EQUIVAC WNV

Land: Australië

Taal: Engels

Bron: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Werkstoffen:

WEST NILE VIRUS (INACTIVATED) (STRAIN VM-2)

Beschikbaar vanaf:

ZOETIS AUSTRALIA PTY LTD

INN (Algemene Internationale Benaming):

West Nile virus

farmaceutische vorm:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Samenstelling:

WEST NILE VIRUS (INACTIVATED) (STRAIN VM-2) VACCINE-VIRAL Active 0.0 U

Eenheden in pakket:

10x1 mL; 2x1 mL; 4x1 mL

klasse:

VM - Veterinary Medicine

Geproduceerd door:

ZOETIS AUSTRALIA

Therapeutisch gebied:

IMMUNOTHERAPY

Product samenvatting:

Poison schedule: 0; Withholding period: WHP: Zero (0) days; Host/pest details: HORSE: [WEST NILE VIRUS]; Poison schedule: 0; Withholding period: ; Host/pest details: HORSE: [WEST NILE VIRUS]; For the active immunisation of horses 6 months of age or older against West Nile virus (formally Kunjin virus) disease by reducing the number of viraemic horses.Only healthy animals should be vaccinated. See Precautions, Side Effects, etc. on label

Autorisatie-status:

Registered

Autorisatie datum:

2023-07-01

Bijsluiter

Product Name:
APVMA Approval No:
EQUIVAC WNV
67146 / 118335
Label Name:
EQUIVAC WNV
Signal Headings:
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each 1mL dose contains inactivated West Nile Virus strain VM-2 RP ≥
1.0.
Claims:
For the active immunisation of horses 6 months of age or older against
West Nile virus
(formally Kunjin virus) disease by reducing the number of viraemic
horses.
Net Contents:
2, 4 or 10 x 1mL dose syringes
Directions for Use:
Restraints:
Contraindications:
Precautions:
No information is available on the safety and efficacy of this vaccine
when used with any
other veterinary medicinal product. A decision to use this vaccine
before or after any other
veterinary medicinal product therefore needs to be made on a case by
case basis.
The use of Equivac WNV reduces the number of animals with viraemia
after natural
infection, but may not systematically prevent it.
Vaccination may interfere with existing sero-epidemiological surveys.
No specific studies have been conducted to demonstrate absence of
interferences
from maternally derived antibodies on vaccine take. It is therefore
recommended not to
vaccinate foals of less than 6 months of age.
The vaccine can be used during pregnancy and lactation. However, no
specific efficacy
studies were conducted in pregnant mares. As a consequence, it cannot
be excluded that RLP APPROVED
transient immunodepression that may be observed during pregnancy could
interfere with
vaccine uptake.
Side Effects:
Transient local reactions in the form of a mild, local swelling at the
injection site post
vaccination (maximum 1 cm in diameter) that resolve spontaneously
within 1 to 2 days and
that are sometimes associated with pain and mild depression were
reported in very rare
cases. In very rare cases transient hyperthermia may occur for up to 2
days.
Dosage and
Administration:
Only healthy animals should be vaccinated.
For intramuscular use.
Administer one dose (1 mL), by deep intramuscular injection in the
neck region, according
to the