Dosage Form: FOR ANIMAL USE ONLY
Bimeda, Inc. Division of Cross Vetpharm Group Pro-Pen-G Injection (Penicillin G Procaine) NADA 056-505, Approved by FDA
Description
Penicillin G Procaine Injectable Suspension is available in 100-mL, 250-mL and 500-mL multiple-dose vials. Each mL contains: penicillin g potassium 300,000 units*, procaine hydrochloride 130.8 mg*, 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 insidiosa, as well as the gram negative organism Pasteurella multocida.
Indications
Penicillin G Procaine is indicated for the treatment of:
1. Cattle and sheep - bacterial pneumonia (shipping fever) caused by Pasteurella multicoda.
2. Swine - erysipelas caused by Erysipelothrix insidiosa.
3. Horses - strangles caused by Streptococcus equi.
Restricted Drug (California) - Use Only as Directed.
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.
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 syringe.
5. Insert the needle deep into the muscle, attach the syringe and 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 Penicillin G Procaine Injectable Suspension should show noticeable improvement within 36 to 48 hours.
Dosage and Administration
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 or veterinarian.
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.
Storage and Handling
Penicillin G Procaine Injectable Suspension should be stored in a cold room temperature between (2 degrees and 8 degrees C) (36 degrees - 46 degrees F). Avoid freezing the product.
How Supplied
Penicillin G Procaine Injectable Suspension is supplied in 100-mL, 250-mL and 500-mL multiple-dose vials.
Warning
WARM TO ROOM TEMPERATURE AND SHAKE WELL BEFORE USING.
Not for use in horses intended for food. Milk taken from animals during treatment and for 48 hours after the last treatment must not be used for food. Treatment should not exceed seven days in non-lactating dairy cattle and beef cattle, sheep and swine, or five days in lactating dairy cattle.
Discontinue use of this drug 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.
General Statements
TAKE TIME OBSERVE LABEL DIRECTIONS
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California) Use Only as Directed
See insert for directions and dosage.
Package Label Principle Display Panel
(Penicillin G Procaine Injectable Suspension)
Aqueous Suspension
Antibiotic
300,000 units per mL
For Intramuscular Use Only
Sterile, Multiple Dose Vial
Restricted Drug (California) - Use Only as Directed
NADA 065-505, Approved by FDA
Net Contents: 250 mL
Penicillin G Potassium 300,000 units*, Procaine hydrochloride 130.8 mg*, Sodium citrate 10 mg, Povidone 5 mg, Lecithin 6 mg, Sodium carboxymethylcellulose 1 mg, Methylparaben 1.3 mg, Propylparaben 0.2 mg, Sodium formaldehyde sulfoxylate 0.2 mg, Procaine hydrochloride 20 mg, and Water for Injection, q.s.
*PENICILLING G POTASSIUM AND PROCAINE HYDROCHLORIDE REACT TO FORM PENICILLIN G PROCAINE.
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA065505 | 08/09/2006 | |
| Labeler - Bimeda, Inc. Division of Cross Vetpharm Group (043653216) |
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