Spirovac
Leptospira Hardjo Bacterin, cattle (including pregnant and/or lactating cows) older than 4 weeks. Meat withdrawal: 21 days.
SPIROVAC�
Zoetis
Leptospira Hardjo Bacterin
PRODUCT DESCRIPTION: Spirovac is for vaccination of healthy cattle 4 weeks of age or older, including those pregnant and/or lactating, for the prevention of infection by Leptospira borgpetersenii serovar hardjo, including reproductive and renal tract colonization, and urinary shedding for up to 12 months. Vaccination with Spirovac also aids in the prevention of fetal infection. Spirovac contains chemically inactivated whole cultures of L. borgpetersenii serovar hardjo-bovis.
DISEASE DESCRIPTION: Infection with L. borgpetersenii serovar hardjo (type hardjo-bovis), previously classified as Leptospira interrogans serovar hardjo, is the primary cause of leptospirosis of cattle in the United States1-2 and in much of the world.3 L. borgpetersenii serovar hardjo is also an important zoonotic disease causing a flu-like syndrome in humans and is recognized as an important occupational disease in many industrial countries.3 Cattle are the primary reservoir for L. borgpetersenii serovar hardjo, resulting in maintenance infections that are often chronic and subclinical in nature but that can cause economic loss to cow-calf and dairy operations.4
The disease is usually transmitted by direct or indirect contact with leptospira-infected urine or can be sexually transmitted. In calves, clinical signs of leptospirosis may include fever, prostration, loss of appetite, shortness of breath, anemia, and blood in the urine. In adult cattle, clinical signs include decreased milk production and reproduction loss, including abortions, stillbirths, weak calves, and infertility.4-7
SAFETY AND EFFICACY: The safety of Spirovac was demonstrated in field studies representing different management practices in three different geographic locations in the United States. A total of 1431 beef and dairy cattle were evaluated where 615 calves (224 calves were between 4 and 4 1/2 weeks of age) and 816 cows (804 were pregnant) were vaccinated according to label recommendations. Safety in each trimester of pregnancy was established in dairy cows: 212 cows in the first trimester, 245 cows in the second trimester, and 144 cows in the third trimester. No systemic reactions or significant injection site reactions were observed in vaccinated animals.
DIRECTIONS:
1. General Directions: Vaccination of healthy cattle is recommended. Shake well. Aseptically administer 2 mL subcutaneously. In accordance with Beef Quality Assurance guidelines, this product should be administered subcutaneously (under the skin) in the neck.
2. Primary Vaccination: Healthy cattle should receive 2 doses administered 4-6 weeks apart. When used as an aid in preventing fetal infection, administer the second dose at least 2 weeks prior to breeding.
3. Revaccination: Annual revaccination with a single dose is recommended.
4. Good animal husbandry and herd health management practices should be employed.
PRECAUTIONS:
1. Store away from light at 2�-7�C. Prolonged exposure to higher temperatures may adversely affect potency. Do not freeze.
2. Use entire contents when first opened.
3. Sterilized syringes and needles should be used to administer this vaccine.
4. Do not vaccinate within 21 days before slaughter.
5. As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.
6. 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.
