ProteqFlu-Te

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
03-09-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
03-09-2021
Public Assessment Report Public Assessment Report (PAR)
13-11-2014

Active ingredient:

Tetani клостридия virus анатоксин / PDS 2242 virus / virus Vcp1529 / Vcp1533 virus / vCP3011

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI05AI01

INN (International Name):

equine influenza (live recombinant) and tetanus vaccine

Therapeutic group:

Konji

Therapeutic area:

Immunologicals for equidae, Live viral and inactivated bacterial vaccines, equine influenza virus + clostridium

Therapeutic indications:

Aktivna imunizacija konja od četiri mjeseca ili starije od konjske gripe radi smanjenja kliničkih znakova i izlučivanja virusa nakon infekcije i protiv tetanusa radi sprječavanja smrtnosti.

Product summary:

Revision: 16

Authorization status:

odobren

Authorization date:

2003-03-06

Patient Information leaflet

                                13
B. UPUTA O VMP
14
UPUTA O VMP
PROTEQFLU-TE SUSPENZIJA ZA INJEKCIJE ZA KONJE
1.
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I
NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
PROIZVODNE SERIJE, AKO JE RAZLIČITO
Nositelj odobrenja za stavljanje u promet:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
NJEMAČKA
Nositelj odobrenja za proizvodnju za puštanje proizvodne serije:
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l'Aviation
69800 Saint Priest
FRANCUSKA
2.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
ProteqFlu-Te suspenzija za injekcije za konje
3.
NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
Jedna doza od 1 ml sadrži:
DJELATNE TVARI
Virus influence konja A/ aq/Ohio/03 [H
3
N
8
] rekombiniran s virusom
boginja kanarinca (vCP2242)
...................................................................................
≥ 5,3 log10 FAID
50
*
Virus influence konja A/eq/Richmond/1/07 [H
3
N
8
] rekombiniran s
virusom boginja kanarinca (vCP3011)
.....................................................................
≥ 5,3 log10 FAID
50
*
_Clostridium tetani_
toksoid
.......................................................................................................
≥ 30 -IU**
* vCP sadržaj provjeren globalnim FAID
50
(fluorescentna analiza infektivne doze 50 %) uz qPCR
odnos za vCP.
** titar antitoksičnih protutijela induciran nakon ponovljenog
cijepljenja u serumu zamorčića prema
Ph. Eur.
ADJUVANS:
Karbomer
...........................................................................................................................................
4 mg
4.
INDIKACIJE
Aktivna imunizacija konja starih 4 mjeseca ili starijih protiv
influence konja za smanjenje kliničkih
znakova i izlučenja virusa nakon infekcije, kao i protiv tetanusa u
svrhu sprječavanja smrtnosti.
Početak imuniteta: 14 dana nakon prvog cijepljenja.
Shema trajanja imuniteta induciranog cijepljenjem:
-
5 dana nakon prvog cijepljenja;
-
nakon prvog cijepljenja i poticajne
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA
2
1.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
ProteqFlu-Te suspenzija za injekcije za konje
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna doza od 1 ml sadrži:
DJELATNE TVARI
Virus influence konja A/eq/Ohio/03 [H
3
N
8
] rekombiniran s virusom
boginja kanarinca (vCP2242)
...................................................................................
≥ 5,3 log10 FAID
50
*
Virus influence konja A/ eq/Richmond/1/07 [H
3
N
8
] rekombiniran s
virusom boginja kanarinca(vCP3011)
......................................................................
≥ 5,3 log10 FAID
50
*
_Clostridium tetani_
toksoid
........................................................................................................
≥ 30 IU**
* vCP sadržaj provjeren globalnim FAID
50
(fluorescentna analiza infektivne doze 50 %) uz qPCR
odnos za vCP.
** titar antitoksičnih protutijela induciran nakon ponovljenog
cijepljenja u serumu zamorčića rema
Ph. Eur.
ADJUVANS:
Karbomer
...........................................................................................................................................
4 mg
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
3.
FARMACEUTSKI OBLIK
Suspenzija za injekciju.
4.
KLINIČKE POJEDINOSTI
4.1
CILJNE VRSTE ŽIVOTINJA
Konji
4.2
INDIKACIJE ZA PRIMJENU, NAVESTI CILJNE VRSTE ŽIVOTINJA
Aktivna imunizacija konja starih 4 mjeseca ili starijih protiv
influence konja za smanjenje kliničkih
znakova i izlučenja virusa nakon infekcije, kao i protiv tetanusa u
svrhu sprječavanja smrtnosti.
Početak imuniteta: 14 dana nakon prvog cijepljenja.
Shema trajanja imuniteta induciranog cijepljenjem:
-
5 dana nakon prvog cijepljenja;
-
nakon prvog cijepljenja i poticajne doze 5 mjeseci kasnije: 1 godinu
na influencu konja i
2 godine na tetanus.
4.3
KONTRAINDIKACIJE
Nema.
4.4
POSEBNA UPOZORENJA
Nema.
3
4.5
POSEBNE MJERE PREDOSTROŽNOST ZA PRIMJENU
POSEBNE MJERE PREDOSTROŽNOST ZA PRIMJENU NA ŽIVOTINJAMA
Cijepiti se smiju samo zdrave životinje.
POSEBNE MJERE PREDOSTROŽNOS
                                
                                Read the complete document

Similar products

Active ingredient Tetani клостридия virus анатоксин / PDS 2242 virus / virus Vcp1529 / Vcp1533 virus / vCP3011

Tetani клостридия virus анатоксин / PDS 2242 virus / virus Vcp1529 / Vcp1533 virus / vCP3011

ATC code QI05AI01

QI05AI01

Marketed by Boehringer Ingelheim Vetmedica GmbH

Boehringer Ingelheim Vetmedica GmbH

INN (International Name) equine influenza (live recombinant) and tetanus vaccine

equine influenza (live recombinant) and tetanus vaccine

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 03-09-2021
Summary of Product characteristics Summary of Product characteristics Bulgarian 03-09-2021
Public Assessment Report Public Assessment Report Bulgarian 13-11-2014
Patient Information leaflet Patient Information leaflet Spanish 03-09-2021
Summary of Product characteristics Summary of Product characteristics Spanish 03-09-2021
Public Assessment Report Public Assessment Report Spanish 13-11-2014
Patient Information leaflet Patient Information leaflet Czech 03-09-2021
Summary of Product characteristics Summary of Product characteristics Czech 03-09-2021
Public Assessment Report Public Assessment Report Czech 13-11-2014
Patient Information leaflet Patient Information leaflet Danish 03-09-2021
Summary of Product characteristics Summary of Product characteristics Danish 03-09-2021
Public Assessment Report Public Assessment Report Danish 13-11-2014
Patient Information leaflet Patient Information leaflet German 03-09-2021
Summary of Product characteristics Summary of Product characteristics German 03-09-2021
Public Assessment Report Public Assessment Report German 13-11-2014
Patient Information leaflet Patient Information leaflet Estonian 03-09-2021
Summary of Product characteristics Summary of Product characteristics Estonian 03-09-2021
Public Assessment Report Public Assessment Report Estonian 13-11-2014
Patient Information leaflet Patient Information leaflet Greek 03-09-2021
Summary of Product characteristics Summary of Product characteristics Greek 03-09-2021
Public Assessment Report Public Assessment Report Greek 13-11-2014
Patient Information leaflet Patient Information leaflet English 03-09-2021
Summary of Product characteristics Summary of Product characteristics English 03-09-2021
Public Assessment Report Public Assessment Report English 13-11-2014
Patient Information leaflet Patient Information leaflet French 03-09-2021
Summary of Product characteristics Summary of Product characteristics French 03-09-2021
Public Assessment Report Public Assessment Report French 13-11-2014
Patient Information leaflet Patient Information leaflet Italian 03-09-2021
Summary of Product characteristics Summary of Product characteristics Italian 03-09-2021
Public Assessment Report Public Assessment Report Italian 13-11-2014
Patient Information leaflet Patient Information leaflet Latvian 03-09-2021
Summary of Product characteristics Summary of Product characteristics Latvian 03-09-2021
Public Assessment Report Public Assessment Report Latvian 13-11-2014
Patient Information leaflet Patient Information leaflet Lithuanian 03-09-2021
Summary of Product characteristics Summary of Product characteristics Lithuanian 03-09-2021
Public Assessment Report Public Assessment Report Lithuanian 13-11-2014
Patient Information leaflet Patient Information leaflet Hungarian 03-09-2021
Summary of Product characteristics Summary of Product characteristics Hungarian 03-09-2021
Public Assessment Report Public Assessment Report Hungarian 13-11-2014
Patient Information leaflet Patient Information leaflet Maltese 03-09-2021
Summary of Product characteristics Summary of Product characteristics Maltese 03-09-2021
Public Assessment Report Public Assessment Report Maltese 13-11-2014
Patient Information leaflet Patient Information leaflet Dutch 03-09-2021
Summary of Product characteristics Summary of Product characteristics Dutch 03-09-2021
Public Assessment Report Public Assessment Report Dutch 13-11-2014
Patient Information leaflet Patient Information leaflet Polish 03-09-2021
Summary of Product characteristics Summary of Product characteristics Polish 03-09-2021
Public Assessment Report Public Assessment Report Polish 13-11-2014
Patient Information leaflet Patient Information leaflet Portuguese 03-09-2021
Summary of Product characteristics Summary of Product characteristics Portuguese 03-09-2021
Public Assessment Report Public Assessment Report Portuguese 13-11-2014
Patient Information leaflet Patient Information leaflet Romanian 03-09-2021
Summary of Product characteristics Summary of Product characteristics Romanian 03-09-2021
Public Assessment Report Public Assessment Report Romanian 13-11-2014
Patient Information leaflet Patient Information leaflet Slovak 03-09-2021
Summary of Product characteristics Summary of Product characteristics Slovak 03-09-2021
Public Assessment Report Public Assessment Report Slovak 13-11-2014
Patient Information leaflet Patient Information leaflet Slovenian 03-09-2021
Summary of Product characteristics Summary of Product characteristics Slovenian 03-09-2021
Public Assessment Report Public Assessment Report Slovenian 13-11-2014
Patient Information leaflet Patient Information leaflet Finnish 03-09-2021
Summary of Product characteristics Summary of Product characteristics Finnish 03-09-2021
Public Assessment Report Public Assessment Report Finnish 13-11-2014
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Summary of Product characteristics Summary of Product characteristics Swedish 03-09-2021
Public Assessment Report Public Assessment Report Swedish 13-11-2014
Patient Information leaflet Patient Information leaflet Norwegian 03-09-2021
Summary of Product characteristics Summary of Product characteristics Norwegian 03-09-2021
Patient Information leaflet Patient Information leaflet Icelandic 03-09-2021
Summary of Product characteristics Summary of Product characteristics Icelandic 03-09-2021

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