ProSystem RCE (Canada)

PORCINE ROTAVIRUS VACCINE

Modified Live Virus

CLOSTRIDIUM PERFRINGENS TYPE C - ESCHERICHIA COLI BACTERIN-TOXOID

Contains 2 Major Rotavirus Serotypes, 4 Major E. coli Pilus Antigens and C. perfringens Toxoid

FOR SOWS AND GILTS ONLY

INTRODUCTION:

This product contains two major Rotavirus serotypes, four major Escherichia coli antigens (K88, K99, F41 and 987P) and Clostridium perfringens Type C toxoid. When used to vaccinate healthy pregnant swine, the Rotavirus, E. coli K88, K99, F41 antigens and Clostridium perfringens Type C toxoid aid in the prevention of rotaviral diarrhea, enterotoxemia and colibacillosis in their nursing piglets. Additionally, the E. coli 987P antigen aids in the prevention of mortality and reduction of clinical disease caused by this serotype in nursing piglets. These etiologic agents are among the most important causes of neonatal porcine diarrhea and they occur very often in combination with each other. When they occur in combination, morbidity and mortality losses often are increased. Furthermore, the diseases may produce similar clinical signs in baby pigs; therefore it is highly desirable to provide broad spectrum protection to nursing pigs. Laboratory confirmation of the cause of baby pig diarrhea is recommended since other viral, bacterial and coccidial agents also can cause similar disease signs.

PRODUCT DESCRIPTION:

The Porcine Rotavirus vaccine contains two modified live G serotypes 5 and 4 of Serogroup A rotavirus, in desiccated form. The C. perfringens-E. coli bacterin-toxoid is a purified, adjuvanted liquid product containing the C. perfringens type C toxoid and four major E. coli pilus antigens - K88, K99, F41 and 987P. Each serial of ProSystem^® CE (C. perfringens - E. coli bacterin-toxoid) is demonstrated to be compatible (non-viricidal) with ProSystem^® Rota (Porcine Rotavirus vaccine) and therefore can be used as a diluent when packaged with the viral vaccine.

SAFETY AND EFFICACY:

Safety and efficacy of the Rotavirus vaccine and C. perfringens-E. coli bacterin-toxoid have been extensively evaluated in experimental tests and in field trials conducted by veterinarians. Both fractions have been demonstrated to be safe for pregnant swine and laboratory animals. Pregnant sows and gilts, when vaccinated intramuscularly with rotavirus, subsequently develop high persisting levels of rotavirus antibody in their milk, thereby aiding in the control of rotaviral diarrhea in their nursing pigs.

Vaccination of pregnant swine with C. perfringens type C toxoid and four major E. coli pilus antigens (K88, K99, F41 and 987P) also greatly reduced the incidence and severity of enterotoxemia and colibacillosis in their litters in experimental tests.

Baby pigs are protected from rotaviral diarrhea, enterotoxemia and colibacillosis by receiving colostral and milk antibodies from vaccinated dams. Therefore, it is mandatory for both viral and bacterial passive immunity that sows and gilts are lactating and baby pigs are nursing.

DOSAGE GUIDELINES: Follow directions carefully.

1. For primary vaccination, each pregnant sow and gilt must receive at least 2 doses of Rotavirus vaccine rehydrated with ProSystem^® CE. Administer one 2 mL dose of the ProSystem^® RCE combination intramuscularly (IM) at 5 weeks and again one 2 mL dose IM at 2 weeks before farrowing. In subsequent farrowings, administer one 2 mL dose intramuscularly about 2 weeks before farrowing.

2. Rehydrate ProSystem^® Rota with the ProSystem^® CE which accompanies the vaccine vial. Shake well before use. To rehydrate the 25 dose ProSystem^® Rota vial, transfer 10-15 mL of the bacterin-toxoid to the vaccine vial. Then return all the vaccine bacterin-toxoid mixture to the 50 mL plastic bacterin-toxoid vial, to provide 25 doses of both ProSystem^® Rota and ProSystem^® CE.

CAUTIONS:

1. Store in the dark at not over 2°-7°C (35°-45°F). Do not freeze.

2. Use entire contents immediately after rehydration. Dispose of containers and all unused vaccine according to local biohazardous waste disposal regulations.

3. Use in healthy pregnant swine only, and do not vaccinate within 21 days before slaughter.

4. Conditions which interfere with lactation adversely affect immunity in baby pigs.

5. If allergic reaction follows use of this product, treat with epinephrine.

6. Although this product has been shown to be efficacious, some animals may be unable to develop or maintain an adequate immune response following vaccination if they are incubating any infectious disease, are malnourished or parasitized, or stressed due to shipment or adverse environmental conditions.

7. Contains gentamicin, polymyxin B and thimerosal as preservatives.

SUPPLIED:

One 10-dose vial each of ProSystem^® Rota and ProSystem^® CE or

One 25-dose vial each of ProSystem^® Rota and ProSystem^® CE.

QUALITY Tested for Purity, Potency, and Safety

INTERVET INC., Omaha, NE 68103 USA

U.S. Veterinary License No. 165A

1 866 683-7838 (Canada)

FOR ANIMAL USE ONLY

06120707-02

12-0028INS

CPN: 12081563