NEOPHARM ANTIBIOTIC FEED ADDITIVE

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:

NEOMYCIN BASE (AS THE SULFATE)

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

neomycin as sulfate(600g/kg)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

NEOMYCIN BASE (AS THE SULFATE) ANTIBIOTIC Active 600.0 mg/g

Units in package:

10kg; 1kg; 500g

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: MEAT: REMOVE ALL MEDICATED FEED 5 days (broilers) 14 days (turkeys) 14 days (laying hens) 20 days (pigs) 30 days (cattle) before slaughter for hum an consumption. MILK: Nil EGGS: Nil; Host/pest details: CATTLE: [ESCHERICHIA COLI (E. COLI), PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA SPP., SCOURS]; PIGS: [ESCHERICHIA COLI (E. COLI), PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA SPP., SCOURS]; POULTRY: [ESCHERICHIA COLI (E. COLI), PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA SPP., SCOURS]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ESCHERICHIA COLI (E. COLI), PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA SPP., SCOURS]; PIGS: [ESCHERICHIA COLI (E. COLI), PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA SPP., SCOURS]; POULTRY: [ESCHERICHIA COLI (E. COLI), PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA SPP., SCOURS]; For the treatment of bacterial scours caused by organisms sensitive to Neomycin in poultry, pigs and cattle.

Authorization status:

Stopped

Authorization date:

2023-07-01

Patient Information leaflet

LABEL NAME:
NEOPHARM ANTIBIOTIC FEED ADDITIVE
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Active constituent: NEOMYCIN (as Neomycin Sulphate) minimum 600g/kg
CLAIMS:
For the treatment of bacterial scours caused by organisms sensitive to
Neomycin, including
Neomycin sensitive strains of E.coli, Salmonella spp, Pseudomonas spp
and Proteus spp.
in poultry, pigs and cattle.
NET CONTENTS:
10kg
1kg
500g
DIRECTIONS FOR USE:
RESTRAINTS:
CONTRAINDICATIONS:
PRECAUTIONS:
SIDE EFFECTS:
DOSAGE AND
ADMINISTRATION:
BLEND WITH A SMALL QUANTITY OF FEED BEFORE MIXING INTO LARGER
QUANTITIES.
Incoroporate into feeds at 100 -200g neomycin/tonne or as directed by
the veterinarian.
The minimum daily dose is 8mg neomycin/kg bodyweight.
Use medicated feed for 3 to 5 days. If no improvement is seen after 3
days, the diagnosis
should be re-established.
COMPANY NAME:
PRODUCT NAME:
PRODUCT NUMBER:
BAYER AUSTRALIA LTD (ANIMAL HEALTH)
NEOPHARM ANTIBIOTIC FEED ADDITIVE
58671/101686 RLP APPROVED
For Official Use Only
GENERAL DIRECTIONS:
Any variation by the prescribing veterinarian to the approved dose,
frequency, duration,
route, disease or target species may result in the need to extend the
approved withholding
period.
WITHHOLDING
PERIODS:
MEAT: REMOVE ALL MEDICATED FEED 5 days (broilers),14days (turkeys), 14
days
(laying hens), 20 days (pigs), 30 days (cattle) before slughter for
human consumption.
MILK: Zero (0) days
EGGS: Zero (0) days
TRADE ADVICE:
EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for
this product.
Note—observing the meat withholding period may not be sufficient to
mitigate potential
risks to export trade. Trade advice should be sought from Bayer
Australia Ltd on 1800 678
368 before using this product.
SAFETY DIRECTIONS:
FIRST AID
INSTRUCTIONS:
If poisoning occurs, contact a doctor or Poisons Information Centre,
Phone Australia
131126
FIRST AID WARNINGS:
ADDITIONAL USER
SAFETY:
ENVIRONMENTAL
STATEMENTS:
DISPOSAL:
Shake and empt

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Summary of Product characteristics

PAGE 1 OF 6

SAFETY DATA SHEET

A18315/01/AUS


NEOPHARM ANTIBIOTIC FEED ADDITIVE

SECTION 1 – IDENTIFICATION, CONTACTS

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
NEOPHARM ANTIBIOTIC FEED ADDITIVE
Other Names
None allocated

Product Use
FOR ANIMAL TREATMENT ONLY
Treatment of bacterial scours caused by organisms sensitive
to
neomycin, including neomycin
sensitive strains of _Escherichia coli_,
_Salmonella_ sp., _Pseudomonas_ sp. and _Proteus_ sp. in poultry,
pigs and
cattle.
Creation Date
April 2013

Revision Date
New SDS

SECTION 2 – HAZARDS IDENTIFICATION
Hazard Classification

NON- HAZARDOUS SUBSTANCE
NON- DANGEROUS GOODS According to the Criteria of NOHSC,
and the ADG Code.
Poisons Schedule
S5
Risk Phrases
Nil
Safety Phrases
Nil

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Neomycin Sulphate
1405-10-3
60%
This is a commercial product whose exact ratio
of components may vary slightly. Minor
quantities of other non
hazardous ingredients are also present.

A18315/01/AUS:
NEOPHARM ANTIBIOTIC FEED ADDITIVE

PAGE 2 OF 6

SECTION 4 – FIRST AID MEASURES
Label Regulated First
Aid Statement
If poisoning occurs contact a doctor or the Poisons Information
Centre (In Australia: Phone 13 11 26).
Scheduled Poisons
S5
Inhalation
Move affected person to fresh air. Seek medical attention if
breathing difficulty occurs.
Skin contact
If on skin, wash thoroughly. If sprayed in mouth rinse mouth
with
water ensuring mouthwash is not swallowed.
Eye contact
If in eyes, hold eyes open, f

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