Penject+B

Company: Henry Schein^® Animal Health

PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE INJECTABLE SUSPENSION

AQUEOUS SUSPENSION ANTIBIOTIC

300,000 UNITS PER mL

STERILE, MULTIPLE-DOSE VIAL

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

FOR SUBCUTANEOUS USE ONLY - FOR USE IN BEEF CATTLE ONLY

Description

Penicillin G Benzathine and Penicillin G Procaine Injectable Suspension is available as an aqueous suspension in 100-mL and 250-mL multiple-dose vials. Each mL contains: 150,000 units penicillin G benzathine, 150,000 units penicillin G procaine, 11.7 mg lecithin, 1.75 mg sodium formaldehyde sulfoxylate, 1.20 mg methylparaben, 0.14 mg propylparaben, 8.19 mg Tween 40, 11.3 mg Span 40, 3.98 mg sodium citrate (anhydrous), 20 mg procaine hydrochloride, 1.04 mg sodium carboxymethylcellulose, Water for Injection, q.s.

ACTION: Penicillin G is an antibiotic which shows a marked bactericidal effect against certain organisms during their growth phase. It is relatively specific in its action against gram-positive bacteria but is usually ineffective against gram-negative organisms.

It is normally recommended that any bacterial infection be treated as early as possible and with a dosage that will give effective blood levels. Although the recommended dosage will give longer detectable penicillin blood levels than penicillin G procaine alone, it is recommended that a second dose be administered at 48 hours when treating a penicillin-susceptible bacterial infection.

The use of antibiotics in the management of disease is based on an accurate diagnosis and an adequate course of treatment. When properly used in the treatment of diseases caused by penicillin-susceptible organisms, most animals treated with this product will show a noticeable improvement within 24 to 48 hours. If improvement does not occur within this time period, the diagnosis and course of treatment should be re-evaluated. It is recommended that the diagnosis and treatment of animal diseases be carried out by a veterinarian. Since many diseases look alike but require different types of treatment, the use of professional veterinary and laboratory services can reduce treatment time, costs, and needless losses. Good housing, sanitation and nutrition are important in the maintenance of healthy animals and are essential in the treatment of disease.

Warning

Beef cattle should be withheld from slaughter for food use for thirty (30) days following the last treatment. Treatment in beef cattle must be limited to two (2) doses, by subcutaneous injection only. Do not inject intramuscularly.

Penject+B Indications

This product is indicated for the treatment of the following bacterial infections in beef cattle due to penicillin-susceptible microorganisms that are susceptible to the serum levels common to this particular dosage form, such as:

1. Bacterial Pneumonia (shipping fever complex) (Streptococcus spp., Corynebacterium pyogenes, Staphylococcus aureus).

2. Upper Respiratory Infections such as rhinitis or pharyngitis (Corynebacterium pyogenes).

3. Blackleg (Clostridium chauvoei).

Precautions

Exceeding the recommended doses and dosage levels may result in antibiotic residues beyond the withdrawal time. Do not inject this product intramuscularly.

Penicillin G is a substance of low toxicity. However, side effects, or so-called allergic or anaphylactic reactions - sometimes fatal, have been known to occur in animals hypersensitive to penicillin and procaine. Such reactions can occur unpredictably with varying intensity. Animals administered penicillin G should be kept under close observation for at least one-half hour. Should allergic or anaphylactic reactions occur, discontinue use of the product and immediately administer epinephrine following manufacturer’s recommendations and call a veterinarian.

As with all antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. A lack of response by the treated animal, or the development of new signs or symptoms suggests that an overgrowth of non-susceptible organisms has occurred. In such instances, consult your veterinarian.

Since bacterial drugs may interfere with the bacteriostatic action of tetracyclines, it is advisable to avoid giving penicillin in conjunction with tetracyclines.

The product should be stored between 2°-8°C (36°-46°F). Avoid freezing. Warm to room temperature, and shake well before using.

ADMINISTRATION: The recommended dosage for beef cattle should be administered by subcutaneous injection only. Failure to use the subcutaneous route of administration may result in antibiotic residues in meat beyond the withdrawal time.

Dosage:

Beef cattle: 2mL per 150 lb body weight given subcutaneously only (2000 units penicillin G procaine and 2000 units penicillin G benzathine per lb body weight). Treatment should be repeated in 48 hours.

IMPORTANT: Treatment in beef cattle should be limited to two (2) doses given by subcutaneous injection only.

Directions For Use

A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized by boiling in water for 15 minutes).

Before withdrawing the solution from the bottle, disinfect the rubber cap on the bottle with a suitable disinfectant, such as 70 percent alcohol. The injection site should be similarly cleaned with the disinfectant. Needles of 14 to 16 gauge, and not more than 1 inch long, are adequate for injections.

A subcutaneous injection should be made by pinching up a fold of the skin between the thumb and forefinger. The mid-neck region is the preferred injection site. Insert the needle under the fold in a direction approximately parallel to the surface of the body. When the needle is inserted in this manner, the medication will be delivered underneath the skin between the skin and the muscles. Proper restraint, such as the use of a chute and nose lead is needed for proper administration of the product.

STORE BETWEEN 2°-8°C (36°-46°F). AVOID FREEZING.

SHAKE WELL BEFORE USING. FOR ANIMAL USE ONLY.

RESTRICTED DRUG (UNDER CALIFORNIA LAW); USE ONLY AS DIRECTED.

Manufactured by: Bimeda, Inc., Irwindale, CA 91706

Manufactured for HENRY SCHEIN ANIMAL HEALTH, Dublin, Ohio 43017

NADA 65-506, Approved by FDA

8BEN301-203

CPN: 10820035