Polyflex (Canada)

Company: Boehringer

Ampicillin for Injectable Suspension

Sterile

Veterinary Use Only

DIN 00849405

Active ingredient per vial: 25 g Ampicillin (as Ampicillin trihydrate)

Preservatives per vial:

Description

Polyflex (ampicillin for injectable suspension) 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 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 and many strains of Salmonella, Escherichia coli and Pasteurella multocida. The drug does not resist destruction by penicillinase and, hence, is not effective against strains of staphylococcus resistant to penicillin G.

Polyflex Indications

Polyflex has been proven effective in the treatment of many infections previously beyond the spectrum of penicillin therapy.

This drug is particularly indicated in the treatment of susceptible strains of organisms causing the following infections:

Cattle: Bacterial pneumonia, shipping fever complex and enteritis caused by Staphylococcus sp and Escherichia coli susceptible to ampicillin.

Swine: Metritis-mastitis agalactiae syndrome in sows, (MMA).

Dogs and cats: Upper respiratory tract infections due to hemolytic streptococci, Staphylococcus aureus, Escherichia coli, Proteus mirabilis and Pasteurella sp. Urinary tract infections due to Proteus mirabilis, Escherichia coli, Staphylococcus sp, hemolytic streptococci and Enterococcus sp. Skin, soft-tissue and post-surgical infections including wound infections and abscesses due to Escherichia coli, Proteus mirabilis, hemolytic streptococci, Staphylococcus sp and Pasteurella sp.

Polyflex is also indicated for surgical prophylaxis.

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 (ampicillin for injectable suspension) 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).

Dosage: The dosage of Polyflex will vary according to the animal being treated, the severity of the infection and the animal’s response.

Cattle and swine: For cattle and swine, the dosage is 6 mg/kg of body weight once daily by intramuscular injection.

Dogs and cats: The recommended dose for dogs and cats is 6.5 mg/kg of body weight administered twice daily by subcutaneous or intramuscular injection.

Treatment should be continued for 48 to 72 hours after the animal has become afebrile or asymptomatic.

Warnings

Do not treat cattle or swine for more than 7 days. Milk taken from treated animals during treatment and within 48 hours after the latest treatment must not be used as food. Treated animals must not be slaughtered for use in food for at least 6 days (CATTLE) and 4 days (SWINE) after the latest treatment with this drug. Keep out of reach of children.

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 the following schedules:

SHAKE WELL TO RESUSPEND.

After reconstitution this product is stable for 3 months under refrigeration. At the time of reconstitution the vial should be dated and the concentration noted on the label. This product, whether in the dry powder or reconstituted form, should not be used after the original expiration date.

Storage

Store at or below 25°C with excursions permitted up to 30°C. After reconstitution, store under refrigeration up to 3 months.

Boehringer Ingelheim (Canada) Ltd., 5180 South Service Road, Burlington, Ontario L7L 5H4

Rev. 10/2016

CPN: 1230089.2