<text/> <effectiveTime value="20211220"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="13744-525" codeSystem="2.16.840.1.113883.6.69"/> <name>GleptoForte</name> <formCode code="C42946" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="INJECTION"/> <asEntityWithGeneric> <genericMedicine> <name>gleptoferron</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator value="200" unit="mg"/> <denominator value="1" unit="mL"/> </quantity> <ingredientSubstance> <code code="898723IQHQ" codeSystem="2.16.840.1.113883.4.9"/> <name>GLEPTOFERRON</name> <activeMoiety> <activeMoiety> <code code="898723IQHQ" codeSystem="2.16.840.1.113883.4.9"/> <name>GLEPTOFERRON</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="100" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="13744-525-01" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43210" displayName="VIAL, MULTI-DOSE" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> <asContent> <quantity> <numerator value="250" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="13744-525-02" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43210" displayName="VIAL, MULTI-DOSE" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> </manufacturedProduct> <subjectOf> <approval> <id extension="ANADA200587" root="2.16.840.1.113883.3.150"/> <code code="C73583" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ANADA"/> <author> <territorialAuthority> <territory> <code code="USA" codeSystem="2.16.840.1.113883.5.28"/> </territory> </territorialAuthority> </author> </approval> </subjectOf> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20160913"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <characteristic> <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/> <value code="C48325" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="white" xsi:type="CE"/> </characteristic> </subjectOf> <consumedIn> <substanceAdministration> <routeCode code="C28161" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="INTRAMUSCULAR"/> </substanceAdministration> </consumedIn> </manufacturedProduct> </subject> </section> </component> <component> <section ID="Lf2cc9d0c-8330-43a4-954e-b4d84df641e4"> <id root="87a76dea-3d0e-4dd0-b209-60afc383f315"/> <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/> <text> <paragraph> <content styleCode="bold">GleptoForte<sup>®</sup> </content> </paragraph> <paragraph> <content styleCode="bold">(gleptoferron)</content> </paragraph> <paragraph> <content styleCode="bold">200 mg/mL of iron</content> </paragraph> <paragraph> <content styleCode="bold">Solution for intramuscular injection</content> </paragraph> <paragraph> <content styleCode="bold">NOT FOR USE IN HUMANS</content> </paragraph> <paragraph> <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content> </paragraph> <paragraph> <content styleCode="bold">Approved by FDA under ANADA # 200-587</content> </paragraph> </text> <effectiveTime value="20211220"/> <component> <section ID="L78cdc469-dfed-479b-a64b-16ab569fa59e"> <id root="0a72ad5b-f04a-4a80-8aa6-980e81495be0"/> <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/> <text> <paragraph> <content styleCode="bold">DESCRIPTION: </content>GleptoForte<sup>®</sup> is a sterile aqueous colloidal solution of gleptoferron, a macromolecular complex of ferric hydroxide and dextran glucoheptonic acid. Each milliliter contains 200 mg of elemental iron. The solution contains 0.5% phenol as preservative.</paragraph> </text> <effectiveTime value="20211220"/> <component> <section ID="La015ee31-1031-4a06-b428-ee128129dd2b"> <id root="5f79089a-e5c6-4049-a0b4-6e257601dbcb"/> <code code="43679-0" codeSystem="2.16.840.1.113883.6.1" displayName="MECHANISM OF ACTION SECTION"/> <text> <paragraph> <content styleCode="bold">ACTIONS: </content>GleptoForte<sup>®</sup> contains gleptoferron which provides a rapidly absorbed and readily utilizable form of iron for the prevention and treatment of baby pig anemia.</paragraph> </text> <effectiveTime value="20211220"/> <component> <section ID="L3784e662-d810-4f50-a982-ba063ff88b63"> <id root="d9c91816-8e41-4f22-9cd2-751045a78c08"/> <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> <text> <paragraph> <content styleCode="bold">INDICATIONS: </content>GleptoForte<sup>®</sup> is recommended for both the routine prevention and treatment of baby pig anemia due to iron deciency.</paragraph> <paragraph> <content styleCode="bold">NOTICE:</content> Organic iron preparations injected intramuscularly into pigs beyond 4 weeks of age may cause staining of the muscle tissue.</paragraph> </text> <effectiveTime value="20211220"/> </section> </component> </section> </component> </section> </component> </section> </component> <component> <section ID="Le567938f-8b66-4cc6-9b82-af9e9e245de9"> <id root="46533e70-2dd9-4546-bf92-b931374eed4b"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <text> <paragraph> <content styleCode="bold">DOSAGE AND </content> <content styleCode="bold">ADMINISTRATION: </content>GleptoForte<sup>®</sup> is for intramuscular use only. Prevention: 1 mL (200 mg iron) per pig on or before 3 days of age. Treatment: 1 mL (200 mg iron) per pig as soon as signs of deficiency appear.</paragraph> <paragraph> <content styleCode="bold">WITHDRAWAL PERIODS: </content>No withdrawal period is required when used according to labeling.</paragraph> <paragraph> <content styleCode="bold">ANIMAL SAFETY WARNINGS AND PRECAUTIONS:</content> Occasionally pigs may show a reaction to injectable iron, clinically characterized by prostration with muscular weakness. In extreme cases, death may occur.</paragraph> <paragraph>For a copy of the Safety Data Sheet (SDS) or to report suspected adverse drug events, contact CEVA at 1-800-999-0297.</paragraph> <paragraph>For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth.</paragraph> <paragraph> <content styleCode="bold">HOW TO INJECT:</content> </paragraph> <paragraph>What to use</paragraph> <paragraph>1. GleptoForte<sup>®</sup> (gleptoferron) injection</paragraph> <paragraph>2. Ordinary 10 mL syringe with 18-guage needle or smaller, or dosage delivery device with 4-guage draw off spike or smaller</paragraph> <paragraph>3. Disinfectant (rubbing alcohol or tincture of iodine)</paragraph> <paragraph> <content styleCode="italics"> <content styleCode="bold">Where to use:</content> </content> </paragraph> <paragraph>GleptoForte<sup>®</sup> is for intramuscular use. The preferred site of injection is the ham muscle. Push the needle directly into the ham to approximately a one-half (1/2) inch depth. Avoid injection into a blood vessel. This is best avoided by pulling back slightly on the plunger after the needle is seated in the ham. If properly located, resistance will be offered to this effort. If the plunger is pulled back easily, remove and relocate the needle.</paragraph> <paragraph> <renderMultiMedia referencedObject="L793ff37f-f9b7-4cbf-a4b2-81761297a683"/> </paragraph> <paragraph> <content styleCode="bold">Step 1 </content>The pig is held under-arm, between knees, or by an assistant. Disinfect the injection site. Pull down skin and fat with thumb as shown. Approximately halfway along a line between the anus and the thumb is the best injection site.</paragraph> <paragraph> <renderMultiMedia referencedObject="Lf83728ff-9ee4-45d1-b44e-80d5778dd9c6"/> </paragraph> <paragraph> <content styleCode="bold">Step 2 </content>Before injecting GleptoForte<sup>®</sup>, point the needle upward and gently press the plunger to expel all air from syringe. The needle is inserted at right-angle to the skin into the ham approximately a one-half (1/2) inch depth and the injection made.</paragraph> <paragraph> <renderMultiMedia referencedObject="L9f9b3b3f-e4e9-41bd-aab2-2522b50b461e"/> </paragraph> <paragraph> <content styleCode="bold">Step 3 </content>Use a new needle between each stopper puncture. Protect the needle from contamination and disinfect between animal injections.</paragraph> </text> <effectiveTime value="20211220"/> <component> <observationMedia ID="L793ff37f-f9b7-4cbf-a4b2-81761297a683"> <text>step 1 picture</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Diagram 0.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="Lf83728ff-9ee4-45d1-b44e-80d5778dd9c6"> <text>step 2 picture</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Diagram 1.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="L9f9b3b3f-e4e9-41bd-aab2-2522b50b461e"> <text>step 3 picture</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Diagram 2.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="Lf859546d-bff9-42a9-b6c0-fc099d8ef65a"> <id root="1f04bb49-1653-430f-b9ea-fe31bb99a439"/> <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/> <text> <paragraph> <content styleCode="bold">HOW SUPPLIED:</content> </paragraph> <paragraph>GleptoForte<sup>®</sup> (gleptoferron) injection is available in 100 mL and 250 mL multi-dose vials.</paragraph> </text> <effectiveTime value="20211220"/> </section> </component> <component> <section ID="L0532d618-8b93-4f39-a880-76cb6c3ec11b"> <id root="ad81bdf3-01d6-48e0-bd50-256899869431"/> <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/> <text> <paragraph> <content styleCode="bold">STORAGE: </content>Store at 20°C - 25°C (68°F - 77°F). Do not freeze.</paragraph> <paragraph> <content styleCode="bold">100 mL Vial</content>: Use within 28 days of first puncture and puncture a maximum of seventy-five (75) times with an 18-guage needle or five (5) times with a dosage delivery device. If using a needle larger than 18-guage or a draw-off spike larger than 4-guage, discard any remaining product immediately ater use.</paragraph> <paragraph> <content styleCode="bold">250 mL Vial</content>: Use within 28 days of first puncture and puncture a maximum of one hundred (100) times with an 18-guage needle or five (5) times with a dosage delivery device. If using a needle larger than 18-guage or a draw-off spike larger than 4-guage, discard any remaining product immediately ater use. </paragraph> <paragraph/> <paragraph> <content styleCode="bold">Manufactured for:</content> <br/>Ceva Animal Health, LLC, Lenexa, KS 66215<br/>1-800-999-0297</paragraph> <paragraph>GleptoForte<sup>®</sup> is a registered trademark of Ceva Santé Animale</paragraph> <paragraph/> </text> <effectiveTime value="20211220"/> </section> </component> <component> <section ID="L77348a9c-5b0a-41f3-8254-7ad925751354"> <id root="1e6f4a33-b6f6-4d35-9742-726f7053bf6e"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>Principal Display Panel


               
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                     <content styleCode="bold">(gleptoferron)</content>
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                  <paragraph>
                     <content styleCode="bold">200 mg/mL of iron</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Solution for intramuscular injection</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NOT FOR USE IN HUMANS</content>
                  </paragraph>
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                     <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content>
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                     <content styleCode="bold">Approved by FDA under ANADA # 200-587</content>
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                           <content styleCode="bold">DESCRIPTION: </content>GleptoForte<sup>®</sup> is a sterile aqueous colloidal solution of gleptoferron, a macromolecular complex of ferric hydroxide and dextran glucoheptonic acid. Each milliliter contains 200 mg of elemental iron. The solution contains 0.5% phenol as preservative.</paragraph>
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                                 <content styleCode="bold">ACTIONS: </content>GleptoForte<sup>®</sup> contains gleptoferron which provides a rapidly absorbed and readily utilizable form of iron for the prevention and treatment of baby pig anemia.</paragraph>
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                                       <content styleCode="bold">INDICATIONS: </content>GleptoForte<sup>®</sup> is recommended for both the routine prevention and treatment of baby pig anemia due to iron deciency.</paragraph>
                                    <paragraph>
                                       <content styleCode="bold">NOTICE:</content> Organic iron preparations injected intramuscularly into pigs beyond 4 weeks of age may cause staining of the muscle tissue.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">DOSAGE AND </content>
                     <content styleCode="bold">ADMINISTRATION: </content>GleptoForte<sup>®</sup> is for intramuscular use only. Prevention: 1 mL (200 mg iron) per pig on or before 3 days of age. Treatment: 1 mL (200 mg iron) per pig as soon as signs of deficiency appear.</paragraph>
                  <paragraph>
                     <content styleCode="bold">WITHDRAWAL PERIODS: </content>No withdrawal period is required when used according to labeling.</paragraph>
                  <paragraph>
                     <content styleCode="bold">ANIMAL SAFETY WARNINGS AND PRECAUTIONS:</content> Occasionally pigs may show a reaction to injectable iron, clinically characterized by prostration with muscular weakness. In extreme cases, death may occur.</paragraph>
                  <paragraph>For a copy of the Safety Data Sheet (SDS) or to report suspected adverse drug events, contact CEVA at 1-800-999-0297.</paragraph>
                  <paragraph>For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth.</paragraph>
                  <paragraph>
                     <content styleCode="bold">HOW TO INJECT:</content>
                  </paragraph>
                  <paragraph>What to use</paragraph>
                  <paragraph>1. GleptoForte<sup>®</sup> (gleptoferron) injection</paragraph>
                  <paragraph>2. Ordinary 10 mL syringe with 18-guage needle or smaller, or dosage delivery device with 4-guage draw off spike or smaller</paragraph>
                  <paragraph>3. Disinfectant (rubbing alcohol or tincture of iodine)</paragraph>
                  <paragraph>
                     <content styleCode="italics">
                        <content styleCode="bold">Where to use:</content>
                     </content>
                  </paragraph>
                  <paragraph>GleptoForte<sup>®</sup> is for intramuscular use. The preferred site of injection is the ham muscle. Push the needle directly into the ham to approximately a one-half (1/2) inch depth. Avoid injection into a blood vessel. This is best avoided by pulling back slightly on the plunger after the needle is seated in the ham. If properly located, resistance will be offered to this effort. If the plunger is pulled back easily, remove and relocate the needle.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L793ff37f-f9b7-4cbf-a4b2-81761297a683"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Step 1 </content>The pig is held under-arm, between knees, or by an assistant. Disinfect the injection site. Pull down skin and fat with thumb as shown. Approximately halfway along a line between the anus and the thumb is the best injection site.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lf83728ff-9ee4-45d1-b44e-80d5778dd9c6"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Step 2 </content>Before injecting GleptoForte<sup>®</sup>, point the needle upward and gently press the plunger to expel all air from syringe. The needle is inserted at right-angle to the skin into the ham approximately a one-half (1/2) inch depth and the injection made.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L9f9b3b3f-e4e9-41bd-aab2-2522b50b461e"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Step 3 </content>Use a new needle between each stopper puncture. Protect the needle from contamination and disinfect between animal injections.</paragraph>
               </text>
               <effectiveTime value="20211220"/>
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                  <paragraph>
                     <content styleCode="bold">HOW SUPPLIED:</content>
                  </paragraph>
                  <paragraph>GleptoForte<sup>®</sup> (gleptoferron) injection is available in 100 mL and 250 mL multi-dose vials.</paragraph>
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               <effectiveTime value="20211220"/>
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                     <content styleCode="bold">STORAGE: </content>Store at 20°C - 25°C (68°F - 77°F). Do not freeze.</paragraph>
                  <paragraph>
                     <content styleCode="bold">100 mL Vial</content>: Use within 28 days of first puncture and puncture a maximum of seventy-five (75) times with an 18-guage needle or five (5) times with a dosage delivery device. If using a needle larger than 18-guage or a draw-off spike larger than 4-guage, discard any remaining product immediately ater use.</paragraph>
                  <paragraph>
                     <content styleCode="bold">250 mL Vial</content>: Use within 28 days of first puncture and puncture a maximum of one hundred (100) times with an 18-guage needle or five (5) times with a dosage delivery device. If using a needle larger than 18-guage or a draw-off spike larger than 4-guage, discard any remaining product immediately ater use. </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Manufactured for:</content>
                     <br/>Ceva Animal Health, LLC, Lenexa, KS 66215<br/>1-800-999-0297</paragraph>
                  <paragraph>GleptoForte<sup>®</sup> is a registered trademark of Ceva Santé Animale</paragraph>
                  <paragraph/>
               </text>
               <effectiveTime value="20211220"/>
            </section>
         </component>
         <component>
            <section ID="L77348a9c-5b0a-41f3-8254-7ad925751354">
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               <title>Principal Display Panel - 100 mL Bottle Label
               
                  
                     GleptoForte^®
                     
                  
                  
                     (gleptoferron) 200 mg/mL of iron
                  
                  Solution for intramuscular injection
                  For the prevention and treatment of Baby Pig Anemia due to iron deficiency
                  
                     NOT FOR USE IN HUMANS
                  
                  
                     KEEP OUT OF REACH OF CHILDREN
                  
                  Approved by FDA under ANADA # 200-587
                  Net Contents: 100mL
                  
                     
                  
               
               
               
                  
                     bottle label