Estrumate by is a Animal medication manufactured, distributed, or labeled by Merck Sharp & Dohme Corp., Vet Pharma Friesoythe GmbH, Piramal Healthcare Uklimited, Cayman Pharma s.r.o.. Drug facts, warnings, and ingredients follow.
250 mcg cloprostenol/mL (equivalent to 263 mcg cloprostenol sodium/mL)
A sterile solution of a prostaglandin F2α analogue for intramuscular injection in beef cows, lactating dairy cows, and replacement beef and dairy heifers
Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION:
Estrumate® (cloprostenol injection) is a synthetic prostaglandin analogue structurally related to prostaglandin F2 α (PGF2 α). Each mL of the sterile colorless aqueous solution contains 250 mcg cloprostenol (equivalent to 263 mcg cloprostenol sodium), 6.1 mg sodium citrate, 0.56 mg anhydrous citric acid, 6.7 mg sodium chloride, 20 mg benzyl alcohol, and water for injection, q.s.
INDICATIONS FOR USE:
Estrumate causes functional and morphological regression of the corpus luteum (luteolysis) in cattle. In normal, non-pregnant cycling animals, this effect on the life span of the corpus luteum usually results in estrus 2 to 5 days after treatment. In animals with prolonged luteal function (pyometra, mummified fetus, and luteal cysts), the induced luteolysis usually results in resolution of the condition and return to cyclicity. Pregnant animals may abort depending on the stage of gestation.
DOSAGE AND ADMINISTRATION:
Two mL of Estrumate (500 mcg cloprostenol) should be administered by INTRAMUSCULAR INJECTION using the specific dosage regimen for the indication.
20 mL bottle size: Use within 28 days of first puncture.
100 mL bottle size: Use within 28 days of first puncture and puncture a maximum of 12 times. Use only with automatic injection equipment or repeater syringe. Discard bottle after one stopper puncture with draw-off spike.
Any breeding program recommended should be completed by either:
Management considerations for use of Estrumate for estrus synchronization:
A variety of programs can be designed to best meet the needs of individual management systems. A breeding program should be selected which is appropriate for the existing circumstances and management practices. Before a breeding program is planned, the producer's objectives must be examined and the producer must be made aware of the projected results and limitations. The producer and the consulting veterinarian should review the operation's breeding history, herd health, and nutritional status and agree that a breeding program is practical in the producer's specific situation. For any successful breeding program:
There is no difference in the fertility achieved following the single or double dosage regimen when breeding occurs at induced estrus, or at 72 and 96 hours post-treatment. Conception rates may be lower than expected in those fixed time breeding programs employing Estrumate alone which omit the second insemination (ie, the insemination at or near 96 hours). This is especially true if a fixed time insemination is used following a single Estrumate injection.
USER SAFETY WARNINGS: Not for use in humans. Keep this and all drugs out of the reach of children.
Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product.
Estrumate is readily absorbed through the skin and can cause abortion and/or bronchospasms. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.
To obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact Merck Animal Health at 1-800-211-3573 or http://www.merck.com
ANIMAL SAFETY WARNINGS:
As with all parenteral products, careful aseptic techniques should be employed to decrease the possibility of post-injection bacterial infection. Severe localized clostridial infections associated with injection of Estrumate have been reported. In rare instances, such infections have resulted in death. Aggressive antibiotic therapy should be employed at the first sign of infection at the injection site, whether localized or diffuse.
At 50 and 100 times the recommended dose, mild side effects may be detected in some cattle. These include increased uneasiness, slight frothing, and milk let-down.
NDC: 0061-5995-01
10 Doses
20 mL
Estrumate®
(cloprostenol injection)
250 mcg cloprostenol/mL
(equivalent to 263 mcg
cloprostenol sodium/mL)
A sterile solution of a
prostaglandin F2α analogue
for intramuscular injection
in beef cows, lactating dairy
cows, and replacement beef
and dairy heifers.
CAUTION: Federal (USA) law
restricts this drug to use by or
on the order of a licensed
veterinarian.
MERCK
Animal Health
ESTRUMATE
cloprostenol sodium injection |
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Labeler - Merck Sharp & Dohme Corp. (001317601) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Vet Pharma Friesoythe GmbH | 341934053 | MANUFACTURE |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Piramal Healthcare Uklimited | 215586998 | API MANUFACTURE |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Cayman Pharma s.r.o. | 495076551 | API MANUFACTURE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ESTRUMATE 77084378 not registered Dead/Abandoned |
INTERVET INC. 2007-01-17 |
ESTRUMATE 73086007 1102497 Live/Registered |
IMPERIAL CHEMICAL INDUSTRIES LIMITED 1976-05-04 |