ProteqFlu-Te

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Clostridium tetani toxoid / Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus

MAH:

Boehringer Ingelheim Vetmedica GmbH

ATC_code:

QI05AI01

INN:

equine influenza (live recombinant) and tetanus vaccine

therapeutic_group:

Horses

therapeutic_area:

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

therapeutic_indication:

Active immunisation of horses of four months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.

leaflet_short:

Revision: 16

authorization_status:

Authorised

authorization_date:

2003-03-06

PIL

13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET:
PROTEQFLU-TE SUSPENSION FOR INJECTION FOR HORSES
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer for the batch release:
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l'Aviation
69800 Saint Priest
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ProteqFlu-Te suspension for injection for horses
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose of 1 ml contains:
ACTIVE SUBSTANCES:
Influenza A/eq/Ohio/03 [H
3
N
8
] recombinant canarypox virus (vCP2242) ........... ≥ 5.3 log10 FAID
50
*
Influenza A/eq/Richmond/1/07 [H
3
N
8
] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID
50
*
_Clostridium tetani_
toxoid
.........................................................................................................
≥ 30 IU**
* vCP content checked by global FAID
50
(fluorescent assay infectious dose 50 %) and qPCR ratio
between vCP.
** antitoxic antibody titre induced after repeated vaccination in
guinea pig sera according to Ph. Eur.
ADJUVANT:
Carbomer
.........................................................................................................................................
4 mg.
4.
INDICATION(S)
Active immunisation of horses of 4 months of age or older against
equine influenza to reduce clinical
signs and virus excretion after infection, and against tetanus to
prevent mortality.
Onset of immunity: 14 days after primary vaccination course.
Duration of immunity induced by the vaccination scheme:
-
5 months after the primary vaccination course;
-
after the primary vaccination course and the booster injection 5
months later: 1 year with regard
to equine influenza and 2 years with regard to tetanus.
5.
CONTRAINDICATIONS
None.
15
6.
ADVERSE REACTIONS
•
A transient swelling which usually regres

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ProteqFlu-Te suspension for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 1 ml contains:
ACTIVE SUBSTANCES:
Influenza A/eq/Ohio/03 [H
3
N
8
] recombinant Canarypox virus (vCP2242) .......... ≥ 5.3 log10 FAID
50
*
Influenza A/eq/Richmond/1/07 [H
3
N
8
] recombinant Canarypox virus (vCP3011) ≥ 5.3 log10 FAID
50
*
_Clostridium tetani_
toxoid
.........................................................................................................
≥ 30 IU**
* vCP content checked by global FAID
50
(fluorescent assay infectious dose 50 %) and qPCR ratio
between vCP.
** antitoxic antibody titre induced after repeated vaccination in
guinea pig sera according to Ph. Eur.
ADJUVANT:
Carbomer
.........................................................................................................................................
4 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of horses of 4 months of age or older against
equine influenza to reduce clinical
signs and virus excretion after infection, and against tetanus to
prevent mortality.
Onset of immunity: 14 days after primary vaccination course.
Duration of immunity induced by the vaccination scheme:
-
5 months after the primary vaccination course;
-
after the primary vaccination course and the booster injection 5
months later: 1 year with regard
to equine influenza and 2 years with regard to tetanus.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Only healthy animals should be vaccinated.
3
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet