Patient leaflet - Panacur AquaSol
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Panacur AquaSol 200 mg/ml suspension for use in drinking water for pigs and chickens
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
Intervet International B.V.
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer responsible for batch release:
Intervet Productions S.A.
Rue de Lyons
27460 Igoville
France
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Panacur AquaSol 200 mg/ml suspension for use in drinking water for pigs and chickens Fenbendazole
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3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
The veterinary medicinal product is a white to off-white suspension for use in drinking water containing 200 mg/ml of fenbendazole and 20 mg/ml of benzyl alcohol (E1519).
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4. INDICATION(S)
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)
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- Capillaria spp. (L5 and adult stages)
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
None known.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Pigs and chickens.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
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.
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 chicken 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) |
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9. ADVICE ON CORRECT ADMINISTRATION
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.
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 hour also 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, the animals must be allowed access to unmedicated drinking water as soon as possible.
Ensure that the total amount of medicated water offered is consumed.
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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.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Do not freeze. Protect from frost.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Shelf life after first opening the immediate packaging: 6 months.
Shelf life after dilution according to directions: 24 hours.
12.
SPECIAL WARNINGS
Special precautions for use in animals :
Parasitic resistance to any particular class of anthelmintic may develop following frequent repeated use of an anthelmintic of that class.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
This product may be toxic to humans after ingestion. Embryotoxic effects cannot be excluded.
Pregnant women must take extra precautions when handling this 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.
Pregnancy, lactation and lay:
Can be used during pregnancy and lactation or lay.
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Panacur AquaSol should not enter water courses as this may be dangerous for fish and other aquatic organisms.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED