Pyramid FP 5 + Presponse SQ (Canada)

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

Modified Live Virus

Mannheimia Haemolytica Toxoid

Veterinary use only

Pyramid FP 5 + Presponse SQ Indications

For vaccination of healthy dairy or beef cattle as an aid in the prevention of disease caused by bovine rhinotracheitis virus, bovine viral diarrhea (types 1 and 2), bovine parainfluenza 3, bovine respiratory syncytial virus, and as an aid in the reduction of severity of pneumonic pasteurellosis caused by Mannheimia haemolytica. This product aids in the prevention of persistent BVD types 1 and 2 infection of the fetal calf when used subcutaneously in the cow or heifer 30 to 60 days pre-breeding. 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

This product contains IBR, BVD types 1 and 2, PI3, and BRSV modified live viruses, and M. haemolytica toxoid. Contains neomycin, polymyxin B, and thimerosal as preservatives.

Pyramid FP 5 + Presponse SQ Dosage And Administration

Aseptically rehydrate with the accompanying diluent. Shake well. Inject one 2 mL dose subcutaneously using aseptic technique. Protect animals from exposure for at least 14 days after vaccination. Calves vaccinated under 6 months of age should be revaccinated at 6 months of age. Healthy cattle should be vaccinated a minimum of 14 days prior to shipping or exposure to stress which may precipitate infectious conditions.

For viral fractions, annual revaccination with Pyramid^® FP 5 is recommended. For Mannheimia haemolytica, although only a single dose is necessary to confer immunity, a booster dose with Presponse^® SQ is recommended whenever subsequent stress is likely.

Summary Of Pregnant Cow Safety Study

Safety in pregnant cows and heifers was demonstrated in trials conducted in three separate herds of more than 1,400 cows. Prior to breeding, all animals were vaccinated with Pyramid^® FP 5, a modified live virus (MLV) vaccine containing IBR, BVD types 1 & 2, PI3, and BRSV. During the first, second or third trimester of pregnancy, the animals were vaccinated again. The pregnant cows received either Pyramid FP 5 or a killed virus (KV) IBR, BVD types 1 & 2, PI3, and BRSV vaccine (Triangle^® 4 + Type II BVD).

From pregnancy vaccination through calving, the cows were observed for fetal loss. Fetal loss in both groups was similar with 0.9% in the Pyramid FP 5 vaccinated groups and 1.6% in the KV vaccinated groups. In addition, no abortions due to IBR or BVD were identified in either group. Following birth, each calf’s health was monitored for 30 days. The health of calves born to Pyramid FP 5 vaccinated dams was similar to the health of calves born to the KV vaccinated dams.

Fetal health risks associated with vaccination of pregnant animals with modified live vaccines cannot be unequivocally determined by clinical trials conducted for licensure. Vaccination of pregnant animals with modified live vaccines should be discussed with a veterinarian.

Precautions

Store in dark at 2 - 7°C. Do not freeze. Use entire contents when first opened. A small percentage of animals may show transient mild injection site swelling. Do not vaccinate within 21 days before slaughter. Burn container and all unused contents. In case of anaphylactoid reaction, administer epinephrine.

Presponse^®, Pyramid^® and Triangle® are registered trademarks of Boehringer Ingelheim Vetmedica, Inc. Express^® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH. Used under license.

Manufactured by Boehringer Ingelheim Vetmedica, Inc., St. Joseph, Missouri 64506 U.S.A.

US Vet. Lic. No. 124

Manufactured for Boehringer Ingelheim (Canada) Ltd., Burlington, Ontario L7L 5H4

158706-01

CPN: 1230116.3