Ultifend ND IBD

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

Buy It Now

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

Active ingredient:

Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant

Available from:

Ceva-Phylaxia Veterinary Biologicals Co. Ltd

ATC code:

QI01AD16

INN (International Name):

Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

Therapeutic group:

Embryonated chicken eggs; Chicken

Therapeutic area:

Immunoloogilised ained

Therapeutic indications:

For the active immunisation of one-day-old chicks or 18-day-old chicken embryonated eggs to reduce mortality, clinical signs and lesions caused by Newcastle disease virus (NDV) and to reduce virus shedding; to reduce mortality, clinical signs and bursa lesions caused by very virulent infectious bursal disease virus (IBDV); to reduce mortality, clinical signs and lesions caused by classical Marek’s disease virus (MDV).

Authorization status:

Volitatud

Authorization date:

2021-04-20

Patient Information leaflet

                                14
B. PAKENDI INFOLEHT
15
PAKENDI INFOLEHT
ULTIFEND ND IBD, SÜSTESUSPENSIOONI KONTSENTRAAT JA LAHUSTI KANADELE
1.
MÜÜGILOA HOIDJA NING, KUI NEED EI KATTU, RAVIMIPARTII VABASTAMISE
EEST VASTUTAVA TOOTMISLOA HOIDJA NIMI JA AADRESS
Müügiloa hoidja ja partii vabastamise eest vastutav tootja:
Ceva-Phylaxia Co. Ltd.
Szállás u. 5
1107 Budapest
Ungari
2.
VETERINAARRAVIMI NIMETUS
Ultifend ND IBD, süstesuspensiooni kontsentraat ja lahusti kanadele
3.
TOIMEAINETE JA ABIAINETE SISALDUS
Üks annus (0,05 ml või 0,2 ml) sisaldab:
TOIMEAINED:
rakuga seonduv elus rekombinantne kalkuni herpesviirus (rHVT/ND/IBD),
mis ekspresseerib
Newcastle'i viiruse fusioonivalke ja lindude nakkava bursiidi viiruse
VP2 valke:
min 4000, max 12
000 PFU
*
*
Naaste moodustav ühik
Kontsentraat: kollakaspruun homogeenne kontsentraat.
Lahusti: selge oranž kuni punane lahus.
4.
NÄIDUSTUS(ED)
Ühe päeva vanuste tibude või 18 päeva vanuste embrüonaalses
staadiumis kanamunade aktiivseks
immuniseerimiseks:
•
et vähendada suremust, kliinilisi nähte ja kahjustusi, mille
põhjuseks on nakatumine Newcastle'i
viirusega (NDV), ning vähendada viiruse eritamist;
•
et
vähendada
suremust,
kliinilisi
nähte
ja
kloaagipauna
kahjustusi,
mille
põhjuseks
on
nakatumine väga virulentse lindude nakkava bursiidi viirusega (IBDV);
•
et vähendada suremust, kliinilisi nähte ja kahjustusi, mille
põhjuseks on nakatumine klassikalise
Mareki haiguse viirusega (MDV).
Immuunsuse teke:
Broileritel
NDV: 4 nädalat
IBDV: 3 nädalat
MDV: 9 päeva
Munakanadel
NDV: 4 nädalat
IBDV: 4 nädalat
MDV: 9 päeva
Immuunsuse kestus:
Broileritel
NDV: 9 nädalat
16
IBDV: 9 nädalat
MDV: eluaegne
Munakanadel
NDV: 18 nädalat
IBDV: 9 nädalat
MDV: eluaegne
5.
VASTUNÄIDUSTUSED
Ei ole.
6.
KÕRVALTOIMED
Ei ole teada.
Kui täheldate ükskõik milliseid kõrvaltoimeid, isegi neid, mida
pole käesolevas pakendi infolehes
mainitud, või arvate, et veterinaarravim ei toimi, teavitage palun
sellest oma veterinaararsti.
7.
LOOMALIIGID
Kanad ja embrüonaalses staadiumis kanamunad.
8
                                
                                Read the complete document

Summary of Product characteristics

                                1
LISA I
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
VETERINAARRAVIMI NIMETUS
Ultifend ND IBD, süstesuspensiooni kontsentraat ja lahusti kanadele
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Üks annus (0,05 ml või 0,2 ml) sisaldab:
TOIMEAINE:
Rakuga seonduv elus rekombinantne kalkuni herpesviirus (rHVT/ND/IBD),
mis ekspresseerib
Newcastle'i viiruse fusioonivalke ja lindude nakkava bursiidi viiruse
VP2 valke:
min 4000, max 12 000 PFU
*
*
Naaste moodustav ühik
Abiainete täielik loetelu on esitatud lõigus 6.1.
3.
RAVIMVORM
Süstesuspensiooni kontsentraat ja lahusti.
Kontsentraat: kollakaspruun homogeenne kontsentraat.
Lahusti: selge oranž kuni punane lahus.
4.
KLIINILISED ANDMED
4.1
LOOMALIIGID
Kana ja embrüonaalses staadiumis kanamuna.
4.2
NÄIDUSTUSED, MÄÄRATES KINDLAKS VASTAVAD LOOMALIIGID
Ühe päeva vanuste tibude või 18 päeva vanuste embrüonaalses
staadiumis kanamunade aktiivseks
immuniseerimiseks:
•
et vähendada suremust, kliinilisi nähte ja kahjustusi, mille
põhjuseks on nakatumine Newcastle'i
viirusega (NDV), ning vähendada viiruse eritamist;
•
et
vähendada
suremust,
kliinilisi
nähte
ja
kloaagipauna
kahjustusi,
mille
põhjuseks
on
nakatumine väga virulentse lindude nakkava bursiidi viirusega (IBDV);
•
et vähendada suremust, kliinilisi nähte ja kahjustusi, mille
põhjuseks on nakatumine klassikalise
Mareki haiguse viirusega (MDV).
Immuunsuse teke:
Broileritel
NDV: 4 nädalat
IBDV: 3 nädalat
MDV: 9 päeva
Munakanadel
NDV: 4 nädalat
IBDV: 4 nädalat
MDV: 9 päeva
Immuunsuse kestus:
3
Broileritel
NDV: 9 nädalat
IBDV: 9 nädalat
MDV: eluaegne
Munakanadel
NDV: 18 nädalat
IBDV: 9 nädalat
MDV: eluaegne
4.3
VASTUNÄIDUSTUSED
Ei ole.
4.4
ERIHOIATUSED IGA LOOMALIIGI KOHTA
Vaktsineerida ainult terveid loomi.
Väga suure IBDV või MDV vastaste maternaalsete antikehade hulgaga
kanadel võib selle
veterinaarravimiga vaktsineerimisel võtta immuunsuse teke umbes
nädal aega kauem.
4.5
ETTEVAATUSABINÕUD
Ettevaatusabinõud kasutamisel loomadel
Kõik karjas olevad kanad tuleb vaktsineerida korraga.
Vaktsin
                                
                                Read the complete document

Similar products

Active ingredient Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant

Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant

ATC code QI01AD16

QI01AD16

Marketed by Ceva-Phylaxia Veterinary Biologicals Co. Ltd

Ceva-Phylaxia Veterinary Biologicals Co. Ltd

INN (International Name) Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

Documents in other languages

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
Summary of Product characteristics Summary of Product characteristics Czech 01-01-1970
Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Danish 01-01-1970
Public Assessment Report Public Assessment Report Danish 01-01-1970
Patient Information leaflet Patient Information leaflet German 01-01-1970
Summary of Product characteristics Summary of Product characteristics German 01-01-1970
Public Assessment Report Public Assessment Report German 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
Summary of Product characteristics Summary of Product characteristics English 01-01-1970
Public Assessment Report Public Assessment Report English 01-01-1970
Patient Information leaflet Patient Information leaflet French 01-01-1970
Summary of Product characteristics Summary of Product characteristics French 01-01-1970
Public Assessment Report Public Assessment Report French 01-01-1970
Patient Information leaflet Patient Information leaflet Italian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Italian 01-01-1970
Public Assessment Report Public Assessment Report Italian 01-01-1970
Patient Information leaflet Patient Information leaflet Latvian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Latvian 01-01-1970
Public Assessment Report Public Assessment Report Latvian 01-01-1970
Patient Information leaflet Patient Information leaflet Lithuanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Lithuanian 01-01-1970
Public Assessment Report Public Assessment Report Lithuanian 01-01-1970
Patient Information leaflet Patient Information leaflet Hungarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Hungarian 01-01-1970
Public Assessment Report Public Assessment Report Hungarian 01-01-1970
Patient Information leaflet Patient Information leaflet Maltese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Maltese 01-01-1970
Public Assessment Report Public Assessment Report Maltese 01-01-1970
Patient Information leaflet Patient Information leaflet Dutch 01-01-1970
Summary of Product characteristics Summary of Product characteristics Dutch 01-01-1970
Public Assessment Report Public Assessment Report Dutch 01-01-1970
Patient Information leaflet Patient Information leaflet Polish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Polish 01-01-1970
Public Assessment Report Public Assessment Report Polish 01-01-1970
Patient Information leaflet Patient Information leaflet Portuguese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Portuguese 01-01-1970
Public Assessment Report Public Assessment Report Portuguese 01-01-1970
Patient Information leaflet Patient Information leaflet Romanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Romanian 01-01-1970
Public Assessment Report Public Assessment Report Romanian 01-01-1970
Patient Information leaflet Patient Information leaflet Slovak 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovak 01-01-1970
Public Assessment Report Public Assessment Report Slovak 01-01-1970
Patient Information leaflet Patient Information leaflet Slovenian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovenian 01-01-1970
Public Assessment Report Public Assessment Report Slovenian 01-01-1970
Patient Information leaflet Patient Information leaflet Finnish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Finnish 01-01-1970
Public Assessment Report Public Assessment Report Finnish 01-01-1970
Patient Information leaflet Patient Information leaflet Swedish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Swedish 01-01-1970
Public Assessment Report Public Assessment Report Swedish 01-01-1970
Patient Information leaflet Patient Information leaflet Norwegian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Norwegian 01-01-1970
Patient Information leaflet Patient Information leaflet Icelandic 01-01-1970
Summary of Product characteristics Summary of Product characteristics Icelandic 01-01-1970
Patient Information leaflet Patient Information leaflet Croatian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Croatian 01-01-1970
Public Assessment Report Public Assessment Report Croatian 01-01-1970

Search alerts related to this product

Alerts Ultifend IBD Turkey herpes virus, strain Newcastle disease, infectious bursal

Ultifend IBD Turkey herpes virus, strain Newcastle disease, infectious bursal

View documents history

Documents history Documents history

Ultifend ND IBD