VANGUARD CPV-L.

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Live canine parvovirus strain NL-35-D; Inactivated leptospira canicola; Inactivated leptospira icterohaemorrhagiae

MAH:

Zoetis Belgium S.A.

ATC_code:

QI07AI05

INN:

Live canine parvovirus strain NL-35-D; Inactivated leptospira canicola; Inactivated leptospira icterohaemorrhagiae

dosage:

.

pharmaceutical_form:

Solution for injection

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Dogs

therapeutic_area:

live canine parvovirus + inactivated leptospira

therapeutic_indication:

Immunological - Mixed Vaccine (L & A)

authorization_status:

Authorised

authorization_date:

2014-09-12

SPC

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vanguard CPV-L solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose contains:
ACTIVE SUBSTANCES:
Live attenuated canine Parvovirus, strain NL-35-D, low passage,
minimum: 10
7.0
CCID
50
*
Inactivated
_Leptospira canicola_
, between 420 and 740 RU**/dose
Inactivated
_ Leptospira icterohaemorrhagiae_
,between 463 to 915 RU**/dose .
*Cell culture infectious dose-
50
**Relative units
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Modified Eagles medium
A clear to slightly turbid liquid.
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 mortality and clinical signs
including leucopenia and
reduce viral shedding caused by canine parvovirus (types 2a, 2b and
2c) 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 months, after the last dose of the Basic
Vaccination Scheme based on
serology/challenge data.
3.3
CONTRAINDICATIONS
Do not use in unhealthy animals.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
The canine parvovirus vaccinal strain may be shed from vaccinated
animals for a number of days
following vaccination. However, due to the low pathogenicity of this
strain, it is not necessary to keep
vaccinated animals separated from non-vaccinated animals.
Due to the presence of maternally derived antibodies, a small
percentage of pups may fail to mount an
adequate immune response to vaccination and may be at risk from
disease when the local disease
challenge is sufficiently high. The percentage of puppies that fail t