Label: SKYCIS- narasin granule
- NDC Code(s): 58198-1542-1
- Packager: Elanco US Inc.
- Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated April 4, 2023
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Indication:
Indications
Appropriate Concentration of Narasin in
Type C Medicated FeedFor increased rate of weight gain
in growing-finishing swine
when fed for at least 4 weeks13.6 to 27.2 g/ton (15 ppm to 30 ppm)
For increased rate of weight gain and improved
feed efficiency in growing-finishing swine
when fed for at least 4 weeks18.1 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 Add
per Ton To Make a Type B
Medicated FeedResulting 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 Add
Per Ton of Type C Medicated FeedResulting Narasin Concentration
in Type C Medicated Feed0.3 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.
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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, USARestricted Drug (California) – Use Only as Directed
Approved by FDA under NADA # 141-340
Net Weight: 25 kg
(55.12 lb)TAKE TIME
OBSERVE LABEL
DIRECTIONSSkycis, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2022 Elanco or its affiliates
Microtracer® is a trademark of Micro-Tracers, Inc., USA used under license.
BG103780X
- Principal Display Panel - 25 kg Bag Label
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INGREDIENTS AND APPEARANCE
SKYCIS
narasin granuleProduct 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 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)
