/ or use.
A. < FREMSTILLER( E) AF DE( T) BIOLOGISK AKTIVE STOF( FER) OG > INDEHAVER( E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
FREMSTILLER( E) AF DE( T) BIOLOGISK AKTIVE STOF OG > INDEHAVER( E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Navn og adresse på fremstilleren (fremstillerne) af de( t) biologisk aktive stof
Name and address of the manufacturer of the biological active substance
Wim de Körverstraat 35 5831 AN Boxmeer Holland
Intervet International Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
< I henhold til artikel 71 i Europa- Parlamentets og Rådets direktiv 2001/ 82/ EF, med senere ændringer, kan en medlemsstat forbyde indførsel, salg, levering og/ eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
a) at behandling af dyr med lægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret,
a) 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
2377/ 90 ikke.
• For the active principle of biological origin intended to produce immunity, Council Regulation (EEC) No 2377/ 90 does not apply.
2377/ 90 i overensstemmelse med nedenstående tabel:
• The adjuvants and excipients listed are included in Annex II of Council Regulation (EEC) No 2377/ 90.
7 De( t) farmakologisk aktive stof( fer)
7 Pharmacologically active substance Mineral hydrocarbons, low to high viscosity including microcristalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compounds.
Alle fødevareproducerende dyrearter
Animal Species All food producing species
Udelukker aromatiske og umættede forbindelser
Other provisions Excludes aromatic and unsaturated compounds
Alle fødevareproducerende dyrearter Alle fødevareproducerende dyrearter
All food producing species All food producing species
• Sorbitanoleat (E494), kaliumdihydrogenphosphat (E340), dinatriumhudrogenphosphat (E339) og kaliumchlorid (E508) er godkendt som tilsætningsstoffer i fødevarer til mennesker og er derfor medtaget i bilag II til Rådets forordning (EØF) nr.
(E 339) and Potassium chloride (E 508) are approved as additives in foodstuffs for human consumption and therefore covered by Annex II of Council Regulation (EEC) No.
2377/ 90 for substanser med et E - nummer1 (med undtagelse af konserveringsmidler medtaget i del C af bilag III til Rådets Direktiv 95/ 2/ EC2.).
2377/ 90 for substances with an E- number1 (with the exception of preservatives listed in part C of Annex III to Council Directive 95/ 2/ EC2.).
______________________________ 1 OJ Nr.
1 OJ No L272 of 25.10.1996, p.
L61 af 18. 03. 1995, s.
2 2 OJ No L 61 of 18.3.1995, p.
Inaktiveret helcellesuspension af Ornithobacterium rhinotracheale serotype A, stamme B3263/ 91 1 x 107 celler * * inducerer en gennemsnitstiter i kyllingerne fra potencytesten på mindst 11, 2 (log2).
Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A strain B3263/ 91 1 x 107 cells * * inducing a mean titre in the chickens of the potency test of at least 11.2 (log2).
107, 21 mg Spor af formaldehyd
107.21 mg Traces of formaldehyde
DYREARTER
Chickens
Subkutan injektion i nakken eller intramuskulær injektion i brystet af 1 dosis af 0, 25 ml.
Subcutaneous injection in the neck or intramuscular injection in the breast of one dose of 0.25 ml.
Bør ikke anvendes fugle, der er i æglægning.
Oil adjuvanted vaccine Do not use for birds in lay.
Udløbsdato {MM/ ÅÅÅÅ} Anvendes umiddelbart efter åbning
Use immediately after opening
Batch:
Lot: ……
13 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
12 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
107, 21 mg Spor af formaldehyd
Inactivated whole cell suspension of O. rhinotracheale Light liquid paraffin
PAKNINGSSTØRRELSE
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
250 ml (1000 doser) 500 ml (2000 doser)
250 ml (1000 doses) 500 ml (2000 doses)
ANVENDELSESMÅDE OG INDGIVELSESVEJ( E)
ROUTES OF ADMINISTRATION
Subkutan injektion i nakken eller intramuskulær injektion i brystet af 1 dosis af 0, 25 ml.
s. c. injection or i. m. injection of one dose of 0.25 ml.
Udløbsdato {MM/ ÅÅÅÅ} Anvendes umiddelbart efter åbning
Use immediately
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Holland
Intervet International
Batch:
Batch: ……
MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE)
EU Number
INDLÆGSSEDDEL
15 PACKAGE LEAFLET
Inaktiveret helcellesuspension af Ornithobacterium rhinotracheale serotype A, stamme B3263/ 91 1 x 107 celler * * inducerer en gennemsnitstiter i kyllingerne fra potencytesten på mindst 11, 2 (log2).
Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A strain B3263/ 91 1 x 107 cells *
17 7.
16 7.
Enkelt dosis af 0, 25 ml.
Single dose of 0.25 ml.
Lad vaccinen opnå stuetemperatur (15- 25°C) inden brug.
Allow the vaccine to reach room temperature (15-25°C) before using the vaccine.
Vaccinationsprogrammet består af to injektionen med en dosis af 0, 25 ml, der gives subkutant i nakken eller intramuskulært i brystet.
The vaccination scheme consists of two injections with a dose of 0.25 ml, administered subcutaneously in the neck or intramuscularly in the breast.
Den første vaccination gives ved 6- 12 ugers alderen.
The first injection can be administered at an age of 6 - 12 weeks.
Den anden vaccination skal gives mindst 6 uger senere ved 14- 18 ugers alderen.
The second injection has to be administered at least 6 weeks later at an age of 14 - 18 weeks.
Opbevares utilgængeligt for børn Opbevares og transporteres ved 2- 8°C.
Store and transport at 2 - 8°C.
18 Til lægen:
17 To the physician:
Af og til er iagtaget en lille lokal hård hævelse (0, 5 – 2, 0 cm) som forsvinder igen indenfor 21 dage efter vaccination.
Occasionally hardened minor local swellings (0.5 – 2.0 cm) were observed which disappeared within 21 days after vaccination.
Må ikke blandes med andre vacciner/ immunologiske produkter.
Do not mix with any other vaccine/ immunological product.
Lægemidlet indeholder inaktiveret helcellesuspension af Ornithobacterium rhinotracheale serotype A, stamme B3263/ 91, iblandet en oliadjuvans.
The product contains the inactivated whole cells of Ornithobacterium rhinotracheale serotype A, strain B3263/ 91 mixed with an oil adjuvant.
Hvad er Nobilis IB 4- 91?
What is Nobilis IB 4-91?
Nobilis IB 4- 91 er en lyofiliseret (frysetørret) vaccine i form af en klump, som forberedes til en opløsning til dosering.
Nobilis IB 4-91 is a lyophilised (freeze dried) vaccine pellet which is made into a solution for dosing.
Nobilis IB 4- 91 indeholder det levende svækkede (ændret så det ikke fremkalder sygdom) aviære Infectious Bronchitis Virus (IBV).
Nobilis IB 4-91 contains the live attenuated (altered so that it does not cause the disease) avian Infectious Bronchitis Virus (IBV).
Hvad anvendes Nobilis IB 4- 91 til?
What is Nobilis IB 4-91 used for?
Nobilis IB 4- 91 anvendes til immunisering af kyllinger for at reducere de respiratoriske symptomer på infektiøs bronkitis, som forårsages af stammevarianten IB 4- 91, som forårsager infektiøs bronkitis hos kyllinger.
Nobilis IB 4-91 is used to immunise chickens to reduce the respiratory signs of Infectious Bronchitis caused by the variant strain IB 4-91, which causes infectious bronchitis in chickens.
Nobilis IB 4- 91 kan gives til daggamle eller ældre kyllinger via grov spray, intranasal (indåndet gennem næseborene) eller okulær (absorberet via øjnene) administration.
Nobilis IB 4-91 can be given to 1-day-old chicks and older chickens by coarse spray or by intranasal (breathed in through the nose) or ocular (absorbed by the eyes) administration.
For at opnå forlænget immunitet bør kyllingerne revaccineres hver 6. uge efter første vaccination.
For long-lasting immunity, chickens should be revaccinated every 6 weeks.
Hvordan virker Nobilis IB 4- 91?
How does Nobilis IB 4-91 work?
Nobilis IB 4- 91 indeholder det levende IBV- virus, som er blevet attenueret (svækket), så det ikke fremkalder sygdom.
Nobilis IB 4-91 contains the live IBV virus that has been attenuated (altered) so that it does not cause the disease.
Når kyllingerne eksponeres for dette attenuerede virus, hjælper denne lille eksponering kyllingens immunsystem til at genkende og angribe IBV- virus.
When the chickens are exposed to this attenuated virus, this small exposure helps the chickens’ immune systems to recognise and attack the IBV virus.
Hvis kyllingerne eksponeres for IBV senere i livet, vil de enten ikke blive inficeret eller vil få en langt mindre alvorlig infektion.
When exposed to IBV later in life, the chickens will either not become infected or have a much less serious infection.
Hvordan blev virkningen af Nobilis IB 4- 91 undersøgt?
How has the effectiveness of Nobilis IB 4-91 been studied?
Vaccinen blev givet via grov spray til kyllinger med forskellig alder.
The Nobilis IB 4-91 vaccine has been studied in various vaccination schedules in a number of trials The vaccine was given by coarse spray to chicken of various ages.
De primære effektmål omfattede dannelse af antistoffer mod IB 4- 91- virus, den samlede dødelighed hos kyllingerne og den procentvise andel af kyllinger, som blev kasseret på grund af sygdom.
The main measures of effectiveness included the development of antibodies to the IB 4-91 virus, the overall death rate of the chickens and the percentage of chicken rejected because of disease..
Nobilis IB 4- 91- vaccine er også blevet sammenlignet med kontrolkyllinger, dvs. kyllinger, som ikke var blevet vaccineret.
Nobilis IB 4-91 vaccine has also been compared with controls, i. e. chickens that were not vaccinated.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 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 Hvilken fordel viser undersøgelserne, at der er ved Nobilis IB 4- 91?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 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 What benefit has Nobilis IB 4-91 shown during the studies?
Der sås et tydeligt immunrespons mod Nobilis IB 4- 91.
There was a clear immune response to Nobilis IB 4-91.
I den ene undersøgelse havde 100% af kyllingerne efter tre uger dannet antistoffer mod IB 4- 91- virus sammenlignet med 17% af kontrolkyllingerne.
In one trial, after three weeks 100% of chickens had developed antibodies to the IB 4-91 virus compared with 17% for the controls.
Hvilke bivirkninger har Nobilis IB 4- 91?
What are the side effects of Nobilis IB 4-91?
Nobilis IB 4- 91 kan forårsage milde respiratoriske symptomer på sygdom, som kan vare i nogle få dage, afhængigt af den enkelte kyllings helbred og tilstand.
Nobilis IB 4-91 can cause mild respiratory signs of disease which may last for a few days depending on the health and condition of the chickens.
Der skal ikke træffes nogen foranstaltninger af den pågældende person, men det anbefales at vaske og desinficere sine hænder og udstyret efter vaccinationen for at undgå spredning af virusset.
There are no precautions for the person, but it is recommended that they wash and disinfect hands and equipment after vaccinating to avoid spread of the virus.
Hvorfor blev Nobilis IB 4- 91 godkendt?
Why has Nobilis IB 4-91 been approved?
Udvalget for Veterinærlægemidler (CVMP) konkluderede, at Nobilis IB 4- 91’ s gavnlige virkninger er større end de mulige risici ved immunisering af kyllinger for at reducere de respiratoriske symptomer på infektiøs bronkitis, som forårsages af stammevarianten IB 4- 91.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Nobilis IB 4-91 are greater than any risks to immunise chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Nobilis IB 4- 91.
They recommended that Nobilis IB 4-91 should be given a marketing authorisation.
Øvrige oplysninger om Nobilis IB 4- 91:
Other information about Nobilis IB 4-91:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobilis IB 4- 91 til Intervet International BV den 9. juni 1998.
The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis IB 4-91 to Intervet International B. V. on 9 June 1998.
Lægemiddelform Dyrearter, som lægemidlet er beregnet til:
Pharmaceutical form
Pakningss tørrelse
Package size
Tilbage - holdelsestid
Withdrwal period
Levende attenueret aviær Infektiøs Bronkitis Virus (IBV) stammevariant 4 - 91: ≥ 3, 6 log10 EID50 *
Live attenuated avian Infectious Bronchitis Virus (IBV) variant strain 4-91: ≥ 3.6 log10 EID50 *
En frysetørret Kyllinger vaccinesubstans til rekonstituering
A lyophilised vaccine pellet for reconstitution
sprayvaccination, drikkevand eller intranasal/ okulær administration.
For intranasal/ ocular, spray or drinking water administration
hætteglas af hydrolytisk klasse Type II glas
vial of Type II hydrolytic glass
EU/ 2/ 98/ 006/ 003 Nobilis IB4- 91
EU/ 2/ 98/ 006/ 003 Nobilis IB 4-91
En frysetørret vaccinesubstans til rekonstituering
A lyophilised vaccine pellet for reconstitution
10 x 1000 doser
10 x 1000 doses
/ 2/ 98/ 006/ 006
EU/ 2/ 98/ 006/ 006 Nobilis IB 4-91
10 x 2500 doser
10 x 2500 doses
EU/ 2/ 98/ 006/ 007
EU/ 2/ 98/ 006/ 007 Nobilis IB 4-91
10 ml hætteglas af hydrolytisk klasse Type II glas
vial of Type II hydrolytic glass
10 x 5000 Doser
10 x 5000 doses
EU/ 2/ 98/ 006/ 008
EU/ 2/ 98/ 006/ 008 Nobilis IB 4-91
10 x 10000 Doser
10 x 10000 doses
EU/ 2/ 98/ 006/ 009 Nobilis IB4- 91
EU/ 2/ 98/ 006/ 009 Nobilis IB 4-91
500 10 ml Doser
500 doses 10 ml vial
EU/ 2/ 98/ 006/ 010 Nobilis IB4- 91
EU/ 2/ 98/ 006/ 010 Nobilis IB 4-91
Levende attenueret En frysetørret aviær Infektiøs vaccinesubstans til Bronkitis Virus rekonstituering (IBV) stammevariant 4 - 91: ≥ 3, 6 log10 EID50 *
Live attenuated avian Infectious Bronchitis Virus (IBV) variant strain 4-91: ≥ 3.6 log10 EID50 *
Kyllinger
A lyophilised vaccine pellet for reconstitution
10 x 500 10 ml Doser
10 x 500 10 ml vial doses
* EID50 = 50% embryo infective dose: den virustiterværdi, som er nødvendig for at forårsage infektion i 50% af de inokulerede embryoer.
* EID50 = 50% Embryo infective dose: the virus titre required to produce infection in 50% of the embryos inoculated.
Nobilis IB 4- 91, lyofilisat, suspension
Nobilis IB 4-91, lyophilisate for suspension
Hvert hætteglas indeholder pr. dosis:
Each vial contains per dose:
Levende attenueret aviær Infektiøs Bronchitis Virus (IBV) stammevariant 4- 91: ≥ 3, 6 log10 EID50 *
Live attenuated avian Infectious Bronchitis Virus (IBV) variant strain 4-91: ≥ 3.6 log10 EID50 *
Se en fuldstændig fortegnelse over hjælpestoffer i afsnit 6. 1.
For a full list of excipients, see section 6.1
Lyofilisat, suspension.
Lyophilisate for suspension.
Aktiv immunisering af kyllinger for at reducere de respiratoriske symptomer på infektiøs Bronkitis, som forårsages af stammevarianten IB 4- 91.
Active immunisation of chickens to reduce the respiratory signs of Infectious Bronchitis caused by the variant strain IB 4-91.
Kommende æglæggere og avlsfugle bør ikke vaccineres før 3- ugers alderen.
Future layers and breeders should not be vaccinated before 3 weeks of age.
Vaccination af daggamle kyllinger med Nobilis IB 4- 91 kan have negativ indflydelse på effekten af vaccination mod Turkey Rhinotracheitis (TRT), der er givet inden for 7 dage, hvorfor dette vaccinationsprogram er kontraindiceret.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of Turkey Rhinotracheitis (TRT) vaccine given within 7 days; therefore this vaccination scheme is contraindicated.
Vaccinevirus kan evt. spredes fra vaccinerede til ikke- vaccinerede kyllinger, og der skal drages fornøden omsorg for at skille vaccinerede fra ikke- vaccinerede.
The vaccine virus may spread from vaccinated to non-vaccinated chickens and appropriate care should be taken to separate vaccinated from non-vaccinated.
Nobilis IB 4- 91 er udelukkende beregnet til beskyttelse af kyllinger mod respiratoriske symptomer på sygdom der er forårsaget af IBV- stammevariant 4- 91, og bør ikke anvendes som erstatning for andre
Nobilis IB 4-91 is intended to protect chickens against respiratory signs of disease caused by IBV variant strain 4-91 only and should not be used as a replacement for other IBV vaccines.
2/ 17 IBV vacciner.
2/ 17 relevant in the area.
Der skal udøves forsigtighed, således at introduktion af stammevarianten i et område, hvor den ikke er til stede undgås.
Care should be taken to avoid the introduction of the variant strain into an area where it is not present.
Vaccination med Nobilis IB 4- 91 kan inducere milde, respiratoriske symptomer på sygdom, som kan vare i et par dage, afhængigt af kyllingernes helbred og tilstand.
Vaccination with Nobilis IB 4-91 may induce mild respiratory signs of disease which may persist for a few days depending on the health and condition of the chickens.
Det er vist, at Nobilis IB 4- 91 er sikker at anvende til æglæggere og avlsfugle i æglægningsperioden.
Nobilis IB4-91 has been shown to be safe in layers and breeders during lay.
Vaccination af daggamle kyllinger med Nobilis IB 4- 91 kan have negativ indflydelse på effekten af vaccination mod Turkey Rhinotracheitis (TRT), der er giver inden for 7 dage.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of Turkey Rhinotracheitis (TRT) vaccine given within 7 days.
Mindst 3, 6 log10 EID50 (1 dosis) pr. dyr enten ved sprayvaccination, drikkevand eller intranasal/ okulær administration.
At least 3.6 log10 EID50 (1 dose) per animal by either spray vaccination, drinking water or intranasal/ ocular administration.
Retningslinjer:
Guideline:
Kyllinger:
Broiler:
Denne vaccine kan bruges til daggamle og ældre kyllinger via spray eller intranasal/ intraokulær administration.
The vaccine can be administered to 1-day-old chicks and older chickens by coarse spray or by intranasal/ ocular administration.
Kommende æglæggere og avlsfugle:
Future layers and breeders: