Express FP 5/Somnugen (Canada)

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial Virus Vaccine, Modified Live Virus

Haemophilus Somnus Bacterin

Veterinary Use Only

Express FP 5/Somnugen Indications

For vaccination of healthy cows and replacement heifers prior to breeding for prevention of persistently infected calves caused by bovine viral diarrhea virus types 1 and 2. Four non-cytopathic BVD challenge viruses were used in five different challenge studies to determine the efficacy of this product in preventing persistently infected calves due to BVD types 1 and 2. The challenge viruses included two BVD type 1b and two BVD type 2 strains.

For vaccination of healthy, susceptible cattle as an aid in prevention of respiratory disease caused by infectious bovine rhinotracheitis (IBR) virus, bovine viral diarrhea virus (BVD) types 1 and 2, and bovine respiratory syncytial virus (BRSV), as an aid in reduction of respiratory disease caused by parainfluenza 3 (PI3) virus, and bovine respiratory syncytial virus (BRSV), and as an aid in the prevention of disease caused by Haemophilus somnus. This vaccine may be used in pregnant females or calves nursing pregnant females, provided the females were vaccinated pre-breeding according to label directions with any Express^® FP vaccine with fetal protection indications.

Composition

The product in the amber glass vial contains IBR, BVD type 1 (Singer 1a cytopathic) and type 2 (296 cytopathic), PI3, and BRSV modified live viruses. The plastic vial contains H. somnus in an adjuvant system. Neomycin and thimerosal are used as preservatives.

Directions

Shake the accompanying bottle of bacterin diluent, then rehydrate the modified live virus vaccine by aseptically adding the diluent to the vaccine vial. Shake the rehydrated vaccine and use immediately.

Dosage

Using aseptic technique, inject 2 mL subcutaneously in front of the shoulder and midway of the neck, away from the suprascapular lymph node. If initial vaccination, repeat with any Express^® vaccine containing H. somnus and BRSV modified live virus (MLV) in 14-28 days. Calves vaccinated before 6 months of age should be revaccinated at 6 months. A 2 mL booster dose is recommended annually. Cows and Heifers: Using aseptic technique, annually inject a single 2 mL dose subcutaneously at or about 4 weeks prior to breeding. Pregnant cows and nursing calves may be vaccinated following a pre-breeding vaccination. See Indications. If initial vaccination, see above.

Precautions

Store in dark at 2-7°C. Do not freeze. Use entire contents when first opened. Burn vaccine container and all unused contents. Do not vaccinate within 21 days before slaughter. Stressed cattle should not be vaccinated. Injection site swelling may occur. Anaphylactoid reactions may occur. Antidote: Epinephrine.

Supporting Data, Fetal Protection Study (Nonpregnant females)

Study Design: A fetal protection study was performed using a serial of Express^® FP 5 (IBR, BVD type 1, BVD type 2, PI3 and BRSV modified live virus rehydrated with water diluent) with the BVD 1 and 2 components at minimum immunizing antigen content.

Healthy Angus-cross heifers (N=55) were chosen for use in the trial based upon both negative antibody status and T cell mediated reactivity status to both BVD type 1 and BVD type 2. The heifers were randomly assigned to 4 treatment groups: Group 1A, 18 heifers, vaccinated/challenged BVD type 1; Group 1B, 10 heifers, placebo/challenged BVD type 1; Group 2A, 19 heifers, vaccinated/challenged BVD type 2; Group 2B, 8 heifers, placebo/challenged BVD type 2. Heifers were vaccinated with a single 2 mL subcutaneous dose of Express^® FP 5 or placebo (sterile water) approximately 4 to 7 weeks prior to insemination. Pregnant heifers were challenged intranasally with heterologous strains of either type 1 or type 2 BVD on ~day 75 of gestation.

The heifers were followed for clinical signs and any signs of abortion. Viremia (measured by virus isolation) and leukopenia (defined as a 40% or greater drop in white blood cell counts compared to baseline level) were measured post-challenge in the heifers. Serum samples were obtained from the heifers for determination of antibody titres.

Results: Viremia and Leukopenia results are shown in the following table:

Serum antibody titres are shown in the following table:

The heifers were sacrificed on ~day 150 of gestation (~200 days post-vaccination, ~75 days post-challenge) and the fetuses harvested. All heifers had a viable fetus at the time of sacrifice. Fetal tissues, including spleen, thymus, cerebellum, and heart blood, were tested by virus isolation for the presence of virus.

The results of virus isolations from the fetal tissues are shown in the table below:

Conclusion: Vaccination with Express^® FP 5 gave excellent protection against development of persistently infected calves caused by type 1 and type 2 BVD.

Summary Of Pregnant Cow Safety Study

Safety in pregnant cows and heifers was demonstrated in a field study that utilized more than 1600 cattle from three separate herds, as well as a serological study from a fourth herd. All cows and heifers enrolled in the study were vaccinated prior to breeding with Express^® FP 10, a modified live virus (MLV) vaccine containing IBR, BVD 1, BVD 2, PI3, and BRSV, as well as Leptospira canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae, L. pomona bacterin. Approximately one-third of the enrolled cattle were assigned to each one of the three trimesters. After confirmation of pregnancy status, a second vaccination was administered during the assigned trimester. Half of each trimester group was given Express^® FP 10 and the remaining half was given the Lepto-5 bacterin. All of the enrolled cattle were observed closely through calving. Any fetal losses were recorded and fetuses were subjected to a full necropsy. Fetal losses were similar in both treatment groups. Overall fetal losses were 1.6% (13 of 810) in the test vaccination group and 1.9% (15 of 776) in the control group. There were no abortions or fetal losses diagnosed as due to IBR or BVD. The health of the calves from the enrolled cattle was monitored for 30 days after birth. There were no differences noted in the health status of calves between the two treatment groups.

In addition, a separate newborn calf serology study was conducted. A total of 120 calves from dams revaccinated in the second or third trimester were negative for pre-colostral antibodies to bovine viral diarrhea virus types 1 and 2 and infectious bovine rhinotracheitis, further demonstrating that the Express^® MLV products do not cause fetal infection when administered during pregnancy to previously vaccinated cows or heifers.

Fetal health risks associated with vaccination of pregnant animals with modified live vaccines cannot be unequivocally determined by clinical trials conducted for licensure. Management strategies based on vaccination of pregnant animals with modified live vaccines 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 BVDV may have a devastating effect on herd health.

Express^® is a registered trademark of Boehringer Ingelheim Vetmedica, Inc. 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

126805-04

Presentation: 10 doses (20 mL) and 50 doses (100 mL).

CPN: 1230017.8