<text/> <effectiveTime value="20170615"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="61133-5485" codeSystem="2.16.840.1.113883.6.69"/> <name>SpectoGard Water Soluble Powder</name> <formCode code="C42973" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POWDER, FOR SOLUTION"/> <asEntityWithGeneric> <genericMedicine> <name>spectinomycin</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator value="500" unit="g"/> <denominator value="1000" unit="g"/> </quantity> <ingredientSubstance> <code code="93AKI1U6QF" codeSystem="2.16.840.1.113883.4.9"/> <name>SPECTINOMYCIN</name> <activeMoiety> <activeMoiety> <code code="93AKI1U6QF" codeSystem="2.16.840.1.113883.4.9"/> <name>SPECTINOMYCIN</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="1000" unit="g"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="61133-5485-1" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43181" displayName="CANISTER" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> </manufacturedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20160614"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <approval> <id extension="NADA038661" root="2.16.840.1.113883.3.150"/> <code code="C73593" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="NADA"/> <author> <territorialAuthority> <territory> <code code="USA" codeSystem="2.16.840.1.113883.5.28"/> </territory> </territorialAuthority> </author> </approval> </subjectOf> <consumedIn> <substanceAdministration> <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/> </substanceAdministration> </consumedIn> </manufacturedProduct> </subject> </section> </component> <component> <section ID="L4fc38464-c11f-4ef6-8d8b-92536e0eb902"> <id root="55fcee29-2877-4096-adca-37a71be692fe"/> <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> <text> <paragraph> <content styleCode="bold">SpectoGard<sup>®</sup> Water Soluble Powder</content> <br/> <content styleCode="bold">(spectinomycin)</content> <br/> <content styleCode="bold">FOR GROWING CHICKENS</content> <br/> <content styleCode="italics"> <content styleCode="bold">Anti-infective</content> </content> <br/> <content styleCode="bold">CAUTION: </content>Federal law restricts this drug to use by or on the order of a licensed veterinarian.<br/> <content styleCode="bold">NOT FOR USE IN HUMANS</content> <br/> <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content> <br/> <content styleCode="bold">Restricted Drug (California) - Use only as directed</content> <br/>Approved by FDA under NADA # 038-661</paragraph> </text> <effectiveTime value="20231206"/> </section> </component> <component> <section ID="L0b849c55-675e-44af-a040-a737002c5d6b"> <id root="14780729-6fb2-4893-84d0-c0d33d188ff7"/> <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> <text> <paragraph> <content styleCode="bold">INDICATIONS, DOSAGE AND ADMINISTRATION:</content> </paragraph> <paragraph>As an aid in the prevention or control of losses due to CRD associated with <content styleCode="italics">M. gallisepticum</content> (PPLO). Administer two (2) grams per gallon of water as the only source of drinking water for the first three days of life and for one day following each vaccination.</paragraph> <paragraph>As an aid in controlling infectious synovitis due to <content styleCode="italics">Mycoplasma synoviae</content> in broiler chickens. Administer one (1) gram per gallon of water as the only source of drinking water for the first three to five days of life.</paragraph> </text> <effectiveTime value="20231116"/> </section> </component> <component> <section ID="L5b7c28ad-7eea-441f-9bd5-b651c79a2eaa"> <id root="147b6aa6-eb5b-456b-997c-614a12ba0ab0"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <text> <paragraph> <content styleCode="bold">DIRECTIONS FOR USE:</content> <br/>To provide 2 g/gal: Dissolve contents in 250 gallons of water. For proportioners, dissolve contents of 1/2 package in 1 gallon of water. Meter at 1 oz/gal.</paragraph> <paragraph>To provide 1 g/gal: Dissolve contents in 500 gallons of water. For proportioners, dissolve contents of 1/2 package in 2 gallons of water. Meter at 1 oz/gal.</paragraph> </text> <effectiveTime value="20231116"/> </section> </component> <component> <section ID="L86b3a05e-a18f-4940-8d4f-052dd46f0f86"> <id root="9c1992c8-66d3-4bd4-b3cc-ba5479a2fd48"/> <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/> <text> <paragraph> <content styleCode="bold">RESIDUE WARNING:</content> DO NOT administer this drug within 5 days of slaughter. DO NOT administer to laying chickens.</paragraph> </text> <effectiveTime value="20231116"/> </section> </component> <component> <section ID="L94dc6aa1-7635-4124-a3c6-a8e9ee8b539f"> <id root="f941cbeb-ae59-41af-9f76-671789fd4f0e"/> <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">PRECAUTION:</content> <br/>Rarely, some individuals who handle spectinomycin develop serious reactions involving skin, nails and eyes. Individuals who have experienced rash or other evidence of allergic reaction should avoid further contact with spectinomycin.</paragraph> <paragraph>The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Bimeda, Inc. at 1888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.</paragraph> </text> <effectiveTime value="20231116"/> </section> </component> <component> <section ID="Lbf7eb876-d5f6-4c76-a087-71e739df35f2"> <id root="3f3004c9-1f35-46f6-acde-07b7c9c1128c"/> <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/> <text> <paragraph> <content styleCode="bold">Store at controlled room temperature 20°C - 25°C (68°F - 77°F), with excursions permitted 15°C - 30°C (59°F - 86°F).</content> </paragraph> </text> <effectiveTime value="20231116"/> </section> </component> <component> <section ID="Laa1420cc-eb3d-429d-a3a2-2a6afd773fc4"> <id root="7211ed8f-7ab0-4bb4-8439-4a7562acd45c"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <text> <renderMultiMedia referencedObject="L3cd4ddf3-272f-4840-8d13-af94b77228d3"/> </text> <effectiveTime value="20231206"/> <component> <observationMedia ID="L3cd4ddf3-272f-4840-8d13-af94b77228d3"> <text>image description</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="label.jpg"/> </value> </observationMedia> </component> </section> </component> </structuredBody> </component> </document>


               
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                     <content styleCode="bold">SpectoGard<sup>®</sup> Water Soluble Powder</content>
                     <br/>
                     <content styleCode="bold">(spectinomycin)</content>
                     <br/>
                     <content styleCode="bold">FOR GROWING CHICKENS</content>
                     <br/>
                     <content styleCode="italics">
                        <content styleCode="bold">Anti-infective</content>
                     </content>
                     <br/>
                     <content styleCode="bold">CAUTION: </content>Federal law restricts this drug to use by or on the order of a licensed veterinarian.<br/>
                     <content styleCode="bold">NOT FOR USE IN HUMANS</content>
                     <br/>
                     <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content>
                     <br/>
                     <content styleCode="bold">Restricted Drug (California) - Use only as directed</content>
                     <br/>Approved by FDA under NADA # 038-661</paragraph>
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                  <paragraph>
                     <content styleCode="bold">INDICATIONS, DOSAGE AND ADMINISTRATION:</content>
                  </paragraph>
                  <paragraph>As an aid in the prevention or control of losses due to CRD associated with <content styleCode="italics">M. gallisepticum</content> (PPLO). Administer two (2) grams per gallon of water as the only source of drinking water for the first three days of life and for one day following each vaccination.</paragraph>
                  <paragraph>As an aid in controlling infectious synovitis due to <content styleCode="italics">Mycoplasma synoviae</content> in broiler chickens. Administer one (1) gram per gallon of water as the only source of drinking water for the first three to five days of life.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">DIRECTIONS FOR USE:</content>
                     <br/>To provide 2 g/gal: Dissolve contents in 250 gallons of water. For proportioners, dissolve contents of 1/2 package in 1 gallon of water. Meter at 1 oz/gal.</paragraph>
                  <paragraph>To provide 1 g/gal: Dissolve contents in 500 gallons of water. For proportioners, dissolve contents of 1/2 package in 2 gallons of water. Meter at 1 oz/gal.</paragraph>
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                     <content styleCode="bold">RESIDUE WARNING:</content> DO NOT administer this drug within 5 days of slaughter. DO NOT administer to laying chickens.</paragraph>
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                     <content styleCode="bold">PRECAUTION:</content>
                     <br/>Rarely, some individuals who handle spectinomycin develop serious reactions involving skin, nails and eyes. Individuals who have experienced rash or other evidence of allergic reaction should avoid further contact with spectinomycin.</paragraph>
                  <paragraph>The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Bimeda, Inc. at 1888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.</paragraph>
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                     <content styleCode="bold">Store at controlled room temperature 20°C - 25°C (68°F - 77°F), with excursions permitted 15°C - 30°C (59°F - 86°F).</content>
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