Gastropell Forte Oral Paste for Horses

Nchi: Australia

Lugha: Kiingereza

Chanzo: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Viambatanisho vya kazi:

OMEPRAZOLE

Inapatikana kutoka:

RANDLAB AUSTRALIA PTY LTD

INN (Jina la Kimataifa):

omeprazole(100mg/mL)

Dawa fomu:

ORAL PASTE

Tungo:

OMEPRAZOLE IMIDAZOLE Active 100.0 mg/ml

Vitengo katika mfuko:

50x30ml; 5x30ml; syringes

Darasa:

VM - Veterinary Medicine

Viwandani na:

RANDLAB AUSTRALIA

Eneo la matibabu:

ALIMENTARY SYSTEM

Bidhaa muhtasari:

Poison schedule: 4; Withholding period: MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE in horses that may be used for huma n consumption.; Host/pest details: HORSE - RACEHORSE: [GASTRIC ULCERS]; For the treatment & prevention of the recrrence of gastric ulcers in high perforamce racehorsesDO NOT USE in horses that may be used for human consumption

Idhini hali ya:

Registered

Idhini ya tarehe:

2023-07-01

Taarifa za kipeperushi

Gastropell Forte Oral Paste for Horses
82722/106538
Product Name:
APVMA Approval No:
Label Name:
Gastropell Forte Oral Paste for Horses
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
Omeprazole 100 mg/mL
Claims:
For the treatment and prevention of the recurrence of gastric ulcers
in high performance
racehorses.
Net Contents:
5 x 30 mL syringes in a printed carton.
50 x 30 mL syringes in a plastic pail with lid.
Directions for Use:
Restraints:
DO NOT USE in horses that may be used for human consumption.
Contraindications:
Precautions:
Side Effects:
Dosage and
Administration:
Give orally by syringe.
ADULT HORSES:
Treatment: 10 mL/500 kg BW (2.0 mg/kg BW) once daily for two weeks
followed by daily
maintenance dosing. RLP APPROVED
Maintenance: 5 mL/500 kg BW (1.0 mg/kg BW) once daily while horses
remain in training,
as directed by a veterinarian.
General Directions:
If used in performance animals, the regulations of relevant
authorities regarding medication
should be observed.
Gastropell Forte contains omeprazole, a dose-dependent inhibitor of
gastric acid secretion.
Clinical trial data indicates that omeprazole will inhibit gastric
acid secretion to maintain
gastric acidity at a non-aggressive level, which allows existing
ulcers to heal within
two weeks of commencing treatment, and that an ongoing daily dose will
prevent the
recurrence of ulcers.
ACTIONS
Omeprazole is an inhibitor of gastric acid secretion. When given on a
daily basis,
omeprazole inhibits the enzyme system regarded as the acid (proton)
pump within the
gastric mucosa of the stomach by binding to the enzyme and blocking
the first step of acid
production.
Even though it is dosed orally, Gastropell Forte does not act directly
on the stomach fluid
as it is ingested. The drug passes through the stomach to the small
intestine, where it is
absorbed and travels via the bloodstream to the acid secreting cells
of the stomach.
The powerful antisecretory effect of

Tabia za bidhaa

PRODUCT NAME: GASTROPELL FORTE ORAL PASTE FOR
HORSES
PAGE: 1 OF 5
This revision issued: April, 2014
SAFETY DATA SHEET
Issued by: Randlab Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
RANDLAB AUSTRALIA PTY LTD
PHONE: [phone]
7/85 ALFRED RD
FAX: [phone]
CHIPPING NORTON, NSW 2170, AUSTRALIA
CHEMICAL NATURE:
Omeprazole in a suitable oil based medium.
TRADE NAME:
GASTROPELL FORTE ORAL PASTE FOR HORSES
PRODUCT USE:
For the treatment and prevention of the recurrence of gastric ulcers
in horses.
CREATION DATE:
JULY, 2011
THIS VERSION ISSUED:
APRIL, 2014
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.
P262: Do not get in eyes, on skin, or on clothing.
RESPONSE
P337: If eye irritation persists: seek medical attention.
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P411: Store at temperatures not exceeding 30°C.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming is not possible, use a
commercial waste disposal service
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Off white paste.
ODOUR:
Pleasant almond odour.
MAJOR HEALTH HAZARDS:
no sig