Animal NDC 57926-474-20 Panacur
Fenbendazole
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 57926-474-20 |
| Proprietary Name | Panacur What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| Non-Proprietary Name | Fenbendazole What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| Labeler Name | Merck Sharp & Dohme Corp. |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Marketing Category | NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| FDA Application Number | NADA121473 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
Panacur Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Other
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
CAUTION: Do not use 14 days before or during the hunting season.
Directions: The daily dose of 10 mg/kg (4.54 mg/lb) can be achieved as follows:
Using a gram scale, weigh out 1 gram of Panacur® Granules 22.2% for each 22 kg or 50 lbs body weight.
Manufactured by:
Intervet GesmbH
Vienna, Austria
Distributed by:
Intervet Inc.
(d/b/a Merck Animal Health)
Madison, NJ 07940
Fenbendazole (active ingred.)
Made in: see imprint. Formulated in Austria.
Approved by FDA under
NADA # 121-473
Rev. 07/22
Description
Panacur® (fenbendazole) Granules 22.2% contains the active anthelmintic, fenbendazole. The chemical name of fenbendazole is methyl 5-(phenylthio)-2-benzimidazole carbamate.
The CAS Registry Number is 43210-67-9.
The chemical structure is:
Panacur® Granules 22.2% contains 222 mg/g of fenbendazole.
Actions
The antiparasitic action of Panacur® Granules 22.2% is believed to be due to the inhibition of energy metabolism in the parasite.
For The Following Carnivorous/Omnivorous Animals
Lions (Panthera leo), Tigers (Panthera tigris), Cheetahs (Acinonyx jubatus), Pumas (Felis concolor), Jaguars (Panthera onca), Leopards (Panthera pardus), Panthers (Panthera spp.), Grizzly Bears (Ursus horribilis), Polar Bears (Ursus maritimus), Black Bears (Ursus americanus)
Indications
Panacur® Granules 22.2% is used for control of the following internal parasites of the families Felidae and Ursidae.
Felidae: Lions (Panthera leo). For control of ascarids (Toxocara cati, Toxascaris leonina), hookworms (Ancylostoma spp.).
Tigers (Panthera tigris). For control of ascarids (Toxocara cati, Toxascaris leonina), hookworms (Ancylostoma spp.).
Cheetahs (Acinonyx jubatus). For control of ascarids (Toxocara cati, Toxascaris leonina).
Pumas (Felis concolor), Panthers (Panthera spp.), Leopards (Panthera pardus), Jaguars (Panthera onca). For control of ascarids (Toxocara cati, Toxascaris leonina), hookworms (Ancylostoma spp.), tapeworms (Taenia hydatigena, T. krabbei, T. taeniaeformis).
Ursidae: Black Bears (Ursus americanus). For control of ascarids (Baylisascaris transfuga, Toxascaris leonina), hookworms (Ancylostoma caninum), tapeworms (Taenia hydatigena, T. krabbei).
Polar Bears (Ursus maritimus) and Grizzly Bears (Ursus horribilis). For control of ascarids (Baylisascaris transfuga, Toxascaris leonina).
Directions
Efficacy is dependent on the correct dose level based on body weight over the appropriate treatment period. When possible, animals should be weighed to determine body weight accurately, otherwise weights can be estimated.
It is important that the appropriate dose of Panacur® be ingested. This may best be accomplished by applying the granules as a top dressing or mixing with a small portion of the food prior to offering the main meal.
Refer to the DOSAGE AND ADMINISTRATION portion of the labeling for determining the appropriate dose for each species of animal.
The daily dosage of 50 mg/kg (22.7 mg/lb) can be achieved as follows:
Using a gram scale, weigh out 1 gram of Panacur® (fenbendazole) Granules 22.2% for each 4.44 kg or 10 lbs body weight.
Daily dosages must be repeated for 3 consecutive days. Mix the appropriate amount of drug with a small amount of the usual food: dry dog food may require slight moistening to facilitate mixing with the drug.
Dosage And Administration
The dose for Felidae and Ursidae is 10 mg/kg BW daily for 3 consecutive days. Please see INDICATIONS for details as to claims for animal and parasite.
Toxicology Data
Panacur® has been fed to pregnant and non-pregnant females and to male animals including Felidae and Ursidae at ten times the recommended dose for twice the recommended treatment period without effect on reproduction. In one puma and one jaguar, ten times the recommended dose given for twice the recommended duration showed evidence of inappetence when administered the Panacur® Granules.
Panacur® Granules 22.2% did not cause toxicity when administered to weaned pups at doses equal to 5 times the recommended daily dose and for 2 times the duration of treatment.
Side Effects
In studies conducted in a variety of captive animals, loose stools have been reported in pumas, black bears, and ruminants. In one puma and one jaguar, periods of inappetence followed the initial consumption of fenbendazole at ten times the recommended treatment level.
Drug Reactions
There are currently no data available to support the use of Panacur® Granules 22.2% in conjunction with other nutritional and drug substances in Felidae and Ursidae. However, experience with the drug under actual conditions of use has not revealed any incompatibilities with Panacur®.
Panacur® Granules 22.2% has been administered to dogs in clinical trials along with a wide variety of other drugs including antibiotics, steroids, anesthetics, tranquilizers, vitamins, and minerals. No incompatibilities with other drugs are known at this time.
Precautions
Medicated food must be fully consumed for Panacur® to be effective.
Medicated food must be fully consumed to be effective. Dispensing containers must be labeled with drug identification and directions for use.
Dosage
50 mg/kg (22.7 mg/lb) daily for 3 consecutive days for the removal of ascarids (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia pisiformis).
Contraindications
None known.
Adverse Reactions
Another benzimidazole has been reported to cause hepatotoxicity clinically in canines. However, this effect has not been reported during the clinical use of fenbendazole. In US clinical studies, 3 of 240 dogs vomited which may have been drug related.
How Supplied
Panacur® Granules 22.2% is supplied in 1 lb jars.
Keep this and all medication out of the reach of children.
Storage And Handling
Store at controlled room temperature 68-77°F (20-25°C).
Principal Display Panel - 454 G Jar Carton
MERCK
Animal Health
panacur®
(fenbendazole)
Dewormer
Granules 22.2%
(222 mg/g)
FOR DOGS AND FOR ONLY THE
CARNIVOROUS/OMNIVOROUS ANIMALS
LISTED ON THE SIDE PANEL
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
1 lb (454 g)
Retain carton for complete
product information.
MERCK
Animal Health
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