LevaMed Soluble Drench Powder: Product Information

LEVAMED SOLUBLE DRENCH POWDER- levamisole hydrochloride powder
Bimeda, Inc.

LevaMedTM

(levamisole hydrochloride)

Soluble Drench Powder

CATTLE AND SHEEP DEWORMER FOR ORAL USE

Anthemintic

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:

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

ANADA 200-386, Approved by FDA

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: 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.

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.

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: 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).

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LEVAMED SOLUBLE DRENCH POWDER
levamisole hydrochloride powder
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-0270
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVAMISOLE HYDROCHLORIDE (LEVAMISOLE) LEVAMISOLE 46.8 g in 52 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61133-0270-1 52 g in 1 POUCH None
2 NDC:61133-0270-2 403 g in 1 JUG None
3 NDC:61133-0270-3 605 g in 1 JUG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200386 12/05/2014
Labeler — Bimeda, Inc. (060492923)
Registrant — Bimeda, Inc. (060492923)
Establishment
Name Address ID/FEI Operations
Bimeda, Inc. 060492923 manufacture
Establishment
Name Address ID/FEI Operations
YangZhou Pharmaceutical Co Ltd 544854599 api manufacture

Revised: 11/2020 Bimeda, Inc.

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