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Safe-Guard AquaSol for Swine

This page contains information on Safe-Guard AquaSol for Swine for veterinary use.
The information provided typically includes the following:
  • Safe-Guard AquaSol for Swine Indications
  • Warnings and cautions for Safe-Guard AquaSol for Swine
  • Direction and dosage information for Safe-Guard AquaSol for Swine

Safe-Guard AquaSol for Swine

This treatment applies to the following species:
Manufacturer: Intervet/Merck Animal Health

Product Information

NADA 141-449, Approved by FDA

(fenbendazole oral suspension)

Suspension Concentrate, Antiparasitic

200 mg of 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.

Safe-Guard AquaSol for Swine Indications

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); nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); 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

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:

Dose calculation:

The daily dose of 2.2 mg fenbendazole per kg BW (1 mg/lb) which is equivalent to 0.011 mL 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 x 0.0.011 mL = mL Safe-Guard® AquaSol/day

Examples:

Total body weight of animals 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 x 110 mL = 330 mL

80,000 kg (176,000 lb)

880 mL

3 x 880 mL = 2640 mL

320,000 kg (704,000 lb)

3520 mL

3 x 3520 mL = 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 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.

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: Swine intended for human consumption must not be slaughtered within 2 days from the last treatment.

OTHER WARNING: 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

A multi-site, masked, negative-controlled dose confirmation field study was conducted to provide substantial evidence of the effectiveness of Fenbendazole (FBZ) Suspension (20% w/v) administered orally in drinking water to pigs for three consecutive days to provide a dose of 2.2 mg FBZ/kg body weight daily against the dose-limiting worm Trichuris suis (T. suis). A common protocol was implemented in two different geographical locations and with two different investigators.

Weaned, growing-finishing pigs of approximately 6 weeks of age were used in the study. Each study site selected pigs from one source herd verified to be free of T. suis infection. Barrow and gilt breeds representative of U.S. commercial production were used. Housing, management, and husbandry procedures were typical of commercial production practice. A complete feed, adequate to meet the nutritional needs of the study animals, was offered to the animals in self-feeders throughout the study. The feed did not contain antibiotics, anthelmintics, or any other medication.

Fifty-six days prior to treatment administration, all suitable study candidates were orally dosed with approximately 4000 embryonated T. suis eggs. A natural field isolate of T. suis collected in April 2010 from a sow located on a commercial farrow to wean operation located in the U.S. was used. Individual fecal samples were obtained from each candidate animal 46, 47, and 48 days after T. suis inoculation and analyzed for the presence of T. suis eggs. Animals with at least two fecal examinations positive for T. suis eggs were eligible for inclusion in the study.

In each study, 24 healthy pigs were randomized to two treatment groups (FBZ treated and non-medicated) by first blocking by weight in blocks of 4 pigs each and within each weight block, fecal egg count (FEC) in blocks of 2 pigs. The two pigs with the two lowest FEC counts within a weight block were randomized one per treatment group and the two pigs with the highest FEC counts within a weight block were randomized one per treatment group. The two animals assigned to the same treatment group within the same weight block were then assigned to the same pen. Six pens of 2 pigs each were used per treatment group.

Non-medicated water consumption of the pigs in each treatment pen was measured prior to treatment administration to estimate the amount of water required for dosing on each day of the treatment period. The amount of FBZ Suspension administered in drinking water to the study pigs was calculated from pre-treatment body weights. Medicated water was prepared on each treatment day by diluting FBZ Suspension in drinking water to provide a daily dose of 2.2 mg FBZ/kg body weight to the FBZ treated group. The control group received non-medicated drinking water.

Only two pigs at the Minnesota (MN) site that were treated with FBZ had abnormal post-treatment observations (“loose stools”). These two pigs had exhibited abnormal fecal consistency prior to treatment with FBZ. There were no abnormal observations made at the California (CA) site on pigs after FBZ administration. There were no abnormal post-treatment observations attributed to administration of FBZ at either study site.

The study animals were euthanized after either 8 or 9 days following the last FBZ administration for retrieval of the large intestinal tract. Adult T. suis worms attached to the tract and in the contents of the tract were counted.

Adequacy of infection was demonstrated at both study sites by having more than 6 non-medicated pigs (11 of the 12 non-medicated animals in MN and 9 of the 12 non-medicated animals in CA) with adult T. suis worm counts of 100 or more per animal.

There was a significant treatment effect in T. suis worm counts between medicated and non-medicated treatment groups at each study site (p=0.0006 in MN and p=0.0003 in CA). The percent reduction in T. suis worm counts in the FBZ medicated animals was greater than 90% (98.5% in MN and 98.6% in CA) compared to the non-medicated animals using transformed data (geometric means).

Palatability: A pivotal palatability study was conducted to evaluate the palatability of 20% Fenbendazole Suspension in pigs through voluntary consumption of medicated water when offered for approximately 5 hours a day over 3 consecutive days at a dose of 2.2 mg fenbendazole/kg body weight (BW) per day (label dose). The average percent of medicated water consumed was 98.18%, thus the study demonstrated that 20% Fenbendazole Suspension has acceptable palatability.

ANIMAL SAFETY: Animal safety was established using a combination of swine pharmacokinetic, physiologic, and pharmacologic data that provided a basis for bridging the safety data of Safe-Guard Type A medicated article (NADA 131-675) to Safe-Guard AquaSol oral suspension in swine.

STORAGE INFORMATION: Store at room temperature 30 °C (86 °F). Once opened, do not store the container above 25 °C (77 °F). Do not freeze. Protect from light. Use within 6 months after opening. Use the medicated water within 24 hours.

How Supplied

1 Liter and 1 Gallon (3,785 mL) HDPE plastic containers

For Patent Information:

http://www.merck.com/product/patent/home.html

Use Only as Directed

For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573.

Copyright© 2015 Intervet Inc. a subsidiary of Merck & Co., Inc., Madison, NJ 07940

All rights reserved

Made in France

Distributed by: Intervet Inc., 2 Giralda Farms, Madison, NJ 07940

NADA 141-449, Approved by FDA

Revision Date: 11/2015

Net volume

Code No.

 

1 Liter

AFR11702

155036 R5

1 Gallon

AFR11701

154975 R5

NAC No.: 1047518.0

MERCK ANIMAL HEALTH
Intervet Inc.

2 GIRALDA FARMS, MADISON, NJ, 07940
Customer Service:   800-521-5767
Order Desk:   800-648-2118
Technical Service (Companion Animal):   800-224-5318
Technical Service (Livestock):   800-211-3573
Fax:   973-937-5557
Website:   www.merck-animal-health-usa.com
Every effort has been made to ensure the accuracy of the Safe-Guard AquaSol for Swine information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2016 North American Compendiums. Updated: 2016-08-21

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