Estrumate (Canada)

Each 2 mL contains:

Active Ingredient

500 µg cloprostenol (as cloprostenol sodium USP);

Preservative

0.1% w/v chlorocresol;

Non-medicinal Ingredients

1.12 mg citric acid

12.2 mg sodium citrate

13.4 mg sodium chloride

1982 mg water for injection

Estrumate Indications

By its ability to shorten the life span of the corpus luteum ESTRUMATE can be used to treat certain clinical conditions which delay breeding, to manipulate the estrous cycle to better fit certain management practices, and to induce abortion.

Therapeutic Indications

Sub-estrus (silent Heat Or Non-detected Estrus)

Cows which fail to exhibit normal estrous behaviour although ovarian cyclicity continues can be treated with ESTRUMATE while in the luteal phase of the estrous cycle. They may then either be closely observed for estrus over a scheduled time period and bred on detection of estrus or bred at 72 and 96 hours after injection without estrus detection.

Pyometra Or Chronic Endometritis

Damage to the reproductive tract at calving or postpartum retention of the placenta frequently leads to infection and inflammation of the uterus which is usually referred to as endometritis. Under certain circumstances, this may progress into chronic endometritis with the uterus becoming distended with purulent matter. This condition, frequently referred to as pyometra, is characterized by lack of cyclical estrous behaviour and the presence of a persistent corpus luteum. This condition can be successfully treated by causing regression of the C.L. by treatment with ESTRUMATE. Where necessary, treatment may be repeated after 10-14 days.

Pregnancies From Mis-mating

Unwanted pregnancies can be safely and efficiently terminated from one week after mating until about 4 1/2 months of gestation. The induced abortion is uncomplicated, the fetus and placenta are usually expelled about 4 or 5 days after the injection and the reproductive tract returns to normal soon after the abortion. Trial results have demonstrated that an abortion rate of approximately 95% can be expected up to 4 1/2 months of gestation. The ability of ESTRUMATE to induce abortion decreases beyond 4 1/2 months while the risk of dystocia and its consequences increases.

Mummified Fetus

Death of the conceptus during gestation may be followed by its degeneration and dehydration. Induction of luteolysis with ESTRUMATE usually results in the expulsion of the mummified fetus from the uterus.

(Manual assistance may be necessary to remove the fetus from the vagina. Normal cyclical activity should then follow.)

Controlled Breeding

The luteolytic action of ESTRUMATE can be used to schedule estrus and ovulation for an individual animal or a group of animals. This allows control of the time at which cycling cows or heifers can be bred.

Abortion In Feedlot Heifers

Unwanted pregnancies can be safely and efficiently terminated from one week after mating until about 4 1/2 months of gestation. The induced abortion is uncomplicated, the fetus and placenta are usually expelled about 4 or 5 days after the injection and the reproductive tract returns to normal soon after the abortion. Trial results have demonstrated that an abortion rate of 95% can be expected up to 4 1/2 months of gestation. The ability of ESTRUMATE to induce abortion decreases beyond 4 1/2 months while the risk of dystocia and its consequences increases.

Estrumate Dosage And Administration

ESTRUMATE should be administered by INTRAMUSCULAR INJECTION. Only cattle with functional C.L. can respond to the luteolytic action of ESTRUMATE. In the cycling animal there are refractory periods of 4 to 5 days before and after ovulation when cattle are not responding to prostaglandin. Contents should be used within 28 days after the first dose is removed.

For Therapeutic Indications: 2 mL; For Controlled Breeding: 2 mL; For Abortion: 1.5 mL (2 mL for animals over 455 kg).

Injection Regimens

For abortion and for therapeutic indications - one injection. For controlled breeding - Veterinarians and their client dairy and beef producers should select the controlled breeding program (A, B or C) which is appropriate for the existing circumstances and management practices.

First service conception rates in Canada using existing artificial insemination practices are generally agreed to be between 40% and 60% for beef cattle and 50% to 60% for dairy cattle. The spread of calf crops indicates similar levels are attained using natural service. Field trial results have demonstrated that producers can achieve similar conception rates using ESTRUMATE. If existing management breeding practices are resulting in higher or lower conception rates, similar levels can be expected using ESTRUMATE. Following the controlled breeding program those animals not conceiving should be rebred. This may be done by:

- observing animals for a return to estrus (especially during the third week after injection) and inseminating or hand mating animals returning to estrus, or

- turning in clean-up bull(s) 7 to 8 days after the last injection to cover any animal returning to estrus.

Many factors affect conception rates. Before a controlled breeding program is planned, the producer and his consulting veterinarian should review the operation’s breeding history, herd health and nutritional status and agree that a controlled breeding program is practical in the producer’s specific situation. For a successful controlled breeding program:

- Cows and heifers must be cycling. Cattle should be palpated.

- Cattle should be in good condition for breeding. Animals in poor or medium condition should be fed to ensure a positive nutritional balance for 4-6 weeks before ESTRUMATE treatment and for 4 weeks after treatment.

- Proper program planning and record keeping are essential;

- Artificial insemination must be performed by competent inseminators using high quality semen. Inseminator fatigue must be avoided.

Contra-indications

Since ESTRUMATE results in an abortion rate of approximately 95% in cattle up to 4 1/2 months of gestation and causes some cattle in later pregnancy to abort, it should not be given to pregnant animal unless induced abortion is desired.

Adverse reactions have not been seen at the recommended dose of 500 µg. At 50 and 100 times recommended dose mild side effects may be detected. These include increased uneasiness, mild transient diarrhea, slight frothing and milk let-down. ESTRUMATE has a good margin of safety and no deleterious effects have been reported on the progeny conceived at the estrus following treatment.

Estrumate Cautions

A low incidence of clostridial and other infections at the injection site has been reported following prostaglandin administration. Treated animals should be closely observed post injection and appropriate antibiotic therapy initiated at the first sign(s) of infection.

Warnings

Treated cattle must not be slaughtered for use in food for at least 48 hours after the latest treatment with this drug. No withholding time is required for milk when used according to the label. Keep out of reach of children.

ESTRUMATE can be absorbed through the skin. Therefore, care should be taken when handling the product, especially by women of child bearing age and by asthmatics.

Accidental spillage on the skin should be washed off immediately with water. Prostaglandins of the F₂ type may cause bronchospasm in man although the possible incidence of this effect with ESTRUMATE is not known.

Should respiratory embarrassment result from accidental inhalation or injection, the inhalation of a rapid acting bronchodilator is indicated.

Action

ESTRUMATE causes functional and morphological regression of the corpus luteum in cattle. This effect on the life span of the C.L. usually results in estrus two to five days after treatment, followed by ovulation with normal fertility. ESTRUMATE alone will not increase fertility.

Storage

Do not store above 25 °C. Protect from freezing. Protect from light.

How Supplied

10 mL, 20 mL, 50 mL and 100 mL multidose vials

Intervet Canada Corp., Kirkland, Quebec, H9H 4M7, 1-888-306-0069

Intervet Canada Corp is a subsidiary of Merck & Co., Inc.

Version 17 October 2011

Nac No.