ILIUM MELOXICAM 20 ANTI-INFLAMMATORY INJECTION FOR CATTLE, SHEEP, PIGS AND HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MELOXICAM

Available from:

TROY LABORATORIES PTY LTD

INN (International Name):

meloxicam(20mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

MELOXICAM UNGROUPED Active 20.0 mg/ml

Units in package:

100mL; 250mL

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

CATTLE | PIGS | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | GILT | HEI

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

ANALGESIC | ANTI-INFLAMMATORY AGENT | ANTIPYRETIC | ANTIPYRETIC | BONE SORENESS | BRUISING | BURSITIS | COLIC | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MUSCLE RELAXANT | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SEDATIVE | SPASMOLYTIC | SPRAINS | STRAINS | TENDON SPRAINS | TRAUMATIC SWELLING

Product summary:

Poison schedule: 4; Withholding period: MEAT: Cattle: DO NOT USE less than 8 da ys before slaughter for human consumptio n. Sheep: DO NOT USE less than 11 days before slaughter for human consumption. Pigs: DO NOT USE less than 4 days befor e slaughter for human consumption. ME AT WITHHOLDING PERIOD (HORSES): 28 days before slaughter for human consumption. MILK: Milk collected from cows within 6 days (12 milkings) following treatmen t MUST NOT BE USED or processed for huma n consumption, or fed to bobby calves. DO NOT USE in lactating ewes or pregnant ewes within 11 days of lambing where mi lk may be used or processed for human co nsumption. CATTLE and SHEEP: Repeat t reatments (more than ONCE), higher doses or injection into the muscle could resu lt in residues above the MRLs unless the label withholding period is extended. PIGS: Repeat doses (more than TWICE) or higher doses could result in residues ab ove the MRLs unless the label withholdin g period is extended. Any variation b y the prescribing veterinarian to the ap proved use pattern, may require an exten ded withholding period. EXPORT SLAUGHTE R INTERVAL (ESI): CATTLE: DO NOT USE le ss than 21 days before slaughter for exp ort. SHEEP: DO NOT USE less than 11 day s before slaughter to export. PIGS: DO NOT USE less than 4 days before slaughte r before export. Before using this prod uct, confirm the current ESI from Troy L aboratories on [phone] or the APV MA website (www.apvma.gov.au/residues).; Host/pest details: CATTLE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; PIGS: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; SHEEP: [PAIN AND INFLAMMATION]; Poison schedule: 4; Withholding period: MEAT: DO NOT USE less than 8 days (cattl e), 11 days (sheep), 4 days (pigs), 28 d ays (horses) before slaughter for human consumption. MILK: Milk collected from cows within 6 days (12 milkings) followi ng treatment MUST NOT BE USED or process ed for human consumption, or fed to bobb y calves. DO NOT USE in lactating ewes or pregnant ewes within 11 days of lamb ing where milk may be used or processed for human consumption. CATTLE and SHEEP : Repeat treatments (more than ONCE), hi gher doses or injection into the muscle could result in residues above the MRLs unless the label withholding period is e xtended. PIGS: Repeat doses (more than TWICE) or higher doses could result in r esidues above the MRLs unless the label withholding period is extended. The pre scribing veterinarian would need to advi se on an extended withholding period. CATTLE: An ESI has not been established for this product. Note - observing the meat withholding period may not be suffi cient to mitigate potential risks to exp ort trade. Trade advice should be sough t from Troy Laboratories on (02) 8808 36 00 before using the product. SHEEP: DO NOT slaughter for export less than 11 da ys after final treatment. PIGS: DO NOT slaughter for export less than 4 days af ter final treatment.. Before using this product, confirm the current ESI from T roy Laboratories on [phone] or t he APVMA website (www.apvma.gov.au/resid ues).; Host/pest details: CATTLE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; PIGS: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; SHEEP: [PAIN AND INFLAMMATION]; Poison schedule: 4; Withholding period: WITHOLDING PERIOD: MEAT: Do not use le ss than 8 days for cattle and 4 days fo r pigs before slaughter for human consu mption. MILK: Milk collected from cows within 6 days (12 milkings) of treatmen t MUST NOT be used for human consumptio n, processing or fed to bobby calves. TRADE ADVICE EXPORT SLAUGHTER INTERVAL : CATTLE: This product does not have an ESI established for cattle. For advic e on the ESI contact the manufacturer on [phone] before using this pro duct. PIGS: Do not use less than 4 days before slaughter for export. The ESI on this label was correct at the time o f label approval. Before using this pro duct confirm the current ESI from the manutacfturer on [phone] or the APVMA website (www.apvma.gov.au/residu es/ESI.shtml); Host/pest details: CATTLE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; PIGS: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; SHEEP: [PAIN AND INFLAMMATION]; Poison schedule: 4; Host/pest details: ; Poison schedule: 4; Withholding period: WITHOLDING PERIOD: MEAT: Do not use le ss than 8 days for cattle and 4 days fo r pigs before slaughter for human consu mption. MILK: Milk collected from cows within 6 days (12 milkings) of treatmen t MUST NOT be used for human consumptio n, processing or fed to bobby calves. TRADE ADVICE EXPORT SLAUGHTER INTERVAL : CATTLE: This product does not have an ESI established for cattle. For advic e on the ESI contact the manufacturer on [phone] before using this pro duct. PIGS: Do not use less than 4 days before slaughter for export. The ESI on this label was correct at the time o f label approval. Before using this pro duct confirm the current ESI from the manutacfturer on [phone] or the APVMA website (www.apvma.gov.au/residu es/ESI.shtml); Host/pest details: CATTLE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; PIGS: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; PIGS: [ANALGESIC, ANTI-INFLAMMATORY AGENT, ANTIPYRETIC]; A non-steroidal anti-inflammatory analgesic - antipyretic for use in cattle and pigs.Use other than as a single administration may require extended withholding periods - consult prescribing veterinarian. See PRECAUTIONS/CONTRAINDICATIONS/SIDE EFFECTS for additional information.

Authorization status:

Registered

Authorization date:

2022-07-01

Patient Information leaflet

ILIUM MELOXICAM 20 ANTI-INFLAMMATORY INJECTION FOR CATTLE, SHEEP,
PIGS AND HORSES
62535/137059
Product Name:
APVMA Approval No:
Label Name:
ILIUM MELOXICAM 20 ANTI-INFLAMMATORY INJECTION FOR CATTLE, SHEEP, PIGS
AND HORSES
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
20 mg/mL MELOXICAM
Claims:
A non steroidal anti-inflammatory, analgesic, antipyretic for use in
cattle, sheep, pigs and
horses.
Cattle:
For the use in acute respiratory infection and diarrhoea in
combination with appropriate
antibiotic therapy to reduce clinical symptoms in calves and young
cattle. For use in
acute mastitis, in combination with antibiotic therapy, as
appropriate, to reduce the clinical
symptoms in lactating cows. For use to assist in the control of pain
following the dehorning
of cattle, particularly that following heat cautery of young cattle.
It is recommended that the
injection be administered approximately 10 minutes before dehorning
and be accompanied
by a cornual nerve block anaesthesia.
Sheep:
For single dose use in sheep and lambs 14 days of age or older for the
alleviation of pain
and inflammation.
Pigs:
For use in acute non-infectious locomotor disorders to reduce symptoms
of lameness
and inflammation. For use in puerperal septicaemia and toxaemia
(mastitis, metritis
and agalactia syndrome) with appropriate antibiotic therapy to reduce
clinical signs of
inflammation, oppose the effects of endotoxins and hasten recovery.
Horses:
For single dose rapid initiation of therapy of musculoskeletal
disorders and relief of pain
associated with colic.
Net Contents:
100 mL
250 mL RLP APPROVED
Directions for Use:
Restraints:
Contraindications:
Contraindicated for use in animals suffering from haemorrhagic
gastrointestinal disorders,
impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there
is evidence of individual hypersensitivity to the product. Concurrent
administration with
glucocorticosteroids, other non-steroidal anti-inflamm

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: ILIUM MELOXICAM 20 ANTI-INFLAMMATORY INJECTION FOR
CATTLE AND PIGS.
PAGE: 1 OF 4
THIS REVISION ISSUED: FEBRUARY, 2012
MATERIAL SAFETY DATA SHEET
Issued by: Troy Laboratories Australia Pty Ltd
Phone: [phone]
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:
[phone]
31-35 GLENDENNING ROAD
FAX:
[phone]
GLENDENNING NSW 2761
CHEMICAL NATURE:
Meloxicam and other minor ingredients in a suitable solvent system.
TRADE NAME:
ILIUM MELOXICAM 20 ANTI-INFLAMMATORY INJECTION FOR CATTLE AND PIGS.
PRODUCT USE:
Non-steroidal anti-inflammatory analgesic antipyretic for use in
cattle and pigs.
CREATION DATE:
FEBRUARY, 2012
THIS VERSION ISSUED:
FEBRUARY, 2012
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.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S24/25. Avoid contact with skin and eyes.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Clear yellow solution, free of lint or suspended particulate matter.
ODOUR:
Ethanol odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. This is
a physiologically active
product and so contact should be minimised, especially if the user is
taking a form of medication, as interactions can
sometimes give unexpected and undesired results.
POTENTIAL HEALTH EFFECTS
SELF INJECTION: IN ALL INSTANCES OF ACCIDENTAL SELF INJECTION CONTACT
A DOCTOR AS SOON AS POSSIBLE. FURTHER
INFORMATION ON TREATMENT IS AVAILABLE FROM POISONS INFORMATION CENTRE.
PHONE 131 126.
INHALATION:
SHORT TER