FarrowSure Plus B (Canada)

Manufacturer: Pfizer

Parvovirus Vaccine

Killed Virus

Erysipelothrix Rhusiopathiae-leptospira-bratislava-canicola-grippotyphosa-hardjo-icterohaemorrhagiae-pomona Bacterin

For use in swine only

Product Description

FarrowSure Plus B is for vaccination of healthy breeding swine as an aid in preventing reproductive failure caused by porcine parvovirus (PPV), erysipelas caused by Erysipelothrix rhusiopathiae, and leptospirosis caused by Leptospira bratislava, L. canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae and L. pomona. A 26-week duration of immunity following vaccination has been demonstrated against erysipelas. FarrowSure Plus B is a liquid preparation of porcine parvovirus grown in an established porcine cell line, a serum-free, clarified E. rhusiopathiae culture, and whole cell cultures of the 6 Leptospira serovars identified above. The antigens have been chemically inactivated and adjuvanted with 2 adjuvants, including Amphigen^®, to enhance the immune response.

Disease Description

PPV and Leptospira are common agents of reproductive loss in swine. While infection with either of these pathogens may produce subclinical disease, infection with PPV during pregnancy may result in fetal resorption, fetal mummification and stillbirths. Infection by Leptospira during the second half of pregnancy may cause abortions and stillbirths; late-term abortions are the most important economic effect of leptospirosis. Leptospirosis caused by any of the serovars represented here cannot be clinically differentiated. Abortions may also occur in sows infected with E. rhusiopathiae during pregnancy.

Safety And Efficacy

The safety of FarrowSure Plus B was demonstrated under both controlled laboratory and field conditions. No serious systemic or allergic reactions were observed following vaccination. In field studies, 1191 sows and gilts were vaccinated with FarrowSure Plus B. Approximately 10% of the sows and gilts vaccinated exhibited transient local swelling at the site of injection 24 hours after vaccination under field conditions. By 21 days after vaccination, less than 1% of sows and gilts exhibited swelling at the injection site. Efficacy of the fractions of FarrowSure Plus B was demonstrated in controlled challenge-of-immunity and immunogenicity tests. Serologic responses to all components of FarrowSure Plus B were compared to those of FarrowSure B. In all cases FarrowSure Plus B stimulated higher antibody titers than FarrowSure B. These results are summarized in Table 1.

Table 1. Comparison Of Farrowsure B And Farrowsure Plus B Geometric Mean Titers And The Lower 95% Confidence Limit (cl) Of The Difference As A Percent Of The Farrowsure B Titer

Antigen	Farrowsure B	Farrowsure Plus B	Lower 95% Cl
E. rhusiopathiae	552.8	2305.8	279.9
Porcine Parvovirus	53.2	124.6	145.0
L. bratislava	1024.0	6109.9	384.8
L. canicola	9.6	47.7	242.5
L. grippotyphosa	147.0	1262.2	439.9
L. hardjo	4.2	121.4	1322.0
L. icterohaemorrhagiae	157.6	650.8	256.2
L. pomona	9.0	37.6	195.0

Duration Of Immunity

In addition to the above studies, duration-of-immunity studies in pigs were conducted for the E. rhusiopathiae fraction. The purpose of these studies was to demonstrate protection against challenge with virulent E. rhusiopathiae 20 and 26 weeks after the second vaccination with FarrowSure Plus B.

20 Week Duration-of-immunity Study

Four to 5-month-old pigs received 2 doses approximately 3 weeks apart, followed by challenge with virulent E. rhusiopathiae 20 weeks after the second vaccination. Following challenge, pigs were monitored daily for rectal temperature and clinical signs of disease. Eight of 10 control pigs (80%) were determined to be positive for infection following challenge. Eighteen of 20 vaccinated pigs (90%) were protected.

26 Week Duration-of-immunity Study

Four to 5-month-old pigs received 2 doses approximately 3 weeks apart, followed by challenge with virulent E. rhusiopathiae 26 weeks after the second vaccination. Following challenge, pigs were monitored daily for rectal temperature and clinical signs of disease. Seven of 10 control pigs (70%) were determined to be positive for infection after challenge. Seventeen of 20 vaccinated pigs (85%) were protected. Results of these studies are illustrated in Tables 2 and 3.

Table 2. Results Of e. Rhusiopathiae Challenge In Control Pigs

Study	No. Of Control Pigs	# Positive	# Protected	% Protected
20-week	10	8	2	20%
26-week	10	7	3	30%

Control pigs were considered to be positive for erysipelas if they met one or more of the following criteria: 1) Two consecutive days of temperatures at or above 40.9°C (105.6°F); 2) Sudden death following evidence of systemic erysipelas (including less than 2 consecutive days of elevated temperatures and/or systemic clinical signs); or 3) Recovery of E. rhusiopathiae from the spleen or liver.

Table 3. Results Of e. Rhusiopathiae Challenge In Vaccinated Pigs

Study	No. Of Vaccinated Pigs	# Positive	# Protected	% Protected
20-week	20	2	18	90%
26-week	20	3	17	85%

Vaccinated pigs were considered to be protected if they were free of the following criteria: 1) Two consecutive days of temperatures at or above 40.3°C (104.6°F); 2) Sudden death following evidence of systemic erysipelas (including less than 2 consecutive days of elevated temperatures and/or systemic clinical signs); or 3) Recovery of E. rhusiopathiae from the spleen or liver.

Directions

1. General Directions: Shake well. Aseptically administer 5 mL intramuscularly.

2. Primary Vaccination: Healthy swine should receive 2 doses 3-5 weeks apart with the second dose administered 2-4 weeks prior to breeding. Healthy gilts, however, should receive the second dose as near as possible to 14 days prior to breeding.

3. Revaccination: Revaccination with a single dose is recommended prior to subsequent breedings. Boars should be revaccinated semiannually.

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. Contains gentamicin as preservative.

6. Temporary swelling at the injection site may be observed.

7. As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.

8. 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 Pfizer Animal Health Technical Services, (800) 366-5288 (USA), (800) 461-0917 (Canada).

For veterinary use only

U.S. Veterinary License No. 189

Pfizer Animal Health, Exton, PA 19341, USA, Div. of Pfizer Inc., NY, NY 10017

75-5141-13

^® Registered trademark of Pfizer Products Inc; Pfizer Canada Inc., licensee

Presentation

10 doses and 50 doses.

Nac No.

11982511