STORAGE AND HANDLING PRECAUTIONS Store at or below room temperature, 25°C (77°F). Keep out of reach of children. Once reconstituted, CHORULON ® should be used immediately. Unused solution should be disposed of properly and not stored for future use.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION SECTION
DESCRIPTION
CHORULON® is a freeze-dried preparation of chorionic gonadotropin (human Chorionic Gonadotropin or hCG) for intramuscular administration after reconstitution. When reconstituted with the accompanying sterile diluent, each 10 mL vial contains 10,000 International Units chorionic gonadotropin (equivalent to 10,000 USP Units chorionic gonadotropin) and 10 mg mannitol, with mono- and disodium phosphate to adjust the pH of the solution.
MECHANISM OF ACTION SECTION
ACTION
Chorionic gonadotropin has luteinizing hormone-like activity with little or no follicle stimulating or estrogenic activity. Product does not conform to the USP monograph for estrogenic activity. Demonstration of the lack of estrogenic activity is performed at the drug substance level.
INDICATIONS & USAGE SECTION
INDICATIONS
SPL UNCLASSIFIED SECTION
COWS: CHORULON® is indicated for intramuscular use in cows for the treatment of nymphomania (frequent or constant heat) due to cystic ovaries.
SPL UNCLASSIFIED SECTION
FINFISH: CHORULON® is indicated for use as an aid in improving spawning function in male and female brood finfish.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
To reconstitute, transfer the contents of one vial of sterile diluent into one vial of freeze-dried powder. The resulting 10 mL of CHORULON® contains 10,000 International Units chorionic gonadotropin.
SPL UNCLASSIFIED SECTION
COWS: The contents of one vial (10 mL) of reconstituted CHORULON® should be administered as a single deep intramuscular injection. Dosage may be repeated in 14 days if the animal's behavior or rectal examination of the ovaries indicates the necessity for retreatment.
SPL UNCLASSIFIED SECTION
FINFISH: CHORULON® should be administered via intramuscular injection just ventral to the dorsal fin for one (1) to three (3) injections. Any single injection should be administered, depending on the fish species, at a dose of 50 to 510 International Units/lb body weight (bw) for males and 67 to 1816 International Units/lb bw for females. Depending on body weight and dose administered, it may be necessary to divide the dose among two or more injection sites to avoid injecting a large volume at a single site.
Summaries of doses tested in representative fish species are contained within the following tables. The dose of CHORULON® to be used in other species of finfish may differ from those species listed in the tables, but should fall within the suggested range of 50 to 510 International Units/lb bw for males and 67 to 1816 International Units/lb bw for females.
Table 1: Tested Fish Species/Dose Combinations Found to be Effective
Nomenclature Common Name, Genus & Species, Family
Tested Dose(s) (International Units/lb bw/injection)
Table 2: Tested Fish Species/Dose Combinations Found to be Safe
Nomenclature Common Name, Genus & Species, Family
Tested Dose(s) (International Units/lb bw/injection)
Number of Injections
Injections Interval (h)
Males
Females
white bass, Morone chrysops, Percichthyidae
750
1500
1
-
walleye, Stizostedion vitreum, Percidae
750
1500
1
-
grass carp, Ctenopharyngodon idella, Cyprinidae
2500
5000
1
-
channel catfish, Ictalurus punctatus, Ictaluridae
2500
5000
1
-
ADVERSE REACTIONS SECTION
ADVERSE REACTIONS
Chorionic gonadotropin is a protein. In the unlikely event of an anaphylactic reaction, epinephrine should be administered. The administration of an antihistamine may also be indicated.
RESIDUE WARNING SECTION
RESIDUE WARNINGS
No withdrawal period is required for cows or brood finfish treated according to label directions. The total dose administered (all injections combined) should not exceed 25,000 International Units (25 mL) per fish in fish intended for human consumption.
STORAGE AND HANDLING SECTION
STORAGE AND HANDLING PRECAUTIONS
Store at or below room temperature, 25°C (77°F). Keep out of reach of children. Once reconstituted, CHORULON® should be used immediately. Unused solution should be disposed of properly and not stored for future use.
HOW SUPPLIED SECTION
HOW SUPPLIED
CHORULON® is supplied in cartons containing five vials of freeze-dried powder and five 10 mL vials of sterile diluent.
SPL UNCLASSIFIED SECTION
Distributed by Intervet Inc. (d/b/a Merck Animal Health), Rahway, NJ 07065.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.