Skycis by Elanco US Inc. SKYCIS- narasin granule

Skycis by

Drug Labeling and Warnings

Skycis by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Elanco

AF1542

Skycis™ 100

Narasin

For Use in Swine Feeds only

Type A Medicated Article

Do Not Feed Undiluted

Important: Must be thoroughly mixed into feeds before use. Follow label directions.

Indication:

• Indications: Appropriate Concentration of Narasin in; Type C Medicated Feed
• For increased rate of weight gainin growing-finishing swinewhen fed for at least 4 weeks: 13.6 to 27.2 g/ton (15 ppm to 30 ppm)
• For increased rate of weight gain and improvedfeed efficiency in growing-finishing swinewhen fed for at least 4 weeks: 18.1 to 27.2 g/ton (20 ppm to 30 ppm)

No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 15 ppm (13.6 g/ton).

Active Ingredients: Narasin – 100 g per kg

Inactive Ingredients: Roughage products.

Feeding Directions: Feed continuously for at least four weeks to swine during the growing-finishing period as the sole ration. Effectiveness has not been demonstrated when fed for durations less than four weeks.

Mixing Directions: Thoroughly mix Skycis 100 Type A Medicated Article with non-medicated swine feed according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 5,400 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

• Pounds of Skycis 100 To Addper Ton To Make a Type BMedicated Feed: Resulting Narasin Concentration; in Type B Medicated Feed; [grams/ton (grams/pound)]
• 55.12: 2,500 (1.25)
• 110.23: 5,000 (2.50)

Thoroughly mix Skycis 100 Type A Medicated Article with a complete swine feed according to the table below to obtain the proper concentration in the Type C Medicated Feed. Prepare an intermediate pre-blend of the premix prior to mixing in a complete feed. Thoroughly mix the required amount in a convenient quantity of feed ingredients, then add to the remaining feed ingredients to make complete feed.

• Pounds of Skycis 100 to AddPer Ton of Type C Medicated Feed: Resulting Narasin Concentration; in Type C Medicated Feed
• 0.3 lb: 13.6 g/ton (15 ppm)
• 0.4 lb: 18.1 g/ton (20 ppm)
• 0.6 lb: 27.2 g/ton (30 ppm)

Caution: Do not allow adult turkeys, horses or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals.

Swine being fed with Skycis (narasin) should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.

NOT FOR HUMAN USE.

Warnings:

Withdrawal Period

No withdrawal period is required when used according to the label

When mixing and handling Skycis, use protective clothing, impervious
gloves and a dust mask. Operators should wash thoroughly with soap
and water after handling. If accidental eye contact occurs, immediately
rinse thoroughly with water.

Store at or below 25°C (77°F). Excursions permitted to 37°C (99°F).

Not to be used after the date printed on the bag.

To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

Skycis 100

Manufactured For: Elanco US Inc.
Greenfield, IN 46140, USA

Restricted Drug (California) – Use Only as Directed

Approved by FDA under NADA # 141-340

Net Weight: 25 kg
(55.12 lb)

TAKE TIME

OBSERVE LABEL
DIRECTIONS

Skycis, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

BG102244X

Principal Display Panel - 25 kg Bag Label

Elanco

AF1542

Skycis™ 100

Narasin

For Use in Swine Feeds only

Type A Medicated Article

Do Not Feed Undiluted

INGREDIENTS AND APPEARANCE

SKYCIS 
narasin granule

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 58198-1542
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
narasin (UNII: DZY9VU539P) (narasin - UNII:DZY9VU539P)	narasin	100 g  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
RICE BRAN (UNII: R60QEP13IC)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-1542-1	25 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141340	10/16/2012

Labeler - Elanco US Inc. (966985624)