ORBENIN EYE OINTMENT
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
19-06-2017
Active ingredient:
CLOXACILLIN AS THE BENZATHINE SALT
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
cloxacillin as benzathine(500mg/Sg)
Pharmaceutical form:
MISC. AURAL, OPHTHALMIC, ORO/NASO PHARYNGEAL
Composition:
CLOXACILLIN AS THE BENZATHINE SALT ANTIBIOTIC Active 500.0 mg/Sg
Units in package:
20x3g Syr; 24x3g Syr; Syr = 3g
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
CAT | CATTLE | DOG | HORSE | SHEEP | BEEF | BITCH | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | CASTRA
Therapeutic area:
OPHTHALMIC PREPARATIONS
Therapeutic indications:
BACTERIAL KERATO CONJUNCTIVITIS
Product summary:
Poison schedule: 4; Withholding period: WHP: nil TRADE ADVICE: ESI: Not Establ ished; Host/pest details: CAT: [BACTERIAL KERATO CONJUNCTIVITIS]; CATTLE: [BACTERIAL KERATO CONJUNCTIVITIS]; DOG: [BACTERIAL KERATO CONJUNCTIVITIS]; HORSE: [BACTERIAL KERATO CONJUNCTIVITIS]; SHEEP: [BACTERIAL KERATO CONJUNCTIVITIS]; for the treatment of cloxacillin susceptible bacterial keratoconjunctivitis in cattle, sheep, horses, dogs and cats.Do not administer to animals with a history of allergic reactions to penicillin.
Authorization status:
Registered
Authorization date:
2023-07-01
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Summary of Product characteristics
PRODUCT NAME: ORBENIN EYE OINTMENT
PAGE: 1 OF 5
THIS REVISION ISSUED: AUGUST, 2011
MATERIAL 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:
Blend of ingredients.
TRADE NAME:
ORBENIN EYE OINTMENT
PRODUCT USE:
For the treatment of bacterial keratoconjunctivitis in cattle, sheep,
horses, dogs and
cats. Bactericidal with activity against cloxacillin susceptible
bacteria including
_Moraxella bovis_
CREATION DATE:
JULY, 2006
THIS VERSION ISSUED:
AUGUST, 2011
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
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
: Creamy lotion 500mg cloxacillin presented in 3g syringe.
ODOUR:
Mild odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. A
significant ingredient is an
antibiotic. Any person with a history of allergies to this class of
substances should avoid all contact with this product
as it may cause sensitisation.
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
This is an antibiotic preparation, and has mild acute effects.
However, if taken in large quan
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