Respotil 300 mg/mL Tilmicosin Phosphate Solution for Injection

Страна: Австралія

мова: англійська

Джерело: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Активний інгредієнт:

TILMICOSIN

Доступна з:

PROBUS PHARMACEUTICALS PTY LTD

Фармацевтична форма:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Склад:

TILMICOSIN ANTIBIOTIC Active 300.0 mg/ml

Одиниць в упаковці:

100mL; 250mL

Клас:

VM - Veterinary Medicine

Терапевтична области:

ANTIBIOTIC & RELATED

Огляд продуктів:

Poison schedule: 4; Withholding period: MEAT: DO NOT USE less than 28 days befor e slaughter for human consumption. MI LK: DO NOT USE in cows which are produci ng or may in the future produce milk tha t may be used or processed for human con sumption. Any variation by the prescr ibing veterinarian to the approved dose, frequency, duration, route, disease, or target species may require extending th e approved withholding period. DO NOT U SE less than 42 days before slaughter fo r export. Before using this product, con firm the current ESI with Probus Pharmac euticals Pty Ltd on 1800 940 556 or the APVMA website www.apvma.gov.au/residues/ .; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, MANNHEIMIA HAEMOLYTICA, PASTEURELLA MULTOCIDA]

Статус Авторизація:

Registered

Дата Авторизація:

2023-07-01

інформаційний буклет

Product Name:
APVMA Approval No:
Respotil 300 mg/mL Tilmicosin Phosphate Solution for Injection
89712/125867
Label Name:
Respotil 300
mg/mL Tilmicosin Phosphate Solution for Injection
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 body weight. Tilmicosin may be
fatal in horses.
Precautions:
The safety of tilmicosin has not been established in pregnant cattle.
Side Effects: RLP APPROVED
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