Summary of medicine characteristics - Panacur AquaSol
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Panacur AquaSol 200 mg/ml suspension for use in drinking water for pigs and chickens
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
Fenbendazole 200 mg
Excipient:
Benzyl alcohol (E1519) 20 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White to off-white suspension for use in drinking water.
The suspension particles are in the sub micron size range.
4. CLINICAL PARTICULARS4.1 Target species
Pigs and chickens
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4.2 Indications for use, specifying the target species
Pigs:
Treatment and control of gastro-intestinal nematodes in pigs infected with:
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- Ascaris suum (adult, intestinal and migrating larval stages)
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- Oesophagostomum spp. (adult stages)
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- Trichuris suis (adult stages)
Chickens:
Treatment of gastro-intestinal nematodes in chickens infected with:
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- Ascaridia galli (L5 and adult stages)
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- Heterakis gallinarum (L5 and adult stages) - Capillaria spp. (L5 and adult stages)
4.3 Contraindications
None.
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4.4 Special warnings for each target species
Parasitic resistance to any particular class of anthelmintic may develop following frequent repeated use of an anthelmintic of that class.
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4.5 Special precautions for use
Special precautions for use in animals
In the absence of available data, treatment of chicken less than 3 weeks of age should be based on a benefit/risk assessment by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This veterinary medicinal product may be toxic to humans after ingestion. Embryotoxic effects cannot be excluded. Pregnant women must take extra precautions when handling this veterinary medicinal product.
Avoid contact with skin, eye and mucous membranes. People with known hypersensitivity to fenbendazole should avoid contact with the veterinary medicinal product.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product and cleaning the measuring device. Wash hands after use.
In case of accidental spillage onto skin and/or eye, immediately rinse with plenty of water. Remove contaminated clothes after spillage.
Other precautions
The veterinary medicinal product should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
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4.6 Adverse reactions (frequency and seriousness)
None known.
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4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy, lactation or lay.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
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4.9 Amounts to be administered and administration route
In drinking water use.
To ensure administration of the correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be 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.
Pigs:
The dose is 2.5 mg fenbendazole per kg body weight per day (equivalent to 0.0125 ml Panacur AquaSol). For the treatment and control of Ascaris suum and Oesophagostomum spp. this dose has to be administered on 2 consecutive days. For the treatment and control of Trichuris suis the dose has to be administered on 3 consecutive days.
Dose calculation:
The required daily amount of product is calculated from the total estimated body weight (kg) of the entire group of pigs to be treated. Please use the following formula:
ml product/day = Total estimated body weight (kg) of pigs to be treated x 0.0125 ml
Examples:
| Total body weight of pigs to be treated | Day 1 amount of product | Day 2 amount of product | Day 3 amount of product | Total amount (for 2 days) | Total amount (for 3 days) |
| 80,000 kg | 1,000 ml | 1,000 ml | 1,000 ml | 2 × 1,000 ml | 3 × 1,000 ml |
| 320,000 kg | 4,000 ml | 4,000 ml | 4,000 ml | 2 × 4,000 ml | 3 × 4,000 ml |
Chickens:
Ascaridia galli and Heterakis gallinarum: 1 mg fenbendazole per kg body weight per day (equivalent to 0.005 ml Panacur AquaSol) for 5 consecutive days.
Capillaria spp.: 2 mg fenbendazole per kg body weight per day (equivalent to 0.01 ml Panacur
AquaSol) for 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 to be treated. Please use the following formula:
Treatment of Ascaridia galli and Heterakis gallinarum:
ml product/day = Total estimated body weight (kg) of chicken to be treated x 0.005 ml
Treatment of Capillaria spp.
ml product/day = Total estimated body weight (kg) of chicken to be treated x 0.01 ml
Examples:
| Total body weight of chickens to be treated | Amount of product per day for 1 mg FBZ/ kg (ml/day) | Total amount of product (ml/for 5 days) | Amount of product per day for 2 mg FBZ/ kg (ml/day) | Total amount of product (ml/for 5 days) |
| 40,000 kg 160,000 kg | 200 ml 800 ml | 1,000 ml (5×200 ml) 4,000 ml (5× 800 ml) | 400 ml 1600 ml | 2,000 ml (5×400 ml) 8,000 ml (5×1600 ml) |
Follow the instructions in the order described below to prepare the medicated water. Use a sufficiently accurate measuring device, which should be properly cleaned after use.
For each treatment day the medicated water needs to be freshly prepared.
Prepare a predilution of the veterinary medicinal product with an equal amount of water:
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1) Select a measuring device that has at least double volume of the calculated daily product volume.
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2) Pour a volume of water equal to the calculated volume of product needed into the measuring device.
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3) Shake the product well before mixing.
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4) Fill up the measuring device containing the water with the calculated volume of the product to obtain the predilution.
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5) Add the obtained predilution to the water supply system as described below.
For use in medication tank:
Add the entire content of the measuring device (predilution) to the volume of drinking water usually consumed by the animals in between 3 to 24 hours.
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 entire content of the measuring device (predilution) 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 the volume of drinking water usually consumed by the animals in between 3 and 24 hours.
Stir until content in the stock suspension container is visibly homogeneous. The medicated water appears hazy.
At concentrations of up to 5 ml/l stock suspension (1 g fenbendazole/l) no stirring is required.
At concentrations above 5 ml/l stock suspension and up to 75 ml/l stock suspension (15 g fenbendazole/l) and within an administration period of up to 8 hours no stirring of the stock suspension is required. If the administration period exceeds 8 hours, but being no longer than 24 hours, the stock suspension container needs to be equipped with a stirring device.
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 unmedicated drinking water as soon as possible.
Ensure that the total amount of medicated water offered is consumed.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Pigs:
No adverse reactions have been observed at up to ten-fold overdose in pigs.
Chickens:
No adverse reactions have been observed at up to 2.5-fold the maximum recommended dose of 2 mg fenbendazole/ kg body weight in layers and broilers (aged 21 days). A transient mild to moderate reduction in bone marrow cellularity accompanied by a transient reduction in peripheral white blood cell counts and heterophils was observed in 4 out of 12 chickens administered an overdose of 10 mg fenbendazole/kg bodyweight for 21 consecutive days. No adverse reactions have been observed at up to 1.5-fold the maximum recommended dose of 2 mg fenbendazole/ kg body weight in breeders. No detrimental effects on hatchability and chick viability were evident. Higher overdoses have not been tested.
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4.11 Withdrawal period(s)
Pigs:
Meat and offal: 4 days.
Chickens:
Meat and offal: 6 days for 1 mg fenbendazole /kg dose;
9 days for 2 mg fenbendazole /kg dose.
Eggs: zero days.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anthelmintics, benzimidazole and related substances – 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 is effective and has a dose dependent effect on adult and immature stages. Fenbendazole has an ovicidal effect on nematode eggs.
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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 pigs, oxfendazole is the main component detected in plasma, accounting for about 2/3 of the total AUC (i.e. the sum of the AUC for fenbendazole, oxfendazole and oxfendazole sulphone). In chickens, oxfendazole sulfone is the main component 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 and to a small extent in the urine (pigs).
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Polysorbate 80
Simethicone emulsion 30 %
Benzyl alcohol (E1519)
Purified water
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: 6 months.
Shelf life after dilution according to directions: 24 hours.
6.4. Special precautions for storage
Do not freeze. Protect from frost.
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6.5 Nature and composition of immediate packaging
HDPE container with pulp board/aluminium/polyester/MDPE seal closed with child-resistant polypropylene screw cap.
Pack sizes: 1 litre and 4 litres.
The 4 litre container is provided with a separate dispenser made of low density polyethylene and polypropylene.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
Tel.: +31 485 587600
Fax: +31 485 577333
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/11/135/002
EU/2/11/135/003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 9 December 2011
Date of last renewal: 26 August 2016