Jurox Tulathromycin Injection

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TULATHROMYCIN

Available from:

JUROX PTY 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: MEAT Cattle: DO NOT USE less than 35 da ys before slaughter for human consumptio n. Pigs: DO NOT USE less than 14 days b efore slaughter for human consumption. MILK: DO NOT USE in dairy cows, except r eplacement dairy heifers, that are produ cing milk or may in the future produce milk for human consumption or processing . DO NOT USE in bobby calves. DO NOT U SE in dairy heifers following the first mating. Any variation by the prescribin g veterinarian to the approved dose, fre quency, duration, route, disease or tar get species may result in the need to ex tend the approved withholding period. EXPORT SLAUGHTER INTERVAL (ESI): Cattle : DO NOT USE less than 35 days before sl aughter for export. Pigs: DO NOT USE le ss than 26 days before slaughter for exp ort. The ESIs on this label were correc t at the time of label approval. Before using this product, confirm the current ESI from the manufacturer on 1800 023 3 12 or the APVMA website (www.apvma.gov. au/residues/).; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE FIRST MATING) – BOVINE (DAIRY): [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:
Jurox Tulathromycin Injection
89488/125049
Label Name:
Jurox 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 subcutaneous injection in cattle, including dairy heifers up to
the point of first mating,
and intramuscular injection in pigs.
Cattle
Jurox 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
Jurox Tulathromycin Injection is indicated for the treatment of swine
respiratory disease
(SRD) associated with Pasteurella multocida, Mycoplasma hyopneumoniae,
and
Haemophilus parasuis sensitive to tulathromycin.
Net Contents:
50 mL
100 mL
Directions for Use:
READ LEAFLET BEFORE USING THIS PRODUCT
Restraints:
DO NOT USE in dairy cows, except replacement dairy heifers, that are
producing milk or
may in the future produce milk for human consumption or processing.
DO NOT USE in bobby calves.
DO NOT USE in dairy heifers following the first mating.
RE-TREATMENT INTERVALS:
Cattle: DO NOT RE-TREAT cattle for 12 weeks after last treatment
DO NOT RE-TREAT dairy heifers.
Pigs: DO NOT RE-TREAT pigs for 8 weeks after the last treatment. RLP APPROVED
Contraindications:
Precautions:
Avoid using the product simultaneously with other macrolides or
lincosamides.
Laboratory studies in rats and rabbits have not produced any evidence
of teratogenic,
foetotoxic or maternotoxic effects. However, the effects of Jurox
Tulathromycin Injection
on bovine and porcine reproductive performance, pregnancy and
lactation have not been
determined.
Side Effects:
Subcutaneous administration of Jurox Tulathromycin Injection to cattle
frequently causes
transient pain reactions, and local swellings at the injection site
that can persist for up to 30
days.