LINCOMYCIN HYDROCHLORIDE powder, for solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

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SPC SPC (SPC)
26-04-2023

active_ingredient:

LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)

MAH:

Huvepharma, Inc.

INN:

LINCOMYCIN HYDROCHLORIDE

composition:

LINCOMYCIN 0.4 g in 1 g

administration_route:

ORAL

prescription_type:

PRESCRIPTION

therapeutic_indication:

For Oral Use in Swine and Broiler Chickens Only Not for use in layer and breeder chickens Keep Out of Reach of Children INDICATIONS AND USAGE: Swine: Lincomycin Hydrochloride Soluble Powder is indicated for the treatment of swine dysentery (bloody scours). Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is indicated for the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin. For Oral Use in Swine and Broiler Chickens Only Not for use in layer or breeder chickens Keep Out of Reach of Children INDICATIONS AND USAGE: Swine: Lincomycin Hydrochloride Soluble Powder is indicated for the treatment of swine dysentery (bloody scours). Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is indicated for the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin. For Oral Use in Swine and Broiler Chickens Only Not for use in layer and breeder chickens Keep Out of Reach of Children INDICATIONS AND USAGE: Swine: Li

authorization_status:

Abbreviated New Animal Drug Application

SPC

                                LINCOMYCIN HYDROCHLORIDE- LINCOMYCIN HYDROCHLORIDE POWDER, FOR
SOLUTION
HUVEPHARMA, INC.
----------
LINCOMYCIN HYDROCHLORIDE
80 GRAM PACKET FRONT PANEL
LINCOMYCIN HYDROCHLORIDE SOLUBLE POWDER
ANTIBACTERIAL
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A
LICENSED VETERINARIAN.
This packet contains as an active ingredient:
Lincomycin HCl, equivalent to 32 g lincomycin
Store between 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted
between 15˚C - 40˚C (59˚F - 104˚F).
See back for instructions.
NET WEIGHT
80 GRAMS
(2.82 OZ)
FOR ORAL USE IN SWINE AND BROILER CHICKENS ONLY
NOT FOR USE IN LAYER AND BREEDER CHICKENS
KEEP OUT OF REACH OF CHILDREN
INDICATIONS AND USAGE:
SWINE: Lincomycin Hydrochloride Soluble Powder is indicated for the
treatment of swine
dysentery (bloody scours).
BROILER CHICKENS: Lincomycin Hydrochloride Soluble Powder is indicated
for the control
of necrotic enteritis caused
by _Clostridium perfringens_ susceptible to lincomycin.
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.
RESIDUE WARNINGS:
NO DRUG WITHDRAWAL PERIOD IS REQUIRED BEFORE SLAUGHTER OF SWINE
RECEIVING
LINCOMYCIN HYDROCHLORIDE
SOLUBLE POWDER AT THE APPROVED LEVEL OF 250 MG PER GALLON OF DRINKING
WATER,
NOR BEFORE SLAUGHTER
OF BIRDS RECEIVING LINCOMYCIN HYDROCHLORIDE SOLUBLE POWDER AT THE
APPROVED
LEVEL OF 64 MG PER
GALLON OF DRINKING WATER.
Restricted Drug (California) - Use only as directed.
Not for Human Use.
Approved by FDA under ANADA # 200-189
KCP-S00054
P08-3902BF (Rev. 03-2022)
HUVEPHARMA®
Manufactured for:
Huvepharma, Inc.
525 Westpark Drive, Suite 230
Peachtree City, GA 30269
SWINE: DIRECTIONS FOR USE
DOSAGE AND ADMINISTRATION
DOSAGE: Administer at a dose rate of 250 mg of lincomycin per gallon
of drinking water
                                
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