2.2mg/ml Oral Solution for Horses

Presentation 

A light yellow oily solution for oral administration.  Each ml contains 2.2mg altrenogest.

Uses

In mares with significant follicular activity during the transitional period between seasonal anoestrus and in the breeding season (follicles of at least 20-25mm present at the beginning of treatment):

•  Suppression/prevention of oestrus (usually after 1 to 3 days of treatment) during prolonged periods of oestrus.
  
  
• Control of the time of initiation of oestrus (approximately 90% of mares show signs of oestrus within 5 days following the end of treatment) and synchronisation of ovulation (60% of mares ovulate between days 11 and 14 following the end of treatment). 

In order to ensure effective use of the product, the transitional status of mares showing some follicular activity should first be established.

Dosage and Administration

For oral administration.

1ml Regumate Equine per 50kg bodyweight (0.044mg altrenogest per kg) per day for 10 consecutive days.

Carefully withdraw the volume of product corresponding to the mare’s bodyweight and administer this orally.

• 150, 300 and 1000ml bottles: Wearing gloves remove the original cap and in its place screw on the luer lock cap.  Keeping the bottle upright, screw the syringe onto the luer lock cap orifice, turn the bottle upside down, and carefully withdraw the solution from the bottle using the syringe.  Turn the bottle the right way up before detaching the syringe.  Securely replace the small cap on the luer lock cap
  
  
• 250ml bottles: Wearing gloves, remove the white cap and the aluminium foil seal from the neck of the measuring compartment.  Keeping the bottle upright, press the body of the bottle until the required volume of product is accumulated into the measuring compartment.  Carefully pour the contents of the measuring compartment on the mare’s feed. 

The product should be added to the mare’s feed, at a single feeding per day, or directly administered into the mouth using a syringe.  Medicated feed should be offered to mares being treated as soon as the product has been added, and should not be stored.

Contra-indications, warnings etc.
Do not use in mares where endometritis has been diagnosed.
Do not use in males.
Adverse reactions, such as uterine infection, are extremely rare.

Operator warnings:

Women who are pregnant, or suspected of being pregnant, should not use this product.  Women of childbearing age should handle this product with extreme care.  The product should not be handled by persons with known or suspected progesterone-dependent tumours or thrombo-embolic disorders.

Direct contact with the skin should be avoided.  Personal protective clothing (gloves and overalls) must be worn when handling the product.  Porous gloves may let this product pass through.  Transcutaneous absorption may be even higher when the area is covered by an occlusive material, such as latex or rubber gloves.  Accidental spillage on the skin should be washed off immediately with soap and water.  Wash hands after treatment and before meals.

In case of accidental contact with the eye, rinse abundantly with water.  Seek medical attention.

Effects of overexposure:

Repeated accidental absorption could lead to disruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation of pregnancy or headache.

Withdrawal periods:

Meat and offal: 21 days.

Not permitted for use in lactating animals producing milk for human consumption.

For animal treatment only.  Keep out of reach of children.

Pharmaceutical precautions

This medicinal product does not need any special storage conditions.

Once opened, use by 14 days for the 150ml bottle and   28 days for the 250, 300 and 1000ml bottles.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Part consumed feed must be stored in a closed container and must be safely destroyed according to local or national requirements and not given to any other animal.

Legal Category 
POM-V

Package quantities
Package quantities: 150ml, 250ml, 300ml and 1 litre bottles.
Not all pack sizes may be marketed.

Further Information

Nil

Marketing Authorisation number    

Vm 01708/4503

Marketing Authorisation holder

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

MK7 7AJ

Date of text preparation                               
April 2005