Target Species:
Chickens (pullets, chickens for reproduction and layer hens).
Indications for use
Treatment of poultry red mite (Dermanyssus gallinae) infestation in pullets, chickens for reproduction and layer hens.
Contraindications
None.
Special warnings for each target species
Unnecessary use of antiparasitics or use deviating from the instructions given may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features for each flock.
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
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.
Operator warnings
The veterinary medical 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.
Adverse Reactions
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Use during pregnancy or lactation
The safety of the veterinary medicinal product has been demonstrated in layers and breeders. The product can be used during lay.
Interactions
None known.
Amounts to be administered and administration route
For use 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 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.
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.
•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.
For small poultry farms using 4-ml or 50-ml bottles of the veterinary medicinal product:
Check that the water system functions properly and is free of leaks.
For each day of treatment, medicated water must be freshly prepared.
Mix the required volume of the product with the determined amount of water in a measuring device.
Add product and water simultaneously in order to avoid foaming.
Stir stock solution gently but thoroughly until the medicated water is homogeneous.
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.
Ensure that medicated water is evenly divided to all drinkers.
At time of initial use, remove the original cap from the bottle and discard it. Twist on the in-use cap provided in the carton box. Doing so will permanently insert the syringe adaptor into the neck of the bottle.
To dose:
Remove the in-use cap.
Attach a 1-ml dosing syringe to the bottle by gently pushing the end of the syringe into the syringe adapter.
Turn the bottle/syringe upside down. Pull down on the plunger to withdraw the correct dose volume. If any air bubbles are seen in the syringe, push them out and pull down again on the plunger until the correct volume is withdrawn.
Turn the bottle/syringe upright. Remove the syringe from the syringe adaptor.
Replace the in-use cap.
Administer the dose in the drinking water.
Rinse the 1-ml dosing syringe and add the rinse water to the drinker.
Store the syringe clean and dry between the uses.
Overdose
No adverse reactions were observed following the treatment of 3-week old and adult chickens dosed with 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 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 3 times the recommended dose for twice the recommended duration of treatment.
Withdrawal periods
Meat and offal: 14 days.
Eggs: zero days.