Express FP 3-VL5 HB

Company: Boehringer Ingelheim Animal Health

Bovine Rhinotracheitis-Virus Diarrhea Vaccine

Modified Live Virus

Campylobacter Fetus-Leptospira Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

BEEF & DAIRY CATTLE

Express FP 3-VL5 HB Indications

This product has been shown to be effective for the vaccination of healthy cattle, including pregnant cows, against reproductive and respiratory disease due to infectious bovine rhinotracheitis (IBR) and bovine virus diarrhea types 1 and 2 (BVD1 & BVD2); against reproductive disease due to Campylobacter fetus var. venerealis; and against 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 against IBR-induced abortion and against BVD1b & BVD2, including persistently infected calves, is at least 12 months. The duration for the remaining organisms 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 abortion due to IBR; against persistently infected calves due to BVD1b & BVD2; against infertility, delayed conception, or abortion due to C. fetus var. venerealis; and against urinary shedding of L. borgpetersenii serovar hardjo (type hardjo-bovis). 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 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 within the past 12 months.

Composition

The amber glass vial contains IBR, BVD1 (Singer 1a cytopathic), and BVD2 (296 cytopathic) modified live viruses (MLV). The plastic vial contains C. fetus and the Leptospira organisms listed, in an adjuvant system. Neomycin and thimerosal added as preservatives.

Directions and dosage: Mix the accompanying bottle of diluent. Rehydrate the vaccine by aseptically adding the diluent to the vaccine vial. Mix well and use immediately. Using aseptic technique, inject 2 mL subcutaneously or intramuscularly. For cows or heifers, vaccinate at or about 4 weeks prior to breeding. If using subcutaneous route, inject in front of the shoulder and midway of the neck, away from the suprascapular lymph node. If initial vaccination, repeat with Citadel^® VL5 vaccine (C. fetus-Leptospira) in 14 to 28 days. Contact your veterinarian or the manufacturer for information on revaccination frequency.

Precautions

Store out of direct sunlight at 35-46°F (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. Injection site swelling may occur. Stressed cattle should not be vaccinated. In case of anaphylactoid reaction, administer epinephrine. In case of human exposure, contact a physician. Inactivate unused contents before disposal.

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.

No vaccine can be expected to have 100% efficacy under all conditions. A small number of calves persistently infected with BVD may have a devastating effect on herd health.

Note: It is possible that healthy-appearing cattle can be persistently infected with or incubating virulent BVD virus at the time of vaccination. In view of these findings and suggested causes, BVD vaccine is contraindicated in persistently infected cattle and use should be limited only to healthy, immunocompetent, unstressed cattle.

Express^® and Citadel^® are registered trademarks of Boehringer Ingelheim Animal Health USA Inc.

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

Phone: 1 (888) 637-4251

VLN/PCN 124/4141.20

CPN: 1028168.4