Panacur® Aquasol

FOR ANIMAL USE ONLY

PANACUR^® AQUASOL

Reg. No. G4316 (Act 36/1947)

ORAL SUSPENSION FOR USE IN DRINKING WATER FOR PIGS AND CHICKENS

Only for use by or under the supervision of persons registered in terms of, or authorized in terms of, Section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982).

INDICATIONS

For the treatment and control of gastrointestinal nematodes in pigs infected with Ascaris suum (adult, intestinal and migrating larval stages), Oesophagostomum spp. (adult stages), Hyostrongylus rubidus (adult and larval stages), and Trichuris suis (adult stages) and in chickens infected with Ascaridia galli and Heterakis gallinarum (pre-adult and adult stages). Panacur^® AquaSol has an ovicidal effect on nematode eggs.

COMPOSITION

Contains:Fenbendazole 200 mg/mℓ

Preservative: Benzyl alcohol 20 mg/mℓ

*benzimidazole

CAUTION

STORAGE

• Store at or below 30 °C.
• Do not freeze.
• After first opening the immediate packaging, use within 6 months.
• Use the medicated water within 24 hours.

WARNINGS

• Withdrawal Periods:   Pigs              – 4 days withdrawal period for meat and offal.

                                       Chickens     – 6 days for meat and offal at 1 mg/kg.

                                                              -9 days for meat and offal at 2 mg/kg.

                                       Eggs             – zero days.

• Parasitic resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
• Can be used during pregnancy and lactation.
• In the absence of compatibility studies, Panacur^® AquaSol must not be mixed with other veterinary medicinal products.
• Panacur^® AquaSol should not enter water sources as it is dangerous to aquatic organisms.
• Dispose of any containers, disposable equipment and any other waste after use, in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008) and do not reuse for any other purpose.
• KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
• Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING PANACUR^® AQUASOL TO ANIMALS

• This product may cause hypersensitivity reactions.
• Wear protective gloves while handling the product.
• Direct contact with the product should be avoided. Wash hands after use.
• In case of skin and/or eye contact, immediately rinse eyes with plenty of water.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

• Shake well before use.
• For use in drinking water.
• To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.

DOSAGE

Pigs

The dose is 2,5 mg fenbendazole/kg body weight/day (equivalent to 0,0125 mg Panacur^® AquaSol). For the treatment and control of Ascaris suum, Oesophagostomum spp. and Hyostrongylus rubidus 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:

Amount of product/day = Total estimated body weight (kg) of pigs to be treated x 0,0125 mℓ.

Example

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 x 1 000 mℓ	3 x 1 000 mℓ
320 000 kg	4 000 mℓ	4 000 mℓ	4 000 mℓ	2 x 4 000 mℓ	3 x 4 000 mℓ

Chickens

The dose is 1 mg fenbendazole/kg body weight/day (equivalent to 0,005 mℓ Panacur^® AquaSol). This dose has to be administered on 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:

Amount of product/day = Total estimated body weight (kg) of chickens to be treated x 0,005 mℓ.

Example

Total body weight of chickens to be treated	Amount of product per day (mℓ/day)	Total amount of product (mℓ/for 5 days)
40 000 kg	200 mℓ	1 000 mℓ (5 x 200 mℓ)
160 000 kg	800 mℓ	4 000 mℓ (5 x 800 mℓ)

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 product with an equal amount of water:
• Select a measuring device that has at least double volume of the calculated daily product volume.
• Pour a volume of water equal to the calculated volume of product needed into the measuring device.
• Shake the product well before mixing.
• Fill up the measuring device containing the water with the calculated volume of the product to obtain the predilution.
• Add the obtained predilution to the water supply system as described below.

For use in medication tank

• Add the entire contents of the measuring device (predilution) to the volume of drinking water usually consumed by the animals between 3 to 24 hours.
• Stir until contents in the medicated tank is visibly homogeneous. The medicated water appears hazy. No further stirring during administration is necessary.

For use in dosing pump

• Add the entire contents 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 between 3 and 24 hours.
• Stir until contents in the stock suspension container is visibly homogeneous. The medicated water appears hazy.
• For all 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 up to 8 hour administration period 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 pigs or chickens must have solely but unrestricted access to the medicated water.
• During treatment, after complete consumption of the medicated water, the pigs or chickens must be allowed access to unmedicated water as soon as possible.
• Ensure that the total amount of medicated water offered is consumed.

OVERDOSE

No undesirable effects have been observed in chickens at up to five times the recommended dose.

PRESENTATION

White to off-white oral suspension filled into a clear 1 ℓ or 4 ℓ high density polyethylene (HDPE) container with a thermo seal and closed with red propylene child-resistant, screw caps.

The 4 ℓ container is provided with a separate polyethylene dispenser (aeroflow tap).

Not all pack sizes may be marketed.

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road, Spartan

1619, RSA

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

11 February 2019