GASTROZOL DAILY ORAL PASTE FOR HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OMEPRAZOLE

Available from:

VIRBAC (AUSTRALIA) PTY LTD

INN (International Name):

omeprazole(50mg/mL)

Pharmaceutical form:

ORAL PASTE

Composition:

OMEPRAZOLE IMIDAZOLE Active 50.0 mg/ml

Units in package:

100X30mL; 30mL; 5 x 30mL; 50x30mL

Class:

VM - Veterinary Medicine

Manufactured by:

VIRBAC

Therapeutic group:

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

Therapeutic area:

ALIMENTARY SYSTEM

Therapeutic indications:

GASTRIC ULCERS | HEAL/REDUCE GASTRIC ULCERATION

Product summary:

Poison schedule: 4; Withholding period: MEAT WHP: NOT TO BE USED ON HORSES THAT MAY BE SLAUGHTERED FOR HUMAN CONSUMPT ION.; Host/pest details: HORSE: [GASTRIC ULCERS]; For the treatment & prevention of the recurrence of gastric ulcers in horses and foals.If used on performance animals, regulations of relevant authorities regarding medication should be observed.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

GASTROZOL DAILY ORAL PASTE FOR HORSES
58757/119533
Product Name:
APVMA Approval No:
Label Name:
GASTROZOL DAILY ORAL PASTE FOR HORSES
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
Constituent
Statements:
50 mg/mL OMEPRAZOLE
Claims:
For the treatment and prevention of the recurrence of gastric ulcers
in horses.
Gastrozol Daily is omeprazole, a dose-dependent inhibitor of gastric
acid secretion.
Clinical trial data indicates that Gastrozol Daily inhibits gastric
acid secretion to maintain
gastric acidity at a non-aggressive level, which allows existing
ulcers to heal within two (2)
weeks of commencing treatment, and that a reduced daily dose prevents
the recurrence of
ulcers.
INDICATIONS:
The lower region of the stomach is permanently exposed to gastric acid
and has a
prostaglandin protective mechanism, which guards against acid attack.
The squamous
mucosa in the upper region of the stomach has, however, no inherent
protection and
frequent splashing with acidic gastric fluid soon erodes the stomach
lining to cause spot
lesions, which can develop into deep haemorrhaging ulcers within
weeks.
For the stabled performance horse given two or three feeds a day, the
stomach is left for
long periods without ingestion of feed and without the mat of ingesta
on the surface of the
stomach fluid that helps to contain the acidic fluid. This exposure to
acid is then increased
during intense exercise when the stomach volume is reduced to half
that of the rested
horse and the gastric fluid is forced into the squamous region where
it attacks the stomach
lining.
The stomach lining is in a continual process of erosion and repair
depending on the acidity
of the stomach fluid and the horse’s feeding and exercise pattern.
The pattern of regular sessions of intense training and long periods
of the day without
ingestion of feed is, however, well tolerated by the performance horse
in training if gastric
acid secretion is blocked with Gastro

Summary of Product characteristics

GASTROZOL DAILY ORAL PASTE FOR HORSES
CHEMWATCH INDEPENDENT MATERIAL SAFETY DATA SHEET
ISSUE DATE: 27-NOV-2009
CHEMWATCH 4614-47
NC317ECP
VERSION NO:5
CD 2009/3  PAGE 1 OF 12
SECTION 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
PRODUCT NAME
GASTROZOL DAILY ORAL PASTE FOR HORSES
SYNONYMS
"anti-ulcerative equine oral paste"
PROPER SHIPPING NAME
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S.(contains zinc oxide)
PRODUCT USE
Anti-ulcerative equine oral paste.
SUPPLIER
Company: AXON Animal Health
Div of Birch International Pty Ltd
Unit 14, 25 Narabang Way
NSW 2085
AUS
Telephone: [phone]
Fax: [phone]
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
DANGEROUS GOODS. NON-HAZARDOUS SUBSTANCE. ACCORDING TO
 THE ADG CODE AND
 NOHSC CRITERIA.
POISONS SCHEDULE
S4
RISK
Risk Codes
Risk Phrases
R51/53
■
Toxic to aquatic organisms may cause long- term adverse
effects in the aquatic environment.
SAFETY
Safety Codes
Safety Phrases
S24
■
Avoid contact with skin.
S401
■
To clean the floor and all objects contaminated by this
material use water and detergent.
S35
■
This material and its container must be disposed of in a
safe way.
S57
■
Use appropriate container to avoid environment
contamination.
S61
■
Avoid release to the environment. Refer to special
instructions/ safety data sheets.
S60
■
This material and its container must be disposed of as
hazardous waste.
CONTINUED...
GASTROZOL DAILY ORAL PASTE FOR HORSES
CHEMWATCH INDEPENDENT MATERIAL SAFETY DATA SHEET
ISSUE DATE: 27-NOV-2009
CHEMWATCH 4614-47
NC317ECP
VERSION NO:5
CD 2009/3  PAGE 2 OF 12
SECTION 3 - COMPOSITION / INFORMATION ON INGREDIENTS
NAME
CAS RN
%
omeprazole
73590-58-6
1-10
zinc oxide
1314-13-2
1-10
performance additives, nonhazardous
>60
SECTION 4 - FIRST AID MEASURES
SWALLOWED
■
 - Immediately give a glass of water.
- First a