ChronoMate (altrenogest)

Company: Ceva Animal Health

Oral solution, 2.2 mg altrenogest per mL (0.22%)

Synthetic progestin

FOR USE IN SWINE ONLY

USES:

For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle. Treatment with ChronoMate^® results in estrus (standing heat) 4 to 9 days after completion of the 14-day treatment period.

It is a violation of Federal law to use this drug product other than as directed in the labeling or as directed by your veterinarian.

Description

ChronoMate^® (altrenogest) Oral Solution contains 2.2 mg altrenogest per mL (0.22%) in an oil solution.

Warnings

USER SAFETY WARNINGS:

Not for use in humans. Keep out of reach of children.

Skin contact must be avoided as ChronoMate^® is readily absorbed through unbroken skin, and exposure may result in serious side effects to both women and men. Always wear vinyl, neoprene, or nitrile protective gloves when handling ChronoMate^® or when in contact with equipment or surfaces contaminated by this product. Latex gloves are not protective.

PREGNANT WOMEN OR WOMEN WHO MAY BE PREGNANT SHOULD NOT HANDLE ChronoMate^® (altrenogest). WOMEN OF CHILDBEARING AGE SHOULD EXERCISE EXTREME CAUTION WHEN HANDLING THIS PRODUCT.

Accidental absorption, such as absorption through the skin, could lead to a disruption of the menstrual cycle or prolongation of pregnancy. Wash off accidental spillage on the skin immediately with soap and water. Any equipment or surfaces that come in contact with ChronoMate^® should be adequately cleaned and decontaminated to prevent human exposure.

PEOPLE WHO SHOULD NOT HANDLE ChronoMate^®:*

1. Women who are or may be pregnant.

2. Anyone with blood clots or clotting disorders, or with a history of these events.

3. Anyone with a history of heart disease or stroke.

4. Women with known or suspected breast cancer.

5. People with known or suspected estrogen-dependent cancer.

6. Women with vaginal bleeding of unknown cause.

7. People with tumors which developed during the use of oral contraceptives or other estrogen-containing products.

8. Anyone with liver dysfunction or disease.

*Based on known effects of long-term progestin use in humans.

ACCIDENTAL EXPOSURE:

ChronoMate^® is readily absorbed from contact with the skin. In addition, this oil-based product can penetrate latex or other types of porous gloves. Always wear vinyl, neoprene, or nitrile protective gloves when handling ChronoMate^®. Latex gloves are not protective. If ChronoMate^® gets inside gloves by damage or spilling, the covered skin may absorb more of the drug. Side effects after a single exposure are possible; however, continued daily exposure has the potential for more serious effects.

IN CASE OF ACCIDENTAL EXPOSURE:

Skin exposure and/or clothing contamination: Wash skin immediately with soap and water, and launder clothing with detergent.

Eye exposure: Immediately flush with plenty of water for 15 minutes. Get medical attention. If wearing contact lenses, flush eyes immediately with water before removing lenses.

If swallowed: Do not induce vomiting. Seek medical attention immediately. ChronoMate^® contains an oil. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. If possible, bring the labeling to the physician.

Reported HUMAN Effects from Exposure:

Side effects have been reported in women and men following accidental exposure to altrenogest products, including ChronoMate^®, either through handling of the product or contact with contaminated surfaces.

● Reproductive side effects reported in women included abnormal or absent menstrual cycles.

● Reproductive side effects in men included decreased libido.

● Other side effects reported in women and men included headaches, fever, abdominal pain, nausea, diarrhea, vomiting, and rashes.

ANIMAL SAFETY WARNINGS:

Do not use ChronoMate^® in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute, or chronic endometritis). Underdosing of ChronoMate^® may lead to the occurrence of cystic follicles.

OTHER EFFECTS YOU MAY NOTICE:

A small percentage (less than 5%) of treated gilts may exhibit estrus (standing heat) during the 14-day treatment period. Gilts nearing estrus at the start of the 14-day treatment period may express estrus early in that period.

Directions For Use

While wearing vinyl, neoprene, or nitrile gloves, remove shipping cap and seal; replace with enclosed plastic dispensing cap. This product can penetrate latex or other types of porous gloves. Latex gloves are not protective. Remove cover from bottle dispensing tip and connect luer lock syringe (without needle). Draw out appropriate volume of ChronoMate^®. (Note: Do not remove syringe while bottle is inverted as spillage may result.) Detach syringe and replace cover on bottle dispensing tip to prevent leakage.

Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days. Treat gilts on an individual basis by top-dressing ChronoMate^® on a portion of each gilt’s daily feed allowance. To produce the desired synchronization of estrus in a group of gilts, treat all of the gilts daily for the same 14-day period.

How Supplied

ChronoMate^® (altrenogest) Oral Solution contains 2.2 mg/mL (0.22%) of the active ingredient, packaged in 1,000 mL plastic bottles.

STORAGE, HANDLING, AND DISPOSAL:

Store ChronoMate^® solution bottle at or below room temperature 77°F (25°C). Close tightly.

Place empty drug containers, waste, protective gloves, or other articles that contact this product in a leak-resistant container for disposal in accordance with applicable Federal, state, and local regulations.

QUESTIONS? COMMENTS?

● To report side effects, contact Ceva Animal Health, LLC at 1-800-999-0297.

● To obtain product information, including safety data sheet (SDS), call 1-800-999-0297.

● For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or on line at: www.fda.gov/reportanimalae

Approved by FDA under ANADA # 200-579

Restricted Drug (California) - use only as directed.

Manufactured for:

Ceva Animal Health, LLC, Lenexa, KS 66215

Chronomate^® is a registered trademark of Ceva Santé Animale S.A.

CPN: 1328095.2