Ulcershield Paste for Horses

Kraj: Australia

Język: angielski

Źródło: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Składnik aktywny:

OMEPRAZOLE

Dostępny od:

RANDLAB AUSTRALIA PTY LTD

INN (International Nazwa):

omeprazole(370mg/g)

Forma farmaceutyczna:

ORAL PASTE

Skład:

OMEPRAZOLE IMIDAZOLE Active 370.0 mg/g

Sztuk w opakowaniu:

#75 x 33g; #syringes; *50x33g; *syringes; @100 x 33g; @syringes; 6x33g

Klasa:

VM - Veterinary Medicine

Wyprodukowano przez:

RANDLAB AUSTRALIA

Dziedzina terapeutyczna:

ALIMENTARY SYSTEM

Podsumowanie produktu:

Poison schedule: 4; Withholding period: MEAT WITHHOLDING PERIOD (HORSES): NOT TO BE USED in horses intended for huma n consumption.; Host/pest details: HORSE: [GASTRIC ULCERS]; HORSE FOAL: [GASTRIC ULCERS]; For the treatment and prevention of gastric ulcers in horses and foals.see Precautions (SAFETY TO HORSES) on label

Status autoryzacji:

Registered

Data autoryzacji:

2023-07-01

Ulotka dla pacjenta

COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
RANDLAB AUSTRALIA PTY LTD
ULCERSHIELD PASTE FOR HORSES
81799/106129
LABEL NAME:
GOLDGUARD Paste for Horses
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
CONSTITUENT
STATEMENTS:
370 mg/g OMEPRAZOLE
CLAIMS:
For the treatment and prevention of gastric ulcers in horses and foals
NET CONTENTS:
6x33g
DIRECTIONS FOR USE:
RESTRAINTS:
CONTRAINDICATIONS:
PRECAUTIONS:
SAFETY TO HORSES: Omeprazole has a wide safety margin in horses and
foals and can
be used in foals from one month old. Ulcershield can be safety
administered to stallions
used for breeding. Safety in pregnant or lactating mares has not been
established. The
safety of omeprazole for longer than 91 days treatment has not been
determined.
CONCOMITANT THERAPY: Ulcershield can be used concomitantly with other
medications
including anthelmintics, antibiotics, non-steroidal
anti-inflammatories and other commonly
administered veterinary preparations.
SIDE EFFECTS: RLP APPROVED
DOSAGE AND
ADMINISTRATION:
Treatment Dose: 4 mg/kg. Adult horse (600 kg) give 6 ml daily for 28
days (1 ml per 100
kg).
Prevention Dose: 1 mg/kg. Adult horse (600 kg) give 1.5 ml daily for
28 days (0.25 ml per
100 kg).
Ensure horse's mouth contains no feed prior to treatment. Set dial-a
dose syringe to
required volume and administer into the side of the mouth far back
into the pocket between
the teeth and the cheek or over the back of the tongue.
The product is very sticky so ensure that 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
any of the dose is lost, re-
dosing
is recommended.
Gastric ulcers may recur following completion of the initial
treatment, unless treatment is
continued at the preventative dose.
GENERAL DIRECTIONS:
FEATURES

Charakterystyka produktu

PRODUCT NAME: ULCERSHIELD PASTE FOR HORSES
PAGE: 1 OF 5
This revision issued: February, 2016
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:
ULCERSHIELD PASTE FOR HORSES
PRODUCT USE:
For treatment and prevention of recurrence of gastric ulcers in horses
and foals.
CREATION DATE:
JULY, 2011
THIS VERSION ISSUED:
FEBRUARY, 2016
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.
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
: Pale yellow paste.
ODOUR:
Almond/aniseed odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. This is
a physiologically active
product and so contact should

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COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
RANDLAB AUSTRALIA PTY LTD
ULCERSHIELD PASTE FOR HORSES
81799/104073
LABEL NAME:
Ulcershield Paste for Horses
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
CONSTITUENT
STATEMENTS:
Omeprazole 370 mg/g
CLAIMS:
For the treatment and prevention of gastric ulcers in horses and foals
NET CONTENTS:
6 x 33 g
DIRECTIONS FOR USE:
RESTRAINTS:
CONTRAINDICATIONS:
PRECAUTIONS:
SAFETY TO HORSES: Omeprazole has a wide safety margin in horses and
foals and can
be used in foals from one month old. Ulcershield can be safety
administered to stallions
used for breeding. Safety in pregnant or lactating mares has not been
established. The
safety of omeprazole for longer than 91 days treatment has not been
determined.
CONCOMITANT THERAPY: Ulcershield can be used concomitantly with other
medications
including anthelmintics, antibiotics, non-steroidal
anti-inflammatories and other commonly
administered veterinary preparations.
SIDE EFFECTS: RLP APPROVED
DOSAGE AND
ADMINISTRATION:
Treatment Dose: 4 mg/kg. Adult horse (600 kg) give 6 ml daily for 28
days (1 ml per 100
kg).
Prevention Dose: 1 mg/kg. Adult horse (600 kg) give 1.5 ml daily for
28 days (0.25 ml per
100 kg).
Ensure horse's mouth contains no feed prior to treatment. Set dial-a
dose syringe to
required volume and administer into the side of the mouth far back
into the pocket between
the teeth and the cheek or over the back of the tongue.
The product is very sticky so ensure that 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
any of the dose is lost, re-
dosing is recommended.
Gastric ulcers may recur following completion of the initial
treatment, unless treatment is
continued at the preventative dose.
GENERAL DIRECTIONS:
FEA