REG-U-LATE ORAL PROGESTAGEN FOR 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; 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: WITHOLDING PERIOD: Meat Witholding Per iod (Horses): Do not use less than 28 d ays before slaughter for human consumpt ion.; Host/pest details: HORSE MARE (FEMALE): [CONTROL OF OESTRUS, CONTROL OF OVULATION]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE MARE (FEMALE): [CONTROL OF OESTRUS, CONTROL OF OVULATION]; For regulation and control of the breeding cycle of mares and for the maintenance of pregnancy in habitually aborting mares or mares at risk of early abortion; To induce ovulatory oestrus early in the breeding cycle of mares & maintenance of pregnancy . .Not indicated for use in male horses or for use in mares suffering uterine infections. See Precautions, etc. on label.

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:
REG-U-LATE ORAL PROGESTAGEN FOR HORSES
ELABEL APPLICATION NO:
DC12-82057882E34
APVMA APPROVAL NO:
61210/102182
PRODUCT NO:
61210
VERSION NO:
4.0
APPLICATION STARTED:
2015-Apr-01 15:16:53
VERSION CREATED:
2015-Jul-01 16:31:48
STARTED BY:
Alison Kilford
PRINTED:
2015-Jul-03 10:52:18
LABEL NAME:
REG-U-LATE ORAL PROGESTAGEN FOR 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:
125 mL
500 mL
1 L
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.
• Reg-u-late must be added to the feed immediately prior to
consumption and not stored.
DOSAGE AND
ADMINISTRATION:
For oral administration.
Administer 1 mL Reg-u-late 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
Reg-u-late daily for 10
consecutive days.
• For the suppression of oestrus in normally cycling ma

Summary of Product characteristics

PRODUCT NAME: REGULATE ORAL PROGESTAGEN FOR HORSES
AND OVU-MATE ORAL PROGESTAGEN TO REGULATE OESTRUS IN HORSES
PAGE: 1 OF 5
THIS REVISION ISSUED: FEBRUARY, 2011
MATERIAL 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]
10/53 LORRAINE ST
FAX: [phone]
PEAKHURST, NSW 2210
CHEMICAL NATURE:
Blend of ingredients; active ingredient is a hormone.
TRADE NAME:
REGULATE ORAL PROGESTAGEN FOR HORSES
(APVMA 61210)
THIS MSDS IS ALSO INTENDED FOR OVU-MATE ORAL PROGESTAGEN TO REGULATE
OESTRUS IN HORSES (APVMA 65653).
PRODUCT USE:
For regulation and control of the breeding cycle of mares
CREATION DATE:
SEPTEMBER, 2008
THIS VERSION ISSUED:
FEBRUARY, 2011
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.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Clear, straw coloured liquid.
ODOUR:
Mild odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
POTENTIAL HEALTH EFFECTS
The potential hazards that this product offers is not measured by
acute toxicity values. This product alters the oestrus
cycle in mares and has the potential to act similarly in women. Thus
CARE SHOULD BE TAKEN TO AVOID CONTACT
BETWEEN THE SOLUTION AND WOMEN OF CHILD BEARING AGE.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In add