AQUACILLIN
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penicillin g procaine injection, suspension
Vedco, Inc.
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Drug FactsDescription General Information
Procaine penicillin G is a potent antibacterial agent which is effective against a variety of pathogenic organisms, chiefly in the Gram-positive category. AQUACILLIN is a free-flowing product prepared by combining penicillin G and procaine, molecule for molecule, with dispersing agents.
Residue Warnings
RESIDUE WARNINGS: (FDA Requested Revision) 100mL & 250mL-Label
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 treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.
RESIDUE WARNINGS:(FDA Requested Revision) 100mL & 250mL-Onsert
Milk that has been 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 treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.
WARNING: (Old revision) 500mL-Label
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 veal calves.
Discontinue use of this drug for the following time periods before treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.
WARNING: (Old revision) 500mL-Onsert
Milk that has been 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 veal calves.
Discontinue use of this drug for the following time periods before treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.
AQUACILLIN is a registered trademark of VEDCO, Inc.
LOT
EXP DATE
760001
Directions for Use
AQUACILLIN 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 AQUACILLIN 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, 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 of AQUACILLIN contains 300,000 units of procaine penicillin G and approximately: 0.08% sodium citrate; 0.15% sodium carboxymethylcellulose; 25% sorbitol solution; 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)
Refer to package insert for complete directions.
SHAKE WELL BEFORE USING.
Manufactured for VEDCO, Inc.
Manufactured By Teva Animal Health, Inc. Fort Dodge, IA 50501
Front Panel Label
AQUACILLIN
Penicillin-G Procaine In Aqueous Suspension
Injectable Antibiotic
For the treatment of disease in cattle, swine, sheep and horses.
For Intramuscular Use Only.
NOT FOR HUMAN USE
USE ONLY AS DIRECTED
NADA 65-110, Approved by FDA
Indications
INDICATIONS: (FDA Requested Revision) 100mL & 250mL-label
AQUACILLIN is recommended 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.
INDICATIONS: (Old reversion) 500mL-label
AQUACILLIN 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.
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.
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.
AQUACILLIN 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 AQUACILLIN 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
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 16 to 18 gauge and not more than 1 to 1½ 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.
SHAKE WELL BEFORE USING
FOR ANIMAL USE ONLY
RESTRICTED DRUG (CALIFORNIA)
USE ONLY AS DIRECTED
NOT FOR HUMAN USE
Storage
Store between 2°-8°C (36°-46°F)
Restricted Drug (California)-Use Only As Directed
Refer to label insert for complete directions.
SHAKE WELL BEFORE USING.
760001-
Rev
Manufactured By Teva Animal Health, Inc. Fort Dodge, IA 50501
Package Information
AQUACILLIN available in vials of 100mL, 250mL and 500mL with each mL containing 300,000 units of procaine penicillin G. The 500mL vial is intended for use with automatic syringes
FOR ANIMAL USE ONLY
RESTRICTED DRUG (California)
USE ONLY AS DIRECTED.
NOT FOR HUMAN USE.
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| AQUACILLIN
penicillin g procaine injection, suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA65110 | 07/18/2003 | 07/31/2009 |
| Labeler - Vedco, Inc. (021634266) |