ELANCO AH0230 MICOTIL 300 INJECTION (TILMICOSIN)

Land: Australien

Sprog: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiv bestanddel:

TILMICOSIN

Tilgængelig fra:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

tilmicosin as phosphate(300mg/mL)

Lægemiddelform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sammensætning:

TILMICOSIN ANTIBIOTIC Active 300.0 mg/ml

Enheder i pakken:

100mL; 250mL

Klasse:

VM - Veterinary Medicine

Fremstillet af:

ELANCO ANIMAL HEALTH

Terapeutisk gruppe:

CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER

Terapeutisk område:

ANTIBIOTIC & RELATED

Terapeutiske indikationer:

BOVINE RESPIRATORY DISEASE | MANNHEIMIA HAEMOLYTICA | PASTEURELLA MULTOCIDA | FOWL CHOLERA | SHIPPING FEVER

Produkt oversigt:

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)

Autorisation status:

Registered

Autorisation dato:

2023-07-01

Indlægsseddel

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

Produktets egenskaber

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
[phone]
Fax
[phone]
e-mail
[e-mail]
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 [phone] (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