LINCOMYCIN-SPECTINOMYCIN WATER SOLUBLE POWDER- lincomycin-spectinomycin powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F), SPECTINOMYCIN HYDROCHLORIDE (UNII: HWT06H303Z) (SPECTINOMYCIN - UNII:93AKI1U6QF)

Available from:

Huvepharma, Inc

Administration route:

Oral

Prescription type:

PRESCRIPTION

Therapeutic indications:

                                                            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. WARNING:    Not for Human Use                      Keep Out of Reach of Children To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

LINCOMYCIN-SPECTINOMYCIN WATER SOLUBLE POWDER- LINCOMYCIN-
SPECTINOMYCIN POWDER, FOR SOLUTION
HUVEPHARMA, INC
----------
LINCOMYCIN-SPECTINOMYCIN
WATER SOLUBLE POWDER
Antibacterial and Antimycoplasmal
CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DRUG TO
USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN.
FOR USE IN CHICKENS ONLY
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
Approved by FDA under ANADA # 200-407
NET WEIGHT: 2.65 OZ (75 GRAMS)
Registered Trademark of Huvepharma, Inc 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 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 Lincomycin-Spectinomycin
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
ensure 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
PRECAUTION: Discard medicated drinking water daily and replace with
fresh medicated
drinking water.
WARNING: Not for Human Use
Keep Out of Reach of Children
TO REPORT SUSPECTED ADVERSE DRUG EVENTS, FOR TECHNICAL ASSISTANCE OR
TO
OBTAIN A
COPY OF THE SAFETY DATA SHEET (SDS), CONTAC