Target species
Chickens
Pheasants
Indications for use, specifying the target species
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).
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients
Special warnings for each target species
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.
Special precautions for use
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
Adverse reactions (frequency and seriousness)
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 the national competent authority via the national reporting system. See also section ‘Contact details’ of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
See also section 4.10
Laying birds:
Chickens: can be used during lay. See also section 4.10 ‘Overdose (symptoms, emergency procedures), if necessary’.
Fertility:
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.
Amount(s) to be administered and administration route
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:
Treatment of Ascaridia galli and Heterakis gallinarum:
ml veterinary medicinal product/day = total estimated body weight (kg) of chickens/pheasants to be treated x 0.005 ml
Treatment of Capillaria obsignata:
ml veterinary medicinal product/day = total estimated body weight (kg) of chickens to be treated x 0.01 ml
Treatment of Raillietina echinobothrida:
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 medication tank:
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.
For use in dosing pump:
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
Withdrawal period(s)
Chickens:
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
Pheasants:
Meat and offal: 6 days
Do not release pheasants for hunting for at least 6 days after the end of medication.
Eggs: zero days