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THE ZOETIS HENDRA EQUINE VACCINATION- Equivac HeV
THE ZOETIS HENDRA EQUINE VACCINATION- Equivac HeV
In Australia
In Australia
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Pg 1 of 2

You are strongly advised to read the full text on these 2 pages and investigate the links.

The vaccine costs between $100 and $200 a dose, depending on the vet's call-out fee.

Equivac HeV is a non-infectious formulation of a recombinantly expressed subunit vaccine comprising the virus surface protein G, developed originally by scientists at the USAMRID and later transferred to CSIRO (Pallister et al., 2011). Immunisation induces the production of neutralising antibodies that provide protection if the animal is subsequently exposed to live virus.

Only accredited veterinarians may administer the vaccine

It is a requirement that all vaccinated horses are microchipped.

REGISTRATION APVMA

Australian Pesticides and Veterinary Medicines Authority (APVMA)

In the period from 10 August 2012 to 4 August 2015, Zoetis was granted the following minor use permits:

(a) minor use permit number PER13510 in force from 1O August 2012 to 3 August 2014;

(b) minor use permit number PER14876 in force from 4 August 2014 to 4 August 2015;and

(c) minor use permit number PER14887 in force from 31 March 2015 to 4 August 2015, (together, Permits).

 On 5 August 2015, Equivac HeV received full registration from the APVMA.

See details about the registered product, including the approved label here-

SOURCE LINK:

https://apvma.gov.au/node/15786

 

APVMA CHEMICALS DATABASE.

Australian Pesticides and Veterinary Medicines Authority (APVMA)

Details about the registered product, including the approved label

EQUIVAC HEV HENDRA VIRUS VACCINE FOR HORSES

Product Number 68996.

SOURCE LINK:

https://productsearch.apvma.gov.au/products#SearchTerm=68996&Filters=Status%3DApproved%2CStatus%3DRegistered

 

ZOETIS CLAIMS ON THE PRODUCT BOX, LABEL & INSERT – 

 

January 29, 2016

ZOETIS AUSTRALIA PTY LTD

EQUIVAC HEV HENDRA VIRUS VACCINE FOR HORSES  68996/103910

Label Name: EQUIVAC HEV HENDRA VIRUS VACCINE FOR HORSES

Signal Headings: FOR ANIMAL TREATMENT ONLY

 

Statements:

100 µg/mL G-POTEIN (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

Restraints: Not Applicable

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 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 clinical signs have included urticaria, sweating, oedema and colic. Clinical signs may vary in severity and occasionally may require veterinary intervention.

Systemic allergic reactions such as anaphylaxis may require parenteral treatment with adrenaline, corticosteroid and antihistamine as appropriate and should be followed by appropriate supportive therapy.

Dosage and Administration:

Contents must be left in outer package until immediately before use.

The dose on all occasions is 1 mL injected intramuscularly in horses 4 months of age and older. The most convenient site for injection is the centre of the side of the neck. Before the vaccine is injected, the proposed site of inoculation on the horse's skin may be cleaned by swabbing with cotton-wool soaked in a suitable antiseptic solution, such as methylated spirits.

For primary immunisation two doses of vaccine should be administered 3 to 6 weeks apart.

A third dose 6 months after the second primary dose is also required. Booster doses are required every 6 months thereafter.

When vaccinating foals born to mares vaccinated with Equivac HeV, it is recommended that the foal’s primary vaccination course be delayed until 6 months of age to ensure an effective immune response to vaccine antigen.

Summary of Dosing Schedule

Vaccination Type ---- Timing Interval

First Dose ---- Day 1

Second Dose ---- Day 21 - 42

Third Dose ---- 6 months after the second dose

Followed by 6 monthly boosters

It is recommended that good hygiene practices are observed when horses are being handled.

General Directions: Equivac HeV Hendra virus vaccine for horses contains soluble forms of G-Protein [sG] of Hendra Virus adjuvanted with immunostimulating complex.

Each mL of vaccine contains ≥100 µg G-Protein [sG] of Hendra Virus.

Thiomersal at 0.1 mg/mL has been added as a preservative.

This vaccine may contain residual hygromycin.

 

Withholding Periods:

MEAT WITHHOLDING PERIOD: Not Applicable

Trade Advice: EXPORT SLAUGHTER INTERVAL (ESI): ESI Not Applicable

Safety Directions: Not Applicable

First Aid Instructions:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131126.

 

First Aid Warnings:

Additional User Safety: User Safety Information

Take care to avoid accidental self-injection. Accidental self-administration may result in local bruising, pain and swelling. In the event of self-administration, seek medical attention and show the package leaflet or the label, to the Medical Practitioner.

This material may cause a mild allergic reaction in sensitive individuals on skin contact. Avoid skin contact. If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water. If splashed in eyes, wash out immediately with water.

Personal Protective Equipment (PPE) should be worn whenever Hendra virus disease is suspected even in vaccinated horses as not all vaccines can provide a guaranteed protection.

Storage: Store between 2°C and 8°C (Refrigerate. Do not freeze). Protect from light.

 

SEE ALSO-

https://www.health4horses.com.au/range/products/equivac-hev.aspx?ReturnUrl=/index.aspx

 

Download label /leaflet information here

http://websvr.infopest.com.au/labelrouter/label?productcode=68996&labeltype=L&Mode=1

 

https://www.csiro.au/en/Research/BF/Areas/Protecting-Animal-and-Human-Health/Zoonotic-capability/Hendra

 

The Hendra vaccination was registered in August with Australian Pesticides and Veterinary Medicines Authority after it underwent a limited release program from December 2012.

A vaccine to prevent Hendra virus infection in horses has been available since November 2012. The Hendra virus vaccine was registered by the Australian Pesticide and Veterinary Medicines Authority (APVMA) on 4 August 2015. Further information can be found on the APVMA website and in product information accompanying the vaccine. While the vaccine has been shown to be safe and to provide high levels of protection in horses, continued efforts to reduce exposure of horses to Hendra virus are essential.

 

SOURCE LINK:

http://conditions.health.qld.gov.au/HealthCondition/condition/14/217/363/hendra-virus-infection

See also - Class action 

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