FluSure/RespiSure/ER Bac Plus

This page contains information on FluSure/RespiSure/ER Bac Plus for veterinary use.
The information provided typically includes the following:
  • FluSure/RespiSure/ER Bac Plus Indications
  • Warnings and cautions for FluSure/RespiSure/ER Bac Plus
  • Direction and dosage information for FluSure/RespiSure/ER Bac Plus

FluSure/RespiSure/ER Bac Plus

This treatment applies to the following species:
Manufacturer: Zoetis

Swine Influenza Vaccine, H1N1 & H3N2

Killed Virus

Erysipelothrix Rhusiopathiae-Mycoplasma Hyopneumoniae Bacterin

For use in swine only

PRODUCT DESCRIPTION: FluSure/RespiSure/ER Bac Plus is for vaccination of healthy swine, including pregnant sows and gilts, 3 weeks of age or older as an aid in preventing respiratory disease caused by swine influenza virus (SIV) subtypes H1N1 and H3N2, erysipelas caused by Erysipelothrix rhusiopathiae for a period of 20 weeks, and respiratory disease caused by Mycoplasma hyopneumoniae. Vaccination with FluSure/RespiSure/ER Bac Plus has been shown to reduce clinical signs, lung lesions, viral shedding (numbers of animals and numbers of days) and viral persistence in the lung following challenge with either SIV H1N1 or H3N2. A duration of immunity of at least 10 weeks, as demonstrated by a significant reduction in lung lesions, has been established against SIV H3N2. FluSure/RespiSure/ER Bac Plus is a freeze-dried preparation containing 2 type A field isolates, subtypes H1N1 and H3N2, of inactivated swine influenza viruses grown in an established cell line, plus a liquid preparation of a chemically inactivated whole cell culture of M. hyopneumoniae and a serum-free, clarified E. rhusiopathiae culture. The liquid component contains Amphigen®, a unique oil-in-water adjuvant to enhance the immune response, and is used to rehydrate the freeze-dried vaccine.

DISEASE DESCRIPTION: Swine influenza (SI) is an acute respiratory disease caused by Type A influenza viruses. In the USA, 2 subtypes of SIV (H1N1 and H3N2) have emerged as the major disease-causing agents. SIV and M. hyopneumoniae are both common components of porcine respiratory disease complex (PRDC). A typical outbreak of SI is characterized by sudden onset and rapid spread within herds. Clinical signs include depression, anorexia, coughing, fever (105-107°F/40.5-41.7°C) and serous discharge from the eyes and nose. The duration of the disease is usually 5-7 days. While clinical signs can be severe, recovery is generally rapid and death loss is usually less than 1%. However, SIV does predispose animals to secondary infections. The virus multiplies in the epithelial cells lining the bronchi and bronchioles causing necrosis of these cells.1 Gross lung lesions appear firm and purple and are indistinguishable in many cases from M. hyopneumoniae lesions. Laboratory testing is required for definitive diagnosis.

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%2-93%.3 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.4 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 if sows are 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.5

SAFETY AND EFFICACY: The safety of FluSure/RespiSure/ER Bac Plus in pigs 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 safety of FluSure/RespiSure/ER Bac Plus in pregnant sows and gilts was also demonstrated in 3 field safety studies conducted in 3 different geographic locations. Four hundred thirty-one sows and gilts were vaccinated at 6-7 and 3-4 weeks prior to farrowing. No abortions associated with vaccination were observed, and the percentage of animals farrowing and the number of pigs born alive, dead, and mummified were unaffected by vaccination.

Efficacy of FluSure/RespiSure/ER Bac Plus was demonstrated in 2 host animal challenge studies. Pigs were vaccinated at 3-15 days of age and again 14 days later. Sixteen days following the second vaccination, the pigs were challenged with a heterologous isolate of either SIV H1N1 or H3N2. Pigs were necropsied 5 days postchallenge and lung damage evaluated. As compared to nonvaccinated controls, pigs vaccinated with FluSure/RespiSure/ER Bac Plus had significantly lower rectal temperatures, clinical signs, and lung lesion scores following challenge with either SIV H1N1 or H3N2. Study results are presented in Tables 1-4.

H1N1 Challenge Study:

Table 1. H1N1 serum hemagglutination inhibition geometric mean titers:

 

Day 0*

Day 14

Day 28

Day 35

Controls

5.0**

5.0

5.0a

11.7a

Vaccinates

5.2

5.7

49.5b

49.4b

* Day 0 = Day of first vaccination

** Titers of < 10 were factored as 5.0 in calculation of geometric mean titers.

a,bGeometric mean titers within the same column with different lower-case superscripts are significantly different.

Table 2. Mean percent lung damage and frequency of clinical signs:

 

Mean percent lung damage*

Frequency of animals with at least 1 clinical sign** postchallenge

Controls

23.41a

9/18a

Vaccinates

5.04b

0/19b

* Back-transformed least-squares means

** Depression and/or rapid breathing and/or persistent coughing

a,bNumbers within the same column with different lower-case superscripts are significantly different.

H3N2 Challenge Study:

Table 3. H3N2 serum hemagglutination inhibition geometric mean titers:

 

Day 0*

Day 14

Day 28

Day 35

Controls

5.0**

5.0a

5.9a

9.7a

Vaccinates

5.0

7.5b

267.2b

166.3b

* Day 0 = Day of first vaccination

** Titers of < 10 were factored as 5.0 in calculation of geometric mean titers.

a,bGeometric mean titers within the same column with different lower-case superscripts are significantly different.

Table 4. Mean percent lung damage and frequency of clinical signs:

 

Mean percent lung damage*

Frequency of animals with at least 1 clinical sign** postchallenge

Controls

33.43a

13/20a

Vaccinates

0.65b

0/19b

* Back-transformed least-squares means

** Depression and/or rapid breathing and/or persistent coughing

a,bNumbers within the same column with different lower-case superscripts are significantly different.

Directions For Use

1. General Directions: Vaccination of all pigs on the premises is recommended to enhance herd immunity. Shake diluent before use. Aseptically rehydrate the freeze-dried vaccine with the liquid bacterin provided, shake well, and 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 Flusure™/ER Bac Plus® approximately 3 weeks later. In young pigs, vaccinate after maternally derived antibodies to SIV and 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.

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 or rehydrated.

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.

References

1. Easterday BC, Van Reeth K: Swine Influenza. In: Straw BE, D’Allaire S, Mengling WL, et al. (eds.) Disease of Swine, 8th Edition, pp. 277-290. ISU Press, Ames, Iowa USA.

2. Gois M, Kuksa F, Sisak F: Microbial findings in the lungs of slaughter pigs. Proc 6th Int Congr Pig Vet Soc, Copenhagen, 6:214, 1980.

3. Yamamoto K, Ogata M: Mycoplasmal and bacterial flora in the lungs of pigs. Proc 7th Int Congr Pig Vet Soc, Mexico City, 7:94, 1982.

4. Ross, RF: Mycoplasmal Diseases. In: Straw BE, D’Allaire S, Mengling WL, et al. (eds.) Diseases of Swine, 8th Edition, pp. 495-509. ISU Press, Ames, Iowa USA.

5. Wood RL: Erysipelas. In: Straw BE, D’Allaire S, Mengling WL, et al. (eds.) Diseases of Swine, 8th Edition. Ames, Iowa: Iowa State University Press, 419-430, 1999.

Technical inquiries should be directed to Zoetis Inc. Veterinary Services, (888) 963-8471.

For veterinary use only

U.S. Veterinary License No. 190

Zoetis Inc., Kalamazoo, MI 49007

75-0784-01

Presentation: 50 dose (100 mL) vials.

NAC No.: 36902352

ZOETIS INC.
333 PORTAGE STREET, KALAMAZOO, MI, 49007
Telephone:   269-833-4000
Customer Service:   800-733-5500 and 800-793-0596
Veterinary Medical Investigations & Product Support:   800-366-5288
Technical Services (USA):   800-366-5288
Website:   www.zoetis.com
Every effort has been made to ensure the accuracy of the FluSure/RespiSure/ER Bac Plus information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-04-11

(web4)