EQUIVAC HEV HENDRA VIRUS VACCINE FOR HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

G GLYCOPROTEIN OF HENDRA VIRUS (SG - PROTEIN); THIOMERSAL

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

Hendra virus G-protein(100ug/mL)

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

G GLYCOPROTEIN OF HENDRA VIRUS (SG - PROTEIN) VACCINE-VIRAL Active 100.0 ug; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

10mL; 1mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic area:

IMMUNOTHERAPY

Product summary:

Poison schedule: 0; Withholding period: Zero (0) days; Host/pest details: HORSE: [HENDRA VIRUS]; Poison schedule: 0; Withholding period: ; Host/pest details: HORSE: [HENDRA VIRUS]; An aid in the prevention of clinical symptoms of the disease caused by Hendra virus in horses 4 months of age and older.This product should not be used in sick or immunocompromised horses.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

ZOETIS AUSTRALIA PTY LTD
EQUIVAC HEV HENDRA VIRUS VACCINE FOR HORSES
68996/105049
COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
LABEL NAME:
EQUIVAC HEV HENDRA VIRUS VACCINE FOR HORSES
SIGNAL HEADINGS:
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
100 µg/mL G-PROTEIN (sG) OF HENDRA VIRUS
0.1 mg/mL THIOMERSAL
CLAIMS:
An aid in the prevention of clinical symptoms of the disease caused by
Hendra virus in
horses 4 months of age and older.
NET CONTENTS:
10 mL glass vial,
1 mL glass syringe
DIRECTIONS FOR USE:
Read the enclosed leaflet for full instructions
DIRECTIONS FOR USE
CONTRAINDICATIONS:
The Product should not be used in sick or immunocompromised horses.
PRECAUTIONS:
The effectiveness of Equivac HeV vaccine in the face of Hendra virus
disease outbreak has
not been studied.
While all horses receiving the recommended vaccine course and booster
vaccination at 6
months were antibody positive, the potential for vaccinated horses to
shed virus if exposed
to and infected with the Hendra virus cannot be ruled out.
It is recommended that good hygiene practices are observed when horses
are being
handled.
This product has been found to be safe for administration to pregnant
mares. However,
in pregnant mares it is important to avoid the use of vaccines during
critical stages of
pregnancy. For this reason avoid vaccinating during the first 45 days
after mating and the
last 14 days before the expected date of foaling.
Duration of immunity has not been demonstrated for more than 6 months
following the
primary vaccination course.
The compatibility of Equivac HeV Hendra virus vaccine with other
vaccines and veterinary RLP APPROVED
chemical products has not been studied.
SIDE EFFECTS:
Transient swelling may develop at the site of vaccination in some
horses but should resolve
within one week without treatment.
In some horses transient post-vaccination reactions including
injection site reaction, pain,
increase in body temperature, lethargy, inappetence, and muscle
stiffness have also been
observed. Additional reported clinica

Summary of Product characteristics

Issue date: 14-September-2016
Supersedes date: 14-September-2016
Revision Date: 15-September-2016
Version number: 02
SAFETY DATA SHEET
1. IDENTIFICATION
EQUIVAC HEV
PRODUCT IDENTIFIER
OTHER MEANS OF IDENTIFICATION
Equivac HeV Hendra Virus Vaccine for horses
SYNONYMS
RECOMMENDED USE OF THE CHEMICAL AND RESTRICTIONS ON USE
Veterinary vaccine
RECOMMENDED USE
Not for human use
RESTRICTIONS ON USE
DETAILS OF MANUFACTURER OR IMPORTER
MANUFACTURER
COMPANY NAME (AU)
Zoetis Australia Pty Ltd
ABN 94 156 476 425
Level 6, 5 Rider Boulevard
Rhodes NSW 2138 AUSTRALIA
TEL
1800 814 883
FAX
[phone]
EMAIL
[e-mail]
EMERGENCY PHONE
1800 814 883 (all hours)
POLICE AND FIRE BRIGADE
Dial 000
IF INEFFECTIVE
Dial Poisons Information Centre (13 1126 from anywhere in Australia)
2. HAZARD(S) IDENTIFICATION
CLASSIFICATION OF THE HAZARDOUS CHEMICAL
Not classified.
PHYSICAL HAZARDS
Not classified.
HEALTH HAZARDS
Not classified.
ENVIRONMENTAL HAZARDS
LABEL ELEMENTS, INCLUDING PRECAUTIONARY STATEMENTS
None.
HAZARD SYMBOL(S)
SIGNAL WORD
None.
HAZARD STATEMENT(S)
The mixture does not meet the criteria for classification.
PRECAUTIONARY STATEMENT(S)
PREVENTION
Observe good industrial hygiene practices.
RESPONSE
Wash hands after handling.
STORAGE
Store away from incompatible materials.
DISPOSAL
Dispose of waste and residues in accordance with local authority
requirements.
OTHER HAZARDS WHICH DO NOT
RESULT IN CLASSIFICATION
In the event of accidental injection, an allergic reaction may occur.
SUPPLEMENTAL INFORMATION
None.
3. COMPOSITION/INFORMATION ON INGREDIENTS
MIXTURE
CONCENTRATION OF
INGREDIENTS
IDENTITY OF CHEMICAL INGREDIENTS
0.01
CAS NUMBER AND OTHER
UNIQUE IDENTIFIERS
54-64-8
Thimerosal
100
µ
g/mL
Not established
Hendra virus HeV soluble G (sG) protein
*
Not assigned
Synthetic adjuvant
1 / 8
Material name: Equivac HeV
3298
SDS AUSTRALIA
*Designates that a specific chemical identity and/or percentage of
composition has been withheld
as a trade secret.
COMPOSITION COMMENTS
4. FIRST-AID MEASURES
DESCRIPTION OF NE