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Hygromix 8

Elanco Animal Health Co

Hygromix 8Hygromycin B


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

For Use in Chicken and Swine Feeds Only

An Anthelmintic

Type A Medicated Article

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.

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 12g/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.

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 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
1.00 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:

Chickens: Feed 8-12 g/ton in complete feed.

Swine: Feed 12 g/ton in complete feed. In Market Hogs: Use Hygromix 8 for 8 weeks during the growing period.

NOT FOR HUMAN USE

RESIDUE WARNING:

Chickens: Feeds containing Hygromix 8 must be withdrawn 3 days before slaughter.

Swine: Feeds containing Hygromix 8 must be withdrawn 15 days before slaughter.

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 material 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. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

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 Animal Health
A Division of Eli Lilly and Company
Indianapolis, IN 46285, 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 of Eli Lilly and Company.

BG5585DEAMB (V01 -11 -2011)

Principal Display Panel – Bag Label

Elanco ® AF2080

For Use in Chicken and Swine Feeds Only

Hygromix® 8
Hygromycin B

Net Weight: 25 kg
(55.12lb)

Hygromix 8

HYGROMYCIN B GRANULE

Product Information

Product Type Otc type a medicated article animal drug label Item Code (Source) NDC:0986-2080
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYGROMYCIN B HYGROMYCIN B 8 g

Inactive Ingredients

Ingredient Name Strength
SOYBEAN OIL
SOYBEAN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0986-2080-09 25 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA010918 2011-12-15


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