País: Austràlia
Idioma: anglès
Font: APVMA (Australian Pesticides and Veterinary Medicines Authority)
TILMICOSIN
ELANCO AUSTRALASIA PTY LTD
tilmicosin as phosphate(300mg/mL)
PARENTERAL LIQUID/SOLUTION/SUSPENSION
TILMICOSIN ANTIBIOTIC Active 300.0 mg/ml
100mL; 250mL
VM - Veterinary Medicine
ELANCO ANIMAL HEALTH
CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER
ANTIBIOTIC & RELATED
BOVINE RESPIRATORY DISEASE | MANNHEIMIA HAEMOLYTICA | PASTEURELLA MULTOCIDA | FOWL CHOLERA | SHIPPING FEVER
Poison schedule: 4; Withholding period: WHP: Meat: Do not use less than 28 day s before slaughter for human consumption . Milk: Do not use on lactating cows wh ere milk or milk products may be used fo r human consumption. Trade Advice: Exp ort Slaughter Interval (ESI): DO NOT USE less than 42 days before slaughter for export. Before using this product confir m the current ESI from the registrationh older on 1800 226 324 or the APVMA webs ite (www.apvma.gov.au/residues).; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, MANNHEIMIA HAEMOLYTICA, PASTEURELLA MULTOCIDA]; Poison schedule: 4; Withholding period: WHP: Meat:Do not use less than 28 days before slaughter for human consumption . Milk:Do not use on lactating cows w here milk or milk products may be used for human consumption. Trade Advice: Export Slaughter Interval (ESI): DO N OT USE less than 42 days before slaught er for export. Before using this produ ct confirm the current ESI from the r egistrationholder on 1800 226 324 or t he APVMA website (www.apvma.gov.au/res idues).; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, MANNHEIMIA HAEMOLYTICA, PASTEURELLA MULTOCIDA]; 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.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. (see label)
Registered
2023-07-01
For Official Use Only E-LABEL APPLICATION (DRAFT) COMPANY NAME: ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD PRODUCT NAME: ELANCO AH0230 MICOTIL 300 INJECTION (TILMICOSIN) ELABEL APPLICATION NO: DC12-99004481E3 APVMA APPROVAL NO: 45653/101569 PRODUCT NO: 45653 VERSION NO: 6.0 APPLICATION STARTED: 2014-Aug-12 15:21:49 VERSION CREATED: 2015-Oct-09 14:16:31 STARTED BY: Carolyn Trincado PRINTED: 2015-Oct-09 14:35:54 LABEL NAME: ELANCO AH0230 MICOTIL 300 INJECTION (TILMICOSIN) SIGNAL HEADINGS: PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY CONSTITUENT STATEMENTS: ACTIVE CONSTITUENT 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 (Pasturella) haemolytica, Pasturella multocida, and other organisms susceptible to tilmicosin. NET CONTENTS: 100mL 250mL DIRECTIONS FOR USE: For Subcutaneous Injection Only in Cattle RESTRAINTS: 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 15kg bodyweight. Tilmicosin may be fatal in horses. PRECAUTIONS: The safety of tilmicosin has not been established in pregnant cattle. RLP APPROVED For Official Use Only SIDE EFFECTS: DOSAGE AND ADMINISTRATION: Use the contents of the vial within 90 days of initial broaching and discard any unused portion. Administer a single subcutaneous injection of 10mg tilmicosin/kg bodyweight (1mL per 30kg), using a standard disposable syringe or multi-filling syringe. With a single hand on the syringe, i Llegiu el document complet
Issue date: 25-September-2015 Version number: 01 SAFETY DATA SHEET 1. Identification Elanco AH0230 Micotil 300 Injection (Tilmicosin) Product identifier Other means of identification Tylosin, 4A-O-de(2,6-dideoxy-3-C-methyl-a-L-ribo-hexopyranosyl )-20-deoxo-20-[(3R,5S)-3,5-dimethyl-1-piperidinyl]-,p hosphate (1:1) (salt) * Tilmicosin Formulation * Tilmicosin Phosphate Formulation Synonyms AH0230 Item Code Recommended use of the chemical and restrictions on use Veterinary Pharmaceutical Recommended use Not available. Restrictions on use Details of manufacturer or importer Manufacturer Company name Elanco Animal Health A Division of Eli Lilly Australia Pty Ltd Address A.B.N. 39 000 233 992 112 Wharf Road, West Ryde, N.S.W. 2114, Australia Telephone (02) 9878 7777 Fax (02) 9878 7720 e-mail lilly_msds@lilly.com Emergency phone number Elanco Animal Health: 1800 226 324 (Toll free) OR Poisons Information Centre: 131126 (Australia-wide) 24 hr emergency contact number CHEMWATCH 1800 039 008 (spills and accidents) 24 hr emergency contact number (Local) CHEMWATCH +61 2 9186 1132 (spills and accidents) 2. Hazard(s) identification Classification of the hazardous chemical Not classified. Physical hazards Category 4 Acute toxicity, oral Health hazards Category 2 Serious eye damage/eye irritation Category 1 Sensitization, respiratory Category 1 Sensitization, skin Category 2 Specific target organ toxicity following repeated exposure Category 1 Hazardous to the aquatic environment, acute hazard Environmental hazards Category 1 Hazardous to the aquatic environment, long-term hazard Label elements, including precautionary statements Hazard symbol(s) Health hazard Exclamation mark Environment Signal word Danger 1 / 10 Material name: Elanco AH0230 Micotil 300 Injection (Tilmicosin) 4899 SDS AUSTRALIA Hazard Statement(s) Harmful if swallowed. May cause an allergic skin reaction. Causes eye irritation. May cause allergy or asthma symptoms or breathing difficulties if inhaled. May cause damage to organs (Heart) through prolonged or repe Llegiu el document complet