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ONE SHOT ULTRA® 8

CLOSTRIDIUM CHAUVOEI-SEPTICUM-HAEMOLYTICUM-NOVYI-SORDELLII-PERFRINGENS TYPES C AND D MANHEIMIA HAEMOLYTICA BACTERIN-TOXOID

One Shot Ultra 8 is for vaccination of healthy cattle as an aid in preventing blackleg caused by Clostridium chauvoei, malignant edema caused by Cl. septicum, bacillary hemoglobinuria caused by Cl. haemolyticum, black disease caused by Cl. novyi, gas-gangrene caused by Cl. sordellii, enterotoxemia and enteritis caused by Cl.perfringens types B, C, and D, and bovine pneumonia caused by Mannheimia (Pasteurella) haemolytica type A1. Although Cl. perfringens type B is not a significant problem in North America, immunity is provided by the beta toxoid of type C and the epsilon toxoid of type D. The freeze-dried component is a preparation of inactivated whole cultures of M. haemolytica propagated to increase the production of leukotoxin and capsular and cell-associated antigens. The liquid component consists of killed, standardized cultures of Cl. chauvoei, Cl. septicum, Cl. haemolyticum, Cl. novyi, Cl. sordellii, and Cl. perfringens types C and D, with a special, water-soluble adjuvant (Stimugen®) to enhance the immune response.

Uses

Aids in the prevention of diseases caused by the clostridial agents (Clostridium chauvoei, Cl. septicum, Cl. haemolyticum, Cl. novyi, Cl. sordellii, Cl. perfringens types B, C and D) and bovine pneumonia caused by Mannheimia haemolytica Type A1.

Efficacy of One Shot Ultra 8 against M. haemolytica was demonstrated in a challenge-of-immunity study. Cattle (300-550 lb) vaccinated with one dose of One Shot Ultra 8 were subjected to severe experimental challenge at two weeks post vaccination with a heterologous strain of M. haemolytica type A1.
Four days post-challenge, animals were necropsied and individual lungs were
evaluated for lung damage and lesions characteristic of M. haemolytica type
A1 infection. Vaccinates demonstrated a statistically significant reduction
(82.6%) in lung damage compared to animals receiving a placebo. Immunogenicity
of the clostridial fractions was confirmed by serologic studies

Key Features

• Helps prevent eight clostridial diseases (including diseases caused by CI. haemolyticum and CI perfringens Types B, C, and D), which continue to be of economic importance in cattle.  Clostridium bacteria are universally present and produce potent toxins that can result in rapid death of otherwise healthy animals.
• Helps protect against the primary cause of respiratory death in cattle, shipping fever and pneumonia caused by Mannheimia haemolytica Type A1.
• Produces leukotoxin and whole-cell antibody responses, helping provide protection needed to withstand Mannheimia haemolytica challenge.
• Contains Stimugen®, a patented, water-soluble adjuvant that enhances the immune response with minimal risk of injection-site reactions.
• No age restrictions on use.
• Subcutaneous (SC) dose is 2 mL followed by a second 2-mL dose of UltraChoice® 8 four to six weeks later.
• For CI. haemolyticum, repeat the dose every six months in animals subject to re-exposure.

Packaging: 50-dose vials.

Directions

1. General directions: Vaccination of healthy cattle is recommended. Aseptically rehydrate the freeze-dried bacterin-toxoid (One Shot Ultra 8) with the accompanying vial of diluent (UltraChoice 8), shake well, and administer 2 mL subcutaneously. In accordance with Beef Quality Assurance guidelines, this product should be administered subcutaneously (SC) under the skin.
2. Primary vaccination: Administer a single 2-mL dose to healthy cattle, followed by a second 2-mL dose of UltraChoice 8 four to six weeks later. For Cl. haemolyticum repeat the dose every 6 months in animals subject to reexposure.
3. Revaccination: Annual revaccination with a single dose of UltraChoice 8 is recommended. Good management practices support revaccination with One Shot® whenever subsequent stress or exposure is likely.
4. Good animal husbandry and herd health management practices should be employed.

Precautions

1. Store 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 bacterin-toxoid.
4. Do not vaccinate within 21 days before slaughter.
5. Not for use in sheep.
6. Contains formalin as a preservative.
7. Temporary local swelling at injection site may occur after administration.
8. Field reports and a clinical study indicate that a transient reduction in milk production may occur following vaccination of lactating dairy cattle.
9. As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.
10. 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 bacterin-toxoid is not administered in accordance with label directions.

Important Safety Information

In safety studies involving 595 animals, no untoward reactions were noted following vaccination. Vaccination did result in small, temporary injection site swellings.

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