LOXICOM 0.5MG/ML ORAL SUSPENSION FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MELOXICAM

Available from:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (International Name):

meloxicam(0.5mg/mL)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

MELOXICAM UNGROUPED Active 0.5 mg

Units in package:

15mL; 30mL

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

MUSCOSKELETAL DISCOMFORT | MUSCULOSKELETAL CONDITIONS | ARTHRITIS | ARTHROSIS | BURSITIS | EXTERNAL MYOPATHY | INFLAMATION OF SOFT TISSUES AN | INFLAMMATION | OSTEITIS | OSTEOARTHRITIS | PAIN | TENDON AND LIGAMENT SPRAINS | TENDONITIS | TENOSYNOVITIS | TRAUMATIC JOINT AND CONNECTIVE

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [MUSCOSKELETAL DISCOMFORT, MUSCULOSKELETAL CONDITIONS]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [MUSCOSKELETAL DISCOMFORT, MUSCULOSKELETAL CONDITIONS]; For the alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders in dogs.Product should not be administered to pregnant or lactating bitches in the last third of pregnancy.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

TEXT LABEL: LOXICOM 0.5mg/mL ORAL SUSPENSION FOR DOGS
Immediate Container Label: Main Panel
Text appearing above the Header and below the Footer lines is not
included in the label
23
rd
August 2011 62948_44386_Label_RLP_V2
Page 1 of 7
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
LOXICOM 0.5 MG/ML ORAL
SUSPENSION FOR DOGS
Active Constituent per mL:
Meloxicam 0.5mg
For the alleviation of inflammation and pain in both acute and
chronic musculoskeletal disorders in dogs.
15 mL [30 mL]
[Norbrook logo] RLP APPROVED
Infopest
Verified
TEXT LABEL: LOXICOM 0.5mg/mL ORAL SUSPENSION FOR DOGS
Immediate Container Label: Ancillary Panel
Text appearing above the Header and below the Footer lines is not
included in the label
23
rd
August 2011 62948_44386_Label_RLP_V2
Page 2 of 7
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE
PRODUCT SHOULD NOT BE ADMINISTERED TO PREGNANT OR LACTATING BITCHES IN
THE LAST
THIRD OF PREGNANCY.
DOSAGE AND ADMINISTRATION:
SHAKE WELL BEFORE USE.
DISCARD 6 MONTHS AFTER INITIAL USE WHEN STORED BELOW 25
O
C (AIR CONDITIONING).
CLEAN AND DRY SYRINGES AFTER EACH USE.
Initial dose 0.2mg/kg bodyweight.
Maintenance dose 0.1mg/kg bodyweight.
FIRST AID: If poisoning occurs, contact a doctor or Poisons
Information Centre.
Phone Australia 131 126.
DISPOSE of empty container by wrapping with paper and putting in
garbage.
STORE below 25
o
C (Air conditioning). Discard 6 months after initial use.
APVMA 62948/44386
Batch No.:
Expiry Date:
TEXT LABEL: LOXICOM 0.5mg/mL ORAL SUSPENSION FOR DOGS
Carton: Main Panel
Text appearing above the Header and below the Footer lines is not
included in the label
23
rd
August 2011 62948_44386_Label_RLP_V2
Page 3 of 7
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
LOXICOM 0.5 MG/ML ORAL
SUSPENSION FOR DOGS
Active Constituent per mL:
Meloxicam 0.5mg
For the alleviation of inflammation and pain in both acute and chronic
musculoskeletal disorders in dogs.
15 mL [30 mL]
[Norbrook logo]
TEXT LA

Summary of Product characteristics

PRODUCT NAME: LOXICOM 0.5 MG/ML ORAL SUSPENSION FOR DOGS 
PAGE: 1 OF 4 
THIS REVISION ISSUED: AUGUST, 2012 
MATERIAL SAFETY DATA SHEET 
Issued by: Norbrook Laboratories Australia Pty Ltd 
Freecall: 1800 665 866 
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA,
(0800 764 766 IN NEW ZEALAND)

SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY 
NORBROOK LABORATORIES AUSTRALIA PTY LTD 
FREECALL: 1800 665 866 
UNIT 7/1 TRADE PARK DRIVE 

TULLAMARINE, VIC 3043 AUSTRALIA 

CHEMICAL NATURE:  
Water suspension and solution of ingredients.

TRADE NAME:  
LOXICOM 0.5 MG/ML ORAL SUSPENSION FOR DOGS 
PRODUCT CODE: 

62948 
PRODUCT USE:  
For the alleviation
of inflammation and pain in both acute and chronic musculoskeletal 
disorders in dogs.

CREATION DATE: 
AUGUST, 2012 
THIS VERSION ISSUED: 
AUGUST, 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 
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.  
RESPONSE 
P301+P330+P331: IF SWALLOWED: Rinse
mouth. Do NOT induce vomiting. 
P370+P378: Not combustible. Use extinguishing media suited
to burning materials.  
DISPOSAL 
P501: Dispose of small quantities and empty containers by wrapping with
paper and putting in garbage. For 
larger quantities, if recycling
or reclaiming is not possible, use a commercial waste
disposal service.  
EMERGENCY OVERVIEW 
PHYSICAL D

Safety Data Sheet

TEXT LABEL: LOXICOM 0.5mg/mL ORAL SUSPENSION FOR DOGS
Immediate Container Label: Main Panel
Text appearing above the Header and below the Footer lines is not
included in the label
23
rd
August 2011 62948_44386_Label_RLP_V2
Page 1 of 7
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
LOXICOM 0.5 MG/ML ORAL
SUSPENSION FOR DOGS
Active Constituent per mL:
Meloxicam 0.5mg
For the alleviation of inflammation and pain in both acute and
chronic musculoskeletal disorders in dogs.
15 mL [30 mL]
[Norbrook logo]
TEXT LABEL: LOXICOM 0.5mg/mL ORAL SUSPENSION FOR DOGS
Immediate Container Label: Ancillary Panel
Text appearing above the Header and below the Footer lines is not
included in the label
23
rd
August 2011 62948_44386_Label_RLP_V2
Page 2 of 7
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE
PRODUCT SHOULD NOT BE ADMINISTERED TO PREGNANT OR LACTATING BITCHES IN
THE LAST
THIRD OF PREGNANCY.
DOSAGE AND ADMINISTRATION:
SHAKE WELL BEFORE USE.
DISCARD 6 MONTHS AFTER INITIAL USE WHEN STORED BELOW 25
O
C (AIR CONDITIONING).
CLEAN AND DRY SYRINGES AFTER EACH USE.
Initial dose 0.2mg/kg bodyweight.
Maintenance dose 0.1mg/kg bodyweight.
FIRST AID: If poisoning occurs, contact a doctor or Poisons
Information Centre.
Phone Australia 131 126.
DISPOSE of empty container by wrapping with paper and putting in
garbage.
STORE below 25
o
C (Air conditioning). Discard 6 months after initial use.
APVMA 62948/44386
Batch No.:
Expiry Date:
TEXT LABEL: LOXICOM 0.5mg/mL ORAL SUSPENSION FOR DOGS
Carton: Main Panel
Text appearing above the Header and below the Footer lines is not
included in the label
23
rd
August 2011 62948_44386_Label_RLP_V2
Page 3 of 7
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
LOXICOM 0.5 MG/ML ORAL
SUSPENSION FOR DOGS
Active Constituent per mL:
Meloxicam 0.5mg
For the alleviation of inflammation and pain in both acute and chronic
musculoskeletal disorders in dogs.
15 mL [30 mL]
[Norbrook logo]
TEXT LABEL: LOXICOM 0.5mg/mL ORAL SUSP