Polyflex (Canada)

Company: Boehringer Ingelheim Animal Health

Ampicillin for Injectable Suspension

Veterinary Use Only

Sterile

DIN 00849405

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 cattle are reached 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).

Contraindications

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

Cautions: 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).

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

Preservatives per vial:

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.

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.

Polyflex^® is a registered trademark of Boehringer Ingelheim Animal Health USA Inc.

Boehringer Ingelheim Animal Health Canada Inc., 5180 South Service Road, Burlington ON L7L 5H4

Rev 06/2021

471213-00

51736808

CPN: 1182227.0