Vectormune FP ILT

Country: European Union

Language: Italian

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
01-01-1970
Download Summary of Product characteristics (SPC)
01-01-1970
Download Public Assessment Report (PAR)
01-01-1970

Active ingredient:

recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus, live

Available from:

CEVA-Phylaxia Co. Ltd.

INN (International Name):

Fowlpox and avian infectious laryngotracheitis vaccine (live, recombinant)

Therapeutic group:

pollo

Therapeutic indications:

For active immunisation of chickens from 8 weeks of age in order to reduce the skin lesions due to fowlpox and to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis.

Authorization status:

autorizzato

Authorization date:

2020-12-09

Patient Information leaflet

                                19
B.
FOGLIETTO ILLUSTRATIVO
20
FOGLIETTO ILLUSTRATIVO:
VECTORMUNE FP ILT
LIOFILIZZATO E SOLVENTE PER SOSPENSIONE INIETTABILE PER POLLI
1.
NOME E INDIRIZZO DEL TITOLARE DELL’AUTORIZZAZIONE ALL’IMMISSIONE
IN
COMMERCIO E DEL TITOLARE DELL’AUTORIZZAZIONE ALLA PRODUZIONE
RESPONSABILE DEL RILASCIO DEI LOTTI DI FABBRICAZIONE, SE DIVERSI
Titolare dell’autorizzazione all’immissione in commercio e
produttore responsabile del rilascio dei lotti di
fabbricazione:
Ceva-Phylaxia Co. Ltd.
1107 Budapest
Szállás u. 5.
Ungheria
2.
DENOMINAZIONE DEL MEDICINALE VETERINARIO
Vectormune FP ILT liofilizzato e solvente per sospensione iniettabile
per polli
3.
INDICAZIONE DEL(I) PRINCIPIO(I) ATTIVO(I) E DEGLI ALTRI INGREDIENTI
Ogni dose (0,01 ml) contiene:
PRINCIPI ATTIVI:
Virus vivo ricombinante del vaiolo aviare che esprime la proteina di
fusione delle membrane e la proteina
dell’incapsidazione del virus della laringotracheite infettiva
aviare (rFP-LT) da 2,7 a 4,5 log10
DITC50*
* 50% Dose Infettante Coltura Tissutale
Liofilizzato: rosa o beige.
Solvente: liquido blu, limpido.
4.
INDICAZIONE(I)
Per l’immunizzazione attiva di polli da 8 settimane di età per
ridurre i sintomi clinici (lesioni della cute)
dovuti al vaiolo aviare, per ridurre i sintomi clinici e le lesioni
tracheali causati dalla laringotracheite
infettiva aviare.
Inizio dell’immunità
Vaiolo aviare e laringotracheite infettiva aviare: 3 settimane dopo la
vaccinazione
Durata dell’immunità:
Vaiolo aviare: 34 settimane dopo la vaccinazione.
Laringotracheite infettiva aviare: 57 settimane dopo la vaccinazione.
5.
CONTROINDICAZIONI
Nessuna.
21
6.
REAZIONI AVVERSE
Lieve gonfiore/croste tipicamente dovuti ad assunzione del vaccino del
vaiolo sono molto comuni e
dovrebbero scomparire entro 14 giorni dopo la vaccinazione.
La frequenza delle reazioni avverse è definita usando le seguenti
convenzioni:
- molto comuni (più di 1 su 10 animali trattati manifesta reazioni
avverse)
- comuni (più di 1 ma meno di 10 animali su 100 animali trattati)
- non comuni (pi
                                
                                Read the complete document

Summary of Product characteristics

                                1
ALLEGATO I
RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO
2
1.
DENOMINAZIONE DEL MEDICINALE VETERINARIO
Vectormune FP ILT liofilizzato e solvente per sospensione iniettabile
per polli
2.
COMPOSIZIONE QUALITATIVA E QUANTITATIVA
Ogni dose (0,01 ml) contiene:
PRINCIPI ATTIVI:
Virus vivo ricombinante del vaiolo aviare che esprime la proteina di
fusione delle membrane e la proteina
d’incapsidazione del virus della laringotracheite aviare infettiva
(rFP-LT) da 2,7 a 4,5 log10 DITC50*
* 50% Dose Infettante Coltura Tissutale
Per l’elenco completo degli eccipienti, vedere paragrafo 6.1.
3.
FORMA FARMACEUTICA
Liofilizzato e solvente per sospensione iniettabile.
Liofilizzato: rosa o beige.
Solvente: liquido blu, limpido.
4.
INFORMAZIONI CLINICHE
4.1
SPECIE DI DESTINAZIONE
Polli
4.2
INDICAZIONI PER L’UTILIZZAZIONE, SPECIFICANDO LE SPECIE DI
DESTINAZIONE
Per l’immunizzazione attiva di polli da 8 settimane di età per
ridurre le lesioni cutanee dovute al vaiolo
aviare e per ridurre i sintomi clinici e le lesioni tracheali causati
dalla laringotracheite infettiva aviare.
Inizio dell’immunità
Vaiolo aviare e laringotracheite infettiva aviare: 3 settimane dopo la
vaccinazione
Durata dell’immunità:
Vaiolo aviare: 34 settimane dopo la vaccinazione.
Laringotracheite infettiva aviare: 57 settimane dopo la vaccinazione.
4.3
CONTROINDICAZIONI
Nessuna.
4.4
AVVERTENZE SPECIALI PER CIASCUNA SPECIE DI DESTINAZIONE
Vaccinare solo animali sani.
4.5
PRECAUZIONI SPECIALI PER L’IMPIEGO
Precauzioni speciali per l’impiego negli animali
3
Nessuna.
Precauzioni speciali che devono essere adottate dalla persona che
somministra il medicinale veterinario agli
animali
In caso di auto-iniezione accidentale, rivolgersi immediatamente ad un
medico mostrandogli il foglietto
illustrativo o l’etichetta.
4.6
REAZIONI AVVERSE (FREQUENZA E GRAVITÀ)
Lieve gonfiore/croste tipicamente dovuti ad assunzione del vaccino del
vaiolo sono molto comuni e
dovrebbero scomparire entro 14 giorni dopo la vaccinazione.
La frequenza delle reazioni avverse è
                                
                                Read the complete document

Similar products

Active ingredient recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus, live

recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus, live

Marketed by CEVA-Phylaxia Co. Ltd.

CEVA-Phylaxia Co. Ltd.

INN (International Name) Fowlpox and avian infectious laryngotracheitis vaccine (live, recombinant)

Fowlpox and avian infectious laryngotracheitis vaccine (live, recombinant)

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Patient Information leaflet Patient Information leaflet Bulgarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Bulgarian 01-01-1970
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
Patient Information leaflet Patient Information leaflet Spanish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Spanish 01-01-1970
Public Assessment Report Public Assessment Report Spanish 01-01-1970
Patient Information leaflet Patient Information leaflet Czech 01-01-1970
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Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
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Public Assessment Report Public Assessment Report Danish 01-01-1970
Patient Information leaflet Patient Information leaflet German 01-01-1970
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Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 01-01-1970
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Public Assessment Report Public Assessment Report Estonian 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
Summary of Product characteristics Summary of Product characteristics Greek 01-01-1970
Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 01-01-1970
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Public Assessment Report Public Assessment Report English 01-01-1970
Patient Information leaflet Patient Information leaflet French 01-01-1970
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Patient Information leaflet Patient Information leaflet Maltese 01-01-1970
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Patient Information leaflet Patient Information leaflet Romanian 01-01-1970
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Public Assessment Report Public Assessment Report Romanian 01-01-1970
Patient Information leaflet Patient Information leaflet Slovak 01-01-1970
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Public Assessment Report Public Assessment Report Slovak 01-01-1970
Patient Information leaflet Patient Information leaflet Slovenian 01-01-1970
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Patient Information leaflet Patient Information leaflet Finnish 01-01-1970
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Public Assessment Report Public Assessment Report Finnish 01-01-1970
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Patient Information leaflet Patient Information leaflet Croatian 01-01-1970
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Public Assessment Report Public Assessment Report Croatian 01-01-1970

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