SOL-U-MOX AMOXYCILLIN SOLUBLE POWDER

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

amoxycillin as trihydrate(870mg/g)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 870.0 mg/g

Units in package:

100g; 1kg; 20kg; 250g; 25kg; 500g; 50kg; 5kg

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Do not administer later than 2 day s before slaughter for human consumptio n.; Host/pest details: POULTRY: [ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; Poison schedule: 4; Withholding period: ; Host/pest details: POULTRY: [ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; A broad spectrum water soluble medication for the treatment of amoxycillin susceptible infections of the alimentary, urogenital and respiratory tract of poultry, including organisms associated with CRD complex and diseases caused by E. coli.DO NOT USE in birds which are producing or may in the future produce eggs which may be used or processed for human consumption.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
BAYER AUSTRALIA LTD (ANIMAL HEALTH)
PRODUCT NAME:
SOL-U-MOX AMOXYCILLIN SOLUBLE POWDER
ELABEL APPLICATION NO:
DC14-84362492E139
APVMA APPROVAL NO:
52444/101167
PRODUCT NO:
52444
VERSION NO:
4.0
APPLICATION STARTED:
2014-Dec-09 17:02:11
VERSION CREATED:
2015-Jul-30 14:13:15
STARTED BY:
Rebecca Milton
PRINTED:
2015-Jul-30 15:52:16
LABEL NAME:
SOL-U-MOX AMOXYCILLIN SOLUBLE POWDER
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
870 mg/g AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE
CLAIMS:
SOL-U-MOX AMOXYCILLIN SOLUBLE POWDER is a broad-spectrum water-soluble
medication for the treatment of Amoxycillin susceptible infections of
the alimentary,
urogenital, and respiratory tract of poultry, including organisms
associated with the Chronic
Respiratory Disease (CRD) complex and diseases caused by E. coli.
NET CONTENTS:
100g
250g
500g
1kg
5kg
20kg
25kg
50kg
DIRECTIONS FOR USE:
DIRECTIONS FOR USE:
RESTRAINTS:
DO NOT USE in birds which are producing or may in the future produce
eggs which may
be used or processed for human consumption.
CONTRAINDICATIONS:
PRECAUTIONS:
SIDE EFFECTS: RLP APPROVED
For Official Use Only
DOSAGE AND
ADMINISTRATION:
SOL-U-MOX AMOXYCILLIN SOLUBLE POWDER is for use as a water medication
for
poultry species. Water consumption varies with the climate and the age
of the birds.
General dose rate of Amoxycillin for poultry is 8-20mg/kg body weight
daily, depending
on the severity of the condition. This may be achieved by adding 110g
SOL-U-MOX
AMOXYCILLIN POWDER to 900-1000L of drinking water for 3-5 days.
The material dissolves and disperses readily in water. Administer as
the only source of
drinking water for 3-5 days. Medicated water should be consumed within
12 hours, and
fresh solution prepared daily. Water tanks and lines should be flushed
thoroughly to avoid
any holdover of residues of the product.
GENERAL DIRECTIONS:
WITHHOLDING
PERIODS:
MEAT: DO NOT USE less than 2 day

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Summary of Product characteristics

PAGE 1 OF 7

SAFETY DATA SHEET

A18328/1/AUS


SOL-U-MOX AMOXYCILLIN SOLUBLE POWDER

SECTION 1 – IDENTIFICATION, CONTACTS, HAZARDOUS NATURE

Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073

EMERGENCY TELEPHONE NUMBER
1800 033 111
24 hour Emergency Service Australia Wide, Toll Free

CONTACT POINT (FOR NON-EMERGENCY CALLS)
Animal Health Division
(02) 9391 6000
Full Product Name
SOL-U-MOX AMOXYCILLIN SOLUBLE POWDER
Other Names
None allocated.

Product Use
FOR ANIMAL TREATMENT ONLY
For the prevention
and treatment of amoxicillin susceptible infections
of the alimentary, urogenital and respiratory tract in
poultry.
Creation Date
1 August 2013

Revision Date
New SDS

SECTION 2 – HAZARDS IDENTIFICATION
Hazard Classification
NOT CLASSIFIED AS A HAZARDOUS SUBSTANCE
NOT CLASSIFIED AS DANGEROUS GOODS according to criteria
of NOHSC Australia and ADG Code.
Poison Schedule S4
Risk Phrases
None allocated.
Safety Phrases
S22 Do not breathe dust
S24/25 Avoid contact with eyes and skin

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Amoxycillin trihydrate
61336-70-7
100%

A18328/1/AUS  SOL-U-MOX AMOXYCILLIN SOLUBLE POWDER

PAGE 2 OF 7

SECTION 4 – FIRST AID MEASURES
Label Regulated First
Aid Statement
If poisoning occurs contact a doctor or Poisons Information
Centre.
Phone Australia 13 11 26.
Scheduled Poisons
Poison schedule S4.
Inhalation
Move affected person to fresh air and keep
at rest until recovered. If
in doubt, contact a doctor or Poisons Information Centre. Phone
Australia 131 126.
Skin contact
Remove contaminated clothing and wash affected areas thoroughly
with soap and water for at least 5 minutes or until chemical
is
removed. Seek medical attention if irri

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