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                  <paragraph>Approved by FDA under NADA # 140-927</paragraph>
                  <paragraph>
                     <content styleCode="bold">FOR ANIMAL USE ONLY</content>
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               <effectiveTime value="20231113"/>
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                  <paragraph>CAUTION</paragraph>
                  <paragraph>Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
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                  <paragraph>DESCRIPTION</paragraph>
                  <paragraph>CHORULON<sup>®</sup> 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.</paragraph>
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                  <paragraph>ACTION</paragraph>
                  <paragraph>Chorionic gonadotropin has luteinizing hormone-like activity with little or no follicle stimulating or estrogenic activity.</paragraph>
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                  <paragraph>INDICATIONS</paragraph>
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                        <paragraph>COWS: CHORULON<sup>®</sup> is indicated for intramuscular use in cows for the treatment of nymphomania (frequent or constant heat) due to cystic ovaries.</paragraph>
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                        <paragraph>FINFISH: CHORULON<sup>®</sup> is indicated for use as an aid in improving spawning function in male and female brood finfish.</paragraph>
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               <text>
                  <paragraph>DOSAGE AND ADMINISTRATION</paragraph>
                  <paragraph>To reconstitute, transfer the contents of one vial of sterile diluent into one vial of freeze-dried powder. The resulting 10 mL of CHORULON<sup>®</sup> contains 10,000 I.U. chorionic gonadotropin.</paragraph>
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                        <paragraph>COWS: The contents of one vial (10 mL) of reconstituted CHORULON<sup>®</sup> 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.</paragraph>
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                        <paragraph>FINFISH: CHORULON<sup>®</sup> 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.</paragraph>
                        <paragraph>Summaries of doses tested in representative fish species are contained within the following tables. The dose of CHORULON<sup>®</sup> 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.</paragraph>
                        <table width="100%" ID="table1">
                           <caption>Table 1: Tested Fish Species/Dose Combinations Found to be Effective</caption>
                           <col width="40%" valign="top" align="left"/>
                           <col width="15%" valign="bottom" align="center"/>
                           <col width="15%" valign="bottom" align="center"/>
                           <col width="15%" valign="bottom" align="center"/>
                           <col width="15%" valign="bottom" align="center"/>
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                                 <th align="center" rowspan="2" valign="middle">Nomenclature Common Name, <content styleCode="italics">Genus &amp; Species,</content> Family</th>
                                 <th colspan="2" align="center" valign="bottom">Tested Dose(s)<br/>
                                    <content styleCode="underline">(I.U./lb bw/injection)</content>
                                 </th>
                                 <th>Number of Injection</th>
                                 <th>Injections Interval (h)</th>
                              </tr>
                              <tr>
                                 <th align="center">Males</th>
                                 <th>Females</th>
                              </tr>
                           </thead>
                           <tfoot>
                              <tr>
                                 <td colspan="5" align="left">
                                    <content styleCode="bold">Footnotes: </content>1, nt = not tested</td>
                              </tr>
                           </tfoot>
                           <tbody>
                              <tr>
                                 <td>yellow perch, <content styleCode="italics">Perca flavescens,</content> Percidae</td>
                                 <td>nt<sup>1</sup>
                                 </td>
                                 <td>67-300</td>
                                 <td>1</td>
                                 <td>-</td>
                              </tr>
                              <tr>
                                 <td>striped bass, <content styleCode="italics">Morone saxitilis</content>, Percichthyidae</td>
                                 <td>50-500</td>
                                 <td>75-252</td>
                                 <td>1</td>
                                 <td>-</td>
                              </tr>
                              <tr>
                                 <td>white bass, <content styleCode="italics">Morone chrysops</content>, Percichthyidae</td>
                                 <td>65-510</td>
                                 <td>91-750</td>
                                 <td>1</td>
                                 <td>-</td>
                              </tr>
                              <tr>
                                 <td>razorback sucker, <content styleCode="italics">Xyrauchen texanus</content>, Catostomidae</td>
                                 <td>nt</td>
                                 <td>100</td>
                                 <td>3</td>
                                 <td>24</td>
                              </tr>
                              <tr>
                                 <td>walleye, <content styleCode="italics">Stizostedion vitreum</content>, Percidae</td>
                                 <td>75-400</td>
                                 <td>145-830</td>
                                 <td>1-3</td>
                                 <td>72</td>
                              </tr>
                              <tr>
                                 <td>red snapper, <content styleCode="italics">Lutjanus campechanus</content>, Lutjanidae</td>
                                 <td>250</td>
                                 <td>500</td>
                                 <td>1</td>
                                 <td>-</td>
                              </tr>
                              <tr>
                                 <td>sauger, <content styleCode="italics">Stizostedion canadense</content>, Percidae</td>
                                 <td>500</td>
                                 <td>500-1000</td>
                                 <td>1</td>
                                 <td>-</td>
                              </tr>
                              <tr>
                                 <td>Chinese catfish, <content styleCode="italics">Clarius fuscus</content>, Clariidae</td>
                                 <td>nt</td>
                                 <td>1816</td>
                                 <td>1</td>
                                 <td>-</td>
                              </tr>
                           </tbody>
                        </table>
                        <table width="100%" ID="table2">
                           <caption>Table 2: Tested Fish Species/Dose Combinations Found to be Safe</caption>
                           <col width="40%" valign="top" align="left"/>
                           <col width="15%" valign="bottom" align="center"/>
                           <col width="15%" valign="bottom" align="center"/>
                           <col width="15%" valign="bottom" align="center"/>
                           <col width="15%" valign="bottom" align="center"/>
                           <thead>
                              <tr>
                                 <th align="center" rowspan="2" valign="middle">Nomenclature Common Name, <content styleCode="italics">Genus &amp; Species</content>, Family</th>
                                 <th colspan="2" align="center" valign="bottom">Tested Dose(s)<br/>
                                    <content styleCode="underline">(I.U./lb bw/injection)</content>
                                 </th>
                                 <th>Number of Injection</th>
                                 <th>Injections Interval (h)</th>
                              </tr>
                              <tr>
                                 <th align="center">Males</th>
                                 <th>Females</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>white bass, <content styleCode="italics">Morone chrysops</content>, Percichthyidae</td>
                                 <td>750</td>
                                 <td>1500</td>
                                 <td>1</td>
                                 <td>-</td>
                              </tr>
                              <tr>
                                 <td>walleye, <content styleCode="italics">Stizostedion vitreum</content>, Percidae</td>
                                 <td>750</td>
                                 <td>1500</td>
                                 <td>1</td>
                                 <td>-</td>
                              </tr>
                              <tr>
                                 <td>grass carp, <content styleCode="italics">Ctenopharyngodon idella</content>, Cyprinidae</td>
                                 <td>2500</td>
                                 <td>5000</td>
                                 <td>1</td>
                                 <td>-</td>
                              </tr>
                              <tr>
                                 <td>channel catfish, <content styleCode="italics">Ictalurus punctatus</content>, Ictaluridae</td>
                                 <td>2500</td>
                                 <td>5000</td>
                                 <td>1</td>
                                 <td>-</td>
                              </tr>
                           </tbody>
                        </table>
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                  <paragraph>ADVERSE REACTIONS</paragraph>
                  <paragraph>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.</paragraph>
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               <text>
                  <paragraph>RESIDUE WARNINGS</paragraph>
                  <paragraph>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.</paragraph>
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                  <paragraph>STORAGE AND HANDLING PRECAUTIONS</paragraph>
                  <paragraph>Store at or below room temperature, 77° F (25°C). Keep out of reach of children. once reconstituted, CHORULON<sup>®</sup> should be used immediately. unused solution should be disposed of properly and not stored for future use.</paragraph>
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               <text>
                  <paragraph>HOW SUPPLIED</paragraph>
                  <paragraph>CHORULON<sup>®</sup> 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.</paragraph>
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               <text>
                  <paragraph>Intervet Inc., d/b/a Merck Animal Health<br/>Rahway, NJ 07065</paragraph>
                  <paragraph>Manufactured by:<br/>Intervet International GmbH<br/>Unterschleissheim, Germany</paragraph>
                  <paragraph>Copyright © 2023 Merck &amp; Co., Inc., Rahway,<br/>NJ, USA and its affiliates. All rights reserved.</paragraph>
                  <paragraph>Rev. 6/2023</paragraph>
                  <paragraph>395398 R2</paragraph>
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               <title>PRINCIPAL DISPLAY PANEL - Kit Carton</title>
               <text>
                  <paragraph>5 vials with diluent</paragraph>
                  <paragraph>chorulon<sup>®</sup>
                     <br/>(chorionic gonadotropin)</paragraph>
                  <paragraph>MERCK<br/>Animal Health</paragraph>
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                     <text>PRINCIPAL DISPLAY PANEL - Kit Carton</text>
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