Zorabel
Active substance
ATC code
Species
Chicken (pullets and chickens for reproduction) and turkey
Indications
For the treatment of coccidiosis caused by:
Chicken (pullets and chickens for reproduction): Eimeria acervulina, E. brunetti, E. maxima, E. necatrix and E. tenella.
Turkey: Eimeria adenoides, E. meleagrimitis.
Dose to be administered and administration route
Administration: In drinking water use
The recommended dose rate is 7 mg toltrazuril per kg of body weight (equivalent to 28 ml of medicinal product per 100 kg of body weight) daily given for 2 consecutive days.
In order to ensure administration of a correct dose, accurately determine the body weight of the animals.
The treatment is recommended to be given either continuously over 24 h or alternatively at a treatment duration of 8 hours per day.
For the preparation of medicated water the body weight of the animals to be treated and their actual daily water consumption should be taken into account. Consumption may vary depending on factors like species, age, state of health, breed and husbandry system (e.g. different temperature, different light regimes).
Considering continuous treatment over 24 hours the following calculation should be made for providing the required amount of veterinary medicinal product in ml per litre drinking water:
Total demand of ZORABEL 25 mg/ml per day (24 hours):
The calculated volume (x ml ZORABEL 25 mg/ml per litre) should then be multiplied with the total daily water consumption (l) for the 24 hour period.
Considering a treatment duration of 8 hours per day the following calculation should be made for providing the required amount of veterinary medicinal product in ml per litre drinking water:
Total demand of ZORABEL 25 mg/ml for a treatment duration of 8 hours:
The calculated volume (x ml ZORABEL 25 mg/ml per litre) should then be multiplied with the water consumption (l) for the 8 hour period.
The veterinary medicinal product should be dissolved in drinking water (gentle mixing) before use.
The use of acidic water may cause precipitation of the active substance at recommended doses. The solution should be prepared daily.
At doses ranging from 1 ml to 3 ml of the veterinary medicinal product per litre of drinking water, the solubility is ensured over the treatment period. Dilutions more concentrated than 3:1,000 (3 ml of product to 1 litre drinking water) may result in precipitation.
Because of potential solubility issue, the administration via header tanks should be avoided.
The use of suitably calibrated weighing equipment is recommended if part of containers is used.
Sufficient access to the system of water supply should be available for the animals to be treated to ensure adequate water consumption. No other source of drinking water should be available during the medication period. In free range husbandry systems animals should be kept in the stable during treatment.
After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Adverse reactions
None known
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
ZORABEL 25 mg/ml Solution for use in Drinking Water for chickens and turkeys
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance:
Toltrazuril 25 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for use in drinking water
Clear colourless to brown solution
4. CLINICAL PARTICULARS
4.1 Target species
Chicken (pullets and chickens for reproduction) and turkey
4.2 Indications for use, specifying the target species
For the treatment of coccidiosis caused by:
Chicken (pullets and chickens for reproduction): Eimeria acervulina, E. brunetti, E.
maxima, E. necatrix and E. tenella.
Turkey: Eimeria adenoides, E. meleagrimitis.
4.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings for each target species
As with any antiparasiticide, frequent and prolonged use of an antiprotozoal of the same class of active sub-stance and underdosing due to underestimation of the live weight may result in the development of resistances.
It is recommended to treat all animals in a pen. For best results, treatment should be initiated before the clinical signs of disease have spread throughout the whole group.
4.5 Special precautions for use
Special precautions for use in animals
The veterinary medicinal product is a strongly alkaline solution and should not be administered undiluted.
Hygiene measures help to reduce the risk of coccidiosis. It is therefore recommended that attention be paid during treatment to hygiene in confinement buildings, particularly in terms of general cleanliness and moisture reduction.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product is an alkaline solution-contact with skin and mucous membranes should be avoided. Personal protective equipment consisting of gloves and goggles should be worn when handling this product. Wash any splashes from skin or eyes immediately with water. In case of irritation of eyes or skin after exposure, seek medical advice immediately and show the package leaflet or the label to the physician.
People with known sensitivity to toltrazuril, or any excipient, should avoid contact with this product.
Do not eat, drink or smoke while handling the product.
Do not ingest. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
None known
4.7 Use during pregnancy, lactation or lay
Not applicable (see section 4.11)
4.8 Interaction with other medicinal products and other forms of interaction
Combination of the product with antibiotics may result in reduced water intake in turkeys. The concomitant administration of other substances to the drinking water should be avoided.
4.9 Amounts to be administered and administration route
Administration: In drinking water use
The recommended dose rate is 7 mg toltrazuril per kg of body weight (equivalent to 28 ml of medicinal product per 100 kg of body weight) daily given for 2 consecutive days.
In order to ensure administration of a correct dose, accurately determine the body weight of the animals.
The treatment is recommended to be given either continuously over 24 h or alternatively at a treatment duration of 8 hours per day.
For the preparation of medicated water the body weight of the animals to be treated and their actual daily water consumption should be taken into account. Consumption may vary depending on factors like species, age, state of health, breed and husbandry system (e.g. different temperature, different light regimes).
Considering continuous treatment over 24 hours the following calculation should be made for providing the required amount of veterinary medicinal product in ml per litre drinking water:
|
0.28 ml ZORABEL 25 mean body weight (kg) mg/ml per kg bodyweight X of animals to be treated = x ml ZORABEL 25 per day mg/ml per litre drinking |
|
mean water consumption (l) per animal (24 hours) water |
Total demand of ZORABEL 25 mg/ml per day (24 hours):
The calculated volume (x ml ZORABEL 25 mg/ml per litre) should then be multiplied with the total daily water consumption (l) for the 24 hour period.
Considering a treatment duration of 8 hours per day the following calculation should be made for providing the required amount of veterinary medicinal product in ml per litre drinking water:
|
0.28 ml ZORABEL 25 mean body weight (kg) mg/ml per kg bodyweight X of animals to be treated = x ml ZORABEL 25 per day mg/ml per litre drinking |
|
mean water consumption (l) per animal per 8 hours water |
Total demand of ZORABEL 25 mg/ml for a treatment duration of 8 hours:
The calculated volume (x ml ZORABEL 25 mg/ml per litre) should then be multiplied with the water consumption (l) for the 8 hour period.
The veterinary medicinal product should be dissolved in drinking water (gentle mixing) before use.
The use of acidic water may cause precipitation of the active substance at recommended doses. The solution should be prepared daily.
At doses ranging from 1 ml to 3 ml of the veterinary medicinal product per litre of drinking water, the solubility is ensured over the treatment period. Dilutions more concentrated than 3:1,000 (3 ml of product to 1 litre drinking water) may result in precipitation.
Because of potential solubility issue, the administration via header tanks should be avoided.
The use of suitably calibrated weighing equipment is recommended if part of containers is used.
Sufficient access to the system of water supply should be available for the animals to be treated to ensure adequate water consumption. No other source of drinking water should be available during the medication period. In free range husbandry systems animals should be kept in the stable during treatment.
After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
The first signs of intolerance such as reduced water intake were observed beyond 35 times the recommended dose.
4.11 Withdrawal period(s)
Chicken
Meat and offal: 18 days
Eggs: Not for use in birds producing or intended to produce eggs for human consumption. Do not use within 4 weeks of the start of the laying period.
Turkey
Meat and offal: 16 days
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antiprotozoals. Triazines.
ATCvet code: QP 51AJ01
5.1 Pharmacodynamic properties
Toltrazuril is an anticoccidial of the triazinetrione group, active against Eimeria spp, Its activity affects the intracellular development stages of the parasitewithout affecting the extracellular stages of the parasites.
At parasite level, toltrazuril decreases the enzymatic activity of the respiratory chain, causing inflammation of the endoplasmic reticulum and Golgi apparatus, perinuclear space modifications and alteration of division of the nucleus.
5.2 Pharmacokinetic particulars
In chickens and turkeys, totrazuril is absorbed at rate of at least 50%. Distribution is higher in liver and kidney. The active substance is rapidly metabolised and the main metabolite is characterised as a toltrazuril sulfone.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Trolamine
Macrogol 200
6.2 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 21 months
Shelf-life after first opening the immediate packaging: 3 months
Shelf-life after dilution or reconstitution according to directions: 24 hours
6.4. Special precautions for storage
Do not store above 30ºC.
6.5 Nature and composition of immediate packaging
Bottle of white high-density polyethylene bottles, closed with a high-density polyethylene screw cap with low-density polyethylene induction sealing.
Package sizes:
Bottle of 1 L
Bottle of 5 L
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Vetpharma Animal Health, S.L
Les Corts, 23
08028 Barcelona
Spain
8. MARKETING AUTHORISATION NUMBER
Vm 32509/4015
9. DATE OF FIRST AUTHORISATION
04 March 2014
10 DATE OF REVISION OF THE TEXT
November 2018
PROHIBITION OF SALE, SUPPLY AND/OR USE
For animal treatment only.
To be supplied only on veterinary prescription
Approved: 23 November 2018
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