Pracetam 40% O.S. (Canada)

Company: Ceva Animal Health

Acetaminophen Oral Solution, Mfr. Std.

Veterinary use only

DIN 02323028

Antipyretic

Warning

Treated swine must not be slaughtered for use in food for at least 3 days after the latest treatment with this drug. When handling the product, avoid direct contact with skin or eyes. Keep out of reach of children.

Active Ingredient

Pracetam 40% O.S. Indications

To reduce fever and associated clinical symptoms in cases of acute respiratory disease in swine.

Dosage and Administration

30 mg of acetaminophen/kg bodyweight/day (0.75 mL Pracetam^® 40% O. S./10 kg/d) administered continuously in drinking water for 5 days. Only medicated drinking water should be provided during the treatment period. Fresh solutions should be prepared daily because the product is stable only for 24 hours once diluted in water.

Herd medication:

The following recommendations for dilution of the product are based on an average daily water consumption equivalent to 10% of bodyweight (i.e. a group of swine weighing a total of 1000 kg and drinking 100 L of water per 24 hours). If the daily water consumption is higher or lower, calculations should be made with the actual water consumption in order to supply swine with an average of 30 mg of acetaminophen/kg bodyweight/day.

Automatic medicator:

Prepare a stock solution by mixing 1 part of Pracetam^® 40% O. S. with 38 parts of lukewarm water. This is equivalent to 25 mL of Pracetam^® 40% O. S. per L of stock solution, or 10 g of acetaminophen per L of stock solution.

To treat 1000 kg of swine, prepare 3 L of stock solution by mixing 75 mL of Pracetam^® 40% O. S. with 2.925 L of water.

Set the apparatus at 3% (30 mL of stock solution per L of drinking water).

Note: the solubility threshold of Pracetam^® 40% O. S. in water at 5°C is 3% (30 mL of Pracetam^® 40% O. S. per L of stock solution) and 6% in water at 20°C. Should you need to adjust the concentration of the stock solution in function of the daily water consumption for swine to be treated, do not go over these concentrations otherwise the solution would be at risk of precipitation.

Contraindications

Do not use in animals with known hypersensitivity to acetaminophen, with severe hepatic impairment or with severe renal impairment.

CAUTIONS: The safety of this product has not been verified in breeding animals.

Clinical Pharmacology

Oral absorption of acetaminophen is fast and almost complete (bioavailability close to 90% after administration in drinking water). Maximum concentrations are reached within a bit less than 2 hours after administration. Acetaminophen is metabolised by the liver and eliminated mainly in urine.

EFFICACY: A multicenter randomized double blind clinical field trial was conducted on 122 fattening pigs with rectal temperature ≥ 40°C and signs of influenza syndrome (dyspnea and/or polypnea, demeanour, and anorexia). The protocol was respected for 79 animals and data from these pigs were used for analysis (39 Pracetam^® O. S. and 40 Placebo). Pracetam^® O. S. was administered in drinking water as per label recommendations for 5 days. Differences in rectal temperature and in adjusted difference in clinical score (based on general condition, respiration, coughing and sneezing) were statistically significant between the two groups in favour of the Pracetam^® O. S. group.

STORAGE CONDITIONS: Store between 15-30°C.

Ceva Animal Health Inc., 6-1040 Fountain St. N., Cambridge ON, N3E 1A3

1-800-510-8864

Last Revised: 2019-03-21

CPN: 1221150.0