Altren Solution 0.22%

While wearing protective gloves, remove shipping cap and seal; replace with enclosed plastic dispensing cap. Remove cover from bottledispensing tip and connect luer lock syringe (without needle). Draw out appropriate volume of Altren solution. (Note: Do not remove syringewhile bottle is inverted as spillage may result.) Detach syringe and administer solution orally at the rate of 1 mL per 110 pounds of body weight(0.044 mg/kg) once daily for 15 consecutive days. Administer solution directly on the base of the mare's tongue or on the mare's usual grainration. Replace cover on bottle dispensing tip to prevent leakage. Excessive use of a syringe may cause the syringe to stick; therefore, replacesyringe as necessary.

Warning:

For oral use in horses only. Keep this and all other medications out of the reach of children. Do not use in horses intended for humanconsumption.

Human Warnings:

Skin contact must be avoided as Altren (altrenogest) Solution 0.22% is readily absorbed through unbroken skin. Protective glovesmust be worn by all persons handling this product. Pregnant women or women who suspect they are pregnant should not handleAltren (altrenogest) Solution 0.22%. Women of childbearing 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 skinshould therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.

Information For Handlers:

Warning: Altren (altrenogest) Solution 0.22% is readily absorbed by the skin. Skin contact must be avoided; protective gloves mustbe 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 otherproducts of the same pharmacological class that have been used in humans. Effects anticipated are due to the progestational activity ofaltrenogest.

Acute effects after a single exposure are possible; however, continued daily exposure has the potential for more untoward effects such asdisruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation of pregnancy andheadaches. 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 achronic 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 shouldnot penetrate intact rubber or impervious gloves; however, if there is leakage (i.e., pinhole, spillage, etc.), the contaminated area covered bysuch 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. Altren (altrenogest) Solution 0.22% contains an oil. Call a physician. Vomiting should be supervisedby a physician because of possible pulmonary damage via aspiration of the oil base. If possible, bring the container and labeling to thephysician.

Storage:

Store at or below 25°C (77°F). Reclose tightly.