Safe-Guard Aquasol

Description

Safe-Guard® AquaSol is a suspension concentrate formulated with fenbendazole, an antiparasitic agent. Each milliliter of Safe-Guard® AquaSol contains 200 mg of fenbendazole, providing a potent dosage for effective treatment.

Uses and Indications

This drug is indicated for the treatment and control of specific parasitic infections in poultry and swine.

In chickens, it is indicated for the treatment and control of adult Ascaridia galli in broiler and replacement chickens. Additionally, it is indicated for the treatment and control of adult A. galli and Heterakis gallinarum in breeding chickens and laying hens.

In swine, the drug is indicated for the treatment and control of various parasitic infections, including lungworms such as adult Metastrongylus apri and Metastrongylus pudendotectus. It is also indicated for the treatment and control of gastrointestinal worms, which include adult and larvae (L3, L4 stages, liver, lung, intestinal forms) of large roundworms (Ascaris suum), adult nodular worms (Oesophagostomum dentatum, O. quadrispinulatum), adult small stomach worms (Hyostrongylus rubidus), and adult and larvae (L2, L3, L4 stages - intestinal mucosal forms) of whipworms (Trichuris suis). Furthermore, it is indicated for the treatment and control of kidney worms, specifically adult and larvae of Stephanurus dentatus.

Dosage and Administration

Safe-Guard® AquaSol is to be administered orally to chickens through the drinking water. The recommended daily dosage is 1 mg/kg body weight (0.454 mg/lb) for a duration of 5 consecutive days.

It is essential that the medicated water is prepared fresh each day prior to administration to ensure optimal efficacy. Healthcare professionals are advised to consult with a veterinarian for guidance regarding the diagnosis, treatment, and control of parasitism in chickens.

Contraindications

Safe-Guard AquaSol is contraindicated for use in humans. It should not be administered to flocks with a total body weight of less than 22 lbs, as accurate dosing cannot be achieved in these cases. Additionally, the product must not be frozen or stored above 25°C (77°F) once opened. The syringe used for administration should not be discarded, as it will be required for subsequent treatments.

Warnings and Precautions

Parasite resistance may develop to any dewormer, necessitating careful consideration in treatment protocols. It is imperative that all dewormers are administered at accurate dosages to ensure optimal therapeutic outcomes.

Following the administration of any dewormer, healthcare professionals should monitor the effectiveness of the treatment. A noted decrease in effectiveness over time may suggest the emergence of resistance to the dewormer used. In such cases, it is crucial to reassess the parasite management plan and make necessary adjustments based on the results of regular monitoring. This proactive approach will help maintain the efficacy of deworming strategies and mitigate the risk of resistance development.

Side Effects

Patients receiving dewormers should be aware of the potential for adverse reactions associated with their use. One significant concern is the possibility of parasite resistance developing to any dewormer. This resistance can lead to a decrease in the effectiveness of the treatment over time, which may necessitate adjustments to the parasite management plan.

Accurate dosing of dewormers is crucial for achieving optimal results. Inadequate dosing may not only compromise treatment efficacy but also contribute to the development of resistance. Therefore, it is essential for healthcare providers to ensure that dosing is precise and tailored to the individual patient's needs.

Following the administration of any dewormer, the effectiveness of the treatment should be closely monitored. Regular assessments can help identify any decrease in effectiveness, which may indicate the emergence of resistance. In such cases, the parasite management plan should be modified accordingly to ensure continued efficacy in treating the parasitic infection.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

The table below lists each NDC Code for Safe-Guard Aquasol (fenbendazole) veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Safe-Guard AquaSol is indicated for use in chickens, including broiler chickens, replacement chickens, breeding chickens, and laying hens. It is not recommended for use in nursing piglets. For chickens, Safe-Guard AquaSol should be administered orally via drinking water at a daily dose of 1 mg/kg body weight for 5 consecutive days.

Efficacy studies have demonstrated effectiveness against adult Ascaridia galli in chickens as young as 4 to 5 weeks old. A field effectiveness study involving 13,244 Hy-Line layer breed replacement chickens at 13 weeks of age confirmed the product's efficacy. Additionally, a second field study conducted in the US with 550 Ross breed broiler chickens aged 4 to 5 weeks showed 100% efficacy.

Safety assessments, including margin of safety studies in growing broiler chickens and laying hens, confirmed that Safe-Guard AquaSol is safe when administered at the recommended dose. No clinically significant effects related to the administration of Safe-Guard AquaSol were observed in studies involving chickens of various ages, including those 4 to 5 weeks old.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding its use during pregnancy have been detailed. Additionally, there are no dosage modifications required for pregnant animals, indicating a lack of identified risks in animal studies. Furthermore, no special precautions regarding the use of this medication during pregnancy have been mentioned. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

Lactating mothers should be aware that this product is not indicated for use in nursing piglets. There is no available data regarding excretion in human breast milk or effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks when advising lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include airway management, monitoring of vital signs, and intravenous fluid administration as necessary. The use of specific antidotes or treatments should be guided by the clinical scenario and the substances involved.

For further management, consultation with a poison control center or a medical toxicologist is recommended to ensure appropriate therapeutic interventions are implemented. Continuous assessment and supportive care remain critical components in the management of overdose cases.

Nonclinical Toxicology

No information is available regarding teratogenic effects associated with Safe-Guard AquaSol.

In margin of safety studies conducted in broiler chickens, laying hens, and broiler breeding chickens, no clinically significant effects were observed related to the administration of Safe-Guard AquaSol.

The margin of safety study in broiler chickens involved 480 birds, with Safe-Guard AquaSol administered orally as medicated drinking water to three groups of 120 chickens (60 male and 60 female in each group) at doses of 1, 3, and 5 mg fenbendazole/kg body weight/day for 15 consecutive days, which is three times the recommended duration. A control group of 120 chickens received non-medicated drinking water. Parameters evaluated included feed and water intake, body weights, clinical health, and mortality. Hematology and clinical chemistry were assessed in 24 chickens from each group. At the conclusion of the treatment phase, gross necropsies were performed on 48 chickens from each group, and organ weights were evaluated. Histopathologic examinations were conducted on 48 chickens from both the control and the 5 mg fenbendazole/kg body weight groups. No clinically significant effects were noted for any evaluated parameters.

In the margin of safety study involving laying hens, 144 hens were administered Safe-Guard AquaSol orally as medicated drinking water in three groups of 36 hens at doses of 1, 3, and 5 times the recommended label dose for 15 consecutive days. A control group of 36 hens received non-medicated drinking water. Evaluated parameters included feed and water intake, body weights, clinical health, mortality, egg production, and egg quality parameters such as eggshell thickness and strength, egg weight, and Haugh unit. Hematology and clinical chemistry were assessed in 12 hens from each group. At the end of the treatment phase, gross necropsies were performed on 12 hens from each group, and organ weights were evaluated. Histopathologic examinations were conducted on 12 hens from both the control and the 5 mg fenbendazole/kg body weight groups. No clinically significant effects were observed for any evaluated parameters.

The reproductive safety study in broiler breeding chickens included 220 birds, with Safe-Guard AquaSol administered orally as medicated drinking water to a group of 110 breeding chickens (10 male and 100 female) at a dose of 3 mg fenbendazole/kg body weight/day for 21 consecutive days, which is four times the recommended duration. A control group of 110 breeding chickens (10 male and 100 female) received non-medicated drinking water. Evaluated parameters 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 assess 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 along with weights of testes and female reproductive tracts were evaluated. Histopathologic evaluations were performed on gross lesions collected during necropsy. No clinically significant effects were noted for any evaluated parameters.

No specific information is provided regarding animal pharmacology and toxicology in the insert.

Postmarketing Experience

Accidental exposure to the product may result in skin and eye irritation. Instances of accidental ingestion have been reported, leading to gastrointestinal disturbances and hypersensitivity reactions in humans. There is a potential for parasite resistance to develop with the use of any dewormer. Following the administration of a dewormer, it is recommended that the effectiveness of the treatment be monitored. A decrease in effectiveness over time may suggest the development of resistance to the dewormer used. Consequently, the parasite management plan should be adjusted based on regular monitoring outcomes.

For technical information or to report a suspected adverse event, individuals are encouraged to contact Merck Animal Health at 1-800-211-3573 or visit www.merck-animal-health-usa.com. For additional information regarding adverse drug experience reporting for animal drugs, the FDA can be contacted at 1-888-FDA-VETS or through http://www.fda.gov/reportanimalae.

Patient Counseling

Healthcare providers should advise patients to consult their veterinarian for assistance in the diagnosis, treatment, and control of parasitism in birds. It is important to instruct patients to provide the medicated water to their birds first thing in the morning, as this is when consumption is at its peak. During the treatment period, all birds must have unrestricted access to the medicated water, and they should not have access to any other sources of water.

Patients should be informed to ensure that the total amount of medicated water offered is fully consumed by the birds. After the medicated water has been completely consumed, the animals should have access to non-medicated drinking water ad libitum.

Healthcare providers must emphasize that this product is not for use in humans and should be kept out of reach of children. Protective gloves should be used when handling the product, and care should be taken to avoid skin and eye exposure as well as accidental ingestion. Patients should be made aware that accidental exposure may result in skin and eye irritation, while accidental ingestion may lead to gastrointestinal disturbances and hypersensitivity reactions in humans.

Providers should direct patients to Safety Data Sheets (SDS) available at https://www.msd.com/research/safety-data-sheets/# or by calling 1-800-521-5767 for further safety information. It is crucial to inform patients that parasite resistance may develop to any dewormer, and that all dewormers require accurate dosing for optimal results. Following the use of any dewormer, the effectiveness of the treatment should be monitored. A decrease in effectiveness over time may indicate the development of resistance to the dewormer administered, necessitating adjustments to the parasite management plan based on regular monitoring.

Storage and Handling

The product is supplied in a 3 mL glass vial. It should be stored at room temperature, not exceeding 30°C (86°F), and must not be frozen. Once opened, the product should be used within 6 months, and the medicated water should be utilized within 24 hours to ensure efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This document includes the full labeling information for Safe-Guard Aquasol, as submitted by Merck Sharp & Dohme Corp. for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)