Pen-Aqueous

Company: Aspen

(penicillin G procaine Injectable Suspension)

FOR CATTLE, SWINE, SHEEP & HORSES

Aqueous Suspension

Antibiotic

300,000 Units per mL

NOT FOR USE IN HUMANS • KEEP OUT OF REACH OF CHILDREN

For Intramuscular Injection Only

Description

Pen-Aqueous^® Alternative Method is available in 100 mL, 250 mL and 500 mL multiple-dose vials. Each mL contains: Active Ingredients: Penicillin G potassium 300,000 units*, Procaine hydrochloride 130.8 mg*. Inactive Ingredients: Methylparaben 1.3 mg, Propylparaben 0.2 mg, Sodium citrate 10 mg, Sodium carboxymethylcellulose 1 mg, Povidone 5 mg, Lecithin 6 mg, Sodium formaldehyde sulfoxylate 0.2 mg, Procaine hydrochloride 20 mg, and Water for Injection, q.s.

*PENICILLIN G POTASSIUM AND PROCAINE HYDROCHLORIDE REACT TO FORM PENICILLIN G PROCAINE.

ACTIONS: Penicillin G is an effective bactericide in the treatment of infections caused primarily by penicillin-sensitive organisms, such as Streptococcus equi and Erysipelothrix rhusiopathiae, as well as the gram negative organism Pasteurella multocida.

Pen-Aqueous Indications

Pen-Aqueous^® is indicated for the treatment of:

1. Cattle and sheep - bacterial pneumonia (shipping fever) caused by Pasteurella multocida.

2. Swine - erysipelas caused by Erysipelothrix rhusiopathiae.

3. Horses - strangles caused by Streptococcus equi.

Directions For Use

The suspension should be administered by deep intramuscular injection within the fleshy muscles of the hip, rump, round or thigh, or into the neck, changing the site for each injection. Do not inject subcutaneously, into a blood vessel, or near a major nerve.

Use a 16 or 18 gauge needle, 1.5 inches long. The needle and syringe should be washed thoroughly before use. The needle and syringe should then be sterilized by placing in boiling water for 15 to 20 minutes. Use this product within 28 days of the first puncture and puncture a maximum of 15 times. Consider using automatic injection equipment or a repeater syringe if necessary to avoid exceeding 15 punctures. When using a draw-off spike or needle with bore diameter larger than 16 gauge, discard any product remaining in the vial immediately after use.

The injection site should be washed with soap and water and painted with a germicide such as tincture of iodine or 70% alcohol. The product should then be administered by using the following procedure:

1. Warm the vial to room temperature and shake thoroughly to ensure uniform suspension.

2. Wipe the rubber stopper on top of the vial with a piece of absorbent cotton soaked in 70% alcohol.

3. Inject air into the vial for easier withdrawal.

4. After filling the syringe, make sure the needle is empty by pulling back the plunger of the syringe until a small air bubble appears. Then detach the needle from the syringe.

5. Insert the needle deep into the muscle, attach the syringe and withdraw the plunger slightly. If blood appears, withdraw the needle and insert it into a different location.

6. Inject the dose slowly. Do not massage the site of injection.

7. Not more than 10 mL should be injected into one location.

Daily treatment should be continued for at least 48 hours after temperature has returned to normal and all other signs of infection have subsided. Animals treated with Pen-Aqueous^® should show noticeable improvement within 36 to 48 hours.

DOSAGE: The dosage for cattle, sheep, swine, and horses is 3000 units per pound of body weight, or 1.0 mL for each 100 pounds of body weight, once daily. Treatment should not exceed 7 days in non-lactating dairy and beef cattle, sheep, and swine, or 5 days in lactating dairy cattle. If no improvement is observed within 48 hours, consult your veterinarian.

RESIDUE WARNINGS:

1. Not for use in horses intended for food.

2. Milk that has been taken from animals during treatment and for 48 hours after the last treatment must not be used for food. The daily treatment schedule should not exceed 7 days of treatment in non-lactating dairy and beef cattle, sheep and swine, or 5 days in lactating dairy cattle.

3. The drug should be discontinued for the following time periods before treated animals are slaughtered for food: Cattle - 4 days, Sheep - 8 days, Swine - 6 days, non-ruminating calves - 7 days.

Precautions

Sensitivity reactions to penicillin and procaine, such as hives or respiratory distress, may occur in some animals. If such signs of sensitivity occur, stop medication and call your veterinarian. In some instances, particularly if respiratory distress is severe, immediate injection of epinephrine or antihistamine may be necessary.

As with any antibiotic preparation, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If this condition is suspected, stop medication and consult your veterinarian.

Exceeding the highest recommended daily dosage of 3000 units per pound of body weight, administering at recommended levels for more than 7 consecutive days and/or exceeding 10 mL intramuscularly per injection site may result in antibiotic residues beyond the withdrawal time.

How Supplied

Pen-Aqueous^® is supplied in 100 mL, 250 mL and 500 mL multiple-dose vials.

STORE BETWEEN 2°C - 8°C (36°F - 46°F). PROTECT FROM FREEZING. WARM TO ROOM TEMPERATURE AND SHAKE WELL BEFORE USING.

RESTRICTED DRUG (CALIFORNIA) - USE ONLY AS DIRECTED.

DISPOSE OF CONTAINERS IN AN APPROVED LANDFILL OR BY INCINERATION.

Pen-Aqueous^® is a registered trademark of Aspen Veterinary Resources^®, Ltd.

Manufactured for: Aspen Veterinary Resources^®, Ltd., Liberty, MO 64068, USA

www.aspenveterinaryresources.com

NADA 065-505, Approved by FDA

CPN: 1475272.2