Elevet+ Tulathromycin Injection

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TULATHROMYCIN

Available from:

AVET HEALTH LIMITED

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TULATHROMYCIN ANTIBIOTIC Active 100.0 mg/ml

Units in package:

100 mL; 50 mL

Class:

VM - Veterinary Medicine

Therapeutic area:

ANTIBIOTIC & RELATED

Product summary:

Poison schedule: 4; Withholding period: WHP: As per label (mentioned below): Ca ttle: MEAT: DO NOT USE less than 35 day s before slaughter for human consumption . Pigs: MEAT: DO NOT USE less than 14 days before slaughter for human consumpt ion. Any variation by the prescribing veterinarian to the approved dose, freq uency, duration, route, disease or targe t species may result in the need to exte nd the approved withholding period. E SI: As per label Cattle: DO NOT USE les s than 35 days before slaughter for expo rt. Pigs: DO NOT USE less than 26 days before slaughter for export. Before usi ng this product, confirm the current ESI from Zoetis on 1800 814 883 or the APVM A website (www.apvma.gov.au/residues); Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE CALVING): [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; PIG - ADULT: [HAEMOPHILUS SPP., MYCOPLASMA HYOPNEUMONIAE, PASTEURELLA MULTOCIDA, RESPIRATORY DISEASE]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
Elevet+ Tulathromycin Injection
92332/135197
Label Name:
Elevet+ Tulathromycin Injection
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
100 mg/mL TULATHROMYCIN
Claims:
For the treatment of respiratory infections in cattle and pigs.
For the treatment of tulathromycin sensitive bacterial respiratory
infections in pigs and in
cattle, including dairy heifers up to the point of first mating.
Cattle
Elevet+ Tulathromycin Injection is indicated for the treatment of
bovine respiratory disease
(BRD) associated with Mannheimia haemolytica, Pasteurella multocida,
Histophilus somni
and Mycoplasma bovis sensitive to tulathromycin.
Pigs
Elevet+ Tulathromycin Injection is indicated for the treatment of
swine respiratory
disease (SRD) associated with Pasteurella multocida, Mycoplasma
hyopneumoniae, and
Haemophilus parasuis sensitive to tulathromycin.
Prudent Use
Indiscriminate use of tulathromycin can contribute to the development
of antibiotic
resistance. Culture and sensitivity tests should be performed when
appropriate to
determine susceptibility of the causative organism(s). Empirical
therapy may be instituted
before results of susceptibility studies are known; however, once
these results become
available, the antibiotic treatment should be adjusted accordingly.
Net Contents:
50 mL, 100 mL
Directions for Use:
Restraints:
USE ONLY in respiratory infections of cattle and swine. RLP APPROVED
DO NOT USE in cows, except replacement dairy heifers, which are
producing or may in the
future produce milk that may be used or processed for human
consumption.
DO NOT USE in dairy heifers following the first mating.
DO NOT USE in bobby calves.
Re-treatment interval: DO NOT re-treat cattle for 12 weeks or pigs for
8 weeks after last
treatment. DO NOT re-treat dairy heifers.
Contraindications:
Precautions:
Avoid using the product simultaneously with other macrolides or
lincosamides. Laboratory
studies in rats and rabbits have not pro