OMOGUARD PASTE FOR HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OMEPRAZOLE

Available from:

CEVA ANIMAL HEALTH PTY LTD

INN (International Name):

omeprazole(370mg/g)

Pharmaceutical form:

ORAL PASTE

Composition:

OMEPRAZOLE IMIDAZOLE Active 370.0 mg/g

Units in package:

!33g; !syringe; 28x6.16g; 40x33g; 50x33g; 6x33g

Class:

VP - Veterinary Pesticide

Manufactured by:

CEVA ANIMAL HEALTH

Therapeutic group:

HORSE | HORSE FOAL | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE

Therapeutic area:

ALIMENTARY SYSTEM

Therapeutic indications:

GASTRIC ULCERS | HEAL/REDUCE GASTRIC ULCERATION

Product summary:

Poison schedule: 4; Withholding period: WHP: MEAT WITHHOLDING PERIOD (HORSES): NOT TO BE USED in horses intended for human consumption.; Host/pest details: HORSE: [GASTRIC ULCERS]; HORSE FOAL: [GASTRIC ULCERS]; For the treatment and prevention of gastric ulcers in horses and foals. Effective in horses under a variety of management conditions, including racing or showing horses and foals as young as one month old.

Authorization status:

Registered

Authorization date:

2020-07-01

Patient Information leaflet

•
I
RECEWED
BY
E-l~s
FTOM
SRADBUM
AT
8:22AM.
_OET _
12.
2010
PRESCRIPTION ANIMAL REMEDY
KEEP OUT
OF
REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
OMOGUARD®
PASTE FOR HORSES
Active constituent: Omeprazole 370 mg/g
For the treatment and prevention
of
gastric ulcers in horses and foals
•
RLP
Approved
Omoguard is effective
in
horses under a variety
of
management conditions, including racing
or
showing horses and foals as young
as
one month old.
[6
x 33 g syringe carton, 33 g carton, 28 X 6.16 g carton]
[for the 6x33g pack size]
Pack provides (for 600 kg horse): 30 days x treatment dose or 120 days
x prevention dose
DIRECTIONS FOR USE:
[for the 28x6.16 pack size).
Pack provides
(for a 570 kg horse):
28 days x Treatment Dose
OR
112 days x Prevention Dose
After administering the initial dose use remaining product within 1
month.
TREATMENT
4 mg/kg. Adult horse (600 kg) give 6
ml
daily for 28 days
(1
ml
per 100 kg).
PREVENTION
1 mg/kg. Adult horse (600 kg) give 1.5
ml
daily for 28 days (0.25
ml
per 100 kg).
[for the 6x33g and 33g pack size]
To administer set dial-a-dose syringe to required volume. Ensure
horse's mouth contains no feed prior
to treatment. Place nozzle into the side
of
the mouth and deposit the paste between the teeth and the
cheek,
or
far over the back of the tongue. The product is very sticky so ensure
it is applied onto the
internal parts of the mouth, not just dropped into the oral cavity.
Immediately raise the horse's head for
a few seconds after dosing to ensure the full dose has been swallowed.
Observe the horse following
·dosing to ensure that no part
of
the dose is rejected·. If a
ny
of
the dose is lost, re-dosing is
recommended. REPLACE THE CAP AFTER EACH USE AND STORE THE SYRINGE
ON
ITS SIDE.
[for the 28x6.16 pack size)
Administer entire syringe for treatment dose
or
set dial-a-dose syringe to required volume. Ensure
horse's mouth contains no feed prior to treatment. Place nozzle into
the side
of
the mouth and deposit
the paste between the teeth

Summary of Product characteristics

PRODUCT NAME: OMOGUARD PASTE FOR HORSES
PAGE: 1 OF 5
THIS VERSION ISSUED: OCTOBER, 2015
SAFETY DATA SHEET
Issued by: Ceva Animal Health Pty Ltd
Phone: [phone] (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: [phone] (OFFICE HOURS)
11 MOORES RD
FAX: [phone]
GLENORIE, NSW 2157
WWW.CEVA.COM.AU
CHEMICAL NATURE:
Omeprazole is a proton pump inhibitor formulated here with magnesia
and other
ingredients in an oily paste.
TRADE NAME:
OMOGUARD PASTE FOR HORSES
APVMA CODE:
59496
PRODUCT USE:
For the treatment and prevention of gastric ulcers in horses and
foals.
CREATION DATE:
OCTOBER, 2015
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
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 Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S36, S24/25. Wear suitable protective clothing. Avoid contact with
skin and eyes.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P352: Wash with plenty of soap and water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: In case of fire, use carbon dioxide, dry chemical, foam,
water fog.
STORAGE
P402: Store in a dry place.
P411: Store at temperatures not exceeding 25°C (air conditioning).
DISPOSAL
P501: Dispose of small quantities and empty containers