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Titanium 5 + PH-M (Canada)

This page contains information on Titanium 5 + PH-M for veterinary use.
The information provided typically includes the following:
  • Titanium 5 + PH-M Indications
  • Warnings and cautions for Titanium 5 + PH-M
  • Direction and dosage information for Titanium 5 + PH-M

Titanium 5 + PH-M

This treatment applies to the following species:
Manufacturer: Elanco

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza3-Respiratory Syncytial Virus Vaccine

Modified Live Virus

Mannheimia Haemolytica-Pasteurella Multocida Bacterin-Toxoid

IBR-BVD-PI3-BRSV-M. haemolytica-P. multocida

CONTENTS:

Infectious Bovine Rhinotracheitis Virus (IBR), Modified Live Virus

Bovine Virus Diarrhea Virus, Type I (BVD), Modified Live Virus

Bovine Virus Diarrhea Virus, Type II (BVD), Modified Live Virus

Bovine Parainfluenza3 Virus (PI3), Modified Live Virus

Bovine Respiratory Syncytial Virus Vaccine (BRSV), Modified Live Virus

Mannheimia haemolytica (M. haemolytica)

Pasteurella multocida (P. multocida)

PRODUCT DESCRIPTION:

Titanium 5 + PH-M contains desiccated Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza3-Respiratory Syncytial Virus Vaccine and a bacterin-toxoid diluent (PHM). Titanium® 5 + PH-M is a multiantigenic modified live vaccine to be used as an aid in the prevention of disease caused by infectious bovine rhinotracheitis virus (IBR), bovine virus diarrhea virus, Type I (BVD), bovine virus diarrhea virus, Type II (BVD), bovine parainfluenza3 virus (PI3), bovine respiratory syncytial virus (BRSV) and a bacterin to aid in the prevention of disease caused by Mannheimia haemolytica and Pasteurella multocida.

The five 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 Mannheimia haemolytica-Pasteurella multocida Bacterin-Toxoid.

The desiccated fraction contains no bovine serum, which reduces the risk of extraneous virus contamination and possible allergic reactions. Controlled tests conducted in our laboratory demonstrated that animals receiving a 10x dose did not shed BRSV or PI3 viruses. Control animals, housed with vaccinates, remained seronegative throughout the testing period.

Mannheimia haemolytica-Pasteurella multocida Bacterin-Toxoid contains toxoids (leukotoxoids) and cell-associated antigens from multiple isolates of M. haemolytica Type A-1 fractions, and cell-associated and soluble antigens from P. multocida.

IMMUNE RESPONSES:

Research demonstrated Titanium 5 + PH-M 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.

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)

Trimester

Controls

Vaccinates

1

205/213 (96.24%)

201/209 (96.17%)

2

295/310 (95.16%)

305/315 (96.83%)

3

197/208 (94.71%)

198/205 (96.59%)

Total

697/731 (95.35%)

704/729 (96.57%)

The fetal loss in the two groups was similar with 3.43% in the Titanium 5 L5 HB vaccinated groups and 4.65% 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.

INDICATIONS FOR USE:

This product contains BVD Type I and BVD Type II and is recommended for the vaccination of healthy cattle, 60 days of age or older, as an aid in the prevention of disease caused by infectious bovine rhinotracheitis virus (IBR), bovine virus diarrhea virus, Type I (BVD), bovine virus diarrhea virus, Type II (BVD), bovine parainfluenza3 virus (PI3), bovine respiratory syncytial virus (BRSV) and Mannheimia haemolytica-Pasteurella multocida. Titanium 5 + PH-M is also recommended for the vaccination of healthy cows and heifers, no less than 30 days prior to breeding, as an aid in the prevention of disease caused by infectious bovine rhinotracheitis virus (IBR), bovine virus diarrhea virus, Type I (BVD), bovine virus diarrhea virus, Type II (BVD), bovine parainfluenza3 virus (PI3), bovine respiratory syncytial virus (BRSV) and Mannheimia haemolytica-Pasteurella multocida. Titanium 5 + PH-M may be administered to pregnant cattle provided they were vaccinated, according to label directions, with any Titanium product containing IBR-BVD 30 to 60 days prior to breeding. To help ensure safety in pregnant cattle, heifers must receive at least two doses of any Titanium product containing IBR-BVD, with the second dose administered approximately 30 days prebreeding. Titanium 5 + PH-M may also be administered to calves nursing pregnant cows provided their dams were vaccinated as described above.

Dosage and Administration

Rehydrate the modified live virus vaccine with accompanying bottle of liquid bacterin-toxoid and shake well. Inject 2 mL subcutaneously using aseptic technique, followed by a second dose of monovalent bovine respiratory syncytial virus vaccine (Titanium BRSV) and M. haemolytica and P. multocida vaccine (Titanium® PH-M) to be given 14 to 28 days after the first dose. Annual revaccination is recommended. Calves vaccinated before weaning should be revaccinated 30 days after weaning when the possible influence of maternal antibodies is decreased.

CAUTIONS:

Recommended for the vaccination of healthy cows and heifers no less than 30 days prior to breeding. Titanium 5 + PH-M may be administered to pregnant cattle provided they were vaccinated, according to label directions, with any Titanium product containing IBR and BVD 30 to 60 days prior to breeding. To help ensure safety in pregnant cattle, heifers must receive at least two doses of any Titanium product containing IBR-BVD, with the second dose administered approximately 30 days prebreeding. Failure to follow label directions may result in abortions. The Titanium line may also be administered to calves nursing pregnant cows provided their dams were vaccinated as described above. Store at 2° to 8°C. DO NOT FREEZE. Shake well before using. Use entire contents when first opened. Do not vaccinate within 21 days before slaughter. Burn container and all unused contents. Contains thimerosal as a preservative. Transient injection site swelling may occur. Allergic reactions may follow the use of vaccines and can cause reduced milk production in lactating dairy cattle.

ANTIDOTE: Epinephrine.

FOR VETERINARY USE ONLY

SUPPLIED:

Code:

AV4185

10 dose (20 mL)

50 per case

AV4185

50 dose (100 mL)

20 per case

Elanco, Titanium and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

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

U.S. Veterinary License No. 213

Distributed by: Elanco, Division Eli Lilly Canada, Inc., Guelph, ON, N1G 4T2 Canada

1-800-265-5475

Revised 17-Apr-15

02302

NAC No.: 1184064.0

ELANCO, Division Eli Lilly Canada Inc. & ELANCO CANADA LIMITED (successor to Novartis Animal Health Canada Inc.)
RESEARCH PARK CENTRE, 150 RESEARCH LANE, SUITE 120, GUELPH, ON, N1G 4T2
Telephone:   519-821-0277
Order Desk:   800-773-7603
Fax:   519-821-7831
Elanco Canada Limited Customer Service Telephone:   800-387-6325
Elanco Canada Limited Customer Service Fax:   800-827-5782
Website:   www.Elanco.ca
Every effort has been made to ensure the accuracy of the Titanium 5 + PH-M information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2016 North American Compendiums. Updated: 2016-08-21

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