Oxytetracycline LA 200 mg/mL Injectable Solution

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OXYTETRACYCLINE AS THE DIHYDRATE

Available from:

AVET HEALTH LIMITED

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

OXYTETRACYCLINE AS THE DIHYDRATE ANTIBIOTIC Active 200.0 mg/ml

Units in package:

100 mL; 250 mL; 500 mL

Class:

VM - Veterinary Medicine

Therapeutic area:

ANTIBIOTIC & RELATED

Product summary:

Poison schedule: 4; Withholding period: MEAT (Cattle): DO NOT USE less than 21 d ays before slaughter for human consumpti on. MEAT (Sheep): DO NOT USE less than 42 days before slaughter for human consu mption. MEAT (Pigs): DO NOT USE less th an 21 days before slaughter for human co nsumption. MILK (Cattle/Sheep): Milk co llected from cows or ewes within 7 days (14 milkings) following treatment MUST N OT BE USED or processed for human consum ption, or fed to bobby calves. Any vari ation by the prescribing veterinarian to the approved dose, frequency, duration, route, disease or target species may re sult in the need to extend the approved withholding period. EXPORT SLAUGHTER IN TERVAL (ESI) Cattle and Sheep: An ESI h as not been established for this product . Note—observing the meat withholding pe riod may not be sufficient to mitigate p otential risks to export trade. Pigs: D O NOT USE less than 21 days before slaug hter for export. Before using this prod uct, confirm the current ESI from Redcap Solutions Pty Ltd on [phone] or the APVMA website (www.apvma.gov.au/resi dues).; Host/pest details: CATTLE: [ANTIBIOTICS - ORAL, PARENTERAL]; PIG - PIGLET: [ANTIBIOTICS - ORAL, PARENTERAL]; PIGS: [ANTIBIOTICS - ORAL, PARENTERAL]; SHEEP: [ANTIBIOTICS - ORAL, PARENTERAL]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Elevet+ Oxytetracycline LA 200 mg/mL Injectable Solution
92653/138232
Product Name:
APVMA Approval No:
Label Name:
Elevet+ Oxytetracycline LA 200 mg/mL Injectable Solution
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
200 mg/mL OXYTETRACYCLINE (as the DIHYDRATE)
Claims:
For the treatment of conditions caused by, or associated with
oxytetracycline-sensitive
organisms and infections in cattle, sheep and pigs.
Resistance may develop to any chemical.
Net Contents:
100 mL
250 mL
500 mL
Directions for Use:
Restraints:
DO NOT administer more than two injections to any pig.
Contraindications:
Precautions:
Occasional sensitivity reactions (anaphylaxis) to oxytetracycline have
been known to occur,
administer adrenaline immediately.
Side Effects:
The use of tetracycline during the period of tooth development,
including late pregnancy,
may lead to tooth discolouration.
Dosage and
Administration:
Use the contents within 90 days of first broaching of the vial.
Discard the unused portion.
Administer 1 mL per 10 kg bodyweight by subcutaneous injection in
cattle or by deep
intramuscular injection in cattle, sheep or pigs to provide a dosage
of 20 mg oxytetracycline RLP APPROVED
per kg bodyweight. Injections should be given in the neck region.
Injection volumes should
not exceed 10 mL per site.
Cattle: 1 mL/10 kg SC or IM
Sheep: 1 mL/10 kg IM
Pigs: 1 mL/10 kg IM
If necessary a second dose may be administered 72 hours after the
initial dose. The
maximum recommended dose volume is 10 mL for intramuscular and
subcutaneous
injection per site.
If given intravenously a second dose may be administered 12-24 hours
after the initial
dose.
Treated animals should be clearly identified in such a way that they
will maintain their
identity during the withholding period.
General Directions:
Withholding Periods:
MEAT (Cattle): DO NOT USE less than 21 days before slaughter for human
consumption.
MEAT (Sheep): DO NOT USE less than 42 days before slaughter for human
consum