ELANCO AH0206 TYLAN 200 TYLOSIN INJECTION 200MG/ML
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
06-06-2022
Summary of Product characteristics
(SPC)
19-06-2017
Active ingredient:
TYLOSIN
Available from:
ELANCO AUSTRALASIA PTY LTD
INN (International Name):
tylosin(200mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
TYLOSIN ANTIBIOTIC Active 200.0 mg/ml
Units in package:
100mL
Class:
VM - Veterinary Medicine
Manufactured by:
ELANCO ANIMAL HEALTH
Therapeutic group:
CATTLE | PIGS | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | GILT | HEI
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
BACTERIAL INFECTION | CALF PNEUMOENTERITIS | CALF PNEUMONIA | DYSENTERY | ERYSIPELAS - SWINE | FOOT ROT | LEPTOSPIROSIS | MASTITIS | METRITIS | MYCOPLASMAL INFECTION | PNEUMONIA | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | BACTERIAL PNEUMONIA | CONTAGIOUS CALF PNEUMONIA | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | L. HARDJO | L. INTERROGANS | L. POMONA | L. TARASSOVI | POST PARTURIENT BACTERIAL INFE | PRIMARY BACTERIAL INFECTION | SUBCLINICAL MASTITIS | SULFADIAZINE SENSITIVE BACTERI | SWINE ERYSIPELAS | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA
Product summary:
Poison schedule: 4; Withholding period: MEAT: Cattle - DO NOT USE less than 21 days before slaughter for human consumpt ion. Pigs - DO NOT USE less than 3 days before slaughter for human consumption. MILK: Cattle - Milk collected from co ws within 72 hours (6 milkings) followin g treatment MUST NOT BE USED or processe d for human consumption or fed to bobby calves. Any variation by the prescribing veterinarian to the approved dose, freq uency, duration, route, disease, or targ et species may require extending the app roved withholding period. Export Slaugh ter Interval (ESI): An ESI has not been established for this product. Note – obs erving the meat withholding period may n ot be sufficient to mitigate potential r isks to export trade. Trade advice shoul d be sought from Elanco Australasia Pty Ltd on 1800226324 before using this prod uct.; Host/pest details: CATTLE: [BACTERIAL INFECTION, CALF PNEUMOENTERITIS, CALF PNEUMONIA, FOOT ROT, LEPTOSPIROSIS, MASTITIS, METRITIS, MYCOPLASMAL INFECTION, PNEUMONIA]; PIGS: [DYSENTERY, ERYSIPELAS - SWINE, MYCOPLASMAL INFECTION, PNEUMONIA]; Poison schedule: 4; Withholding period: WHP:Meat:Cattle-Do not use less than 21 days before slaughter for human consu mption. Milk:Cattle-Milk collected from cows within 72 hours (6 milkings) foll owing treatment must not be used for hu man consumption or processing or fed to bobby calves. Meat:Pigs-Do not use le ss than 3 days before slaughter for hum an consumption.; Host/pest details: CATTLE: [BACTERIAL INFECTION, CALF PNEUMOENTERITIS, CALF PNEUMONIA, FOOT ROT, LEPTOSPIROSIS, MASTITIS, METRITIS, MYCOPLASMAL INFECTION, PNEUMONIA]; PIGS: [DYSENTERY, ERYSIPELAS - SWINE, MYCOPLASMAL INFECTION, PNEUMONIA]; For the treatment of tylosin susceptible bacterial and mycoplasmal infections in cattle and pigs.Do not exceed 5 days of treatment in cattle or 3 days in pigs
Authorization status:
Registered
Authorization date:
2023-07-01
Summary of Product characteristics
Issue date: 29-September-2015
Supersedes date: 29-September-2015
Revision date: 31-March-2016
Version number: 02
SAFETY DATA SHEET
1. Identification
Elanco AH0206 Tylan 200 Tylosin Injection 200 MG/ML
Product identifier
Other means of identification
Tylosin * Tylosin Base * 027892 Formulation * Tylan 200 Injection *
Tylan 50 Injection * Tylan
Synonyms
AF1400, AF1401, AF7200, AF7202, AH0137, AH0205, AH0206
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 Australasia Pty Ltd.
ACN: 076 745 198
Address
112 Wharf Road
West Ryde, NSW 2114
Australia
Telephone
1800 226 324 (toll free)
e-mail
lilly_msds@lilly.com
Emergency phone
number
Elanco Australasia 1800 226 324 (toll free)
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
2.1. Classification of the substance or mixture
The mixture has been assessed and/or tested for its physical, health
and environmental hazards and the following classification
applies.
Classification according to Regulation (EC) No 1272/2008 as amended
May cause allergy or asthma
symptoms or breathing difficulties if
inhaled.
Category 1
Sensitization, respiratory
Health hazards
May cause an allergic skin reaction.
Category 1
Sensitization, skin
Toxic to aquatic life.
Category 2
Hazardous to the aquatic environment, acute
hazard
Environmental hazards
Toxic to aquatic life with long
lasting effects.
Category 2
Hazardous to the aquatic environment,
long-term hazard
2.2. Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Contains:
Benzyl alcohol, Propylene glycol, Tylosin Base
Hazard pictograms
Signal word
Danger
1 / 11
Material name: Elanco AH0206 Tylan 200 Tylosin Injection 200 MG/ML
4903
SDS AUSTRALIA
Hazard statements
May cause an allergic skin reaction. May cause allergy or
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