Pyramid FP 10 (Canada)

Company: Boehringer Ingelheim Animal Health

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial Virus Vaccine

Modified Live Virus

Leptospira Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

BEEF & DAIRY CATTLE

Pyramid FP 10 Indications

This product has been shown to be effective for the vaccination of healthy cattle, including pregnant cows, against infectious bovine rhinotracheitis (IBR), bovine virus diarrhea types 1 and 2 (BVD1 & BVD2), parainfluenza 3 (PI3), bovine respiratory syncytial virus (BRSV), Leptospira canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae, and L. pomona. This product was licensed prior to the requirement to establish a minimum age for use. The duration of immunity has not been determined. For more information regarding efficacy and safety data go to productdata.aphis.usda.gov.

This product has also been shown to be effective against urinary shedding of L. borgpetersenii serovar hardjo (type hardjo-bovis) in heifers 10 months of age or older. Vaccinated animals subsequently exposed to L. borgpetersenii serovar hardjo (type hardjo-bovis) have been shown to clear renal infections within 8 weeks of exposure. This product has also been shown to be effective against persistent BVD1 and BVD2 infection of the fetal calf when it is used subcutaneously in the cow or heifer 30 to 60 days pre-breeding. This vaccine may be used in pregnant cows or calves nursing pregnant cows provided the cows were vaccinated pre-breeding, according to label instructions, with any Express^® FP vaccine, Pyramid^® FP 5, Pyramid^® FP 10, Pyramid^® 2 + Type II BVD, or Pyramid^® FP 5 + Presponse^® SQ.

Composition

Contains IBR, BVD1, BVD2, PI3, and BRSV modified live viruses (MLV), and inactivated L. canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae, and L. pomona, with adjuvant. Gentamicin, neomycin, polymyxin B, and thimerosal added as a preservatives.

Directions and dosage: Aseptically rehydrate the vaccine with the accompanying diluent. Mix well. Inject one 2 mL dose subcutaneously using aseptic technique.

Protect animals from exposure for at least 14 days after vaccination. Contact your veterinarian or the manufacturer for information on revaccination frequency.

Fetal health risks associated with vaccination of pregnant animals with this vaccine cannot be unequivocally determined by clinical trials conducted for licensure. Appropriate strategies to address the risks associated with vaccine use in pregnant animals should be discussed with a veterinarian.

Precautions

Store out of direct sunlight at 2-8°C. Do not freeze. Do not mix with other products, except as specified on the label. Use entire contents when first opened. Do not vaccinate within 21 days before slaughter. A small percentage of animals may show transient mild injection site swelling. In case of anaphylactoid reaction, administer epinephrine. In case of human exposure, contact a physician. Inactivate unused contents before disposal.

For use in animals only.

PYRAMID^® and PRESPONSE^® are registered trademarks of Boehringer Ingelheim Animal Health USA Inc, used under license.

EXPRESS^® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.

Manufactured by:

Boehringer Ingelheim Animal Health USA Inc., St. Joseph, MO 64506

Tel.: 1 (888) 637-4251

VLN/PCN 124/4461.22

Distributed by:

Boehringer Ingelheim Animal Health Canada Inc., Burlington ON L7L 5H4

CPN: 1182233.0