Suspension for use in drinking water.

White to almost white suspension.

Treatment of chickens infected with Heterakis gallinarum (adult stages), Ascaridia galli (adult stages) or Capillaria obsignata (adult stages).

Treatment of pheasants infected with Heterakis gallinarum (adult stages).

For use in drinking water.

Shake well before use.

To ensure administration of the correct dose, body weight should be determined as accurately as possible.

Before allowing animals to have access to the medicated water, the water delivery system should be drained, if possible, and flushed with the medicated water to ensure accuracy of dosing. This procedure may need to be performed on all treatment days.

The uptake of medicated water depends on age and clinical conditions of the birds, ambient temperature and light regime. In order to obtain the correct dosage concentration of the product should be adjusted accordingly.

Ascaridia galli and Heterakis gallinarum: The dose is 1.0 mg fenbendazole per kg body weight per day (equivalent to 0.005 ml of the product). This dose has to be administered on 5 consecutive days.

Capillaria obsignata: The dose is 2.0 mg fenbendazole per kg body weight per day (equivalent to 0.01 ml of the product). This dose has to be administered on 5 consecutive days.

Dose calculation:
The required daily amount of product is calculated from the total estimated body weight (kg) of the entire group of chickens or pheasants to be treated. Please use the following formula:

Treatment of Ascaridia galli and Heterakis gallinarum:

ml product/day = total estimated body weight (kg) of chickens/pheasants to be treated x 0.005 ml

Treatment of Capillaria obsignata:

ml product/day = total estimated body weight (kg) of chickens to be treated x 0.01 ml

Follow the instructions described below to prepare the medicated water. Use a sufficiently accurate commercially available measuring device.

For each treatment day the medicated water needs to be freshly prepared.

For use in a medication tank:

For use in chickens, add the calculated amount of product to 40-80% of the daily water ration. For use in pheasants, add the calculated amount of product to 40% of the daily water ration. Stir until content in the medication tank is visibly homogeneous. The medicated water appears hazy. No further stirring during administration is necessary.

For use in dosing pump:

Add the calculated amount of product to the unmedicated water in the stock suspension container of the dosing pump. The volume of unmedicated water in the stock suspension container has to be calculated taking as a basis the preset injection rate of the dosing pump and 40 to 80% of the chickens’ daily water ration or 40% of the pheasants’ daily water ration. Stir until content in the stock suspension container is visibly homogeneous. The medicated water appears hazy.

During treatment all animals must have solely but unrestricted access to the medicated water.

During treatment, after complete consumption of the medicated water, animals must be allowed access to un-medicated drinking water as soon as possible.

Ensure that the total amount of medicated water offered is consumed.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

the safety of the product at overdose has not been evaluated in the target species (chickens and pheasants) of less than 3 weeks of age.

Use of the product deviating from the instructions in the SPC may increase the risk of development of resistance.

The veterinary medicinal product should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.

Meat and offal: 6 days. Do not release pheasants for hunting for at least 6 days after the end of medication.

Eggs: zero days

Adverse reactions (frequency and seriousness): None known.

Chicken: Can be used during lay. The safety of the veterinary medicinal product has not been established in male birds. Therefore use in male birds only according to the benefit/risk assessment by the responsible veterinarian.

Pheasants: The safety of the product has not been evaluated in breeding pheasants. Therefore in these birds use only according to the benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction: None known.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

No adverse reactions have been observed at up to 5-fold the maximum recommended dose of 2 mg/kg body weight/day over 18 days in broilers (aged approximately 3 weeks) and up to a 40-fold overdose in pheasants (aged approximately 3 weeks). No adverse reactions have been observed at up to 3-fold the maximum recommended dose of 2 mg/kg body weight/day (chickens) in layers and breeders.

Pharmacotherapeutic group: Anthelmintics, benzimidazole derivatives – fenbendazole.

ATCvet Code: QP52AC13

Fenbendazole is an anthelmintic belonging to the benzimidazole-carbamate group. It acts by interfering with the energy metabolism of the nematode.

Fenbendazole inhibits the polymerisation of tubulin to microtubules. This interferes with essential structural and functional properties of the cells of helminths, such as formation the cytoskeleton, formation of the mitotic spindle and the uptake and intracellular transport of nutrients and metabolic products. Fenbendazole is active and has a dose dependent activity on Heterakis gallinarum (adult stages), Ascaridia galli (adult stages) and Capillaria obsignata (adult stages) in chickens, and activity against adult Heterakis gallinarum in pheasants.

After oral administration fenbendazole is only partially absorbed. Following absorption, fenbendazole is rapidly metabolised in the liver mainly to its sulphoxide (oxfendazole) and further to its sulphone (oxfendazole sulphone). In chickens oxfendazole sulfone is the maincomponent detected in plasma, accounting for about 3/4 of the total AUC (i.e. the sum of the AUC for fenbendazole, oxfendazole and oxfendazole sulphone). Fenbendazole and its metabolites are distributed throughout the body, reaching highest concentrations in the liver. The elimination of fenbendazole and its metabolites occurs primarily via the faeces.

White cylindrical High Density Polyethylene (HDPE) bottle with white polypropylene (PP) screw tamper-evident closure of 125 ml and 1 litre; white rectangular HDPE bottle of 1 litre with vertically see-through bar and without graduated scale closed with white PP tamper-evident screw cap; white HDPE canisters with white HDPE ribbed tamperevident screw cap of 2.5 litres and 5 litres.

Not all pack sizes may be marketed.

Shelf life of the veterinary medicinal product as packaged for sale: 30 months.

Shelf life after first opening the immediate packaging: 3 months.

Shelf life of the medicated drinking water: 24 hours.

Product as packed for sales and after first opening: Do not freeze. Protect from frost.

Medicated water: Do not freeze.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. The product should not enter water courses as this may be dangerous for aquatic organisms.

Vm 30282/4037