Relefact LH-RH

When are you taking this medicine? Empty stomach Before food After food With a meal

Relefact LH-RH uses

• Caution
• Description
• Indications for use
• Dosage
• Mechanism of action
• Warnings and precautions
• Residue warnings
• Effectiveness
• Safety and toxicity
• Adverse reactions
• How supplied
• Storage conditions
• Relefact LH-RH reviews

50 mcg Relefact LH-RH per mL (as Relefact LH-RH hydrochloride) Solution for Intramuscular Injection.

For use in cattle only

CAUTION

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

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

Relefact LH-RH 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.

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

INDICATIONS FOR USE

For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers. The treatment effect of Relefact LH-RH 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.

DOSAGE

For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers: Administer 2 mL of Relefact LH-RH 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 Relefact LH-RH Injection (100-200 mcg Relefact LH-RH) per cow as an intramuscular injection in a treatment regimen with the following framework:

- Administer the first dose of Relefact LH-RH 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 Relefact LH-RH Injection.

- Administer a second dose of Relefact LH-RH Injection (2-4 mL) 30 to 72 hours after the LUTALYSE injection.

- Perform FTAI 0 to 24 hours after the second dose of Relefact LH-RH 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:

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

MECHANISM OF ACTION

Follicular cysts are enlarged non-ovulatory follicles resulting from a malfunction of the neuroendocrine mechanism controlling follicular maturation and ovulation. Exogenous administration of agents possessing luteinizing hormone (LH) activity, such as pituitary extracts or human chorionic gonadotropin, often causes ovulation or regression of follicular cysts. Relefact LH-RH Injection induces release of endogenous luteinizing hormone (LH) to produce this same effect.

Relefact LH-RH, through release of LH has been demonstrated to induce ovulation of dominant ovarian follicles present on the bovine ovary during the estrous cycle. Administration of Relefact LH-RH Injection has the same effect.

WARNINGS AND 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 Relefact LH-RH 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 Relefact LH-RH 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 Relefact LH-RH Injection) to two doses of 2, 3 or 4 mL Relefact LH-RH Injection (100-200 mcg Relefact LH-RH) 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 Relefact LH-RH Injection or no injection (Control)

Day 7: 5 mL LUTALYSE Injection (all treatment groups)

Day 9: 2, 3 or 4 mL dose of Relefact LH-RH Injection or no injection (Control)

Day 10: Fixed-time artificial insemination

On Day 9 the second dose of Relefact LH-RH 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 Relefact LH-RH Injection, respectively.

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SAFETY AND TOXICITY

In cows the intramuscular administration of up to 12.5 times maximum recommended dosage (2,500 mcg/day) of Relefact LH-RH 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 Relefact LH-RH 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.

ADVERSE REACTIONS

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.

HOW SUPPLIED

Relefact LH-RH Injection (gonadorelin injection), 50 mcg/mL is available in 20 mL and 50 mL multi-dose vials (box of one).

Storage Conditions

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

NADA 139-237, Approved by FDA

Distributed by:

Zoetis Inc.

Kalamazoo, MI 49007

Revised: May 2015 40004714

Relefact LH-RH pharmaceutical active ingredients containing related brand and generic drugs:

• Gonadorelin

Relefact LH-RH available forms, composition, doses:

• Injectable; Injection; Gonadorelin 0.1 mg / ml

Relefact LH-RH destination | category:

• Human:
• Gonadotropins
• Pituitary

Relefact LH-RH Anatomical Therapeutic Chemical codes:

• H01CA01 - Gonadorelin
• V04CM01 - Gonadorelin

Relefact LH-RH pharmaceutical companies:

• Sanofi-Aventis

References

1. Dailymed."FERTAGYL (GONADORELIN) INJECTION [MERCK SHARP & DOHME CORP.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Relefact LH-RH?

Depending on the reaction of the Relefact LH-RH after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Relefact LH-RH not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Relefact LH-RH addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Relefact LH-RH, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Relefact LH-RH consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology