Panacur AquaSol (Canada)

Company: Merck Animal Health

Fenbendazole Oral Suspension

SWINE and CHICKEN Dewormer

DIN 02458535

Veterinary Use Only

Description

Concentrate suspension for oral administration via drinking water. Each mL contains 200 mg of the active ingredient fenbendazole, an antiparasitic drug.

Warnings

Treated swine must not be slaughtered for use in food for at least two (2) days after the latest treatment with this drug. No withdrawal period is required for chickens when treated according to the label. No withdrawal period is required for eggs obtained from treated hens when this drug is used according to the label. Avoid direct contact with skin and eyes. Protective gloves should be used and care should be taken when handling the product. If accidental eye exposure occurs, rinse eyes with clean water. If accidental skin exposure occurs, wash the skin immediately with soap and water. KEEP OUT OF THE REACH OF CHILDREN.

Storage

Store at or below 30°C. Do not freeze. Once opened, do not store the container above 25°C. Use within 6 months after opening. Use the medicated water within 24 hours.

SWINE

Panacur AquaSol Indications

For the treatment of parasitic infections due to the following internal parasites in growing pigs, sows, gilts and boars:

- Lungworms: Adult stage of Metastrongylus apri and M. pudendotectus

- Small stomach worms: Adult stage of Hyostrongylus rubidus

- Intestinal worms: Adult and developing larval stages of the roundworm Ascaris suum, the whipworm Trichuris suis and the adult stage of the nodular worm Oesophagostomum dentatum

Dosage and Administration

Administer orally to pigs via the drinking water at a daily dosage of 2.2 mg fenbendazole/kg BW for 3 consecutive days.

Dose Calculation:

The daily dose is 2.2 mg fenbendazole per kg BW which is equivalent to 0.011 mL Panacur^® AquaSol™. The required daily volume 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:

Total estimated body weight [kg] of the pigs to be treated x 0.011 mL = mL Panacur^® AquaSol™/day

Examples:

General Mixing Directions:

Follow the instructions in the order described below to prepare the medicated water. The medicated water must be prepared daily prior to each administration.

-Prepare a 1 to 1 dilution (pre-dilution) of Panacur^® AquaSol™ in water:

1) Calculate the volume of Panacur^® AquaSol™ to be administered daily.

2) Select a measuring device capable of accurately measuring a volume of at least twice the calculated Panacur^® AquaSol™ daily volume.

[Note: If the total volume of the 1 to 1 dilution needed exceeds the volume of the largest available measuring device, divide the total volume into two or more smaller batches of 1 to 1 dilution, prepared following the steps below. Panacur^® AquaSol™ should always be measured by adding it to a measuring device that already contains an equivalent volume of water.]

3) Pour a volume of water equal to the calculated volume of product needed into the measuring device.

4) Shake Panacur^® AquaSol™ well before measuring.

5) Fill up the measuring device containing the water with the calculated volume of Panacur^® AquaSol™ to obtain the 1 to 1 dilution.

[Note: If more than the required amount of the product is accidently poured into the measuring device, discard the entire contents and repeat the process from Step 3 above.]

6) Add the prepared 1 to 1 dilution of Panacur^® AquaSol™ in water to the water supply system as described below. Be careful to avoid any accidental spill or loss of the 1 to 1 dilution as this may inadvertently result in less than the required dose of fenbendazole.

7) Rinse the container used to prepare the 1 to 1 dilution of Panacur^® AquaSol™ with additional water, and add the rinse water to the medicated water tank or stock suspension container of the dosing pump.

For use in medication tank:

Add the entire 1 to 1 dilution of Panacur^® AquaSol™ in water to the medication tank containing the volume of drinking water usually consumed by the animals in 3 to 24 hours.

Stir until content in the medication tank is visibly homogeneous. The medicated water should appear hazy. No further stirring during administration is necessary.

For use in dosing pump:

Add the entire 1 to 1 dilution of Panacur^® AquaSol™ (in water) to the water in the stock suspension container (also called stock suspension) of the dosing pump. The volume of water in the stock suspension has to be calculated taking as a basis the pre-set injection rate of the dosing pump and the volume of drinking water usually consumed by the animals over a period of 3 to 24 hours. Stir until the content in the stock suspension is visibly homogeneous. The medicated water should appear hazy.

At concentrations of up to 5 mL Panacur^® AquaSol™/L stock suspension (1 g of fenbendazole/L), no stirring is required during the administration period. At concentrations from 5 mL up to 75 mL Panacur^® AquaSol™/L stock suspension (1 to 15 g of fenbendazole/L) and within up to 8 hours during the treatment administration period, 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 needs to be equipped with a stirring device.

During treatment all swine must have sole and unrestricted access to the medicated water. After complete consumption of the medicated water, the swine should have access to non-medicated drinking water ad libitum. Ensure that the total amount of medicated water offered is consumed.

CHICKENS

Panacur AquaSol Indications

For the treatment of:

1) adult Ascaridia galli infections in broiler chickens and replacement chickens;

2) adult A. galli and Heterakis gallinarum infections in laying hens and breeding chickens.

Dosage and Administration

Administer orally to chickens via the drinking water at a daily dose of 1.0 mg fenbendazole/kg BW for 5 consecutive days.

Dose Calculation:

The daily dose of 1.0 mg fenbendazole per kg BW is equivalent to 0.005 mL Panacur® AquaSol™ per kg BW. The required daily volume 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:

Total estimated body weight [kg] of the chickens to be treated x 0.005 mL = mL Panacur^® AquaSol™/day

Examples:

General Mixing Directions:

Follow the instructions in the order described below to prepare the medicated water. The medicated water must be prepared daily prior to each administration.

-Prepare a 1 to 1 dilution (pre-dilution) of Panacur^® AquaSol™ in water:

1) Calculate the volume of Panacur^® AquaSol™ to be administered daily.

2) Select a measuring device capable of accurately measuring a volume of at least twice the calculated Panacur^® AquaSol™ daily volume.

[Note: If the total volume of the 1 to 1 dilution needed exceeds the volume of the largest available measuring device, divide the total volume into two or more smaller batches of 1 to 1 dilution, prepared following the steps below. Panacur^® AquaSol™ should always be measured by adding it to a measuring device that already contains an equivalent volume of water.]

3) Pour a volume of water equal to the calculated volume of product needed into the measuring device.

4) Shake Panacur^® AquaSol™ well before measuring.

5) Fill up the measuring device containing the water with the calculated volume of Panacur^® AquaSol™ to obtain the 1 to 1 dilution.

[Note: If more than the required amount of the product is accidently poured into the measuring device, discard the entire contents and repeat the process from Step 3 above.]

6) Add the prepared 1 to 1 dilution of Panacur^® AquaSol™ in water to the water supply system as described below. Be careful to avoid any accidental spill or loss of the 1 to 1 dilution as this may inadvertently result in less than the required dose of fenbendazole.

7) Rinse the container used to prepare the 1 to 1 dilution of Panacur^® AquaSol™ with additional water, and add the rinse water to the medicated water tank or stock suspension container of the dosing pump.

For use with a medication tank:

Add the entire 1 to 1 dilution of Panacur^® AquaSol™ in water to the medication tank containing the volume of drinking water usually consumed by the animals in 3 to 24 hours.

Stir until content in the medication tank is visibly homogeneous. The medicated water should appear hazy. No further stirring during administration is necessary.

For use with a dosing pump:

Add the entire 1 to 1 dilution of Panacur^® AquaSol™ (in water) to the water in the stock suspension container (also called stock suspension) of the dosing pump. The volume of water in the stock suspension has to be calculated taking as a basis the pre-set injection rate of the dosing pump and the volume of drinking water usually consumed by the animals over a period of 3 to 24 hours. Stir until the content in the stock suspension is visibly homogeneous. The medicated water should appear hazy.

At concentrations of up to 5 mL Panacur^® AquaSol™ /L stock suspension (1 g of fenbendazole/L), no stirring is required during the administration period. At concentrations from 5 mL up to 75 mL Panacur^® AquaSol™ /L stock suspension (1 to 15 g of fenbendazole/L) and within up to 8 hours during the treatment administration period, 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 needs to be equipped with a stirring device.

During treatment all chickens must have sole and unrestricted access to the medicated water. After complete consumption of the medicated water, the chickens should have access to non-medicated drinking water ad libitum. Ensure that the total amount of medicated water offered is consumed.

CAUTIONS:

- Consult a veterinarian for diagnosis and treatment of parasites in chickens and swine.

- 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 this anthelmintic, or other anthelmintics from the same class, over an extended period of time.

● Administration of a subtherapeutic dose, either intentionally or inadvertently, through underestimating the weight of the individual animal, failure to administer the product correctly or inaccurate calibration of the dosing device.

- Suspected cases of anthelmintic resistance should be further investigated using appropriate tests (e.g. Fecal 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.

Intervet Canada Corp., Subsidiary of Merck & Co., Inc., 16750, route Transcanadienne, Kirkland, QC, H9H 4M7

1-866-683-7838

™ Intervet International B.V., used under license.

^® Intervet International B.V., used under license.

Net Contents: 1 L

21OCT2016rev

CPN: 1208287.0