Animal NDC 61133-0270-2 Levamed Soluble Drench Powder
Levamisole Hydrochloride
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 61133-0270-2 |
| Proprietary Name | Levamed Soluble Drench Powder 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 | Levamisole Hydrochloride 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 | Bimeda, Inc. |
| Product Type | Otc Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Marketing Category | ANADA - ABBREVIATED 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 | ANADA200386 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. |
Levamed Soluble Drench Powder Images
Levamed Soluble Drench Powder 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
Description
LevaMedTM
(levamisole hydrochloride)
Soluble Drench Powder
CATTLE AND SHEEP DEWORMER FOR ORAL USE
Anthelmintic
How Supplied
This Packet contains 46.8 grams of levamisole hydrochloride activity.
Administer as a standard drench with standard drench syringe or administer as a concentrated drench solution with an automatic drenching syringe.
Indications & Usage
INDICATIONS:
LevaMed Souble Drench Powder is a broad spectrum anthelmintic and is effective against the following adult nematode infecctions in cattle and sheep:
SHEEP:
STOMACH WORMS: (Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta). INTESTINAL WORMS: (Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bonostomum trigoncephalum, Oesophagostomum columbianum, Chabertia ovina), LUNGWORMS: (Dictyocaulus filaria).
CATTLE:
STOMACH WORMS: (Haemonchus placei, Trichostrongylus axei, Ostertagia ostertagi). INTESTINAL WORMS: (Trichostrongylus longispicularis, Cooperia oncophora, Cooperia punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum), LUNGWORMS: (Dictyocaulus viviparus).
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California) - Use Only as Directed
Approved by FDA under ANADA 200-386
Dosage & Administration
CATTLE-STANDARD DRENCH SOLUTION:
Place the contents of this packet in a 1 quart (32 fl oz) container, fill with water; swirl until dissolved. Administer as a single drench at a dose of 8 mg/kg body weight as follows:
| Weight | Drench Dosage | Each Packet Will Treat |
| 200 lb | 1/2 fl oz | 64 head |
| 400 lb | 1 fl oz | 32 head |
| 600 lb | 1 1/2 fl oz | 21 head |
| 800 lb | 2 fl oz | 16 head |
CONCENTRATED DRENCH SOLUTION:
For use with 20 mL Automatic Syringe. Place the contents of this packet in a standard household measuring container and add water to the 8 3/4 fl oz level. Swirl until dissolved. Give 2 mL (milliliter) per 100 lb body weight. Refer to the table above for the number of cattle each packet will treat.
SHEEP-STANDARD DRENCH SOLUTION:
Place the contents of this packet in a 1 gallon (128 fl oz) container, fill with water; swirl until dissolved. Administer as a single drench at a dose of 8 mg/kg body weight as follows:
| Weight | Drench Dosage | Each Package Will Treat |
| 50 lb | 1/2 fl oz | 256 head |
| 100 lb | 1 fl oz | 128 head |
| 150 lb | 1 1/2 fl oz | 84 head |
| 200 lb | 2 fl oz | 64 head |
CONCENTRATED DRENCH SOLUTION:
For use with 20 ml Automatic Syringe. Place the contents of this packet in a standard household measuring container and add water to the 17 1/2 fl oz level. Swirl until dissolved. Give 2 mL per 50 lb body weight. Refer to the table above for the number of sheep each packet will treat.
Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.
NOTE: Careful weight estimates are essential for proper performance of this product. Prepare solutions as needed. However, excess solutions may be stored at up to 25°C in clean closed containers for up to 90 days without loss of anthelmintic activity.
Cattle and sheep maintained under conditions of constant helminth exposure may require treatment within 2 to 4 weeks after the first treatment.
Residue Warning
RESIDUE WARNING: Do not administer to cattle within 48 hours of slaughter for food. Do not administer to sheep within 72 hours of slaughter for food. To prevent residues in milk, do not administer to dairy animals of breeding age.
Precautions
CAUTION: Muzzle foam may be observed. However, this reaction will disappear within a few hours. If this condition persists, a veterinarian should be consulted. Follow recommended dosage carefully. Consult a veterinarian before using in severely debilitated animals.
Warnings
OTHER WARNINGS: Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.
Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance.
Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).
A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.
Storage And Handling
STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.