Coopers Bovilis MH Single-Shot RTU READY-TO-USE MH VACCINE FOR CATTLE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

INACTIVATED MANNHEIMIA HAEMOLYTICA STRAIN X387; INACTIVATED M. HAEMOLYTICA LEUCOTOXIN STRAIN X332

Available from:

INTERVET AUSTRALIA PTY LIMITED

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

INACTIVATED MANNHEIMIA HAEMOLYTICA STRAIN X387 VACCINE - GENERAL Active 0.0 P; INACTIVATED M. HAEMOLYTICA LEUCOTOXIN STRAIN X332 VACCINE - GENERAL Active 0.0 P

Units in package:

100 mL; 250 mL; 500 mL

Class:

VM - Veterinary Medicine

Therapeutic area:

IMMUNOTHERAPY

Product summary:

Poison schedule: 0; Withholding period: Zero (0) days. Zero (0) days.; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE]; DAIRY CATTLE LACTATING: [BOVINE RESPIRATORY DISEASE]; PREGNANT CATTLE: [BOVINE RESPIRATORY DISEASE]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Coopers Bovilis MH Single-Shot RTU READY-TO-USE MH VACCINE FOR CATTLE
92022/134188
Product Name:
APVMA Approval No:
Label Name:
Coopers Bovilis MH Single-Shot RTU READY-TO-USE MH VACCINE FOR CATTLE
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
ACTIVE CONSTITUENTS
Inactivated Mannheimia haemolytica
Strain x 387 (Leucotoxin producing) ≥1 x 10^7 orgs/mL
Strain x 332 ≥1 x 10^8 orgs/mL
Claims:
A ready-to-use, fast-acting, single-shot vaccine for the protection of
cattle against Bovine
Respiratory Disease (BRD) caused by Mannheimia haemolytica (MH).
Significant
immunological response achieved within 7 days after a single dose
vaccination and
remains high for at least 180 days (25 weeks).
Net Contents:
100 mL (50 doses)
250 mL (125 doses)
500 mL (250 doses)
Directions for Use:
Restraints:
Contraindications:
Precautions:
Interactions: No information is available on the safety and efficacy
from the concurrent use
of the vaccine with any other.
This vaccine is safe for use in pregnant cattle during the second and
third trimester of
pregnancy. Safety in the first trimester of pregnancy has not been
determined.
Side Effects:
Vaccination can cause a swelling at the site of injection and could
last for up to 21 days.
The area of local reaction is generally less than 10 cm in diameter
but will eventually RLP APPROVED
resolve. A rise in internal body temperature may occur, returning to
normal within 24-48
hours post-vaccination. This may result in some temporary loss of
appetite.
Dosage and
Administration:
Dosage and administration
Shake well to mix before use and keep mixed during use.
USE ALL PRODUCT WITHIN 42 DAYS OF OPENING.
Vaccination program: It is recommended that cattle are vaccinated with
a single 2 mL
injection subcutaneously on the side of the neck. Vaccination should
be undertaken in
advance of situations with a high potential of environmental challenge
with Mannheimia
haemolytica causing BRD to occur. These situations may involve the
assembly, mixing or
movement of cattle - for example, dai