Regu-Mate® Solution (altrenogest)

Product Description

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Oral Progestin - For suppression of estrus in mares. Suppression of estrus allows for a predictable occurrence of estrus following drug withdrawal in mares with ovarian follicles 20 mm or greater. Suppression of estrus will facilitate: • Attainment of regular cyclicity during the transition from winter anestrus to the phsiological breeding season. • Management of prolonged estrus conditions • Scheduled breeding during the phsyiological breeding season. Description: Regu-Mate® (altrenogest) Solution 0.22% contains the active synthetic progestin, altrenogest. The chemical name is 17 -allyl-17ß-hydroxyestra-4,9,11-trien-3-one. Each mL of Regu-Mate® (altrenogest) Solution 0.22% contains 2.2 mg of altrenogest in an oil solution. Actions: Regu-Mate® (altrenogest) Solution 0.22% produces a progestational effect in mares. Indications: Regu-Mate® (altrenogest) Solution 0.22% is indicated to suppress estrus in mares. Suppression of estrus allows for a predictable occurrence of estrus following drug withdrawal. This facilitates the attainment of regular cyclicity during the transition from winter anestrus to the physiological breeding season. Suppression of estrus will also facilitate management of prolonged estrus conditions. Suppression of estrus may be used to facilitate scheduled breeding during the physiological breeding season. Contraindications: Regu-Mate® (altrenogest) Solution 0.22% is contraindicated for use in mares having a previous or current history of uterine inflammation (i.e. acute, subacute, or chronic endometritis). Natural or synthetic gestagen therapy may exacerbate existing low-grade or “smoldering” uterine inflammation into a fulminating uterine infection in some instances. Specific Uses for Regu-Mate® (altrenogest) Solution 0.22% Suppression of Estrus to: 1. Facilitate attainment of regular cycles during the transition period from winter anestrus to the physiological breeding season. To facilitate attainment of regular cycles during the transition phase, mares should be examined to determine the degree of ovarian activity. Estrus in mares with inactive ovaries (no follicles greater than 20 mm in diameter) will be suppressed but these mares may not begin regular cycles following treatment. However, mares with active ovaries (follicles greater than 20 mm in diameter) frequently respond with regular post-treatment estrus cycles. 2. Facilitate management of the mare exhibiting prolonged estrus during the transition period. Estrus will be suppressed in mares exhibiting prolonged behavioral estrus either early or late during the transition period. Again, the post-treatment response depends on the level of ovarian activity. The mares with greater ovarian activity initiate regular cycles and conceive sooner than the inactive mares. Regu-Mate® (altrenogest) Solution 0.22% may be administered early in the transition period to suppress estrus in mares with inactive ovaries to aid in the management of these mares or to mares later in the transition period with active ovaries to prepare and schedule the mare for breeding. 3. Permit scheduled breeding of mares during the physiological breeding season. To permit scheduled breeding, mares which are regularly cycling or which have active ovarian function should be given Regu-Mate® (altrenogest) Solution 0.22% daily for 15 consecutive days beginning 20 days before the date of the planned estrus. Ovulation will occur 5 to 7 days following the onset of estrus as expected for non-treated mares. Breeding should follow usual procedures for mares in estrus. Mares may be regulated and scheduled either individually or in groups.

Instructions

While wearing protective gloves, administer orally at the rate of 1 mL per 110 pounds body weight (0.044 mg/kg) to be given one dose daily for 15 consecutive days. Administer directly on the posteriodorsal surface of the mare's tongue using a dose syringe or suitable plastic syringe. The drug may also be administered on the usual grain ration.

Precautions

Various synthetic progestins, including altrenogest, when administered to rats during the embryogenic stage of pregnancy at doses significantly greater than the recommended equine dose caused fetal anomalies, specifically masculinization of the female genitalia. Warning: Do not use in horses intended for food. Caution for Handlers: Skin contact must be avoided as Regu-Mate® (altrenogest) Solution 0.22% is readily absorbed through unbroken skin. Protective gloves must be worn by all persons handling this product. Pregnant women or women who suspect they are pregnant should not handle Regu-Mate® (altrenogest) Solution 0.22%. Women of child bearing age should exercise extreme caution when handling this product. Accidental absorption could lead to a disruption of the menstrual cycle or prolongation of pregnancy. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water. Information for Handlers: Warning: Regu-Mate® (altrenogest) Solution 0.22% is readily absorbed by the skin. Skin contact must be avoided; protective gloves must be worn when handling this product. Effects of Overexposure: There has been no human use of this specific product. The information contained in this section is extrapolated from data available on other products of the same pharmacological class that have been used in humans. Effects anticipated are due to the progestational activity of altrenogest. Acute effects after a single exposure are possible; however, continued daily exposure has the potential for more untoward effects such as disruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation of pregnancy and headaches. The oil base may also cause complications if swallowed. In addition, the list of people who should not handle this product (see below) is based upon the known effects of progestins used in humans on a chronic basis. People Who Should Not Handle This Product: 1. Women who are or suspect they are pregnant. 2. Anyone with thrombophlebitis or thromboembolic disorders or with a history of these events. 3. Anyone with cerebral-vascular or coronary-artery disease. 4. Women with known or suspected carcinoma of the breast. 5. People with known or suspected estrogen-dependent neoplasia. 6. Women with undiagnosed vaginal bleeding. 7. People with benign or malignant tumors which developed during the use of oral contraceptives or other estrogen-containing products. 8. Anyone with liver dysfunction or disease. Accidental Exposure: Altrenogest is readily absorbed from contact with the skin. In addition, this oil-based product can penetrate porous gloves. Altrenogest should not penetrate intact rubber or impervious gloves; however, if there is leakage (i.e. pinhole, spillage, etc.), the contaminated area covered by such occlusive materials may have increased absorption. The following measures are recommended in case of accidental exposure. Skin Exposure: Wash immediately with soap and water. Eye Exposure: Immediately flush with plenty of water for 15 minutes. Get medical attention. If Swallowed: Do not induce vomiting. Regu-Mate® (altrenogest) Solution 0.22% contains an oil. Call a physician. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. If possible, bring the container and labeling to the physician. Caution: For oral use in horses only. Keep this and all medication out of the reach of children. All pharmaceutical products are shipped according to the manufacturer’s guidelines. In accordance with state and federal regulations, we are unable to accept returns on any pharmaceutical items. For all expedited deliveries UPS is responsible for delivering the package on time. Certain circumstances can arise where UPS is unable to deliver expedites on time due to weather, remoteness of location, etc. All efforts will be made by SmartPak to ensure that packages arrive on time as ordered, but we cannot guarantee that UPS will always act accordingly. In particular, orders indicated for Saturday delivery cannot be guaranteed. We strongly recommend that if the order is for a particular health emergency, customers should seek immediate assistance from their vet. If a UPS expedited delivery fails to arrive on time as ordered, SmartPak will refund the additional shipping charges incurred.

Other Ingredients

Each mL of Regu-Mate® (altrenogest) Solution 0.22% contains 2.2 mg of altrenogest in an oil solution.

Note From SmartPak Western

If you have any questions about the use of this product, please consult your veterinarian. For additional information about our pharmacy, please contact SmartPak Western at the number below.

SmartPak Western LLC

40 Grissom Road, Suite 500

Plymouth, MA 02360

1-888-291-3423

www.SmartPakWestern.com

Note About Our Pricing

We do our best to keep our prices low, to pass along savings where we can, and to give advanced notice of price increases whenever possible. Because supplement prices can fluctuate with commodity prices, our pricing is sometimes subject to change without prior notice.