GENTAMED- gentamicin sulfate powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

gentamicin sulfate (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)

Available from:

Bimeda, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: GentaMed™ Soluble Powder is recommended for the control and treatment of colibacillosis in weanling swine caused by strains of E. coli sensitive to gentamicin and for the control and treatment of swine dysentery associated with Brachyspira hyodysenteriae . CONTRAINDICATIONS: There are no known contraindications to this drug when used as directed. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

Product summary:

HOW SUPPLIED: GentaMed™ Soluble Powder is available in a 360 gram jar with 12 jars per shipper.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

GENTAMED- GENTAMICIN SULFATE POWDER
BIMEDA, INC.
----------
DESCRIPTION: Each gram of GentaMed™ Soluble Powder contains
gentamicin sulfate
equivalent to 333.33 mg gentamicin base.
RESIDUE WARNING: For use in swine drinking water only. Swine treated
with the
recommended dose of GentaMed™ Soluble Powder must not be slaughtered
for food
for at least ten (10) days following the last treatment.
INDICATIONS: GentaMed™ Soluble Powder is recommended for the control
and
treatment of colibacillosis in weanling swine caused by strains of _E.
coli_ sensitive to
gentamicin and for the control and treatment of swine dysentery
associated
with _Brachyspira hyodysenteriae_.
DOSAGE AND ADMINISTRATION:
GentaMed Soluble Powder is available in a 360 gram jar. The 360 gram
jar contains a
scoop that provides approximately 18 grams of product when level full.
For _Control and treatment of Colibacillo_sis-Administer GentaMed
Soluble Powder in
drinking water at the recommended level of 25 mg per gallon (1
scoop/240 gallons) for
three consecutive days.
For _Control and treatment of Swine Dysentery_-Administer GentaMed
Soluble Powder in
drinking water at the recommended level of 50 mg per gallon (1
scoop/120 gallons) for
three consecutive days.
The concentration of the medication should be adjusted in extremely
hot or cold weather
to ensure a gentamicin dosage of approximately 0.5 mg/lb/day for 3
days for
colibacillosis or 1.0 mg/lb/day for 3 days for swine dysentery. A
50-lb pig will, under
average conditions, consume 0.9 gallons of water per day.
For swine dysentery, if the condition recurs, the medication may be
repeated. Because
of the tendency for the disease to recur on a premise with a history
of swine dysentery,
a control program should be used following treatment.
DIRECTIONS FOR USE:
To prepare medicated water, mix GentaMed Soluble Powder and drinking
water
according to the following tables:
PROPORTIONER USE:
_For Control and Treatment of Colibacillosis_
Add 18 g (1 scoop) GentaMed Soluble Powder to 2 gallons of water to
make