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Zoetis

ER Bac Plus-250 Dose

ER Bac Plus-250 Dose

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For vaccination of healthy swine 3 weeks or older as an aid in preventing disease caused by Erysipelas rhusiopathiae for a period of 20 weeks.

Dosage: 2 ml IM, repeat in 3-4 weeks. Revaccinate semiannually. 21-day slaughter withdrawal.

Size: 250 Dose

Manufacturer and/or Label Information

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.
ER Bac® Plus

Zoetis

Erysipelothrix Rhusiopathiae Bacterin

For use in swine only

PRODUCT DESCRIPTION: ER Bac Plus is for vaccination of healthy swine 3 weeks of age or older as an aid in preventing disease caused by Erysipelothrix rhusiopathiae for a period of 20 weeks following the second dose in the vaccination regimen. ER Bac Plus is a liquid, serum-free, clarified bacterin that has been chemically inactivated and combined with the adjuvant Amphigen® to enhance the immune response.

DISEASE DESCRIPTION: Erysipelas is caused by the bacterium E. rhusiopathiae and has been identified as a pathogen in swine since 1878. The disease is worldwide in distribution and is of economic importance throughout Europe, Asia, Australia, and North and South America. Swine 3 months through 3 years of age are most susceptible to erysipelas; outbreaks are usually more severe in herds on soil and during periods of wet weather. Erysipelas can take one of several forms or a combination of the following forms. Acute erysipelas is a general infection by E. rhusiopathiae in the bloodstream. This form often causes sudden death. Abortion may result in sows infected during pregnancy. Skin erysipelas manifests as diamond-shaped patches of swollen, purple skin on a pig’s body, especially the belly and thighs. If the tips of the ears and tail are affected, tissues may die and slough. Arthritic erysipelas is a chronic disease occurring in pigs that have survived acute erysipelas. Affected pigs often have swollen and stiff joints. They do not gain weight efficiently, and their carcasses are often trimmed or condemned by inspectors at packing houses. Cardiac erysipelas usually occurs in older pigs raised on farms where the chronic form exists. Cardiac erysipelas may result in growths on the heart valves altering the normal flow of blood.

SAFETY AND EFFICACY: In laboratory and field safety studies of ER Bac Plus, no serious adverse reactions to vaccination were reported. Efficacy of ER Bac Plus was demonstrated in 2 host animal studies conducted by Zoetis Inc.; an immunogenicity study and a duration-of-immunity study demonstrating efficacy 20 weeks after second vaccination. Pigs vaccinated with ER Bac Plus, followed by challenge, had significantly fewer clinical signs of disease, including death, lesions, and fever, than nonvaccinated control pigs in both of the following studies. Host animal immunogenicity study: The purpose of this study was to demonstrate protection against challenge with virulent E. rhusiopathiae 2 1/2 weeks after the second vaccination. Pigs were vaccinated at approximately 3 and 6 weeks of age. Pigs were monitored daily for rectal temperature and for clinical signs of disease. Ten of 10 control pigs (100%) were determined to be positive for infection after challenge. Nineteen of 20 vaccinated pigs (95%) were protected. These results indicate that vaccination with ER Bac Plus with Amphigen provided significant protection from challenge 2 1/2 weeks after vaccination. (Tables 1 and 2).

Table 1. Results of E. rhusiopathiae Challenge in Control Pigs (100% positive).

Control Pigs

2 days*

1 day only

Clinical signs**

Mortality/Euthanasia

Treated

Organism isolation

10

7

3

8

3

7

3

* Elevation in rectal temperature above 40.9°C (105.6°F) on 2 consecutive days.

** Clinical signs included recumbent, depressed, and/or metastatic skin lesions.

Table 2. Results of E. rhusiopathiae Challenge 2 1/2 Weeks Postvaccination (95% protected).

Vaccinated Pigs

2 days*

1 day only

Clinical signs**

Mortality/Euthanasia

Treated

Organism isolation

20

1

0

0

0

1

Not Sampled

* Elevation in rectal temperature above 40.3°C (104.6°F) on 2 consecutive days.

** Clinical signs included recumbent, depressed, and/or metastatic skin lesions.

Duration-of-immunity study: The purpose of this study was to demonstrate protection against challenge with virulent E. rhusiopathiae in a duration-of-immunity study 20 weeks after the second vaccination or at approximately market weight (26 weeks of age). Pigs were vaccinated at approximately 3 and 6 weeks of age. Pigs were monitored daily for rectal temperature and for clinical signs of disease. Nine of 10 control pigs (90%) were determined to be positive for infection after challenge. Fifteen of 20 vaccinated pigs (75%) were protected. These results indicate that vaccination with ER Bac Plus with Amphigen provided significant protection from challenge 20 weeks after vaccination. (Tables 3 and 4).

Table 3. Results of E. rhusiopathiae Challenge in Control Pigs (90% positive).

Control Pigs

2 days*

1 day only

Clinical signs**

Mortality/Euthanasia

Treated

Organism isolation

10

3

4

9

7

3

5

* Elevation in rectal temperature above 40.9°C (105.6°F) on 2 consecutive days.

** Clinical signs included recumbent, depressed, and/or metastatic skin lesions.

Table 4. Results of E. rhusiopathiae Challenge in 26-week-old Pigs (75% protected).

Vaccinated Pigs

2 days*

1 day only

Clinical signs**

Mortality/Euthanasia

Treated

Organism isolation

20

3

5

5

1

4

1

* Elevation in rectal temperature above 40.3°C (104.6°F) on 2 consecutive days.

** Clinical signs included recumbent, depressed, and/or metastatic skin lesions.

DIRECTIONS:

1. General Directions: Shake well. Aseptically administer 2 mL intramuscularly.

2. Primary Vaccination: Healthy swine 3 weeks of age or older should receive two 2-mL doses administered 3-4 weeks apart.

3. Revaccination: Semiannual revaccination with single dose is recommended.

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 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.

Technical inquiries should be directed to Zoetis Inc. Technical Services, (888) 963-8471 (USA), (800) 461-0917 (Canada).

For veterinary use only

U.S. Veterinary License No. 190

Zoetis Inc., Kalamazoo, MI 49007, USA

30388100

Presentation: 50 dose (100 mL) and 250 dose (500 mL) vials.

CPN: 3690033.4
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

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