DEXONE-5 STEROID ANTI-INFLAMMATORY AGENT

Country: Awstralja

Lingwa: Ingliż

Sors: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ixtrih issa

Fuljett ta 'informazzjoni (PIL)

19-06-2017

Karatteristiċi tal-prodott (SPC)

19-06-2017

Ingredjent attiv:

DEXAMETHASONE SODIUM PHOSPHATE; BENZYL ALCOHOL

Disponibbli minn:

Vetoquinol Australia Pty Ltd

INN (Isem Internazzjonali):

dexamethasone sodium phosphate(5mg/mL)

Għamla farmaċewtika:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Kompożizzjoni:

DEXAMETHASONE SODIUM PHOSPHATE STEROID-GLUCOCORTICOID Active 5.0 mg/ml; BENZYL ALCOHOL BENZENE Other 15.0 mg/ml

Unitajiet fil-pakkett:

50mL

Klassi:

VM - Veterinary Medicine

Grupp terapewtiku:

Żona terapewtika:

ENDOCRINE SYSTEM

Indikazzjonijiet terapewtiċi:

Sommarju tal-prodott:

Poison schedule: 4; Withholding period: WHP: Cattle: Meat: Do not use less than 28 days before slaughter for human co nsumption. Horse: Meat: Do not use less than 28 days before slaughter for huma n consumption. Cattle: Milk: Do not us e less than 28 days before collection o f milk for human consumption. This milk should not be fed to bobby calves.; Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, ARTHRITIS, CORTICOSTEROID, KETOSIS]; HORSE: [ANTI-INFLAMMATORY AGENT, ARTHRITIS, CORTICOSTEROID]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, ARTHRITIS, CORTICOSTEROID, KETOSIS]; HORSE: [ANTI-INFLAMMATORY AGENT, ARTHRITIS, CORTICOSTEROID]; Dexone-5 is an anti-inflammatory steroid and glucocorticoid for intramuscular or intravenous injection for cattle and horses.As an aid in the treatment of ketosis and arthritis in cattle. As an aid in the treatment of arthritis in horses.

L-istatus ta 'awtorizzazzjoni:

Stopped

Data ta 'l-awtorizzazzjoni:

2020-07-01

Fuljett ta 'informazzjoni

VETOQUINOL AUSTRALIA PTY LTD
DEXONE-5 STEROID ANTI-INFLAMMATORY AGENT
41936/105170
COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
LABEL NAME:
DEXONE-5 STEROID ANTI-INFLAMMATORY AGENT
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
5 mg/mL DEXAMETHASONE SODIUM PHOSPHATE LYOPHYLISED
15 mg/mL BENZYL ALCOHOL as PRESERVATIVE
CLAIMS:
Dexone-5 is an anti-inflammatory steroid and glucocorticoid for
intramuscular or
intravenous injection for cattle and horses.
CATTLE: As an aid in the treatment of ketosis (acetonaemia and
arthritis).
HORSES: As an aid in the treatment of arthritis
NET CONTENTS:
50mL
DIRECTIONS FOR USE:
N/A
RESTRAINTS:
N/A
CONTRAINDICATIONS:
PRECAUTIONS:
Prolonged treatment may result in suppression of the adrenal cortex in
which case A.C.T.H.
should be administered once weekly.
SIDE EFFECTS:
N/A
DOSAGE AND
ADMINISTRATION:
Use the contents within 24 hours of first broaching of the vial.
Discard the unused portion.
HORSES:
As an aid in the treatment of arthritis, 2 to 4mL per 500 kg
bodyweight as a single dose.
2mL before strenuous activity. This dose may be repeated in 3 to 5
days if the response is
satisfactory. RLP APPROVED
CATTLE:
As an aid in the treatment of ketosis, arthritis, 2 to 4 mL per 500 kg
bodyweight as an initial
dose followed by a second injection of 2 to 4mL the following day if
necessary.
GENERAL DIRECTIONS:
N/A
WITHHOLDING
PERIODS:
CATTLE: MEAT: DO NOT USE less than 28 days before slaughter for human
consumption.
HORSE: MEAT: DO NOT USE less than 28 days before slaughter for human
consumption.
CATTLE: MILK: DO NOT USE less than 28 days before collection of milk
for human
consumption. This milk SHOULD NOT BE FED to bobby calves.
TRADE ADVICE:
EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for
this product.
Note—observing the meat withholding period may not be sufficient to
mitigate potential
risks to export trade. Trade advice should be sought from Vetoquinol
Australia Pty Ltd on
1800 032 355 b

Aqra d-dokument sħiħ

Karatteristiċi tal-prodott

PRODUCT NAME: DEXONE 5 STEROID ANTI-INFLAMMATORY AGENT
PAGE: 1 OF 5
THIS VERSION ISSUED: OCTOBER, 2015
SAFETY DATA SHEET
Issued by: Vetoquinol Australia Pty Ltd
Phone: 1800 032 355
(BUSINESS HOURS)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETOQUINOL AUSTRALIA PTY LTD
PHONE: 1800 032 355 (BUSINESS HOURS)
UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK,
FAX: 1800 648 460
BRISBANE AIRPORT, QLD 4008
CHEMICAL NATURE:
Dexamethasone is a corticosteroid derivative.
TRADE NAME:
DEXONE 5 STEROID ANTI-INFLAMMATORY AGENT
APVMA CODE:
41936
PRODUCT USE:
Anti-inflammatory steroid and glucocorticoid for cattle and horses.
CREATION DATE:
OCTOBER, 2015
THIS VERSION ISSUED:
OCTOBER, 2015
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:
Xi, Irritating. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
R36. Irritating to eyes.
SAFETY PHRASES:
S25, S36. Avoid contact with eyes. Wear suitable protective clothing.
SUSMP CLASSIFICATION:
S4
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: WARNING
HAZARD STATEMENT:
H320: Causes eye irritation.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contacted areas thoroughly after handling.
P280: Wear protective gloves, protective clothing and eye or face
protection.
RESPONSE
P352: Wash with plenty of soap and water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
P337+P3

Aqra d-dokument sħiħ