ENDOCOX

ENDOCOX, 25 mg/ml,  solution for administration in drinking water for chickens and turkeys

1.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Manufacturing authorisation holder and manufacturer:

Biofaktor Sp. z o.o.

Czysta 4 st.

96-100 Skierniewice

2.

NAME OF VETERINARY MEDICINAL PRODUCT

ENDOCOX, 25 mg/ml,  solution for administration in drinking water for chickens and turkeys

3.

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

  1. 25 mg/ml

4.

INDICATIONS

Treatment of coccydiosis in broliler chickens, chickens for reproduction and turkeys.

ENDOCOX is effective against the following coccydia of Eimeria type:

Chickens: E. acervulina, E. brunetti, E. maxima,, E. tenella, E. mitis, E. necatrix.

Turkeys: E. adenoides, E. meleagrimitis.

5.

CONTRINDICATIONS

None

6.

ADVERSE EFFECTS

Not known.

The occurrence of adverse events after administration of the product or observing any ill effects not listed in this leaflet (including symptoms in people in contact with the drug), you must notify the competent veterinary surgeon, responsible entity or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products . The application form should be downloaded from the website http://www.urpl.gov.pl (Faculty of Veterinary Medicinal Products).

7.

TARGET SPECIES

Chicken, turkey.

8.

DOSING AND ADMINISTRATION ROUTE

Therapeutic dose for chicken and turkey is 7 mg toltrazuril / kg body weight daily. Administer in drinking water during 2 consecutive days in quantities 1 ml of preparation per 1 litre of water available constantly it means 24 hours per day, or 3 ml preparation per 1 litre of water available for 8 hours daily.

Treatment period is 2 consecutive days. In case of hard infections treatment may be repeated after 5 days.

Administration route: in drinking water.

Preparation must be prepared directly before administration. Shake before use. During preparation of solution maintain general safety rules (see pt. 4.5).

9.

RECOMMENDATIONS FOR PROPER USE

Use according to the attached leaflet.

10.

WITHDRAWAL PERIOD

Edible chicken tissues – 14 days.

Edible turkey tissues – 16 days.

Do not use in hens laying eggs for human consumption.

11.

SPECIAL PRECAUTIONS DURING STORAGE AND TRANSPORT

Keep away from children.

Store below 25oC.

Product must be used within 14 days after first opening of the immediate packaging.

Use within 24 hours after reconstitution according to instruction.

12.

SPECIAL WARNINGS AND PRECAUTIONS IF NECESSARY

ENDOCOX is alkaline solution.

During the preparation and application of solution for drinking, use rubber gloves and goggles. In case of accidental contact with skin or eyes, rinse immediately with water.

During the administration do not eat, drink or smoke.

At a concentration of less than 1 ml of ENDOCOX  in 1000 ml of water, precipitation may occur. It is recommended to prepare fresh solution on the day of administration.

ENDOCOX can be used in laying hens during lay in breeding flocks.

ENDOCOX can be used in conjunction with commonly used feed additives and veterinary medicinal products.

5-fold increased dose is well tolerated by the animals, but may occur a slight decrease in the consumption of water and feed.

13.

SPECIAL WARNINGS FOR DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM THIS PRODUCT, IF NECESSARY

Medicines should not be disposed of to wastewater or household waste.

About disposal of medicines ask your veterinarian. This will help to protect the environment.

14.

DATE OF APPROVAL OF TEXT

03-03-2011

15.

OTHER INFORMATION

In order to obtain information on this veterinary medicinal product, contact marketing authorisation holder.

Packaging sizes:

Bottle containing 100 ml or 100 ml of solution

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