Label: GENTAMED- gentamicin sulfate powder

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 Colibacillosis-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 stock solution and dispense at the rate of one ounce per gallon of drinking water. This will result in drinking water that contains 25 mg/gallon.

For Control and Treatment of Swine Dysentery

Add 18 g (1 scoop) GentaMed Soluble Powder to 1 gallon of water to make stock solution and dispense at the rate of one ounce per gallon of drinking water. This will result in drinking water that contains 50 mg/gallon.

Bulk Preparation:

For Control and Treatment of Colibacillosis

Add 18 g (1 scoop) GentaMed Soluble Powder to 240 gallons of water.

For Control and Treatment of Swine Dysentery

Add 18 g (1 scoop) GentaMed Soluble powder to 120 gallons of water.

Medicated drinking water should not be stored or offered in rusty containers since the drug is quickly destroyed in such containers.

Medicated water should be prepared daily and be the sole source of drinking water for 3 consecutive days.

The daily water consumption figures shown below are approximations for mild temperatures and are presented as a guide only. Actual water consumption varies with environmental temperature, humidity, and diet.

Approximate Daily Water Consumption

SIDE EFFECTS: There have been no reported side effects following the recommended use of GentaMed™ Soluble Powder in swine.

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.

PRECAUTIONS: 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).

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

GentaMed™ Soluble Powder

(Gentamicin Sulfate)

Contains 120 grams of Gentamicin per jar

Antibacterial

FOR ANIMAL USE ONLY - KEEP OUT OF REACH OF CHILDREN

Restricted Drug (California)-Use Only as Directed

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

Approved by FDA under ANADA # 200-494

Net weight: 360 g (12.7 oz)