American Livestock Supply Inc.

American Livestock Supply, Inc. has taken great care in assembling this label information. But, due to the possibility of human error or manufacture label changes, American Livestock Supply, Inc. disclaims responsibility for use or misuse of this product. Before use, always read and follow the manufacturer's label on the physical product.

BOVISHIELD4:Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza3-Respiratory Syncytial Virus Vaccine
Modified Live VirusBovi-Shield™ 4

PRODUCT DESCRIPTION: Bovi-Shield 4 is for vaccination of healthy, nonpregnant cattle as an aid in preventing infectious bovine rhinotracheitis caused by infectious bovine rhinotracheitis (IBR) virus, bovine viral diarrhea (Type 1 and Type 2) caused by bovine viral diarrhea (BVD) virus, and disease caused by parainfluenza3 (PI3) virus and bovine respiratory syncytial virus (BRSV). Bovi-Shield 4 is a freeze-dried preparation of modified live virus (MLV) strains of IBR, BVD, PI3, and BRSV viruses, plus a sterile diluent used to rehydrate the freeze-dried vaccine. Viral antigens are propagated on established cell lines.

DISEASE DESCRIPTION: IBR, BVD, PI3, and BRSV viruses are commonly associated with respiratory disease and/or reproductive failure in cattle. IBR virus infection is characterized by high temperature, excessive nasal discharge, conjunctivitis and ocular discharge, inflamed nose (“red nose”), increased rate of respiration, coughing, loss of appetite, and depression. Cattle infected during pregnancy may abort.
BVD virus may be transmitted in nasal secretions, saliva, blood, feces, and/or urine, and by direct contact with contaminated objects; it invades through the nose and mouth and replicates systemically. Infection during pregnancy may result in abortion, fetal resorption, or congenital malformation of the fetus. Moreover, if susceptible cows are infected with noncytopathic BVD virus during the first trimester of pregnancy, their calves may be born persistently infected with the virus. Exposure of those calves to certain virulent cytopathic BVD virus strains may precipitate BVD-mucosal disease. Clinical signs of BVD include loss of appetite, ulcerations in the mouth, profuse salivation, elevated temperature, diarrhea, dehydration, and lameness.
PI3 virus usually localizes in the upper respiratory tract, causing elevated temperature and moderate nasal and ocular discharge. Although clinical signs typically are mild, PI3 infection weakens respiratory tissues. Invasion and replication of other pathogens, particularly Pasteurella spp., is thereby facilitated and may result in pneumonia.
BRSV is the etiologic agent of a specific viral respiratory disease of cattle of all ages, including nursing calves. Infection is characterized by rapid breathing, coughing, loss of appetite, discharge from the nose and eyes, fever, and swelling around the throat and neck. In an acute outbreak, deaths may follow within 48 hours after onset of signs. Clinically, BRSV infection may be indistinguishable from other viral infections associated with the bovine respiratory disease complex. BRSV infection, like PI3, facilitates invasion and replication of other respiratory pathogens. Exacerbation of clinical signs has been documented when concurrent BRSV and BVD or IBR infection exists.

SAFETY AND EFFICACY: In safety studies of the fractions of Bovi-Shield 4, no adverse reactions to vaccination were observed.Efficacy of each fraction of Bovi-Shield 4 was demonstrated in challenge-of-immunity studies. Cattle vaccinated with any fraction of Bovi-Shield 4, followed by challenge with a disease-causing strain of that fraction, showed no signs or had significantly fewer clinical signs than nonvaccinated control cattle. Serologic studies demonstrated no immunologic interference among the fractions of Bovi-Shield 4.

DIRECTIONS:
1. General Directions: Vaccination of healthy, nonpregnant cattle is recommended. Aseptically rehydrate the freeze-dried vaccine with the sterile diluent provided, shake well, and administer 2 mL intramuscularly. In accordance with Beef Quality Assurance guidelines, this product should be administered in the muscular region of the neck.
2. Primary Vaccination: Administer a single 2-mL dose to healthy cattle, followed by a second dose of Bovi-Shield BRSV 3–4 weeks later.
3. Revaccination: Annual revaccination with a single dose is recommended.
4. Good animal husbandry and herd health management practices should be employed.

PRECAUTIONS:
1. Do not use in pregnant cows (abortions can result) or in calves nursing pregnant cows.
2. Store at 2?–7?C. Prolonged exposure to higher temperatures and/or direct sunlight may adversely affect potency. Do not freeze.
3. Use entire contents when first opened.
4. Sterilized syringes and needles should be used to administer this vaccine. Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine.
5. Burn containers and all unused contents.
6. Do not vaccinate within 21 days before slaughter.
7. Contains gentamicin as preservative.
8. As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.
9. 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.Technical inquiries should be directed to Pfizer Animal Health Technical Services, (800) 366-5288 (USA), (800) 461-0917 (Canada).For veterinary use only
U.S. Veterinary License No. 189
Pfizer Animal Health
Exton, PA 19341, USA
Div. of Pfizer Inc
NY, NY 10017988
75

ADVANTAGES: Provides proven 4-way, modified live virus (MLV) protection for respiratory disease caused by IBR, BVD, PI and BRSV. Provides single-dose protection against highly virulent BVD Type 1 and 2 strains. The MLV strain of IBR virus in Bovi-Shield 4 stimulates circulating antibodies and cellular immunity, a dual immune response that optimizes protection by killing IBR virus-infected cells and exposing them to circulating antibodies. The MLV antigens in Bovi-Shield 4 stimulate killer T-cells in the body, providing important cell-mediated immunity that aids in the prevention of IBR abortion. The BRSV component provides protection against respiratory disease of increased severity in cases of concurrent infection with other respiratory viruses, Haemophilus somnus or Pasteurella. Vaccinating nursing calves with Bovi-Shield 4 is a safe and effective way to protect calves prior to peak stress, without risking the pregnancy of their dams, if used according to label directions. Bovi- Shield 4 does not cause post-vaccination reactions at the injection site and was proven as safe as a placebo when administered to 1-week-old calves. Texas A&M ranch-to-rail data showed that compared to sick or treated calves, healthy, quality calves posted advantages of: -$17 efficiency in cost of gain/head - $23 savings in medicine cost/head - 14% more choice carcasses - $117 greater profitablilty/head. Unlike some MLV vaccines, there is no age restriction on use of Bovi-Shield Vaccines. Buyers pay more for calves vaccinated against viral respiratory diseases. Colorado State University research showed that weaned, vaccinated calves sold for $21 a head more than non-Vaccinated, unweaned calves. Vial sizes include a convenient, cost-effective 100 dose vial, allowing cattle to be worked faster and more efficiently. -4156-01