Factrel for Cattle - Injection Solution (GnRH) - 50mL (50 mcg/mL) - [Ovarian Treatment]

Factrel Injection gonadorelin injection is approved for use with Lutalyse to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows. IT is also indicated for the treatment of ovarian follicular cysts in cattle. When used in this manner, treatment effect is to reduce the number of days to next estrus. This product may improve breeding efficiency and works with a flexible treatment regimen to meet the needs of various individual operations

Key Benefits

• Gonadorelin injection
• Estrous synchronization in dairy cattle
• Treatment of ovarian follicular cysts
• Requires a veterinarian's prescription

Indications

For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers. The treatment effect of FACTREL Injection when used in lactating dairy cows, beef cows, and replacement dairy and beef heifers is a reduction in the number of days to first estrus.

For use with LUTALYSE (dinoprost tromethamine injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.

View Factrel Injection Solution Drug Facts Sheet.

For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers: Administer 2 mL of FACTREL Injection as a single intramuscular injection.

For use with LUTALYSE (dinoprost tromethamine injection) Injection 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 injection) Injection 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.

Warnings & Precautions:

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

Residue Warnings:

No withdrawal period or milk discard time is required when used according to labeling.

Effectiveness:

For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers:

The treatment effect of FACTREL Injection when used in lactating dairy cows, beef cows, and replacement dairy and beef heifers is a reduction in the number of days to first estrus.

There were no significant differences in days from treatment to conception, frequency of cows conceiving at first or subsequent heats, or conception rates among treated or non-treated control animals, when FACTREL Injection was used alone for treatment of cystic ovaries.

For use with LUTALYSE (dinoprost tromethamine injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows:,

A field study was conducted to compare control (0 mL FACTREL Injection) to two doses of 2, 3 or 4 mL FACTREL Injection (100-200 mcg gonadorelin) for use with LUTALYSE Injection to synchronize estrous cycles to allow FTAI in lactating dairy cows under field conditions. Cows were examined prior to study start and only clinically normal cows were enrolled. A total of 1142 cows were enrolled at 6 commercial dairies. Cows were assigned randomly in blocks of 4 cows to each of 4 treatment groups consisting of:

• Day 0: 2, 3 or 4 mL dose of FACTREL Injection or no injection (Control)
• DDay 7: 5 mL LUTALYSE Injection (all treatment groups)
• DDay 9: 2, 3 or 4 mL dose of FACTREL Injection or no injection (Control)Day 10: Fixed-time artificial insemination

On Day 9 the second dose of FACTREL Injection (cows received the same dose as for first treatment) was given either 48 or 56 hours after the dose of LUTALYSE Injection and FTAI was conducted 24 or 17 hours later, respectively. For control cows FTAI was performed 72 hours after the LUTALYSE Injection dose was administered. All treatment groups had significantly greater pregnancy rates to FTAI than cows administered LUTALYSE Injection alone, and were 17.1, 27.3, 29.1 and 32.2% for cows receiving 0 (Control), 2, 3 or 4 mL FACTREL Injection, respectively.

Safety & Toxicity

In cows the intramuscular administration of up to 12.5 times maximum recommended dosage (2,500 mcg/day) of FACTREL Injection for 3 days did not affect any physiological or clinical parameter. Likewise, single intramuscular doses of 500 mcg did not interfere with pregnancy. No evidence of irritation at injection site was found in any animal.

A total of 1142 cows were enrolled in the previously noted field study that evaluated the effectiveness of two doses of 2, 3 or 4 mL of FACTREL Injection for use with LUTALYSE Injection to synchronize estrous cycles to allow FTAI in lactating dairy cows. Cows were observed daily for abnormal clinical signs. Over the course of the study there were 148 adverse health events documented in 118 cows. These adverse health events were common conditions in dairy cows (mastitis, lameness and pneumonia) and are not considered related to treatment.

Storage:

Store at refrigerator temperature 2° to 8°C (36° to 46°F). Use contents within 1 month of first vial puncture.