LINCOMIX 50- lincomycin hydrochloride granule

Lincomix 50 by

Drug Labeling and Warnings

Lincomix 50 by is a Animal medication manufactured, distributed, or labeled by Phibro Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LINCOMIX® 50

(lincomycin Type A medicated article)

50 grams/lb

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 further manufacturing only. 

 

 

INDICATIONS FOR USE

INDICATIONS FOR USE
For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. Not for use in laying hens, breeder chickens, or turkeys.

For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine.

For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae in swine.

Each pound contains:

Active Drug Ingredient

Lincomycin.................................50 grams

(as lincomycin hydrochloride agricultural grade)

Inactive Ingredients

Soybean hulls, #20 grind; light liquid paraffin, Ph.Eur.

STORAGE, HANDLING AND DISPOSAL

Store opened bag in dry place to prevent caking. Store at room temperature.

Approved by FDA under NADA # 097-505

LOT:

EXP:

MFG:

 

NET WEIGHT 50 lb (22.7 kg)

BROILERS

BROILER CHICKENS

INDICATIONS FOR USE

For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. Not for use in laying hens, breeding chickens, or turkeys.

MIXING DIRECTIONS (Type C medicated feeds)
Thoroughly mix LINCOMIX 50 Type A medicated article with non-medicated broiler chicken feed to obtain 2 g/ton lincomycin in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete Type C medicated feed. Thoroughly mix 0.04 lb (18 grams) of the Type A medicated article in a convenient quantity of feed ingredients, then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.

FEEDING DIRECTIONS
Feed a Type C medicated feed containing 2 g/ton lincomycin as the sole ration to broiler chickens.

SWINE

SWINE
INDICATIONS FOR USE
For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine. For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae in swine.

MIXING DIRECTIONS (Type B medicated feeds)
Thoroughly mix LINCOMIX 50 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 (201 to 40,000 grams lincomycin per ton).

The following table gives examples of how some Type B medicated feed concentrations can be prepared:

• Pounds of LINCOMIX 50 Type A Medicated Article to Add per Ton to Make a Type B Medicated Feed:

  Resulting Lincomycin Concentration in

  Type B Medicated Feed (grams/ton)

• 4.02: 201
• 20: 1,000
• 100: 5,000
• 200: 10,000
• 400: 20,000
• 800: 40,000

MIXING DIRECTIONS (Type C medicated feeds)
Thoroughly mix LINCOMIX 50 Type A medicated article with non-medicated swine feed according to the table below to obtain the proper concentration of lincomycin in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete Type C medicated feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients, then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.

The following table gives examples of how some Type C medicated feed concentrations can be prepared:

• Pounds of LINCOMIX 50 Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed:

  Resulting Lincomycin Concentration in

  Type C Medicated Feed (grams/ton)

• 0.8: 40
• 2: 100
• 3: 150
• 4: 200

FEEDING DIRECTIONS
For the treatment of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine.

Feed a Type C medicated feed containing 100 g/ton lincomycin as the sole ration to swine for 3 weeks or until signs of disease (watery, mucoid, or bloody stools) disappear.

For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine.

Feed a Type C medicated feed containing 100 g/ton lincomycin as the sole ration to swine for 3 weeks or until signs of disease (water, mucoid, or bloody stools) disappear, followed by a Type C medicated feed containing 40 g/ton lincomycin as the sole ration.

For the control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine.

For use in swine or on premises with a history of swine dysentery but where symptoms have not yet occurred. Feed a Type C medicated feed containing 40 g/ton lincomycin as the sole ration to swine.

For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae in swine.

Feed a Type C medicated feed containing 100 to 200 g/ton lincomycin as the sole ration to swine for 21 days.

WITHDRAWAL PERIODS

No withdrawal period is required when used according to labeling.

USER SAFETY WARNING

Not for use in humans. Keep out of reach of children.

ANIMAL SAFETY WARNINGS

Occasionally, swine fed lincomycin may within the first two days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within five to eight days without discontinuing the lincomycin treatment. The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.

Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.

SPL UNCLASSIFIED SECTION

ADDITIONAL RECOMMENDATIONS
Good Manufacturing Practices should be observed in preparing feeds containing LINCOMIX 50. This includes appropriate clean-out procedures to avoid cross-contamination.

Restricted Drug (California)—Use Only as Directed
Phibro, Phibro logo and Lincomix are trademarks owned by or licensed to Phibro Animal Health Corporation or its affiliates.

Questions/Comments? For technical assistance or to obtain a Safety Data Sheet(s), contact Phibro Animal Health Corporation
at 888-403-0074 or http://www.pahc.com. To report side effects, contact Phibro Animal Health Corporation at 1-888-475-7355.
For additional information about reporting side effects, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Distributed by:
Phibro Animal Health Corporation 871-9015-04
Teaneck, NJ 07666

871-9015-04

Made in China

Take time statement

PRINCIPAL DISPLAY PANEL

Lincomix 50 Label

INGREDIENTS AND APPEARANCE

LINCOMIX 50 
lincomycin hydrochloride granule

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 66104-1494
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)	LINCOMYCIN	50 g  in 0.453 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66104-1494-2	22.7 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA097505	06/30/1976

Labeler - Phibro Animal Health (006989008)