FORT DODGE PHENYLBUTAZONE WITH SODIUM SALICYLATE

Country: Australia

Bahasa: Inggeris

Sumber: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Beli sekarang

Risalah maklumat (PIL)

20-06-2017

Ciri produk (SPC)

20-06-2017

Bahan aktif:

PHENYLBUTAZONE; SODIUM SALICYLATE

Boleh didapati daripada:

ZOETIS AUSTRALIA PTY LTD

INN (Nama Antarabangsa):

phenylbutazone(186mg/mL)+sodium salicylate(50mg/mL)

Borang farmaseutikal:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Komposisi:

PHENYLBUTAZONE ANALGESIC Active 186.0 mg/ml; SODIUM SALICYLATE PHENOL Active 50.0 mg/ml

Unit dalam pakej:

100mL

Kelas:

VM - Veterinary Medicine

Dikeluarkan oleh:

ZOETIS AUSTRALIA

Kumpulan terapeutik:

Kawasan terapeutik:

MUSCULOSKELETAL SYSTEM

Tanda-tanda terapeutik:

Ringkasan produk:

Poison schedule: 4; Withholding period: WHP: Meat withholding period: not to be used in horses intended for human con sumption.; Host/pest details: DOG: [ANALGESIC, ANTI-INFLAMMATORY AGENT, MUSCULOSKELETAL CONDITIONS]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, MUSCULOSKELETAL CONDITIONS]; HORSE FOAL: [ANALGESIC, ANTI-INFLAMMATORY AGENT, MUSCULOSKELETAL CONDITIONS]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ANALGESIC, ANTI-INFLAMMATORY AGENT, MUSCULOSKELETAL CONDITIONS]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, MUSCULOSKELETAL CONDITIONS]; HORSE FOAL: [ANALGESIC, ANTI-INFLAMMATORY AGENT, MUSCULOSKELETAL CONDITIONS]; For the relief of painful musculoskeletal conditions in dogs and horses.Contra indications: serious cardiac, hepatic or renal dysfunction, history of blood disorders (especially haemoglobinuria), gastro intestinal disturbances.

Status kebenaran:

Registered

Tarikh kebenaran:

2023-07-01

Risalah maklumat

APPROVED
LABEL
Info
PEST

Verified
ACTION:
Phenylbutazone is a non-steroidal
anti-inflammatory and analgesic agent.
Sodium salicylate is an antipyretic analgesic agent. The combination
of these
two drugs provides both rapid action (sodium salicylate) and prolonged
effect
(phenylbutazone).
INDICATIONS:
For the relief of painful
musculoskeletal
conditions of dogs and horses.
Such conditions include arthritis, arthrosis, osteitis,
osteoarthritis, bursitis,
tendonitis, tenosynovitis, and the inflammation of soft tissues and
skin. When
used for the relief of febrile conditions, treatment of the underlying
cause
should be provided concurrently with Fort Dodge Phenylbutazone with
Sodium Salicylate.
DIRECTIONS FOR USE:
CONTRAINDICATIONS:
Serious cardiac, hepatic or renal
dysfunction, history of blood disorders
(especially haemoglobinuria), gastro-intestinal
disturbances.
ADVERSE REACTIONS:
Toxic reactions to Fort Dodge Phenylbutazone with Sodium Salicylate
are
uncommon but may be expressed as oedema of legs, jaundice, blood
dyscrasia, or gastric irritation.
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
FORT DODGE
PHENYLBUTAZONE WITH
SODIUM SALICYLATE
Contains 186 mg/mL PHENYLBUTAZONE and 50 mg/mL SODIUM SALICYLATE
100% actual
size when printed on A4.
51035_43909_leaflet_MPL_VI.pdf
DOSAGE AND ADMINISTRATION:
DISCARD UNUSED PORTION WITHIN 28 DAYS OF FIRST BROACHING VIAL.
Administer by SLOW INTRAVENOUS INJECTION at room temperature.
• Horses and foals:
Initially 5 - 10 mL per 225 kg per day.
Subsequent doses, depending on response, may be reduced to 2.5 - 5 mL
per 225 kg daily.
• Dogs:
0.5 to 2.5 mL per day.
Treatment in both species should be continued for 5-6 days depending
on
severity of condition.
MEAT WITHHOLDING PERIOD:
NOT TO BE USED IN HORSES INTENDED FOR HUMAN CONSUMPTION.
DISPOSAL:
Dispose of empty container by wrapping with paper and putting in
garbage.
STORAGE:
Store between 2
o
C and 8
o
C (Refrigerate. Do not freeze). Protect from light.
Discard unused portion within 2

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Ciri produk

PRODUCT NAME: FORT DODGE PHENYLBUTAZONE WITH SODIUM SALICYLATE
PAGE: 1 OF 5
THIS REVISION ISSUED: JULY, 2012
SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: 1800 814 883
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Pfizer Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: 1800 814 883
Fax: (02) 9850 3399
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
CHEMICAL NATURE:
Water solution of ingredients (see below).
TRADE NAME:
FORT DODGE PHENYLBUTAZONE WITH SODIUM SALICYLATE
APVMA CODE:
51035
PRODUCT USE:
For the relief of painful musculoskeletal conditions in horses.
CREATION DATE:
JULY, 2012
THIS VERSION ISSUED:
JULY, 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:
S25. Avoid contact with eyes.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: Aqueous solution.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F
F
E
E
E
C
C
C
T
T
T
S
S
S
NOTE: DIFFERENT HAZARD ASSESSMENT CRITERIA OF SWA AND TGA MAY RESULT
IN SEEMING INCONSISTENCIES BETWEEN
MSDS AND LABEL. EFFECTS DESCRIBED IN THIS MSDS RELATE TO SHORT TERM
EMERGENCY SITUATIONS, SUCH AS ACCIDENTS
AND SPILLS WITH THE POTENTIAL FOR GROSS OVEREXPOSURE, AND TO LONG TERM
INDUSTRIAL AND MANUFACTURING EXPOSURE.
SEE PRODUCT LABEL FOR ASSESSMENT OF HEALTH EFFECTS OF

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