Vanguard Lepto-ci

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Leptospira icterohaemorrhagiae inactivated; Leptospira canicola inactivated

Tilgjengelig fra:

Zoetis Belgium S.A.

ATC-kode:

QI07AB01

INN (International Name):

Leptospira icterohaemorrhagiae inactivated; Leptospira canicola inactivated

Dosering :

.

Legemiddelform:

Solution for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Dogs

Terapeutisk område:

leptospira

Indikasjoner:

Immunological - Inactivated Vaccine

Autorisasjon status:

Authorised

Autorisasjon dato:

2014-09-12

Preparatomtale

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vanguard Lepto-ci solution for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quantity per 1 ml dose
ACTIVE SUBSTANCES
Inactivated
_Leptospira canicola_
, between 420 and 740 RU*/dose
Inactivated
_Leptospira icterohaemorrhagiae_
, between 463 to 915 RU*/dose.
* Relative units
EXCIPIENTS
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Sodium chloride
Anhydrous disodium phosphate
Monobasic potassium phosphate
Water for injections
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs from 6 weeks of age.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For active immunisation of dogs to reduce infection caused by
_Leptospira canicola _
and
_Leptospira _
_icterohaemorrhagiae_
.
Onset of immunity: approximately two weeks following the second
vaccination.
Duration of immunity: twelve months have been demonstrated in studies
performed on animals
vaccinated at 8-9 weeks.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
In case of accidental self-injection, wash the area immediately with
water. If symptoms develop, seek
medical advice and show the package leaflet or the label to the
physician.
Special precautions for the protection of the environment:
Not applicable.
3.6
ADVERSE EVENTS
Dogs:
Common
(1 to 10 animals / 100 animals
treated):
Injection site swelling
1
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Anaphylaxis
2
1
transient, for up to 7 days after vaccination
2
If an anaphylactic reaction occurs e.g. vomiting, administer
adrenaline or an equivalent
Reporting
adverse
events
is
important.
It
allows
continuous
safety
monitoring
of
a
veterinary
medicinal product. Reports should be sent, preferably via a
veterinarian, to either the marketing
a