<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="ab57763a-29b1-4b86-8aec-836e8c41e3f3"/>
   <code code="50578-4" codeSystem="2.16.840.1.113883.6.1" displayName="PRESCRIPTION ANIMAL DRUG LABEL"/>
   <effectiveTime value="20230511"/>
   <setId root="808813f1-d473-406b-9385-10e9ef6b5252"/>
   <versionNumber value="3"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="019926120" root="1.3.6.1.4.1.519.1"/>
            <name>MWI Veterinary Supply, Inc.</name>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="fbdd15b4-7eff-4d70-9bde-2393a3de8f20"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL listing data elements section"/>
               <effectiveTime value="20240506"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="13985-944" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>VETRIMYCIN<suffix>200</suffix>
                        </name>
                        <formCode code="C42946" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="INJECTION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Oxytetracycline</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="200" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="X20I9EN955" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>OXYTETRACYCLINE </name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="SLF0D9077S" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>OXYTETRACYCLINE ANHYDROUS </name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="KKL5D39EOL" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PYRROLIDONE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="X4ZGP7K714" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SODIUM FORMALDEHYDE SULFOXYLATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="FZ989GH94E" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POVIDONE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="3A3U0GI71G" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>MAGNESIUM OXIDE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>Water</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="QTT17582CB" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>Hydrochloric acid</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="5KV86114PT" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>Monoethanolamine</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="100" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="13985-944-10" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43226" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="VIAL"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="250" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="13985-944-25" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43226" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="VIAL"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="500" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="13985-944-50" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43226" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="VIAL"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20180725"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <id extension="ANADA200128" 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>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38299" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SUBCUTANEOUS"/>
                        </substanceAdministration>
                     </consumedIn>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38276" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="INTRAVENOUS"/>
                        </substanceAdministration>
                     </consumedIn>
                     <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 root="69d6f1c5-5d7c-45dc-90a7-e48728e341e5"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Vetrimycin™ 200</content>
                     <br/>(<content styleCode="italics">oxytetracycline injection</content>)<br/>
                     <content styleCode="bold">Antibiotic</content>
                  </paragraph>
               </text>
               <effectiveTime value="20240506"/>
            </section>
         </component>
         <component>
            <section ID="L5f1b2cfe-9b2f-42a6-95d6-02df5519f9f9">
               <id root="d8457f8d-548c-43e0-964a-b4b67919c483"/>
               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <text>
                  <paragraph>Vetrimycin™ 200 (oxytetracycline injection) is a sterile, preconstituted solution of the broad-spectrum antibiotic<br/>oxytetracycline. Each mL contains 200 mg of oxytetracycline base as oxytetracycline dihydrate, and on a w/v basis,<br/>40.0% 2-pyrrolidone, 5.0% povidone, 1.8% magnesium oxide, 0.2% sodium formaldehyde sulfoxylate (as a preservative),<br/>monoethanolamine and/or hydrochloric acid as required to adjust pH.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section>
               <id root="317cc8e9-6d11-4579-8a46-153886c63d00"/>
               <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> When administered to cattle, muscle discoloration may necessitate trimming of the injection site(s)<br/>and surrounding tissues during the dressing procedure.</paragraph>
                  <paragraph>
                     <content styleCode="bold">WARNINGS:</content> Discontinue treatment at least 28 days prior to slaughter of cattle and swine. Milk taken from<br/>animals during treatment and for 96 hours after the last treatment must not be used for food.</paragraph>
                  <paragraph>
                     <content styleCode="bold">PRECAUTIONS:</content> Exceeding the highest recommended level of drug per lb of body weight per day, administering<br/>more than the recommended number of treatments, and/or exceeding 10 mL subcutaneously per injection site<br/>in adult beef and dairy cattle, and 5 mL intramuscularly per injection site in adult swine, may result in<br/>antibiotic residues beyond the withdrawal period.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section ID="L0ea7e96b-e564-4da1-b991-0f2d1b447457">
               <id root="0c697acc-918e-4332-9280-739a64d01abe"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Distributed by: MWI<br/>Boise, ID 83705<br/>www.VetOne.net</paragraph>
                  <paragraph>LOT NO.:                EXP. DATE:</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section ID="Lad501692-7289-4f37-8ab3-f8f828438b1d">
               <id root="802ad470-1455-4f02-a8e4-b66485e772e0"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">DOSAGE: Cattle:</content> A single dosage of 9 mg of oxytetracycline per lb of body weight (4.5 mL/100 lb)<br/>administered subcutaneously is recommended in the treatment of the following conditions: 1)<br/>bacterial pneumonia caused by <content styleCode="italics">Pasteurella</content> spp. (shipping fever) in calves and yearlings, where<br/>retreatment is impractical due to husbandry conditions, such as cattle on range, or where<br/>repeated restraint is inadvisable; 2) infectious bovine keratoconjunctivitis (pinkeye) caused by<br/>
                     <content styleCode="italics">Moraxella bovis</content>.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Swine:</content> A single dosage of 9 mg of oxytetracycline per lb of body weight (4.5 mL/100 lb) administered<br/>
                     <content styleCode="italics">intramuscularly</content> is recommended in the treatment of bacterial pneumonia caused by <content styleCode="italics">Pasteurella</content>
                     <br/>
                     <content styleCode="italics">multocida</content> in swine, where retreatment is impractical due to husbandry conditions or where repeated<br/>restraint is inadvisable.</paragraph>
                  <paragraph>Refer to Package Onsert for Complete Directions.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section ID="L7718801b-0823-4fb6-8fe3-4e67fcd24385">
               <id root="87eea62f-af7e-4457-bb79-8a172cae70bb"/>
               <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">HOW SUPPLIED:</content> Vetrimycin™ 200 is available in 100 mL, 250 mL and 500 mL<br/>multi-dose amber vials.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section ID="Lea964477-a182-449e-86f1-9a7ef76dec80">
               <id root="2820396a-70e3-4d40-98a7-9d43691d4bd2"/>
               <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 room temperature<br/>15°-25°C (59°-77°F). Keep from freezing.<br/>Use within 12 months of first puncture.<br/>Puncture a maximum of 100 times.</paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content>Not For Human Use</content>
                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section ID="Lc1f8836f-d17a-4dab-9cd8-b710cb5a426b">
               <id root="086a780d-6895-4360-a50d-cbceb41e69c1"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L176f8ceb-a775-48d9-8d46-1e9c0439543c"/>
                  </paragraph>
               </text>
               <effectiveTime value="20240501"/>
               <component>
                  <observationMedia ID="L176f8ceb-a775-48d9-8d46-1e9c0439543c">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Take Time 1.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L4d4be86b-2924-4bef-9e20-fc10ebe8e675">
               <id root="ee53536f-4edf-4b48-a26f-57911bf928e4"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Vetrimycin™ 200</content>
                     <br/>(<content styleCode="italics">oxytetracycline injection</content>)<br/>
                     <content styleCode="bold">Antibiotic</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution:</content> Federal law restricts this drug to use by or on the order of a licensed veterinarian.<content styleCode="italics"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">Each mL contains 200 mg of oxytetracycline base as oxytetracycline dihydrate.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">For treatment of diseases in beef cattle; dairy cattle; calves, including preruminating (veal) calves; and swine</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">For animal use only</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Read Entire Package Onsert Carefully Before</content>
                     <br/>
                     <content styleCode="bold">Using This Product.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section ID="L8f518b7f-6de8-42dd-894f-51885cf402ae">
               <id root="e0587365-c4a0-468c-803e-131625147189"/>
               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <text>
                  <paragraph>Vetrimycin™ 200 (oxytetracycline injection) is a sterile, ready-to-use solution<br/>for the administration of the broad-spectrum antibiotic oxytetracycline by<br/>injection.</paragraph>
                  <paragraph>Vetrimycin™ 200 administered to cattle or swine for the treatment of bacterial<br/>pneumonia at a dosage of 9 mg of oxytetracycline per lb of body weight has been<br/>demonstrated in clinical trials to be as effective as 2 or 3 repeated, daily<br/>treatments of oxytetracycline injectable at 3-5 mg/lb of body weight.</paragraph>
                  <paragraph>Vetrimycin™ 200 does not require refrigeration; however, it is recommended that<br/>it be stored at room temperature, 15°-25°C (59°-77°F). The antibiotic activity<br/>of oxytetracycline is not appreciably diminished in the presence of body fluids,<br/>serum, or exudates.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section ID="L9d0f9bcb-38fb-47f6-bffa-c19d15b18b3f">
               <id root="ee54547a-1edf-4592-bd55-756ef2dfc707"/>
               <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> When administered to cattle, muscle discoloration may necessitate<br/>trimming of the injection site(s) and surrounding tissues during the<br/>dressing procedure.</paragraph>
                  <paragraph>
                     <content styleCode="bold">WARNINGS:</content> Discontinue treatment at least 28 days prior to slaughter of<br/>cattle and swine. Milk taken from animals during treatment and for 96<br/>hours after the last treatment must not be used for food. Rapid<br/>intravenous administration may result in animal collapse. Oxytetracycline<br/>should be administered intravenously slowly over a period of at least<br/>5 minutes.</paragraph>
                  <paragraph>
                     <content styleCode="bold">PRECAUTIONS:</content> Exceeding the highest recommended dosage level of drug per<br/>lb of body weight per day, administering more than the recommended number<br/>of treatments, and/or exceeding 10 mL subcutaneously per injection site in<br/>adult beef and dairy cattle, and 5 mL intramuscularly per injection site<br/>in adult swine, may result in antibiotic residues beyond the withdrawal<br/>period.</paragraph>
                  <paragraph>At the first sign of any adverse reaction, discontinue use of the product<br/>and seek the advice of your veterinarian. Some of the reactions may be<br/>attributed either to anaphylaxis (an allergic reaction) or to cardiovascular<br/>collapse of unknown cause.</paragraph>
                  <paragraph>Shortly after injection, treated animals may have transient hemoglobinuria<br/>resulting in darkened urine.</paragraph>
                  <paragraph>As with all antibiotic preparations, use of this drug may result in overgrowth<br/>of non-susceptible organisms, including fungi. A lack of response by the treated<br/>animal, or the development of new signs, may suggest that an overgrowth of<br/>nonsusceptible organisms has occurred. If any of these conditions occur, consult<br/>your veterinarian.</paragraph>
                  <paragraph>Since bacteriostatic drugs may interfere with the bactericidal action of penicillin,<br/>it is advisable to avoid giving Oxytetracycline Injection in conjunction with<br/>penicillin.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section>
               <id root="e359d16a-5313-47f2-ac83-31fc56d4b0d7"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">ADVERSE REACTIONS:</content> Reports of adverse reactions associated with oxytetracycline<br/>administration include injection site swelling, restlessness, ataxia, trembling,<br/>swelling of eyelids, ears, muzzle, anus and vulva (or scrotum and sheath in males),<br/>respiratory abnormalities (labored breathing), frothing at the mouth, collapse<br/>and possibly death. Some of these reactions may be attributed to anaphylaxis (an<br/>allergic reaction) or to cardiovascular collapse of unknown cause.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section>
               <id root="808b3204-2a50-48c5-b46b-8d970dd0b1eb"/>
               <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 room temperature 15°-25°C (59°-77°F). Keep from freezing.<br/>Use within 12 months of first puncture. Puncture a maximum of 100 times.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section>
               <id root="fe87e4ab-7965-47c9-bb1a-616b95982939"/>
               <code code="50744-2" codeSystem="2.16.840.1.113883.6.1" displayName="INFORMATION FOR OWNERS/CAREGIVERS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">CARE OF SICK ANIMALS:</content> The use of antibiotics in the management of diseases is based<br/>on an accurate diagnosis and an adequate course of treatment. When properly used in<br/>the treatment of diseases caused by oxytetracycline-susceptible organisms, most<br/>animals that have been treated with Oxytetracycline Injection show a noticeable<br/>improvement within 24-48 hours.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section>
               <id root="ddc6be05-3608-4aa7-b741-4d31372cb529"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">INDICATIONS:</content> Vetrimycin™ 200 (oxytetracycline injection) is intended for use in<br/>the treatment of the following diseases in beef cattle; dairy cattle; calves,<br/>including preruminating (veal) calves; and swine when due to<br/>oxytetracycline-susceptible organisms:</paragraph>
                  <paragraph>
                     <content styleCode="bold">Cattle:</content> Vetrimycin™ 200 (oxytetracycline injection) is indicated in the treatment<br/>of pneumonia and shipping fever complex associated with<content styleCode="italics"> Pasteurella</content> spp. and<br/>
                     <content styleCode="italics">Haemophilus</content> spp; infectious bovine keratoconjunctivitis (pinkeye) caused by <content styleCode="italics">Moraxella</content>
                     <br/>
                     <content styleCode="italics">bovis</content>; foot rot and diphtheria caused by <content styleCode="italics">Fusobacterium necrophorum</content>; bacterial<br/>enteritis (scours) caused by <content styleCode="italics">Escherichia coli</content>; wooden tongue caused by <content styleCode="italics">Actinobacillus</content>
                     <br/>
                     <content styleCode="italics">lignieresii</content>; leptospirosis caused by <content styleCode="italics">Leptospira pomona</content>; and wound infections and acute<br/>metritis caused by strains of staphylococci and streptococci organisms sensitive to<br/>oxytetracycline.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Swine:</content> Vetrimycin™ 200 is indicated in the treatment of bacterial enteritis (scours,<br/>colibacillosis) caused by <content styleCode="italics">Escherichia coli</content>; pneumonia caused by <content styleCode="italics">Pasteurella multocida</content>;<br/>and leptospirosis caused by <content styleCode="italics">Leptospira pomona</content>.</paragraph>
                  <paragraph>In sows, Vetrimycin™ 200 is indicated as an aid in the control of infectious enteritis<br/>(baby pig scours, colibacillosis) in suckling pigs caused by <content styleCode="italics">Escherichia coli</content>.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section>
               <id root="dabb658d-25ed-44dd-ae65-48eeb1bb6d09"/>
               <code code="43678-2" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE FORMS &amp; STRENGTHS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">DOSAGE:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"/>
                     <content styleCode="bold">Cattle:</content> Vetrimycin™ 200 is to be administered by subcutaneous (SC, under the skin) or<br/>intravenous injection according to Beef Quality Assurance Guidelines.</paragraph>
                  <paragraph>A single dosage of 9 mg of Vetrimycin™ 200 per lb of body weight administered subcutaneously<br/>is recommended in the treatment of the following conditions: 1) bacterial pneumonia caused by<br/>
                     <content styleCode="italics">Pasteurella</content> spp. (shipping fever) in calves and yearlings, where retreatment is impractical<br/>due to husbandry conditions, such as cattle on range, or where their repeated restraint is<br/>inadvisable; 2) infectious bovine keratoconjunctivitis (pinkeye) caused by <content styleCode="italics">Moraxella bovis</content>.</paragraph>
                  <paragraph>Vetrimycin™ 200 (oxytetracycline injection) can also be administered by subcutaneous or<br/>intravenous injection at a level of 3-5 mg of oxytetracycline per lb of body weight per day.<br/>In the treatment of severe foot rot and advanced cases of other indicated diseases, a dosage<br/>level of 5 mg/lb of body weight per day is recommended. Treatment should be continued 24-48<br/>hours following remission of disease signs; however, not to exceed a total of 4 consecutive<br/>days. Consult your veterinarian if improvement is not noted within 24-48 hours of the beginning<br/>of treatment.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Swine:</content> A single dosage of 9 mg of Vetrimycin™ 200 per lb of body weight administered<br/>
                     <content styleCode="italics">intramuscularly</content> in the neck region is recommended in the treatment of bacterial<br/>pneumonia caused by <content styleCode="italics">Pasteurella multocida</content> in swine, where retreatment is impractical<br/>due to husbandry conditions or where repeated restraint is inadvisable.</paragraph>
                  <paragraph>Vetrimycin™ 200 can also be administered by intramuscular injection at a level of 3-5 mg<br/>of oxytetracycline per lb of body weight per day. Treatment should be continued 24-48 hours<br/>following remission of disease signs; however, not to exceed a total of 4 consecutive days.<br/>Consult your veterinarian if improvement is not noted within 24-48 hours of the beginning of<br/>treatment.</paragraph>
                  <paragraph>For sows, administer once intramuscularly in the neck region 3 mg of oxytetracycline per<br/>lb of body weight approximately 8 hours before farrowing or immediately after completion<br/>of farrowing.</paragraph>
                  <paragraph>
                     <content styleCode="italics">For swine weighing 25 lb of body weight and under</content>, Vetrimycin™ 200 should be administered<br/>
                     <content styleCode="italics">undiluted</content> for treatment at 9 mg/lb but should be administered <content styleCode="italics">diluted</content> for treatment at<br/>3 or 5 mg/lb.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L7c4bf75c-2663-4c85-99a4-df35643a51b8"/>
                  </paragraph>
                  <paragraph>* To prepare dilution, add 1 part Vetrimycin™ 200 (oxytetracycline<br/>injection) to 3, 5 or 7 parts of sterile water, or 5% dextrose solution<br/>as indicated; the diluted product should be used immediately.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
               <component>
                  <observationMedia ID="L7c4bf75c-2663-4c85-99a4-df35643a51b8">
                     <text>Dosing</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Dosing.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="b5be8d9b-6559-4b23-a177-e04d7669a799"/>
               <code code="60562-6" codeSystem="2.16.840.1.113883.6.1" displayName="ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">DIRECTIONS FOR USE:</content> Vetrimycin™ 200 is intended for use in the treatment of disease<br/>due to oxytetracycline-susceptible organisms in beef cattle; dairy cattle; calves,<br/>including preruminating (veal) calves; and swine. A thoroughly cleaned, sterile<br/>needle and syringe should be used for each injection (needles and syringes may be<br/>sterilized by boiling in water for 15 minutes). In cold weather, Vetrimycin™ 200<br/>should be warmed to room temperature before administration to animals. Before<br/>withdrawing the solution from the bottle, disinfect the rubber cap on the bottle<br/>with suitable disinfectant, such as 70% alcohol. The injection site should be<br/>similarly cleaned with the disinfectant. Needles of 16-18 gauge and 1-1/2 inches<br/>long are adequate for intramuscular and subcutaneous injections. Needles 2-3 inches<br/>are recommended for intravenous use.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Intramuscular Administration: </content>
                  </paragraph>
                  <paragraph>Intramuscular injections in swine should be made by directing the needle of suitable<br/>gauge and length into the fleshy part of a thick muscle in the neck region; avoid<br/>blood vessels and major nerves. Before injecting the solution, pull back gently on<br/>the plunger. If blood appears in the syringe, a blood vessel has been entered; withdraw<br/>the needle and select a different site. No more than 5 mL should be injected at any<br/>one site in adult swine; rotate injection sites for each succeeding treatment.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Subcutaneous Administration: </content>
                  </paragraph>
                  <paragraph>Subcutaneous injections in beef cattle, dairy cattle, and calves, including preruminating<br/>(veal) calves, should be made by directing the needle of suitable gauge and length through<br/>the loose folds of the neck skin in front of the shoulder. Care should be taken to ensure<br/>that the tip of the needle has penetrated the skin but is not lodged in muscle. Before<br/>injecting the solution, pull back gently on the plunger. If blood appears in the syringe,<br/>a blood vessel has been entered; withdraw the needle and select a different site. The<br/>solution should be injected slowly into the area between the skin and muscles. No more than<br/>10 mL should be injected subcutaneously at any one site in adult beef and dairy cattle;<br/>rotate injection sites for each succeeding treatment. The volume administered per injection<br/>site should be reduced according to age and body size so that 1-2 mL per site is injected<br/>in small calves.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Intravenous Administration:</content>
                     <br/>Vetrimycin™ 200 (oxytetracycline injection) may be administered intravenously to beef and<br/>dairy cattle. As with all highly concentrated materials, Vetrimycin™ 200 should be<br/>administered <content styleCode="italics">slowly</content> by the intravenous route.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Preparation of the Animal for Injection:</content>
                     <br/>1. Approximate location of vein. The jugular vein runs in the jugular groove on each side<br/>of the neck from the angle of the jaw to just above the brisket and slightly above and to<br/>the side of the windpipe. (See Fig. I)</paragraph>
                  <paragraph>2. Restraint. A stanchion or chute is ideal for restraining the animal. With a halter, rope,<br/>or cattle leader (nose tongs), pull the animal's head around the side of the stanchion,<br/>cattle chute, or post in such a manner to form a bow in the neck (See Fig. II), then snub<br/>the head securely to prevent movement. By forming the bow in the neck, the outside curvature<br/>of the bow tends to expose the jugular vein and make it easily accessible.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution:</content> Avoid restraining the animal with a tight rope or halter around the throat or upper<br/>neck which might impede blood flow. Animals that are down present no problem so far as restraint<br/>is concerned.</paragraph>
                  <paragraph>3. Clip hair in area where injection is to be made (over the vein in the upper third of the<br/>neck). Clean and disinfect the skin with alcohol or other suitable antiseptic.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="MM2"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Entering the Vein and Making the Injection:</content>
                  </paragraph>
                  <paragraph>1. Raise the vein. This is accomplished by tying the choke rope tightly around the neck close<br/>to the shoulder. The rope should be tied in such a way that it will not come loose and so<br/>that it can be untied quickly by pulling the loose end (See Fig. II). In thick-necked animals,<br/>a block of wood placed in the jugular groove between the rope and the hide will help considerably<br/>in applying the desired pressure at the right point. The vein is a soft flexible tube through<br/>which blood flows back to the heart. Under ordinary conditions it cannot be seen or felt with the<br/>fingers. When the flow of blood is blocked at the base of the neck by the choke rope, the vein<br/>becomes enlarged and rigid because of the back pressure. If the choke rope is sufficiently tight,<br/>the vein stands out and can be easily seen and felt in thin-necked animals. As a further check in<br/>identifying the vein, tap it with the fingers in front of the choke rope. Pulsations that can be<br/>seen or felt with the fingers in front of the point being tapped will confirm the fact that the<br/>vein is properly distended. It is impossible to put the needle into the vein unless it is distended.<br/>Experienced operators are able to raise the vein simply by hand pressure, but the use of a choke<br/>rope is more certain.</paragraph>
                  <paragraph>2. Inserting the needle. This involves 3 distinct steps. First, insert the needle through the hide.<br/>Second, insert the needle into the vein. This may require 2 or 3 attempts before the vein is entered.<br/>The vein has a tendency to roll away from the point of the needle, especially if the needle is not<br/>sharp. The vein can be steadied with the thumb and finger of one hand. With the other hand, the needle<br/>point is placed directly over the vein, slanting it so that its direction is along the length of the<br/>vein, either toward the head or toward the heart. Properly positioned this way, a quick thrust of the<br/>needle will be followed by a spurt of blood through the needle, which indicates that the vein has been<br/>entered. Third, once in the vein, the needle should be inserted along the length of the vein all the<br/>way to the hub, exercising caution to see that the needle does not penetrate the opposite side of the<br/>vein. Continuous steady flow of blood through the needle indicates that the needle is still in the vein.<br/>If blood does not flow continuously, the needle is out of the vein (or clogged) and another attempt<br/>must be made. If difficulty is encountered, it may be advisable to use the vein on the other side of<br/>the neck.</paragraph>
                  <paragraph>3. While the needle is being placed in proper position in the vein, an assistant should get the<br/>medication ready so that the injection can be started without delay after the vein has been entered.</paragraph>
                  <paragraph>4. Making the injection. With the needle in position as indicated by continuous flow of blood, release<br/>the choke rope by a quick pull on the free end. This is essential - the medication cannot flow into<br/>the vein while it is blocked. Immediately connect the syringe containing Vetrimycin™ 200 (oxytetracycline<br/>injection) to the needle and slowly depress the plunger. If there is resistance to depression of the<br/>plunger, this indicates that the needle has slipped out of the vein (or is clogged) and the procedure will<br/>have to be repeated. Watch for any swelling under the skin near the needle, which would indicate that the<br/>medication is not going into the vein. Should this occur, it is best to try the vein on the opposite side<br/>of the neck.</paragraph>
                  <paragraph>5. Removing the needle. When injection is complete, remove needle with straight pull. Then apply pressure<br/>over area of injection momentarily to control any bleeding through needle puncture, using cotton soaked<br/>in alcohol or other suitable antiseptic.</paragraph>
               </text>
               <effectiveTime value="20240506"/>
               <component>
                  <observationMedia classCode="OBS" moodCode="EVN" ID="MM2">
                     <text>Injection Diagram</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="Injection.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L8d8ebf14-36e4-4f39-8adc-af1316beccdc">
               <id root="d911d51c-4863-412a-8802-59a6666a51c4"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Not For Human Use</content>
                  </paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-128</paragraph>
                  <paragraph>
                     <content styleCode="bold">Distributed by: MWI</content>
                     <br/>
                     <content styleCode="bold">Boise, ID 83705</content>
                     <br/>
                     <content styleCode="bold">www.VetOne.net</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <renderMultiMedia referencedObject="L5e98852c-4617-41cc-9294-ffc56d6985b2"/>
                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20240506"/>
               <component>
                  <observationMedia ID="L5e98852c-4617-41cc-9294-ffc56d6985b2">
                     <text>Take Time 2</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Take Time 2.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="bbdb10ad-5240-43e4-b976-3dc577f72463"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">DOSAGE: Cattle:</content> A single dosage of 9 mg of oxytetracycline per lb of body weight<br/>(4.5 mL/100 lb) administered subcutaneously is recommended in the treatment of the<br/>following conditions: 1) bacterial pneumonia caused by <content styleCode="italics">Pasteurella</content> spp. (shipping<br/>fever) in calves and yearlings, where retreatment is impractical due to husbandry<br/>conditions, such as cattle on range, or where repeated restraint is inadvisable;<br/>2) infectious bovine keratoconjunctivitis (pinkeye) caused by <content styleCode="italics">Moraxella bovis</content>.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Swine:</content> A single dosage of 9 mg of oxytetracycline per lb of body weight (4.5 mL/100 lb)<br/>administered <content styleCode="italics">intramuscularly</content> is recommended in the treatment of bacterial pneumonia<br/>caused by <content styleCode="italics">Pasteurella multocida</content> in swine, where retreatment is impractical due to<br/>husbandry conditions or where repeated restraint is inadvisable.</paragraph>
                  <paragraph>Refer to Package Onsert for Complete Directions.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section ID="Le22022bb-efa0-4ab6-bb59-eb3511245539">
               <id root="83b1523f-2800-4b04-8a90-394d7bbbe6d5"/>
               <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">HOW SUPPLIED:</content> Vetrimycin™ 200 is available in 100 mL, 250 mL and 500 mL<br/>multi-dose amber vials.</paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section ID="Le9c43921-54ba-4a19-b64e-dfffd2a758e8">
               <id root="3c58bf9e-974c-4bc6-84d1-65e889e21fe8"/>
               <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 room temperature<br/>15°-25°C (59°-77°F). Keep from freezing.<br/>Use within 12 months of first puncture.<br/>Puncture a maximum of 100 times.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Not For Human Use</content>
                  </paragraph>
               </text>
               <effectiveTime value="20240501"/>
            </section>
         </component>
         <component>
            <section ID="L232f2e09-d8f7-404b-a9b6-6c9ac9067730">
               <id root="3bf87cb7-9943-4407-98c5-87559f367210"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L16e533aa-eb08-4f8c-9e61-b0d6a64a9783"/>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L1d721b9c-186e-43b4-981f-bbfb513ca4e2"/>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Ld21ea664-9781-4d8b-a36b-4b6c5bb8935b"/>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L04e59057-5ce3-4b7d-bf90-2a339ca6b856"/>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lb0bdd192-3073-4938-839c-ae4a0ce4f39c"/>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <renderMultiMedia referencedObject="L81c2eb67-c296-463a-8c63-adc38242a37f"/>
                  </paragraph>
               </text>
               <effectiveTime value="20240506"/>
               <component>
                  <observationMedia ID="L16e533aa-eb08-4f8c-9e61-b0d6a64a9783">
                     <text>Vetrimycin Unit</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Vetrimycin_500mL_Label_RX_06-2023.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L1d721b9c-186e-43b4-981f-bbfb513ca4e2">
                     <text>Vetrimycin Onsert 1-3</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Vetrimycin_500mL_Onsert_RX_06-2023 1-3.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="Ld21ea664-9781-4d8b-a36b-4b6c5bb8935b">
                     <text>Vetrimycin Onsert 4-6</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Vetrimycin_500mL_Onsert_RX_06-2023 4-6.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L04e59057-5ce3-4b7d-bf90-2a339ca6b856">
                     <text>Vetrimycin Onsert 7-9</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Vetrimycin_500mL_Onsert_RX_06-2023 7-9.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="Lb0bdd192-3073-4938-839c-ae4a0ce4f39c">
                     <text>Vetrimycin Onsert 10-12</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Vetrimycin_500mL_Onsert_RX_06-2023 10-12.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L81c2eb67-c296-463a-8c63-adc38242a37f">
                     <text>Vetrimycin Carton</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Vetrimycin_500mL_Carton_RX_06-2023_.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>