Zuritol 25 mg/ml solution for use in drinking water for chickens

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Toltrazuril
Available from:
LABORATORIOS CALIER S.A.
ATC code:
QP51AJ01
INN (International Name):
Toltrazuril
Dosage:
25 milligram(s)/millilitre
Pharmaceutical form:
Oral solution
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Chickens
Therapeutic area:
toltrazuril
Therapeutic indications:
Coccidiostats
Authorization status:
Authorised
Authorization number:
VPA10665/004/001
Authorization date:
2012-07-13

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Zuritol 25 mg/ml solution for use in drinking water for chickens

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3 PHARMACEUTICAL FORM

Solution for use in drinking water.

Clear colourless to brown solution.

4 CLINICAL PARTICULARS

4.1 Target Species

Chickens (pullets and breeders).

4.2 Indications for use, specifying the target species

Treatment of coccidiosis in pullets and broiler breeders.

4.3 Contraindications

Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

with all

anticoccidials,

frequent

and prolonged use of

an antiprotozoal

the same class

may result

in the

development of resistances.

Each 1 ml contains:

Active substance:

Toltrazuril

25.0 mg

For the full list of excipients, see section 6.1

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4.5 Special precautions for use

i) Special precautions for use in animals

Good hygiene can reduce the risk of coccidiosis. It is therefore recommended any deficiencies in husbandry should be

addressed in addition to treatment. Poultry houses should be kept clean and dry. It is recommended that all individuals

in the group are treated. For best results, treatment should be initiated before the clinical signs of disease have spread

throughout the whole group.

Then veterinary medicinal product is a strongly alkaline solution and should not be administered undiluted.

ii) 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.

iii) Other precautions

None

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Not applicable

4.8 Interaction with other medicinal products and other forms of interaction

None known.

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4.9 Amounts to be administered and administration route

For oral administration (in drinking water)

The recommended dose rate is 7 mg per kg of body weight (equivalent to 28 ml of medicinal product per 100 kg of

body weight or 1.4 ml of the product per liter of drinking water based on a water consumption of 1 litre per 5 kg body

weight) daily given for 2 consecutive days.

This medicinal product should be administered either continuously over 48 hours, or for one 8 hour period per day for 2

consecutive days.

The total weight of the treated animals and the daily water consumption must be accurately calculated.

The consumption of water may vary depending in particular on the clinical condition, the ambient temperature, the lighting

program, the drinking system used, the age and breed. If the water consumption is more or less than the above standards, the

concentration of the medicinal product in the drinking water should be adjusted accordingly.

Use appropriate and properly calibrated dosing equipment. Medicated water should be the only drinking source.

The medicated water is only usable for 24 hours and should be made freshly every day.

Dilutions more concentrated than 3 : 1,000 (3 ml of product to 1 litre drinking water) may result in precipitation. Predilution

and the administration through a dosing pump (proportioner) are not recommended. Use preferably a bulk tank.

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 5 times the recommended dose.

4.11 Withdrawal Period(s)

Meat and offal : 16 days.

Eggs: Not authorised for use in laying birds producing eggs for human consumption. Do not use within 4 weeks of onset of

laying

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: antiprotozoals, triazines

ATCVet Code: QP51AJ01

5.1 Pharmacodynamic properties

Toltrazuril is a triazinone derivative anticoccidial; its mode of action is unknown.

It is active against coccidia of the

genus

Eimeria.

active against

intracellular

development

stages

schizogony (asexual

multiplication)

gametogony (sexual stage).

5.2 Pharmacokinetic properties

In poultry, toltrazuril is absorbed at a rate of at least 50 %. The active substance is rapidly metabolized. The main

metabolite is Toltrazuril sulfone.

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Trolamine

Macrogol 300

6.2 Incompatibilities

Do not mix with other veterinary medicinal products.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 4 years

Shelf-life after dilution according to directions: 24 hours

Shelf-life after first opening the immediate packaging: 3 months

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

1 litre high-density polyethylene bottles with high-density polyethylene screw cap and removable polyethylene sealing

disk.

5 litre high-density polyethylene barrels with high-density polyethylene screw cap and removable polyethylene sealing

disk.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be

disposed of in accordance with local requirements.

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7 MARKETING AUTHORISATION HOLDER

Laboratorios Calier, S.A.

Barcelones

26 (Pla del Ramassa)

Les Franqueses del Valles

Barcelona

Spain

8 MARKETING AUTHORISATION NUMBER(S)

VPA: 10665/004/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13th July 2012

Date of last renewal: 1st March 2017

10 DATE OF REVISION OF THE TEXT

March 2017

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