Titanium 4 L5 HB

Company: Elanco US

See productdata.aphis.usda.gov for a summary of the studies approved by the USDA for licensing this product. The package insert also contains additional information developed by the licensee.

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza₃ Vaccine

Modified Live Virus

Leptospira Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

from the Signature cell line^®

CONTENTS:

Infectious Bovine Rhinotracheitis Virus (IBR), Modified Live Virus

Bovine Virus Diarrhea Virus (BVD), Modified Live Virus

Bovine Parainfluenza₃ Virus (PI₃), Modified Live Virus

Leptospira Canicola

Leptospira Grippotyphosa

Leptospira Hardjo

Leptospira Icterohaemorrhagiae

Leptospira Pomona

INDICATIONS FOR USE:

This product has been shown to be effective for the vaccination of healthy cattle against infectious bovine rhinotracheitis virus (IBR), bovine virus diarrhea Type I (BVD), bovine virus diarrhea Type II (BVD), bovine parainfluenza₃ virus (PI₃), and Leptospira borgpetersenii serovar hardjo-bovis, and Leptospira canicola-grippotyphosa-hardjo-icterohaemorrhagiae and pomona. The duration of immunity has not been determined. This product was licensed prior to the requirement to establish a minimum age for use. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Titanium 4 L5 HB may be used in pregnant cows and calves nursing pregnant cows provided they were vaccinated, 30 to 60 days pre-breeding, with Titanium 3, Titanium 3 LP, Titanium 3 + BRSV, Titanium 3 + BRSV LP, Titanium 4, Titanium 4 L5 HB, Titanium 5, or Titanium 5 L5 HB.

This product contains BVD Type I and BVD Type II.

Dosage and Administration

Rehydrate the desiccated vial with accompanying diluent and shake well. Inject 2 mL subcutaneously using aseptic technique. The need for annual booster vacccinations has not been established for this product. The presence of maternal antibody is known to interfere with the development of active immunity in calves and additional boosters will be required in most young animals. For advice on revaccination frequency, consult your veterinarian. Do not mix with other products, except as specified on the label.

CAUTIONS:

Fetal health risks associated with the vaccination of pregnant animals with this vaccine cannot be unequivocally determined during clinical trials conducted for licensure. Appropriate strategies to address the risk associated with vaccine use in pregnant animals should be discussed with a veterinarian. Failure to follow label directions may result in abortions. Store at 35-46°F (2-8°C). DO NOT FREEZE. Use entire contents when first opened. Do not vaccinate within 21 days of slaughter. In case of human exposure, contact a physician. Inactivate unused contents before disposal. Allergic reactions may follow the use of vaccines; ANTIDOTE: Epinephrine.

Contains thimerosal as a preservative.

PRODUCT DESCRIPTION:

Titanium 4 L5 HB contains desiccated Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza₃ Vaccine and a bacterin diluent (Lepto 5).

The four viral antigens are combined in the proper ratio, stabilized and desiccated into one cake. The desiccated viral fractions are rehydrated for use with a specially processed liquid Leptospira Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin.

DISEASES:

The viruses listed below are considered contributors to the respiratory disease complex of cattle. Multiple infections do occur, and secondary bacterial infections may exacerbate the disease signs.

Infectious Bovine Rhinotracheitis Virus

IBR is an acute upper respiratory disease. Signs of IBR may include elevated temperature, hyperpnea, dyspnea, excessive nasal and ocular discharge, rapid breathing, cough and depression. Reproductive problems including abortions have been observed.

Bovine Virus Diarrhea Virus

BVD is often obscured or confused with other conditions of the respiratory disease complex. Clinical signs may include fever, anorexia, coughing, depression, diarrhea, and occasional lameness. BVD may be inapparent, chronic, or a fatal mucosal disease. BVD may cause suppression of the immune system. Affected animals have increased susceptibility to secondary infections. BVD in pregnant animals may cause abortions or malformed and weak calves at birth. Chronic disease with erosions in the alimentary tract is referred to as “Mucosal Disease” and is usually fatal.

Bovine Parainfluenza₃ Virus

Parainfluenza₃ infections may cause few noticeable signs. Disease signs caused by PI₃ virus generally appear within 14 days after shipment and arrival of calves at their destination. Signs are weakness, depression, watery to mucopurulent nasal discharge, fever, coughing, and weight loss. PI₃ is a contributor to the Bovine Respiratory Disease Complex.

Leptospira Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona

Leptospirosis is widespread in the animal population of the United States and is considered one of the most infectious diseases of farm animals.

Man can become infected either from animals with the disease or from an infective environmental source. In animals, the disease is known to cause reproduction disorders, loss of weight, decreased milk production and sometimes death. The economic losses suffered are very large. The disease can be caused by several specific leptospires.

Five important serovars have been identified and are included in this product. Because specific serovar diagnosis is very difficult, and also due to the widespread nature of potential infection, it is recommended that all animals be vaccinated before introduction into the concentrated holding areas currently utilized on many premises. When infection is diagnosed, it is advisable to separate those animals showing disease signs and to vaccinate the remainder of the herd with Lepto 5 alone. The apparent effectiveness of Lepto 5 will depend upon the number of animals exposed and incubating the disease at the time of vaccination. Vaccination cannot be expected to protect animals already in the incubating stages of the disease.

Serologic studies indicate widespread distribution of all of these causative agents.

IMMUNE RESPONSES:

Research demonstrated Titanium 4 L5 HB is safe and efficacious; however, individual animals may be unable to develop an adequate immune response following vaccination due to: concurrent disease, malnutrition parasitism, or stress due to shipment or environmental conditions. For more information on revaccination in the face of stress or an exposure, contact your veterinarian.

SAFETY:

Safety in pregnant heifers and cows was demonstrated in trials conducted at three separate sites. The heifers and cows were vaccinated prior to breeding with Titanium 5 L5 HB followed by a post-breeding vaccination at the first, second or third trimester of pregnancy. The cows were observed from pregnancy vaccination through calving for fetal loss. Heifers and cows vaccinated with Titanium 5 L5 HB had abortions and calving rates similar to the control cows.

Calving Rates (normal calves delivered/total deliveries)

The fetal loss in the two groups was similar with 4% in the Titanium 5 L5 HB vaccinated groups and 5% in the control groups. Following calving, each calf’s health was monitored for 4 weeks. The health of the calves in the Titanium 5 L5 HB vaccinated dams was similar to the health of calves born to the control dams. WARNING: 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.

FOR USE IN ANIMALS ONLY

SUPPLIED:

Manufactured by:

Diamond Animal Health, Inc., Des Moines, Iowa 50327 U.S.A.

U.S. Veterinary License No. 213

Product Code No. 4439.20

Distributed by:

Elanco US, Inc., Greenfield, IN 46140 U.S.A.

1-800-428-4441

Titanium, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2021 Elanco or its affiliates

PA101811X

W1

CPN: 1131134.0