Label: CHORULON- gonadotrophin, chorionic kit
- NDC Code(s): 57926-475-62
- Packager: Merck Sharp & Dohme Corp.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 13, 2023
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DESCRIPTION
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 I.U. 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
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
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 I.U. chorionic gonadotropin.
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.
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 I.U./lb body weight (bw) for males and 67 to 1816 I.U./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 I.U./lb bw for males and 67 to 1816 I.U./lb bw for females.
Table 1: Tested Fish Species/Dose Combinations Found to be Effective Nomenclature Common Name, Genus & Species, Family Tested Dose(s)
(I.U./lb bw/injection)Number of Injection Injections Interval (h) Males Females Footnotes: 1, nt = not tested yellow perch, Perca flavescens, Percidae nt1 67-300 1 - striped bass, Morone saxitilis, Percichthyidae 50-500 75-252 1 - white bass, Morone chrysops, Percichthyidae 65-510 91-750 1 - razorback sucker, Xyrauchen texanus, Catostomidae nt 100 3 24 walleye, Stizostedion vitreum, Percidae 75-400 145-830 1-3 72 red snapper, Lutjanus campechanus, Lutjanidae 250 500 1 - sauger, Stizostedion canadense, Percidae 500 500-1000 1 - Chinese catfish, Clarius fuscus, Clariidae nt 1816 1 - Table 2: Tested Fish Species/Dose Combinations Found to be Safe Nomenclature Common Name, Genus & Species, Family Tested Dose(s)
(I.U./lb bw/injection)Number of Injection 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
- RESIDUE WARNING
- STORAGE AND HANDLING
- HOW SUPPLIED
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- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
CHORULON
gonadotrophin, chorionic kitProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:57926-475 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57926-475-62 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 5 VIAL 5 Part 2 5 VIAL 50 mL Part 1 of 2 CHORULON
gonadotrophin, chorionic injection, powder, lyophilized, for solutionProduct Information Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHORIONIC GONADOTROPIN (UNII: 20ED16GHEB) (CHORIONIC GONADOTROPIN - UNII:20ED16GHEB) CHORIONIC GONADOTROPIN 10000 [iU] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140927 11/22/1991 Part 2 of 2 DILUENT FOR CHORULON
sterile phosphate buffered water injection, solutionProduct Information Route of Administration INTRAMUSCULAR Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140927 11/22/1991 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140927 11/22/1991 Labeler - Merck Sharp & Dohme Corp. (001317601) Establishment Name Address ID/FEI Business Operations Intervet International GMBH 328855635 MANUFACTURE Establishment Name Address ID/FEI Business Operations Ningbo Renjian Pharmaceutical Group Co., Ltd. 529358491 API MANUFACTURE
