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(a) For related tolerances see § 556.500 of this chapter.
(b)(1) Specifications. The drug contains 50 milligrams of oxytetracycline hydrochloride in each milliliter of sterile solution.
(2) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(3) Conditions of use - (i) Amount. The drug is intended for use in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves for treatment of disease conditions caused by one or more of the following oxytetracycline sensitive pathogens listed as follows: pneumonia and shipping fever complex (Pasteurella spp.; Hemophilis spp.; Klebsiella spp. ), bacterial enteritis (scours) (E. coli ), foot-rot (Spherophorus necrophorus ), diphtheria (Spherophorus necrophorus ), wooden tongue (Actinobacillus lignieresi ), leptospirosis (Leptospira pomona ), and wound infections; acute metritis; traumatic injury (caused by a variety of bacterial organisms (such as streptococcal and staphylococcal organisms).)
(ii) Indications for use. It is administered by intramuscular injection of 3 to 5 milligrams of oxytetracycline hydrochloride per pound of body weight per day. Leptospirosis, severe foot-rot and severe forms of the indicated diseases should be treated with 5 milligrams per pound of body weight per day. Treatment should be continued for 24 to 48 hours following remission of disease symptoms; however, not to exceed a total of 4 consecutive days. Only 2 milliliters of the drug should be injected per site in case of calves weighing 100 pounds or less and not more than 10 milliliters should be injected per site in adult cattle.
(iii) Limitations. Discontinue treatment with the drug at least 20 days prior to slaughter of the animal. When administered to animals within 30 days of slaughter, muscle discoloration may necessitate trimming of injection site and surrounding tissues.
(c)(1) Specifications. Each milliliter of sterile solution contains 50 or 100 milligrams of oxytetracycline (as oxytetracycline hydrochloride).
(2) Sponsor. See 069043 in § 510.600(c) of this chapter.
(3) Conditions of use - (i) Beef cattle and nonlactating dairy cattle - (A) Amount. Three to 5 milligrams of oxytetracycline per pound of body weight per day; 5 milligrams per pound of body weight per day for the treatment of anaplasmosis, severe foot-rot, and severe cases of other indicated diseases.
(B) Indications for use. Treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., foot-rot and diphtheria caused by Spherophorus necrophorus, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresi, leptospirosis caused by Leptospira pomona, and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. If labeled for use by or on the order of a licensed veterinarian, it may be used for the treatment of anaplasmosis caused by Anaplasma marginale.
(C) Limitations. For 50-milligram-per-milliliter solution, administer intramuscularly or intravenously; for 100-milligram-per-milliliter solution, administer intramuscularly only. Treatment of all diseases should be instituted early and continue for 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 4 consecutive days. Consult your veterinarian if no improvement is noted within 48 hours. Do not inject more than 10 milliliters per site in adult cattle, reducing the volume according to age and body size to 0.5 to 2 milliliters in small calves. Exceeding the highest recommended dose of 5 milligrams per pound of body weight, administering at recommended levels for more than 4 consecutive days, and/or exceeding 10 milliliters intramuscularly per injection site may result in antibiotic residues beyond the withdrawal time. Discontinue treatment at least 18 days prior to slaughter. Not for use in lactating dairy cattle.
(ii) Swine - (A) Amount. Three to 5 milligrams of oxytetracycline per pound of body weight per day. Sows: 3 milligrams of oxytetracycline per pound of body weight, approximately 8 hours before farrowing or immediately after completion of farrowing.
(B) Indications for use. For treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona. Sows: as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
(C) Limitations. Administer intramuscularly. Do not inject more than 5 milliliters per site. Do not use for more than 4 consecutive days. Discontinue treatment at least 26 days before slaughter.
(d)(1) Specifications. Each milliliter of solution contains 100 mg of oxytetracycline hydrochloride.
(2) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(3) Conditions of use in beef cattle and nonlactating dairy cattle - (i) Amount. Administer 3 to 5 mg of oxytetracycline per pound of body weight per day by intramuscular injection, not to exceed a total of 4 consecutive days. Administer 5 mg/lb of body weight per day for treatment of anaplasmosis, severe foot-rot, or severe cases of other indicated diseases, not to exceed a total of 4 consecutive days.
(ii) Indications for use. For treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp., foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. For treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
(iii) Limitations. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Discontinue treatment at least 15 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e)(1) Specifications. Each milliliter of solution contains 50 mg of oxytetracycline hydrochloride.
(2) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(3) Conditions of use in beef cattle and nonlactating dairy cattle. It is used as follows:
(i) Amount. Administer by intravenous or intramuscular injection at 3 to 5 mg/lb of body weight per day, not exceed a total of 4 consecutive days.
(ii) Indications for use. For treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; foot-rot and diphtheria caused by Spherophorus necrophorus; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; wound infections and acute metritis caused by staphylococcal and streptococcal organisms; and treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
(iii) Limitations. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Discontinue treatment at least 22 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) Conditions of use in swine. It is used in swine as follows:
(i) Amount. Administer by intramuscular injection at 3 to 5 mg/lb of body weight per day to swine, not to exceed a total of 4 consecutive days. Administered to sows at 3 mg/lb of body weight approximately 8 hours before farrowing or immediately after farrowing.
(ii) Indications for use. It is used for the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. Administered to sows as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
(iii) Limitations. Discontinue treatment at least 22 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(5) Poultry (broilers, turkeys, and breeding chickens). It is used as follows:
(i) Amount. Administer subcutaneously to chickens and turkeys according to age as directed on labeling.
(ii) Indications for use. For the treatment of air sacculitis (air-sac disease, chronic respiratory disease) caused by Mycoplasma gallisepticum and Escherichia coli; fowl cholera caused by Pasteurella multocida; infectious sinusitis caused by Mycoplasma gallisepticum; and infectious synovitis caused by Mycoplasma synoviae.
(iii) Limitations. Do not administer to laying hens unless the eggs are used for hatching only. Discontinue treatment at least 5 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(f)(1) Specifications. Each milliliter of solution contains 100 mg of oxytetracycline hydrochloride.
(2) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(3) Conditions of use in beef cattle and nonlactating dairy cattle - (i) Amount. Administer 3 to 5 mg of oxytetracycline per pound of body weight per day by intramuscular injection, not to exceed a total of 4 consecutive days. Administer 5 mg/lb of body weight per day for treatment of anaplasmosis, severe foot-rot, or severe cases of other indicated diseases, not to exceed a total of 4 consecutive days.
(ii) Indications for use. For treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp., foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. For treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
(iii) Limitations. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Discontinue treatment at least 15 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(g)(1) Specifications. Each milliliter of sterile solution contains 100 milligrams of oxytetracycline as oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(3) Conditions of use. The drug is used for the treatment of diseases due to oxytetracycline-susceptible organisms as follows:
(i) Beef cattle, beef calves, nonlactating dairy cattle, and dairy calves - (A) Amount. 3 to 5 milligrams of oxytetracycline per pound of body weight per day.
(B) Indications for use. For the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., Haemophilus spp., or Klebsiella spp.
(C) Limitations. Administer by intramuscular, intravenous, or subcutaneous injection. In severe forms of the indicated diseases, administer 5 milligrams of oxytetracycline per pound of body weight per day. Continue treatment 24 to 48 hours following remission of disease symptoms, not to exceed a total of 4 consecutive days. If no improvement is noted within 48 hours, consult a veterinarian. Do not inject more than 10 milliliters per injection site intramuscularly in adult cattle; no more than 1 milliliter per site in calves weighing 100 pounds or less. Do not slaughter cattle for 13 days after intramuscular or intravenous treatment, or 2 days after subcutaneous treatment. Exceeding the highest recommended dosage or duration of treatment (not more than 4 consecutive days) may result in residues beyond the withdrawal period. A withdrawal period has not been established for use of this product in preruminating calves. Do not use in calves to be processed for veal.
(ii) Swine - (A) Amount. 3 to 5 milligrams of oxytetracycline per pound of body weight per day. Sows: Administer once 3 milligrams of oxytetracycline per pound of body weight, approximately 8 hours before farrowing or immediately after completion of farrowing.
(B) Indications for use. For treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona. Sows: As an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
(C) Limitations. Administer intramuscularly. If no improvement is noted within 24 hours, consult a veterinarian. Do not inject more than 5 milliliters per site. Discontinue treatment at least 20 days prior to slaughter.
(h)(1) Specifications. Each milliliter of sterile solution contains 50 or 100 milligrams of oxytetracycline hydrochloride.
(2) Sponsors. See No. 069043 in § 510.600(c) of this chapter for use of 50 and 100 milligrams per milliliter solution; and Nos. 016592 and 055529 in § 510.600(c) for use of 100 milligrams per milliliter solution.
(3) Conditions of use - (i) Amount. The drug is used in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves as follows: 3 to 5 milligrams of oxytetracycline hydrochloride per pound of body weight per day; 5 milligrams per pound of body weight per day for treatment of severe forms of the indicated diseases.
(ii) Indications for use. The drug is used for treatment of bacterial pneumonia and shipping fever complex associated with Pasteurella spp.; foot-rot and calf diphtheria caused by Fusobacterium necrophorum bacterial enterities (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; wound infections, acute metrities, and traumatic injury caused by staphylococcal and streptococcal organisms.
(iii) Limitations. Administer 50-milligram-per-milliliter solution intramuscularly; administer 100-milligram-per-milliliter solution intravenously. Continue treatment 24 to 48 hours following remission of disease symptoms, not to exceed a total of 4 consecutive days. If no improvement is noted within 24 to 48 hours, consult a veterinarian for diagnosis and therapy. When injecting the drug intramuscularly, do no inject more than 10 milliliters per site in adult cattle. Reduce the volume administered per injection site according to age and body size. In calves weighing 100 pounds or less, do no inject more than 2 milliliters intramuscularly per site. Discontinue treatment at least 22 days before slaughter. Not for use in lactating dairy animals. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(i)(1) Specifications. Each milliliter of solution contains 50 milligrams (mg) of oxytetracycline hydrochloride.
(2) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(3) Conditions of use in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves - (i) Amount. Administer 3 to 5 mg/lb body weight per day by intramuscular injection not to exceed a total of 4 consecutive days.
(ii) Indications for use. For treatment of bacterial pneumonia and shipping fever complex associated with Pasteurella spp.; foot-rot and diphtheria caused by Spherophorus necrophorus; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; wound infections and acute metritis caused by staphylococcal and streptococcal organisms susceptible to oxytetracycline.
(iii) Limitations. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Discontinue treatment at least 18 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(j)(1) Specifications. Each milliliter of sterile solution contains either 50 or 100 milligrams of oxytetracycline hydrochloride.
(2) Sponsor. See No. 061133 in § 510.600(c) of this chapter.
(3) Conditions of use in beef cattle and nonlactating dairy cattle - (i) Amount. Administer by intravenous injection 3 to 5 milligrams per pound of body weight daily. Administer 5 milligrams per pound for anaplasmosis, severe foot rot, and severe forms of other diseases. Treatment should be continued 24 to 48 hours following remission of disease symptoms, but not to exceed a total of 4 consecutive days.
(ii) Indications for use. Treatment of diseases due to oxytetracycline-susceptible organisms as follows: pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli ; wooden tongue caused by Actinobacillus lignieresii ; leptospirosis caused by Leptospira pomona ; acute metritis and wound infections caused by staphylococcal and streptococcal organisms; if labeled for use by or on the order of a licensed veterinarian, it may be used for treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
(iii) Limitations. Not for use in lactating dairy cattle. Discontinue use at least 19 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975. Redesignated at 88 FR 14898, Mar. 10, 2023] Editorial Note: For Federal Register citations affecting § 522.1662a, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.
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