Leptoferm-5 Cattle and Swine

ZOETIS INC.
333 PORTAGE STREET, KALAMAZOO, MI, 49007
Telephone: 269-359-4414
Customer Service: 888-963-8471
Website: www.zoetis.com
THIS SERVICE AND DATA ARE PROVIDED "AS IS". DVMetrics assumes no liability, and each user assumes full risk, responsibility, and liability, related to its use of the DVMetrics service and data. See the Terms of Use for further details.
LEPTOFERM-5®

Zoetis

Leptospira Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

U.S. Vet. Lic. No.: 190

Description: LEPTOFERM-5® contains chemically inactivated whole cultures of the 5 Leptospira serovars listed above.

Indications: LEPTOFERM-5® is for vaccination of healthy swine and cattle as an aid in preventing leptospirosis caused by Leptospira canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae, and L. pomona.

Directions:

1. General Directions: Vaccination of healthy swine and cattle is recommended. Shake well. Aseptically 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. Healthy swine should receive 2 doses administered 3-6 weeks apart.

3. Revaccination: Annual revaccination with a single dose is recommended for both species.

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

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

Use entire contents when first opened.

Sterilized syringes and needles should be used to administer this vaccine.

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: Leptospirosis is a worldwide disease of animals and humans and causes serious economic loss to the livestock industry.1 The disease is usually transmitted by direct or indirect contact with leptospire-infected urine.

Leptospirosis in swine is characterized by poor productivity, fever, anemia, kidney inflammation, and abortions; late-term abortions are the most important effect. 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, the most common clinical sign is reproductive loss, including abortion and premature or full-term birth of weak calves. Decreased milk production may also occur.2 Leptospira spp. are known zoonotic pathogens.

All the above Leptospira serovars produce identical clinical signs, yet immunity to leptospirosis is serovar-specific.1 Vaccination against each serovar, therefore, is indicated for protection.

Trial Data: Safety and Efficacy: During developmental tests and in extensive field use of LEPTOFERM-5®, no significant postvaccination reactions were reported.

Although L. hardjo has been isolated from field cases of leptospirosis, attempts to experimentally induce clinical disease with that serovar had yielded unreliable results. Hence, no valid challenge-of-immunity tests on L. hardjo bacterin had been possible. Recent reports, however, have identified a method to induce clinical L. hardjo infection in cattle2 and have also identified 2 distinct genotypes of L. hardjo in cattle.3,4

Accordingly, challenge-of-immunity tests were conducted to determine the efficacy of LEPTOFERM-5® against both L. hardjo genotypes.5 Seventeen healthy heifers were divided into 2 groups of 6 vaccinates each and a group of 5 nonvaccinated controls. Vaccinates were administered the L. hardjo fraction of LEPTOFERM-5® in 1- or 2-dose regimens. Subsequently all cattle were challenged with disease-causing strains of both L. hardjo genotypes. After challenge, leptospires were recovered from the urine of all controls, which continued shedding leptospires in the urine until necropsy at 31-49 days after challenge. Three controls (60%) also experienced fever and developed leptospires in the blood. Conversely, leptospires were not recovered from the urine or kidneys of any vaccinates, and leptospires were recovered from the blood of only 1 vaccinate (8%) for 1 day.

Thus, efficacy of the L. hardjo fraction against both genotypes in cattle was confirmed. These results are similar to results of previously conducted challenge-of-immunity tests on the other 4 fractions of LEPTOFERM-5® in both cattle and swine. In those studies also, vaccinated animals remained healthy after challenge, while nonvaccinated animals developed clinical signs of leptospirosis.

References: Available upon request.

75-4475-02

Presentation: 10 dose and 50 dose vials.

CPN: 3690057.2

COLORADO SERUM COMPANY4950 YORK STREET, P.O. BOX 16428, DENVER, CO, 80216-0428Telephone: 303-295-7527Order Desk: 800-525-2065Fax: 303-295-1923Website: www.colorado-serum.comEmail: colorado-serum@colorado-serum.comTHIS SERVICE AND DATA ARE PROVIDED "AS IS". DVMetrics assumes no liability, and each user assumes full risk, responsibility, and liability, related to its use of the DVMetrics service and data. See the Terms of Use for further details.

TETANUS TOXOID-CONCENTRATED

Colorado Serum

Adjuvanted

GENERAL INFORMATION: This product has been shown to be effective for the vaccination of healthy horses, cattle, sheep, goats, and swine against tetanus. This product was licensed prior to the requirement to establish a minimum age for use. The duration of immunity is unknown. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Safety in pregnant animals is unknown.

Tetanus Toxoid is prepared by detoxifying tetanus toxin in such a manner as to allow the antigenic properties to remain intact. Product is purified, concentrated and adjuvanted to provide a low dose effective immunizing agent.

Each serial is tested for purity, safety, and potency in accordance with USDA requirements.

Tetanus is caused by a neurotoxin produced by growth of Clostridium tetani, an anaerobic (lives without air) micro-organism, in necrotic tissue. Affected animals become stiff, have difficulty swallowing, and have an increased pulse rate. Breathing is labored. Spasmodic contractions of the muscular system occur, such as contracting muscles of the jaw.

Spasmodic contractions of the muscular system occur, such as contracting muscles of the jaw. Thus, the term “lockjaw” is often used. Legs and tail are often stiff with abdominal muscles contracted. Tetanus stricken animals may be unusually sensitive to light and heat. Temperature of the animal generally remains normal, elevating only shortly before death.

Protective antibody levels usually occur about two weeks after the second injection of the primary immunization series. In contrast, administration of Tetanus Antitoxin is recommended for immediate, emergency, passive treatment of exposed animals with unknown vaccination history or with signs of tetanus infection.

DIRECTIONS: Do not vaccinate within 21 days before slaughter. Store at 2-8° C. Do not freeze. Do not mix with other products. Shake well before use. Use entire contents when first opened.

PRECAUTIONS: A transitory local reaction may occur at injection site. Anaphylactoid reaction may occur following administration of products of this nature. If noted, administer adrenalin or equivalent. In case of human exposure, consult a physician.

DOSAGE & ADMINISTRATION: For primary immunization, two doses should be administered subcutaneously or intramuscularly approximately 30 days apart. Use intramuscularly for horses as local reactions are more likely to occur if injected subcutaneously.

Horses: 1 ml IM

Cattle: 1 ml SC or IM

Sheep, Goats, Swine: 0.5 ml SC or IM

Historically, annual single dose revaccination has been recommended. Contact veterinarian for advice.

OTHER INFORMATION: Contains thimerosal and formalin as preservatives. Tetanus Toxoid Concentrate is available in single dose size packaged 10 vials to the carton, and in 10 dose vials.

THE PEAK OF QUALITY SINCE 1923

VLN: 188 / PCN: 8601.00

COLORADO SERUM COMPANY, 4950 York Street, Denver, Colorado 80216

303-295-752

www.colorado-serum.com

Contact us for information on other Colorado Serum Company products. Fine Veterinary Products since 1923.

FOR VETERINARY USE ONLY

Order #

10 - 1 ml vials

10 - 1 dose vials

11411

10 ml

10 doses

11415

CPN: 1101033.3