PANOLOG 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)

01-07-2013

Active ingredient:

NEOMYCIN AS THE SULFATE; NYSTATIN; THIOSTREPTON; TRIAMCINOLONE ACETONIDE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

triamcinolone acetonide(1mg/mL)+neomycin as sulfate(2.5mg/mL) + others

Pharmaceutical form:

TOPICAL CREAM, OINTMENT, PASTE, GEL, LOTION

Composition:

NEOMYCIN AS THE SULFATE ANTIBIOTIC Active 2.5 mg/ml; NYSTATIN ANTIBIOTIC Active 100000.0 units/ml; THIOSTREPTON ANTIBIOTIC Active 2500.0 units/ml; TRIAMCINOLONE ACETONIDE STEROID-GLUCOCORTICOID Active 1.0 mg/ml

Units in package:

15mL

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

Therapeutic area:

EAR,NOSE,THROAT PREPS.

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A.; Host/pest details: CAT: [EAR INFECTIONS, INFECTIONS OF THE SKIN]; DOG: [EAR INFECTIONS, INFECTIONS OF THE SKIN]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [EAR INFECTIONS, INFECTIONS OF THE SKIN]; DOG: [EAR INFECTIONS, INFECTIONS OF THE SKIN]; For treatment of most skin and ear infections of dogs and cats.See PRECAUTIONS on leaflet

Authorization status:

Cancelled

Authorization date:

2017-12-13

Patient Information leaflet

Product
nam
e: PANOLOG Ointment
Date: 19 December 2013
APVMA No.: 39839
ACVM: A000698
Page
: 1
of6
Text above this
lin
e is not included in the actual labe
l.
TUBE
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
PANOLOG®
OINTMENT
Active constituent
s:
TRIAMCINOLONE ACETONIDE
NEOMYCIN (AS SULFATE)
THIOSTREPTON
NYSTATIN
1 mg/mL
2.5 mg/mL
2500 units/mL
100 000 units/mL
For treatment of most skin and ear infections
in
dogs and cats.
®
Registered trademark of Novartis AG, Basel, Swit
ze
rland
=
Plastibase is a reg. Trademark of E.R.
Sq
uibb and Sons,
In
c.
15
mL
IN
PLASTIBASE=
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS:
Apply to affected areas two to three times daily.
DISPOSAL:
Dispose
of
empty containers by wrapping with paper and putting
in
garbage.
STORAGE:
Store below 25°C (Air Conditioning).
AUSTRALIA
Novartis
An
imal Health Australasia Pty Limit
ed
ACN 076 745 198
54 Waterloo Road
North Ryde
NSW
21
13
APVMA Approval No. 39839/59345
NEW
ZEALAND
Novartis New Zealand
Li
mited
Building G
5 Orbit Drive
Rosedale, Auckland 0632
RESTRICTED VETERINARY MEDICINE
Registered p
ur
suant to the ACVM Act 1997, No. A000698.
See www.foodsafety.qovt.nz for registration conditions.
RLP
Approved
Product
name: P ANOLOG Ointment
Date:
19
December 2013
APVMA No.: 39839
ACVM: A000698
Page: 2
of6
Text above this line is not
in
clud
ed
in
the actual labe
l.
Carton
(Front
panel)
PRESCRIPTION ANIMAL REMEDY
KEEP OUT
OF
REACH
OF
CHILDREN
FOR ANIMAL TREATMENT
ONLY
PANOLOG®
Ointment
Active constituents:
TRIAMCINOLONE ACETONIDE
NEOMYCIN (AS SULFATE)
THIOSTREPTON
NYSTATIN
1 mg/mL
2.5 mg/
mL
2500 units/mL
100 000 units/mL
For treatment
of
most skin and ear infections in dogs and cats.
15 mL
IN
PLASTIBASE
~
Product
nam
e:
PANOLOG Ointment
Date:
19
December 2013
APVMA No.: 39839
ACVM: A000698
Page: 3
of6
Text above this line is not included
in
the actual labe
l.
Carton
(Ancillary
panels)
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS: Apply to affected areas two to three times d

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Summary of Product characteristics

PRODUCT NAME: PANOLOG® OINTMENT
PAGE: 1 OF 5
THIS REVISION ISSUED: AUGUST, 2013

SAFETY DATA SHEET
Issued by: Novartis Animal Health Australasia Pty Ltd.
Phone: 02 9805 3555 (office hours)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA,
(0800 764 766 IN NEW ZEALAND)

SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LTD.
ABN 64 076 745 198

TELEPHONE 02 9805 3555
(OFFICE HOURS)

54 WATERLOO RD
FAX 02 9888 8387
NORTH RYDE, NSW  2113

CHEMICAL NATURE:
Nystatin, Neomycin sulfate, Triamcinolone
acetonide and Thiostrepton in a suitable
medium.

TRADE NAME:
PANOLOG
®
OINTMENT

APVMA CODE:

39839
PRODUCT USE:
For treatment of most skin and ear infections in dogs and cats.

CREATION DATE:
AUGUST, 2013
THIS VERSION ISSUED:
AUGUST, 2013
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

GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
RESPONSE
P352: Wash with plenty of soap and water.
P301+P330+P331: IF SWALLOWED: Rinse
mouth. Do NOT induce vomiting.
P332+P313: If skin irritation occurs: Get medical advice.
P337+P313: If eye irritation persists: Get medical advice.
P391: Collect spillage.
P370+P378: In case of fire, use carbon dioxide, dry chemical,
foam, water fog.
STO

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