Suspension for use in drinking water.

White to almost white suspension.

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

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

In drinking water use.

Shake well before use.

Underdosing could result in ineffective use and may favour resistance development.

To ensure a correct dosage, body weight should be determined as accurately as possible.

If animals are to be treated collectively, reasonably homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one. Accuracy of the dosing device should be thoroughly checked.

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 intake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of fenbendazole may need to 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 veterinary medicinal 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 veterinary medicinal product). This dose has to be administered on 5 consecutive days.

Raillietina echinobothrida: The dose is 3.0 mg fenbendazole per kg body weight per day (equivalent to 0.015 ml of the veterinary medicinal product). This dose has to be administered on 10 consecutive days.

Dose calculation: The required daily amount of veterinary medicinal 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:

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

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

ml veterinary medicinal product/day = total estimated body weight (kg) of chickens to be treated x 0.015 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 chickens, add the calculated amount of veterinary medicinal product to 40-80% of the daily water ration. For use in pheasants, add the calculated amount of veterinary medicinal 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.

Add the calculated amount of veterinary medicinal 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 unrestricted access to the medicated water as the sole source of drinking 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.

The veterinary medicinal product is to be used at the maximum recommended dose of 3 mg/kg/day for 10 consecutive days for the treatment of Raillietina echinobothrida which is encountered in free-ranging and traditionally reared poultry.

Do not use the veterinary medicinal product at this dose regimen in intensively reared broiler chickens which are unlikely to be infected with Raillietina echinobothrida.

Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the parasitic species and burden, or of the risk of infection based on its epidemiological features, for each flock.

Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a flock, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole flock should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific flock should be sought from the responsible veterinarian.

The use of this veterinary medicinal product should take into account local information about susceptibility of the target parasites, where available.

It is recommended to further investigate cases of suspected resistance, using an appropriate diagnostic method (e.g. Faecal Egg Count Reduction Test (FECRT). Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.

i). Special precautions for use in animals

The safety of the veterinary medicinal product at overdose has not been evaluated in chickens of less than 14 days of age and in pheasants of less than 3 weeks of age.

ii). Special precautions to be taken by the person administering the veterinary medicinal product to animals

- Embryotoxic effects cannot be excluded. Pregnant women must take extra precautions when handling this veterinary medicinal product.

- This veterinary medicinal product may be toxic to humans after ingestion.

- This veterinary medicinal product may cause eye irritation.

- Contact with the skin and the eyes or accidental ingestion of the veterinary medicinal product should be avoided.

- Do not smoke, eat or drink when handling the veterinary medicinal product.

- In the event of accidental ingestion, rinse mouth with plenty of clean water and seek medical advice. In the event of accidental contact with the skin or eyes, rinse with plenty of clean water and seek medical advice.

- Wash hands after use.

iii). Other precautions

The veterinary medicinal product should not enter water courses as fenbendazole may be dangerous for fish and other aquatic organisms.

Meat and offal: 6 days for the dosage 1 and 2 mg fenbendazole/kg body weight/day 8 days for the dosage 3 mg fenbendazole/kg body weight/day

Eggs: zero days

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.

Chickens: can be used during lay. See also section 4.10 ‘Overdose (symptoms, emergency procedures), if necessary’.

Chickens: 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 veterinary medicinal 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 6.7-fold the maximum recommended dose of 3 mg/kg body weight/day over 30 days in broilers (aged approximately 14 days) and up to a 40-fold overdose in pheasants (aged approximately 3 weeks).

No adverse reactions have been observed in layers and breeders administered a dose rate of 4-fold the maximum recommended dose of 3 mg/kg body weight/day (i.e., 12 mg/kg body weight/day) over 30 days, however offspring viability (including reduced incubation survival, reduced fertility (fewer eggs hatched) and lower body weight of chicks) was adversely affected at this dose rate.

Increased frequency of physical abnormalities of eggs was observed at dose rates of 3- and 4-fold the maximum recommended dose of 3 mg/kg body weight/day administered over 30 days.

No adverse effects on offspring viability or egg physical characteristics were observed at 2-fold the maximum recommended dose of 3 mg/kg/day (chickens) over 30 days 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 or cestode.

Fenbendazole inhibits the polymerisation of tubulin to microtubules. This interferes with essential structural and functional properties of the cells of helminths, such as formation of 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), Capillaria obsignata (adult stages) and Raillietina echinobothrida (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.

Medicines should not be disposed of via wastewater or household waste. The veterinary medicinal product should not enter water courses as fenbendazole may be dangerous for fish and other aquatic organisms. Dispose of waste materials in accordance with local requirements. Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

Vm 30282/4037