CHORULON: Product Information

CHORULON- gonadotrophin, chorionic
Merck Sharp & Dohme Corp.

Approved by FDA under NADA # 140-927

FOR ANIMAL USE ONLY

CAUTION

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

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.

ACTION

Chorionic gonadotropin has luteinizing hormone-like activity with little or no follicle stimulating or estrogenic activity.

INDICATIONS

COWS: CHORULON® is indicated for intramuscular use in cows for the treatment of nymphomania (frequent or constant heat) due to cystic ovaries.

FINFISH: CHORULON® is indicated for use as an aid in improving spawning function in male and female brood finfish.

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

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 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 i.u. (25 mL) per fish in fish intended for human consumption.

STORAGE AND HANDLING PRECAUTIONS

Store at or below room temperature, 77° F (25°C). 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

CHORULON® is supplied in cartons containing five vials of freeze-dried powder and five 10 mL vials of sterile diluent. order Code No. CH-475-1.

Intervet Inc., d/b/a Merck Animal Health
Rahway, NJ 07065

Manufactured by:
Intervet International GmbH
Unterschleissheim, Germany

Copyright © 2023 Merck & Co., Inc., Rahway,
NJ, USA and its affiliates. All rights reserved.

Rev. 6/2023

395398 R2

PRINCIPAL DISPLAY PANEL — Kit Carton

5 vials with diluent

chorulon®
(chorionic gonadotropin)

MERCK
Animal Health

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
CHORULON
gonadotrophin, chorionic kit
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:57926-475
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57926-475-62 1 KIT in 1 CARTON None
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 solution
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHORIONIC GONADOTROPIN (CHORIONIC GONADOTROPIN) CHORIONIC GONADOTROPIN 10000 [iU]
Packaging
# Item Code Package Description Multilevel Packaging
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL None
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, solution
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 10 mL in 1 VIAL None
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 Operations
Intervet International GMBH 328855635 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Ningbo Renjian Pharmaceutical Group Co., Ltd. 529358491 API MANUFACTURE

Revised: 11/2023 Merck Sharp & Dohme Corp.

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