HRF

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HRF uses



50 mcg gonadorelin per mL (as HRF) 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

HRF 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.

HRF 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 HRF 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 HRF 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 HRF 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 HRF Injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:

- Administer the first dose of HRF 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 HRF Injection.

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

- Perform FTAI 0 to 24 hours after the second dose of HRF 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 HRF


1st HRF


1st HRF


Day 7 (the following

Monday)


LUTALYSE


LUTALYSE


LUTALYSE


Day 9

(Wednesday)


2nd HRF

+ FTAI at

48 hours after

LUTALYSE


2nd HRF

48 hours after

LUTALYSE


2nd HRF

56 hours after

LUTALYSE


Day 10

(Thursday)


NA


FTAI

24 hours after

2nd HRF


FTAI

18 hours after

2nd HRF


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. HRF Injection induces release of endogenous luteinizing hormone (LH) to produce this same effect.

Gonadorelin, 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 HRF 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 HRF 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 HRF 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 HRF Injection) to two doses of 2, 3 or 4 mL HRF 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 HRF Injection or no injection (Control)

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

Day 9: 2, 3 or 4 mL dose of HRF Injection or no injection (Control)

Day 10: Fixed-time artificial insemination

On Day 9 the second dose of HRF 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 HRF Injection, respectively.

.

SAFETY AND TOXICITY

In cows the intramuscular administration of up to 12.5 times maximum recommended dosage (2,500 mcg/day) of HRF 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 HRF 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

HRF 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

HRF pharmaceutical active ingredients containing related brand and generic drugs:


HRF available forms, composition, doses:


HRF destination | category:


HRF Anatomical Therapeutic Chemical codes:


HRF pharmaceutical companies:


References

  1. Dailymed."FACTREL (GONADORELIN HYDROCHLORIDE) INJECTION [ZOETIS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming HRF?

Depending on the reaction of the HRF after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider HRF 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 HRF 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.

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

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