Factrel label

Factrel

Factrel Recall

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Side Effects & Adverse Reactions

For use in animals only. Not for human use. Keep out of reach of children.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

There is currently no usage information available for this product. We apologize for any inconvenience.

History

There is currently no drug history available for this drug.

Other Information

FACTREL Injection is a sterile solution containing 50 micrograms of synthetic gonadorelin (as hydrochloride) per mL in aqueous formulation containing 0.6% sodium chloride and 2% benzyl alcohol (as a preservative).

Gonadorelin is the gonadotropin releasing hormone (GnRH) which is produced by the hypothalamus and causes the release of the gonadotropin luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the anterior pituitary.

FACTREL Injection has the identical amino acid sequence as endogenous gonadorelin; 5-oxo Pro-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH2 with identical physiological activities. The molecular weight of gonadorelin is 1182 with a molecular formula of C55H75N17O13. The corresponding values for gonadorelin hydrochloride are 1219 (1 HCl) expressed as C55H75N17O13HCl, or 1255 (2 HCl) expressed as C55H75N17O13 2HCl.

Factrel Manufacturers

  • Fdah, Division Of Wyeth
    Factrel | Fdah, Division Of Wyeth
    No Recall

    Factrel | Fdah, Division Of Wyeth

    Factrel | Fdah, Division Of Wyeth

    For the treatment of ovarian follicular cysts in cattle: Administer 2 mL of FACTREL Injection as a single intramuscular injection.

    For use with LUTALYSE (dinoprost tromethamine) Sterile Solution to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer 2 to 4 mL FACTREL Injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:

    Administer the first dose of FACTREL Injection (2-4 mL) at Day 0 Administer LUTALYSE (25 mg dinoprost, as dinoprost tromethamine) Sterile Solution by intramuscular injection 6-8 days after the first dose of FACTREL Injection. Administer a second dose of FACTREL Injection (2-4 mL) 30 to 72 hours after the LUTALYSE injection. Perform FTAI 0 to 24 hours after the second dose of FACTREL Injection, or inseminate cows on detected estrus using standard herd practices.

    Below are three examples of treatment regimens for FTAI that fit within the dosage regimen framework described immediately above:

    Example 1 Example 2 Example 3 Day 0 (Monday) 1st FACTREL 1st FACTREL 1st FACTREL Day 7 (the following Monday) LUTALYSE LUTALYSE LUTALYSE Day 9 (Wednesday) 2nd FACTREL + FTAI at 48 hours after LUTALYSE 2nd FACTREL 48 hours after LUTALYSE 2nd FACTREL 56 hours after LUTALYSE Day 10 (Thursday) FTAI 24 hours after 2nd FACTREL FTAI 18 hours after 2nd FACTREL