TIAMULABS TIAMULIN SOLUBLE POWDER

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TIAMULIN AS TIAMULIN HYDROGEN FUMARATE

Available from:

ABBEY LABORATORIES PTY LTD

INN (International Name):

tiamulin fumarate(980g/kg)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

TIAMULIN AS TIAMULIN HYDROGEN FUMARATE ANTIBIOTIC Active 980.0 g/kg

Units in package:

10kg; 1kg; 20kg; 25kg; 5kg

Class:

VM - Veterinary Medicine

Manufactured by:

ABBEY LABORATORIES

Therapeutic area:

ANTIBIOTIC & RELATED

Product summary:

Poison schedule: 4; Withholding period: MEAT (PIGS, POULTRY): DO NOT USE less th an 5 days before slaughter for human con sumption. Any variation by the prescrib ing veterinarian to the approved dose, f requency, duration, route, disease or ta rget species may require extending the a pproved withholding period.; Host/pest details: PIG: [PNEUMONIA, SWINE DYSENTERY]; POULTRY: [BIRD, CHRONIC RESPIRATORY DISEASE]; Poison schedule: 4; Withholding period: WITHHOLDING PERIODS: MEAT (PIGS POULT RY): DO NOT USE less than 5 days befor e slaughter for human consumtion. EGG S: DO NOT USE in birds which are produ cing or may in the future produce eggs that may be used or processed for huma n consumption.; Host/pest details: PIG: [PNEUMONIA, SWINE DYSENTERY]; POULTRY: [BIRD, CHRONIC RESPIRATORY DISEASE]; Poison schedule: 4; Withholding period: ; Host/pest details: PIG: [PNEUMONIA, SWINE DYSENTERY]; POULTRY: [BIRD, CHRONIC RESPIRATORY DISEASE]; For the treatment of swine dysentery and swine enzootic pneumonia; as an aid in the control of swine enzootic pneumonia in growing pigs; for the treatment and prevention of chronic respiratory disease in non-laying chickens.DO NOT USE in birds which are producing or may in the future produce eggs or egg products for human consumption

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

+
APPENDIX 2
RLP
Approved
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
ll5l
New Product (include all applicable RLPs)
OR
D
Variation (highlight instructions that are being varied). Approval
no.
of label being varied:
................
.
Signal
heading:
Product
name:
Active
constituenUs:
Statement
of
claims:
Net
contents:
Directions
for
Use
Heading:
Restraints:
CONTRAINDICATIONS:
PRECAUTIONS:
Side
effects:
Dosage
&
administration:
GENERAL
DIRECTIONS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
TIAMULABS TIAMULIN SOLUBLE POWDER
gsog/kg TIAMULIN HYDROGEN FUMARATE equivalent to 7g3g/kg TIAMULIN
base.
For the treatment
of
swine dysentery caused by
Serpulina hyodysenteriae
and swine
enzootic pneumonia caused
by
Mycoplasma hyopneumoniae;
as
an
aid
in
the control
of swine enzootic pneumonia caused by
_M. _
hyopneumoniae
in growing pigs; for the
treatment and prevention of chronic respiratory disease caused by
Mycoplasma
gallisepticum
in non-laying chickens.
1
kg,
5kg, 1
Okg,
20kg, 25kg
DO NOT
USE
in birds which are producing or may in the future produce eggs that
may
be
used or processed for human consumption.
Animals and birds should NOT receive products containing Monensin,
Salinomycin or
Narasin, during or for at least seven days before or after treatment
with Tiamulin
Soluble Powder.
PIGS:
Swine
dysentery-
8.8mg Tiamulin Hydrogen Fumarate/kg bodyweight.
Mix 25.5g per
400L of drinking water.
Administer continuously for 3-5 days.
Enzootic
pneumonia-
17.6mg Tiamulin Hydrogen Fumarate/kg bodyweight.
Mix
25.5g per 200L of drinking water.
Administer continuously for 6 days.
POULTRY:
Chronic respiratory disease
:Young
chicks-
20mg Tiamulin Hydrogen Fumarate/kg
bodyweight.
Mix 25.5g per 200L drinking water.
Administer continuously for 3-5
days.
Older
birds-
40mg Tiamulin Hydrogen Fumarate/kg bodyweight.
Mix 25.5g per 1
OOL
drinking water.
Administer continuously for 3-5 days.
During treatment withh

Summary of Product characteristics

PRODUCT NAME: TIAMULABS SOLUBLE POWDER
PAGE: 1 OF 5
THIS VERSION ISSUED: JANUARY 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:
Tiamulin hydrogen fumarate in a meal based substrate.
TRADE NAME:
TIAMULABS TIAMULIN SOLUBLE POWDER
APVMA CODE:
68980
PRODUCT USE:
For the treatment of certain conditions in pigs and chickens as
indicated on the
product label.
CREATION DATE:
JANUARY, 2017
THIS VERSION ISSUED:
JANUARY, 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
P352: Wash with plenty of soap and water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: In case of fire, use carbon dioxide, dry chemical, foam,
water fog.
STORAGE
P410: Protect from sunlight.
P411: Store at temperatures not exceeding 25°C.
P402+P404: Store in a dry place. Store in a closed container.
DISPOSAL
P501: Dispose of contents and containers as specified on the
registered label.
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: A white powder.
MAJOR HEALTH HAZARDS:
no