OVU-MATE ORAL PROGESTAGEN TO REGULATE OESTRUS IN HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

ALTRENOGEST

Available from:

RANDLAB AUSTRALIA PTY LTD

INN (International Name):

altrenogest(2.2mg/mL)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

ALTRENOGEST STEROID-PROGESTIN Active 2.2 mg/ml

Units in package:

125mL; 1L; 2L; 500mL

Class:

VM - Veterinary Medicine

Manufactured by:

RANDLAB AUSTRALIA

Therapeutic group:

HORSE MARE (FEMALE) | FEMALE HORSE

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

CONTROL OF OESTRUS | CONTROL OF OVULATION

Product summary:

Poison schedule: 4; Withholding period: WHP: MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE less than 28 days before s laughter for human consumption.; Host/pest details: HORSE MARE (FEMALE): [CONTROL OF OESTRUS, CONTROL OF OVULATION]; Poison schedule: 4; Withholding period: WHP: MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE less than 28 days before sla ughter for human consumption.; Host/pest details: HORSE MARE (FEMALE): [CONTROL OF OESTRUS, CONTROL OF OVULATION]; For regulation and control of the breeding cycle of mares and the maintenance of pregnancy in habitually aborting mares, or mares at risk of early abortion; to induce ovulatory oestrus early in the breeding season in mares where some follicular . . .Not indicated for use in male horses or for use in mares suffering uterine infections.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
RANDLAB AUSTRALIA PTY LTD
PRODUCT NAME:
OVU-MATE ORAL PROGESTAGEN TO REGULATE OESTRUS IN HORSES
ELABEL APPLICATION NO:
DC12-28089945E89
APVMA APPROVAL NO:
65653/102181
PRODUCT NO:
65653
VERSION NO:
4.0
APPLICATION STARTED:
2015-Mar-25 13:47:08
VERSION CREATED:
2015-Jul-03 10:56:02
STARTED BY:
Alison Kilford
PRINTED:
2015-Jul-03 10:58:22
LABEL NAME:
OVU-MATE ORAL PROGESTAGEN TO REGULATE OESTRUS IN HORSES
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
CONSTITUENT
STATEMENTS:
2.2 mg/mL ALTRENOGEST in a vegetable oil solution.
CLAIMS:
For regulation and control of the breeding cycle of mares and the
maintenance of
pregnancy in habitually aborting mares, or mares at risk of early
abortion.
• To induce ovulatory oestrus early in the breeding season in mares
where some follicular
activity exists.
• For the suppression of oestrus either during prolonged oestrus or
in normally cycling
mares.
• For the control of the ovarian cycle in the breeding mares to
allow the most efficient use of
the stallion.
NET CONTENTS:
125mL
500mL
1L
DIRECTIONS FOR USE:
DIRECTIONS FOR USE
CONTRAINDICATIONS:
This product is not indicated for use in male horses.
This product is contraindicated for use in mares suffering from
uterine infections.
PRECAUTIONS:
• Unused feed must be destroyed and not given to any other animals.
• Ovu-Mate must be added to the feed immediately prior to
consumption and not stored.
DOSAGE AND
ADMINISTRATION:
For oral administration.
Administer 1 mL Ovu-Mate per 50 kg bodyweight (equivalent to 0.044 mg
altrenogest per
kg) daily (12.5 mL per 625 kg mare). RLP APPROVED
For Official Use Only
1. Regulation and control of the breeding cycle of mares.
• For the induction of ovulatory oestrus or to induce cyclical
ovarian activity in mares
with some follicle activity early in the breeding season: administer
Ovu-Mate daily for 10
consecutive days.
• For the suppression of oestr

Summary of Product characteristics

PRODUCT NAME: OVU-MATE ORAL PROGESTAGEN TO
REGULATE OESTRUS IN 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:
Blend of ingredients; active ingredient is a hormone.
TRADE NAME:
OVU-MATE ORAL PROGESTAGEN TO REGULATE OESTRUS IN HORSES
APVMA CODE:
65653
PRODUCT USE:
For regulation and control of the breeding cycle of mares
CREATION DATE:
SEPTEMBER, 2008
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:
S20, S36, S24/25. When using, do not eat or drink. Wear suitable
protective clothing. 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
EM

Safety Data Sheet

Front
Back
OVU-MATE
®
PRESCRIPTION
ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
ORAL PROGESTAGEN TO
REGULATE OESTRUS IN HORSES
Contents: 2 Litre
ACTIVE CONSTITUENT:
2.2 MG/ML ALTRENOGEST IN A VEGETABLE OIL SOLUTION
For regulation and control of the breeding cycle of mares
and the maintenance of pregnancy in habitually aborting
mares, or mares at risk of early abortion.
OVU-MATE
®
ORAL PROGESTAGEN TO REGULATE OESTRUS IN HORSES
WWW.RANDLAB.COM.AU
• To induce ovulatory oestrus early in the breeding season in mares
where some follicular activity exists.
• For the suppression of oestrus either during prolonged oestrus or
in
normally cycling mares.
• For the control of the ovarian cycle in the breeding mares to
allow the
most efficient use of the stallion.
DIRECTIONS FOR USE
CONTRAINDICATIONS:
This product is not indicated for use in male horses. This product is
contraindicated
for use in mares suffering from uterine infections.
PRECAUTIONS:
• Unused feed must be destroyed and not given to any other animals.
• Ovu-Mate must be added to the feed immediately prior to
consumption and
not stored.
DOSAGE AND ADMINISTRATION
FOR ORAL ADMINISTRATION
Administer 1 mL Ovu-Mate per 50 kg body-weight (equivalent to 0.044 mg
altrenogest per kg) daily (12.5 mL per 625 kg mare).
1. Regulation and control of the breeding cycle of mares:
• For the induction of ovulatory oestrus or to induce cyclical
ovarian activity
in mares with some follicle activity early in the breeding season:
administer
Ovu-Mate daily for 10 consecutive days.
• For the suppression of oestrus in normally cycling mares:
administer
Ovu-Mate daily for 15 consecutive days.
• For the suppression of prolonged oestrus administer Ovu-Mate daily
for 10
consecutive days.
• To control the breeding cycle of mares to allow efficient use of
the stallion:
administer Ovu-Mate daily for 15 consecutive days.
2. For the treatment of habitually aborting mares, or mares at risk of
early embryonic
death or abortion: adm