TYLOVET 200 TYLOSIN INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TYLOSIN AS TARTRATE

Available from:

ABBEY LABORATORIES PTY LTD

INN (International Name):

tylosin as tartrate(200mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TYLOSIN AS TARTRATE ANTIBIOTIC Active 200.0 mg/ml

Units in package:

100mL; 12x100mL; 15x50mL; 50mL

Class:

VM - Veterinary Medicine

Manufactured by:

ABBEY LABORATORIES

Therapeutic area:

ANTIBIOTIC & RELATED

Product summary:

Poison schedule: 4; Host/pest details: ; Poison schedule: 4; Withholding period: WHP:Meat:Cattle-Do not use less than 21 days before slaughter for human cons umption. Meat:pigs-Do no use less than 3 days before slaughter for human con sumption. Milk:Milk collected from ani mals within 72 hours (6 milkings) foll owing treatment must not be used for h uman consumption or processing or fed to bobby calves. An ESI has not been established for this product. Note- Ob serving the meat withholding period may not be sufficient to mitigate potential risks to export trade. Trade advice sho uld be sought from the distributor, Abbe y Animal Health Pty Ltd on 02 8088 0720 before using this product.; Host/pest details: CATTLE: [BACTERIAL INFECTION, CALF PNEUMONIA, ENTERITIS, FOOT ROT, LEPTOSPIROSIS, MASTITIS, METRITIS, PNEUMONIA]; PIGS: [BACTERIAL INFECTION, DYSENTERY, ERYSIPELAS - SWINE, PNEUMONIA]; For the treatment of infections caused by organisms sensitive to tylosin in cattle & pigs.Should not be mixed with other parenteral solutions.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

TYLOVET 200 TYLOSIN INJECTION
82653/110356
Product Name:
APVMA Approval No:
Label Name:
TYLOVET 200 TYLOSIN INJECTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Active constituent: 200 mg/mL tylosin as tylosin tartrate
Claims:
For the treatment of infections caused by organisms sensitive to
Tylosin in cattle and pigs.
INDICATIONS
For the treatment of Tylosin susceptible bacterial and mycoplasmal
infections in cattle and
pigs as follows:-
Cattle: TYLOVET 200 TYLOSIN INJECTION is effective in cattle for the
treatment of
pneumonia, metritis, foot rot, leptospirosis, acute mastitis,
contagious calf pneumonia,
pneumoenteritis of calves, secondary bacterial infections associated
with virus diseases,
and as an aid in combating infections associated with surgical
procedures or injuries. In
general, this drug is effective against those conditions associated
with or caused by
bacteria sensitive to Tylosin.
Pigs: TYLOVET 200 TYLOSIN INJECTION is indicated as an aid in treating
the secondary
bacterial invaders in virus diseases. Pig diseases reported responding
to TYLOVET 200
TYLOSIN INJECTION therapy are: erysipelas, pneumonia and dysentery in
pigs.
Net Contents:
100mL
50mL
12 X 100mL
15 X 50mL
Directions for Use:
Restraints: RLP APPROVED
Contraindications:
TYLOVET 200 TYLOSIN INJECTION should not be mixed with other
parenteral solutions
as this may cause precipitation of the active ingredient.
Precautions:
If there is no response to therapy in three days, diagnosis and
treatment should be
reassessed.
Side Effects:
Occasionally pigs have been observed with reaction to TYLOVET 200
TYLOSIN
INJECTION. This consists of an oedema of the rectal mucosa, mild anal
protrusion,
diarrhoea, erythema and pruritus. Discontinuation of the treatment has
affected an
uneventful recovery from these symptoms. As with the injection of any
foreign substance,
an injection site reaction may very occasionally occur in some pigs.
If the reaction is
of concern to the pro

Summary of Product characteristics

PRODUCT NAME: SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
PAGE: 1 OF 5
THIS VERSION ISSUED: MAY, 2017
SAFETY DATA SHEET
Issued by: Abbey Laboratories Pty Ltd
Phone: [phone] (office hours)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
ABBEY LABORATORIES PTY LTD
PHONE: [phone] (OFFICE HOURS)
BUILDING T2A, NIRIMBA EDUCATION PRECINCT
EASTERN ROAD, QUAKERS HILL NSW 2763
CHEMICAL NATURE:
Tylosin is a fermentation product of _Streptomyces fradiae_. Present
here in a suitable
solvent for injection.
TRADE NAME:
TYLOVET 200 TYLOSIN INJECTION
PRODUCT USE:
For the treatment of infections caused by organisms sensitive to
Tylosin in cattle and
pigs.
CREATION DATE:
MAY, 2017
THIS VERSION ISSUED:
MAY, 2017
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P411: Store at temperatures not exceeding 25°C (Air Conditioning).
P402+P404: Store in a dry place. Store in a closed container.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage.