Animal NDC 51072-119-00 Mate

Altrenogest

Animal Product Information

Field Name Field Value
Animal NDC Code 51072-119-00
Proprietary Name Mate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Altrenogest What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Aurora Pharmaceutical, Inc.
Product Type Prescription Animal Drug
Usage Information
    For regulation and control of the breeding cycle of mares• 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 breeding mares to allow the most efficient use of the stallionFor the maintenance of pregnancy in habitually aborting mares, or mares at risk of early embryonic death or abortion, where progesterone deficiency is thought to be the underlying cause.
Active Ingredient(s)
  • Altrenogest
Marketing Category EXPORT ONLY What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Mate Images

Mate Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Dosage Forms & Strengths



2.2 mg/mL altrenogest


Veterinary Indications



For regulation and control of the breeding cycle of mares
• 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 breeding mares to allow the most efficient use of the stallion

For the maintenance of pregnancy in habitually aborting mares, or mares at risk of early embryonic death or abortion, where progesterone deficiency is thought to be the underlying cause.


Contraindications



Read the carton for full instruction

DIRECTIONS FOR USE

Restraints:
DO NOT USE on male animals.

Contraindications:
Contraindicated for use in mares suffering from uterine infections.

Precautions:
Use with caution as unused feed must be destroyed and not given to any other animals.
MATE must be added to the feed immediately prior to consumption and not stored.


Dosage And Administration:



For oral administration.
Administer 1 mL MATE per 50 kg bodyweight (equivalent to 0.044 mg altrenogest per kg) daily.
1. Regulation and control of the breeding cycle of mares
a. For the induction of ovulatory oestrus or to induce cyclical ovarian activity in mares with some follicle activity early in the breeding season: Administer MATE daily for 10 consecutive days.
b. For the suppression of oestrus in normally cycling mares: Administer MATE daily for 15 consecutive days. For the suppression of prolonged oestrus: Administer MATE daily for 10 consecutive days.
c. To control the breeding cycle of mares to allow efficient use of the stallion: Administer MATE daily for 15 consecutive days.
2. For the treatment of habitually aborting mares, or mares at risk of early embryonic death or abortion: Administer MATE daily, from the 2nd or 3rd day after ovulation in the mated or inseminated mare, continuing until day 120 of gestation.

NOTE: Ultrasound scanning to confirm pregnancy is recommended on day 14 or 15 after ovulation. If the mare is not pregnant, it is advised to cease MATE administration and to administer an injection of prostaglandin F2α to destroy any luteal tissue that may be still present, allowing the mare to return to oestrus and be re-mated.

MEAT WITHHOLDING PERIODS (HORSES)

DO NOT USE less than 28 days before slaughter for human consumption.


Safety Directions



Product is harmful if absorbed by skin contact, inhaled or swallowed. Avoid contact with eyes and skin. Do not inhale. When using the product wear rubber gloves. After use and before eating, drinking or smoking, wash hands, arms and face thoroughly with soap and water. After each day's use, wash gloves. Care should be taken to avoid contact between the solution and women of child bearing age.

FIRST AID INSTRUCTIONS
If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 13 11 26.

ADDITIONAL USER SAFETY INFORMATION
Additional information is listed in the safety data sheet (SDS).


Storage



Store below 25°C (air conditioning). Protect from light.


Other



Manufactured by:
Aurora Pharmaceutical, Inc.

Distributed by:
South Yarra Pharma Pty Ltd
27-33 Piper Line, East Bendigo VIC 3550
Australia
Call Toll-free: 1800 426 142

APVMA Approval No.: 92068/134364


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL - 1000 mL bottle label

IN 50-1715 06/2023


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.