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Oxytocin injection contains 20 USP Units of Oxytocin and less than 0.4 units of presser activity per mL. Each mL of sterile solution also contains 0.9% w/v sodium chloride, 0.5% w/v chlorobutanol (as a preservative), with water for injection q.s. and pH adjusted to 3.0 to 5.0 with acetic acid.</paragraph> <paragraph> <content> <content styleCode="bold"/> </content> </paragraph> <paragraph> <content styleCode="bold">ACTIONS:</content> Oxytocin acts directly on the smooth musculature of the uterus in all species to induce rhythmic contractions, although in some species the uterine cervix does not respond to oxytocin. The responsiveness of the uterine musculature to oxytocin varies greatly with the stage of the reproductive cycle. During the early phases of pregnancy the uterus is relatively insensitive to the effects of oxytocin, while in the late phases the sensitivity is markedly increased. Most authorities attribute this varying response to the varying levels of estrogen and progesterone during the course of pregnancy. Oxytocin also has been shown to exert a milk ejecting effect, occasionally referred to as the galactogogic effect. The actual mechanism by which oxytocin stimulates the release of milk from the mammary glands is not know with certainty, but oxytocin is presumed to act on certain smooth muscle elements in the gland.</paragraph> <paragraph> <content> <content styleCode="bold"/> </content> </paragraph> </text> <effectiveTime value="20230622"/> </section> </component> <component> <section ID="L1ca732d6-6e07-4246-a853-b4d31c9ec1bf"> <id root="536f27d8-7103-4ea9-893a-832f9c0fc5e3"/> <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> <text> <paragraph> <content styleCode="bold">INDICATIONS: </content>Because of the specific action of oxytocin upon the uterine musculature, it is recommended as an aid in the management of the following conditions:</paragraph> <paragraph> <content>1. To precipitate labor.</content> <content>2. To accelerate normal parturition.</content> <content>3. Postpartum evacuation of uterine debris.</content> <content>4. Postoperative contraction of the uterus following a cesarean section and control of uterine hemorrhage.</content> </paragraph> <paragraph>Oxytocin will contract the smooth muscle cells of the mammary gland to induce milk let-down if the udder is in a proper physiological state.</paragraph> <paragraph/> </text> <effectiveTime value="20230622"/> </section> </component> <component> <section ID="L78dfb122-63aa-4bce-a920-a55d35ac8876"> <id root="7c93f05d-d200-4869-83d5-5b7ae9e43adb"/> <code code="34070-3" codeSystem="2.16.840.1.113883.6.1" displayName="CONTRAINDICATIONS SECTION"/> <text> <paragraph> <content> <content styleCode="bold">CONTRAINDICATION: </content> </content>Do not use in dystocia due to abnormal presentation of the fetus until correction is accomplished.</paragraph> </text> <effectiveTime value="20230622"/> </section> </component> <component> <section ID="L82467f17-2050-4fb3-8876-472edb7f56a3"> <id root="3bbedbae-555f-4a06-858e-2a148a7d9296"/> <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/> <text> <paragraph> <content> <content styleCode="bold">PRECAUTIONS: </content> </content>Oxytocin is a potent preparation, accordingly, it should be administered with due caution. For prepartum usage full dilation of the cervix should be accomplished either naturally or through the administration of estrogen prior to oxytocin therapy.</paragraph> </text> <effectiveTime value="20230622"/> </section> </component> <component> <section ID="Lcf732987-c48c-4ade-becc-0972ce5db304"> <id root="f6dc046d-c857-47eb-b3ca-34aa416f088a"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <text> <paragraph> <content styleCode="bold">DOSAGE AND ADMINISTRATION: </content> </paragraph> <paragraph>Obstetrical Use: Inject aseptically by the intravenous, intramuscular or subcutaneous route as follows:</paragraph> <paragraph>Ewes, Sows:</paragraph> <paragraph>1.5 to 2.5mL......................30 to 50 USP Units</paragraph> <paragraph>Cows, Horses:</paragraph> <paragraph>5.0mL...............................100 USP Units</paragraph> <paragraph>These dosages are recommended, and may be repeated as indicated.</paragraph> <paragraph/> <paragraph> <content styleCode="bold">Milk Let-down:</content> </paragraph> <paragraph>Inject aseptically by the intravenous, intramuscular or subcutaneous route</paragraph> <paragraph>Cows:</paragraph> <paragraph>0.5 to 1.0mL.....................10 to 20 USP Units</paragraph> <paragraph>Sows:</paragraph> <paragraph>0.25 to 1.0mL....................5 to 20 USP Units</paragraph> <paragraph/> <paragraph>These dosages are recommended and may be repeated as necessary.</paragraph> <paragraph>Note: Oxytocin will not induce milk let-down unless the udder is in proper physiological state.</paragraph> </text> <effectiveTime value="20230622"/> </section> </component> <component> <section ID="L12734588-1107-499c-8a9b-dbf0dc87bc30"> <id root="ab8db9fc-0b6a-40ba-b4f0-a9cf2ea4c76f"/> <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/> <text> <paragraph>To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. 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="20230622"/> </section> </component> <component> <section ID="L58aad7d6-382a-48de-b4b3-73a588f3ea64"> <id root="f576ad41-1ab4-4c93-aeb4-c77526f659ee"/> <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/> <text> <paragraph> <content styleCode="bold">HOW SUPPLIED: </content> <content>100mL multiple dose vials.</content> </paragraph> <paragraph> <content>Approved by FDA under ANADA # 200-328</content> </paragraph> </text> <effectiveTime value="20230622"/> </section> </component> <component> <section ID="L9059c68e-543d-4082-8f27-91bb7192796a"> <id root="f1cc1d13-e934-4797-be70-90309dd0d1c0"/> <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. </content> <content styleCode="bold">Protect from freezing.</content> </paragraph> </text> <effectiveTime value="20230622"/> </section> </component> <component> <section ID="L6c0f1a41-839c-4897-9931-a222d19b286c"> <id root="c2c39f04-2ef0-4c9d-a838-69d0a78f7102"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <text> <renderMultiMedia referencedObject="L8decf307-cd09-4b4e-89d9-a75856af66a5"/> </text> <effectiveTime value="20231213"/> <component> <observationMedia ID="L8decf307-cd09-4b4e-89d9-a75856af66a5"> <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">Oxytocin</content>
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                     <content>
                        <content styleCode="bold">(purified oxytocic principle)<br/>INJECTION FOR HORSES, COWS, SOWS, & EWES</content>
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                  <paragraph>20 USP Units per mL</paragraph>
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                     <content styleCode="bold">HAZARDOUS</content>
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                     <content styleCode="bold">CAUTION:</content> Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>
                     <content>
                        <content styleCode="bold"/>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">DESCRIPTION:</content> Oxytocin injection is a sterile aqueous solution of highly purified oxytocic principle derived by synthesis or obtained from the posterior lobe of the pituitary gland of healthy domestic animals used for food by humans. Oxytocin injection contains 20 USP Units of Oxytocin and less than 0.4 units of presser activity per mL. Each mL of sterile solution also contains 0.9% w/v sodium chloride, 0.5% w/v chlorobutanol (as a preservative), with water for injection q.s. and pH adjusted to 3.0 to 5.0 with acetic acid.</paragraph>
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                     <content styleCode="bold">ACTIONS:</content> Oxytocin acts directly on the smooth musculature of the uterus in all species to induce rhythmic contractions, although in some species the uterine cervix does not respond to oxytocin. The responsiveness of the uterine musculature to oxytocin varies greatly with the stage of the reproductive cycle. During the early phases of pregnancy the uterus is relatively insensitive to the effects of oxytocin, while in the late phases the sensitivity is markedly increased. Most authorities attribute this varying response to the varying levels of estrogen and progesterone during the course of pregnancy. Oxytocin also has been shown to exert a milk ejecting effect, occasionally referred to as the galactogogic effect. The actual mechanism by which oxytocin stimulates the release of milk from the mammary glands is not know with certainty, but oxytocin is presumed to act on certain smooth muscle elements in the gland.</paragraph>
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                     <content styleCode="bold">INDICATIONS: </content>Because of the specific action of oxytocin upon the uterine musculature, it is recommended as an aid in the management of the following conditions:</paragraph>
                  <paragraph>
                     <content>1. To precipitate labor.</content>
                     <content>2. To accelerate normal parturition.</content>
                     <content>3. Postpartum evacuation of uterine debris.</content>
                     <content>4. Postoperative contraction of the uterus following a cesarean section and control of uterine hemorrhage.</content>
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                  <paragraph>Oxytocin will contract the smooth muscle cells of the mammary gland to induce milk let-down if the udder is in a proper physiological state.</paragraph>
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                        <content styleCode="bold">PRECAUTIONS: </content>
                     </content>Oxytocin is a potent preparation, accordingly, it should be administered with due caution. For prepartum usage full dilation of the cervix should be accomplished either naturally or through the administration of estrogen prior to oxytocin therapy.</paragraph>
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                     <content styleCode="bold">DOSAGE AND ADMINISTRATION:                                                                                                                                                   </content>
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                  <paragraph>Obstetrical Use: Inject aseptically by the intravenous, intramuscular or subcutaneous route as follows:</paragraph>
                  <paragraph>Ewes, Sows:</paragraph>
                  <paragraph>1.5 to 2.5mL......................30 to 50 USP Units</paragraph>
                  <paragraph>Cows, Horses:</paragraph>
                  <paragraph>5.0mL...............................100 USP Units</paragraph>
                  <paragraph>These dosages are recommended, and may be repeated as indicated.</paragraph>
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                  <paragraph>Inject aseptically by the intravenous, intramuscular or subcutaneous route</paragraph>
                  <paragraph>Cows:</paragraph>
                  <paragraph>0.5 to 1.0mL.....................10 to 20 USP Units</paragraph>
                  <paragraph>Sows:</paragraph>
                  <paragraph>0.25 to 1.0mL....................5 to 20 USP Units</paragraph>
                  <paragraph/>
                  <paragraph>These dosages are recommended and may be repeated as necessary.</paragraph>
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                  <paragraph>To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. 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>100mL multiple dose vials.</content>
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                     <content>Approved by FDA under ANADA # 200-328</content>
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