Bimeda, Inc.Bimeda, Inc.Bimeda, Inc.LevaMed Soluble Drench PowderLevamisole HydrochlorideLEVAMISOLE HYDROCHLORIDELEVAMISOLELevaMedTM (levamisole hydrochloride) Soluble Drench Powder CATTLE AND SHEEP DEWORMER FOR ORAL USE AnthelminticThe 52 g packet contains 46.8 grams of levamisole hydrochloride activity. The 403 g bottle contains 362.7 grams of levamisole hydrochloride activity. The 605 g bottle contains 544.5 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 (levamisole hydrochloride) Soluble Drench Powder is a broad spectrum anthelmintic and is effective against the following adult nematode infections 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 # 200-386DOSAGE AND ADMINISTRATION52 g pouchCATTLE-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.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.DOSAGE AND ADMINISTRATION 403 g When you are ready to deworm your cattle or sheep, add 2 liters of water to the solution in this bottle. Swirl to mix thoroughly before using. If any solution is left over, it may be stored at up to 25°C for up to 3 months in this tightly capped bottle. Shake well before using.Month ______ Day _______ Year _______ Administer as a single drench at a dose of 8 mg/kg body weight as follows:DOSAGE AND ADMINISTRATION605 g When you are ready to deworm your cattle or sheep, add 3 liters of water to the solution in this bottle. Swirl to mix thoroughly before using. If any solution is left over, it may be stored at up to 25°C for up to 3 months in this tightly capped bottle. Shake well before using.Month ______ Day _______ Year _______ Administer as a single drench at a dose of 8 mg/kg body weight as follows: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 weigh estimates are essential for proper performance of this product.Cattle and sheep maintained under conditions of constant helminth exposure may require treatment within 2 to 4 weeks after the first treatment.image descriptionimage descriptionRESIDUE 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.Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.STORAGE: Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (59°F-86°F).CONTACT INFORMATION: To report adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalaeimage description