CHLORONEX- chlortetracycline hydrochloride powder, for solution

Chloronex by

Drug Labeling and Warnings

Chloronex by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc., Huvepharma EOOD, Huvepharma, Inc. - St. Louis, Huvepharma, Inc - Longmont. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

6.4 oz. Front Panel

Chloronex®
(Chlortetracycline hydrochloride)
Soluble Powder

CAUTION: Federal (USA) law restricts this drug to use by or on the
order of a licensed veterinarian.

Chlortetracycline HCl, 64 g/lb

Antibiotic

For Animal Use in Drinking Water
Net Wt: 6.4 oz (181.4 g)
NADA 065-440, Approved by FDA

Huvepharma®

1114143009
Rev. 12-2015

Not for Human Use. Restricted Drug (California)-Use Only as Directed

Chloronex is a registered trademark of Huvepharma EOOD
Manufactured for: Huvepharma, Inc.

525 Westpark Dr., Suite 230, Peachtree City, GA 30269 U.S.A.

Lot No. & Exp. Date

Indications and Directions for Use

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

Growing Turkeys

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

Dose

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 the indicated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

Growing Turkeys

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

Dose

25 mg/lb body weight (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.

Swine

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.

Dose - 10 mg/pound body weight daily

(10 packets/256 gallons will treate 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

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.

Dose - 10 mg/pound body weight daily

Use 1/2 oz of poweder 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.

Chickens

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

Dose

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 inidcated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

Chickens

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

Dose

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.

Chickens

Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.

Dose

1000 mg/gal (10 packets/256 gallons). This is equivalent to 1/4 oz of powder per 1 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.

Medicate chickens and turkeys continuously at the first clinical signes 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 your veterinarian.

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. Animals must actually consume enough medicated water to provide the desired therapeutic dose under the conditions that prevail.

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 preruminating calves. Do not use in calves to processed for veal.

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, administer one hour before or two hours after feeding is recommended.

Storage and Handling

Store at or below 25°C (77°F)

25.6 oz. Front Panel

Chloronex®
(Chlortetracycline hydrochloride)
Soluble Powder

CAUTION: Federal (USA) law restricts this drug to use by or on the
order of a licensed veterinarian.

Chlortetracycline HCl, 64 g/lb

Antibiotic

For Animal Use in Drinking Water
Net Wt: 6.4 oz (181.4 g)
NADA 065-440, Approved by FDA

Huvepharma®

1114143009
Rev. 12-2015

Not for Human Use. Restricted Drug (California)-Use Only as Directed

Chloronex is a registered trademark of Huvepharma EOOD
Manufactured for: Huvepharma, Inc.

525 Westpark Dr., Suite 230, Peachtree City, GA 30269 U.S.A.

Lot No. & Exp. Date

Indications and Directions for Use

This 25.6 oz packet contains 102.4 g chlortetracycline HCl (64 g/lb) and will make the resulting concentrations:

Gallons of water                              1024       512        256       128        102.4

Chlortetracycline HCl per gallon         100 mg   200 mg   400 mg  800 mg  1000 mg 

Growing Turkeys

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

Dose

400 mg/gal (2 packets/512 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.

Growing Turkeys

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

Dose

25 mg/lb body weight/day (1 packet for every 4,096 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.

Swine

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.

Dose - 10 mg/pound body weight daily

(5 packets/512 gallons will treat 512 100-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

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.

Dose - 10 mg/pound body weight daily

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 for 3 to 5 days.

Water Medicators: Dissolve the contents of one 25.6 oz packet in 100 oz of fresh water to prepare a stock solution, that when metered at the rate of 1 oz per gallon of drinking water, will deliver 1000 mg of chlortetracycline HCl per gallon. At this rate, a gallon of drinking water will treat a 100 lb pig or 100 lb calf at the rate of 10 mg per lb of body weight for one day. Adjust if needed based on actual water intake to acheive 10 mg per lb of body weight.

Chickens

Contol of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

Dose

200-400 mg/gal (1-2 packets/512 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.

Chickens

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

Dose

400-800 mg/gal (2-4 packets/512 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.

Chickens

Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.

Dose

1000 mg/gal (5 packets/512 gallons). This is equivalent to 1/4 oz of powder per 1 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 your veterinarian.

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. Animals must actually consume enough medicated water to provide the desired therapeutic dose under the conditions that prevail.

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 preruminating calves. Do not use in calves to processed for veal.

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, administer one hour before or two hours after feeding is recommended.

Storage and Handling

Store at or below 25°C (77°F)

6.4 oz Packet Label

25.6 oz Packet Label

INGREDIENTS AND APPEARANCE

CHLORONEX 
chlortetracycline hydrochloride powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 23243-4500
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORTETRACYCLINE HYDROCHLORIDE (UNII: O1GX33ON8R) (CHLORTETRACYCLINE - UNII:WCK1KIQ23Q)	CHLORTETRACYCLINE HYDROCHLORIDE	64 g  in 0.45 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-4500-1	0.181 kg in 1 POUCH
2	NDC: 23243-4500-2	0.726 kg in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA065440	10/30/2015

Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma EOOD (552691651)

Establishment
Name	Address	ID/FEI	Business Operations
Huvepharma, Inc. - St. Louis		883128204	manufacture, analysis, pack, label, medicated animal feed manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Huvepharma, Inc - Longmont		080346321	label, manufacture, pack