Safe-Guard AquaSol: Product Information

SAFE-GUARD AQUASOL- fenbendazole suspension
Merck Sharp & Dohme Corp.

PRODUCT INFORMATION
1Liter

Approved by FDA under NADA # 141-449

Safe-Guard® AquaSol(fenbendazole oral suspension)

Suspension Concentrate, Antiparasitic

200 mg fenbendazole/mL

For oral administration via drinking water

DESCRIPTION: Safe-Guard® AquaSol is a suspension concentrate containing fenbendazole, an antiparasitic. Each mL of Safe-Guard® AquaSol contains 200 mg of fenbendazole.

INDICATIONS:

Chickens: Safe-Guard® AquaSol is indicated for the treatment and control of adult Ascaridia galli in broiler chickens and replacement chickens and for the treatment and control of adult A. galli and Heterakis gallinarum in breeding chickens and laying hens.

Swine: Safe-Guard® AquaSol is indicated for swine, except for nursing piglets, for the treatment and control of: Lungworms: Adult Metastrongylus apri, Adult Metastrongylus pudendotectus ; Gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms (Ascaris suum) ; Adult nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); Adult small stomach worms (Hyostrongylus rubidus); Adult and larvae (L2, L3, L4 stages — intestinal mucosal forms) whipworms (Trichuris suis), and Kidney worms: Adult and larvae Stephanurus dentatus.

DOSAGE AND ADMINISTRATION:

Chickens: Safe-Guard® AquaSol must be administered orally to chickens via the drinking water at a daily dose of 1 mg/kg BW (0.454 mg/lb) for 5 consecutive days.

Swine: Safe-Guard® AquaSol must be administered orally to swine via the drinking water at a daily dose of 2.2 mg/kg BW (1 mg/lb) for 3 consecutive days.

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

GENERAL MIXING DIRECTIONS:

Chickens:

Dose calculation:

The daily dose of 1 mg fenbendazole per kg BW (0.454 mg/lb) is equivalent to 0.005 mL Safe-Guard® AquaSol per kg BW (0.00227 mL/lb). 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 × 0.005 mL = mL Safe-Guard® AquaSol/day

Examples:

Total body weight of birds to be treated Volume of Safe-Guard® AquaSol per day Volume of Safe-Guard® AquaSol (for 5 days)
5,000 kg (11,000 lb) 25 mL 5 × 25 mL = 125 mL
10,000 kg (22,000 lb) 50 mL 5 × 50 mL = 250 mL
80,000 kg (176,000 lb) 400 mL 5 × 400 mL = 2,000 mL
320,000 kg (704,000 lb) 1,600 mL 5 × 1,600 mL = 8,000 mL

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

Swine:

Dose calculation:

The daily dose is 2.2mg fenbendazole per kg BW (1 mg/lb) which is equivalent to 0.011mL Safe-Guard® AquaSol per kg BW (0.0045 mL/lb).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 × 0.011 mL = mL Safe-Guard® AquaSol/day

Examples:

Total body weight of pigs to be treated Volume of Safe-Guard® AquaSol per day Volume of Safe-Guard® AquaSol (for 3 days)
10,000 kg (22,000 lb) 110 mL 3 × 110mL = 330 mL
80,000 kg (176,000 lb) 880 mL 3 × 880mL = 2640 mL
320,000 kg (704,000 lb) 3520 mL 3 × 3520mL = 10,560 mL

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 Safe-Guard AquaSol in water:

1) Calculate the volume of Safe-Guard® AquaSol to be administered daily.

2) Select a measuring device capable of accurately measuring a volume of at least twice the calculated Safe-Guard® 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. Safe-Guard® 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 the product well before mixing.

5) Fill up the measuring device containing the water with the calculated volume of the product 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 1 to 1 dilution of Safe-Guard® AquaSol in water to the water supply system as described below. Be careful to avoid any accidental spill or loss of 1 to 1 dilution which may inadvertently result in less than the required dose of fenbendazole.

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

For use with a medication tank:

Add the entire 1 to 1 dilution of Safe-Guard® AquaSol in water to the medication tank containing the volume of drinking water usually consumed by the animals in 3 to 24 hours. Stir the medicated water in the medication tank until the medicated water 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 Safe-Guard® AquaSol in water to the water in the stock suspension tank of the dosing pump. The volume of water in the stock suspension container has to be calculated taking as a basis the present 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 tank is visibly homogeneous. The medicated water should appear hazy.

At concentrations of up to 5 mL/L stock suspension (1 g fenbendazole/L) no stirring is required. At concentrations from 5 mL up to 75 mL of product /L stock suspension (1,000 mg to 15,000 mg 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 container needs to be equipped with a stirring device.

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

USER SAFETY WARNINGS: Not for use in humans. Keep out of reach of children. Protective gloves should be used and care should be taken when handling the product to avoid skin and eye exposure and accidental ingestion. Accidental exposure may result in skin and eye irritation. Accidental ingestion may cause gastrointestinal disturbances and hypersensitivity reactions in humans. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or http://www.fda.gov/AnimalVeterinary/SafetyHealth.

RESIDUE WARNING: Chickens: No withdrawal period is required when used according to labeling. Swine: Swine intended for human consumption must not be slaughtered within 2 days from the last treatment.

OTHER WARNINGS: Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.

EFFECTIVENESS:

Page 1 of 3 1 2 3

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2022. All Rights Reserved.