Details
Purpose/Benefits:
- For intramuscular use for estrus synchronization in cattle
- Treatment of unobserved silent estrus and pyometra chronic endometritis in cattle
- For abortion of feedlot and other non-lactating cattle
- For parturition induction in swine
- For controlling the timing of estrus in estrous cycling mares and clinically anestrous mares that have a corpus luteum.
INDICATIONS FOR USE
Cattle: LUTALYSE Injection is indicated as a luteolytic agent. LUTALYSE Injection is effective only in those cattle having a corpus luteum, i.e., those which ovulated at least five days prior to treatment. Future reproductive performance of animals that are not cycling will be unaffected by injection of LUTALYSE Injection.
• For estrus synchronization in beef cattle and non-lactating dairy heifers
• For unobserved (silent) estrus in lactating dairy cows with a corpus luteum
• For treatment of pyometra (chronic endometritis) in cattle
• For abortion of feedlot and other non-lactating cattle
• For use with FACTREL (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows
• For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows
• For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers
Swine:
• For parturition induction in swine
Mares:
• For controlling the timing of estrus in estrous cycling mares
• For difficult-to-breed mares (clinically anestrous mares that have a corpus luteum)
WARNINGS AND PRECAUTIONS
User Safety: Not for human use. Keep 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. In the early stages, women may be unaware of their pregnancies. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water.
To report suspected adverse events, for technical assistance or to obtain a copy of the Material Safety Data Sheet (MSDS) contact Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.
Residue Warnings: No milk discard or preslaughter drug withdrawal period is required for labeled uses in cattle. No preslaughter drug withdrawal period is required for labeled uses in swine. Use of this product in excess of the approved dose may result in drug residues. Do not use in horses intended for human consumption.
Instructions
DOSAGE AND ADMINISTRATION
As with any multi-dose vial, practice aseptic techniques in withdrawing each dose to decrease the possibility of post-injection bacterial infections. Adequately clean and disinfect the vial stopper prior to entry with a sterile needle and syringe. Use only sterile needles, and use each needle only once.
No vial stopper should be entered more than 20 times. For this reason, the 100 mL bottle should only be used for cattle. The 30 mL bottle may be used for cattle, swine, or mares.
It is important to follow your Veterinarian's prescription instructions.
Ingredients
LUTALYSE® Injection (5 mg dinoprost/mL) is a sterile solution containing the naturally occurring prostaglandin F2 alpha (dinoprost) as the tromethamine salt. Each mL contains dinoprost tromethamine equivalent to 5 mg dinoprost: also, benzyl alcohol, 16.5 mg added as preservative.
