OMEGA 3 FATTY ACID SUPPLEMENT

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:

LINOLENIC ACID; LINOLEIC ACID; DOCOSAHEXAENOIC ACID; EICOSAPENTAENOIC ACID

Available from:

CEVA ANIMAL HEALTH PTY LTD

INN (International Name):

eicosapentaenoic acid(85mg/g)+docosahexaenoic acid(59mg/g) + others

Pharmaceutical form:

ORAL PASTE

Composition:

LINOLENIC ACID ACID-ESSENTIAL FATTY Active 120.0 mg/g; LINOLEIC ACID ACID Active 38.0 mg/g; DOCOSAHEXAENOIC ACID ACID-FATTY Active 59.0 mg/g; EICOSAPENTAENOIC ACID ACID-FATTY Active 85.0 mg/g

Units in package:

1L; 200mL; 250mL

Class:

VM - Veterinary Medicine

Manufactured by:

CEVA ANIMAL HEALTH

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

ALLERGIC DERMATITIS | DERMATOSES - INFLAMATION | ATOPY

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: DOG: [ALLERGIC DERMATITIS, DERMATOSES - INFLAMATION]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG: [ALLERGIC DERMATITIS, DERMATOSES - INFLAMATION]; May aid in the treatment of allergic and inflammatory dermatological conditions responsive to poly-unsaturated fatty acids in dogs.This product is registered as a complementary animal health product. If used for treatment of flea-allergy dermatitis, flea control measures should also be used.

Authorization status:

Stopped

Authorization date:

2020-07-01

Patient Information leaflet

RECEIVED
By
E-Labe/s
JWebb
at
9:27
am,
Oct
26,
2010
FOR
ANIMAL
TREATMENT
ONLY
OMEGA3
Fatty
Acid
Supplement
ACTIVE CONSTITUENTS:
Each 1 9 contains a minimum of
EICOSAPENTAENOIC
ACID
85
mg
DOCOSAHEXAENOIC
ACID
59
mg
LINOLENIC
ACID
120 mg
LINOLEIC
ACID
38
mg
sourced from
fish oil
and linseed oil
RLP
Approved
THIS
PRODUCT
IS
REGISTERED
AS A
COMPLEMENTARY
ANIMAL
HEALTH
PRODUCT
May aid in the
treatment
of
allergic and inflammatory dermatological
conditions responsive to
polyunsaturated
fally
acids in dogs.
200 mL (250 mL,
1 L)
DIRECTIONS
FOR USE:
Administer
orally 1 mL
per
7 kg bodyweighl
per day,
or as directed by
your
vetermartan
For the 200 mL and 250 mL
pa ck
size
One
press of
plunge
r delivers approximately
2
rnl..
If used for
treatment
of
flea-allergy dermatitis,
flea control
measures should also be used.
FIRST
AID:
If poisoning occurs,
contact
a cocror
or Poisons Information Centre (Phone Australia
131126.
Dispose
of
empty
container by wrapping wilh
paper
and
pulling
in the garbage.
Store
below
25
D
C (air conditioning).
Protect
from light.
Store in a dry place.
EXPIRY
DATE
BATCH
NO:
APVMA
No.
359081 51603
PRODUCT
OF
AUSTRALIA
Nature Vet
Ply.
lid.
11 Moores Rd.
Glenorie.
NSW
Tel:
(61)
2 9652
7000
Fax:
(61) 2
9652
7001
wvvw.na lurevet. com. au
Info
PEST

Verified

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Summary of Product characteristics

PRODUCT NAME: OMEGA 3 FATTY ACID SUPPLEMENT
PAGE: 1 OF 5
THIS VERSION ISSUED: MARCH, 2013

SAFETY DATA SHEET
Issued by: Ceva Animal Health Pty Ltd
Phone: 02 9652 7000 (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
CEVA ANIMAL HEALTH PTY LTD
PHONE: 02 9652 7000 (OFFICE HOURS)
11 MOORES RD
FAX: 02 9652 7017
GLENORIE, NSW 2157
WWW.CEVA.COM.AU
CHEMICAL NATURE:
Blend of fish and linseed oils.

TRADE NAME:
OMEGA 3 FATTY ACID SUPPLEMENT
APVMA CODE: 35908
PRODUCT USE:
An aid in the treatment of allergic and inflammatory dermatological
conditions,
responsive to polyunsaturated fatty acids, in dogs.

CREATION DATE:
MARCH, 2013
THIS VERSION ISSUED:
MARCH, 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: S25. Avoid contact with eyes.
SUSMP CLASSIFICATION: None allocated.
ADG CLASSIFICATION: None allocated. Not a Dangerous Good under the
ADG Code.
UN NUMBER: None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
HAZARD STATEMENT:
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.
P370+P378: In case of fire, use carbon dioxide, dry chemical,
foam, water fog.
STORAGE
P411+P235: Store at temperatures not exceeding 30°C. Keep cool.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
lar

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