![SAFE-GUARD AQUASOL (FENBENDAZOLE) SUSPENSION [MERCK SHARP & DOHME CORP.]](https://medic.hrt.org//dailymed/images/62bd7997-81e5-46ca-806c-7407344449ae/safeguard-01.jpg)
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- DESCRIPTION
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INDICATIONS & USAGE
INDICATIONS: Safe-Guard® AquaSol is indicated for the treatment and control of adult Ascaridia galli in broiler chickens and replacement chickens intended to become breeding chickens and for the treatment and control of adult A. galli and Heterakis gallinarum in breeding chickens.
Not for use in laying hens and replacement chickens intended to become laying hens.
- DOSAGE & ADMINISTRATION
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SPL UNCLASSIFIED SECTION
GENERAL MIXING DIRECTIONS:
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.
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 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.
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USER SAFETY WARNINGS
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/AnimalVeternary/SafetyHealth.
- RESIDUE WARNING
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WARNINGS
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
EFFECTIVENESS: Six pivotal dose confirmation studies and five field effectiveness studies were conducted to evaluate the effectiveness of Safe-Guard® AquaSol oral suspension against adult A. galli in broiler chickens and replacement chickens intended to become breeding chickens and against A. galli and H. gallinarum in breeding chickens. Safe-Guard® AquaSol was administered orally in drinking water at 1 mg fenbendazole/kg body weight/day for 5 consecutive days. The chickens were necropsied 7 to 8 days after the last treatment, and adult worms in the intestines and ceca of the chickens in the control and treated groups were counted to determine percent efficacy.
Three dose confirmation studies were conducted in European Union (EU), using 105 Rhode Island Red breed hens (2 years old) for each study. In all three studies, the efficacy against A. galli (97.9%, 97.3%, and 93.9%) and H. gallinarum (99.8%, 96.9%, and 97.3%) was greater than 90%. A fourth dose confirmation study was conducted in the United States (US) using 264 Rhode Island Red breed hens (12 months old). In the study, the efficacy against adult A. galli and H. gallinarum was 98.7% and 99.2%, respectively. A fifth dose confirmation study was conducted in the US using 176 Cobb breed broiler chickens (4 to 5 weeks old). In the study, the efficacy against adult A. galli was 99.4%. A sixth dose confirmation study was conducted in the US using 176 Ross breed broiler chickens (4 to 5 weeks old). In the study, the efficacy against adult A. galli was 100%.
A field effectiveness study was conducted in the EU in a flock of 13,244 Hy-Line layer breed replacement chickens (13 weeks old). Fifteen chickens were necropsied before treatment initiation, and 15 chickens were necropsied seven days after treatment for worm counts. The efficacy against adult A. galli was 90.2%. A second field effectiveness study was conducted in the US using 550 Ross breed broiler chickens (4 to 5 weeks old). The efficacy against adult A. galli was 100%. A third field effectiveness study was conducted in the US using 550 White Leghorn breed replacement chickens (14 weeks old). The efficacy against adult A. galli and H. gallinarum was 100% and 88.9%, respectively. A fourth field effectiveness study was conducted in the US using 550 Cobb breed breeder hens (63 weeks old). The efficacy against adult A. galli and H. gallinarum was 97.6% and 95.3%, respectively. A fifth effectiveness study was conducted in the US using 550 Cobb breed broiler chickens (4 to 5 weeks old). The efficacy against adult A. galli was 100%.
The pivotal dose confirmation studies and field effectiveness studies demonstrated substantial evidence of effectiveness of Safe-Guard® AquaSol at the dose of 1 mg fenbendazole/kg body weight/day for 5 consecutive days against adult A. galli in broiler chickens and replacement chickens intended to become breeding chickens and against adult A. galli and H. gallinarum in breeding chickens.
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SPL UNCLASSIFIED SECTION
ANIMAL SAFETY: Two margin of safety studies (growing broiler chickens and laying hens at peak egg production) and one reproductive safety study (broiler breeder chickens) were conducted. These studies supported the safety of Safe-Guard® AquaSol in broiler chickens, replacement chickens intended to become breeding chickens, and breeding chickens when administered in drinking water at 1 mg fenbendazole/kg body weight/day for 5 consecutive days.
The margin of safety in broiler chickens was conducted in 480 broiler chickens. Safe-Guard® AquaSol was administered orally as medicated drinking water to three groups of 120 chickens (60 male and 60 female in each group) at 1, 3, and 5 mg fenbendazole/kg body weight/day (1, 3, and 5 times the recommended label dose) for 15 consecutive days (3 times the recommended duration). Another group of 120 chickens (60 male and 60 female) was provided non-medicated drinking water and used as a control group. In all chickens, feed and water intake, body weights, clinical health, and mortality were recorded. Hematology and clinical chemistry parameters were evaluated in 24 chickens from each group. At the end of the treatment phase, gross necropsies were performed on 48 chickens from each group, and organs weights were evaluated. Histopathologic examinations were performed on 48 chickens each from the control and 5 mg fenbendazole/kg body weight groups. No clinically significant effects related to the administration of Safe-Guard® AquaSol were observed for any of the parameters evaluated.
The margin of safety in laying hens was conducted in 144 laying hens. Safe-Guard® AquaSol was administered orally as medicated drinking water to three groups of 36 hens at 1, 3, and 5 times the recommended label dose (1, 3, and 5 mg fenbendazole/kg body weight/day) for 15 consecutive days (3 times the recommended duration). Another group of 36 hens was provided non-medicated drinking water and used as a control group. In all hens, feed and water intake, body weights, clinical health, mortality, egg production, and egg quality parameters (including egg shell thickness and strength, egg weight, and Haugh unit) were evaluated. Hematology and clinical chemistry parameters were evaluated in 12 hens from each group. At the end of the treatment phase, gross necropsies were performed on 12 hens from each group, and organs weights were evaluated. Histopathologic examinations were performed on 12 hens each from the control and 5 mg fenbendazole/kg body weight groups. No clinically significant effects related to the administration of Safe-Guard® AquaSol were observed for any of the parameters evaluated.
The reproductive safety in broiler breeding chickens was conducted in 220 broiler breeder chickens. Safe-Guard® AquaSol was administered orally as medicated drinking water to a group of 110 breeding chickens (10 male and 100 female) at 3 mg fenbendazole/kg body weight/day (3 times the recommended label dose) for 21 consecutive days (4 times the recommended duration). Another group of 110 breeding chickens (10 male and 100 female) were provided non-medicated drinking water and used as a control group. The parameters evaluated in the study included feed and water intake, body weights, clinical health, egg production and weight, fertility, hatchability, and 14-day old chick viability. Necropsy of unhatched eggs was performed to record the percentage of dead embryos and dead and culled hatchlings. At the end of the treatment phase, 30 breeding chickens (10 male and 20 female) from each group were necropsied; and gross pathology and weights of testes and female reproductive tracts were evaluated. Histopathologic evaluations were performed on the gross lesions collected during the necropsy. No clinically significant effects related to the administration of Safe-Guard® AquaSol were observed for any of the parameters evaluated.
- STORAGE AND HANDLING
- HOW SUPPLIED
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SPL UNCLASSIFIED SECTION
For patent information:
http://www.merck.com/product/patent/home.html.Use Only as Directed
Copyright© 2015 Intervet Inc., a sudsidiary of Merck & Co., Inc.
Madison, NJ 07940
All rights reserved
Made in FranceDistributed by:
Intervet Inc.
2 Giralda Farms
Madison, NJ 07940Made in France
NADA 141-449, Approved by FDA
Revision Date: 7/2015
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PRINCIPAL DISPLAY PANEL - 1 Liter Container Label
NADA 141-449, Approved by FDA
1 Liter
safe-guard® AquaSol
(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.
INDICATIONS: Safe-Guard® AquaSol is indicated for the treatment and control of adult Ascaridia galli in broiler chickens and replacement chickens intended to become breeding chickens and for the treatment and control of adult A. galli and Heterakis gallinarum in breeding chickens.
Not for use in laying hens and replacement chickens intended to become laying hens.
DOSAGE AND ADMINISTRATION: 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. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
RESIDUE WARNING: No withdrawal period is required when used according to labeling. Do not use the drug in laying hens.
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.
The container was opened (write the date here): _________________
See attached Product Information Insert for complete directions and warnings before using.
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 FranceNet volume (1 Liter)
Code No. 148720
MERCK
Animal Health
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INGREDIENTS AND APPEARANCE
SAFE-GUARD AQUASOL
fenbendazole suspensionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:0061-1433 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FENBENDAZOLE (UNII: 621BVT9M36) (FENBENDAZOLE - UNII:621BVT9M36) FENBENDAZOLE 200 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0061-1433-02 3785 mL in 1 CONTAINER 2 NDC:0061-1433-01 1000 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141449 11/20/2015 Labeler - Merck Sharp & Dohme Corp. (001317601) Establishment Name Address ID/FEI Business Operations Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. 420823163 API MANUFACTURE