Exzolt acaricide oral suspension,10 mg fluralaner, 4ml

EXZOLT ACARICIDE ORAL SUSPENSION 4ML

Exzolt 10 mg/ml solution for administration in drinking water for chickens.

One ml contains:
Active substance:
10 mg fluralaner

Solution for administration in drinking water. Light yellow to dark yellow solution.

INDICATIONS:
Treatment against red mite infestation (Dermanyssus gallinae) in chickens.

CONTRAINDICATIONS:
None.

ADVERSE REACTIONS:
None.
If you notice any adverse reactions, even those not already included in this leaflet or you think that the medicine has not had an effect, please inform your veterinarian.

TARGET SPECIES:
Chickens (chickens, breeders and laying hens).

METHOD OF ADMINISTRATION:
For administration in drinking water.
The dose is 0.5 mg fluralaner per kg body weight (equivalent to 0.05 ml of product), administered twice, 7 days apart. The full course of treatment must be administered for the full therapeutic effect.
If another course of treatment is indicated, the interval between two courses of treatment should be at least 3 months.

RECOMMENDATIONS ON CORRECT ADMINISTRATION:
Determine the period of time (between 4 and 24 hours) in which the medicated water is administered on the day of treatment. This period of time should be long enough to allow all birds to receive the required dose. Estimate how much water the birds will consume during the treatment period based on the volume of water consumed by the birds on the previous days. The product should be added to the volume of water that the birds will consume in one day.
No other source of water should be available during the treatment period.
Calculate the volume of product required based on the total weight of the birds to be treated. To ensure the correct dose is administered, body weight should be determined as accurately as possible and the calculated volume of product to be administered should be measured as accurately as possible.
The volume of product required for each day of treatment is calculated for the total body weight (kg) of the entire flock of birds to be treated:
Product volume (ml) for the day of treatment = Total body weight (kg) of the birds to be treated x 0.05 ml/kg.
For example, 1 ml of product treats 20 kg body weight (e.g. 10 birds of 2 kg body weight each) on the day of treatment. A complete treatment consists of two administrations at an interval of 7 days.
For the preparation of the medicated water, follow the instructions below:
· Ensure that the drinking system is functioning properly and is free of leaks.
· For each day of treatment, the medicated water should be freshly prepared.
· Mix the required volume of product with the determined amount of water in a measuring device.
· Add the product and water simultaneously to avoid foaming.
· Stir the stock solution gently but thoroughly until the medicated water is homogeneous.
· It is important to rinse the measuring device to ensure that the birds are given the full dose and that no residue remains. Add the rinse water to the drinkers.
· Ensure that the medicated water is evenly distributed to the drinkers.

WITHDRAWAL PERIOD:
Meat and offal: 14 days.
Eggs: zero days.

SPECIAL STORAGE PRECAUTIONS:
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 1 year.
Shelf life of the medicated water: 24 hours.

SPECIAL WARNINGS:
Special precautions for each target species:
The following practices should be avoided as they increase the risk of resistance development and may ultimately result in ineffective therapy:
– too frequent and repeated use of acaricides from the same class for too long a period of time,
– underdosing, which may result from an incorrect estimation of body weight, incorrect administration of the product, lack of calibration of the volume measuring device.
Special precautions for use in animals:
To ensure long-term control of the mite population in the treated house, it is essential that other infested poultry houses in the vicinity of the treated house are also treated.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
The veterinary medicinal product may cause mild skin and/or eye irritation.
Avoid contact with skin, eyes and mucous membranes.
Do not eat, drink or smoke when handling the product.
After using the product, wash hands and any skin that has come into contact with it with soap and water.
In case of contact with eyes, rinse immediately with water.

Special precautions for environmental protection:
Medicated drinking water should not enter surface waters.
Laying birds:
The safety of the veterinary medicinal product has been demonstrated in layers and breeders.
The product can be used during laying.
Interactions with other medicinal products and other forms of interaction:
None known.
Overdose:
Safety has been demonstrated in 3-week-old chickens and adults treated with overdoses of up to 5 times the recommended dose for 3 times the recommended duration of treatment.
No adverse effects on egg production were observed when laying hens were treated with overdoses of up to 5 times the recommended dose for 3 times the recommended duration of treatment.
No adverse effects on reproductive performance were observed when breeding chickens were treated with overdoses of 3 times the recommended dose, recommended for 2 times the recommended duration of treatment.
Major incompatibilities:
In the absence of compatibility studies, do not mix this veterinary medicinal product with other veterinary medicinal products.
Environmental properties:
Fluralaner has been shown to be very persistent in soil under both aerobic and anaerobic conditions. Fluralaner degrades in aquatic sediments under anaerobic conditions, while it has been shown to be very persistent under aerobic conditions.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY:
Exzolt should not be emptied into water courses as it may be harmful to aquatic invertebrates.
Medicinal products should not be disposed of via wastewater or household waste.
Ask your veterinarian how to dispose of medicines no longer required. These measures will help to protect the environment.

VOLUME:
Vial x 4 ml