Vanguard Lepto-ci

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Leptospira icterohaemorrhagiae inactivated; Leptospira canicola inactivated

Pieejams no:

Zoetis Belgium S.A.

ATĶ kods:

QI07AB01

SNN (starptautisko nepatentēto nosaukumu):

Leptospira icterohaemorrhagiae inactivated; Leptospira canicola inactivated

Deva:

.

Zāļu forma:

Solution for injection

Receptes veids:

POM: Prescription Only Medicine as defined in relevant national legislation

Ārstniecības grupa:

Dogs

Ārstniecības joma:

leptospira

Ārstēšanas norādes:

Immunological - Inactivated Vaccine

Autorizācija statuss:

Authorised

Autorizācija datums:

2014-09-12

Produkta apraksts

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