Gallifen
Active substance
ATC code
Species
Chickens and pheasants.
Indications
Treatment of chickens infected with Heterakis gallinarum (L5 and adult stages) and Ascaridia galli (adult stages).
Treatment of pheasants infected with Heterakis gallinarum (adult stages).
Dose to be administered and administration route
In feed use.
The daily dose is 1 mg fenbendazole per kg bodyweight per day administered in feed for 5 consecutive days.
For the preparation of medicated feed:
1 mg fenbendazole per kg bodyweight per day corresponds to 0.025 g of the veterinary medicinal product per kg bodyweight per day.
For the preparation of the medicated feed the bodyweight of the animals to be treated and their actual daily intake of feed should be taken into due account.
To provide the required amount of fenbendazole per kg medicated feed the premix has to be incorporated into the feed according to the following formula:
For incorporation into dry feed at the registered mill:
A manufacturer who is approved to incorporate veterinary medicinal products, or premixtures containing such veterinary medicinal products, directly at any concentration, must be responsible for mixing when incorporation is less than 2 kg per tonne for final feed.
To ensure adequate distribution of the veterinary medicinal product in the final feed it is recommended to premix the veterinary medicinal product at a ratio of 1:10 with feed ingredients before blending into the final feed. If the premix is used for supplementation of pelleted feed, the pelleting temperature should not exceed 105 °C.
Not to be mixed in liquid feed.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.
The uptake of medicated feed depends on the clinical condition of the animals and environmental factors. The feed intake should be monitored regularly and the incorporation rate adjusted accordingly in order to guarantee an intake of 1 mg fenbendazole per kg bodyweight per day.
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 the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Gallifen 40 mg/g premix for medicated feeding stuff for chickens and pheasants
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
Active substance:
Fenbendazole 40 mg
Excipients:
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Premix for medicated feeding stuff. Off-white to light yellow granules.
4. CLINICAL PARTICULARS
4.1 Target species
Chickens.
Pheasants.
4.2 Indications for use, specifying the target species
Treatment of chickens infected with Heterakis gallinarum (L5 and adult stages) and Ascaridia galli (adult stages).
Treatment of pheasants infected with Heterakis gallinarum (adult stages).
4.3 Contraindications
Do not use in cases of hypersensitivity to the active substance, other benzimidazoles or any of the excipients.
4.4 Special warnings for each target species
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.
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:
• Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
• Under dosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any).
4.5 Special precautions for use
Special precautions for use in animals
The safety of the product at overdose has not been evaluated in chickens less than 8 weeks old.
Do not use in cases of Capillaria spp. infestations. The efficacy of the veterinary medicinal product at the recommended dosage is not sufficient for the treatment of infections with Capillaria spp. The absence of Capillaria spp. infestation should be confirmed prior to use of the product. In case of Capillaria infestation another appropriate anthelmintic veterinary medicinal product should be used. Use of the product deviating from the instructions in the SPC may increase the risk of development of resistance.
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.
Accidental ingestion of the product should be avoided.
In the event of accidental ingestion, rinse mouth with plenty of clean water and seek medical advice.
This product may cause eye irritation and skin sensitisation.
Avoid contact with the eyes and skin.
When handling or mixing, care should be taken to avoid direct contact with the skin and eyes, and inhalation of dust, by wearing goggles, impervious gloves and a disposable half-mask respirator conforming to European Standard EN149 or a nondisposable respirator to European Standard EN 140 with a filter to EN 143.
Wash hands after use.
In case of skin and/or eye contact, immediately rinse with plenty of water.
Other precautions
The veterinary medicinal product should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
4.6 Adverse reactions (frequency and seriousness)
None known.
4.7 Use during pregnancy, lactation or lay
Can be used in chickens in lay.
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.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
Oral use. In feed use.
The daily dose is 1 mg fenbendazole per kg b.w. per day administered in feed for 5 consecutive days.
For the preparation of medicated feed:
1 mg fenbendazole per kg bw per day corresponds to 0.025 g of the product per kg bw per day.
For the preparation of the medicated feed the body weight of the animals to be treated and their actual daily intake of feed should be taken into due account.
To provide the required amount of fenbendazole per kg medicated feed the premix has to be incorporated into the feed according to the following formula:
0.025 g of the product average body weight (kg)
per kg b.w. daily X of the animals to be treated
------------------------------------------------------------------------------------ = g of the
product
average daily feed intake per animal (kg) per kg feed
For incorporation into dry feed at the registered mill:
A manufacturer who is approved to incorporate veterinary medicinal products, or premixtures containing such products, directly at any concentration, must be responsible for mixing when incorporation is less than 2 kg per tonne for final feed.
To ensure adequate distribution of the product in the final feed it is recommended to premix the product at a ratio of 1:10 with feed ingredients before blending into the final feed. If the premix is used for supplementation of pelleted feed, the pelleting temperature should not exceed 105 °C.
Not to be mixed in liquid feed.
To ensure administration of a correct dose, body weight should be determined as accurately as possible.
The uptake of medicated feed depends on the clinical condition of the animals and environmental factors. The feed intake should be monitored regularly and the incorporation rate adjusted accordingly in order to guarantee an intake of 1 mg fenbendazole per kg bodyweight per day.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No undesirable effects have been observed in chickens (8-9 weeks of age) at up to 5 times the recommended dose.
Although not observed in studies investigating the effects of overdosing in other classes of the target species, an increase in water intake compared with controls has been reported in laying hens treated with a dose exceeding 3X the recommended dose.
A small (<3%) but statistically significant difference in mean body weight of chicks from treated layers was observed in conditions of overdosing (3X the recommended dose for a duration exceeding 3X the recommended one in clinical conditions).
4.11 Withdrawal periods
Meat and offal: 8 days. Do not release pheasants for hunting for at least 8 days after the end of medication.
Eggs: zero days.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anthelmintics, benzimidazole derivatives - fenbendazole ATCvet Code: QP52AC13
5.1 Pharmacodynamic properties
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 of the cytoskeleton, formation of the mitotic spindle and the uptake and intracellular transport of nutrients and metabolic products. Fenbendazole has activity against Ascaridia galli (adult stage) and Heterakis gallinarum (L5 and adult stages) in chickens and against H. gallinarum (adult stage) in pheasants.
5.2 Pharmacokinetic particulars
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 main component detected in plasma, accounting for about 3/4 of the total AUC (ie 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.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize Starch
Starch, pregelatinised
6.2 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 3 months.
Shelf life after incorporation into meal or pelleted feed: 3 months.
6.4 Special precautions for storage
Veterinary medicinal product as packaged for sale: no special storage precautions.
After first opening of the immediate packaging: do not store above 25°C.
Medicated feed (mash and pelleted): no special storage precautions.
6.5 Nature and composition of immediate packaging
Polyethylene-aluminium-paper /paper/paper bag of 20 kg.
Polyethylene/aluminium foil/polyethylene terephthalate zipper bags of 1, 2 and 5 kg.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
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 fish and other aquatic organisms.
7. MARKETING AUTHORISATION HOLDER
Huvepharma N.V.
Uitbreidingstraat 80
2600 Antwerpen
Belgium
8. MARKETING AUTHORISATION NUMBER
Vm 30282/4029
9. DATE OF FIRST AUTHORISATION
24 January 2017
10. DATE OF REVISION OF THE TEXT
December 2021
Approved: 16/12/21
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