Exzolt - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET (50-ml presentation):

Exzolt 10 mg/ml solution for use in drinking water for chickens

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Intervet International BV

Wim de Korverstraat 35

5831 AN Boxmeer

The Netherlands

Manufacturer responsible for batch release:

Intervet Productions SA

Rue de Lyons

27460 Igoville

France

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Exzolt 10 mg/ml solution for use in drinking water for chickens fluralaner

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Active substance:

Fluralaner 10 mg.

Solution for use in drinking water.

Light yellow to dark yellow solution.

• 4. INDICATION(S)

Treatment of poultry red mite (Dermanyssus gallinae ) infestation in pullets, breeders and layer hens.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

None known.

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Chickens (pullets, breeders and layer hens).

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

For use in drinking water.

The dose is 0.5 mg fluralaner per kg body weight (equivalent to 0.05 ml of solution) administered twice, 7 days apart. The complete course of treatment must be administered for a full therapeutic effect. If another course of treatment is indicated, the interval between two courses of treatment should be at least 3 months.

• 9. ADVICE ON CORRECT ADMINISTRATION

Determine the duration of time (between 4 and 24 hours) over which to administer the medicated water on the treatment day. This period of time must be long enough to allow all the birds to receive the required dose. Estimate how much water birds will consume during treatment based on the previous day’s water consumption. The product should be added to a volume of water that the chickens will consume in one day. No other source of drinking water should be available during the medication period.

Calculate the volume of product needed based on the total weight of all birds to be treated. To ensure administration of the correct dose, the body weight should be determined as accurately as possible and the calculated volume of the product to be administered should be measured as accurately as possible.

The required volume of product for each treatment day is calculated from the total body weight (kg) of the entire group of chickens to be treated:

Volume of product (ml) per treatment day = Total body weight (kg) of chickens to be treated x 0.05 ml/kg

As an example, 1 ml of product treats 20 kg body weight (e.g., 10 chickens of 2 kg body weight each) per day of administration. A full treatment consists of two administrations, 7 days apart.

The instructions below need to be followed to prepare the medicated water:

• Check that the water system functions properly and is free of leaks
• For each day of treatment, medicated water must be freshly prepared.

o Mix the required volume of the product with the determined amount of water in a measuring device.

o Add product and water simultaneously in order to avoid foaming.

o Stir stock solution gently but thoroughly until the medicated water is homogeneous.

o It is important to rinse the measuring device to ensure that the complete dose is provided to the chickens and that no residues remain. Add the rinse water to the drinkers.

o Ensure that medicated water is evenly divided to all drinkers.

• 10. WITHDRAWAL PERIOD(S)

Meat and offal: 14 days.

Eggs: zero days.

• 11. 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 after first opening the container: 1 year.

Shelf life after dilution according to directions: 24 hours.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

The following practices should be avoided because they increase the risk of development of resistance and could ultimately result in ineffective therapy:

• – too frequent and repeated use of acaricides from the same class, over an extended period of time – underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the volume measuring device.

Special precautions for use in animals:

To ensure long term control of the mite populations in a flock, suitable measures should be implemented to prevent re-infestation of the treated flock. It is essential to avoid any contact to potentially infested birds and to treat any other infested poultry in flocks in proximity to the treated one.

Special precautions to be taken by the person administering the veterinary medicinal product to animals :

The veterinary medicinal product may be slightly irritating to skin and/or eyes.

Avoid contact with skin, eyes and mucous membranes.

Do not eat, drink or smoke while handling the product.

Wash hands and contacted skin with soap and water after use of the product.

In case of eye contact, immediately rinse thoroughly with water.

If the product is spilled, remove any affected clothes.

Fertility and lay:

The safety of the veterinary medicinal product has been demonstrated in layers and breeders. The product can be used during lay.

Overdose (symptoms, emergency procedures, antidotes):

Safety was demonstrated in 3-week-old and adult chickens treated with overdoses of up to 5 times the recommended dose for 3 times the recommended duration of treatment.

No negative effects on egg production were observed when layer hens were treated with overdoses of up to 5 times the recommended dose for 3 times the recommended duration of treatment.

There were no adverse effects on reproductive performance when breeding chickens were treated with overdoses of 3 times the recommended dose for twice the recommended duration of treatment.

Incompatibilities :

In the absence of compatibility studies, do not mix this veterinary medicinal product with other veterinary medicinal products.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Exzolt should not enter water courses as this may be dangerous for aquatic invertebrates.

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

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

DD/MM/YYYY

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency.

Bottle of 50 ml, 1 litre or 4 litres. Not all pack sizes may be marketed.

Environmental properties:

Fluralaner has been shown to be very persistent in soil under both, aerobic and anaerobic conditions.

Fluralaner degrades in aquatic sediment under anaerobic conditions while it has been shown to be very persistent under aerobic conditions.

PACKAGE LEAFLET (1– and 4-litre presentations):

Exzolt 10 mg/ml solution for use in drinking water for chickens

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Intervet International BV

Wim de Korverstraat 35

5831 AN Boxmeer

The Netherlands

Manufacturer responsible for batch release:

Intervet Productions SA

Rue de Lyons

27460 Igoville

France

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Exzolt 10 mg/ml solution for use in drinking water for chickens fluralaner

• 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

One ml contains:

Active substance:

Fluralaner 10 mg.

Solution for use in drinking water.

Light yellow to dark yellow solution.

• 4. INDICATION(S)

Treatment of poultry red mite (Dermanyssus gallinae ) infestation in pullets, breeders and layer hens.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

None known.

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Chickens (pullets, breeders and layer hens).

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

For use in drinking water.

The dose is 0.5 mg fluralaner per kg body weight (equivalent to 0.05 ml of solution) administered twice, 7 days apart. The complete course of treatment must be administered for a full therapeutic effect. If another course of treatment is indicated, the interval between two courses of treatment should be at least 3 months.

• 9. ADVICE ON CORRECT ADMINISTRATION

Determine the duration of time (between 4 and 24 hours) over which to administer the medicated water on the treatment day. This period of time must be long enough to allow all the birds to receive the required dose. Estimate how much water birds will consume during treatment based on the previous day’s water consumption. The product should be added to a volume of water that the chickens will consume in one day. No other source of drinking water should be available during the medication period.

Calculate the volume of product needed based on the total weight of all birds in the house to be treated. To ensure administration of the correct dose, the body weight should be determined as accurately as possible and an accurate measuring device should be used for measuring the calculated volume of the product to be administered.

The required volume of product for each treatment day is calculated from the total body weight (kg) of the entire group of chickens to be treated:

Volume of product (ml) per treatment day = Total body weight (kg) of chickens to be treated x 0.05 ml/kg

Therefore 500 ml of product treats 10,000 kg body weight (e.g., 5,000 chickens of 2 kg body weight each) per day of treatment administration.

The instructions below need to be followed, in the order described, to prepare the medicated water:

• Check the water system to ensure it works properly and is free of leaks; also ensure that water is available to all nipple or bell drinkers.
• For each day of treatment, medicated water must be freshly prepared.

o Mix the required volume of the product with water into a large medication tank or create a stock solution in a small container. The stock solution must be further diluted with drinking water and administered over time, using a proportioner or dosing pump. Always add product and water simultaneously in order to avoid foaming. It is important to rinse the measuring device used to measure the required product volume during the filling phase in order to ensure that the complete dose is emptied into the medication tank or the stock solution and that no residues remain in the measuring device. Stir the stock solution or the content of the medication tank gently until the medicated water is homogeneous. Connect the medication tank or the proportioner or dosing pump to the drinking water system.

• Make sure the dosing pump is properly set to deliver the medicated water during the predetermined treatment period (hours).
• Prime the drinker lines with medicated water and check to see when medicated water has reached the end of the line. This procedure should be repeated on each day of administration.

After each treatment administration, fill the stock solution container with clean (unmedicated) water to rinse the water lines.

• 10. WITHDRAWAL PERIOD(S)

Meat and offal: 14 days.

Eggs: zero days.

• 11. 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 after first opening the container: 1 year.

Shelf life after dilution according to directions: 24 hours.

• 12. SPECIAL WARNINGS

Special warnings for each target species:

The following practices should be avoided because they increase the risk of development of resistance and could ultimately result in ineffective therapy:

• – too frequent and repeated use of acaricides from the same class, over an extended period of time – underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the volume measuring device.

Special precautions for use in animals:

Strict biosecurity measures at house and farm level should be implemented to prevent re-infestation of treated houses. To ensure long term control of the mite populations in a treated house, it is essential to treat any other infested poultry in houses in proximity to the treated one.

Special precautions to be taken by the person administering the veterinary medicinal product to animals :

The veterinary medicinal product may be slightly irritating to skin and/or eyes.

Avoid contact with skin, eyes and mucous membranes.

Do not eat, drink or smoke while handling the product.

Wash hands and contacted skin with soap and water after use of the product.

In case of eye contact, immediately rinse thoroughly with water.

If the product is spilled, remove any affected clothes.

Fertility and lay:

The safety of the veterinary medicinal product has been demonstrated in layers and breeders. The product can be used during lay.

Overdose (symptoms, emergency procedures, antidotes):

Safety was demonstrated in 3-week-old and adult chickens treated with overdoses of up to 5 times the recommended dose for 3 times the recommended duration of treatment.

No negative effects on egg production were observed when layer hens were treated with overdoses of up to 5 times the recommended dose for 3 times the recommended duration of treatment.

There were no adverse effects on reproductive performance when breeding chickens were treated with overdoses of 3 times the recommended dose for twice the recommended duration of treatment.

Incompatibilities :

In the absence of compatibility studies, do not mix this veterinary medicinal product with other veterinary medicinal products.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Exzolt should not enter water courses as this may be dangerous for aquatic invertebrates.

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

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED