Baycox (toltrazuril) 5% Oral Suspension (Canada)This page contains information on Baycox (toltrazuril) 5% Oral Suspension for veterinary use.
The information provided typically includes the following:
- Baycox (toltrazuril) 5% Oral Suspension Indications
- Warnings and cautions for Baycox (toltrazuril) 5% Oral Suspension
- Direction and dosage information for Baycox (toltrazuril) 5% Oral Suspension
Baycox (toltrazuril) 5% Oral SuspensionThis treatment applies to the following species:
5% Oral Suspension
VETERINARY USE ONLY
1-[3-methyl-4- (4’-trifluoromethylthiophenoxy)-phenyl]-3 methyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
MOLECULAR WEIGHT: 425.38
MEDICINAL INGREDIENT PER ML: 50 mg toltrazuril
INDICATION: Baycox® (toltrazuril) 5% Oral Suspension is indicated for the treatment of preclinical coccidiosis due to Isospora suis in neonatal piglets.
MODE OF ACTION: Light and electron microscope studies show that toltrazuril is active against all intracellular stages of coccidia, including schizonts, micro and macrogamonts. It interferes with the division of the protozoal nucleus, the activity of the mitochondria and damages the wall forming bodies in the microgametes. Toltrazuril produces severe vacuolisation of the protozoal endoplasmic reticulum in all intracellular development stages.
PHARMACODYNAMICS, PHARMACOKINETICS: After oral administration to piglets, toltrazuril is absorbed slowly from the gut, indicated by a radioactive study using [triazine-2-14C]-marked toltrazuril. This is followed by a long-lasting distribution among the different compartments of the body. The plasma half-life is 51 hours. Excretion is characterized by a high fecal fraction with a relatively high excretion rate. There is no significant enterohepatic circulation.
Two metabolites of toltrazuril, both oxidation products, toltrazuril-sulfoxide and toltrazuril-sulfone, are found in the tissues and organs of piglets.
Dosage and AdministrationShake well before use. Weigh three representative litters at 3 days of age to determine an average piglet weight. The recommended dosage of toltrazuril is 20 mg per kg body weight.
This corresponds to a dose of 1 ml Baycox® 5% Oral Suspension per 2.5 kg body weight.
Administer a single oral dose at 3 to 4 days of age.
EFFICACY: The efficacy of a single oral treatment with toltrazuril against preclinical neonatal coccidiosis in pigs has been widely demonstrated by several investigators in countries as diverse as Australia, Canada, Denmark, Italy, Malaysia and Venezuela, under various conditions of management and hygiene. Treated piglets showed improvement regarding their clinical picture (diarrhea was the most frequently noted criterion), oocyst shedding, and had better weight gains than the untreated animals.
SAFETY: The tolerance of neonatal pigs to Baycox® (toltrazuril) 5% Oral Suspension was tested extensively under controlled conditions and assessed on the basis of clinical, haematological and clinicochemical parameters, which were determined before and after treatment and by comparison with untreated controls.
Animals were also examined for gross pathological and histological changes.
Studies performed with single treatments of 20 mg/kg (recommended rate), 60 mg/kg (3 x recommended), 100 mg/kg (5 x recommended) and at 30 mg/kg once a day for 2 days showed that the formulation is well tolerated at the therapeutic dosage:
- there was no influence on body weight development in any of the groups,
- the haematological and clinical-chemical investigations revealed no changes related to treatment,
- the gross pathology studies showed no indication of change to the animals or their organs.
WarningsTreated swine must not be slaughtered for use in food for at least 70 days after the latest treatment with this drug. Do not use in piglets intended to be used as suckling or barbecue pigs since they may be marketed before 70 days after administration of this drug. Avoid direct contact with skin by wearing rubber gloves while handling this drug. Dispose the unused drug in accordance with the Provincial/Municipal guidelines.
Keep out of reach of children.
StorageStore below 30 °C.
Protect from freezing.
Baycox® (toltrazuril) 5% Oral Suspension is available in 250 mL bottles.
® Baycox, Bayer and Bayer Cross are trademarks of Bayer AG used under license by Bayer Inc.
Bayer Inc., Toronto, Ontario M9W 1G6
NAC No.: 12230491
Animal Health Division, Bayer Inc.
77 BELFIELD ROAD, TORONTO, ON, M9W 1G6
|Telephone:||416-248-0771 or 800-268-1331|
|Order Desk Fax:||800-361-3306|
|Every effort has been made to ensure the accuracy of the Baycox (toltrazuril) 5% Oral Suspension information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.|
Copyright © 2013 North American Compendiums. Updated: 2013-09-18