ILIUM MELOXICAM 12 ANTI-INFLAMMATORY ORAL SUSPENSION FOR FOALS

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(12mg/mL)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

MELOXICAM UNGROUPED Active 12.0 mg/ml

Units in package:

100 mL; 250 mL

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

HORSE FOAL

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

ANTI-INFLAMMATORY AGENT | MUSCOSKELETAL DISCOMFORT | ANTIPYRETIC | BONE SORENESS | BRUISING | BURSITIS | INFLAMMATION | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MUSCLE SORENESS | OSTEOARTHRITIS | PAIN | PLATELET ACTIVITY | RHEUMATISM | SPRAINS | STRAINS | TENDON SPRAINS | TRAUMATIC SWELLING

Product summary:

Poison schedule: 4; Withholding period: MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE less than 28 days before slaughter for human consumption.; Host/pest details: HORSE FOAL: [ANTI-INFLAMMATORY AGENT, MUSCOSKELETAL DISCOMFORT]; Poison schedule: 4; Withholding period: WHP: MEAT (HORSES):28 days; Host/pest details: HORSE FOAL: [ANTI-INFLAMMATORY AGENT, MUSCOSKELETAL DISCOMFORT]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE FOAL: [ANTI-INFLAMMATORY AGENT, MUSCOSKELETAL DISCOMFORT]; Non-steroidal anti-inflammatory for the alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders in foals less than six weeks of age.Contraindicated for use in pregnant or lactating mares or in horses less than 6 weeks of age. Refer to product leaflet also. NOT TO BE USED IN FOOD PRODUCING SPECIES.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

ILIUM MELOXICAM 12 ANTI-INFLAMMATORY ORAL SUSPENSION FOR FOALS
65030/138023
Product Name:
APVMA Approval No:
Label Name:
ILIUM MELOXICAM 12 ANTI-INFLAMMATORY ORAL SUSPENSION FOR FOALS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
12 mg/mL meloxicam
Claims:
Non-steroidal anti-inflammatory for the alleviation of inflammation
and pain in both acute
and chronic musculoskeletal disorders in foals less than six weeks of
age. An analgesic
and anti-pyretic agent.
Net Contents:
100 mL
250 mL
Directions for Use:
Restraints:
Contraindications:
Contraindicated for use in animals suffering from gastrointestinal
disorders such as irritation
and haemorrhage, impaired hepatic, cardiac or renal function and
haemorrhagic disorders,
or where there is evidence of individual hypersensitivity to the
product. Also contraindicated
in pregnant or lactating mares.
Precautions:
Administration concurrently with glucocorticoids, other non-steroidal
anti-inflammatory
drugs or with anti-coagulant agents should be avoided. Product
interactions with
ilium Meloxicam 12 suspension have not been studied. Avoid use in any
dehydrated,
hypovolaemic or hypotensive animal, as there is a potential risk of
increased renal toxicity.
Side Effects:
Reactions symptomatic of NSAID treatment (primarily diarrhoea) may
occur following
the recommended dose of ilium Meloxicam 12 Suspension.
Gastrointestinal side effects RLP APPROVED
are in most cases transient and disappear following the termination of
treatment.
If gastrointestinal side effects are persistent, or severe, treatment
should be discontinued,
and your veterinarian consulted. Transient urticaria can also occur.
In margin of safety
studies done on foals of less than 6 weeks the product was found to
have a narrow margin
of safety. In 1 group of foals which received 1x dose for 3x the
recommended duration
of treatment (0.6 mg/kg bodyweight twice daily for 21 days) followed
by a 7 day washout
and then 3x dos

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: MELOXICAM SUSPENSION FOR FOALS
PAGE: 1 OF 4
THIS REVISION ISSUED: JULY, 2010
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:
Water suspension of ingredients.
TRADE NAME:
MELOXICAM SUSPENSION FOR FOALS
PRODUCT CODE:
3467, 3468
PRODUCT USE:
Oral preparation for pain relief (especially arthritis) in foals.
CREATION DATE:
NOVEMBER, 2009
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:
Xn Harmful
.
Hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R22. Harmful if swallowed.
SAFETY PHRASES:
S24/25. Avoid contact with skin and 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
: Viscous translucent yellow suspension.
ODOUR:
Odourless.
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
INHALATION:
SHORT TERM EXPOSURE:
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