LOXICOM 0.5 MG/ML ORAL SUSPENSION FOR CATS

Country: Australia

Bahasa: Inggeris

Sumber: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Bahan aktif:

MELOXICAM

Boleh didapati daripada:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (Nama Antarabangsa):

meloxicam(0.5mg/mL)

Borang farmaseutikal:

ORAL SOLUTION/SUSPENSION

Komposisi:

MELOXICAM UNGROUPED Active 0.5 mg/ml

Unit dalam pakej:

15mL; 30mL; 5mL

Kelas:

VM - Veterinary Medicine

Kumpulan terapeutik:

CAT | CAT - QUEEN | CAT - TOM | KITTEN

Kawasan terapeutik:

MUSCULOSKELETAL SYSTEM

Tanda-tanda terapeutik:

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

Ringkasan produk:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [MUSCULOSKELETAL CONDITIONS]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [MUSCULOSKELETAL CONDITIONS]; For the alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.This product is contraindicated for use in pregnant or lactating animals as no data has been established. See Contraindications, Precautions & Side Effects sections on product leaflet.

Status kebenaran:

Registered

Tarikh kebenaran:

2023-07-01

Risalah maklumat

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
NORBROOK LABORATORIES AUSTRALIA PTY LIMITED
PRODUCT NAME:
LOXICOM 0.5 MG/ML ORAL SUSPENSION FOR CATS
ELABEL APPLICATION NO:
DC14-50695282E178
APVMA APPROVAL NO:
64038/101192
PRODUCT NO:
64038
VERSION NO:
2.0
APPLICATION STARTED:
2014-Dec-15 12:23:04
VERSION CREATED:
2015-Sep-08 14:41:58
STARTED BY:
Adrian Jaszewski
PRINTED:
2015-Sep-08 14:57:33
LABEL NAME:
LOXICOM 0.5 MG/ML ORAL SUSPENSION FOR CATS
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Meloxicam 0.5 mg/mL
CLAIMS:
For the alleviation of inflammation and pain in both acute and chronic
musculoskeletal
disorders
NET CONTENTS:
5mL
15mL
30mL
DIRECTIONS FOR USE:
RESTRAINTS:
CONTRAINDICATIONS:
This product is contraindicated for use in pregnant or lactating
animals as no data has been
established.
As for all NSAIDs use in any animal less than 6 weeks of age or in
debilitated aged animals
may involve additional risk. If use in such animals cannot be avoided
careful clinical
management may be required.
The use of the product is contra-indicated in animals suffering from
cardiac, hepatic
or clinical renal disease. Older cats considered for chronic treatment
should be
screened for pre-existing renal, hepatic or gastrointestinal disorders
or hypovolaemia
(using haematology, serum biochemical analysis and urinalysis as
necessary) before
administration of Loxicom 0.5 mg/mL Oral Suspension For Cats.
This is also the case when there is the possibility of
gastro-intestinal ulceration of bleeding,
or where there is evidence of a haemorrhagic disorder or individual
hypersensitivity to the
product. RLP APPROVED
For Official Use Only
PRECAUTIONS:
Loxicom 0.5 mg/mL Oral Suspension should not be administered
concurrently with
steroidal or other non-steroidal anti-inflammatory drugs,
aminoglycoside antibiotics or anti-
coagulant agents. Concurrent administration of potential nephrotoxic
drugs should be
avoided.
Pre-treatment with anti-infla

Ciri produk

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 CATS 
PRODUCT CODE: 

64038 
PRODUCT USE:  
For the alleviation
of inflammation and pain in both acute and chronic musculoskeletal 
disorders in cats.

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�

Lembaran Data Keselamatan

TEXT LABEL: LOXICOM 0.5 mg/mL ORAL SUSPENSION FOR CATS
Immediate Container Label: Main Panel
Text appearing above the Header and below the Footer lines is not
included in the label
30
th
March 2012 64038_47244_Label_V3
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 CATS
Meloxicam 0.5 mg/mL
For the alleviation of inflammation and pain in both acute and
chronic musculoskeletal disorders.
15mL[30mL]
[Norbrook logo]
TEXT LABEL: LOXICOM 0.5 mg/mL ORAL SUSPENSION FOR CATS
Immediate Container Label: Ancillary Panel
Text appearing above the Header and below the Footer lines is not
included in the label
30
th
March 2012 64038_47244_Label_V3
Page 2 of 7
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
STORE below 25
o
C (Air conditioning). Discard 6 months after initial use.
APVMA 64038/47244
Batch No.:
Expiry Date:
TEXT LABEL: LOXICOM 0.5 mg/mL ORAL SUSPENSION FOR CATS
Carton: Main Panel
Text appearing above the Header and below the Footer lines is not
included in the label
30
th
March 2012 64038_47244_Label_V3
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 CATS
Active Constituent per mL:
Meloxicam 0.5mg
For the alleviation of inflammation and pain in both acute and chronic
musculoskeletal disorders.
15mL[30mL]
[Norbrook logo]
TEXT LABEL: LOXICOM 0.5 mg/mL ORAL SUSPENSION FOR CATS
Carton: Ancillary Panels
Text appearing above the Header and below the Footer lines is not
included in the label
30
th
March 2012 64038_47244_Label_V3
Page 4 of 7
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE
THIS PRODUCT IS CONTRAINDICATED FOR USE IN PREGNANT OR LACTATING
ANIMALS AS NO
DATA HAS BEEN ESTABLISHED.
SHAKE WELL BEFORE USE.
Should be administered orally either mixed with food or directly into
the mouth
around meal times. Initial dose (first day of treatment) a single dose
of 0.1 mg/kg
bodyweight should be given.
Maintenance dose 0.05 m