VANGUARD 7.

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Canine distemper virus strain N-CDV (live, attenuated); Canine adenovirus type 2 virus, strain manhattan (live, attenuated); Canine parainfluenza type 5 virus, strain NL-CPI-5 (live, attenuated); Canine parvovirus strain NL-35-D (live, attenuated); Leptospira canicola inactivated ; Leptospira icterohaemorrhagiae inactivated

Verfügbar ab:

Zoetis Belgium S.A.

ATC-Code:

QI07AI02

INN (Internationale Bezeichnung):

Canine distemper virus strain N-CDV (live, attenuated); Canine adenovirus type 2 virus, strain manhattan (live, attenuated); Canine parainfluenza type 5 virus, strain NL-CPI-5 (live, attenuated); Canine parvovirus strain NL-35-D (live, attenuated); Leptospira canicola inactivated ; Leptospira icterohaemorrhagiae inactivated

Dosierung:

.

Darreichungsform:

Lyophilisate and solvent for solution for injection

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Dogs

Therapiebereich:

live canine distemper virus + live canine adenovirus + live canine parainfluenza virus + live canine parvovirus + inactivated leptospira

Anwendungsgebiete:

Immunological - Mixed Vaccine (L & A)

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2014-09-12

Fachinformation

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vanguard 7 lyophilisate and solvent for solution for injection for
dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose contains:
ACTIVE SUBSTANCES:
Freeze dried fraction: Vanguard DA
2
Pi
Canine distemper virus, strain N-CDV (live attenuated) minimum titre:
10
3.0
CCID
50
*
Canine adenovirus Type 2, strain Manhattan (live attenuated) minimum
titre: 10
3.2
CCID
50
*
Canine parainfluenza virus, strain NL-CPI-5 (live attenuated) minimum
titre: 10
6.0
CCID
50
*
Liquid fraction: Vanguard CPV-L
Canine Parvovirus, strain NL-35-D, low passage (live attenuated)
minimum titre : 10
7.0
CCID
50
*
_Leptospira canicola _
(inactivated) between 420 and 740 RU**/dose
_Leptospira icterohaemorrhagiae _
(inactivated) between 463 to 915 RU**/dose
*Cell culture infectious dose-
50
** Relative units
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Modified Eagles medium
Dextran 40
Casein hydrolysate
Lactose
Sorbitol 70% (solution)
Sodium hydroxide
Water for Injection
Freeze-dried: lightly colored pellets.
Liquid: pinkish pink, transparent to slightly cloudy.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs from 6 weeks of age.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Active immunisation of dogs to prevent clinical signs of disease and
reduce infection caused by canine
adenovirus Type 2, to prevent mortality and clinical signs including
leucopenia and reduce viral
shedding caused by canine parvovirus (types 2a, 2b and 2c), to prevent
clinical signs of disease caused
by canine distemper virus and canine adenovirus Type 1, to reduce
pathological signs of disease
caused by parainfluenzavirus and to reduce infection caused by
_Leptospira canicola_
and
_Leptospira _
_icterohaemorrhagiae_
.
Onset of immunity: 2 weeks after the last dose of the Basic
Vaccination Scheme.
7 days after a single dose when animals are vaccinated from 9 weeks of
age for the
canine parvovirus component (type 2b
)
Duration of immunity: 12 mo