ILIUM SULPRIM ORAL POWDER

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Patient Information leaflet (PIL)

02-05-2023

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

TRIMETHOPRIM; SULFADIMIDINE

Available from:

TROY LABORATORIES PTY LTD

INN (International Name):

sulfadimidine(430mg/g)+trimethoprim(86mg/g)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

TRIMETHOPRIM PYRIMIDINE Active 86.0 mg/g; SULFADIMIDINE SULFANYL Active 430.0 mg/g

Units in package:

1kg; 250g

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: MEAT WITHHOLDING PERIOD (CALVES, PIGS, P OULTRY): DO NOT USE less than 14 days be fore slaughter for human consumption. M EAT WITHHOLDING PERIOD (HORSES): DO NOT USE less than 28 days before slaughter f or human consumption. Any variation by the prescribing veterinarian to the appr oved use pattern, may require an extende d withholding period. An ESI has not been established for this product. Note – observing the meat withholding period may not be sufficient to mitigate potent ial risks to export trade. Trade advice should be sought from Troy Laboratories on (+61) 2 8808 3600 before using this p roduct.; Host/pest details: CALF: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; HORSE: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; PIGS: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; POULTRY: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; PULLET-LAYING REPLACEMENT: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; Poison schedule: 4; Withholding period: WHP:Meat:Calves Pigs Poultry-Do not use less than 14 days before slaughter for human consumption. EGGS - DO NOT USE in birds which are producing eggs o r egg products for human consumption. PULLETS - DO NOT USE within 14 days of the onset of lay. Discard any pullet eggs produced within 14 days of the fi nal treatment. MEAT WITHHOLDING PERIOD (HORSES): 28 days TRADE ADVICE EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI established. For advice on the ESI, contact the manufact urer on (02) 9604 6266 before using thi s product.; Host/pest details: CALF: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; HORSE: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; PIGS: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; POULTRY: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; PULLET-LAYING REPLACEMENT: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; Poison schedule: 4; Withholding period: ; Host/pest details: CALF: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; HORSE: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; PIGS: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; POULTRY: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; PULLET-LAYING REPLACEMENT: [BACTERIAL INFECTION, BRUCELLA SPP., CORYNEBACTERIUM - EXCLUSIONS SEE LABEL, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., HAEMOPHILUS SPP., KLEBSIELLA SPP., NOCARDIA SPP., ORGANISMS SENSITIVE TO COMBINATION OF, PASTEURELLA SPP., PROTEUS SPP., PSEUDOMONAS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCI, STREPTOCOCCI]; For the treatment of infections in horses, calves, pigs and poultry due to organisms susceptible to the combination of sulfadimidine and trimethoprim.DO NOT USE in birds which are producing or may in the future produce eggs or egg products for human consumption or processing.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
ILIUM SULPRIM ORAL POWDER
51718/138478
Label Name:
ILIUM
SULPRIM ORAL POWDER
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
430 mg/g sulfadimidine
86 mg/g trimethoprim
Claims:
For the treatment of infections in horses, calves, pigs and poultry
due to organisms
susceptible to the combination of sulfadimidine and trimethoprim.
Indiscriminate use of ilium Sulprim may contribute to the development
of antibiotic
resistance.
Net Contents:
250 g
1 kg
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.
Pullets: DO NOT USE within 14 days of the onset of lay. Discard any
pullet eggs produced
within 14 days of the final treatment.
Contraindications:
Precautions:
Side Effects: RLP APPROVED
Dosage and
Administration:
For oral use only.
One level large scoop contains 5 g sulfadimidine and 1 g trimethoprim.
One level small
scoop contains 1.25 g sulfadimidine and 0.25 g trimethoprim.
HORSES: One level large scoop per 200 kg body weight twice daily.
CALVES: One level small scoop per 50 kg body weight daily.
Administer on dampened food or mixed with honey or molasses.
PIGS: One level small scoop per 50 kg body weight daily.
POULTRY: One to two level small scoops per 12 L drinking water for 3
to 5 days. Do not
exceed a dose of 25 mg/kg body weight sulfadimidine (5 mg/kg
bodyweight trimethoprim).
Administer mixed thoroughly with food or dissolved in drinking water.
General Directions:
Withholding Periods:
MEAT (CALVES, PIGS, POULTRY): DO NOT USE less than 14 days before
slaughter for
human consumption.
MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE less than 28 days before
slaughter for human consumption.
Any variation by the prescribing veterinarian to the approved use
pattern, may require an
extended withholding period.
Trade Advice:
EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for
this product.
Not

Read the complete document

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: SULPRIM ORAL POWDER
PAGE: 1 OF 4
THIS REVISION ISSUED: JULY, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Troy Laboratories Australia Pty Ltd
Phone: 02 9677 9000
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
TROY LABORATORIES AUSTRALIA PTY. LTD ABN: 21 000 283 769
TEL:
(02)9677 9000
31-35 GLENDENNING ROAD
FAX:
(02) 9677 9300
GLENDENNING NSW 2761
CHEMICAL NATURE:
Blend of ingredients. Active ingredients are antibiotics.
TRADE NAME:
SULPRIM ORAL POWDER
PRODUCT CODE:
3692
PRODUCT USE:
Treatment of certain infections in horses, calves, pigs and poultry.
CREATION DATE:
AUGUST, 2005
THIS VERSION ISSUED:
JULY, 2010
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S22, S25. Do not breathe dust. Avoid contact with eyes.
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 light free-flowing powder.
ODOUR:
Mild odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. Two
ingredients in this product
are antibiotics. Any person with a history of allergies to this class
of substances should avoid all contact with this
product as it may cause sensitisation.
POTENTIAL HEALTH EFFECTS
This is a pharmacologically active preparation, and contact should be
avoided except for its intended veterinary use. If
you have come into contact with this product, seek medical attention
if you experience any unusual symptoms.
INHALATION
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely. Long
term inhalation of high

Read the complete document