Vaxxitek HVT+IBD

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
07-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
07-01-2022
Public Assessment Report Public Assessment Report (PAR)
17-02-2021

Active ingredient:

Rekombinant tyrkiet herpesvirus, stamme vhvt013-69, live

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI01AD15

INN (International Name):

Infectious bursal disease and Marek's disease vaccine (live recombinant)

Therapeutic group:

Embryonated eggs; Chicken

Therapeutic area:

Immunologicals for aves, tamhøns, Immunologicals

Therapeutic indications:

Til aktiv immunisering af kyllinger:for At forhindre dødelighed og til at reducere kliniske tegn og læsioner af Infectious Bursal disease. For at reducere dødeligheden, kliniske tegn og læsioner af Marek ' s disease.

Product summary:

Revision: 17

Authorization status:

autoriseret

Authorization date:

2002-08-09

Patient Information leaflet

                                13
B. INDLÆGSSEDDEL
14
INDLÆGSSEDDEL
VAXXITEK HVT+IBD SUSPENSION OG SOLVENS TIL INJEKTIONSVÆSKE,
SUSPENSION
1.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER
ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
Indehaver af markedsføringstilladelsen
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Tyskland
Fremstiller ansvarlig for batchfrigivelse
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’Aviation
69800 Saint-Priest
Frankrig
2.
VETERINÆRLÆGEMIDLETS NAVN
Vaxxitek HVT+IBD suspension og solvens til injektionsvæske,
suspension
3.
ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER
En vaccinedosis indeholder:
Aktivt stof:
Levende vHVT013-69 rekombinant virus, min.
..................................................... 3,6 – 4,4
log10 PFU*
Hjælpestoffer
............................................................................................................................
q.s. 1 dosis
Solvens:
Solvens
.....................................................................................................................................
q.s. 1 dosis
*Plaque forming unit
4.
INDIKATIONER
Til aktiv immunisering af kyllinger:
•
For at forebygge dødelighed samt reducere kliniske symptomer og
læsioner forårsaget af
infektiøs bursal sygdom.
Beskyttelse indtræder efter 2 uger og varer op til 9 uger.
•
For at nedsætte dødelighed, kliniske symptomer og læsioner
forårsaget af Marek’s sygdom.
Beskyttelse indtræder efter 4 dage. En enkelt vaccination er
tilstrækkelig til at yde beskyttelse i
hele risikoperioden.
5.
KONTRAINDIKATIONER
Bør ikke anvendes til avlsfugle og æglæggende fugle.
1
1
1
1
1
15
6.
BIVIRKNINGER
Ingen kendte.
Hvis De bemærker alvorlige bivirkninger eller andre bivirkninger, som
ikke er omtalt i denne
indlægsseddel, bedes De kontakte Deres dyrlæge.
7.
DYREARTER
Daggamle kyllinger og 18-dages embryonerede æg.
8.
DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG
                                
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Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUME
2
1.
VETERINÆRLÆGEMIDLETS NAVN
Vaxxitek HVT+IBD suspension og solvens til injektion (suspension)
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
En vaccinedosis indeholder:
Aktivt stof:
Levende vHVT013-69 rekombinant virus, min.
..................................................... 3,6 – 4,4
log10 PFU*
Hjælpestoffer:
...........................................................................................................................
q.s. 1 dosis
Solvens:
Solvens
.....................................................................................................................................
q.s. 1 dosis
* Plaque forming unit
Alle hjælpestoffer er anført under pkt. 6.1
3.
LÆGEMIDDELFORM
Suspension og solvens til injektionsvæske, suspension
4.
KLINISKE OPLYSNINGER
4.1
DYREARTER, SOM LÆGEMIDLET ER BEREGNET TIL
Daggamle kyllinger og 18-dages embryonerede æg.
4.2
TERAPEUTISKE INDIKATIONER MED ANGIVELSE AF DYREARTER, SOM LÆGEMIDLET
ER BEREGNET TIL
Til aktiv immunisering af kyllinger:
•
For at forebygge dødelighed samt reducere kliniske symptomer og
læsioner forårsaget af
infektiøs bursal sygdom.
Beskyttelse indtræder efter 2 uger og varer op til 9 uger.
•
For at nedsætte dødelighed, kliniske symptomer og læsioner
forårsaget af Marek’s sygdom.
Beskyttelse indtræder efter 4 dage. En enkelt vaccination er
tilstrækkelig til at yde beskyttelse i
hele risikoperioden.
4.3
KONTRAINDIKATIONER
Må ikke anvendes til æglæggende fugle eller avlsfugle.
4.4
SÆRLIGE ADVARSLER FOR HVER ENKELT DYREART, SOM LÆGEMIDLET ER
BEREGNET TIL
Vacciner kun raske fugle.
4.5
SÆRLIGE FORSIGTIGHEDSREGLER VEDRØRENDE BRUGEN
Særlige forsigtighedsregler vedrørende brug til dyr
Anvend sædvanlige aseptiske forholdsregler ved alle
administrationsprocedurer.
Da det er en levende vaccine, udskilles vaccinestammen fra
vaccinerede fugle og kan spredes til
kalkuner. Undersøgelser for sikkerhed og reversion til virulens har
vist, at stammen er sikker for
3
kalkuner. Imidlertid bør der tages forho
                                
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Similar products

Active ingredient Rekombinant tyrkiet herpesvirus, stamme vhvt013-69, live

Rekombinant tyrkiet herpesvirus, stamme vhvt013-69, live

ATC code QI01AD15

QI01AD15

Marketed by Boehringer Ingelheim Vetmedica GmbH

Boehringer Ingelheim Vetmedica GmbH

INN (International Name) Infectious bursal disease and Marek's disease vaccine (live recombinant)

Infectious bursal disease and Marek's disease vaccine (live recombinant)

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 07-01-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 07-01-2022
Public Assessment Report Public Assessment Report Bulgarian 17-02-2021
Patient Information leaflet Patient Information leaflet Spanish 07-01-2022
Summary of Product characteristics Summary of Product characteristics Spanish 07-01-2022
Public Assessment Report Public Assessment Report Spanish 17-02-2021
Patient Information leaflet Patient Information leaflet Czech 07-01-2022
Summary of Product characteristics Summary of Product characteristics Czech 07-01-2022
Public Assessment Report Public Assessment Report Czech 17-02-2021
Patient Information leaflet Patient Information leaflet German 07-01-2022
Summary of Product characteristics Summary of Product characteristics German 07-01-2022
Public Assessment Report Public Assessment Report German 17-02-2021
Patient Information leaflet Patient Information leaflet Estonian 07-01-2022
Summary of Product characteristics Summary of Product characteristics Estonian 07-01-2022
Public Assessment Report Public Assessment Report Estonian 17-02-2021
Patient Information leaflet Patient Information leaflet Greek 07-01-2022
Summary of Product characteristics Summary of Product characteristics Greek 07-01-2022
Public Assessment Report Public Assessment Report Greek 17-02-2021
Patient Information leaflet Patient Information leaflet English 07-01-2022
Summary of Product characteristics Summary of Product characteristics English 07-01-2022
Public Assessment Report Public Assessment Report English 17-02-2021
Patient Information leaflet Patient Information leaflet French 07-01-2022
Summary of Product characteristics Summary of Product characteristics French 07-01-2022
Public Assessment Report Public Assessment Report French 17-02-2021
Patient Information leaflet Patient Information leaflet Italian 07-01-2022
Summary of Product characteristics Summary of Product characteristics Italian 07-01-2022
Public Assessment Report Public Assessment Report Italian 17-02-2021
Patient Information leaflet Patient Information leaflet Latvian 07-01-2022
Summary of Product characteristics Summary of Product characteristics Latvian 07-01-2022
Public Assessment Report Public Assessment Report Latvian 17-02-2021
Patient Information leaflet Patient Information leaflet Lithuanian 07-01-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 07-01-2022
Public Assessment Report Public Assessment Report Lithuanian 17-02-2021
Patient Information leaflet Patient Information leaflet Hungarian 07-01-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 07-01-2022
Public Assessment Report Public Assessment Report Hungarian 17-02-2021
Patient Information leaflet Patient Information leaflet Maltese 07-01-2022
Summary of Product characteristics Summary of Product characteristics Maltese 07-01-2022
Public Assessment Report Public Assessment Report Maltese 17-02-2021
Patient Information leaflet Patient Information leaflet Dutch 07-01-2022
Summary of Product characteristics Summary of Product characteristics Dutch 07-01-2022
Public Assessment Report Public Assessment Report Dutch 17-02-2021
Patient Information leaflet Patient Information leaflet Polish 07-01-2022
Summary of Product characteristics Summary of Product characteristics Polish 07-01-2022
Public Assessment Report Public Assessment Report Polish 17-02-2021
Patient Information leaflet Patient Information leaflet Portuguese 07-01-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 07-01-2022
Public Assessment Report Public Assessment Report Portuguese 17-02-2021
Patient Information leaflet Patient Information leaflet Romanian 07-01-2022
Summary of Product characteristics Summary of Product characteristics Romanian 07-01-2022
Public Assessment Report Public Assessment Report Romanian 17-02-2021
Patient Information leaflet Patient Information leaflet Slovak 07-01-2022
Summary of Product characteristics Summary of Product characteristics Slovak 07-01-2022
Public Assessment Report Public Assessment Report Slovak 17-02-2021
Patient Information leaflet Patient Information leaflet Slovenian 07-01-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 07-01-2022
Public Assessment Report Public Assessment Report Slovenian 17-02-2021
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Summary of Product characteristics Summary of Product characteristics Finnish 07-01-2022
Public Assessment Report Public Assessment Report Finnish 17-02-2021
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Summary of Product characteristics Summary of Product characteristics Swedish 07-01-2022
Public Assessment Report Public Assessment Report Swedish 02-08-2007
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Patient Information leaflet Patient Information leaflet Croatian 07-01-2022
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