EXZOLT® 10 mg/mℓ ORAL SOLUTION

FOR ANIMAL USE ONLY

EXZOLT^® 10 mg/mℓ ORAL SOLUTION

Reg. No. G4363 (Act 36/1947)

INDICATIONS

For the treatment and control of poultry red mite (Dermanyssus gallinae) and Northern fowl mite (Ornithonyssus sylviarum) infestation in pullets, breeders and layers.

COMPOSITION

Each 1 mℓ contains 10 mg fluralaner.

STORAGE INSTRUCTIONS

Store at or below 30 °C in a cool, dry place in the tightly closed, original container.

PHARMACOLOGICAL ACTION

Pharmacodynamic Properties

Fluralaner is an acaricide and an insecticide. It is efficacious against poultry mites, including Dermanyssus gallinae (poultry red mite) and Ornithonyssus sylviarum (Northern fowl mite). Fluralaner has a high potency against mites, mostly by exposure via feeding, i.e., it is systemically active on target parasites.

Fluralaner is a potent inhibitor of parts of the arthropod nervous system by acting antagonistically on ligand-gated chloride channels (GABA-receptor and glutamate receptor). In molecular on-target studies on insect GABA receptors of fleas and flies, fluralaner is not affected by dieldrin resistance.

The onset of efficacy against Dermanyssus gallinae is within 4 hours after exposure of the mites to treated chickens. All mites feeding on treated chickens are killed for at least 2 weeks after the first Exzolt^® 10 mg/mℓ Oral Solution administration. Fluralaner stops the production of eggs by female mites.

The mite life cycle is broken due to the rapid onset of activity of fluralaner, the very high efficacy in killing mites feeding on treated chickens for a duration of at least 2 mite life cycles, and the absence of egg production from female mites exposed to treated chickens.

Exzolt^® 10 mg/mℓ Oral Solution contributes toward the long-term control of the mite population in the poultry house. In clinical field studies, it was shown that treatment quickly eliminated Dermanyssus gallinae populations in treated houses and that parasite population regrowth was controlled when proper biosecurity measures were implemented.

In vitro bio-assays show that fluralaner is effective against parasites having proven field resistance including amidines (ticks), organophosphates (ticks, mites), cyclodienes (ticks, fleas, flies) macrocyclic lactones (sea lice), phenylpyrazoles (ticks, fleas) benzophenyl ureas (ticks), pyrethroids (ticks, mites) and carbamates (mites).

Pharmacokinetic Properties

After oral administration, fluralaner is absorbed rapidly, reaching maximum concentrations in plasma within 2 hours following start of administration via medicated drinking water. The bioavailability is high, approximately 90 % of the dose. Fluralaner is highly bound to protein. Fluralaner is widely distributed throughout the body, with the highest concentrations reported in liver and skin/fat. No significant metabolites are observed in chickens, and fluralaner is mainly eliminated via the hepatic route. The apparent elimination half-life is approximately 4 days following oral administration.

WARNINGS

• Withdrawal period:    Meat and offal – 12 days.

                                                        Eggs – zero days.

• Shelf-life after first opening the immediate packaging: 12 months, when stored at or below 30 °C.
• Shelf-life of the medicated drinking water: 24 hours.
• Shelf-life of the medicated drinking water (in concentrations lower than 300 µg/mℓ) in contact with rusty materials, when prepared and administered above 30 °C (up to
  40 °C): 8 hours.
• Fluralaner medicated water (FMW) prepared with Exzolt^® 10 mg/mℓ Oral Solution, are considered as stable for 24 hours at least, with no special condition of use for the end user when prepared with purified water, tap water, hard and high pH water, soft and low pH water, hypochlorite water, Vac-Safe^® and when in contact with PVC materials and galvanised materials.

       Regarding FMW in contact with rusty materials:

• For concentrations greater than 300 µg/mℓ, the FMW is considered as stable for
  24 hours at least, with no special condition of use for the end user.
  • For concentrations lower than 300 µg/mℓ, the stability is demonstrated if the following conditions of use are controlled:
    • The preparation and administration of the FMW is performed at or below
      30 °C. The FMW is stable for 24 hours accordingly.
    • The preparation and administration of the FMW is performed above 30 °C (up to 40 °C). The administration of FMW should be completed within 8 hours following the preparation of the FMW.
• In the absence of compatibility studies, Exzolt^® 10 mg/mℓ Oral Solution must not be mixed with other veterinary medicinal products.
• KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
• Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

SPECIAL PRECAUTIONS

Special precautions for use in animals

• Generally accepted biosecurity practices should be implemented to prevent reinfestation 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 house in proximity to the treated one.

Special precautions to be taken by the person administering Exzolt^® 10 mg/mℓ Oral Solution to animals

• Exzolt^® 10 mg/mℓ Oral Solution may be slightly irritating to skin and/or eyes.
• Do not eat, drink or smoke while handling the product.
• Avoid contact with skin, eyes and mucous membranes.
• In case of eye contact, immediately rinse thoroughly with water.
• Wear protective clothing, masks, gloves, boots etc. according to hazard standards.
• Wash hands and exposed skin with soap and water after use of the product. Remove clothes affected by spillage.
• Vac-Safe^® (blue dye/chlorine neutralising agent) can be used concomitantly with Exzolt^® 10 mg/mℓ Oral Solution to monitor treatment administration and distribution in the water system.
• Dispose of any containers, disposable equipment and any other waste after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
• Do not contaminate rivers, dams or any water sources with containers or waste.

SAFETY IN LAY

The safety of Exzolt^® 10 mg/mℓ Oral Solution has been demonstrated in layers and breeders. The product can be used during lay.

In clinical field studies in laying hens, it was shown that treatment of mite infestation was usually associated with an increased laying rate.

DOSAGE AND DIRECTIONS FOR USE – USE ONLY AS DIRECTED

For use in drinking water

The dose is 0,5 mg fluralaner/kg body weight (equivalent to 0,05 mℓ Exzolt^® 10 mg/mℓ Oral Solution) administered twice, 7 days apart. The full course of therapy must be administered for full therapeutic effect.

Determine the time period (in hours) to administer the treatment on the treatment day. This period must allow all chickens to receive the required dose. Estimate how much water chickens will consume during treatment based on their water consumption during the same period the day before commencing treatment.

Calculate the volume of Exzolt^® 10 mg/mℓ Oral Solution needed based on the total weight of the group of chickens to be treated. To ensure administration of the correct dose, body weight should be determined as accurately as possible, and a sufficiently accurate measuring device should be used.

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

mℓ product/treatment day = Total estimated body weight (kg) of chickens to be treated

x 0,05 mℓ

One litre of Exzolt^® 10 mg/mℓ Oral Solution treats 10 000 kg body weight (i.e., 5 000 chickens of 2 kg body weight each).

The instructions below need to be followed in the order described to correctly 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 Exzolt^® 10 mg/mℓ Oral Solution into a large medication tank or with additional water to create a stock solution to be dosed by proportioner or dosing pump. Always add product and water simultaneously in order to avoid foaming. It is important to rinse the container 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 homogenous and 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 per day).
• 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 unmedicated water to rinse the water lines.

ADVERSE REACTIONS

None known.

OVERDOSE

No adverse reactions were observed following treatment of 3-week old and adult chickens dosed at up to 5 times the recommended dose, for 3 times the recommended duration of treatment.

No negative effect on egg production was observed when laying hens were treated at 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 at 3 times the recommended dose, for 2 times the recommended duration of treatment.

IDENTIFICATION

A light yellow to yellowish-brown solution for use in drinking water. The colour of the Exzolt^® 10 mg/mℓ Oral Solution may change slightly over time due to the presence of the antioxidant, α-tocopherol.

PRESENTATION

Pack sizes of 1 ℓ or 4 ℓ packed in high-definition polyethylene (HDPE) bottle closed with an aluminium foil seal and a child-resistant polypropylene screw cap.

Pack size of 50 mℓ packed in a Type III amber coloured glass bottle closed with a child resistant screw cap made of polypropylene and a tear away ring.

Not all pack sizes may necessarily be marketed.

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road

Spartan, 1619, RSA

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF NOTIFICATION OF APPROVAL OF THIS PACKAGE INSERT

28 October 2022

Zimbabwe Reg. No. 2019/80.16.00/9778 Pharmacological classification: 80.16.00 Distribution category: VMGD