Vectormune FP ILT

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
01-01-1970
Summary of Product characteristics Summary of Product characteristics (SPC)
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:

Kjúklingur

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:

Leyfilegt

Authorization date:

2020-12-09

Patient Information leaflet

                                19
B. FYLGISEÐILL
20
FYLGISEÐILL:
VECTORMUNE FP ILT
FROSTÞURRKAÐ STUNGULYF OG LEYSIR, DREIFA, FYRIR HÆNSNI
1.
HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA OG ÞESS FRAMLEIÐANDA
SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
Markaðsleyfishafi og framleiðandi sem ber ábyrgð á lokasamþykkt:
Ceva-Phylaxia Co. Ltd.
1107 Budapest, Szállás u. 5.
Ungverjaland
2.
HEITI DÝRALYFS
Vectormune FP ILT frostþurrkað stungulyf og leysir, dreifa, fyrir
hænsni.
3.
VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI
Hver skammtur (0,01 ml) inniheldur:
VIRK INNIHALDSEFNI:
Lifandi, erfðabreytt fuglabólusóttarveira sem tjáir
himnusamrunaprótein (membrane fusion protein) og
hjúpprótein (encapsidation protein) smitandi kverka- og
barkabólguveiru fugla (rFP-LT)
2,7 til 4,5 log10 TCID
50
*
* Sá skammtur sem þarf til að sýkja 50% af frumum í vefjaræktun
(
50% Tissue Culture Infective Dose)
Frostþurrkaður stofn: bleikur eða drapplitur.
Leysir: tær, blár vökvi.
4.
ÁBENDING(AR)
Til virkrar ónæmingar hjá kjúklingum frá 8 vikna aldri til að
draga úr klínískum einkennum
(húðskemmdum) af völdum fuglabólusóttar (fowlpox), til að draga
úr klínískum einkennum og
skemmdum í barka af völdum smitandi kverka- og barkabólgu (avian
infectious laryngotracheitis).
Ónæmi myndast:
Fuglabólusótt og smitandi kverka- og barkabólga: 3 vikum eftir
bólusetningu.
Ónæmi endist í:
Fuglabólusótt: 34 vikur eftir bólusetningu.
Smitandi kverka- og barkabólga: 57 vikur eftir bólusetningu.
5.
FRÁBENDINGAR
Engar.
21
6.
AUKAVERKANIR
Mjög algengt er að fram komi litlir bólguhnúðar/hnútar, sem eru
dæmigerðir fyrir bóluefni gegn
fuglabólusótt, og ættu þeir að hverfa innan 14 daga eftir
bólusetningu.
Tíðni aukaverkana er skilgreind samkvæmt eftirfarandi:
- Mjög algengar (aukaverkanir koma fyrir hjá fleiri en 1 af hverjum
10 dýrum sem fá meðferð)
- Algengar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 100
dýrum sem fá meðferð)
- Sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 1
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI DÝRALYFS
Vectormune FP ILT frostþurrkað stungulyf og leysir, dreifa, fyrir
hænsni.
2.
INNIHALDSLÝSING
Hver skammtur (0,01 ml) inniheldur:
VIRK INNIHALDSEFNI:
Lifandi, erfðabreytt fuglabólusóttarveira sem tjáir
himnusamrunaprótein (membrane fusion protein) og
hjúpprótein (encapsidation protein) smitandi kverka- og
barkabólguveiru fugla (rFP-LT)
2,7 til 4,5 log10 TCID
50
*
* Sá skammtur sem þarf til að sýkja 50% af frumum í vefjaræktun
(
50% Tissue Culture Infective Dose)
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Frostþurrkað stungulyf og leysir, dreifa.
Frostþurrkaður stofn: Bleikur eða drapplitur.
Leysir: tær, blár vökvi.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
DÝRATEGUNDIR
Hænsni
4.2
ÁBENDINGAR FYRIR TILGREINDAR DÝRATEGUNDIR
Til virkrar ónæmingar hjá kjúklingum frá 8 vikna aldri til að
draga úr húðskemmdum af völdum
fuglabólusóttar (fowlpox), til að draga úr klínískum einkennum
og skemmdum í barka af völdum
smitandi kverka- og barkabólgu (avian infectious laryngotracheitis).
Ónæmi myndast gegn:
Fuglabólusótt og smitandi kverka- og barkabólga: 3 vikum eftir
bólusetningu.
Ónæmi endist gegn:
Fuglabólusótt: 34 vikur eftir bólusetningu.
Smitandi kverka- og barkabólga: 57 vikur eftir bólusetningu.
4.3
FRÁBENDINGAR
Engar.
4.4
SÉRSTÖK VARNAÐARORÐ FYRIR HVERJA DÝRATEGUND
Einungis skal bólusetja heilbrigð dýr.
4.5
SÉRSTAKAR VARÚÐARREGLUR VIÐ NOTKUN
Sérstakar varúðarreglur við notkun hjá dýrum
3
Á ekki við.
Sérstakar varúðarreglur fyrir þann sem gefur dýrinu lyfið
Ef sá sem annast lyfjagjöf sprautar sig með dýralyfinu fyrir
slysni skal tafarlaust leita til læknis og
hafa meðferðis fylgiseðil eða umbúðir dýralyfsins.
4.6
AUKAVERKANIR (TÍÐNI OG ALVARLEIKI)
Mjög algengt er að fram komi litlir bólguhnúðar/hnútar, sem eru
dæmigerðir fyrir bóluefni gegn
fuglabólusótt, og ættu þeir að hverfa innan 14 daga eftir
bólusetningu.
Tíðni aukaverkana er s
                                
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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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Summary of Product characteristics Summary of Product characteristics Bulgarian 01-01-1970
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
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