Pfizer Animal Health

Equine Rhinopneumonitis Vaccine, Modified Live Virus

U.S. Vet. Lic. No.: 189

Description: RHINOMUNE^® is prepared by growing an attenuated strain of EHV-1 on an equine cell line and is packaged in freeze-dried form. The sterile diluent is used to rehydrate the freeze-dried component.

Contains gentamicin as preservative.

Indications: RHINOMUNE^® is for vaccination of healthy horses 3 months of age or older as an aid in preventing respiratory disease caused by equine herpesvirus type 1 (EHV-1).

Directions:

1. General Directions: Vaccination of all horses on the premises is recommended to enhance herd immunity. Aseptically rehydrate the freeze-dried vaccine with the sterile diluent provided, shake well, and administer 1 mL intramuscularly. Appropriate preparation of the inoculation site is advised to prevent introduction of bacterial contaminants.

2. Primary Vaccination: Healthy horses 3 months of age or older should receive 2 doses administered 3-4 weeks apart. Foals should be vaccinated when maternal antibodies have declined, generally at 3 months of age. If vaccinated earlier, foals should receive the 2-dose series after reaching 3 months of age. Pregnant mares should be vaccinated after the second month of pregnancy.

3. Revaccination: Revaccination every 3 months with a single dose is recommended.¹

4. Good animal husbandry and herd health management practices should be employed.

Precaution(s): Store at 2°-7°C. Prolonged exposure to higher temperatures and/or direct sunlight may adversely affect potency. Do not freeze.

Use entire contents when first opened.

Sterilized syringes and needles should be used to administer this vaccine. Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine.

Burn containers and all unused contents.

Caution(s): As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.

This product has been shown to be efficacious in healthy animals. A protective immune response may not be elicited if animals are incubating an infectious disease, are malnourished or parasitized, are stressed due to shipment or environmental conditions, are otherwise immunocompromised, or the vaccine is not administered in accordance with label directions.

Warning(s): Do not vaccinate within 21 days before slaughter.

For veterinary use only.

Discussion: Disease Description: Primary infection with EHV-1 causes an acute respiratory disease characterized by nasal discharge, coughing, labored breathing, fever, slight loss of appetite, and depression. Annual outbreaks may occur among foals in areas with a large equine population. Clinical signs, occasionally persisting as long as 7 days, are generally more severe in young horses, and may be exacerbated by strenuous activity. Subclinical reinfection may also occur, with latent carriers the probable reservoir of EHV-1. Immunity following natural infection typically endures for 3-9 months and is usually enhanced by subclinical or mild reinfection.

Trial Data: Safety and Efficacy: In extensive laboratory and field tests, no adverse reactions were reported in vaccinated horses, including young, susceptible foals and pregnant mares. Mares vaccinated after the second month of pregnancy remained clinically normal and delivered live, healthy foals. In challenge-of-immunity tests, vaccinated horses remained clinically normal after challenge with EHV-1 that produced typical signs of respiratory disease in nonvaccinated horses.

References: Available upon request.

75-4842-06

Presentation: 1 dose and 5 dose vials.

NAC No.: 36901360