Equilis Prequenza

País: Nueva Zelanda

Idioma: inglés

Fuente: Ministry for Primary Industries

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Ficha técnica Ficha técnica (SPC)
01-12-2021

Ingredientes activos:

equine influenza virus (inactivated)

Disponible desde:

Ministry for Primary Industries

Designación común internacional (DCI):

equine influenza virus (inactivated)

Composición:

equine influenza virus (inactivated) 0 vaccine

Área terapéutica:

Vaccine

Estado de Autorización:

ACVM Registered

Fecha de autorización:

2005-12-22

Ficha técnica

                                NZ LABEL FOR INSERT
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
TRADE NAME
Equilis® Prequenza
ACTIVE INGREDIENT(S) AND QUANTITIES
Equilis® Prequenza is a vaccine suspension containing per 1ml:
•
Equine Influenza virus strains:
•
A/equine-2/South Africa/4/03 50 AU*
•
A/equine-2/Newmarket/2/93 50 AU
•
Purified saponin (adjuvant) : 375 µg
•
Cholesterol 125
µ
g
•
Phosphatidylcholine 62.5
µ
g.
*
antigenic units
PRESENTATION
Cardboard box with 10 x 1 mL glass vials or cardboard box with 10, 5
or 1 x 1 mL
pre- filled syringe (needle enclosed).
INDICATION
Active immunisation of horses from 6 months of age against equine
influenza to reduce
clinical signs and virus excretion after infection.
Onset of immunity: 2 weeks after the primary vaccination course
Duration of immunity: 5 months after the primary vaccination course.
12 months after the
first revaccination.
DIRECTIONS FOR USE
By law the distribution and use of this product must comply with
the requirements of the relevant operating plan.
•
Use in healthy horses only. Intramuscular injection of one dose (1 ml)
per animal.
•
Allow the vaccine to reach room temperature (15-25°C) before use.
•
Shake well before use.
ADVERSE EFFECTS, PRECAUTIONS AND CONTRAINDICATIONS
•
Do not mix the vaccine with other vaccines, or administer another
vaccine
shortly before or after vaccination with this product.
•
Accidental self-injection may lead to a severe local allergic
reaction.
Consult a physician immediately and show this package insert to the
physician.
•
A transient swelling may occur after vaccination regressing within 2
days. In some cases, fever may occur after vaccination.
•
Avoid intravenous injection.
WITHHOLDING PERIODS
Meat:
Nil.
Milk: Nil.
STORAGE
•
Store in the dark between 2 °C and 8 °C. Do not freeze.
•
Avoid prolonged or repetitive exposure to high ambient
temperatures following withdrawal from the refrigerator prior to
use.
•
Protect from direct sunlight.
•
Keep the vial in the outer carton, in order to protect from l
                                
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