Fort Dodge

AMPICILLIN FOR INJECTABLE SUSPENSION, VETERINARY

For Aqueous Injection

NADA 55-030, Approved by FDA

CAUTION

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

DESCRIPTION

POLYFLEX (ampicillin for injectable suspension, veterinary) is a broad-spectrum penicillin which has bactericidal activity against a wide range of common gram-positive and gram-negative bacteria.

ACTION

The antimicrobial action of ampicillin is bactericidal, and only a small percentage of the antibiotic is serum-bound. Peak serum levels in dogs and cats are reached approximately one-half hour following subcutaneous or intramuscular injection, and in cattle 1 hour to 2 hours following intramuscular injection.

In vitro studies have demonstrated sensitivity of the following organisms to ampicillin: gram-positive bacteria - alpha- and beta-hemolytic streptococci, staphylococci (non-penicillinase-producing), Bacillus anthracis and most strains of enterococci and clostridia; gram-negative bacteria - Proteus mirabilis, E. coli and many strains of Salmonella and Pasteurella multocida.

The drug does not resist destruction by penicillinase and, hence, is not effective against strains of staphylococci resistant to penicillin G. Susceptibility tests should be conducted to estimate the in vitro susceptibility of bacterial isolates to ampicillin.

INDICATIONS

POLYFLEX has proved effective in the treatment of many infections previously beyond the spectrum of penicillin therapy. This drug is particularly indicated in the treatment of the following infections caused by susceptible strains of organisms:

Dogs and Cats - Respiratory Tract Infections: Upper respiratory infections, tonsillitis and bronchopneumonia due to hemolytic streptococci, Staphylococcus aureus, Escherichia coli, Proteus mirabilis, and Pasteurella spp.

Urinary Tract Infections due to Proteus mirabilis, Escherichia coli, Staphylococcus spp., hemolytic streptococci and Enterococcus spp.

Gastrointestinal Infections due to Enterococcus spp., Staphylococcus spp. and Escherichia coli.

Skin, Soft-Tissue and Post-Surgical Infections: Abscesses, pustular dermatitis, cellulitis and infections of the anal gland, due to Escherichia coli, Proteus mirabilis, hemolytic streptococci, Staphylococcus spp. and Pasteurella spp.

Cattle and Calves Including Non-Ruminating (Veal Calves) - Respiratory Tract Infections: Bacterial pneumonia (shipping fever, calf pneumonia, and bovine pneumonia) caused by Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus spp., Pasteurella multocida and E. coli susceptible to ampicillin trihydrate.

CONTRAINDICATIONS

A history of allergic reactions to penicillin, cephalosporins or their analogues should be considered a contraindication for the use of this agent.

PRECAUTIONS

Because it is a derivative of 6-aminopenicillanic acid, POLYFLEX has the potential for producing allergic reactions. If they should occur, POLYFLEX should be discontinued and the subject treated with the usual agents (antihistamines, pressor amines, corticosteroids).

WARNING

Do not treat for more than 7 days.

Milk from treated cows must not be used for food during treatment, or for 48 hours (4 milkings) after the last treatment.

Treated animals must not be slaughtered for food during treatment, or for 144 hours (6 days) after the last treatment.

DOSAGE

The dosage of POLYFLEX will vary according to the animal being treated, the severity of the infection and the animal's response.

Dogs and Cats - The recommended dose for dogs or cats is 3 mg/lb of body weight administered twice daily by subcutaneous or intramuscular injection.

Cattle and Calves Including Non-Ruminating (Veal Calves) - From 2 mg to 5 mg/lb of body weight once daily by intramuscular injection. Do not treat for more than 7 days.

In all species, 3 days treatment is usually adequate, but treatment should be continued for 48 to 72 hours after the animal has become afebrile or asymptomatic.

DIRECTIONS FOR USE

The multiple-dose dry-filled vials should be reconstituted to the desired concentration by adding the required amount of Sterile Water for Injection, USP, according to label directions.

After reconstitution this product is stable for 3 months under refrigeration will be white to pale yellow in color.

At the time of reconstitution the vial should be dated and the concentration noted on the label.

SUPPLY

POLYFLEX (ampicillin for injectable suspension, veterinary)

For Aqueous Injection - vial containing 10 grams ampicillin activity as ampicillin trihydrate.

POLYFLEX (ampicillin for injectable suspension, veterinary)

For Aqueous Injection - vial containing 25 grams ampicillin activity as ampicillin trihydrate.

NDC 0856-2717-52 - 10 g - vial

NDC 0856-2717-53 - 25 g - vial

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Manufactured for Fort Dodge Animal Health, Fort Dodge, Iowa 50501 USA

by G.C. Hanford Manufacturing Co., Syracuse, NY 13201

00424

Rev. February 2004

4470I

NAC No.: 10031472