RECOMBITEK Equine Influenza Virus Vaccine

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  • RECOMBITEK Equine Influenza Virus Vaccine Indications
  • Warnings and cautions for RECOMBITEK Equine Influenza Virus Vaccine
  • Direction and dosage information for RECOMBITEK Equine Influenza Virus Vaccine

RECOMBITEK Equine Influenza Virus Vaccine

This treatment applies to the following species:
Manufacturer: Merial

Equine Influenza Vaccine, Live Canarypox Vector

rFLU-SD

CONTENTS: RECOMBITEK® Equine Influenza Virus Vaccine contains lyophilized recombinant canarypox viruses plus a sterile liquid diluent. Two canarypox vector viruses have been modified using recombinant technology to express the hemagglutinin (HA) antigens of A/Eq/Kentucky/94 (H3N8) and A/Eq/Newmarket/2/93 (H3N8). After vaccination, the canarypox vector virus does not replicate in the horse, but the HA antigens are expressed by the vaccinate’s cells, inducing an immune response against Equine Influenza virus A2.

RECOMBITEK Equine Influenza Virus Vaccine Indications

RECOMBITEK® Equine Influenza Virus Vaccine is recommended for the vaccination of healthy horses as an aid in the prevention of disease caused by Equine Influenza virus A2.

EFFICACY: The efficacy of the vaccine was evaluated at the Animal Health Trust, Newmarket, United Kingdom (OIE reference laboratory for equine influenza) including 24 influenza-seronegative and unprimed 9 month old ponies. Twelve ponies were vaccinated intramuscularly with two 2 mL doses of RECOMBITEK Equine Influenza Virus Vaccine at an interval of 5 weeks. Twelve ponies were inoculated with two 2 mL doses of diluent and acted as the control group. Two weeks after the second vaccination, the ponies were all challenged by exposure to an aerosol of influenza virus A/eq/Newmarket/5/03 (H3N8). This virus is closely related to equine influenza viruses currently prevalent in North America. After challenge clinical signs were scored daily for 14 days according to a standardized scoring protocol, and nasal swabs were taken daily for 10 days to monitor excretion of virus. To assess the severity of exhibited clinical disease, a sickness score was calculated for each pony using the observation scores for cough, nasal discharge and dyspnea.1

The challenge produced clinical signs typical of influenza (fever, coughing, nasal discharge and dyspnea) in all 12 control ponies. Apart from sporadic coughing in two vaccinates (1 day each), nasal discharge was the only clinical sign observed in the vaccinates. Both incidence and duration of moderate/severe disease were significantly reduced in the vaccinates as compared to the control ponies (P=0.037 and P=0.0004, respectively). The incidence of virus shedding was significantly reduced in the vaccinates as compared to the control ponies (P<0.0001). All of the control ponies shed influenza virus from their nasopharynx, for a mean of 4.9 days, whereas none of the vaccinates shed influenza virus.

Reference

1. Edlund Toulemonde C, Daly J, Sindle T, Guigal PM, Audonnet JC, Minke JM. Efficacy of a recombinant equine influenza vaccine against challenge with an American lineage H3N8 influenza virus responsible for the 2003 outbreak in the United Kingdom. Veterinary Record 2005;156:367-371.

DOSAGE: Reconstitute the lyophilized vaccine with the accompanying liquid diluent and aseptically inject a 2 mL dose by intramuscular route. For primary vaccination, revaccinate with a second 2 mL dose of this product 5 weeks later. Annual revaccination with a single dose is recommended. Revaccination should be based on a veterinarian’s recommendation and risk of exposure.

SAFETY: Extensive field safety testing has demonstrated that RECOMBITEK Equine Influenza Virus Vaccine is safe for use in horses 4 months or older.

Precautions

Store at 2 - 7°C (35 - 45°F). Keep out of direct sunlight. For the preparation and administration of the vaccine, use sterile and antiseptic-free and/or disinfectant-free material. Burn container and all unused contents. Contains gentamicin as a preservative. Do not vaccinate within 21 days prior to slaughter. In some instances, transient local swelling may occur at the injection site. The safety of this product has not been evaluated in pregnant mares. As with any vaccine, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.

For Veterinary Use Only.

SOLD TO VETERINARIANS ONLY.

Manufactured By: MERIAL, INC., Athens, GA 30601 USA, U.S. Vet. Lic. No 298.

1-888-Merial-1 (1-888-637-4251)

Distributed In Canada By: MERIAL CANADA, INC., Baie d’Urfé, Qc H9X 4B6

RECOMBITEK is a registered trademark of MERIAL LIMITED.

RM1097R5

Contains

 

Prod. No.

 

10 Doses

10 x 1 dose (2 mL)

10 x 1 Dose, Lyophilized

10 x 2 mL, Sterile Diluent

63256

RM1091R5

25 Doses

5 x 5 dose (10 mL)

5 x 5 Dose, Lyophilized

5 x 10 mL, Sterile Diluent

66198

RM1094R4

NAC No.: 11111180

MERIAL LTD.
3239 SATELLITE BLVD., DULUTH, GA, 30096
Telephone:   888-637-4251
Website:   www.merial.com
Every effort has been made to ensure the accuracy of the RECOMBITEK Equine Influenza Virus Vaccine information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-09-05

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