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SPL UNCLASSIFIED SECTION
Hygromycin B
An Anthelmintic Type A Medicated Article
CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.
For Use in Chicken and Swine Feeds Only
For Further Manufacturing Only
Active Drug Ingredient: Hygromycin B - 8 g per pound.
Important: Must be mixed in feeds before use. Follow mixing directions carefully.
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Indications:
Chickens: As an aid in the control of infections of the following intestinal parasites: Large roundworms (Ascaris galli), cecal worms (Heterakis gallinae) and capillary worms (Capillaria obsignata).
Swine: As an aid in the control of infections of the following intestinal parasites: Large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum) and whipworms (Trichuris suis).
Indications Appropriate Concentration of Hygromycin B in Type C Medicated Feed Chickens: As an aid in the control of infections of the following intestinal parasites: Large roundworms (Ascaris galli), cecal worms (Heterakis gallinae) and capillary worms (Capillaria obsignata). 8 to 12 g/ton Swine: As an aid in the control of infections of the following intestinal parasites: Large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum) and whipworms (Trichuris suis). 12 g/ton Inactive Ingredient: Soybean meal.
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Mixing Directions:
Chickens: Thoroughly mix Hygromix 8 Type A Medicated Article with feed to provide a Type B medicated feed containing up to 132 grams hygromycin B per ton or to provide a complete Type C medicated feed containing 8 to 12 g hygromycin B per ton. When manufacturing Type C medicated feed by directly mixing Hygromix 8 with the finished feed, thoroughly mix Hygromix 8 with a small quantity of finished feed before incorporation into the bulk of the finished feed.
Pounds to Hygromix 8 to add per ton to make a Type B Medicated Feed Resulting Hygromycin B Concentration in Type B Medicated Feed (Grams/Ton) Resulting Hygromycin B Concentration in Type B Medicated Feed (Grams/Pound) 3.0 24 0.012 6.0 48 0.024 12.0 96 0.048 16.5 132 0.066 Pound of Hygromycin 8 to add per ton of Type C Medicated Feed Resulting Hygromycin B Concentration in Type C Medicated Feed 1.00 8 g/ton 1.25 10 g/ton 1.50 12 g/ton Swine: Thoroughly mix Hygromix 8 Type A Medicated Article with feed to provide a Type B medicated feed containing up to 132 grams hygromycin B per ton or to provide a complete Type C medicated feed containing 12 g hygromycin B per ton. When manufacturing Type C medicated feed by directly mixing Hygromix 8 with the finished feed, thoroughly mix Hygromix 8 with a small quantity of finished feed before incorporation into the bulk of the finished feed.
Pounds of Hygromix 8 to add per ton to make a Type B Medicated Feed Resulting Hygromycin B Concentration in Type B Medicated Feed (Grams/Ton) Resulting Hygromycin B Concentration in Type B Medicated Feed (Grams/Pound) 3.0 24 0.012 6.0 48 0.024 12.0 96 0.048 16.5 132 0.066 Pounds of Hygromix 8 to add per ton of Type C Medicated Feed Resulting Hygromycin B Concentration in Type C Medicated Feed 1.50 12 g/ton - Feeding Directions:
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RESIDUE WARNING:
USER SAFETY WARNINGS: When mixing and handling Hygromix 8 Type A Medicated Article, use protective clothing, impervious gloves and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. Do not breathe dust. Since it may cause severe and potentially permanent eye damage, do not get on skin or in eyes. Appropriate eye protection to avoid eye/dust contact is required. In case of eye contact, flush with water and obtain prompt medical aid. Avoid contact with skin surfaces. For skin exposure, wash with soap and water. In case of ingestion, induce vomiting. The safety data sheet contains more detailed occupational safety information. To report adverse effects, access medical information or obtain additional product information, call 1-800-428-4441.
CAUTION: In gilts to be used as breeding stock: Do not use Hygromix 8 because of hearing and vision impairment side effects. In sows: Consideration should be given to hearing and vision impairment side effects. If fed, use for no longer than 8 weeks during gestation and lactation. A reduced response to sound and vision has been noticed in some swine fed Hygromix 8. This impairment of hearing and vision is not an important problem in the market hog. It should, however, be carefully evaluated for breeding stock. Should sows be affected, they will become less responsive to the squeal of baby pigs, possibly resulting in crushed pigs. Store at or below 25°C (77°F). Excursions permitted to 40°C (104°F).
Not to be used after the date printed on the bag.
NADA # 10-918, Approved by FDA
Restricted Drug (California) – Use Only as Directed
Manufactured for:
Elanco US, Inc.
2500 Innovation Way,
Greenfield, IN 46140, USA
Product of China
To report adverse effects, access medical information or obtain additional product information, call 1-800-428-4441
Elanco, Hygromix and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
- Principal Display Panel - Hygromix 8 Bag Label
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INGREDIENTS AND APPEARANCE
HYGROMIX 8
hygromycin b granuleProduct Information Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:58198-2080 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYGROMYCIN B (UNII: 3XQ2233B0B) (HYGROMYCIN B - UNII:3XQ2233B0B) HYGROMYCIN B 8 g in 0.45 kg Inactive Ingredients Ingredient Name Strength SOYBEAN OIL (UNII: 241ATL177A) SOYBEAN (UNII: L7HT8F1ZOD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-2080-9 25 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA010918 12/15/2011 Labeler - Elanco US Inc. (966985624)