SPECLINX 50- lincomycin spectinomycin powder

SpecLinx 50 by

Drug Labeling and Warnings

SpecLinx 50 by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

SpecLinx-50®

(lincomycin-spectinomycin soluble powder)

FOR USE IN CHICKENS ONLY                                         Antibacterial and

                                                                                        Antimycoplasmal

Water Soluble Powder

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

This packet contains:

Lincomycin hydrochloride

Equivalent to lincomycin..............................................16.7 grams

Spectinomycin dihydrochloride pentahydrate

Equivalent to spectinomycin.........................................33.3 grams

                                         Total Antibiotic Activity......50.0 grams

WARNING:  FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Restricted Drug (California) - Use Only as Directed

ANADA 200-380, Approved by FDA

Net Weight: 2.65 oz (75 g)

INDICATIONS & USAGE

                                                                    DIRECTIONS FOR USE

INDICATIONS AND USAGE: For use in chickens up to 7 days of age as an aid in the control of:
Airsacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin. 
Complicated Chronic Respiratory Disease (Air Sac Infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin. 

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION:

DOSAGE: Provide 2 grams (g) antibiotic activity per gallon of drinking water. Administer as the sole source of water for the first 5 to 7 days of life.

ADMINISTRATION:

• Amount of SpecLinx-50®: Amount of Drinking Water
• 1 packet:

  25 gallons

For proportioners delivering 1 ounce of solution per gallon of drinking water, dissolve contents of 5 packets in each gallon of proportioner solution.

IMPORTANT: Chickens should consume water at the following approximate rate to insure intake of the required dose of lincomycin-spectinomycin indicated:

Broilers and Layer Replacements (Light and Heavy)

Age (Weeks)	Daily Water Intake Gallons/1000	Dosage Mg Antibiotic/Lb
1	5	50 - 65

PRECAUTIONS

PRECAUTION: Discard medicated drinking water daily and replace with fresh medicated drinking water.

STORAGE AND HANDLING

Store at controlled room temperature 20°C - 25°C (68°F - 77°F), with excursions permitted to 15°C - 30°C (59°F - 86°F).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPECLINX 50 
lincomycin spectinomycin powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 61133-5802
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SPECTINOMYCIN HYDROCHLORIDE (UNII: HWT06H303Z) (SPECTINOMYCIN - UNII:93AKI1U6QF)	SPECTINOMYCIN	33.3 g  in 75 g
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)	LINCOMYCIN	16.7 g  in 75 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-5802-1	75 g in 1 POUCH
2	NDC: 61133-5802-2	375 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200380	06/07/2005

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda, Inc.		060492923	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Qilu King-phar Pharmaceutical Co., Ltd.,		421524323	api manufacture