ILIUM AMOXYCILLIN BROAD-SPECTRUM ANTIBIOTIC INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE

Available from:

TROY LABORATORIES PTY LTD

INN (International Name):

amoxycillin as trihydrate(150mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 150.0 mg/ml

Units in package:

100mL; 250mL

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

CAT | CATTLE | DOG | PIGS | BEEF | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | CASTRATE

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

ACTINOBACILLUS EQUULI | ACTINOBACILLUS LIGNIERESII | ACTINOMYCES BOVIS | BACILLUS ANTHRACIS | BACTERIAL INFECTION | BORDETELLA SPP. | CLOSTRIDIUM SPP. | CORYNEBACTERIUM SPP. | ERYSIPELOTHRIX RHUSIOPATHIAE | ESCHERICHIA COLI (E. COLI) | FUSIFORMIS SPP. | FUSOBACTERIUM NECROPHORUM | HAEMOPHILUS SPP. | MORAXELLA SPP. | PASTEURELLA SPP. | PROTEUS MIRABILIS | SALMONELLA SPP. | STAPHYLOCOCCUS - NOT PENICILLIN RESIST | STREPTOCOCCUS SPP. | AMOXYCILLIN SENSITIVE BACTERIA | ANTHRAX | ASSOCIATED WITH VIRAL DISEASE | BACTERIAL CANKER | BORDETELLA BRONCHISEPTICA | CLOSTRIDIUM BOTULINUM | CLOSTRIDIUM CHAUVOEI | CLOSTRIDIUM FALLAX | CLOSTRIDIUM FESERI | CLOSTRIDIUM HEMOLYTICUM | CLOSTRIDIUM NOVYI | CLOSTRIDIUM PERFRINGENS TYPES | CLOSTRIDIUM SEPTICUM | CLOSTRIDIUM SORDELLI | CLOSTRIDIUM SPOROGENES | CLOSTRIDIUM TETANI | EXCLUDING PENICILLIN RESISTANT | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | HAEMOPHILUS AGNI | HAEMOPHILUS BOVIS | HAEMOPHILUS PARAINFLUENZAE | HAEMOPHILUS PARASUIS | HAEMOPHILUS PLEUROPNEUMONIAE

Product summary:

Poison schedule: 4; Withholding period: WHP: Milk: Do not use less than 48 hour s before collection of milk for human consumption or processing. This milk sh ould not be fed to bobby calves. Meat: Do not use less than 14 days in cattle or pigs before slaughter for human cons umption.; Host/pest details: CAT: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA SPP., CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, ESCHERICHIA COLI (E. COLI), FUSIFORMIS SPP., FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCUS SPP.]; CATTLE: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA SPP., CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, ESCHERICHIA COLI (E. COLI), FUSIFORMIS SPP., FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCUS SPP.]; DOG: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA SPP., CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, ESCHERICHIA COLI (E. COLI), FUSIFORMIS SPP., FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCUS SPP.]; PIGS: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA SPP., CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, ESCHERICHIA COLI (E. COLI), FUSIFORMIS SPP., FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCUS SPP.]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA SPP., CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, ESCHERICHIA COLI (E. COLI), FUSIFORMIS SPP., FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCUS SPP.]; CATTLE: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA SPP., CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, ESCHERICHIA COLI (E. COLI), FUSIFORMIS SPP., FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCUS SPP.]; DOG: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA SPP., CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, ESCHERICHIA COLI (E. COLI), FUSIFORMIS SPP., FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCUS SPP.]; PIGS: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA SPP., CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, ESCHERICHIA COLI (E. COLI), FUSIFORMIS SPP., FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCUS SPP.]; For the treatment of bacterial infections sensitive to amoxycillin in dogs, cats, cattle and pigs.Local reaction may occur at the site of injection. Should not be given to penicillin-sensitive animals and should not be used orally/parentally in small herbivores such as rabbits/guinea pigs.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

MAIN
PANEJ-
CARTON
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENTONLY
ILIUM
AMOXYCILLIN
Broad-Spectrum
Antibiotic
Injection
ACTIVE CONSTITUENT:
150mg/mL AMOXYCILLIN (as Amoxyciliin Trlhydrate)
For
the
treatment
of
bacterial
infections
sensitive
to
amoxycillin
in
dogs,
cats,
cattle
and
pigs
(100mL,250mL)
ILIUM
N.R.A.
APPROVED
LABEL
(TEXT)
5'
,fol_/J/C:2-
Label No:
-..
f.&=
.J"
.
Date
•
..IJft,!11~
SignatuJ..'!"
..,....
" ....
dA..
......
_\J_
ILIUM
AMOXYCILLIN
BROAD-SPECTRUM
ANTIBIOTIC
INJECTION
DRAFT
LABEL
56046/ 100mL, 250mL
page 1 of 5
Version 1 12/11/02
Ancillary
panel!-
carlon top
ILIUM
AMOXYCILLIN
Broad-Spectrum
Antibiotic
Injection
(100mL,250mL)
ILIUM
Ancillary panel
2-
cetton side
DIRECTIONS FOR USE
FOR INTRAMUSCULAR OR SUBCUTANEOUS INJECTIONS ONLY.
SHAKE VIAL WELL BEFORE USE TO SUSPEND ACTIVE MATERIAL.
USE A DRY SYRINGE AND NEEDLE TO EXTRACT SUSPENSION FOR INJECTION TO
AVOID
CONTAMINATING REMAINING CONTENTS
OF
VIAL WITH DROPS
AFWATER.
LOCAL
REACTION
MAY
OCCUR
AT
THE
SITE OF INJECTION.
IN FINE SKINNED ANIMALS WHERE
THIS IS CONSIDERED TO BE AN UNDESIRABLE RISK, THIS
product
SHOULD NOT BE USED.
Dose:
7mgikg
(1
mU20kg approx.) bodyweight once daily for 3-5 days.
The following is intended as a guide.
5kg
0.25mL
20kg
1mL
50kg
2.5mL
150kg
7.5mL
450kg
20mL
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.
AMOXYCILLIN
SHOULD
NOT
BE
GIVEN
TO
PENICILLIN-SENSITIVE
ANIMALS
AND
SHOULD
NOT
BE
USED
ORALLY
OR
PARENTERALLY
IN
VERY
SMALL
HERBIVORES
SUCH
AS
RABBITS
OR
GUINEA
PIGS.
DISPOSAL:
DISPOSE
OF
EMPTY
CONTAINER
BY
WRAPPING
WITH
PAPER
AND
PUTTING
IN
GARBAGE.
STORAGE:
Store below 25°C (air conditioning). Dispose of the vial 28 days
after initial
broaching.
Anciilary panel
3
carlon side
WITHHOLDING PERIODS
MILK:
DO NOT USE less than 48
hours
before
collection
of
milk
for
human
consumption
or processing. This
milk
should
not
be fed
to
bobby
calves.
MEAT:

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: ILIUM AMOXYCILLIN BROAD-SPECTRUM ANTIBIOTIC INJECTION
PAGE: 1 OF 4
THIS REVISION ISSUED: MAY, 2006
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
TROY LABORATORIES PTY. LIMITED ABN: 21 000 283 769
TEL:
[phone]
98 LONG STREET
FAX:
[phone]
SMITHFIELD NSW 2164
SUBSTANCE:
Active ingredient is an antibiotic - presented in an oily base.
TRADE NAME:
ILIUM AMOXYCILLIN BROAD-SPECTRUM ANTIBIOTIC INJECTION
PRODUCT USE:
Broad spectrum antibiotic injection.
CREATION DATE:
JUNE, 2005
REVISION DATE:
MAY, 2006
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of NOHSC
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: White liquid suspension.
ODOUR:
Characteristic odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
POTENTIAL HEALTH EFFECTS
THE ACTIVE INGREDIENT IS AN ANTIBIOTIC. ANY PERSON WITH A HISTORY OF
ALLERGIES TO THIS CLASS OF SUBSTANCES
SHOULD AVOID ALL CONTACT WITH THIS PRODUCT AS IT MAY CAUSE
SENSITISATION.
INHALATION
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely.
Available data indicates that
this product is not harmful. In addition product is unlikely to cause
any discomfort or irritation.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. However product may be mildly irritating, but is unlikely
to cause anything more than mild discomfort
which should disappear once contact ceases.
LONG TERM EXPOSURE: