PenOne Pro (penicillin G procaine injectable suspension)

(penicillin G procaine injectable suspension)

Injection

Approved by FDA under NADA # 065-010

For use in Cattle, Sheep, Swine and Horses.

300,000 UNITS PER mL

ANTIBIOTIC

FOR INTRAMUSCULAR INJECTION ONLY

PenOne Pro (penicillin G procaine injectable suspension) Caution

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

READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT

Description

PenOne Pro™ is a suspension of penicillin G procaine in 100, 250 and 500 mL multiple dose vials. Each mL is designed to provide 300,000 units of penicillin G as procaine in a stable suspension. Penicillin G procaine is an antibacterial agent which has activity against a variety of pathogenic organisms, mainly in the Gram-positive category.

Each mL contains 300,000 units Penicillin G Potassium*, 139.0 mg Procaine Hydrochloride*, 2.0% Procaine Hydrochloride, 3.0 mg Potassium Phosphate Monobasic, 6.0 mg Potassium Phosphate Dibasic, 0.4% Sodium Formaldehyde Sulfoxylate, 0.4 mg Polysorbate 80, 2.0 mg Lecithin, 0.1% Methyl Paraben, 0.01% Propyl Paraben, 0.15% Sodium Carboxymethylcellulose, q.s. Water for Injection.

* Penicillin G Potassium and Procaine Hydrochloride react to form penicillin G procaine.

PenOne Pro (penicillin G procaine injectable suspension) Indications

PenOne Pro™ is indicated for treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida in cattle and sheep, erysipelas caused by Erysipelothrix rhusiopathiae in swine, and strangles caused by Streptococcus equi in horses.

Directions For Use

A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized in boiling water for 15 minutes). Before withdrawing the solution from the bottle, disinfect the rubber cap top with 70% alcohol. The injection site should be similarly disinfected with alcohol. Needles of 16 to 18 gauge and 1 to 1.5 inches long are adequate for intramuscular injections.

In livestock intramuscular injections should be made by directing the needle of suitable gauge and length into the fleshy part of a thick muscle, such as rump, hip, or thigh region; avoid blood vessels and major nerves. Before injecting the solution, pull back gently on the plunger. If blood appears in the syringe, a blood vessel has been entered; withdraw the needle and select a different site.

Dosage:

PenOne Pro™ is administered by the intramuscular route. The product is ready for injection after warming the vial to room temperature and shaking to ensure a uniform suspension.

The daily dose of penicillin is 3,000 units per pound of body weight (1 mL per 100 lbs body weight). Continue daily treatment until recovery is apparent and for at least one day after symptoms disappear, usually in two to three days.

Treatment should not exceed four consecutive days.

No more than 10 mL should be injected at any one site. Rotate injection sites for each succeeding treatment.

Care of Sick Animals:

The use of antibiotics in the management of diseases 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 PenOne Pro™ show a noticeable improvement within 24 to 48 hours. If improvement does not occur within this period of time, 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.

Residue Warnings: Exceeding the daily dosage of 3,000 units per pound of body weight, administering for more than four consecutive days, or exceeding the maximum injection site volume per injection site may result in antibiotic residues beyond the withdrawal time. Milk taken from treated dairy animals within 48 hours after the last treatment must not be used for food. Discontinue use of this drug for the following time period before treated animals are slaughtered for food: Cattle - 14 days, Sheep - 9 days, Swine - 7 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Warning Do not use in horses intended for human consumption. Not for use in humans. Keep out of reach of children.

Precautions

Intramuscular injection in cattle, sheep, and swine may result in a local tissue reaction which persists beyond the withdrawal period of 14 days (cattle), 9 days (sheep), or 7 days (swine). This may result in trim loss of edible tissue at slaughter.

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 procaine should be kept under close observation for at least one half hour. Should allergic or anaphylactic reactions occur, discontinue use of the product and call a veterinarian. If respiratory distress is severe, immediate injection of epinephrine or antihistamine following manufacturer’s recommendations may be necessary.

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

It is advisable to avoid giving penicillin in conjunction with bacteriostatic drugs such as tetracyclines.

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Norbrook at 1-866-591-5777. 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.

Storage Conditions:

PenOne Pro™ should be stored between 2 to 8°C (36 to 46°F).

Restricted Drug - California. Use Only as Directed.

SHAKE WELL BEFORE USING.

Made in the UK.

Norbrook Laboratories Limited, Newry, Northern Ireland

Distributed by:

MWI, Boise, ID 83705

www.vetone.net

CPN: 1315016.4