TetraMax Flexi-Dose INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OXYTETRACYCLINE AS OXYTETRACYCLINE HYDROCHLORIDE

Available from:

ABBEY LABORATORIES PTY LTD

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

OXYTETRACYCLINE AS OXYTETRACYCLINE HYDROCHLORIDE ANTIBIOTIC Active 100.0 mg/ml

Units in package:

100 mL; 250 mL

Class:

VM - Veterinary Medicine

Therapeutic area:

ANTIBIOTIC & RELATED

Product summary:

Poison schedule: 4; Withholding period: MEAT (CATTLE AND CALVES): DO NOT USE les s than 14 days before slaughter for hum an consumption. MEAT (SHEEP AND PIGS): DO NOT USE less than 10 days before slau ghter for human consumption. MEAT WITH HOLDING PERIOD (HORSES): DO NOT USE less than 28 days before slaughter for huma n consumption. MILK: Milk collected fro m animals within 72 hours (6 milkings) f ollowing treatment MUST NOT BE USED for human consumption or processing or fed to bobby calves. Any variation by presc ribing veterinarian to the approved dose , frequency, duration, route, disease o r target species may result in the need to extend the approved withholding perio d. EXPORT SLAUGHTER INTERVAL (ESI): Thi s product does not have an ESI establish ed. Note—observing the meat withholding period may not be sufficient to mitigat e potential risks to export trade. Trad e advice should be sought from Abbey Ani mal health Pty Ltd on 02 8088 0720 befo re using this product.; Host/pest details: CALF: [BACTERIA]; CAT: [BACTERIA]; CATTLE: [BACTERIA]; DOG: [BACTERIA]; HORSE: [BACTERIA]; LAMB: [BACTERIA]; PIG - PIGLET: [BACTERIA]; PIGS: [BACTERIA]; SHEEP: [BACTERIA]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

TetraMax Flexi-Dose INJECTION
88734/122118
Product Name:
APVMA Approval No:
Label Name:
TetraMax Flexi-Dose INJECTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
100 mg/mL OXYTETRACYCLINE (AS THE HYDROCHLORIDE)
Claims:
For the treatment of organism sensitive to oxytetracycline in horses,
cattle, sheep, pigs,
dogs and cats.
Net Contents:
100mL, 250mL
Directions for Use:
Restraints:
DO NOT exceed 25mL injection site volume for cattle.
DO NOT exceed 10mL injection site volume for pigs and sheep.
Contraindications:
This product is contraindicated in horses during concomitant therapy
with corticosteroids.
Precautions:
Use this product with caution during the period of tooth development,
including late
pregnancy as it may lead to tooth discoloration.
Use of this product may cause anaphylaxis in cattle. Prompt treatment
with adrenaline or
antihistamine is indicated.
Side Effects:
Dosage and
Administration:
This section contains file attachment. RLP APPROVED
General Directions:
Treated animals should be clearly identified in such a way that they
will maintain their
treatment identity during the withholding period.
Withholding Periods:
MEAT (CATTLE AND CALVES): DO NOT USE less than 14 days before
slaughter for
human consumption.
MEAT (SHEEP AND PIGS): DO NOT USE less than 10 days before slaughter
for human
consumption.
MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE less than 28 days before
slaughter for human consumption.
MILK: Milk collected from cows/ewes within 72 hours (6 milkings)
following treatment MUST
NOT BE USED or processed for human consumption, or fed to bobby
calves.
Any variation by the prescribing veterinarian to the approved dose,
frequency, duration,
route, disease or target species may result in the need to extend the
approved withholding
period.
Trade Advice:
EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for
this product.
Note—observing the meat withholding period may not be sufficient to
mitigate potenti