Draxxin KP plus Ketoprofen Injectable Solution for Cattle

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TULATHROMYCIN; KETOPROFEN

Available from:

ZOETIS AUSTRALIA PTY LTD

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TULATHROMYCIN ANTIBIOTIC Active 100.0 mg/ml; KETOPROFEN ANALGESIC Active 120.0 mg/ml

Units in package:

100 mL; 250 mL; 50 mL; 500 mL

Class:

VM - Veterinary Medicine

Therapeutic area:

ANTIBIOTIC & RELATED

Product summary:

Poison schedule: 4; Withholding period: MEAT: DO NOT USE less than 35 days befor e slaughter for human consumption. MIL K: DO NOT USE in dairy cows, except repl acement dairy heifers, that are producin g milk or may in the future produce milk that may be used or processed for human consumption. Any variation by the prescr ibing veterinarian to the approved dose, frequency, duration, route, disease or target species may result in the need to extend the approved withholding period. EXPORT SLAUGHTER INTERVAL (ESI): DO NOT USE less than 35 days before slaugh ter for export. Before using this produc t, confirm the current ESI from Zoetis A ustralia Pty Ltd on 1800 814 883 or the APVMA website (www.apvma.gov.au/residues ).; Host/pest details: CATTLE: [ANTIPYRETIC, BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; Poison schedule: 4; Withholding period: Meat: DO NOT USE less than 35 days befor e slaughter for human consumption. Milk : DO NOT USE in dairy cows, except repla cement dairy heifers, that are producing milk or may in the future produce milk for human consumption or processing. DO NOT USE in dairy heifers following the first mating. DO NOT USE in bobby calve s. Any variation by the prescribing vet erinarian to the approved dose, frequenc y, duration, route, disease or target sp ecies may result in the need to extend t he approved withholding period. EXPOR T SLAUGHTER INTERVAL (ESI): DO NOT USE l ess than 35 days before slaughter for ex port. Before using this product, confirm the current ESI from Zoetis Australia P ty Ltd on 1800 814 883 or the APVMA webs ite (www.apvma.gov.au/residues).; Host/pest details: CATTLE: [ANTIPYRETIC, BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Draxxin KP plus Ketoprofen Injectable Solution for Cattle
88472/121396
Product Name:
APVMA Approval No:
Label Name:
Draxxin KP plus Ketoprofen Injectable Solution for Cattle
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
120 mg/mL ketoprofen
100 mg/mL tulathromycin
Claims:
For use by or under direction of a registered veterinarian.
For the treatment of bovine respiratory disease (BRD) and the
associated pyrexia in cattle
due to Mannheimia haemolytica, Pasteurella multocida, Histophilus
somni, Mycoplasma
bovis and other organisms sensitive to tulathromycin.
Net Contents:
50 mL, 100 mL, 250 mL and 500 mL
Directions for Use:
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 dairy heifers following the first mating.
DO NOT USE in bobby calves.
DO NOT re-treat animals for 12 weeks after last treatment.
Contraindications:
Precautions:
This product should not be administered with other non-steroidal
anti-inflammatory drugs
(NSAIDs) concurrently or within 24 hours of each other or to cattle
that are dehydrated or
with known renal disease.
This product should not be used 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 DRAXXIN KP
on bovine
reproductive performance, pregnancy and lactation have not been
determined. RLP APPROVED
Side Effects:
For some animals, subcutaneous administration can cause swelling and
inflammation that
will generally disappear within 7 days of treatment, however rarely,
swelling may persist for
up to 32 days.
Dosage and
Administration:
In-use shelf life: Use within 56 days of first broaching vial.
For subcutaneous use only.
1 mL/40 kg bodyweight (3 mg/kg ketoprofen and 2.5 mg/kg tulathromycin)
by a single
subcutaneous injection into the neck regi