RespiSure-One/ER Bac Plus-50 Dose

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.
RESPISURE 1 ONE®/ER BAC PLUS®

Zoetis

Erysipelothrix Rhusiopathiae-Mycoplasma Hyopneumoniae Bacterin

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

Description: RESPISURE-ONE®/ER BAC PLUS® is a liquid preparation of a chemically inactivated whole cell culture of Mycoplasma hyopneumoniae and a serum-free, clarified Erysipelothrix rhusiopathiae culture, plus Amphigen®, a unique oil-in-water adjuvant to enhance the immune response.

Indications: RESPISURE-ONE®/ER BAC PLUS® is for vaccination of healthy swine 3 weeks of age or older as an aid in preventing erysipelas caused by E. rhusiopathiae for a period of 20 weeks and respiratory disease caused by M. hyopneumoniae for a period of 23 weeks.

Directions:

1. General Directions: Vaccination of all pigs on the premises is recommended to enhance herd immunity. Shake well. Aseptically administer 2 mL intramuscularly.

2. Primary Vaccination: Administer a single 2 mL dose to healthy swine 3 weeks of age or older, followed by a single dose of ER Bac Plus® approximately 3 weeks later. In young pigs, vaccinate after maternally derived antibodies to E. rhusiopathiae have declined.

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

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 or rehydrated.

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.

For use in swine only.

For veterinary use only.

Warning(s): Do not vaccinate within 21 days before slaughter.

Discussion: Disease Description: Mycoplasmal pneumonia of swine (MPS), or enzootic pneumonia, is a widespread, chronic disease characterized by coughing, growth retardation, and reduced feed efficiency. The etiologic agent is M. hyopneumoniae; however, the naturally occurring disease often results from a combination of bacterial and mycoplasmal infections.

MPS causes considerable economic loss in all areas where swine are raised. Surveys conducted at various locations throughout the world indicate that lesions typical of those seen with MPS occur in 30%-80% of slaughter-weight swine. Because mycoplasmal lesions may resolve before hogs reach slaughter weight, the actual incidence may be higher. The prevalence of M. hyopneumoniae infection in chronic swine pneumonia has been reported to range from 25%1-93%.2 Pigs of all ages are susceptible to MPS, but the disease is most common in growing and finishing swine. Current evidence indicates that M. hyopneumoniae is transmitted by aerosol or direct contact with respiratory tract secretions from infected swine. Transmission from sow to pig during lactation is possible.3 Once established, MPS occurs year after year in infected herds, varying in severity with such environmental factors as season, ventilation, and concentration of swine.

Clinical signs of MPS include a chronic, nonproductive cough continuing for weeks or months, unthrifty appearance, and retarded growth, even though the appetites of infected swine remain normal. Stunting may occur, resulting in considerable variation in size among affected pigs. Death loss associated with secondary bacterial infection and stress may occur.

M. hyopneumoniae causes a loss of ciliary motility in the bronchial passages. Eventually the cilia are destroyed, resulting in reduction in natural defense in the upper respiratory tract and increased susceptibility to secondary infection with bacterial agents such as Pasteurella multocida, Haemophilus parasuis, Actinobacillus pleuropneumoniae, and Bordetella bronchiseptica. Swine lungworm and roundworm larvae infections may also increase the severity of MPS.

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.4

Trial Data: Safety and Efficacy: The safety of RESPISURE-ONE®/ER BAC PLUS® was demonstrated in 3 field safety studies conducted in 3 different geographic locations. Nine hundred and six pigs were vaccinated at approximately 3 and 6 weeks of age. No injection site reactions or serious systemic reactions were observed following vaccination.

The efficacy of RESPISURE-ONE®/ER BAC PLUS® as an aid in preventing pneumonia caused by M. hyopnuemoniae was demonstrated in host animal challenge studies conducted by Zoetis Inc. Duration-of-immunity studies demonstrated protection against challenge with virulent M. hyopneumoniae up to 23 weeks after a single vaccination in pigs as young as 3 weeks of age. In all studies, vaccinated pigs had significantly lower lung lesion scores than pigs receiving a placebo.

Table 1. Mycoplasma hyopneumoniae Efficacy Studies:

Study

Treatment

No. of Pigs

Vaccination (age in weeks)

Challenge (wks after vacc)

Challenge (age in wks)

% Lung Lesion

1

Placebo

23

3

7

10

9.9a

RESPISURE 1 ONE®/
ER BAC PLUS®

24

3

7

10

1.8b

2

Placebo

20

3

18

21

13.2a

RespiSure 1 One®

19

3

18

21

5.5b

3

Placebo

19

3

23

26

9.0a

RespiSure 1 One®

22

3

23

26

2.1b

a,b Within each study group, values with different superscripts are statistically significant vs. placebo (p≤0.05).

Host animal studies were also conducted to demonstrate the efficacy of RESPISURE-ONE®/ER BAC PLUS® in preventing disease caused by E. rhusiopathiae. Pigs were vaccinated at approximately 3 and 6 weeks of age and challenged at either 4 or 20 weeks post-second vaccination. Pigs were monitored daily for rectal temperature and for clinical signs of disease. In both studies, vaccination provided significant protection from challenge.

Table 2. Erysipelothrix rhusiopathiae Efficacy Studies:

Study

Treatment

No. of Pigs

Challenge (wks after vacc)

Percent of animals with clinical signs of disease

1

Placebo

10

4

100

RESPISURE-ONE®/
ER BAC PLUS®

19

4

0

2

Placebo

10

20

90

ER Bac Plus®

20

20

25

References: Available upon request.

75-0270-00

Presentation: 50 dose (100 mL), 250 dose (500 mL), and 500 dose (1,000 mL) vials.

CPN: 3690201.2COLORADO 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