{"application":{"applicationId":1027,"applicationNumber":0,"applicationType":null,"applicationStatusCode":null,"publish":false,"noohDate":null,"mode":null,"pioneerApplicationNumber":0},"applicationSponsor":null,"applicationProprietary":null,"applicationIngredients":null,"applicationExclusivity":{"application":null,"exclusivityBean":[]},"applicationPatent":{"application":null,"patentBean":[]},"documents":{"eaFonsiBean":[],"foi":[{"foiId":629,"applicationId":1027,"approvalTypeId":1,"approvalType":"Original","approvalDate":"02/03/1999","summary":"For the treatment and control of gastrointestinal roundworms (\n<i>Ascaris suum</i>, adults and fourth-stage larvae; \n<i>Ascarops strongylina</i>, adults; \n<i>Hyostrongylus rubidus</i>, adults and fourth-stage larvae; \n<i>Oesophagostomum</i> spp., adults and fourth-stage larvae), kidneyworms (\n<i>Stephanurus dentatus</i>, adults and fourth-stage larvae), lungworms (\n<i>Metastrongylus</i> spp., adults), threadworms (\n<i>Strongyloides ransomi</i>, adults and somatic larvae and prevention of transmission of infective larvae to piglets, \n<i>via</i> the colostrum or milk, when fed during gestation), lice (\n<i>Haematopinus suis</i>), and mange mites (\n<i>Sarcoptes scabiei</i> var. \n<i>suis</i>).","fileName":"ucm117110.pdf","file":null,"fileContent":null,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null}],"blueBirdLabel":[{"blueBirdLabelId":363,"applicationId":1027,"labelTypeId":1,"labelType":"B","species_class":"Weaned, Growing, and Finishing Pigs","indications":"<p>Ivermectin: 14.5-364 g/ton<br/>Bacitracin methylene disalicylate: 1.0-25 g/lb</p><p>For the treatment and control of gastrointestinal roundworms (<em>Ascaris suum</em>, adults and fourth- stage larvae; <em>Ascarops strongylina</em>, adults; <em>Hyostrongylus rubidus</em>, adults and fourth-stage larvae; <em>Oesophagostomum</em> spp., adults and fourth-stage larvae), kidneyworks (<em>Stephanurus dentatus</em>, adults and fourth-stage larvae), lungworms (<em>Metastrongylus</em> spp., adults), threadworms (<em>Strongyloides ransomi</em>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<em>Haematopinus suis</em>) and mange mites (<em>Sarcoptes scabiei</em> var. <em>suis</em>). </p><p>For control of swine dysentery associated with <em>Treponema hyodysenteriae</em> on premises with a history of swine dysentery but where signs of disease have not yet occurred; or following an approved treatment of the disease condition. <font size=\"3\"></font></p><p></p>","fileName":"N141097 Swine Type B.pdf","file":null,"fileContent":null,"sortOrder":1,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null},{"blueBirdLabelId":397,"applicationId":1027,"labelTypeId":1,"labelType":"B","species_class":"Weaned, Growing and Finishing Pigs","indications":"<p> <font size=\"3\"></font>Ivermectin: 121 -728 g/ton <br/>Bacitracin methylene disalicylate: 1.0-6.0 g/lb </p><p>For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth- stage larvae; Ascarops <em>strongylina</em>, adults;<em> Hyostrongylus rubidus</em>, adult and fourth-stage larvae; <em>Oesophagostomum</em> spp., adult and fourth-stage larvae), kidneyworms (<em>Stephanurus dentatus</em>, adults and fourth-stage larvae), lungworms (<em>Metastrongylus</em> spp., adults), threadworms (<em>Strongyloides ransomi</em>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<em>Haematopinus suis</em>) and mange mites (<em>Sarcoptes scabiei </em>var. <em>suis</em>). </p><p>For increased rate of weight gain and improved feed efficiency in growing and finishing swine. <font size=\"3\"></font></p><p></p>","fileName":"N141097 Swine Type B.pdf","file":null,"fileContent":null,"sortOrder":2,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null},{"blueBirdLabelId":398,"applicationId":1027,"labelTypeId":1,"labelType":"B","species_class":"Weaned, Growing and Finishing Pigs","indications":"<p>Ivermectin: 364-910 g/ton<br/>Bacitracin methylene disalicylate: 1.0-2.5 g/lb</p><p>For the treatment and control of gastrointestinal roundworms (<em>Ascaris suum</em>, adults and fourth- stage larvae; <em>Ascarops strongylina</em>, adults;<em> Hyostrongylus rubidus</em>, adult and fourth-stage larvae; <em>Oesophagostomum</em> spp., adult and fourth-stage larvae), kidneyworms (<em>Stephanurus dentatus</em>, adults and fourth-stage larvae), lungworms (<em>Metastrongylus</em> spp., adults), threadworms (<em>Strongyloides ransomi</em>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<em>Haematopinus suis</em>) and mange mites (<em>Sarcoptes scabiei </em>var. <em>suis</em>). </p><p>For increased rate of weight gain and improved feed efficiency in growing and finishing swine. <font size=\"3\"></font></p>","fileName":"N141097 Swine Type B 364 910gton.pdf","file":null,"fileContent":null,"sortOrder":3,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null},{"blueBirdLabelId":394,"applicationId":1027,"labelTypeId":2,"labelType":"C","species_class":"Weaned, Growing, and Finishing Pigs","indications":"<p> <font size=\"3\"></font>Ivermectin: 1.8 g/ton<br/>Bacitracin methylene disalicylate: 10g/ton</p><p>For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth- stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adult and fourth-stage larvae; Oesophagostomum spp., adult and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (Haematopinus suis) and mange mites (Sarcoptes scabiei var. suis). </p><p></p><p>For increased rate of weight gain and improved feed efficiency in growing and finishing swine. <font size=\"3\"></font></p>","fileName":"N141097 Weaned Growing Finishing Pigs Type C.pdf","file":null,"fileContent":null,"sortOrder":4,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null},{"blueBirdLabelId":400,"applicationId":1027,"labelTypeId":2,"labelType":"C","species_class":"Weaned, Growing and Finishing Pigs","indications":"<p>Ivermectin:Â 1.8 g/ton <br/>Bacitracin methylene disalicylate:Â 30 g/ton</p><p>For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth- stage larvae; Ascarops <em>strongylina</em>, adults;<em> Hyostrongylus rubidus</em>, adult and fourth-stage larvae; <em>Oesophagostomum</em> spp., adult and fourth-stage larvae), kidneyworms (<em>Stephanurus dentatus</em>, adults and fourth-stage larvae), lungworms (<em>Metastrongylus</em> spp., adults), threadworms (<em>Strongyloides ransomi</em>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<em>Haematopinus suis</em>) and mange mites (<em>Sarcoptes scabiei </em>var. <em>suis</em>). </p><p>For increased rate of weight gain and improved feed efficiency in growing and finishing swine. <font size=\"3\"></font></p><p></p>","fileName":"N141097 weaned growing finishing Type C 18 gton.pdf","file":null,"fileContent":null,"sortOrder":5,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null},{"blueBirdLabelId":399,"applicationId":1027,"labelTypeId":1,"labelType":"B","species_class":"Pregnant Sows","indications":"<p>For the treatment and control of gastrointestinal roundworms (<em>Ascaris suum</em>, adults and fourth- stage larvae; <em>Ascarops strongylina</em>, adults; <em>Hyostrongylus rubidus</em>, adults and fourth-stage larvae; <em>Oesophagostomum</em> spp., adults and fourth-stage larvae), kidneyworms (<em>Stephanurus dentatus</em>, adults and fourth-stage larvae), lungworms (<em>Metastrongylus</em> spp., adults), threadworms (<em>Strongyloides ransomi</em>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<em>Haematopinus suis</em>) and mange mites (<em>Sarcoptes scabiei</em> var. <em>suis</em>). </p><p>For control of clostridial enteritis caused by <em>C. perfringens</em> in suckling piglets. <font size=\"3\"></font></p><p></p>","fileName":"N141097 Pregnant Sows Type B.pdf","file":null,"fileContent":null,"sortOrder":6,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null},{"blueBirdLabelId":1846,"applicationId":1027,"labelTypeId":2,"labelType":"C","species_class":"Pregnant Sows and Suckling Piglets","indications":"<p>For the treatment and control of gastrointestinal roundworms (<i>Ascaris suum</i>, adults and fourth- stage larvae; <i>Ascarops strongylina</i>, adults; <i>Hyostrongylus rubidus</i>, adult and fourth-stage larvae; <i>Oesophagostomum spp</i>., adult and fourth-stage larvae), kidneyworms (<i>Stephanurus dentatus</i>, adults and fourth-stage larvae), lungworms (<i>Metastrongylus spp</i>., adults), threadworms (<i>Strongyloides ransomi</i>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<i>Haematopinus suis</i>) and mange mites (<i>Sarcoptes scabiei var. suis</i>). </p><p>For control of clostridial enteritis caused by <i>C. perfringens </i>in suckling piglets.<br/></p>","fileName":"UCM258831.pdf","file":null,"fileContent":null,"sortOrder":7,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null},{"blueBirdLabelId":1854,"applicationId":1027,"labelTypeId":2,"labelType":"C","species_class":"Weaned, Growing, and Finishing Pigs","indications":"<p>For the treatment and control of gastrointestinal roundworms (<i>Ascaris suum</i>, adults and fourth- stage larvae; <i>Ascarops strongylina</i>, adults; <i>Hyostrongylus rubidus</i>, adult and fourth-stage larvae; <i>Oesophagostomum spp</i>., adult and fourth-stage larvae), kidneyworms (<i>Stephanurus dentatus</i>, adults and fourth-stage larvae), lungworms (<i>Metastrongylus spp</i>., adults), threadworms (<i>Strongyloides ransomi</i>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<i>Haematopinus suis</i>) and mange mites (<i>Sarcoptes scabiei var. suis</i>).</p><p>For control of swine dysentery associated with <i>Treponema hyodysenteriae </i>on premises with a history of swine dysentery but where signs of disease have not yet occurred; or following an approved treatment of the disease condition.<br/></p>","fileName":"UCM258830.pdf","file":null,"fileContent":null,"sortOrder":8,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null}],"labeling":[],"eaFonsi":[]},"proprietaryPreviewBean":[{"proprietaryNameId":1319,"applicationId":null,"statusDescription":"OTC","doseFormName":"Medicated Feed","proprietaryName":"BMD® / Ivomec® Premix for Swine","specifications":"Type A medicated article, contains 0.6% ivermectin\r\nType A medicated with 30, 50, 60 and 75 grams of bacitracin activity per pound","sortOrder":0,"routes":["Oral"],"withdrawals":["Swine: 5 days before slaughter."],"species":{"Swine:469":"Sows with litters or about to farrow","Swine:457":"Breeding","Swine:459":"Finishing","Swine:462":"Growing","Swine:456":"Adults"},"ailHeader":[{"ailHeader":"Weaned, Growing and Finishing Pigs","ails":[{"dosageAmount":"Ivermectin: 1.8 g/ton\r\nBacitracin methylene disalicylate: 30 g/ton","indication":"For increased rate of weight gain and improved feed efficiency in growing finishing swine.","limitation":"<p>Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.</p>"},{"dosageAmount":"Ivermectin: 1.8 g/ton\r\nBacitracin methylene disalicylate: 10 g/ton","indication":"For increased rate of weight gain and improved feed efficiency in growing and finishing swine.","limitation":"<p>Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.</p>"},{"dosageAmount":"Ivermectin:  1.8 g/ton\r\nBacitracin methylene disalicylate: 250 g/ton","indication":"<p>For control of swine dysentery associated with <i>Treponema hyodysenteriae</i> on premises with a history of swine dysentery but where signs of disease have not yet occurred; or following an approved treatment of the disease condition.</p>","limitation":"<p>Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.</p>"},{"dosageAmount":"Ivermectin:  1.8 g/ton\r\nBacitracin methylene disalicylate: 250 g/ton","indication":"<p>For the treatment and control of gastrointestinal roundworms (<i>Ascaris suum</i>, adults and fourth-stage larvae; <i>Ascarops strongylina</i>, adults; <i>Hyostrongylus rubidus</i>, adult and fourth-stage larvae; <i>Oesophagostomum</i> spp., adult and fourth-stage larvae), kidneyworms (<i>Stephanurus dentatus</i>, adults and fourth-stage larvae), lungworms (<i>Metastrongylus</i> spp., adults), threadworms (<i>Strongyloides ransomi</i>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<i>Haematopinus suis</i>) and mange mites (<i>Sarcoptes scabiei</i> var. <i>suis</i>).</p>","limitation":"<p>Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. 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Do not contaminate water by direct application or by the improper disposal of drug containers.</p>"},{"dosageAmount":"Ivermectin: 1.8 g/ton\r\nBacitracin methylene disalicylate: 10 g/ton","indication":"<p>For the treatment and control of gastrointestinal roundworms (<i>Ascaris suum</i>, adults and fourth-stage larvae; <i>Ascarops strongylina</i>, adults; <i>Hyostrongylus rubidus</i>, adult and fourth-stage larvae; <i>Oesophagostomum</i> spp., adult and fourth-stage larvae), kidneyworms (<i>Stephanurus dentatus</i>, adults and fourth-stage larvae), lungworms (<i>Metastrongylus</i> spp., adults), threadworms (<i>Strongyloides ransomi</i>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<i>Haematopinus suis</i>) and mange mites (<i>Sarcoptes scabiei</i> var. <i>suis</i>).</p>","limitation":"<p>Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. 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Do not contaminate water by direct application or by the improper disposal of drug containers.</p>"},{"dosageAmount":"Ivermectin: 1.8 g/ton\r\nBacitracin methylene disalicylate: 30 g/ton","indication":"<p>For the treatment and control of gastrointestinal roundworms (<i>Ascaris suum</i>, adults and fourth-stage larvae; <i>Ascarops strongylina</i>, adults; <i>Hyostrongylus rubidus</i>, adult and fourth-stage larvae; <i>Oesophagostomum</i> spp., adult and fourth-stage larvae), kidneyworms (<i>Stephanurus dentatus</i>, adults and fourth-stage larvae), lungworms (<i>Metastrongylus</i> spp., adults), threadworms (<i>Strongyloides ransomi</i>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<i>Haematopinus suis</i>) and mange mites (<i>Sarcoptes scabiei</i> var. <i>suis</i>).</p>","limitation":"<p>Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.</p>"}]},{"ailHeader":"Pregnant Sows","ails":[{"dosageAmount":"Ivermectin: 1.8 g/ton\r\nBacitracin methylene disalicylate: 250 g/ton","indication":"For control of clostridial enteritis caused by <i>C. perfringens</i> in suckling piglets.","limitation":"<p>Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.</p>"},{"dosageAmount":"Ivermectin: 1.8 g/ton\r\nBacitracin methylene disalicylate: 250 g/ton","indication":"<p>For the treatment and control of gastrointestinal roundworms (<i>Ascaris suum</i>, adults and fourth-stage larvae; <i>Ascarops strongylina</i>, adults; <i>Hyostrongylus rubidus</i>, adult and fourth-stage larvae; <i>Oesophagostomum</i> spp., adult and fourth-stage larvae), kidneyworms (<i>Stephanurus dentatus</i>, adults and fourth-stage larvae), lungworms (<i>Metastrongylus</i> spp., adults), threadworms (<i>Strongyloides ransomi</i>, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (<i>Haematopinus suis</i>) and mange mites (<i>Sarcoptes scabiei</i> var. <i>suis</i>).</p>","limitation":"<p>Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.</p>"}]}]}],"ingredientsPreviewBean":[{"activeIngredientName":"Ivermectin","activeIngredientTolerance":"<p>A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in liver (target tissue) as follows: a. In cattle 1.6 parts per million. b. In swine 20 parts per billion. c. In sheep 30 parts per billion. d. In reindeer 15 parts per billion. e. In American bison 15 parts per billion. Muscle residues are not indicative of the safety of other edible tissues. A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in muscle as follows: a. Swine 20 parts per billion b. Cattle 0.65 parts per million</p>"},{"activeIngredientName":"Bacitracin methylenedisalicylate","activeIngredientTolerance":null}],"sponsorPreviewBean":{"sponsorName":"Boehringer lngelheim Animal Health USA, Inc.","address1":"4000 Medley Blvd.","address2":"Suite 300","city":"Johns Creek","state":"Georgia","postalCode":"30097","stateCode":"GA","countryName":"United States"}}