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Relisorm I

Name: Relisorm I drug & pharmaceuticals. Available Forms, Doses, Prices
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Published: 2021-11-11T10:10:10+00:00

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ANADA 200-541, Approved by FDA

GONAbreed®

(gonadorelin acetate)

Equivalent to 100 mcg gonadorelin/mL

Sterile solution

For the treatment of cystic ovaries in dairy cattle

For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

Relisorm I is a sterile solution containing 100 micrograms of gonadorelin (GnRH) as Relisorm I per milliliter suitable for intramuscular or intravenous administration according to the indication. Gonadorelin is a decapeptide composed of the sequence of amino acids –

5-oxoPro-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH₂ –

a molecular weight of 1182.32 and empirical formula C₅₅H₇₅N₁₇O₁₃. The acetate salt has a molecular weight of 60.05 and an empirical formula C₅₅H₇₅N₁₇O₁₃. C₂H₄O₂.

Gonadorelin is the hypothalamic releasing factor responsible for the release of gonadotropins (e.g., LH, FSH) from the anterior pituitary. Synthetic gonadorelin is physiologically and chemically identical to the endogenous bovine hypothalamic releasing factor.

PHARMACOLOGY AND TOXICOLOGY:

Endogenous gonadorelin is synthesized and/or released from the hypothalamus during various stages of the bovine estrous cycle following appropriate neurogenic stimuli. It passes via the hypophyseal portal vessels, to the anterior pituitary to effect the release of gonadotrophins (e.g. LH, FSH). Synthetic gonadorelin administered intravenously or intramuscularly also causes the release of endogenous LH or FSH from the anterior pituitary.

Relisorm I has been shown to be safe. The LD₅₀ for mice and rats is greater than 60 mg/kg, and for dogs, greater than 600 mcg/kg, respectively. No untoward effects were noted among rats or dogs administered 120 mcg/kg/day or 72 mcg/kg/day intravenously for 15 days.

It has no adverse effects on heart rate, blood pressure, or EKG to unanesthetized dogs at 60 mcg/kg. In anesthetized dogs it did not produce depression of myocardial or system hemodynamics or adversely affect coronary oxygen supply or myocardial oxygen requirements.

The intravenous administration of 60 mcg/kg/day of Relisorm I to pregnant rats and rabbits during organogenesis did not cause embryotoxic or teratogenic effects.

The intramuscular administration of 1,000 mcg to normally cycling dairy cattle had no effect on hematology or blood chemistry.

Further, Relisorm I does not cause irritation at the site of intramuscular administration in dogs. The dosage administered was 72 mcg/kg/day for seven (7) days.

INDICATIONS AND

Dosage:

Cystic Ovaries

Relisorm I is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinization which result in nymphomania or irregular estrus.

Historically, cystic ovaries have responded to an exogenous source of luteinizing hormone (LH) such as human chorionic gonadotrophin. Relisorm I initiates release of endogenous LH to cause ovulation and luteinization.

The recommended intravenous or intramuscular dosage of Relisorm I is 100 mcg (1 mL) per cow.

Reproductive Synchrony

Relisorm I is indicated for use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.

The recommended intramuscular dosage of Relisorm I is 100 mcg (1 mL) per cow, used in reproductive synchrony programs similar to the following:

Administer the first Relisorm I injection (1 mL) at Time 0.

Administer 500 mcg cloprostenol (as cloprostenol sodium) by intramuscular injection 6 to 8 days after the first Relisorm I injection.

Administer the second Relisorm I injection (1 mL) 30 to 72 hours after the cloprostenol sodium injection.

Perform FTAI 0 to 24 hours after the second Relisorm I injection, or inseminate cows on detected estrus using standard herd practices.

TARGET ANIMAL SAFETY:

In addition to the target animal safety information presented in the section addressing pharmacology and toxicology, target animal safety of, and injection site reactions to, Relisorm I when used with cloprostenol sodium were evaluated during the conduct of the effectiveness field studies. The incidence of health abnormalities was not significantly greater in cows administered Relisorm I than cows administered a placebo injection.

EFFECTIVENESS:

The effectiveness of Relisorm I (gonadorelin acetate) for use with cloprostenol sodium to synchronize estrous cycles to allow for FTAI in lactating dairy cows was demonstrated in a field study at 10 different locations in the U.S. Four of the locations represented conditions that would typically cause heat stress in lactating cows. A total of 1607 healthy, non-pregnant, primiparous or multiparous lactating dairy cows within 40-150 days postpartum were enrolled in the study. A total of 805 cows were administered Relisorm I (1 mL; 100 mcg gonadorelin as the acetate salt) and 802 cows were administered an equivalent volume of water for injection as an intramuscular injection twice in the following regimen:

Day 0: 1 mL Relisorm I or sterile water for injection

Day 7: 500 mcg cloprostenol (as cloprostenol sodium)

Day 9: 1 mL Relisorm I or sterile water for injection

Fixed time AI was performed on Day 10, approximately 11 - 31 hours after the Day 9 injection. Cows were evaluated for pregnancy on Day 45 ± 5 days by trans-rectal ultrasound or rectal palpation. Pregnancy rate to FTAI was significantly higher (P < 0.0001) in cows treated with Relisorm I (33.4%) than the pregnancy rate to FTAI in cows treated with water (13.6%). The environmental condition (heat stress or not heat stress) did not affect the conclusion of effectiveness.

The effectiveness of Relisorm I (gonadorelin acetate) for use with cloprostenol sodium to synchronize estrous cycles to allow for FTAI in beef cows was demonstrated in a field study at 10 different locations in the U.S. A total of 706 healthy, non-pregnant, primiparous or multiparous beef cows within 40-150 days postpartum were enrolled in the study. A total of 364 cows were administered Relisorm I (1 mL; 100 mcg gonadorelin as the acetate salt) and 342 cows were administered an equivalent volume of water for injection as an intramuscular injection twice in the following regimen:

Day 0: 1 mL Relisorm I or sterile water for injection

Day 7: 500 mcg cloprostenol (as cloprostenol sodium)

Day 9: 1 mL Relisorm I or sterile water for injection

Fixed time AI was performed immediately after the Day 9 injection. Cows were evaluated for pregnancy on Day 55 ± 5 days by trans-rectal ultrasound. Pregnancy rate to FTAI was significantly higher (P = 0.0006) in cows treated with Relisorm I (21.7%) than the pregnancy rate to FTAI in cows treated with water (7.4%).

Each mL of Relisorm I contains:

Gonadorelin (as Relisorm I) 100 mcg

Benzyl alcohol 10 mg

Sodium chloride 7.47 mg

Sodium phosphate monobasic 8.3 mg

Sodium phosphate dibasic 4.8 mg

Water for injection, USP, q.s.

pH adjusted with hydrochloric acid or sodium hydroxide.

PRECAUTIONS:

Not for use in humans.

Keep this and all drugs out of reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To obtain an MSDS or for technical assistance, contact Parnell at 1-800-88-PARNELL (1-800-887-2763). To report suspected adverse drug experiences, contact Parnell at 1-800-88-PARNELL (1-800-887-2763). For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or http://www.fda.gov/AnimalVeterinary.

Discard remaining product 180 days after first use. Once broached, product may be stored at temperatures up to 25°C (77°F).

KEEP UNOPENED VIALS REFRIGERATED: 2° - 8°C (36° - 46°F).

HOW SUPPLIED:

Relisorm I is available in a concentration of 100 mcg gonadorelin/mL as Relisorm I.

Relisorm I is supplied in multidose vials containing 20 mL and 100 mL of sterile solution.

Manufactured by:

PARNELL TECHNOLOGIES PTY. LTD.

4/476 Gardeners Road

Alexandria NSW 2015 Australia

Owner of the trademark Relisorm I

Distributed by:

PARNELL U.S. 1, Inc

7015 College Boulevard

Level 6

Overland Park, KS 66211

ANADA 200-541. Approved by FDA

20 mL: 50297b-05-November 14

100 mL: 50303b-03-November 14

Relisorm I pharmaceutical active ingredients containing related brand and generic drugs:

Gonadorelin Acetate

Relisorm I available forms, composition, doses:

Relisorm I destination | category:

Human:
Gonadotropins
Pituitary

Relisorm I Anatomical Therapeutic Chemical codes:

H01CA01 - Gonadorelin
V04CM01 - Gonadorelin

Relisorm I pharmaceutical companies:

References

Dailymed."GONABREED (GONADORELIN ACETATE) INJECTION, SOLUTION [PARNELL TECHNOLOGIES PTY LTD]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Relisorm I?

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