AMACIN EYE & EAR OINTMENT

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Safety Data Sheet (SDS)

04-07-1996

Active ingredient:

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; SULFACETAMIDE SODIUM; PREDNISOLONE

Available from:

JUROX PTY LIMITED

INN (International Name):

neomycin sulfate(5mg/g)+polymyxin B sulfate(5000IU/g) + others

Pharmaceutical form:

MISC. AURAL, OPHTHALMIC, ORO/NASO PHARYNGEAL

Composition:

NEOMYCIN SULFATE ANTIBIOTIC Active 5.0 mg/g; POLYMYXIN B SULFATE ANTIBIOTIC Active 5000.0 IU/g; SULFACETAMIDE SODIUM SULFANYL Active 50.0 mg/g; PREDNISOLONE STEROID-GLUCOCORTICOID Active 2.5 mg/g

Units in package:

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

EAR,NOSE,THROAT + OCULAR

Therapeutic indications:

EAR INFECTIONS | INFECTION - OCULAR | EYE INFECTIONS | OCULAR INFECTIONS

Product summary:

Poison schedule: 4; Withholding period: WHP: NOT TO BE USED IN FOOD PRODUCING SPECIES OF ANIMALS. MEAT WHP (HORSES): NOT TO BE USED in horses intended for h uman consumption.; Host/pest details: CAT: [EAR INFECTIONS, INFECTION - OCULAR]; DOG: [EAR INFECTIONS, INFECTION - OCULAR]; HORSE: [EAR INFECTIONS, INFECTION - OCULAR]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [EAR INFECTIONS, INFECTION - OCULAR]; DOG: [EAR INFECTIONS, INFECTION - OCULAR]; HORSE: [EAR INFECTIONS, INFECTION - OCULAR]; Topical treatment of ocular and aural infections in dogs, cats and horses.Not to be used in food producing species of animals.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Amacin Eye & Ear Ointment (Draft)
Labelling
21APR11
1/2
Jurox Pty Limited
TUBE (FOR USE WITH AND WITHOUT A CARTON)
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
AMACIN EYE & EAR OINTMENT
5 mg/g NEOMYCIN SULFATE
5,000 I.U./g POLYMYXIN B SULFATE
50 mg/g SULFACETAMIDE SODIUM
2.5 mg/g PREDNISOLONE
4 G NET
[
JUROX LOGO]
Topical treatment of ocular & aural infections in dogs, cats and
horses.
DIRECTIONS FOR USE:
RESTRAINT: NOT TO BE USED IN FOOD PRODUCING SPECIES OF ANIMALS.
Apply once or twice daily as required.
MEAT WITHHOLDING PERIOD (HORSES): NOT TO BE USED IN HORSES
INTENDED FOR HUMAN CONSUMPTION
DISPOSE of container by wrapping in paper and putting in garbage.
Jurox Pty Limited, 85 Gardiner Road RUTHERFORD NSW 2320 AUSTRALIA
STORE below 30°C (RoomTemperature).
See crimp for batch and expiry.
[Item code]
APVMA 36293/53222
CARTON (FOR OPTIONAL USE)
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
AMACIN EYE & EAR OINTMENT
5 mg/g NEOMYCIN SULFATE
4g NET
5,000 I.U./g POLYMYXIN B SULFATE
50 mg/g SULFACETAMIDE SODIUM
2.5 mg/g PREDNISOLONE
[
JUROX LOGO] RLP APPROVED
Info
PEST

Verified
Amacin Eye & Ear Ointment (Draft)
Labelling
21APR11
2/2
Jurox Pty Limited
CARTON (ANZ) (FOR OPTIONAL USE) (CONTINUED)
Topical treatment of ocular & aural infections in dogs, cats and
horses.
DIRECTIONS FOR USE:
RESTRAINT: NOT TO BE USED IN FOOD PRODUCING SPECIES OF ANIMALS.
Apply once or twice daily as required.
MEAT WITHHOLDING PERIOD (HORSES): NOT TO BE USED IN HORSES
INTENDED FOR HUMAN CONSUMPTION
FIRST AID
IF POISONING OCCURS, CONTACT A DOCTOR OR POISONS INFORMATION CENTRE.
PHONE
AUSTRALIA 131 126, NEW ZEALAND 0800 764 766.
DISPOSE of container by wrapping with paper and putting in garbage.
STORE below 30 C (Room Temperature).
Jurox Pty Limited
85 Gardiner Rd
RUTHERFORD NSW 2320 AUSTRALIA
Infoline 1800 023 312
APVMA 36293/53222
B.
EXP.
[Item code] [Bar code]

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Summary of Product characteristics

AMACIN EYE & EAR OINTMENT
Page 1 of 7
Issued by: Jurox Pty Limited
Phone: 1800 023 312
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
ISSUED:
9 FEBRUARY 2016
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
AMACIN EYE & EAR OINTMENT
PRODUCT CODE:
503860 (4g)
RECOMMENDED USE:
An antibiotic sulfacetamide steroid combination for the topical
treatment of various ear and eye infections in dogs, cats and
horses.
RESTRICTIONS ON USE:
For animal treatment only.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street,
Rutherford, NSW 2320,
Australia
EMAIL:
jenq@jurox.com.au
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
13 1126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9am – 5pm, Monday to Friday)
SECTION 2: HAZARDS IDENTIFICATION
HAZARD CLASSIFICATIONS: This product has been assessed according to
GHS and is classified as follows:
GHS CATEGORY
HAZARD CODE
HAZARD STATEMENT
Skin Sensitizer Category 1
H317
May cause an allergic skin reaction
Reproductive Toxicity Category 1B
H360
May damage fertility or the unborn child
SIGNAL WORD: DANGER
GHS PICTOGRAMS:
Exclamation Health
Mark hazard
PRECAUTIONARY STATEMENTS:
Prevention
P201 Obtain special instructions before use.
P280 Wear protective gloves.
P281 Use personal protective equipment as required.
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P272 Contaminated work clothing should not be allowed out of the
workplace.
AMACIN EYE & EAR OINTMENT
Page 2 of 7
Issued by: Jurox Pty Limited
Phone: 1800 023 312
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
Response
P308+P313 IF exposed or concerned: Get medical advice/attention.
P363 Wash contaminated clothing before reuse.
P302+P352 IF ON SKIN: Wash with plenty of soap and water.
P333+P313 If skin irritation or rash occurs: Get medical
advice/attention.
Storage
P405 Store locked up.
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Sulfacetamide sodium
127-56-0
5%
Neomycin

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Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Neomycin sulfate 5 mg/g
Polymixin B sulfate 5,000 IU/g
Prednisolone 2.5 mg/g
Sulfacetamide sodium 50 mg/g
ACTIONS
Amacin® combines antibacterial and anti-inflammatory actions
effective in the majority of commonly occurring eye and ear
infections.
Neomycin sulfate is an aminoglycoside antibiotic. It is bactericidal
by way of irreversible inhibition of bacterial protein synthesis.
Neomycin is broad spectrum and is most active against aerobic
Gram-negative rods (for example _Proteus _spp. and _Pseudomonas_ spp.)
and Gram-positive cocci such as Staphylococci.
Polymixin B causes direct bacterial membrane damage by a
detergent-like action. It is bactericidal even in the absence of cell
growth
and effective only against Gram-negative organisms.
Sulfacetamide sodium has a bacteriostatic action. It is non-irritant
in high concentrations. It is well absorbed with high levels quickly
attained in the cornea, conjunctiva, aqueous humour and iris.
Prednisolone is a corticosteroid with potent anti-inflammatory and
excellent penetrating properties.
The above actives are formulated in a polybase that ensures fluidity
over a wide temperature range for ease of application. It disperses
well, is non-irritating and there is good contact of active
ingredients with the cornea and aural mucosa.
INDICATIONS
For topical treatment of ocular and aural infections in dogs, cat and
horses.
DIRECTIONS FOR USE
Apply once or twice daily as required.
AMACIN
®
Eye & Ear Ointment
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
RESTRAINTS
NOT TO BE USED in food producing species of animals.
WARNING
Amacin® contains a corticosteroid, so should not be used where
corneal ulceration exists.
1
WITHHOLDING PERIODS
NOT TO BE USED in horses intended for human consumption.
FIRST AID
If poisoning occurs, contact a doctor or Poisons Information Centre on
13 1126.
GHS INFORMATION
Fo

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