Title 21—Food and Drugs--Volume 1
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.23   Acepromazine.
(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) acepromazine maleate.
(b) Sponsors. See Nos. 000010 and 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs, cats, and horses —(1) Amount. Dogs: 0.25 to 0.5 mg per pound (/lb) of body weight; Cats: 0.5 to 1.0 mg/lb of body weight; Horses: 2.0 to 4.0 mg per 100 lbs of body weight.
(2) Indications for use. For use as a tranquilizer and as a preanesthetic agent.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.52   Alfaxalone.
(a) Specifications. Each milliliter contains 10 milligrams (mg) alfaxalone.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in cats and dogs —(1) Amount —(i) Cats —(A) Induction of general anesthesia. Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a preanesthetic or 1.0 to 10.8 mg/kg for cats that received a preanesthetic.
(B) Maintenance of general anesthesia following induction. Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes anesthesia in unpreanesthetized cats.
(ii) Dogs —(A) Induction of general anesthesia. Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received a preanesthetic.
(B) Maintenance of general anesthesia following induction. Administer an intravenous bolus containing 1.2 to 1.4 mg/kg to provide an additional 6 to 8 minutes of anesthesia in preanesthetized dogs; a dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 minutes of anesthesia in unpreanesthetized dogs.
(2) Indications for use. For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in dogs and cats.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Alfaxalone is a Class IV controlled substance.
§ 522.56   Amikacin.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of amikacin as amikacin sulfate.
(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 5 mg/pound (lb) of body weight twice daily by intramuscular or subcutaneous injection.
(2) Indications for use. For treatment of genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli and Proteus spp. and skin and soft tissue infections caused by susceptible strains of Pseudomonas spp. and E. coli.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.62   Aminopentamide.
(a) Specifications. Each milliliter of solution contains 0.5 milligram (mg) aminopentamide hydrogen sulfate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer by subcutaneous or intramuscular injection every 8 to 12 hours as follows: For animals weighing up to 10 pounds (lbs): 0.1 mg; For animals weighing 11 to 20 lbs: 0.2 mg; For animals weighing 21 to 50 lbs: 0.3 mg; For animals weighing 51 to 100 lbs: 0.4 mg; For animals weighing over 100 lbs: 0.5 mg. Dosage may be gradually increased up to a maximum of five times the suggested dosage. Following parenteral use, dosage may be continued by oral administration of tablets.
(2) Indications for use. For the treatment of vomiting and/or diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.82   Aminopropazine.
(a) Specifications. Each milliliter of solution contains aminopropazine fumarate equivalent to 25 milligrams (mg) aminopropazine base.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs and cats —(i) Amount. 1 to 2 mg per pound of body weight, repeated every 12 hours as indicated, by intramuscular or intravenous injection.
(ii) Indications for use. For reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses —(i) Amount. Administer 0.25 mg per pound of body weight, repeated every 12 hours as indicated, by intramuscular or intravenous injection.
(ii) Indications for use. For reducing excessive smooth muscle contractions, such as occur in colic spasms.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.88   Amoxicillin.
(a) Specifications. (1) Each vial contains 3 grams (g) of amoxicillin trihydrate. Each milliliter of constituted suspension contains 100 or 250 milligrams (mg) amoxicillin trihydrate for use as in paragraph (d)(1) of this section.
(2) Each vial contains 25 g of amoxicillin trihydrate. Each milliliter of constituted suspension contains 250 mg amoxicillin trihydrate for use as in paragraph (d)(2) of this section.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerance. See § 556.38 of this chapter.
(d) Conditions of use —(1) Dogs and cats —(i) Amount. Administer 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection.
(ii) Indications for use —(A) Dogs. For treatment of infections caused by susceptible strains of organisms as follows: Respiratory infections (tonsillitis, tracheobronchitis) due to Staphylococcus aureus, Streptococcus spp., Escherichia coli, and Proteus mirabilis; genitourinary infections (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal infections (bacterial gastroenteritis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; bacterial dermatitis due to S. aureus, Streptococcus spp., and P. mirabilis; soft tissue infections (abscesses, lacerations, and wounds), due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis.
(B) Cats. For treatment of infections caused by susceptible strains of organisms as follows: Upper respiratory infections due to S. aureus, Staphylococcus spp., Streptococcus spp., Haemophilus spp., E. coli, Pasteurella spp., and P. mirabilis; genitourinary infections (cystitis) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal infections due to E. coli, Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue infections (abscesses, lacerations, and wounds) due to S. aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella multocida.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cattle —(i) Amount. Administer 3 to 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection.
(ii) Indications for use. For treatment of diseases due to amoxicillin-susceptible organisms as follows: Respiratory tract infections (shipping fever, pneumonia) due to P. multocida, P. hemolytica, Haemophilus spp., Staphylococcus spp., and Streptococcus spp. and acute necrotic pododermatitis (foot rot) due to Fusobacterium necrophorum.
(iii) Limitations. Treated animals must not be slaughtered for food during treatment and for 25 days after the last treatment. Milk from treated cows must not be used for human consumption during treatment or for 96 hours (8 milkings) after last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.90   Ampicillin injectable dosage forms.
§ 522.90a   Ampicillin trihydrate suspension.
(a) Specifications. (1) Each milliliter contains ampicillin trihydrate equivalent to 200 milligrams (mg) of ampicillin.
(2) Each milliliter contains ampicillin trihydrate equivalent to 150 mg of ampicillin.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraphs (d)(1), (d)(2), (d)(3)(i)(A), (d)(3)(ii)(A), (d)(3)(iii), and (d)(4) of this section.
(2) No. 054771 for use of product described in paragraph (a)(2) as in paragraphs (d)(3)(i)(B), (d)(3)(ii)(B), and (d)(3)(iii) of this section.
(c) Related tolerances. See § 556.40 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. For enteritis: 3 mg per pound of body weight, intramuscularly, once or twice daily, for up to 3 days. For pneumonia: 3 mg per pound of body weight, intramuscularly, twice daily, for up to 3 days.
(ii) Indications for use. For treatment of bacterial enteritis in calves caused by Escherichia coli and bacterial pneumonia caused by Pasteurella spp. susceptible to ampicillin.
(iii) Limitations. Treated animals must not be slaughtered for food use during treatment or for 9 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine —(i) Amount. 3 mg per pound of body weight by intramuscular injection, once or twice daily, for up to 3 days.
(ii) Indications for use. Treatment of bacterial enteritis (colibacillosis) caused by E. coli and bacterial pneumonia caused by Pasteurella spp. susceptible to ampicillin.
(iii) Limitations. Treated animals must not be slaughtered for food use during treatment or for 15 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Dogs —(i) Amount. (A) 3 to 6 mg per pound of body weight by intramuscular injection, once or twice daily. Usual treatment is 3 to 5 days.
(B) 3 to 5 mg of ampicillin per pound of body weight, once a day for up to 4 days.
(ii) Indications for use. (A) Treatment of respiratory tract infections due to E. coli, Pseudomonas spp., Proteus spp., Staphylococcus spp., and Streptococcus spp.; tonsillitis due to E. coli, Pseudomonas spp., Streptococcus spp., and Staphylococcus spp.; generalized infections (septicemia) associated with abscesses, lacerations, and wounds due to Staphylococcus spp. and Streptococcus spp.
(B) Treatment of bacterial infections of the upper respiratory tract (tonsillitis) due to Streptococcus spp., Staphylococcus spp., E. coli, Proteus spp., and Pasteurella spp., and soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus spp., Streptococcus spp., and E. coli, when caused by susceptible organisms.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) Cats —(i) Amount. 5 to 10 mg per pound of body weight by intramuscular or subcutaneous injection, once or twice daily. Usual treatment is 3 to 5 days.
(ii) Indications for use. Treatment of generalized infections (septicemia) associated with abscesses, lacerations, and wounds due to Staphylococcus spp., Streptococcus spp., and Pasteurella spp.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.90b   Ampicillin trihydrate powder for injection.
(a) Specifications. Each milliliter of aqueous suspension constituted from ampicillin trihydrate powder contains 200, 250, or 400 milligrams (mg) ampicillin equivalents.
(b) Sponsors. See Nos. 000010 and 042791 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.40 of this chapter.
(d) Conditions of use —(1) Dogs and cats —(i) Amount. 3 mg/pound (lb) of body weight twice daily by subcutaneous or intramuscular injection.
(ii) Indications for use. For treatment of strains of organisms susceptible to ampicillin and associated with respiratory tract infections, urinary tract infections, gastrointestinal infections, skin infections, soft tissue infections, and postsurgical infections.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cattle —(i) Amount. 2 to 5 mg/lb of body weight once daily by intramuscular injection.
(ii) Indications for use. For treatment of respiratory tract infections caused by organisms susceptible to ampicillin, bacterial pneumonia (shipping fever, calf pneumonia, and bovine pneumonia) caused by Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus spp., Pasteurella multocida, and Escherichia coli.
(iii) Limitations. Do not treat cattle for more than 7 days. Milk from treated cows must not be used for food during treatment and for 48 hours (4 milkings) after the last treatment. Cattle must not be slaughtered for food during treatment and for 144 hours (6 days) after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.90c   Ampicillin sodium.
(a) Specifications. Each milliliter of aqueous solution constituted from ampicillin sodium powder contains 300 milligrams (mg) ampicillin equivalents.
(b) See Nos. 042791 and 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount : 3 mg per pound of body weight twice daily by intravenous or intramuscular injection.
(2) Indications for use. For the treatment of respiratory tract infections (pneumonia and strangles) due to Staphylococcus spp., Streptococcus spp. (including S. equi ), Escherichia coli , and Proteus mirabilis , and skin and soft tissue infections (abscesses and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli , and P. mirabilis , when caused by susceptible organisms.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.144   Arsenamide.
(a) Specifications. Each milliliter of solution contains 10.0 milligrams arsenamide sodium.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 0.1 milliliter (mL) per pound of body weight (1.0 mL for every 10 pounds) by intravenous injection twice a day for 2 days.
(2) Indications for use. For the treatment and prevention of canine heartworm disease caused by Dirofilaria immitis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.147   Atipamezole.
(a) Specifications. Each milliliter of solution contains 5.0 milligrams atipamezole hydrochloride.
(b) Sponsors. See Nos. 015914, 052483, 068504, and 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 3,750 mcg/m 2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m 2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.
(2) Indications for use. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride and medetomidine hydrochloride.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.150   Azaperone.
(a) Specifications. Each milliliter of solution contains 40 milligrams (mg) azaperone.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.68 of this chapter.
(d) Conditions of use —(1) Indications for use. For control of aggressiveness when mixing or regrouping weanling or feeder pigs weighing up to 80 pounds.
(2) Dosage. 2.2 mg per kilogram (1 mg per pound) by deep intramuscular injection.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.158   Bedinvetmab.
(a) Specifications. Each single-use vial contains 5, 10, 15, 20, or 30 milligrams (mg) bedinvetmab in an extractable volume of 1 milliliter.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer 0.23 mg/pound (0.5 mg/kilogram) body weight monthly by subcutaneous injection.
(2) Indications for use. For the control of pain associated with osteoarthritis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.161   Betamethasone.
(a) Specifications. Each milliliter of suspension contains:
(1) Betamethasone acetate equivalent to 10.8 milligrams (mg) betamethasone and betamethasone disodium phosphate equivalent to 3 mg of betamethasone.
(2) Betamethasone dipropionate equivalent to 5 mg betamethasone and betamethasone sodium phosphate equivalent to 2 mg of betamethasone.
(b) Sponsor. See sponsor numbers in § 510.600(c) of this chapter:
(1) No. 000061 for product described in paragraph (a)(1) of this section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section.
(2) No. 000061 for product described in paragraph (a)(2) of this section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(B), and (c)(2)(iii) of this section.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer by intramuscular injection 0.25 to 0.5 milliliter (mL) per 20 pounds of body weight, depending on the severity of the condition. Frequency of dosage depends on recurrence of pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms recur, not to exceed a total of four injections.
(ii) Indications for use. As an aid in the control of pruritus associated with dermatoses.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses —(i) Amount. Administer 2.5 to 5 mL by intra-articular injection.
(ii) Indications for use. (A) For the treatment of various inflammatory joint conditions; for example, acute and traumatic lameness involving the carpel and fetlock joints.
(B) As an aid in the control of inflammation associated with various arthropathies.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.163   Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension.
(a) Specifications. Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension is a sterile aqueous suspension. Each milliliter of the suspension contains the equivalent of 5 milligrams of betamethasone as betamethasone dipropionate and 2 milligrams of betamethasone as betamethasone sodium phosphate.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs. (i) It is used as an aid in the control of pruritus associated with dermatoses.
(ii) It is administered by intramuscular injection at a dosage of 0.25 to 0.5 milliliter per 20 pounds of body weight, depending on the severity of the condition. Frequency of dosage depends on recurrence of pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms recur, not to exceed a total of 4 injections.
(2) Horses. (i) It is used as an aid in the control of inflammation associated with various arthropathies.
(ii) It is administered aseptically by intraarticular injection at a dosage of 2.5 to 5 milliliters per joint, depending on the severity of the condition and the joint size. Dosage may be repeated upon recurrence of clinical signs. Injection into the joint cavity should be preceded by withdrawal of synovial fluid.
(iii) Not for use in horses intended for food.
(3) Clinical and experimental data. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.
(4) Restrictions. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.167   Betamethasone sodium phosphate and betamethasone acetate.
(a) Specifications. Each milliliter (mL) of suspension contains 6 milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate and 2.85 mg betamethasone acetate).
(b) Sponsor. See No. 010797 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 1.5 mL (9 mg total betamethasone) per joint by intra-articular injection. May be administered concurrently in up to two joints per horse.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in horses.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.204   Boldenone.
(a) Specifications. Each milliliter of solution contains 25 or 50 milligrams (mg) boldenone undecylenate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 0.5 mg per pound body weight by intramuscular injection. Treatment may be repeated at 3-week intervals.
(2) Indications for use. As an aid for treating debilitated horses when an improvement in weight, hair coat, or general physical condition is desired.
(3) Limitations. Do not administer to horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.224   Bupivacaine.
(a) Specifications. Each milliliter (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer 5.3 mg/kg (0.4 mL/kg) by infiltration injection into the tissue layers at the time of incisional closure.
(ii) Indications for use. For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery.
(2) Cats —(i) Amount. Administer 5.3 mg/kg per forelimb (0.4 mL/kg per forelimb), for a total dose of 10.6 mg/kg/cat, as a 4-point nerve block prior to onychectomy.
(ii) Indications for use. For use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy.
§ 522.230   Buprenorphine.
(a) Specifications. Each milliliter of solution contains 1.8 milligrams (mg) buprenorphine.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in cats —(1) Amount. Administer 0.24 mg per kilogram (0.11 mg per pound) by subcutaneous injection once daily, for up to 3 days. Administer the first dose approximately 1 hour prior to surgery.
(2) Indications for use. For the control of postoperative pain associated with surgical procedures in cats.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.234   Butamisole.
(a) Specifications. Each milliliter of solution contains 11 milligrams (mg) butamisole hydrochloride.
(b) Sponsors. See Nos. 054771 and 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 0.1 mg per pound of body weight by subcutaneous injection. In problem cases, retreatment for whipworms may be necessary in approximately 3 months. For hookworms, a second injection should be given 21 days after the initial treatment.
(2) Indications for use. For the treatment of infections with whipworms ( Trichuris vulpis ), and the hookworm ( Ancylostoma caninum ).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.246   Butorphanol.
(a) Specifications. Each milliliter of solution contains butorphanol (as butorphanol tartrate) in the following amounts:
(1) 0.5 milligrams (mg);
(2) 2 mg; or
(3) 10 mg
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section; for use of the product described in paragraph (a)(2) as in paragraph (d)(2) of this section; and for use of the product described in paragraph (a)(3) as in paragraph (d)(3) of this section.
(2) No. 043264 for use of the product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.
(3) Nos. 000061, 017033, 043264, and 059399 for use of the product described in paragraph (a)(3) of this section as in paragraph (d)(3) of this section.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Dogs —(i) Amount. Administer 0.025 mg per pound of body weight by subcutaneous injection at intervals of 6 to 12 hours, as required. If necessary, increase dose to a maximum of 0.05 mg per pound of body weight. Treatment should not normally be required for longer than 7 days.
(ii) Indications for use. For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract.
(2) Cats —(i) Amount. Administer 0.2 mg per pound of body weight by subcutaneous injection. Dose may be repeated up to 4 times per day. Do not treat for more than 2 days.
(ii) Indications for use. For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
(3) Horses —(i) Amount. Administer 0.05 mg per pound of body weight by intravenous injection. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours.
(ii) Indications for use. For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.
(iii) Limitations. Do not use in horses intended for human consumption.
§ 522.275   N-Butylscopolammonium.
(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) N-butylscopolammonium bromide.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 0.3 mg per kilogram of body weight (0.14 mg per pound) slowly intravenously.
(2) Indications for use. For the control of abdominal pain (colic) associated with spasmodic colic, flatulent colic, and simple impactions.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.304   Carprofen.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) carprofen.
(b) Sponsors. See Nos. 016729, 017033, 054771, 055529, 069043, and 086101 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use in dogs —(1) Amount. 2 mg/lb (4.4 mg/kg) body weight once daily or 1 mg/lb (2.2 mg/kg) twice daily, by subcutaneous injection. For the control of postoperative pain, administer approximately 2 hours before the procedure.
(2) Conditions of use. For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.311   Cefovecin.
(a) Specifications. Each milliliter of constituted solution contains 80 milligrams (mg) cefovecin as the sodium salt.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Dogs —(i) Amount. Administer 3.6 mg/pound (lb) (8 mg/kilograms (kg)) body weight as a single subcutaneous injection. A second subcutaneous injection of 3.6 mg/lb (8 mg/kg) may be administered if response to therapy is not complete.
(ii) Indications for use. For the treatment of skin infections (secondary superficial pyoderma, abscesses, and wounds) in dogs caused by susceptible strains of Staphylococcus intermedius and Streptococcus canis (Group G).
(2) Cats —(i) Amount. Administer 3.6 mg/lb (8 mg/kg) body weight as a single, one-time subcutaneous injection.
(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida.
§ 522.313   Ceftiofur injectable dosage forms.
§ 522.313a   Ceftiofur crystalline free acid.
(a) Specifications. The product is a suspension of ceftiofur crystalline free acid.
(1) Each milliliter (mL) contains 100 milligrams (mg) ceftiofur equivalents.
(2) Each mL contains 200 mg ceftiofur equivalents.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.113 of this chapter.
(d) Conditions of use —(1) Swine. The formulation described in paragraph (a)(1) of this section is used as follows:
(i) Amount. 5.0 mg CE per kilogram (kg) of body weight by intramuscular injection in the postauricular region of the neck.
(ii) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Haemophilus parasuis , and Streptococcus suis. For the control of SRD associated with A. pleuropneumoniae, P. multocida, H. parasuis, and S. suis in groups of pigs where SRD has been diagnosed.
(iii) Limitations. Following label use as a single treatment, a 14-day pre-slaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in swine for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved, major food-producing species/production classes.
(2) Cattle. The formulation described in paragraph (a)(2) of this section is used as follows:
(i) Amount. For subcutaneous (SC) injection in the posterior aspect of the ear where it attaches to the head (base of the ear) in lactating dairy cattle. For SC injection in the middle third of the posterior aspect of the ear or in the base of the ear in beef and non-lactating dairy cattle.
(A) Single-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight as a single injection.
(B) Two-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight given as two injections in the base of the ear approximately 72 hours apart.
(ii) Indications for use. (A) Single-dose regimen: For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle. For the control of respiratory disease in beef and non-lactating dairy cattle which are at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.
(B) Two-dose regimen: For the treatment of acute metritis (0-to 10-days postpartum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle.
(iii) Limitations. Following label use as either a single-dose or 2-dose regimen, a 13-day pre-slaughter withdrawal period is required after the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved, major food-producing species/production classes.
(3) Horses. The formulation described in paragraph (a)(2) of this section is used as follows:
(i) Amount. Two intramuscular injections, 4 days apart, at a dose of 3.0 mg/lb (6.6 mg/kg) body weight.
(ii) Indications for use. For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.313b   Ceftiofur hydrochloride.
(a) Specifications. Each milliliter of suspension contains:
(1) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of ceftiofur equivalents in the inactive vehicles phospholipan 90H, sorbitan monooleate, and cottonseed oil;
(2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles polyoxyethylene sorbitan monooleate (polysorbate 80) in a caprylic/capric triglyceride suspension; or
(3) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles aluminum monostearate, sorbitan monooleate, and medium chain triglycerides.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 054771 for products described in paragraphs (a)(1) and (2) of this section; and
(2) No. 055529 for the product described in paragraph (a)(3) of this section.
(c) Related tolerances. See § 556.113 of this chapter.
(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle and swine for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food-producing species/production classes.
(e) Conditions of use —(1) Swine —(i) Amount. 3 to 5 mg per kilogram (/kg) of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
(ii) Indications for use. For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Salmonella Choleraesuis, and Streptococcus suis.
(iii) Limitations. For products described in paragraphs (a)(1) and (3) of this section: Treated swine must not be slaughtered for 4 days following the last treatment. For products described in paragraph (a)(2) of this section: Treated swine must not be slaughtered for 6 days following the last treatment when injection site volumes are greater than 5 mL up to the maximum injection site volume of 15 mL. Treated swine must not be slaughtered for 4 days when injection site volumes are less than or equal to 5 mL.
(2) Cattle —(i) Amount. Administer by subcutaneous or intramuscular injection as follows:
(A) For bovine respiratory disease and acute bovine interdigital necrobacillosis: 1.1 to 2.2 mg/kg of body weight at 24-hour intervals for 3 to 5 consecutive days.
(B) For bovine respiratory disease: 2.2 mg/kg of body weight administered twice at a 48 hour interval.
(C) For acute metritis: 2.2 mg/kg of body weight at 24-hour intervals for 5 consecutive days.
(ii) Indications for use. For treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica , P. multocida , and Histophilus somni ; acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus ; and acute metritis (0 to 14 days post-partum) associated with bacteria susceptible to ceftiofur.
(iii) Limitations. (A) For products described in paragraphs (a)(2) and (3) of this section: Treated cattle must not be slaughtered for 3 days following the last treatment. For products described in paragraph (a)(2) of this section: Treated cattle must not be slaughtered for 4 days following the last treatment.
(B) A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.
§ 522.313c   Ceftiofur sodium.
(a) Specifications. Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents.
(b) Sponsors. See Nos. 017033 and 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.113 of this chapter.
(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle, swine, chickens, and turkeys for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food-producing species/production classes.
(e) Conditions of use —(1) Swine —(i) Amount. 3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days.
(ii) Indications for use. For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Salmonella choleraesuis , and Streptococcus suis.
(iii) Limitations. Treated pigs must not be slaughtered for 4 days following the last treatment.
(2) Cattle —(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
(ii) Indications for use. For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. Also, for the treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
(iii) Limitations. Treated cattle must not be slaughtered for 4 days following the last treatment.
(3) Sheep —(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
(ii) Indications for use. For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
(4) Goats —(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
(ii) Indications for use. For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
(5) Chickens —(i) Amount. 0.08 to 0.20 mg as a single subcutaneous injection in the neck.
(ii) Indications for use. For control of early mortality associated with Escherichia coli organisms susceptible to ceftiofur in day-old chicks.
(6) Turkeys —(i) Amount. 0.17 to 0.5 mg as a single subcutaneous injection in the neck.
(ii) Indications for use. For control of early mortality associated with E. coli organisms susceptible to ceftiofur in day-old poults.
(7) Horses —(i) Amount. 2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body weight by intramuscular injection. Treatment should be repeated every 24 hours, continued for 48 hours after clinical signs have disappeared, and should not exceed 10 days. A maximum of 10 mL should be administered per injection site.
(ii) Indications for use. For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
(iii) Limitations. Do not use in horses intended for human consumption.
(8) Dogs —(i) Amount. 1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals for 5 to 14 days.
(ii) Indications for use. For treatment of canine urinary tract infections associated with E. coli and Proteus mirabilis.
§ 522.380   Chloral hydrate, pentobarbital, and magnesium sulfate.
(a) Specifications. Each milliliter of solution contains 42.5 milligrams (mg) of chloral hydrate, 8.86 mg of pentobarbital, and 21.2 mg of magnesium sulfate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. For general anesthesia: Administer 20 to 50 milliliters per 100 pounds of body weight by intravenous injection until the desired effect is produced. Cattle usually require a lower dosage on the basis of body weight. As a sedative-relaxant: Administer at a level of one-fourth to one-half of the anesthetic dosage level.
(2) Indications for use. For general anesthesia and as a sedative-relaxant in cattle and horses.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.390   Chloramphenicol.
(a) Specifications. Each milliliter of solution contains 100 milligrams of chloramphenicol.
(b) Sponsor. See Nos. 054771 and 069043 in § 510.600(c) of this chapter.
(c) Conditions of use. Dogs —(1) Amount. 5 to 15 milligrams per pound of body weight, intramuscularly or intravenously, every 6 hours. In severe infections, use 4 to 6 hour treatment intervals the first day. If no response is obtained in 3 to 5 days, discontinue use and reevaluate diagnosis.
(2) Indications for use. Treatment of infections of the respiratory tract, the urinary tract, and enteritis and tonsillitis caused by organisms susceptible to chloramphenicol.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.
§ 522.454   Clodronate.
(a) Specifications. Each milliliter of solution contains 60 milligrams (mg) clodronate disodium.
(b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 1.8 mg per kilogram of body weight by intramuscular injection up to a maximum dose of 900 mg per horse.
(2) Indications for use. For the control of clinical signs associated with navicular syndrome.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.460   Cloprostenol.
(a) Specifications. Each milliliter of solution contains cloprostenol sodium equivalent to:
(1) 125 micrograms (µg) of cloprostenol; or
(2) 250 µg of cloprostenol.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter.
(1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) of this section.
(2) No. 000061 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (viii) and (c)(2) of this section.
(3) No. 068504 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (vii), (c)(1)(ix), and (c)(2) of this section.
(c) Conditions of use in cattle —(1) Amount and indications for use.
(i) Administer 375 µg by intramuscular injection to induce abortion in pregnant feedlot heifers from 1 week after mating until 4 1/2 months of gestation.
(ii) Administer 500 µg by intramuscular injection for unobserved or non-detected estrus in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(iii) Administer 500 µg by intramuscular injection for treatment of pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(iv) Administer 500 µg by intramuscular injection for treatment of mummified fetus in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(v) Administer 500 µg by intramuscular injection for treatment of luteal cysts in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(vi) Administer 500 µg by intramuscular injection for abortion of beef cows, lactating dairy cows, and replacement beef and dairy heifers from 1 week after mating until 5 months of gestation. Not for use in heifers placed in feedlots.
(vii) Administer 500 µg by intramuscular injection as a single injection regimen or double injection regimen with a second injection 11 days after the first injection, for estrus synchronization in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(viii) For use with gonadorelin acetate to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows: administer to each cow 86 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 µg gonadorelin by intramuscular injection. Gonadorelin acetate as provided in § 522.1077(a)(1) of this chapter.
(ix) For use with gonadorelin to synchronize estrous cycles to allow for FTAI in lactating dairy cows: administer to each cow by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by gonadorelin by intramuscular injection. Gonadorelin as provided in § 522.1077(a)(1) through (3) of this chapter.
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.468   Colistimethate sodium powder for injection.
(a) Specifications. Each vial contains colistimethate sodium equivalent to 10 grams colistin activity and mannitol to be reconstituted with 62.5 milliliters sterile saline or sterile water for injection. The resulting solution contains colistimethate sodium equivalent to 133 milligrams per milliliter colistin activity.
(b) Sponsor. See 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.167 of this chapter.
(d) Conditions of use. (1) 1- to 3-day-old chickens.
(i) Dosage. 0.2 milligram colistin activity per chicken.
(ii) Indications for use. Control of early mortality associated with Escherichia coli organisms susceptible to colistin.
(iii) Limitations. For subcutaneous injection in the neck of 1- to 3-day-old chickens. Not for use in laying hens producing eggs for human consumption. Do not use in turkeys. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 522.480   Corticotropin.
(a) Specifications. Each milliliter of aqueous solution contains 40 or 80 U.S.P. (I.U.) units of repository corticotropin.
(b) Sponsor. See sponsors in § 510.600(c) of this chapter.
(1) No. 061133 for use as in paragraphs (c)(1) and (2) of this section.
(2) No. 043264 for use as in paragraph (c)(2) and (3) of this section.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer one unit per pound of body weight by intramuscular injection.
(ii) Indications for use. As a diagnostic aid to test for adrenal dysfunction.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs and cats —(i) Amount. Administer one unit per pound of body weight by intramuscular or subcutaneous injection, to be repeated as indicated.
(ii) Indications for use. For stimulation of the adrenal cortex where there is a general deficiency of corticotropin (ACTH).
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Cattle —(i) Amount. Administer 200 to 600 units by intramuscular or subcutaneous injection as an initial dose, followed by a dose daily or every other day of 200 to 300 units.
(ii) Indications for use. As a therapeutic agent for primary bovine ketosis; and for stimulation of the adrenal cortex where there is a general deficiency of ACTH.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.522   Danofloxacin.
(a) Specifications. Each milliliter of solution contains 180 milligrams (mg) danofloxacin as the mesylate salt.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.169 of this chapter.
(d) Conditions of use in cattle —(1) Amount and indications for use. Administer by subcutaneous injection either:
(i) 6 mg per kilogram (/kg) of body weight, repeated in 48 hours, for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica and Pasteurella multocida; or
(ii) 8 mg/kg of body weight as a single dose for the treatment of BRD associated with M. haemolytica and P. multocida and for the control of BRD in beef cattle at high risk of developing BRD associated with M. haemolytica and P. multocida.
(2) Limitations. Animals intended for human consumption should not be slaughtered within 4 days from the last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.
§ 522.533   Deslorelin.
(a) Specifications. (1) Each implant contains 2.1 milligrams (mg) deslorelin acetate.
(2) Each milliliter (mL) of suspension contains 1.8 mg deslorelin acetate.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) No. 051311 for use of product described in paragraph (a)(1) as in paragraph (c)(1) of this section.
(2) No. 043264 for use of product described in paragraph (a)(2) as in paragraph (c)(2) of this section.
(c) Conditions of use —(1) Horses and ponies —(i) Amount. One implant per mare subcutaneously in the neck.
(ii) Indications for use. For inducing ovulation within 48 hours in estrous mares with an ovarian follicle greater than 30 millimeters (mm) in diameter.
(iii) Limitations. Do not use in horses or ponies intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses —(i) Amount. Administer 1.8 mg (1 mL) by intramuscular injection in the neck.
(ii) Indications for use. For inducing ovulation within 48 hours in cyclic estrous mares with an ovarian follicle between 30 and 40 mm in diameter.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.535   Desoxycorticosterone.
(a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) of desoxycorticosterone pivalate.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 043264 for use as in paragraphs (c)(1)(i), (c)(2)(i), and (c)(3) of this section.
(2) No. 058198 for use as in paragraphs (c)(1)(ii), (c)(2)(ii), and (c)(3) of this section.
(c) Conditions of use —(1) Amount. (i) Administer an initial dose of 2.2 mg/kilogram (1 mg/lb) of body weight by subcutaneous injection. Subsequent dosages should be individualized according to label instructions based on patient response to therapy.
(ii) Dosage requirements are variable and must be individualized on the basis of the response of the patient to therapy. Initial dose of 1 milligram per pound (0.45 kilogram) of body weight every 25 days, intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days.
(2) Indications for use —(i) For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's Disease).
(ii) For use as replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.536   Detomidine.
(a) Specification. Each milliliter of solution contains 10 milligrams of detomidine hydrochloride.
(b) Sponsor. See Nos. 015914, 052483, and 059399 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. For sedation, analgesia, or sedation and analgesia: 20 or 40 micrograms per kilogram (0.2 or 0.4 milliliter per 100 kilogram or 220 pounds) by body weight, depending on depth and duration required. For sedation, administer by intraveneous (IV) or intramuscular (IM) injection; for analgesia, administer by IV injection; for both sedation and analgesia, administer by IV injection.
(2) Indication for use. As a sedative and analgesic to facilitate minor surgical and diagnostic procedures in mature horses and yearlings.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.540   Dexamethasone solution.
(a)(1) Specifications. Each milliliter of solution contains 2 milligrams (mg) dexamethasone.
(2) Sponsors. See sponsors in § 510.600(c) of this chapter:
(i) Nos. 000061, 016592, and 061133 for use as in paragraph (a)(3) of this section.
(ii) No. 058005 for use as in paragraphs (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this section.
(3) Conditions of use —(i) Amount. The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary, as follows:
(A) Dogs. 0.25 to 1 mg.
(B) Cats. 0.125 to 0.5 mg.
(C) Horses. 2.5 to 5 mg.
(D) Cattle. 5 to 20 mg, depending on the severity of the condition.
(ii) Indications for use. The drug is indicated:
(A) For the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses;
(B) As an anti-inflammatory agent in dogs and cats.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(b)(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).
(2) Sponsor. See No. 061133 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Amount. Administer 0.25 to 1 mg by intravenous injection, repeated for 3 to 5 days or until a response is noted.
(ii) Indications for use. For use in dogs for the treatment of inflammatory conditions, as supportive therapy in canine posterior paresis, as supportive therapy before or after surgery to enhance recovery of poor surgical risks, and as supportive therapy in nonspecific dermatosis.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(c)(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg of dexamethasone).
(2) Sponsor. See No. 061133 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Amount. Administer 2.5 to 5.0 mg by intravenous injection.
(ii) Indications for use. For use in horses as a rapid adrenal glucocorticoid and/or anti-inflammatory agent.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg of dexamethasone).
(2) Sponsors. See the following numbers in § 510.600(c) of this chapter:
(i) Nos. 016592 and 051031 for intravenous or intramuscular use of 2.0 milligrams dexamethasone injection.
(ii) No. 054771 for intravenous use of 2.0 milligrams dexamethasone injection.
(3) Conditions of use —(i) Amount. Administer by intravenous or intramuscular injection as follows:
(A) Dogs: 0.25 to 1 mg.
(B) Cats: 0.125 to 0.5 mg.
(C) Horses: 2.5 to 5 mg.
(ii) Indications for use. For use in dogs, cats, and horses as an anti-inflammatory agent.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e)(1) Specifications. Each milliliter of solution contains 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).
(2) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Amount. Administer by intravenous injection as follows:
(A) Dogs: 0.25 to 1 mg; may be repeated for 3 to 5 days.
(B) Horses: 2.5 to 5 mg.
(ii) Indications for use. For use in dogs and horses for glucocorticoid and anti-inflammatory effect.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.558   Dexmedetomidine.
(a) Specifications. Each milliliter of solution contains:
(1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or
(2) 0.5 mg dexmedetomidine hydrochloride.
(b) Sponsors. See sponsors in in § 510.600(c) of this chapter for use as in paragraph (c) of this section:
(1) Nos. 017033, 068504, 069043, and 086117 for use of product described in paragraph (a)(2) of this section.
(2) No. 052483 for use of products described in paragraph (a) of this section.
(c) Conditions of use —(1) Dogs —(i) Indications for use and amount. (A) For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms (µg) per square meter (/m 2 ) of body surface area by intravenous injection or 500 µg/m 2 of body surface area by intramuscular injection.
(B) For use as a preanesthetic to general anesthesia, administer 125 µg/m 2 of body surface area or 375 µg/m 2 of body surface area by intramuscular injection.
(ii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. 40 µg/killogram by intramuscular injection.
(ii) Indications for use. For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.563   Diatrizoate.
(a) Specifications. Each milliliter of solution contains 34.3 percent diatrizoate meglumine and 35 percent diatrizoate sodium, or 66 percent diatrizoate meglumine and 10 percent diatrizoate sodium.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. For excretion urography, administer 0.5 to 1.0 milliliter (mL) per pound of body weight to a maximum of 30 mL intravenously. For cystography, remove urine, administer 5 to 25 mL directly into the bladder via catheter. For urethrography, administer 1.0 to 5 mL via catheter into the urethra to provide desired contrasts delineation. For angiocardiography (including aortography) rapidly inject 5 to 10 mL directly into the heart via catheter or intraventricular puncture. For cerebral angiography, rapid injection of 3 to 10 mL via carotid artery. For peripheral arteriography and/or venography and selective coronary arteriography, rapidly inject 3 to 10 mL intravascularly into the vascular bed to be delineated. For lymphography, slowly inject 1.0 to 10 mL directly into the lymph vessel to be delineated. For arthrography, slowly inject 1.0 to 5 mL directly into the joint to be delineated. For discography, slowly inject 0.5 to 1.0 mL directly into the disc to be delineated. For sialography, slowly inject 0.5 to 1.0 mL into the duct to be delineated. For delineation of fistulous tracts, slowly inject quantity necessary to fill the tract. For delineation of peritoneal hernias, inject 0.5 to 1.0 mL per pound of body weight directly into the peritoneal cavity.
(2) Indications for use. For visualization in excretion urography, including renal angiography, uretography, cystography, and urethrography; aortography; angiocardiography, peripheral arteriography, and venography; selective coronary arteriography; cerebral angiography; lymphography; arthrography; discography; and sialography; and as an aid in delineating peritoneal hernias and fistulous tracts.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.650   Dihydrostreptomycin sulfate injection.
(a) Specifications. Each milliliter contains dihydrostreptomycin sulfate equivalent to 500 milligrams of dihydrostreptomycin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerance. See § 556.200 of this chapter.
(d) Conditions of use —(1) Amount. Administer 5 milligrams per pound of body weight by deep intramuscular injection every 12 hours, for 3 to 5 days or until the urine is free of leptospira for at least 72 hours as measured by darkfield microscopic examination.
(2) Indications for use. Treatment of leptospirosis in dogs and horses due to Leptospira canicola, L. icterohemorrhagiae, and L. pomona; in cattle due to L. pomona; and in swine due to L. pomona; and L. grippotyphosa.
(3) Limitations. Discontinue use 30 days before slaughter for food. Not for use in animals producing milk because use of the drug will contaminate the milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.690   Dinoprost.
(a) Specifications. Each milliliter (mL) of solution contains dinoprost tromethamine equivalent to:
(1) 5 milligrams (mg) dinoprost; or
(2) 12.5 mg dinoprost.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) Nos. 054771 and 061133 for use of product described in paragraph (a)(1) as in paragraph (d) of this section.
(2) No. 054771 for use of product described in paragraph (a)(2) as in paragraph (d)(1) of this section.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Cattle. Administer products described in paragraph (a) of this section as follows:
(i) Amount. 25 mg as an intramuscular injection of the 5 mg/mL product or as an intramuscular or subcutaneous injection of the 12.5 mg/mL product.
(ii) Indications for use. As a luteolytic agent; effective only in those cattle having a corpus luteum, i.e., those which ovulated at least 5 days prior to treatment.
(A) For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.
(B) For unobserved (silent) estrus in lactating dairy cows with a corpus luteum.
(C) For treatment of pyometra (chronic endometritis) in cattle.
(D) For abortion in beef cows, beef heifers and replacement dairy heifers.
(E) For use with gonadorelin injection as in § 522.1077 of this chapter to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.
(F) For use with progesterone intravaginal inserts as in § 529.1940 of this chapter for synchronization of estrus in lactating dairy cows.
(G) For use with progesterone intravaginal inserts as in § 529.1940 of this chapter for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.
(2) Horses. Administer product described in paragraph (a)(1) of this section as follows:
(i) Amount. 1 mg per 100 pounds of body weight as a single intramuscular injection.
(ii) Indications for use. (A) For controlling the timing of estrus in estrous cycling mares.
(B) For difficult-to-breed mares (clinically anestrous mares that have a corpus luteum).
(iii) Limitations. Do not use in horses intended for human consumption.
(3) Swine. Administer product described in paragraph (a)(1) of this section as follows:
(i) Amount. 10 mg as a single intramuscular injection.
(ii) Indications for use. For parturition induction in swine.
§ 522.723   Diprenorphine.
(a) Specifications. Each milliliter of solution contains 2 milligrams of diprenorphine hydrochloride.
(b) Sponsors. See No. 053923 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. It is administered intramuscularly or intravenously at a suitable dosage level depending upon the species.
(2) Indications for use. The drug is used for reversing the effects of etorphine hydrochloride injection, veterinary, the use of which is provided for in § 522.883, in wild and exotic animals.
(3) Limitations. For use in wild or exotic animals only. Do not use in domestic food-producing animals. Do not use 30 days before, or during, the hunting season in free-ranging wild animals that might be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Distribution is restricted to veterinarians engaged in zoo and exotic animal practice, wildlife management programs, and researchers.
§ 522.728   Dipyrone.
(a) Specifications. Each milliliter of solution contains 500 milligrams (mg) dipyrone.
(b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 30 mg per kilogram of body weight (13.6 mg per pound) by intravenous injection, once or twice daily at a 12-hour interval for up to 3 days.
(2) Indications for use. For control of pyrexia in horses.
(3) Limitations. Do not use in horses intended for human consumption. Do not use in any food-producing animals, including lactating dairy animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.770   Doramectin.
(a) Specifications. Each milliliter of solution contains 10 milligrams of doramectin.
(b) Sponsors. See Nos. 054771 and 069043 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.222 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. 200 micrograms per kilogram (10 milligrams per 110 pounds).
(ii) Indications for use. For treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites. To control infections and to protect from reinfection with Cooperia oncophora and Haemonchus placei for 14 days, Ostertagia ostertagi for 21 days, and C. punctata, Oesophagostomum radiatum, and Dictyocaulus viviparus for 28 days after treatment.
(iii) Limitations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Administer as a single subcutaneous or intramuscular injection. Do not slaughter cattle for human consumption within 35 days of treatment. Not for use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(2) Swine —(i) Amount. 300 micrograms per kilogram (10 milligrams per 75 pounds).
(ii) Indications for use. For treatment and control of gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites.
(iii) Limitations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Administer as a single intramuscular injection. Do not slaughter swine for human consumption within 24 days of treatment.
§ 522.772   Doramectin and levamisole.
(a) Specifications. Each milliliter of solution contains 5 milligrams (mg) of doramectin and 150 mg levamisole hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.222 and 556.350 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. Inject subcutaneously in the neck as a single dose at a dosage of 0.2 mg doramectin (0.91 mg/lb) and 6 mg of levamisole hydrochloride per kg (2.72 mg/lb) of body weight.
(ii) Indications for use. For treatment and control of gastrointestinal roundworms (adults and fourth stage larvae): Ostertagia ostertagi (including inhibited larvae), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, T. longispicularis (adults only), Cooperia oncophora, C. pectinata (adults only), C. punctata, C. surnabada, Bunostomum phlebotomum (adults only), Strongyloides papillosus (adults only), Oesophagostomum radiatum, Trichuris spp. (adults only) and Nematodirus helvetianus (adults only); lungworms (adults and fourth stage larvae): Dictyocaulus viviparus; eyeworms (adults): Thelazia spp.; grubs (parasitic stages): Hypoderma bovis and H. lineatum; sucking lice: Haematopinus eurysternus, Linognathus vituli, and Solenopotes capillatus; mange mites: Psoroptes bovis and Sarcoptes scabiei in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age. Not for use in beef bulls intended for breeding over 1 year of age, dairy calves, and veal calves.
(iii) Limitations. Cattle must not be slaughtered for human consumption within 15 days following last treatment with this drug product. Not 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 or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 522.784   Doxylamine.
(a) Specifications. Each milliliter contains 11.36 milligrams (mg) of doxylamine succinate.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount —(i) Horses: Administer 25 mg per hundred pounds of body weight by intramuscular, subcutaneous, or slow intravenous injection.
(ii) Dogs and cats: Administer 0.5 to 1 mg per pound of body weight by intramuscular or subcutaneous injection. Doses may be repeated at 8 to 12 hours, if necessary, to produce desired effect.
(2) Indications for use. For use in conditions in which antihistaminic therapy may be expected to alleviate some signs of disease in horses, dogs, and cats.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.800   Droperidol and fentanyl.
(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of droperidol and 0.4 mg of fentanyl citrate.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. (i) For analgesia and tranquilization, administer as follows:
(A) 1 milliliter (mL) per 15 to 20 pounds (lbs) of body weight by intramuscular injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight; or
(B) 1 mL per 25 to 60 lbs of body weight by intravenous injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight.
(ii) For general anesthesia, administer as follows:
(A) Administer 1 mL per 40 lbs of body weight by intramuscular injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight and followed in 10 minutes by an intravenous administration of sodium pentobarbital at the rate of 3 mg per pound of body weight; or
(B) Administer 1 mL per 25 to 60 lbs of body weight by intravenous injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight and followed within 15 seconds by an intravenous administration of sodium pentobarbital at the rate of 3 mg per pound of body weight.
(2) Indications for use. As an analgesic and tranquilizer and for general anesthesia.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.810   Embutramide, chloroquine, and lidocaine solution.
(a) Specifications. Each milliliter (mL) of solution contains 135 milligrams (mg) embutramide; 45 mg chloroquine phosphate, U.S.P.; and 1.9 mg lidocaine, U.S.P.
(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. One mL per 5 pounds of body weight.
(2) Indications for use. For euthanasia.
(3) Limitations. Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.812   Enrofloxacin.
(a) Specifications. Each milliliter (mL) of solution contains:
(1) 22.7 milligrams (mg) enrofloxacin or
(2) 100 mg enrofloxacin.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter:
(1) Nos. 016729, 017033, 055529, 058198, 069043, and 086101 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section; and
(2) Nos. 051311, 055529, 058005, 058198, 061133, 069043, and 086101 for use of product described in paragraph (a)(2) as in paragraphs (e)(2) and (3) of this section.
(c) Related tolerance. See § 556.226 of this chapter.
(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.
(e) Conditions of use —(1) Dogs. Use the product described in paragraph (a)(1) of this section as follows:
(i) Amount. 2.5 mg per kilogram (/kg) of body weight (1.13 mg per pound) as a single, intramuscular, initial dose followed by use of tablets twice daily for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days.
(ii) Indications for use. For the management of diseases associated with bacteria susceptible to enrofloxacin.
(2) Cattle. Use the product described in paragraph (a)(2) of this section as follows:
(i) Amount —(A) Single-dose therapy: For treatment of bovine respiratory disease (BRD), administer 7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL per 100 pounds (/100 lb)) once by subcutaneous injection. For control of BRD, administer 7.5 mg/kg of body weight (3.4 mL/100 lb) once by subcutaneous injection.
(B) Multiple-day therapy: For treatment of BRD, administer 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous injection. Treatment should be repeated at 24-hour intervals for 3 days. Additional treatments may be given on days 4 and 5 to animals that have shown clinical improvement but not total recovery.
(ii) Indications for use —(A) Single-dose therapy: For the treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle; for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.
(B) Multiple-day therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.
(iii) Limitations. Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for 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. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(3) Swine. Use the product described in paragraph (a)(2) of this section as follows:
(i) Amounts and indications for use. (A) Administer 7.5 mg/kg of body weight once, by intramuscular or subcutaneous injection behind the ear, for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma hyopneumoniae.
(B) Administer 7.5 mg/kg of body weight once, by intramuscular or subcutaneous injection behind the ear, for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.
(ii) Limitations. Animals intended for human consumption must not be slaughtered within 5 days of receiving a single-injection dose.
§ 522.814   Eprinomectin.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) eprinomectin.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 500.1410 and 556.227 of this chapter.
(d) Conditions of use in cattle on pasture —(1) Amount. Administer 1 mg/kilogram of body weight by subcutaneous injection.
(2) Indications for use. For the treatment and control of the following internal and external parasites: Gastrointestinal roundworms (adults and fourth-stage larvae) Bunostomum phlebotomum, Cooperia oncophora, C. punctata, C. surnabada, Trichostrongylus axei, Ostertagia ostertagi (including inhibited stage); (adults) Haemonchus placei, Oesophagostomum radiatum, O. lyrata, T. colubriformis; lungworms (adults) Dictyocaulus viviparus; cattle grubs Hypoderma bovis; mites Sarcoptes scabiei var. bovis. Prevents reinfection with C. oncophora, C. punctata, and T. axei for 100 days following treatment; H. placei, O. radiatum, O. lyrata, and O. ostertagi for 120 days following treatment; and B. phlebotomum and D. viviparus for 150 days following treatment.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Animals intended for human consumption must not be slaughtered within 48 days of the last treatment. 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. A withdrawal period has not been established for pre-ruminating calves. Do not use in calves to be processed for veal.
§ 522.820   Erythromycin.
(a) Specifications —(1) Each milliliter (mL) of solution contains 100 milligrams (mg) erythromycin base.
(2) Each mL of solution contains 200 mg erythromycin base.
(b) Sponsor. See No. 061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.230 of this chapter.
(d) Conditions of use —(1) Dog. Administer product described in paragraph (a)(1) of this section as follows:
(i) Amount. 3 to 5 mg per pound (/lb) body weight, intramuscularly, two to three times daily, for up to 5 days.
(ii) Indications for use. For the treatment of bacterial pneumonia, upper respiratory infections (tonsillitis, bronchitis, tracheitis, pharyngitis, pleurisy), endometritis and metritis, and bacterial wound infections caused by Staphylococcus spp., Streptococcus spp., and Corynebacterium spp., sensitive to erythromycin.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats. Administer product described in paragraph (a)(1) of this section as follows:
(i) Amount. 3 to 5 mg/lb body weight, intramuscularly, two to three times daily, for up to 5 days.
(ii) Indications for use. For the treatment of bacterial pneumonia, upper respiratory infections (rhinitis, bronchitis), secondary infections associated with panleukopenia, and bacterial wound infections caused by Staphylococcus spp. and Streptococcus spp., susceptible to erythromycin.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Cattle. Administer products described in paragraph (a) of this section as follows:
(i) Amount. 4 mg/lb body weight by deep intramuscular injection once daily for up to 5 days.
(ii) Indications for use. For the treatment of bovine respiratory disease (shipping fever complex and bacterial pneumonia) associated with Pasteurella multocida susceptible to erythromycin.
(iii) Limitations. Do not use in female dairy cattle over 20 months of age. Do not slaughter treated animals within 6 days of last treatment. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To avoid excess trim, do not slaughter within 21 days of last injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.840   Estradiol.
(a) Specifications. Each silicone rubber implant contains 25.7 or 43.9 milligrams (mg) estradiol and is coated with not less than 0.5 mg oxytetracycline powder.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.240 of this chapter.
(d) Conditions of use —(1) Beef steer calves 2 months of age and older —(i) Amount and indications for use. (A) An extended-release implant containing 25.7 mg estradiol for increased rate of weight gain for up to 200 days.
(B) An extended-release implant containing 43.9 mg estradiol for increased rate of weight gain for up to 400 days.
(ii) Limitations. For subcutaneous ear implantation only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in beef steer calves 2 months of age and older. Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
(2) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) —(i) Amount and indications for use. (A) An extended-release implant containing 25.7 mg estradiol for increased rate of weight gain for up to 200 days.
(B) An extended-release implant containing 43.9 mg estradiol for increased rate of weight gain for up to 400 days.
(ii) Limitations. For subcutaneous ear implantation only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
(3) Growing beef steers and heifers fed in confinement for slaughter —(i) Amount and indications for use. (A) An extended-release implant containing 25.7 mg estradiol for increased rate of weight gain and improved feed efficiency for up to 200 days.
(B) An extended-release implant containing 43.9 mg estradiol for increased rate of weight gain and improved feed efficiency for up to 400 days.
(ii) Limitations. For subcutaneous ear implantation only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter. Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
§ 522.850   Estradiol valerate and norgestomet in combination.
(a) Specifications. The product is a two-component drug consisting of the following:
(1) An implant containing 6.0 milligrams of norgestomet.
(2) An injectable solution (sesame oil) containing 3.0 milligrams of norgestomet and 5.0 milligrams of estradiol valerate per 2 milliliters.
(b) Sponsor. See 000010 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.240 of this chapter.
(d) Conditions of use —(1) Amount. One implant and 2 milliliters of injection at time of implantation.
(2) Indications for use. For synchronization of estrus/ovulation in cycling beef cattle and non-lactating dairy heifers.
(3) Limitations. Insert implant subcutaneously in the ear only; then immediately inject solution intramuscularly only. Counting the day of implantation as day 1, remove the implant on day 10. Collect all implants as they are removed and burn them. While animals are restrained for artificial insemination, avoid other treatments such as vaccinations, dipping, pour-on grub and louse prevention, spraying, etc. When inseminating without estrus detection, the entire treated group should be started at 48 hours after the last implant has been removed and should be completed within 6 hours. Where estrus detection is preferred, insemination should be approximately 12 hours after first detection of estrus. Those that do not conceive can be re-bred when they return to estrus approximately 17 to 25 days after implant removal. Do not use in cows producing milk for human consumption.
§ 522.863   Ethylisobutrazine.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of ethylisobutrazine hydrochloride.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 2 to 5 mg per pound of body weight by intramuscular injection for profound tranquilization. Administer 1 to 2 mg per pound of body weight by intravenous injection to effect.
(2) Indications for use. For use as a tranquilizer.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.883   Etorphine.
(a) Specifications. Each milliliter of solution contains 1 milligram of etorphine hydrochloride.
(b) Sponsor. See No. 053923 in § 510.600(c) of this chapter.
(c) Special considerations. Distribution is restricted to veterinarians engaged in zoo and exotic animal practice, wildlife management programs, and researchers.
(d) Conditions of use —(1) Amount. Administered intramuscularly by hand syringe or syringe dart at a suitable dosage level depending upon the species.
(2) Indications for use. For the immobilization of wild and exotic animals.
(3) Limitations. Do not use in domestic food-producing animals. Do not use 30 days before, or during, the hunting season in free-ranging wild animals that might be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.914   Fenprostalene.
(a) Specifications. (1) Each milliliter of solution contains 0.5 milligram (mg) fenprostalene.
(2) Each milliliter of solution contains 0.25 mg fenprostalene.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section; and for use of product described in paragraph (a)(2) as in paragraph (e)(2) of this section.
(c) Related tolerances. See § 556.277 of this chapter.
(d) Special considerations. Labeling shall bear the following statements: Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. It is readily absorbed through the skin and may cause abortion and/or bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water.
(e) Conditions of use —(1) Cattle —(i) Indications for use and amount. (A) For feedlot heifers to induce abortion when pregnant 150 days or less, administer 1 mg (2 milliliter (mL)) subcutaneously.
(B) For beef or nonlactating dairy cattle for estrus synchronization, administer a single or two 1-mg (2-mL) doses subcutaneously, 11 to 13 days apart.
(ii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine —(i) Amount. Administer a single injection of 0.25 mg (1 mL) subcutaneously.
(ii) Indications for use. For the induction of parturition in sows and gilts pregnant at least 112 days.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.930   Firocoxib.
(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) firocoxib.
(b) Sponsors. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 0.04 mg/pound (lb) (0.09 mg/kilogram (kg)) of body weight (BW) intravenously, once daily, for up to 5 days. If further treatment is needed, firocoxib oral paste can be administered at a dosage of 0.045 mg/lb (0.1 mg/kg) of BW for up to an additional 9 days of treatment.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.955   Florfenicol.
(a) Specifications. Each milliliter of solution contains:
(1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-pyrrolidone and triacetin.
(2) 300 mg florfenicol in the inactive vehicles n-methyl-2-pyrrolidone, propylene glycol, and polyethylene glycol.
(3) 300 mg florfenicol in the inactive vehicles 2-pyrrolidone and glycerol formal.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter:
(1) No. 000061 for use of product described in paragraph (a)(1) as in paragraph (d)(1)(i); and
(2) No. 000061 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(1)(ii) and (d)(2) of this section.
(3) Nos. 054771, 058005, and 069043 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this section.
(4) No. 055529 for use of product described in paragraph (a)(3) as in paragraph (d)(1)(ii).
(c) Related tolerances. See §§ 500.1410 and 556.283 of this chapter.
(d) Conditions of use —(1) Beef and non-lactating dairy cattle. (i) 300 mg per milliliter (mL) florfenicol in the inactive vehicles 2-pyrrolidone and triacetin:
(A) Amount. 40 mg/kilogram (kg) body weight as a single subcutaneous injection.
(B) Indications for use. For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis in beef and non-lactating dairy cattle.
(C) Limitations. Animals intended for human consumption must not be slaughtered within 44 days of treatment. Do not use in female dairy cattle 20 months of age or older. Use of florfenicol in this class of cattle may cause milk residues. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(ii) 300 mg/mL florfenicol in the inactive vehicles n-methyl-2- pyrrolidone, propylene glycol, and polyethylene glycol, or in 2-pyrrolidone and glycerol formal:
(A)( 1 ) Amount. 20 mg/kg of body weight as an intramuscular injection. A second dose should be administered 48 hours later. Alternatively, 40 mg/kg of body weight as a single subcutaneous injection may be used.
( 2 ) Indications for use. For treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida , and Histophilus somni. For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
(B)( 1 ) Amount. 40 mg/kg of body weight as a single subcutaneous injection.
( 2 ) Indications for use. For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.
(C) Limitations. Animals intended for human consumption must not be slaughtered within 28 days of the last intramuscular treatment. Nos. 000061, 054771, 058005, and 069043: Animals intended for human consumption must not be slaughtered within 38 days of subcutaneous treatment. No. 055529: Animals intended for human consumption must not be slaughtered within 33 days of subcutaneous treatment. This 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. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine . (i) 300 mg/mL florfenicol in the inactive vehicles n-methyl-2-pyrrolidone, propylene glycol, and polyethylene glycol:
(A) Amount. 15 mg/kg of body weight as an intramuscular injection. A second dose should be administered 48 hours later.
(B) Indications for use. For the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis, Streptococcus suis, Bordetella bronchiseptica, and Glaesserella (Haemophilus) parasuis in swine except for nursing piglets and swine of reproductive age intended for breeding.
(C) Limitations. Swine intended for human consumption must not be slaughtered within 11 days of the last intramuscular treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(ii) [Reserved]
§ 522.956   Florfenicol and flunixin.
(a) Specifications. Each milliliter (mL) of solution contains 300 milligrams (mg) florfenicol and 16.5 mg flunixin (27.37 mg flunixin meglumine).
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(c) Tolerances. See §§ 556.283 and 556.286 of this chapter.
(d) Conditions for use in cattle —(1) Amount. 40 mg florfenicol/kg body weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW or 6 mL/100 lbs) once, by subcutaneous injection.
(2) Indications for use. For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis , and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.
(3) Limitations. Animals intended for human consumption must not be slaughtered within 38 days of treatment. 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. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.960   Flumethasone injectable dosage forms.
§ 522.960a   Flumethasone suspension.
(a) Specifications. Each milliliter of suspension contains 2 milligrams (mg) of flumethasone.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 6 to 10 mg by intra-articular injection. Dosage is limited to a single injection per week in any one synovial structure.
(2) Indications for use. For use in the various disease states involving synovial structures (joints) of horses where excessive synovial fluid of inflammatory origin is present and where permanent structural changes do not exist. Such conditions include arthritis, carpitis, and osselets.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.960b   Flumethasone acetate solution.
(a) Specifications. Each milliliter of solution contains 2 milligrams (mg) of flumethasone acetate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer by intramuscular injection as follows: Dogs weighing up to 10 pounds (lbs): 2 mg; dogs weighing 10 to 25 lbs: 4 mg; dogs weighing over 25 lbs: 8 mg. Dosage should be adjusted according to the weight of the animal, the severity of the symptoms, and the response noted. Dosage by injection should not exceed 3 days of therapy. With chronic conditions intramuscular therapy may be followed by oral administration of flumethasone tablets at a daily dose of from 0.0625 to 0.25 mg per animal.
(2) Indications for use. For use in certain acute and chronic canine dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.960c   Flumethasone solution.
(a) Specifications. Each milliliter of solution contains 0.5 milligrams (mg) of flumethasone.
(b) Sponsors. See Nos. 054771 and 061133 in § 510.600(c) of this chapter.
(c) Conditions of use. It is used as follows:
(1) Horses —(i) Amount. Administer 1.25 to 2.5 milligrams (mg) daily by intravenous, intramuscular, or intra-articular injection.
(ii) Indications for use. For use in the treatment of musculoskeletal conditions due to inflammation, where permanent structural changes do not exist, e.g., bursitis, carpitis, osselets, and myositis; and allergic states, e.g., hives, urticaria, and insect bites.
(iii) Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs —(i) Amount. Administer 0.0625 to 0.25 mg daily by intravenous, intramuscular, or subcutaneous injection; 0.125 to 1.0 mg daily by intra-lesional injection, depending on the size and location of the lesion; or 0.166 to 1.0 mg daily by intra-articular injection, depending on the severity of the condition and the size of the involved joint.
(ii) Indications for use. For use in the treatment of musculoskeletal conditions due to inflammation of muscles or joints and accessory structures where permanent structural changes do not exist, e.g., arthritis, osteoarthritis, disc syndrome, and myositis (in septic arthritis, appropriate antibacterial therapy should be concurrently administered); certain acute and chronic dermatoses of varying etiology to help control associated pruritus, irritation, and inflammation; otitis externa in conjunction with topical medication; allergic states, e.g., hives, urticaria, and insect bites; and shock and shock-like states by intravenous administration.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Cats —(i) Amount. Administer 0.03125 to 0.125 mg daily by intravenous, intramuscular, or subcutaneous injection.
(ii) Indications for use. For use in the treatment of certain acute and chronic dermatoses of varying etiology to help control associated pruritus, irritation, and inflammation.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.970   Flunixin.
(a) Specifications. Each milliliter of solution contains flunixin meglumine equivalent to 50 milligrams (mg) flunixin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) See Nos. 000061, 055529, and 061133 for use as in paragraph (e) of this section.
(2) See No. 054771 for use as in paragraph (e)(1) of this section.
(3) See Nos. 016592, 058198, and 069043 for use as in paragraphs (e)(1) and (2) of this section.
(c) Related tolerances. See § 556.286 of this chapter.
(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use —(1) Horses —(i) Amount. 0.5 mg per pound (/lb) of body weight per day, intravenously or intramuscularly, for up to 5 days.
(ii) Indications for use. For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.
(iii) Limitations. Do not use in horses intended for human consumption.
(2) Cattle —(i) Amounts and indications for use —(A) Administer 1.1 to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/lb) of body weight per day intravenously, as a single dose or divided into two doses administered at 12-hour intervals, for up to 3 days for control of pyrexia associated with bovine respiratory disease and endotoxemia or for control of inflammation in endotoxemia.
(B) Administer 2.2 mg/kg (1.0 mg/lb) of body weight once intravenously for control of pyrexia associated with acute bovine mastitis.
(ii) Limitations. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Cattle must not be slaughtered for human consumption within 4 days of last treatment. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Do not use in dry dairy cows. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal.
(B) [Reserved]
(3) Swine —(i) Amount. Administer 2.2 mg/kg (1.0 mg/lb) of body weight as a single intramuscular injection.
(ii) Indications for use. For the control of pyrexia associated with swine respiratory disease.
(iii) Limitations. Swine must not be slaughtered for human consumption within 12 days of last treatment.
§ 522.995   Fluprostenol.
(a) Specifications. Each milliliter of solution contains fluprostenol sodium equivalent to 50 micrograms (µg) of fluprostenol.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 0.55 µg fluprostenol per kilogram of body weight by intramuscular injection.
(2) Indications for use. For use in mares for its luteolytic effect to control the timing of estrus in estrous cycling and in clinically anestrous mares that have a corpus luteum.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1002   Follicle stimulating hormone.
(a)(1) Specifications. Each package contains 2 vials. One vial contains dry, powdered, porcine pituitary gland equivalent to 75 units (NIH-FSH-S1) of follicle stimulating hormone. The other vial contains 10 milliliters of aqueous diluent.
(2) Sponsor. See No. 052923 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Dosage. 12.5 units of follicle stimulating hormone twice a day for 3 days (a total of 75 units). To effect regression of the corpus luteum, prostaglandin should be given with the 5th dose.
(ii) Indications for use. For induction of superovulation in cows for procedures requiring the production of multiple ova at a single estrus.
(iii) Limitations. For intramuscular use in cows that are not pregnant and have a normal corpus luteum. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(b)(1) Specifications —(i) Single pack. Each package contains 2 vials. One vial contains 700 international units (IU) porcine-pituitary-derived follicle stimulating hormone (FSH) equivalent to 400 milligrams NIH-FSH-P1, as a dry powder. The other vial contains 20 milliliters (mL) of bacteriostatic sodium chloride injection. When constituted, each milliliter of solution contains 35 IU FSH.
(ii) Dual pack. Each package contains 2 vials. Each vial contains 700 international units (IU) porcine-pituitary-derived FSH equivalent to 400 milligrams NIH-FSH-P1, as a dry powder. Constitute with 20 mL bacteriostatic sodium chloride injection, using strict aseptic technique. When constituted, each milliliter of solution contains 35 IU FSH.
(2) Sponsor. See No. 017030 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Dosage. Administer 2.5 mL (87.5 IU) intramuscularly, twice daily at 12-hour intervals, for 4 consecutive days. In conjunction with the 6th dose, administer an approved prostaglandin product for cattle (cloprostenol sodium or dinoprost tromethamine), using the labeled dosage and administration instructions to cause luteolysis and induce estrus. See § 522.460 for use of cloprostenol sodium or § 522.690 for use of dinoprost tromethamine.
(ii) Indications for use. For the induction of superovulation in beef and dairy heifers and cows.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1008   Frunevetmab.
(a) Specifications. Each milliliter (mL) of solution contains 7 milligrams (mg) frunevetmab.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Cats —(i) Amount. Administer once a month by subcutaneous injection the full contents of one or two 1-mL vials to achieve a minimum dosage of 0.45 mg/lb (1 mg/kg) body weight.
(ii) Indications for use. For the control of pain associated with osteoarthritis in cats.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 522.1010   Furosemide.
(a) Specifications. (1) Each milliliter (mL) of solution contains 50 milligrams (mg) furosemide monoethanolamine.
(2) Each mL of solution contains 50 mg furosemide diethanolamine.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use of products described in paragraph (a) of this section for use as in paragraph (d) of this section.
(1) No. 000010 as described in paragraph (a)(1) of this section for use as in paragraphs (d)(1) and (d)(2)(ii) of this section.
(2) No. 061133 as described in paragraph (a)(2) of this section for use as in paragraph (d)(2)(ii) of this section.
(3) No. 058198 as described in paragraph (a)(2) of this section for use as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section.
(4) No. 000061 as described in paragraph (a)(2) for use as in paragraphs (d)(1), (d)(2)(iii), and (d)(3) of this section.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Dogs and cats —(i) Amount. 1.25 to 2.5 mg per pound (/lb) body weight once or twice daily, intramuscularly or intravenously.
(ii) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.
(2) Horses —(i) Amount. 250 to 500 mg per animal once or twice daily, intramuscularly or intravenously.
(A) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency, and acute noninflammatory tissue edema.
(B) Limitations. Do not use in horses intended for human consumption.
(ii) Amount. 0.5 mg/lb body weight once or twice daily, intramuscularly or intravenously.
(A) Indications for use. For treatment of acute noninflammatory tissue edema.
(B) Limitations. Do not use in horses intended for human consumption.
(iii) Amount. 250 to 500 mg/animal once or twice daily, intramuscularly or intravenously.
(A) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency, and acute noninflammatory tissue edema.
(B) Limitations. Do not use in horses intended for human consumption.
(3) Cattle —(i) Amount. 500 mg/animal once daily, intramuscularly or intravenously; or 250 mg/animal twice daily at 12-hour intervals, intramuscularly or intravenously.
(ii) Indications for use. For the treatment of physiological parturient edema of the mammary gland and associated structures.
(iii) Limitations. Treatment not to exceed 48 hours post-parturition. Milk taken during treatment and for 48 hours (four milkings) after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment.
§ 522.1014   Gamithromycin.
(a) Specifications. Each milliliter (mL) of solution contains 150 milligrams (mg) gamithromycin.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.292 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. Administer 6 mg/kilogram of body weight (2 mL per 110 pounds) one time by subcutaneous injection in the neck.
(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica and P. multocida.
(iii) Limitations. Cattle intended for human consumption must not be slaughtered within 35 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 522.1020   Gelatin.
(a) Specifications. Each 100 milliliters contains 8 grams of gelatin in a 0.85 percent sodium chloride solution.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. The exact dosage to be administered must be determined after evaluating the animal's condition and will vary according to the size of the animal and the degree of shock. A suggested dosage range for small animals such as dogs is 4 to 8 cubic centimeters per pound body weight. The suggested dosage range for large animals such as sheep, calves, cows, or horses is 2 to 4 cubic centimeters per pound of body weight.
(2) Indications for use. For use to restore circulatory volume and maintain blood pressure in animals being treated for shock.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1044   Gentamicin.
(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 5, 50, or 100 milligrams (mg) gentamicin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 000061 for use of 5 mg per milliliter (/mL) solution in swine as in paragraph (d)(4), 50 mg/mL solution in dogs and cats as in paragraph (d)(1), 50 mg/mL and 100 mg/mL solution in chickens and turkeys as in paragraphs (d)(2) and (d)(3) of this section.
(2) No. 058005 for use of 5 mg/mL solution in swine as in paragraph (d)(4) of this section.
(3) No. 069043 for use of 50 mg/mL solution in dogs as in paragraph (d)(5) of this section.
(4) Nos. 016592 and 061133 for use of 100 mg/mL solution in turkeys as in paragraph (d)(2) and in chickens as in paragraph (d)(3) of this section.
(c) Related tolerances. See § 556.300 of this chapter.
(d) Conditions of use —(1) Dogs and cats —(i) Amount. Two milligrams of gentamicin per pound of body weight, twice daily on the first day, once daily thereafter, using a 50 milligram-per-milliliter solution.
(ii) Indications for use —( a ) Dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (tonsillitis, pneumonia, tracheobronchitis), skin and soft tissue (pyodermatitis, wounds, lacerations, peritonitis).
( b ) Cats. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (pneumonitis, pneumonia, upper respiratory tract infections), skin and soft tissue (wounds, lacerations, peritonitis), and as supportive therapy for secondary bacterial infections associated with panleucopenia.
(iii) Limitations. Administer intramuscularly or subcutaneously. If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Turkeys —(i) Amount. Administer subcutaneously in the neck 1 mg of gentamicin per 0.2 mL dose, using the 50- or 100-mg/mL product diluted with sterile saline to a concentration of 5 mg/mL.
(ii) Indications for use. As an aid in the prevention of early mortality in 1- to 3-day old turkey poults due to Arizona paracolon infections susceptible to gentamicin.
(iii) Limitations. Injected poults must not be slaughtered for food for at least 9 weeks after treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Chickens —(i) Amount. Administer subcutaneously in the neck 0.2 mg of gentamicin per 0.2 mL dose, using the 50- or 100-mg/mL product diluted with sterile saline to a concentration of 1.0 mg/mL.
(ii) Indications for use. For prevention of early mortality in day-old chickens caused by Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin.
(iii) Limitations. Injected chicks must not be slaughtered for food for at least 5 weeks after treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) Swine —(i) Amount. Administer 5 mg of gentamicin as a single intramuscular dose using the 5 mg/mL solution.
(ii) Indications for use. For treatment of porcine colibacillosis in piglets up to 3 days old caused by strains of Escherichia coli sensitive to gentamicin.
(iii) Limitations. For single intramuscular dose in pigs up to 3 days of age only. Do not slaughter treated animals for food for at least 40 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(5) Dogs —(i) Amount. 2 milligrams of gentamicin per pound of body weight, twice daily on the first day, then once daily.
(ii) Indications for use. For use in the treatment of urinary tract infections (cystitis) caused by Proteus mirabilis, Escherichia coli, and Staphylococcus aureus.
(iii) Limitations. Administer intramuscularly or subcutaneously. If no improvement is seen after 3 days, treatment should be discontinued and the diagnosis reevaluated. Treatment not to exceed 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1055   Gleptoferron.
(a) Specifications. Each milliliter (mL) contains the equivalent of 200 milligrams of elemental iron as gleptoferron, a complex of ferric hydroxide and dextran glucoheptonic acid.
(b) Sponsors. See No. 013744 in § 510.600(c) of this chapter.
(c) Conditions of use in swine —(1) Indications for use and amounts. (i) Prevention of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection on or before 3 days of age.
(ii) Treatment of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection as soon as signs of deficiency appear.
(2) [Reserved]
§ 522.1066   Glycopyrrolate.
(a) Specifications. Each milliliter of solution contains 0.2 milligram glycopyrrolate.
(b) Sponsors. See Nos. 054771 and 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. 5 micrograms per pound of body weight (0.25 milliliter per 10 pounds of body weight) by intravenous, intramuscular, or subcutaneous injection in dogs or by intramuscular injection in cats.
(2) Indications for use. As a preanesthetic agent.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1077   Gonadorelin.
(a) Specifications. Each milliliter (mL) of solution contains:
(1) 43 micrograms (µg) of gonadorelin as gonadorelin acetate;
(2) 100 µg of gonadorelin as gonadorelin acetate;
(3) 50 µg of gonadorelin as gonadorelin diacetate tetrahydrate (equivalent to 43 µg gonadorelin); or
(4) 50 µg of gonadorelin as gonadorelin hydrochloride.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 000061 for use of the 43-µg/mL product described in paragraph (a)(1) as in paragraphs (e)(1)(i) and (iii) of this section.
(2) No. 068504 for use of the 100-µg/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section.
(3) Nos. 000010 and 061133 for use of the 50-µg/mL product described in paragraph (a)(3) of this section as in paragraphs (e)(1)(i) and (v) of this section.
(4) No. 054771 for use of the 50-µg/mL product described in paragraph (a)(4) as in paragraphs (e)(1)(ii) and (vi) of this section.
(c) Related tolerances. See § 556.304 of this chapter.
(d) Special considerations. (1) Concurrent luteolytic drug use is approved as follows:
(i) Cloprostenol injection for use as in paragraph (e)(1)(iii) of this section as provided by No. 000061 in § 510.600(c) of this chapter.
(ii) Cloprostenol injection for use as in paragraph (e)(1)(iv) of this section as provided by No. 068504 in § 510.600(c) of this chapter.
(iii) Cloprostenol injection for use as in paragraph (e)(1)(v) of this section as provided by Nos. 000010 in § 510.600(c) of this chapter.
(iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this section as provided by No. 054771 in § 510.600(c) of this chapter.
(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use in cattle —(1) Indications for use and amounts. (i) For the treatment of ovarian follicular cysts in dairy cattle: Administer 86 µg gonadorelin (No. 000061), or 100 µg gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100 µg gonadorelin (as gonadorelin acetate; No. 068504) by intramuscular or intravenous injection.
(ii) For the treatment of ovarian follicular cysts in cattle: Administer 100 µg gonadorelin hydrochloride by intramuscular injection.
(iii) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in beef cows and lactating dairy cows: Administer to each cow 86 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 µg gonadorelin by intramuscular injection.
(iv) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 µg gonadorelin by intramuscular injection.
(v) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 µg gonadorelin diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 µg gonadorelin diacetate tetrahydrate by intramuscular injection.
(vi) For use with dinoprost injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 100 to 200 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost by intramuscular injection, followed 30 to 72 hours later by 100 to 200 µg gonadorelin by intramuscular injection.
(2) [Reserved]
§ 522.1079   Serum gonadotropin and chorionic gonadotropin.
(a) Specifications. Each dose consists of 400 international units (I.U.) serum gonadotropin and 200 I.U. chorionic gonadotropin as a freeze-dried powder to be reconstituted with 5 milliliters of sterile aqueous diluent.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.304 of this chapter.
(d) Conditions of use in swine —(1) Amount. 400 I.U. serum gonadotropin with 200 I.U. chorionic gonadotropin per 5 milliliters dose per animal.
(2) Indications for use —(i) Gilts. For induction of fertile estrus (heat) in healthy prepuberal (noncycling) gilts.
(ii) Sows. For induction of estrus in healthy weaned sows experiencing delayed return to estrus.
(3) Limitations. For subcutaneous use only.
(i) Gilts. For use only in gilts over 5 1/2 months of age and weighing at least 85 kilograms (187 pounds).
(ii) Sows. Delayed return to estrus is most prevalent after the first litter. The effectiveness has not been established after later litters. Delayed return to estrus often occurs during periods of adverse environmental conditions, and sows mated under such conditions may farrow smaller than normal litters.
§ 522.1081   Chorionic gonadotropin.
(a) Specifications. Each vial contains 5,000, 10,000 or 20,000 USP units of lyophilized powder for constitution with accompanying diluent to a 10-milliliter solution.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 054771 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B) and (d)(1)(i)(C) of this section.
(2) [Reserved]
(3) No. 000061 for use as in paragraphs (d)(1)(i)(A) and (d)(2) of this section.
(c) Related tolerances. See § 556.304 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. As a single dose. Dosage may be repeated in 14 days if the animal's behavior or examination of the ovaries per rectum indicates retreatment.
(A) 10,000 USP units by intramuscular injection.
(B) 500 to 2,500 USP units by intrafollicular injection.
(C) 2,500 to 5,000 USP units by intravenous injection.
(ii) Indications for use. For parenteral use in cows for treatment of nymphomania (frequent or constant heat) due to cystic ovaries.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Finfish —(i) Amount. 50 to 510 IU per pound of body weight for males, 67 to 1,816 IU per pound of body weight for females, by intramuscular injection. Up to three doses may be administered.
(ii) Indications for use. An aid in improving spawning function in male and female brood finfish.
(iii) Limitations. In fish intended for human consumption, the total dose administered per fish (all injections combined) should not exceed 25,000 IU chorionic gonadotropin. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1083   Gonadotropin releasing factor analog-diphtheria toxoid conjugate.
(a) Specifications. Each milliliter (mL) of solution contains 0.2 milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid conjugate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in swine —(1) Amount. Each intact male pig or gilt should receive two 2-mL (0.4 mg) doses by subcutaneous injection. Administer the first dose no earlier than 9 weeks of age. Administer the second dose at least 4 weeks after the first dose.
(2) Indications for use —(i) Intact male pigs intended for slaughter: For the temporary immunological castration (suppression of testicular function) and reduction of boar taint.
(ii) Gilts intended for slaughter: For the temporary suppression of estrus.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For reduction of boar taint, intact male pigs should be slaughtered no earlier than 3 weeks and no later than 10 weeks after the second dose.
§ 522.1085   Guaifenesin powder for injection.
(a) Specifications. The product is a sterile powder containing guaifenesin. A solution is prepared by dissolving the drug in sterile water for injection to make a solution containing 50 milligrams of guaifenesin per milliliter of solution.
(b) Sponsors. See Nos. 037990 and 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 1 milliliter of prepared solution per pound of body weight by rapid intravenous infusion.
(2) Indications for use. For use as a muscle relaxant.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1086   Guaifenesin solution.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of guaifenesin and 50 mg of dextrose.
(b) Sponsors. See Nos. 037990 and 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 1 milliliter per pound of body weight by rapid intravenous infusion.
(2) Indications for use. For use as a skeletal muscle relaxant.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1125   Hemoglobin glutamer-200 (bovine).
(a) Specifications. Each 125 milliliter bag contains 13 grams per deciliter of polymerized hemoglobin of bovine origin in modified Lactated Ringer's Solution. It is a sterile, clear, dark purple solution.
(b) Sponsor. See No. 063075 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use —(1) Amount. One-time dose of 10 to 30 milliliters per kilogram of body weight administered intravenously at a rate of up to 10 milliliters per kilogram per hour.
(2) Indications for use. For the treatment of anemia in dogs by increasing systemic oxygen content (plasma hemoglobin concentration) and improving the clinical signs associated with anemia, regardless of the cause of anemia (hemolysis, blood loss, or ineffective erythropoiesis).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1145   Hyaluronate.
(a)(1) Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium.
(2) Sponsor. See 054771 in § 510.600(c).
(3) Conditions of use —(i) Amount. Small and medium-size joints (carpal, fetlock): 20 mg; larger joint (hock): 40 mg. Treatment may be repeated at weekly intervals for a total of three treatments.
(ii) Indications for use. Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(b)(1) Specifications. Each milliliter of sterile aqueous solution contains 5 milligrams of hyaluronate sodium.
(2) Sponsor. See 054771 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Amount. Small and medium-size joints (carpal, fetlock): 10 mg; larger joint (hock): 20 mg. Treatment may be repeated at weekly intervals for a total of four treatments.
(ii) Indications for use. Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(c)(1) Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium.
(2) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Amount. Small and medium-size joints (carpal, fetlock): 20 mg. Treatment may be repeated after 1 or more weeks but not to exceed 2 injections per week for a total of 4 weeks.
(ii) Indications for use. For the intra-articular treatment of carpal or fetlock joint dysfunction in horses due to acute or chronic, non-infectious synovitis associated with equine osteoarthritis.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)(1) Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium.
(2) Sponsor. See 000061 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Amount. 50 milligrams in carpal and fetlock joints.
(ii) Indications for use. For treatment of equine carpal and fetlock joint dysfunction caused by traumatic and/or degenerative joint disease of mild to moderate severity.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e)(1) Specifications. Each milliliter of solution contains:
(i) 10 milligrams (mg) hyaluronate sodium; or
(ii) 10 mg hyaluronate sodium with benzyl alcohol as a preservative.
(2) Sponsors. See sponsors in § 510.600(c) of this chapter:
(i) No. 000010 for use of products described in paragraph (e)(1) as in paragraph (e)(3) of this section.
(ii) No. 017030 for use of product described in paragraph (e)(1)(i) as in paragraph (e)(3) of this section.
(3) Conditions of use —(i) Amount. 20 mg of the product described in paragraph (e)(1)(i) of this section by intra-articular injection into the carpus or fetlock; or 40 mg of the product described in paragraph (e)(1)(i) or (e)(1)(ii) of this section by slow intravenous injection into the jugular vein. Treatment may be repeated at weekly intervals for a total of three treatments.
(ii) Indications for use. For treatment of carpal or fetlock joint dysfunction due to noninfectious synovitis associated with equine osteoarthritis.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(f)(1) Specifications. Each milliliter of sterile aqueous solution contains 11 milligrams of hyaluronate sodium.
(2) Sponsor. See 060865 in § 510.600(c).
(3) Conditions of use —(i) Amount. Small and medium-size joints (carpal, fetlock): 22 mg; larger joint (hock): 44 mg. Treatment may be repeated at weekly intervals for a total of three treatments.
(ii) Indications for use. Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1155   Imidocarb powder for injection.
(a) Specifications. The product is a sterile powder containing imidocarb dipropionate. Each milliliter of constituted solution contains 100 milligrams (mg) of imidocarb base.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Special considerations. Imidocarb dipropionate is sold only under permit issued by the Director of the National Program Planning Staff, Veterinary Services, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, to licensed or full-time State, Federal, or military veterinarians.
(d) Conditions of use in horses and zebras —(1) Amount. For Babesia caballi infections, administer 2 mg of imidocarb base per kilogram of body weight by intramuscular injection in the neck region, repeating dosage once after 24 hours. For Babesia equi infections, administer 4 mg of imidocarb base per kilogram of body weight by intramuscular injection in the neck region, repeating dosage four times at 72-hour intervals.
(2) Indications for use. For the treatment of babesiosis (piroplasmosis) caused by Babesia caballi and Babesia equi.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1156   Imidocarb solution.
(a) Specifications. Each milliliter of solution contains 120 milligrams (mg) of imidocarb dipropionate.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 6.6 mg per kilogram (3 mg per pound) of body weight by intramuscular or subcutaneous injection. Repeat the dose after 2 weeks for a total of two treatments.
(2) Indications for use. For the treatment of clinical signs of babesiosis and/or demonstrated Babesia organisms in the blood.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1160   Insulin.
(a) Specifications. (1) Each milliliter (mL) of porcine insulin zinc suspension contains 40 international units (IU) of insulin.
(2) Each mL of protamine zinc recombinant human insulin suspension contains 40 IU of insulin.
(b) Sponsors. See sponsors in § 510.600 of this chapter for use as in paragraph (c) of this section.
(1) No. 000061 for use of product described in paragraph (a)(1) as in paragraphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of this section.
(2) No. 000010 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(i)(B), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii) of this section.
(c) Conditions of use —(1) Dogs —(i) Amount —(A) Porcine zinc insulin zinc. Administer an initial once-daily dose of 0.5 IU per kilogram of body weight by subcutaneous injection concurrently with or right after a meal. Adjust this once-daily dose at appropriate intervals based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained. Twice-daily therapy should be initiated if the duration of insulin action is determined to be inadequate. If twice-daily treatment is initiated, the two doses should be 25 percent less than the once daily dose required to attain an acceptable nadir.
(B) Protamine zinc recombinant human insulin. Administer a starting dose of 0.2 to 0.5 IU/pound of body weight (0.5 to 1.0 IU/kg) once daily. When transitioning from another insulin product, this form of insulin should be started once daily, regardless of the frequency of prior insulin use. The dose should be given concurrently with or right after a meal. Reevaluate the dog at appropriate intervals and adjust the dose based on both clinical signs and laboratory test results until adequate glycemic control has been attained. Twice-daily therapy should be initiated if the duration of insulin action is determined to be inadequate. If twice-daily treatment is initiated, the two doses should be 25 percent less than the once daily dose required to attain an acceptable nadir.
(ii) Indications for use. For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount —(A) Porcine insulin zinc. Administer an initial dose of 1 to 2 IU by subcutaneous injection. Injections should be given twice daily at approximately 12-hour intervals. For cats fed twice daily, the injections should be concurrent with or right after a meal. For cats fed ad libitum, no change in feeding is needed. Adjust the dose at appropriate intervals based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained.
(B) Protamine zinc recombinant human insulin. Administer an initial dose of 0.1 to 0.3 IU/pound of body weight (0.2 to 0.7 IU/kilogram) every 12 hours. The dose should be given concurrently with or right after a meal. Re-evaluate the cat at appropriate intervals and adjust the dose based on both clinical signs and glucose nadirs until adequate glycemic control has been attained.
(ii) Indications for use. For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1182   Iron injection.
(a) Specifications. See § 510.440 of this chapter. Each milliliter (mL) of solution contains the equivalent of:
(1) 100 milligrams (mg) of elemental iron derived from:
(i) Ferric hydroxide;
(ii) Ferric oxide; or
(iii) Elemental iron.
(2) 200 mg of elemental iron derived from ferric hydroxide.
(b) Sponsors and conditions of us e. It is used in young piglets by sponsors in § 510.600(c) of this chapter as follows:
(1) Nos. 016592 and 042552 for use of product described in paragraph (a)(1)(i) of this section as follows:
(i) For prevention of iron deficiency anemia, inject 100 mg (1 mL) by intramuscular injection at 2 to 4 days of age.
(ii) For treatment of iron deficiency anemia, inject 100 mg (1 mL) by intramuscular injection. Dosage may be repeated in approximately 10 days.
(2) No. 054771 for use of product described in paragraph (a)(1)(i) of this section as follows:
(i) For the prevention of anemia due to iron deficiency, administer an initial intramuscular injection of 100 mg at 2 to 4 days of age. Dosage may be repeated in 14 to 21 days.
(ii) For the treatment of anemia due to iron deficiency, administer an intramuscular injection of 200 mg.
(3) Nos. 000061 and 013744 for use of product described in paragraph (a)(1)(i) of this section as follows:
(i) For the prevention of iron deficiency anemia, administer intramuscularly an amount of drug containing 100 to 150 mg of elemental iron to animals from 1 to 3 days of age.
(ii) For the treatment of iron deficiency anemia, administer intramuscularly an amount of drug containing 100 to 200 mg of elemental iron per animal. Dosage may be repeated in 10 days to 2 weeks.
(4) No. 054771 for use of product described in paragraph (a)(1)(ii) of this section as follows:
(i) For prevention of iron deficiency anemia, administer 1 mL by intramuscular injection at 2 to 5 days of age. Dosage may be repeated at 2 weeks of age.
(ii) For treatment of iron deficiency anemia, administer 1 to 2 mL by intramuscular injection at 5 to 28 days of age.
(5) No. 054771 for use of product described in paragraph (a)(1)(iii) of this section as follows:
(i) For prevention of anemia due to iron deficiency, administer 100 mg by intramuscular or subcutaneous injection at 2 to 4 days of age.
(ii) For treatment of anemia due to iron deficiency, administer 100 mg by intramuscular or subcutaneous injection up to 4 weeks of age.
(6) Nos. 016592 and 058005 for use of product described in paragraph (a)(1)(iii) of this section as follows:
(i) For prevention of anemia due to iron deficiency, administer 100 mg by intramuscular injection at 2 to 4 days of age.
(ii) For treatment of anemia due to iron deficiency, administer 100 mg by intramuscular injection. Treatment may be repeated in 10 days.
(7) Nos. 016592, 042552, and 058005 for use product described in paragraph (a)(2) of this section as follows:
(i) For prevention of anemia due to iron deficiency, intramuscularly inject 200 mg of elemental iron (1 mL) at 1 to 3 days of age.
(ii) For treatment of anemia due to iron deficiency, intramuscularly inject 200 mg of elemental iron at the first sign of anemia.
§ 522.1185   Isoflupredone.
(a) Specifications. Each milliliter of suspension contains 2 milligrams (mg) of isoflupredone acetate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Cattle —(i) Amount. Administer 10 to 20 mg by intramuscular injection.
(ii) Indications for use. For use in the treatment of bovine ketosis. For alleviation of pain associated with generalized and acute localized arthritic conditions; for treating acute hypersensitivity reactions; and as an aid in correcting circulatory defects associated with severe toxicity and shock.
(iii) Limitations. Animals intended for human consumption should not be slaughtered within 7 days of last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses and swine —(i) Amount —(A) Horses. Administer 5 to 20 mg by intramuscular injection for systemic effect or by intrasynovial injection into a joint cavity, tendon sheath, or bursa for local effect.
(B) Swine. The usual dose for a 300-pound animal is 5 mg by intramuscular injection.
(ii) Indications for use. For alleviation of pain associated with generalized and acute localized arthritic conditions; for treating acute hypersensitivity reactions; and as an aid in correcting circulatory defects associated with severe toxicity and shock.
(iii) Limitations. Animals intended for human consumption should not be slaughtered within 7 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1192   Ivermectin.
(a) Specifications. (1) [Reserved]
(2) Each mL of solution contains 10 mg ivermectin.
(3) Each mL of solution contains 2.7 mg ivermectin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) Nos. 000010, 016592, 055529, 058005, and 061133 for use of the product described in paragraph (a)(2) of this section as in paragraphs (e)(2) through (e)(5) of this section; and
(2) No. 000010 for use of the product described in paragraph (a)(3) of this section as in paragraphs (e)(3) and (e)(6) of this section.
(c) Related tolerances. See § 556.344 of this chapter.
(d) Special considerations. (1) See § 500.25 of this chapter.
(2) Labeling shall bear the following precaution: “This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.”
(e) Conditions of use —(1) [Reserved]
(2) Cattle —(i) Amount. 200 micrograms per kilogram (µg/kg) of body weight by subcutaneous injection.
(ii) Indications for use. For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) ( Haemonchus placei , Ostertagia ostertagi (including inhibited larvae), O. lyrata , Trichostrongylus axei , T. colubriformis , Cooperia oncophora , C. punctata , C. pectinata , Oesophagostomum radiatum , Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum ); lungworms (adults and fourth-stage larvae) ( Dictyocaulus viviparus ); grubs (parasitic stages) ( Hypoderma bovis , H. lineatum ); sucking lice ( Linognathus vituli , Haematopinus eurysternus , Solenopotes capillatus ); mites ( scabies ) ( Psoroptes ovis (syn. P. communis var. bovis ), Sarcoptes scabiei var. bovis ). For control of infections and to protect from reinfection with D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi , T. axei , and C. punctata for 21 days after treatment; H. placei and C. oncophora for 14 days after treatment.
(iii) Limitations. Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
(3) Swine —(i) Amount. 300 µg/kg of body weight by subcutaneous injection.
(ii) Indications for use. For the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, Ascaris suum ; red stomach worm, Hyostrongylus rubidus ; nodular worm, Oesophagostomum spp.; threadworm, Strongyloides ransomi (adults only)); somatic roundworm larvae (threadworm, S. ransomi (somatic larvae)); lungworms ( Metastrongylus spp. (adults only)); lice ( H. suis ); and mites ( S. scabiei var. suis ).
(iii) Limitations. Do not treat swine within 18 days of slaughter.
(4) American bison —(i) Amount. 200 µg/kg of body weight by subcutaneous injection.
(ii) Indications for use. For the treatment and control of grubs ( H. bovis ).
(iii) Limitations. Do not slaughter within 56 days of last treatment.
(5) Reindeer —(i) Amount. 200 µg/kg of body weight by subcutaneous injection.
(ii) Indications for use. For the treatment and control of warbles ( Oedemagena tarandi ).
(iii) Limitations. Do not treat reindeer within 56 days of slaughter.
(6) Ranch-raised foxes —(i) Amount. 200 µg/kg of body weight by subcutaneous injection. Repeat in 3 weeks.
(ii) Indications for use. For treatment and control of ear mites ( Otodectes cynotis ).
§ 522.1193   Ivermectin and clorsulon.
(a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) (1 percent) ivermectin and 100 mg (10 percent) clorsulon.
(b) Sponsors. See Nos. 000010, 055529, 058005, 061133, and 061651 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.163 and 556.344 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use in cattle —(1) Amount. Administer 1 mL (10 mg ivermectin and 100 mg clorsulon) per 50 kilograms (110 pounds) by subcutaneous injection.
(2) Indications for use. For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) ( Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum; lungworms (adults and fourth-stage larvae) ( Dictyocaulus viviparus ); liver flukes (adults only) ( Fasciola hepatica ); cattle grubs (parasitic stages) ( Hypoderma bovis, H. lineatum ); sucking lice ( Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus ); mange mites (cattle scab) ( Psoroptes ovis (syn. P. communis var. bovis ), Sarcoptes scabiei var. bovis ); and for control of infections of D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; and H. placei and C. oncophora for 14 days after treatment.
(3) Limitations. Do not treat cattle within 21 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
§ 522.1204   Kanamycin.
(a) Specifications. Each milliliter of solution contains 50 or 200 milligrams (mg) of kanamycin as kanamycin sulfate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer by subcutaneous or intramuscular injection 5 mg per pound of body weight per day in equally divided doses at 12-hour intervals.
(2) Indications for use. For the treatment of bacterial infections due to kanamycin sensitive organisms in dogs and cats.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1222   Ketamine.
(a) Specifications. Each milliliter contains ketamine hydrochloride equivalent to 100 milligrams (mg) ketamine base activity.
(b) Sponsors. See Nos. 00010, 017033, 054771, 058198, 059399, and 069043 in § 510.600(c) of this chapter.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Cats —(i) Amount. 5 to 15 mg/pound body weight intramuscularly, depending on the effect desired.
(ii) Indications for use. For restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
(2) Subhuman primates —(i) Amount. 3 to 15 mg/kilogram body weight intramuscularly, depending upon the species, general condition, and age of the subject.
(ii) Indications for use. For restraint.
§ 522.1223   Ketamine, promazine, and aminopentamide.
(a) Specifications. Each milliliter of solution contains ketamine hydrochloride equivalent to 100 milligrams (mg) ketamine base activity, 7.5 (mg) of promazine hydrochloride, and 0.0625 mg of aminopentamide hydrogen sulfate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in cats —(1) Amount. Administer by intramuscular injection 15 to 20 mg ketamine base per pound of body weight, depending on the effect desired.
(2) Indications for use. It is used in cats as the sole anesthetic agent for ovariohysterectomy and general surgery.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1225   Ketoprofen.
(a) Specifications. Each milliliter of solution contains 100 milligrams (mg) ketoprofen.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter.
(1) No. 054771 for use as in paragraphs (d)(1) and (d)(2) of this section.
(2) No. 061133 for use as in paragraph (d)(1) of this section.
(c) Related tolerances. See § 556.345 of this chapter.
(d) Conditions of use —(1) Horses —(i) Amount. Administer by intravenous injection 1.0 mg per pound (/lb) of body weight once daily for up to 5 days.
(ii) Indications for use. For alleviation of inflammation and pain associated with musculoskeletal disorders in horses.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cattle —(i) Amount. Administer by subcutaneous injection 3 mg per kilogram (1.36 mg/lb) of body weight once daily for up to 3 days.
(ii) Indications for use. For the control of pyrexia associated with bovine respiratory disease (BRD) in beef heifers, beef steers, beef calves 2 months of age and older, beef bulls, replacement dairy heifers, and dairy bulls.
(iii) Limitations. Not for use in reproducing animals over 1 year of age. Cattle must not be slaughtered for human consumption within 48 hours following last treatment with this drug product. Not for use in female dairy cattle 1 year 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 or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1242   Levamisole.
(a) Specifications. Each milliliter of solution contains levamisole phosphate equivalent to 136.5 or 182 milligrams of levamisole hydrochloride (13.65 or 18.2 percent).
(b) Sponsor. See Nos. 000061 and 016592 in § 510.600 of this chapter for use of 13.65 percent injection, and see No. 054771 for use of 13.65 and 18.2 percent injection.
(c) Related tolerances. See § 556.350 of this chapter.
(d) Conditions of use —(1) Amount. 2 milliliters per 100 pounds of body weight, subcutaneously in the neck.
(2) Indications for use. (i) The 13.65 percent injection is used as an anthelmintic in cattle for treatment of the following parasites: stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ), intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia ), and lungworms ( Dictyocaulus ).
(ii) The 18.2 percent injection is used as an anthelmintic in cattle for treatment of the following parasites: stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ), intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ) and lungworms ( Dictyocaulus ).
(3) Limitations. Do not administer more than 10 milliliters per site. Cattle that are severely parasitized or maintained under conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after first treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Consult your veterinarian before using in severely debilitated animals or animals under severe stress. Do not administer to cattle within 7 days of slaughter. Do not administer to dairy animals of breeding age.
§ 522.1260   Lincomycin.
(a) Specifications. Each milliliter of solution contains lincomycin hydrochloride monohydrate equivalent to:
(1) 25, 50, 100, or 300 milligrams (mg) lincomycin.
(2) 25, 100, or 300 mg lincomycin.
(3) 300 mg lincomycin.
(4) 100 or 300 mg lincomycin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (e) of this section.
(1) No. 054771 for use of concentrations in paragraph (a)(1) of this section as in paragraph (e) of this section.
(2) Nos. 016592 and 058005 for use of concentrations in paragraph (a)(2) of this section as in paragraph (e)(2) of this section.
(3) No. 054771 for use of concentration in paragraph (a)(3) of this section as in paragraph (e)(2) of this section.
(4) No. 061133 for use of concentrations in paragraph (a)(4) of this section as in paragraph (e)(2) of this section.
(c) Special considerations. When common labeling for use of the drug in dogs, cats, and swine is included with the drug, all such uses are subject to the labeling requirements of § 201.105 of this chapter.
(d) Related tolerances. See § 556.360 of this chapter.
(e) Conditions of use. It is used for animals as follows:
(1) Dogs and cats —(i) Amount. 5 mg per pound (/lb) of body weight twice daily or 10 mg/lb body weight once daily by intramuscular injection; 5 to 10 mg/lb body weight one or two times daily by slow intravenous injection.
(ii) Indications for use. Infections caused by Gram-positive organisms, particularly streptococci and staphylococci.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine —(i) Amount. 5 mg/lb body weight once daily by intramuscular injection for 3 to 7 days.
(ii) Indications for use. Treatment of infectious arthritis and mycoplasma pneumonia.
(iii) Limitations. Do not treat within 48 hours of slaughter. For No 054771: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1289   Lufenuron.
(a) Specifications. Each milliliter of suspension contains 100 milligrams (mg) of lufenuron.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in cats —(1) Amount. 10 mg per kilogram (4.5 mg per pound) of body weight every 6 months, by subcutaneous injection.
(2) Indications for use. For control of flea populations in cats 6 weeks of age and older.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1290   Luprostiol.
(a) Specifications. Each milliliter of solution contains 7.5 milligrams (mg) luprostiol.
(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.
(c) Special considerations. Labeling shall bear the following statements: Warning: Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages, women may be unaware of their pregnancies. Luprostiol is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.
(d) Conditions of use in horses —(1) Amount. 7.5 mg by intramuscular injection.
(2) Indications for use. For estrus control and termination of pregnancy in mares.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.
§ 522.1315   Maropitant.
(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) maropitant as maropitant citrate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer 1.0 mg per kilogram (mg/kg) of body weight by subcutaneous or intravenous injection once daily for up to 5 consecutive days.
(ii) Indications for use. For the prevention and treatment of acute vomiting.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. Administer 1.0 mg/kg of body weight by subcutaneous or intravenous injection once daily for up to 5 consecutive days.
(ii) Indications for use. For the treatment of vomiting.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1335   Medetomidine.
(a) Specifications. Each milliliter of solution contains 1.0 milligrams of medetomidine hydrochloride.
(b) Sponsor. See Nos. 015914 and 052483 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. 750 micrograms intravenously (IV) or 1,000 micrograms intramuscularly per square meter of body surface. The IV route is more efficacious for dental care.
(2) Indications for use. As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The intravenous route of administration is more efficacious for dental care.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1338   Medetomidine and vatinoxan.
(a) Specifications. Each milliliter of solution contains 0.5 milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan hydrochloride.
(b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer by intramuscular injection a dose based on body surface area (BSA). Calculate the dose using 1 mg medetomidine per square meter (/m 2 ) BSA or use the dosing table provided in labeling.
(2) Indications for use. For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures, and minor surgical procedures.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1350   Melatonin implant.
(a) Specifications. The drug is a silicone rubber elastomer implant containing 2.7 milligrams of melatonin.
(b) Sponsor. See No. 053923 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. One implant per mink.
(2) Indications for use. For use in healthy male and female kit and adult female mink ( Mustela vison ) to accelerate the fur priming cycle.
(3) Limitations. For subcutaneous implantation in mink only. Do not implant potential breeding stock. Do not use in food-producing animals.
§ 522.1362   Melarsomine powder for injection.
(a) Specifications. The drug consists of a vial of lyophilized powder containing 50 milligrams of melarsomine dihydrochloride which is reconstituted with the provided 2 milliliters of sterile water for injection.
(b) Sponsor. See Nos. 000010 and 086073 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer only by deep intramuscular injection in the lumbar muscles (L 3 -L 5 ).
(2) Indications. Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage L 5 ) to mature adult infections of Dirofilaria immitis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1367   Meloxicam.
(a) Specifications. Each milliliter of solution contains 5.0 milligrams (mg) meloxicam.
(b) Sponsors. See Nos. 000010, 016729, 017033, 055529, and 086101 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer 0.09 mg per pound (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) by intravenous or subcutaneous injection on the first day of treatment. For treatment after day 1, administer meloxicam suspension orally at 0.045 mg/lb (0.1 mg/kg) body weight once daily as in § 520.1367(c) of this chapter.
(ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. Administer 0.14 mg/lb (0.3 mg/kg) body weight as a single, one-time subcutaneous injection.
(ii) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration when administered prior to surgery.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1372   Mepivacaine.
(a) Specifications. Each milliliter (mL) of solution contains 20 milligrams mepivacaine hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. For nerve block, 3 to 15 mL; for epidural anesthesia, 5 to 20 mL; for intra-articular anesthesia, 10 to 15 mL; for infiltration, as required; for anesthesia of the laryngeal mucosa prior to ventriculectomy, by topical spray, 25 to 40 mL, by infiltration, 20 to 50 mL.
(2) Indications for use. For use as a local anesthetic for infiltration, nerve block, intra-articular and epidural anesthesia, and topical and/or infiltration anesthesia of the laryngeal mucosa prior to ventriculectomy.
(3) Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1380   Methocarbamol.
(a) Specifications. Each milliliter of solution contains 100 milligrams (mg) of methocarbamol.
(b) Sponsor. See No. 051031 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount —(i) Dogs and cats. Administer by intravenous injection 20 mg per pound of body weight for moderate conditions or 25 to 100 mg per pound of body weight for severe conditions (tetanus and strychnine poisoning). The total cumulative dose should not to exceed 150 mg per pound of body weight.
(ii) Horses. Administer by intravenous injection 2 to 10 mg per pound of body weight for moderate conditions or 10 to 25 mg per pound of body weight for severe conditions (tetanus). Additional amounts may be needed to relieve residual effects and to prevent recurrence of symptoms.
(2) Indications for use. As an adjunct for treating acute inflammatory and traumatic conditions of the skeletal muscles and to reduce muscular spasms.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1410   Methylprednisolone.
(a) Specifications. Each milliliter of suspension contains 20 or 40 milligrams (mg) of methylprednisolone acetate.
(b) Sponsors. See Nos. 054771 and 069043 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use —(1) Dogs —(i) Amount. Administer 2 to 40 mg (up to 120 mg in extremely large breeds or dogs with severe involvement) by intramuscular injection or up to 20 mg by intrasynovial injection.
(ii) Indications for use. For treatment of inflammation and related disorders; treatment of allergic and dermatologic disorders; and as supportive therapy to antibacterial treatment of severe infections.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. Administer 10 to 20 mg by intramuscular injection.
(ii) Indications for use. For treatment of inflammation and related disorders; treatment of allergic and dermatologic disorders; and as supportive therapy to antibacterial treatment of severe infections.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Horses —(i) Amount. Administer 200 mg by intramuscular injection or 40 to 240 mg by intrasynovial injection.
(ii) Indications for use. For treatment of inflammation and related disorders.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1450   Moxidectin solution.
(a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) moxidectin.
(b) Sponsors. See Nos. 055529, 058198, and 061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.426 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use in cattle—(1) Amount. Administer by subcutaneous injection 1 mL for each 110 pounds (lb) (50 kilograms (kg)) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight.
(2) Indications for use. Beef and nonlactating dairy cattle: For treatment and control of Gastrointestinal roundworms: Ostertagia ostertagi (adults, fourth-stage larvae, and inhibited larvae), Haemonchus placei (adults), Trichostrongylus axei (adults and fourth-stage larvae), Trichostrongylus colubriformis (adults and fourth-stage larvae), Cooperia oncophora (adults), Cooperia pectinata (adults), Cooperia punctata (adults and fourth-stage larvae), Cooperia spatulata (adults), Cooperia surnabada (adults and fourth-stage larvae), Nematodirus helvetianus (adults), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); Lungworms: Dictyocaulus viviparus (adults and fourth-stage larvae); Cattle grubs: Hypoderma bovis and Hypoderma lineatum; Mites: Psoroptes ovis ( Psoroptes communis var. bovis ); Lice: Linognathus vituli and Solenopotes capillatus. For protection from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 42 days after treatment, with Haemonchus placei for 35 days after treatment, and with Ostertagia ostertagi and Trichostrongylus axei for 14 days after treatment.
(3) Limitations. Cattle must not be slaughtered for human consumption within 21 days of treatment. 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. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal.
§ 522.1451   Moxidectin microspheres for injection.
(a) Specifications. The drug product consists of two separate vials. One vial contains 10 percent moxidectin microspheres and the second vial contains a vehicle for constitution of the moxidectin microspheres.
(1) Each milliliter (mL) of constituted suspension contains 3.4 milligrams (mg) moxidectin.
(2) Each mL of constituted suspension contains 10 mg moxidectin.
(b) Sponsor. See No. 54771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. (i) Using the suspension described in paragraph (a)(1) of this section, administer 0.05 mL of the constituted suspension per kilogram (kg) of body weight (0.023 mL per pound (lb)) as a single subcutaneous injection to provide 0.17 mg/kg body weight (0.0773 mg/lb).
(ii) Using the suspension described in paragraph (a)(2) of this section, administer 0.05 mL of the constituted suspension/kg of body weight (0.023 mL/lb) as a single subcutaneous injection to provide 0.5 mg/kg body weight (0.23 mg/lb).
(2) Indications for use —(i) Suspension described in paragraph (a)(1) of this section. For prevention of heartworm disease caused by Dirofilaria immitis in dogs 6 months of age and older; and for treatment of existing larval and adult hookworm ( Ancylostoma caninum and Uncinaria stenocephala ) infections.
(ii) Suspension described in paragraph (a)(2) of this section. For prevention of heartworm disease caused by Dirofilaria immitis for 12 months in dogs 12 months of age and older; and for treatment of existing larval and adult hookworm ( Ancylostoma caninum and Uncinaria stenocephala ) infections.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1452   Nalorphine.
(a) Specifications. Each milliliter of solution contains 5 milligrams of nalorphine hydrochloride.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. One milligram per 5 pounds; intravenously, intramuscularly, or subcutaneously.
(2) Indications for use. Respiratory and circulatory depression in dogs resulting from overdosage of, or unusual sensitivity to, morphine and certain other narcotics. Not for depression due to any other cause.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1465   Naltrexone.
(a) Specifications. Each milliliter of solution contains 50 milligrams of naltrexone hydrochloride.
(b) Sponsor. See 053923 in § 510.600(c) of this chapter.
(c) Conditions of use in elk and moose —(1) Amount. 100 milligrams of naltrexone hydrochloride for each milligram of carfentanil citrate administered. One-quarter of the dose should be administered intravenously and three-quarters of the dose should be administered subcutaneously.
(2) Indications for use. As an antagonist to carfentanil citrate immobilization in free-ranging or confined elk and moose ( Cervidae ).
(3) Limitations. Do not use in domestic food-producing animals. Do not use in free-ranging animals for 45 days before or during hunting season. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1468   Naproxen for injection.
(a) Specifications. The drug is a lyophilized powder which is reconstituted with sterile water for injection to form a 10 percent sterile aqueous solution (100 milligrams per milliliter).
(b) Sponsor. See 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Dosage. Five milligrams per kilogram of body weight intravenously followed by maintenance oral therapy of 10 milligrams per kilogram of body weight twice daily for up to 14 consecutive days.
(2) Indications for use. For the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of the musculoskeletal system of the horse.
(3) Limitations. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1484   Neomycin.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of neomycin sulfate (equivalent to 35 mg of neomycin base).
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer 5 mg per pound of body weight daily by intramuscular or intravenous injection, divided into portions administered every 6 to 8 hours for 3 to 5 days.
(2) Indications for use. For the treatment of acute and chronic bacterial infections due to organisms susceptible to neomycin.
(3) Limitations. Not for parenteral use in food-producing animals because of prolonged residues in edible tissues. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1503   Neostigmine.
(a) Specifications. Each milliliter of solution contains 2 milligrams (mg) neostigmine methylsulfate.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer to cattle and horses at a dosage level of 1 mg per (/) 100 pounds (lbs) of body weight subcutaneously. Administer to sheep at a dosage level of 1 to 1 1/2 mg/100 lbs body weight subcutaneously. Administer to swine at a dosage level of 2 to 3 mg/100 lbs body weight intramuscularly. These doses may be repeated as indicated.
(2) Indications for use. For treating rumen atony; initiating peristalsis which causes evacuation of the bowel; emptying the urinary bladder; and stimulating skeletal muscle contractions.
(3) Limitations. Not for use in animals producing milk, since this use will result in contamination of the milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1610   Oleate sodium.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of sodium oleate.
(b) Sponsor. See No. 037990 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer by parenteral injection depending on the area of response desired. An injection of 1 milliliter (mL) will produce a response of approximately 15 square centimeters. Do not inject more than 2 mL per injection site. Regardless of the number of injection sites, the total volume used should not exceed 10 mL.
(2) Indications for use. It is used in horses to stimulate infiltration of cellular blood components that subsequently differentiate into fibrous and/or fibrocartilagenous tissue.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1660   Oxytetracycline injectable dosage forms.
§ 522.1660a   Oxytetracycline solution, 200 milligrams/milliliter.
(a) Specifications. Each milliliter of sterile solution contains 200 milligrams of oxytetracycline base.
(b) Sponsors. See Nos. 000010, 016592, 054771, 055529, 061133, and 069254 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.500 of this chapter; and for No. 061133, see also § 500.1410 of this chapter.
(d) Conditions of use —(1) Beef cattle, dairy cattle, and calves including prerumenative (veal) calves —(i) Amounts and indications for use. (A) 3 to 5 mg per pound of body weight (mg/lb BW) per day (/day) intramuscularly, subcutaneously, or intravenously for treatment of 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, wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp., and anthrax caused by Bacillus anthracis.
(B) 5 mg/lb BW/day intramuscularly or intravenously for treatment of anaplasmosis caused by Anaplasma marginale, severe foot-rot, and advanced cases of other indicated diseases.
(C) 9 mg/lb BW intramuscularly or subcutaneously as single dosage where retreatment of calves and yearlings for bacterial pneumonia is impractical, for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis, or where retreatment for anaplasmosis is impractical.
(ii) Limitations. Discontinue treatment at least 28 days prior to slaughter. Milk taken from animals during treatment and for 96 hours after the last treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine —(i) Amounts and indications for use. (A) Sows: 3 mg/lb BW intramuscularly once, approximately 8 hours before farrowing or immediately after completion of farrowing, as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by E. coli.
(B) 3 to 5 mg/lb BW/day intramuscularly for treatment of bacterial enteritis (scours, colibacillosis) caused by E. coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona.
(C) 9 mg/lb BW as a single dosage where retreatment for pneumonia is impractical.
(ii) Limitations. Administer intramuscularly. Do not inject more than 5 mL per site in adult swine. Discontinue treatment at least 28 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1660b   Oxytetracycline solution, 300 milligrams/milliliter.
(a) Specifications. Each milliliter (mL) of solution contains 300 milligrams (mg) oxytetracycline base.
(b) Sponsor. See No. 055529 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.500 of this chapter.
(d) Special considerations. When labeled for use as in paragraph (e)(1)(i)(D) or (e)(1)(i)(E) of this section, labeling shall also bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”.
(e) Conditions of use —(1) Beef cattle, nonlactating dairy cattle, and calves including preruminating (veal) calves —(i) Amounts and indications for use. (A) 3 to 5 mg per pound of bodyweight (mg/lb BW) per day (/day) intramuscularly, subcutaneously, or intravenously for treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Histophilus 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, wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp.
(B) 5 mg/lb BW/day intramuscularly, subcutaneously, or intravenously for treatment of severe foot-rot, and advanced cases of other indicated diseases.
(C) 9 mg/lb BW intramuscularly or subcutaneously as single dosage where retreatment of calves and yearlings for bacterial pneumonia is impractical or for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis.
(D) 9 to 13.6 mg/lb BW intramuscularly or subcutaneously as single dosage where retreatment of calves and yearlings for bacterial pneumonia is impractical or for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis.
(E) 13.6 mg/lb BW intramuscularly or subcutaneously as a single dosage for control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia ( Pasteurella ) haemolytica.
(ii) Limitations. Treatment should be continued 24 to 48 hours following remission of disease signs, however, not to exceed a total of four consecutive days. Do not inject more than 10 mL per site in adult cattle, reducing the volume according to age and body size to 1 to 2 mL in small calves. Exceeding the highest recommended level of drug/lb BW/day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site may result in antibiotic residues beyond the withdrawal time. Rapid intravenous administration may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. Discontinue treatment at least 28 days prior to slaughter. Not for use in lactating dairy animals. For No. 055529: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine —(i) Amounts and indications for use. (A) Sows: 3 mg/lb BW intramuscularly once, approximately 8 hours before farrowing or immediately after completion of farrowing, as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by E. coli.
(B) 3 to 5 mg/lb BW/day intramuscularly for treatment of bacterial enteritis (scours, colibacillosis) caused by E. coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona.
(C) 9 mg/lb BW as a single dosage where retreatment for pneumonia is impractical.
(ii) Limitations. Administer intramuscularly. Treatment should be continued 24 to 48 hours beyond remission of disease signs, however, not to exceed a total of 4 consecutive days. Exceeding the highest recommended level of drug/lb BW/day, administering more than the recommended number of treatments, and/or exceeding 5 mL intramuscularly per injection site may result in antibiotic residues beyond the withdrawal time. Discontinue treatment at least 28 days prior to slaughter. For No. 055529: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1662   Oxytetracycline.
(a) For related tolerances see § 556.500 of this chapter.
(b)(1) Specifications. Each milliliter (mL) of solution contains 50 milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Amount. Administer 3 to 5 mg per pound of body weight (mg/lb) per day by intramuscular injection. Leptospirosis, severe foot-rot, and severe forms of the indicated diseases should be treated with 5 mg/lb per day. Treatment should be continued for 24 to 48 hours following remission of clinical signs of disease, not to exceed 4 consecutive days. Not more than 10 mL should be injected per injection site in adult cattle, and only 2 mL per injection site in calves weighing 100 pounds or less.
(ii) Indications for use. Beef cattle, beef calves, nonlactating dairy cattle, and dairy calves; for treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex ( Pasteurella spp ., Haemophilus spp ., Klebsiella spp.), bacterial enteritis (scours) ( Escherichia coli ), foot-rot ( Spherophorus necrophorus ), diphtheria ( Spherophorus necrophorus ), wooden tongue ( Actinobacillus lignieresii ), leptospirosis ( Leptospira pomona ), and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp.
(iii) Limitations. Discontinue treatment at least 20 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(c)(1) Specifications. Each milliliter (mL) of solution contains 50 or 100 milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Beef cattle and nonlactating dairy cattle —(A) Amount. Administer 3 to 5 mg per pound of body weight (mg/lb) per day; 5 mg/lb per day for the treatment of anaplasmosis, severe foot-rot, and severe cases of other indicated diseases. For 50-mg/mL solution, administer intramuscularly or intravenously; for 100-mg/mL solution, administer intramuscularly only. Treatment should be continued for 24 to 48 hours following remission of clinical signs of disease, not to exceed 4 consecutive days.
(B) Indications for use. For 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 lignieresii, leptospirosis caused by Leptospira pomona, anaplasmosis caused by Anaplasma marginale; and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp.
(C) Limitations. Exceeding the highest recommended dose of 5 mg/lb, administering at recommended levels for more than 4 consecutive days, and/or exceeding 10 mL 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(ii) Swine —(A) Amount. Administer 3 to 5 mg/lb per day by intramuscular injection. Sows: Administer 3 mg/lb by intramuscular injection 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. Do not inject more than 5 mL per injection site. Do not use for more than 4 consecutive days. Discontinue treatment at least 26 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(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 (mL) of solution contains 100 milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(3) Conditions of use. 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. Administer 3 to 5 mg/lb body weight per day by intramuscular, intravenous, or subcutaneous injection. In severe forms of the indicated diseases, administer 5 mg/lb body weight per day. Continue treatment 24 to 48 hours following remission of clinical signs of disease, not to exceed 4 consecutive days.
(B) Indications for use. For the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., Haemophilus spp., or Klebsiella spp.
(C) Limitations. Do not inject more than 10 mL per intramuscular injection site in adult cattle, and no more than 1 mL 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(ii) Swine —(A) Amount. Administer 3 to 5 mg/lb body weight per day by intramuscular injection. Sows: Administer 3 mg/lb body weight once, by intramuscular injection, 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. Do not inject more than 5 mL per site. Discontinue treatment at least 20 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(h)(1) Specifications. Each milliliter (mL) of solution contains 50 or 100 milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsors. See No. 069043 in § 510.600(c) of this chapter for use of 50- and 100-mg/mL solution and Nos. 016592 and 055529 in § 510.600(c) of this chapter for use of 100-mg/mL solution.
(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; 5 mg/lb body weight per day for treatment of severe forms of the indicated diseases.
(ii) Indications for use. For treatment of bacterial pneumonia and shipping fever complex associated with Pasteurella spp., foot-rot and calf diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii; and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp.
(iii) Limitations. Do not inject more than 10 mL 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 not inject more than 2 mL 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(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 (mL) of solution contains either 50 or 100 milligrams (mg) 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 3 to 5 mg/lb body weight daily by intravenous injection. Administer 5 mg/lb for anaplasmosis, severe foot rot, and severe forms of other diseases. Treatment should be continued 24 to 48 hours following remission of clinical signs of disease, but not to exceed 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, anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis; and acute metritis and wound infections caused by staphylococcal and streptococcal organisms.
(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.
§ 522.1663   Oxytetracycline hydrochloride with lidocaine injection.
(a) Specifications. The drug contains 50 or 100 milligrams of oxytetracycline hydrochloride and 2 percent lidocaine in each milliliter of sterile aqueous solution.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is indicated for use in the treatment of diseases of dogs caused by pathogens sensitive to oxytetracycline hydrochloride including treatment for the following conditions in dogs caused by susceptible microorganisms: Bacterial infections of the urinary tract caused by Hemolytic staphylococcus, Streptococcus spp., Bacterial pulmonary infections caused by Brucella bronchiseptica, Streptococcus pyogenes, Staphylococcus aureus, secondary bacterial infections caused by Micrococcus pyogenes var. albus, Brucella bronchiseptica, Streptococcus spp.
(2) The drug is administered intramuscularly at a recommended daily dosage to dogs at 5 milligrams per pound of body weight administered in divided doses at 6 to 12 hour intervals. Therapy should be continued for at least 24 hours after all symptoms have subsided.
(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1664   Oxytetracycline and flunixin.
(a) Specifications. Each milliliter (mL) of solution contains 300 milligrams (mg) oxytetracycline base as amphoteric oxytetracycline and 20 mg flunixin base as flunixin meglumine.
(b) Sponsor. See No. 055529 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.286 and 556.500 of this chapter.
(d) Conditions of use cattle —(1) Amount. Administer once as an intramuscular or subcutaneous injection of 1 mL per 22 pounds (lb) body weight (BW) (13.6 mg oxytetracycline and 0.9 mg flunixin per lb BW) where retreatment of calves and yearlings for bacterial pneumonia is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable.
(2) Indications for use. For the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and nonlactating dairy cattle.
(3) Limitations. Discontinue treatment at least 21 days prior to slaughter of cattle. 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. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1680   Oxytocin.
(a) Specifications. Each milliliter (mL) of solution contains 20 USP units oxytocin.
(b) Sponsors. See Nos. 054771 and 061133 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount —(i) Obstetrical. Administer drug intravenously, intramuscularly, or subcutaneously under aseptic conditions as indicated. The following dosages are recommended and may be repeated as conditions require:
(ii) Milk letdown. Intravenous administration is desirable. The following dosage is recommended and may be repeated as conditions require:
(2) Indications for use. Oxytocin may be used as a uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris. In surgery it may be used postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood. It will contract smooth muscle cells of the mammary gland for milk letdown if the udder is in proper physiological state.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1684   Pegbovigrastim.
(a) Specifications. Each pre-filled, single-dose syringe contains 15 milligrams of pegbovigrastim.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in cattle —(1) Amount. Administer the first dose (syringe) by subcutaneous injection 7 days prior to the cow's or heifer's anticipated calving date. If necessary, the first dose may be administered within a range of 4 to 10 days prior to the anticipated calving date to accommodate management schedules. Administer the second dose (syringe) by subcutaneous injection within 24 hours after calving.
(2) Indications for use. For the reduction in the incidence of clinical mastitis in the first 30 days of lactation in periparturient dairy cows and periparturient replacement dairy heifers.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1696   Penicillin G procaine injectable dosage forms.