YP Tilmicosin Injectable

Land: Australien

Sprog: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiv bestanddel:

TILMICOSIN PHOSPHATE

Tilgængelig fra:

SOUTH YARRA PHARMA PTY LTD

Lægemiddelform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sammensætning:

TILMICOSIN PHOSPHATE ANTIBIOTIC Active 300.0 mg/ml

Enheder i pakken:

100 mL; 250 mL

Klasse:

VM - Veterinary Medicine

Terapeutisk område:

ANTIBIOTIC & RELATED

Produkt oversigt:

Poison schedule: 4; Withholding period: MEAT: DO NOT USE less than 28 days befor e slaughter for human consumption. MILK : DO NOT USE in cows which are producing or may in the future produce milk that may be used or processed for human consu mption. Any variation by the prescribin g veterinarian to the approved dose, fre quency, duration,route, disease, or targ et species may require extending the app roved withholding period. DO NOT USE le ss than 42 days before slaughter for exp ort. Before using this product, confirm the current ESI from South Yarra Pharma Pty Ltd on 1800 426 142 or the APVMA web site (www.apvma.gov.au/residues/).; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, MANNHEIMIA HAEMOLYTICA, PASTEURELLA MULTOCIDA]

Autorisation status:

Registered

Autorisation dato:

2023-07-01

Indlægsseddel

Product Name:
APVMA Approval No:
Bovatil 300
88108/120296
Label Name:
Bovatil 300
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
300 mg/mL TILMICOSIN (as tilmicosin phosphate)
Claims:
For use in lot-fed cattle for the treatment of Bovine Respiratory
Disease (BRD) associated
with Mannheimia (Pasteurella) haemolytica, Pasteurella multocida, and
other organisms
susceptible to tilmicosin.
Net Contents:
100 mL
250 mL
Directions for Use:
Restraints:
DO NOT USE in lactating cows where milk or milk products may be used
for human
consumption.
Contraindications:
This product must not be administered intravenously or
intramuscularly.
Inject subcutaneously only in cattle. Intravenous injection in cattle
has been fatal.
Pneumatic or hydraulically operated syringes should not be used with
this product.
This product is contraindicated for use in pigs, goats and non-human
primates. Injection
has been shown to be fatal in pigs, non-human primates, goats, sheep
(intravenous
injection) and lambs less than 15 kg bodyweight. Tilmicosin may be
fatal in horses.
Precautions:
The safety of tilmicosin has not been established in pregnant cattle. RLP APPROVED
Side Effects:
Dosage and
Administration:
For Subcutaneous Injection Only in Cattle.
Use the contents of the vial within 90 days of initial broaching and
discard any unused
portion.
Administer a single subcutaneous injection of 10 mg tilmicosin/kg
bodyweight (1 mL per 30
kg), using a standard disposable syringe or multi-filing syringe. With
a single hand on the
syringe, insert the needle subcutaneously, at a top-down angle, whilst
avoiding penetration
of underlying muscle. Do not inject more than 25 mL per injection
site.
Subcutaneous injection must be made high into the neck. If no
improvement is noted within
48 hours the diagnosis should be re-evaluated.
Single dose only.
NOTE: Swelling at the subcutaneous site of injection may be observed
but is transient and
usually mild.
General Directions:
Properly restr