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Date: Saturday, May 18, 2024 16:17

Release 4.142
Zorabel 25 mg/ml Solution
 
Species: Chickens, Turkeys
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Coccidiocides
Active ingredient: Toltrazuril
Product:Zorabel 25 mg/ml Solution
Product index: Zorabel
Poultry - meat: Chickens 18 days; Turkeys 16 days
Withdrawal notes: Zorabel is not authorized for use in birds laying eggs for human consumption. It is not to be used within 4 weeks of the onset of laying.
Incorporating:
Presentation
A clear, colourless-to-brown solution containing 25 mg toltrazuril per ml, for use in drinking water.
Uses
For treatment of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. necatrix and E. tenella in chickens (pullets and breeders), and by E. adenoides and E. meleagrimitis in turkeys.
Dosage and administration
Zorabel is to be administered in drinking water. The recommended dosage is 7 mg toltrazuril per kg of body weight, equivalent to 28 ml of Zorabel per 100 kg liveweight, daily, for 2 days.
The treatment is to be given either continuously over 24 hours or over 8 hours per day. For continuous treatment over 24 hours, the volume of Zorabel to be added per litre of drinking water, in ml, is:
0.28 x mean liveweight (kg) of birds to be treated
mean water consumption (litres) per bird over 24 hours
For treatment over 8 hours per day, the volume of Zorabel to be added per litre of drinking water, in ml, is:
0.28 x mean liveweight (kg) of birds to be treated
mean water consumption (litres) per bird over 8 hours
Zorabel should be dissolved in drinking water by gentle mixing before its administration. Acidic water may cause precipitation of the active ingredient at recommended doses. The solution should be prepared daily. At concentrations ranging from 1 to 3 ml of Zorabel per litre of water, solubility is assured over the treatment period. At concentrations greater than 3 ml of Zorabel per litre of water, there may be precipitation. Sufficient access to the medicated water for adequate water consumption should be available for the birds under treatment. No other source of drinking water should be available during the period of medication. In free-range systems, birds should be kept in the house during treatment.
Contra-indications, warnings, etc
Zorabel is a strongly alkaline solution and should not be administered undiluted. The use of Zorabel with antibiotics may reduce water intake in turkeys. The concomitant addition of other substances to the drinking water should be avoided. It is stated in the Summary of Product Characteristics, “Because of potential solubility issue, administration via header tanks should be avoided.”
Withdrawal periods
Chicken meat and offal: 18 days. Turkey meat and offal: 16 days. Zorabel is not authorized for use in birds laying eggs for human consumption. It is not to be used within 4 weeks of the onset of laying.
Zorabel is an alkaline solution: contact with the skin and mucous membranes should be avoided. Protective gloves and goggles should be worn when handling it. Wash any splashes from the skin or eyes immediately with water. In case of irritation of the skin or eyes after exposure, seek medical advice immediately and show the package insert or the label to the physician. People with a known sensitivity to toltrazuril or either of the excipients, trolamine and polyethylene glycol, should avoid contact with Zorabel.
Pharmaceutical precautions
Zorabel should not be stored at temperatures above 30°C.
Legal category
Legal category: POM-V
Packaging quantities
Bottles containing 1 litre
Further information
For the best results, treatment should be initiated before clinical signs of disease have appeared in the whole group.
Marketing Authorisation Holder (if different from distributor)
Vetpharma Animal Health S.L.
Les Corts, 23
08028 Barcelona
Spain
Marketing Authorisation Number
Vm 32509/4015
Significant changes