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Chloronex

Boehringer Ingelheim Vetmedica, Inc.

Chloronex™(chlortetracycline HCl)Soluble Powder Concentrate


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

NDC 0010-4706-01

Chlortetracycline HCl, 64 g/lb

Antibiotic

For Animal Use in Drinking Water

Net Wt: 6.4 oz (181.4 g)

NADA 65-440, Approved by FDA

This 6.4 oz packet contains 25.6 g chlortetracycline HCl (64 g/lb) and will make the resulting concentrations:

Gallons of water 256 128 64 25.6
Chlortetracycline HCl per gallon 100 mg 200 mg 400 mg 1000 mg

Indications and Directions for Use

GROWING TURKEYS DOSE
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

400 mg/gal (4 packets/256 gallons). This is equivalent to 1/2 oz of powder per 5 gallons of water. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline.

25 mg/lb body weight/day (1 packet for every 1,024 lbs of turkeys). 1/8 oz treats a 20 lb turkey for one day. Mix until dissolved. Administer in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

CHICKENS DOSE
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

200-400 mg/gal (2-4 packets/256 gallons). This is equivalent to 1/4 - 1/2 oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

Control of Chronic Respiratory Disease (CRD) and air-sac infections caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline.

400-800 mg/gal (4-8 packets/256 gallons). This is equivalent to 1/2 - 1 oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. 1000 mg/gal (10 packets/256 gallons). This is equivalent to 1/4 oz of powder per one gallon of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

Medicate chickens and turkeys continuously at the first clinical signs of disease and continue for 7 to 14 consecutive days. The dosage ranges permitted provide for different levels based on the severity of the infection. If improvement is not noted in 24-48 hours, consult a veterinarian or a diagnostic laboratory to determine diagnosis and for advice regarding the optimal level of the drug where ranges are permitted.

SWINE DOSE - 10 mg/pound body weight daily

Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae, and Klebsiella spp. susceptible to chlortetracycline.

(10 packets/256 gallons will treat 256 100-lb pigs per day). 1/4 oz of powder will treat a 100 lb pig for one day. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24-hour period. Administer for 3 to 5 days.
CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE DOSE - 10 mg/pound body weight daily
Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. susceptible to chlortetracycline. Use 1/2 oz of powder for each 200 lbs of calf weight, per day. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24-hour period, or as a drench in divided doses. Administer 3 to 5 days.

Residue Warnings

Do not administer to chickens, growing turkeys, swine, and cattle within 24 hours of slaughter. Do not use in lactating dairy cattle and laying chickens. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.

General Information on Dosage

Dosages in terms of packets per 256 gallons are based on stated dosages per unit of body weight and average water consumption of the species. Weather conditions, ambient temperature, humidity, age, class of livestock and other factors may affect consumption and, except where calves are drenched, the unit dosage should be used as a guide to effective use in drinking water. Animal must actually consume enough medicated water to provide the desired therapeutic dose under the conditions that prevail.

Precautions

Use as the sole source of chlortetracycline. Prepare fresh solutions daily. When used in plastic or stainless steel waterers or automatic waterers, prepare fresh solutions every 24 hours. This product has not been demonstrated to provide adequate stability in galvanized waterers. Stability loss may reduce effectiveness of the product. Do not administer in milk or milk replacers. When feeding milk or milk replacers, administration one hour before or two hours after feeding is recommended.

Store at or below 25°C (77°F).

Not for Human Use.

Restricted Drug (California) – Use Only as Directed

Chloronex is a trademark of Boehringer Ingelheim Vetmedica, Inc.

© 2010 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

Manufactured for:
Boehringer Ingelheim Vetmedica, Inc.
St. Joseph, MO 64506 U.S.A.

6622C

10341

Pouch Front and Back

Chloronex

Chloronex

chlortetracycline hydrochloride POWDER, FOR SOLUTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:0010-4706
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlortetracycline Hydrochloride CHLORTETRACYCLINE 64 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0010-4706-01 0.181 in 1 POUCH

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA065440 2012-02-17


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