Safe-Guard

Description

safe-guard® (fenbendazole) is a dewormer formulated for use in beef and dairy cattle as well as goats. This product is presented as a 10% suspension, containing 100 mg of fenbendazole per milliliter. Each container holds 1 gallon, equivalent to 3,785 milliliters. safe-guard® is manufactured by MERCK Animal Health.

Uses and Indications

This drug is indicated for the treatment and control of various parasitic infections in beef and dairy cattle and goats.

In beef and dairy cattle, the recommended dosage is 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of the following:

Lungworms:

• Adult Dictyocaulus viviparus.

Stomach Worms:

• Adult brown stomach worms (Ostertagia ostertagi).

• Adult and fourth stage larvae barberpole worms (Haemonchus contortus & H. placei).

• Adult and fourth stage larvae small stomach worms (Trichostrongylus axei).

Intestinal Worms (Adult and fourth stage larvae):

• Hookworms (Bunostomum phlebotomum).

• Thread-necked intestinal worms (Nematodirus helvetianus).

• Small intestinal worms (Cooperia punctata & C. oncophora).

• Bankrupt worms (Trichostrongylus colubriformis).

• Nodular worms (Oesophagostomum radiatum).

In goats, the same dosage of 2.3 mg/lb (5 mg/kg) body weight is indicated for the treatment and control of:

Stomach Worms (Adults):

• Haemonchus contortus.

• Teladorsagia circumcincta.

Limitations of use have not been specified; however, the drug should be administered according to the recommended dosage for effective treatment and control of the specified parasitic infections.

Dosage and Administration

The drug is to be administered orally. The recommended dosage is 2.3 mg/lb (5 mg/kg) of body weight, which corresponds to 2.3 mL of the drug for every 100 lb of body weight.

For cattle, the following dosing guidelines apply:

• For a 100 lb animal, administer 2.3 mL.

• For a 200 lb animal, administer 4.6 mL.

• For a 300 lb animal, administer 6.9 mL.

• For a 400 lb animal, administer 9.2 mL.

• For a 500 lb animal, administer 11.5 mL.

• For a 1000 lb animal, administer 23.0 mL.

• For a 1500 lb animal, administer 34.5 mL.

For goats, the dosing is as follows:

• For a 25 lb animal, administer 0.6 mL.

• For a 50 lb animal, administer 1.2 mL.

• For a 75 lb animal, administer 1.7 mL.

• For a 100 lb animal, administer 2.3 mL.

• For a 125 lb animal, administer 2.9 mL.

It is critical to avoid underdosing; therefore, each animal must receive a complete dose based on its current body weight.

Contraindications

Use of this product is contraindicated in the following situations:

• This product is not intended for use in humans.

• It should not be administered to beef calves less than 2 months of age, dairy calves, or veal calves.

• The use of this product in lactating goats is contraindicated due to the lack of established milk discard time.

Additionally, milk from treated cows must not be consumed by humans during treatment and for 48 hours post-treatment. Cattle should not be slaughtered for human consumption within 8 days following the last treatment, and goats must not be slaughtered within 6 days after the last treatment. Underdosing is also contraindicated; ensure that each animal receives a complete dose based on current body weight.

Warnings and Precautions

It is imperative to note that this product is not intended for use in humans. Strict adherence to this guideline is essential to ensure safety and efficacy.

To prevent accidental ingestion, the product must be kept out of reach of children. This precaution is critical to avoid potential harm.

For comprehensive occupational safety information, healthcare professionals should refer to the Safety Data Sheet (SDS). The SDS provides detailed insights into handling, storage, and emergency measures related to the product.

In the event of adverse effects or for customer service inquiries, healthcare professionals are encouraged to contact the dedicated support line at 1-800-211-3573. This line is also available for obtaining a copy of the SDS.

For additional guidance on reporting adverse drug experiences related to animal drugs, professionals may reach out to the FDA at 1-888-FDAVETS or visit the FDA's website at http://www.fda.gov/reportanimalaehttp://www.fda.gov/reportanimalae. This resource is vital for ensuring proper monitoring and reporting of any adverse effects associated with the use of this product.

Side Effects

The product is not intended for use in humans and should be kept out of reach of children. Due to the lack of specific adverse reactions or side effects provided in the available data, no further details regarding adverse reactions can be outlined. It is essential for patients and caregivers to adhere strictly to the warnings associated with this product to ensure safety.

Drug Interactions

No specific drug interactions have been identified for the product.

However, it is important to consider interactions related to laboratory tests and diagnostic evaluations. Prior to administering any dewormer, fecal examinations or other diagnostic tests, along with a thorough parasite management history, should be conducted to assess the appropriateness of the treatment for the herd.

Post-treatment, the effectiveness of the dewormer should be monitored. This can be achieved through methods such as a fecal egg count reduction test or other suitable evaluation techniques. A noted decrease in the drug's effectiveness over time, as determined by these tests, may suggest the development of resistance to the dewormer used. Regular monitoring is essential to ensure continued efficacy and to guide future treatment decisions.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not be administered this product, as it is not intended for use in humans. It is crucial to keep this product out of reach of children to prevent accidental ingestion.

In veterinary applications, this product is contraindicated in beef calves less than 2 months of age, as well as in dairy and veal calves. Additionally, a withdrawal period has not been established for this product in pre-ruminating calves, indicating that caution should be exercised in this population.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted clinical data in this population.

Pregnancy

Pregnant patients may use this medication as no explicit safety concerns regarding pregnancy have been detailed in the prescribing information. There are no known dosage modifications required for pregnant animals, and 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

Milk taken from cows during treatment and for 48 hours after the last treatment must not be used for human consumption. There is no established withdrawal period for this product in pre-ruminating calves. Additionally, due to the lack of a milk discard time, this product should not be used in lactating goats.

Healthcare professionals should consider these factors when advising lactating mothers regarding the use of this product.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

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 and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient and to determine the most appropriate interventions.

Overall, vigilance and prompt action are critical in managing cases of suspected overdose to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has revealed that adverse effects may be reported voluntarily or through surveillance programs. It is noted that parasite resistance can develop to any dewormer, with reports indicating this phenomenon across most classes of dewormers. Following the administration of any dewormer, it is recommended that the effectiveness of the treatment be monitored, which can be achieved through methods such as fecal egg count reduction tests. A decrease in the effectiveness of a drug over time, as determined by these tests, may suggest the development of resistance to the dewormer used.

For customer service inquiries, including adverse effects reporting or requests for a copy of the Safety Data Sheet (SDS), individuals may contact 1-800-211-3573. Additional information regarding adverse drug experience reporting for animal drugs can be obtained by contacting the FDA at 1-888-FDAVETS or visiting http://www.fda.gov/reportanimalae.

Patient Counseling

Healthcare providers should advise patients that this product is not intended for use in humans and must be kept out of reach of children. It is essential to inform patients that the Safety Data Sheet (SDS) contains detailed occupational safety information. For inquiries regarding customer service, adverse effects reporting, or to obtain a copy of the SDS, patients should be directed to call 1-800-211-3573. Additionally, for further information about reporting adverse drug experiences related to animal drugs, patients can contact the FDA at 1-888-FDAVETS or visit http://www.fda.gov/reportanimalae.

Providers should discuss the potential for parasite resistance, which may develop with any dewormer, as it has been reported for most classes of dewormers. It is important to emphasize that treatment with a dewormer, in conjunction with appropriate parasite management practices tailored to the geographic area and the specific animals being treated, may help slow the development of resistance.

Patients should be encouraged to conduct fecal examinations or other diagnostic tests, along with reviewing the parasite management history, to determine the appropriateness of the product for their herd prior to administering any dewormer. Following treatment, the effectiveness of the dewormer should be monitored, for instance, through a fecal egg count reduction test or another suitable method. Providers should inform patients that a decrease in the drug's effectiveness over time, as indicated by these tests, may suggest the development of resistance to the administered dewormer, necessitating adjustments to the parasite management plan based on regular monitoring.

Storage instructions should be communicated clearly: the product should be stored at or below 25°C (77°F) and protected from freezing. Patients should be reminded to shake the product well before use. In California, it is classified as a restricted drug and should only be used as directed. Lastly, patients should be advised to consult their veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at or below 25°C (77°F) to maintain its efficacy. Additionally, the product must be protected from freezing to prevent any potential degradation. Prior to administration, it is necessary to shake the product well to ensure proper mixing and uniformity.

Additional Clinical Information

Fecal examinations and other diagnostic tests, along with a history of parasite management, should be utilized to assess the appropriateness of the product for the herd prior to administering any dewormer. Following treatment, the effectiveness should be monitored, for instance, through a fecal egg count reduction test. A decline in drug effectiveness over time may suggest the development of resistance, necessitating adjustments to the parasite management plan based on regular monitoring.

The product is administered orally at a recommended dosage of 2.3 mg/lb (5 mg/kg) of body weight, which corresponds to 2.3 mL for every 100 lb of body weight. It is crucial to note that this product is not intended for human use and should be kept out of reach of children. For detailed occupational safety information, refer to the Safety Data Sheet (SDS). For customer service, adverse effects reporting, or to obtain a copy of the SDS, individuals can call 1-800-211-3573. For additional information regarding adverse drug experience reporting for animal drugs, contact the FDA at 1-888-FDAVETS or visit http://www.fda.gov/reportanimalae. Consultation with a veterinarian is recommended for the diagnosis, treatment, and control of parasitism.

Drug Information (PDF)

This document includes the full labeling information for Safe-Guard, 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)