Tuesday, September 13, 2016

Penject





Dosage Form: FOR ANIMAL USE ONLY
Drug Facts

Description


Procaine penicillin G is a potent antibacterial agent which is effective against a variety of pathogenic organisms, chiefly in the Gram-positive category. Penicillin-G Procaine is a free-flowing product prepared by combining penicillin G and procaine, molecule for molecule, with dispersing agents.



Warning


Milk taken from animals during treatment and for 48 hours (4 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.


Discontinue use of this drug for the following time periods before treatment animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.



Dosage Levels


The recommended daily dosage of penicillin is 3, 000 units per pound of body weight (one mL per 100lb body weight). Continue daily treatment until recovery is apparent and for at least 1 day after Symptoms disappear, usually in 2 or 3 days. Treatment should not exceed 4 consecutive days.



Directions for Use


Penicillin-G Procaine should be administered by the intramuscular route. 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 16 to 18 gauge and 1 to 1½ inches long are adequate for intramuscular injection.


INTRAMUSCULAR INJECTION: In livestock, intramuscular injection should be made by directing the needle of suitable gauge and length into the fleshy part of a thick muscle such as the 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. No more than 10mL should be injected at any one site in adult livestock; rotate injection sites for each succeeding treatment.


Care of sick animals: 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 Penicillin-G Procaine show a noticeable improvement within 24 to 48 hours. I 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, cost, and needless losses. Good housing, sanitation, and nutrition are important in the maintenance of healthy animals and are essential in the treatment of disease.



Contains


Each mL contains 300,000 units of procaine penicillin G and approximately: 0.08% sodium citrate, 0.15% sodium carboxymethylcellulose; 25% sorbitol solution U.S.P; 0.06% povidone; 0.6%lecithin; 0.1% methylparaben; 0.01% propylparaben; 0.25% phenol.


Store between 2°-8°C (36°-46°F)


Restricted Drug (California)-


Use Only As Directed


Not For Human Use


Refer to label insert for complete directions SHAKE WELL BEFORE USING.


Manufactured By Teva Animal Health, Inc. Fort Dodge, IA 50501



NADA 65-110


Penject


Penicillin-G Procaine


In Aqueous Suspension


For Use In Cattle, Sheep, Swine and Horses


READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT


FOR INTRAMUSCULAR USE ONLY



Indications


Penject is recommended for treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida in cattle and sheep, erysipelas caused by Erysipelothrix insidiosa in swine, and strangles caused by streptococcus equi in horses.



Precautions


Exceeding the highest recommended daily dosage of 3,000 units per pound of body weight, administering at recommended levels for more than 4 consecutive days, and/or exceeding 10mL intramuscularly per injection site may result in antibiotic residues beyond the withdrawal time.


Penicillin-G Procaine should be injected deep within the fleshy muscles of the hip, rump, round, or thigh. Do not inject this material subcutaneously (under the skin), into a blood vessel, or near a major nerve.


Procaine 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 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 immediately administer epinephrine following manufacturer’s recommendations; 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 suggest that an overgrowth of non-susceptible organisms has occurred. In such instances, consult your veterinarian. Since bactericidal drugs may interfere with the bacteriostatic action of tetracyclines, it is advisable to avoid giving penicillin in conjunction with tetracyclines. Penicillin-G should be stored between 2-8°C (36-46°F). Warm to room temperature and shake before using.



Directions For Use


Penject should be administered by the intramuscular route. A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized by boiling in later 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.


SHAKE WELL BEFORE USING


FOR ANIMAL USE ONLY


RESTRICTED DRUG (CALIFORNIA)


USE ONLY AS DIRECTED


NOT FOR HUMAN USE



Storage


Penject should be stored between 2°-8°C (36°-46°F) warm to room temperature and shake before using.


Trademark of Butler Animal Health Supply, LLC.


Manufactured By Teva Animal Health, Inc. Fort Dodge, IA 50501


7600021



Package Information


Penicillin-G is available in vials of 100mL and 250mL with each mL containing 300,000 units of procaine penicillin G.


FOR ANIMAL USE ONLY


RESTRICTED DRUG (California)


USE ONLY AS DIRECTED.


NOT FOR HUMAN USE.



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Principle Display Panel










Penject 
penicillin g procaine  injection, suspension










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)11695-3600
Route of AdministrationINTRAMUSCULARDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PENICILLIN G PROCAINE (PENICILLIN G)PENICILLIN G PROCAINE300000 ug  in 1 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
111695-3600-1100 mL In 1 BOTTLE, GLASSNone
211695-3600-2250 mL In 1 BOTTLE, GLASSNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA6511008/17/200607/31/2009


Labeler - Butler Animal Health Supply (017880659)

Registrant - Teva Animal Health, Inc. (625254461)
Revised: 02/2010Butler Animal Health Supply



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