LOXICOM 1MG CHEWABLE TABLETS FOR DOGS

Negara: Australia

Bahasa: Inggris

Sumber: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Beli Sekarang

Unduh Selebaran informasi (PIL)
21-06-2017
Unduh Karakteristik produk (SPC)
09-05-2016

Bahan aktif:

MELOXICAM

Tersedia dari:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (Nama Internasional):

meloxicam(1mg/Tb)

Bentuk farmasi:

ORAL TABLET

Komposisi:

MELOXICAM UNGROUPED Active 1.0 mg/Tb

Unit dalam paket:

10 Tablets; 100 Tabs; 20 Tablets; 500 Tabs

Kelas:

VM - Veterinary Medicine

Area terapi:

ANALGESIC+MUSCULOSKELETAL

Ringkasan produk:

Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: N/A; Host/pest details: DOG: [PAIN/INFLAMMATION MUSCULO-SKELATAL DISOR]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [PAIN/INFLAMMATION MUSCULO-SKELATAL DISOR]; For alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.See Contraindications, Precautions & Side Effects on label

Status otorisasi:

Registered

Tanggal Otorisasi:

2023-07-01

Selebaran informasi

                                18 Wormald Street, Symonston ACT 2609
PO Box 6182, Kingston ACT 2604 Australia
Tel: +61 2 6210 4700 Fax: +61 2 6210 4874
www.apvma.gov.au ABN 19 495 043 447
APPENDIX 2
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS) _(VETERINARY PRODUCTS)_
_Select appropriate: _

New Product (include all applicable RLPs) OR

Variation (highlight instructions that are being varied). Approval no.
of label being
varied:
Signal heading:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Product name:
LOXICOM 1mg CHEWABLE TABLETS FOR DOGS
Active constituent/s:
Each tablet contains 1mg meloxicam
Statement of claims:
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal disorders.
Net contents:
10 tablets
20 tablets
100 tablets
500 tablets
Directions for Use
Heading:
Restraints:
Contraindications:
This product should not be used in bitches in the last third of
pregnancy or during lactation.
This product is contraindicated for use in dogs less than 6 weeks of
age or less than 4 kg
bodyweight.
This product is contraindicated in animals suffering from
gastrointestinal disorders such as
irritation and haemorrhage, impaired hepatic, cardiac or renal
function and haemorrhagic
disorders or individual hypersensitivity to the product.
Precautions:
Loxicom should not be administered concurrently with steroidal or
other non-steroidal anti-
inflammatory drugs, aminoglycoside antibiotics or anti-coagulant
agents. Pre-treatment with
anti-inflammatory drugs may result in additional or increased adverse
effects and accordingly
a treatment-free period with such drugs should be observed for at
least 24 hours before
commencement with Loxicom. The treatment-free period, however, should
take into account
the pharmacokinetic properties of the drugs used previously.
Avoid use in dehydrated, hypovolaemic or hypotensive animals as there
is potential risk of
increased renal toxicity.
Side effects:
Typical adverse reactions of NSAIDs may occur (particularly within the
first 5-14 days of
treatment). Th
                                
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Karakteristik produk

                                PRODUCT NAME: LOXICOM CHEWABLE TABLET
PAGE: 1 OF 5
THIS REVISION ISSUED: SEPTEMBER, 2016
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:
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and fever
reducer effects.
TRADE NAME:
LOXICOM CHEWABLE TABLET
APVMA CODE:
70298 (2.5mg/tab);70299 (1mg/tab)
PRODUCT USE:
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal
disorders in dogs.
CREATION DATE:
SEPTEMBER, 2016
THIS VERSION ISSUED:
SEPTEMBER, 2016
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
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 Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P404: Store in a closed container.
P410: Protect from sunlight.
P403+P235: Store in a well-ventilated place. Keep cool.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quant
                                
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