worm

(Fasciola hepatica, Fascioloides magna); heads and segments of common tapeworms (Moniezia expansa) and fringed tapeworm (Thysanosoma actinioides); adult and fourth stage larvae of stomach worms (brown stomach worm (Ostertagia circumcinta and Marshallagia marshalli), barberpole (Haemonchus contortus), small stomach worm (Trichostrongylus arei)); adult and fourth stage larvae of intestinal worms (thread-necked intestinal (Nematodirus spathiger and N. filicollis), Cooper's worm (Cooperia oncophora), bankrupt worm (Trichostrongylus colubriformis), (Oesophagostomum columbianum), and large-mouth bowel worm (Chabertia ovina)); adult and larval stages of lungworms (Dictyocaulus filaria).

nodular

worm

worm

(iii) Limitations. Administer as a single oral dose using dosing gun or dosing syringe. Do not slaughter within 7 days of last treatment. Do not administer to ewes during first 30 days of pregnancy or for 30 days after removal of rams. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[54 FR 25115, June 13, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 59 FR 65711, Dec. 21, 1994; 60 FR 55658, Nov. 2, 1995; 61 FR 4875, Feb. 9, 1996; 64 FR 1504, Jan. 11, 1999]

$520.45b Albendazole paste.

(a) Specifications. The product contains 30 percent albendazole.

(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.

(c) Related tolerances. See $556.34 of this chapter.

(d) Conditions of use in cattle-(1) Amount. Equivalent to 4.54 milligrams per 1 pound of body weight (10 milligrams per kilogram).

(2) Indications for use. For removal and control of the following internal parasites of cattle: adult liver flukes (Fasciola hepatica); heads and segments of tapeworms (Moniezia benedeni, M. expansa); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae (Ostertagia ostertagi); barberpole worm (Haemonchus contortus, H. placei); small stomach worm (Trichostrongylus axei)); adult and 4th stages larvae of intestinal worms (thread-necked intestinal worm (Nematodirus spathiger, N.

(3) Limitations. Administer as a single oral dose. Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breeding age. Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[54 FR 51385, Dec. 15, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, 1995]

$520.48 Altrenogest solution.

(a) Specifications. Each milliliter of altrenogest solution contains 2.2 milligrams of altrenogest.

(b) Sponsor. See No. 012799 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer orally at the rate of 1 milliliter per 110 pounds body weight (0.044 milligram per kilogram body weight). Give one dose daily for 15 consecutive days.

(2) Indications for use. For suppression of estrus in mares.

(3) Limitations. For oral use in horses only; avoid contact with the skin. Do not administer to horses intended for use as food. The drug is contraindicated for use in mares having a previous or current history of uterine inflammation (i.e., acute, subacute, or chronic endometritis). Natural or synthetic gestagen therapy may exacerbate existing low-grade or smoldering uterine inflammation into a fulminating uterine infection in some instances. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 40887, Sept. 12, 1983, as amended at 55 FR 26431, June 28, 1990; 64 FR 42597, Aug. 5, 1999]

diphenylvaleramide hydrogen sulfate. (b) Specifications. Each tablet contains 0.2 milligram of the drug.

(c) Sponsor. See No. 000856 in $510.600(c) of this chapter.

(d) Conditions of use. (1) It is intended for use in dogs and cats only for the treatment of vomiting and/or diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.

NOTE: Not for use in animals with glaucoma because of the occurrence of mydriasis. (2) Dosage is administered by oral tablet every 8 to 12 hours, as follows:

let

fumarate

(a) Specifications. The drug is in tabform. Each tablet contains aminopropazine fumarate equivalent to 25 milligrams of aminopropazine base. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in dogs and cats for reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis.1

(2) It is administered at a dosage level of 1 to 2 milligrams per pound of body weight. The dosage can be repeated every 12 hours, as indicated.1

(3) Not for use in animals intended for food purposes.

(4) For use only by or on the order of a licensed veterinarian.1

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]

§ 510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in dogs to control bacterial diarrhea caused by organisms susceptible to neomycin and to reduce smooth muscle contractions.1

(2) It is administered at a dosage level of one to two tablets per 10 pounds of body weight twice daily for 3 days.1

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]

$520.88 Amoxicillin oral dosage forms.

§ 520.88a Amoxicillin trihydrate filmcoated tablets.

(a) Specifications. Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams of amoxicillin.

§ 510.600(c) of this chapter.

(c) Conditions of use-(1) Dogs—(i) Amount. 5 milligrams per pound of body weight, twice a day.

(ii) Indications for use. Treatment of infections of the respiratory tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis), gastrointestinal (bacterial

tract

1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

gastroenteritis), and soft tissues (abscesses, lacerations, wounds), caused by susceptible strains of Staphylococcus aureus, Streptococcus spp., Escherichia coli, Proteus mirabilis, and bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis.

(iii) Limitations. Administer for 5 to 7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats (i) Amount. 50 milligrams (5 to 10 milligrams per pound of body weight) once a day.

(ii) Indications for use. Treatment of infections caused by susceptible organisms as follows: upper respiratory tract due to S. aureus, Streptococcus spp., and E. coli; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract due to E. coli; and skin and soft tissue (abscesses, lacerations, and wounds) due to S. aureus, Streptococcus spp., E. coli, and Pasteurella multocida.

(iii) Limitations. Administer for 5 to 7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995]

§ 520.88b Amoxicillin trihydrate for oral suspension.

(a) Specifications. When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin.

(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.

(1) Conditions of use—(i) Dogs—(A) Amount. 5 milligrams per pound of body weight twice daily.

(B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) caused by Staphylococcus aureus, Streptococcus spp., Escherichia coli, and Proteus mirabilis; genitourinary tract (cystitis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastro

intestinal tract (bacterial gastroenteritis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis; and soft tissues (abscesses, lacerations, and wounds) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis.

(C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms have subsided. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(ii) Cats (A) Amount. 50 milligrams (5 to 10 milligrams per pound) once daily.

(B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: upper respiratory tract due to Staphylococcus spp., Streptococcus spp., Hemophilus spp., E. coli, Pasteurella spp., and P. mirabilis; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal tract due to E. coli, Proteus spp., Staphylococcus spp. and Streptococcus spp.; skin and soft tissue (abscesses, lacerations, and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, Pasteurella multocida.

and

(C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms have subsided. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

(c) Sponsor. See Nos. 000031 and 000093 in §510.600(c) of this chapter.

(1) Conditions of use. Dogs-(i) Amount. 5 milligrams per pound of body weight twice daily.

(ii) Indications for use. Treatment of bacterial dermatitis due to S. aureus, Streptococcus spp., Staphylococcus spp., and E. coli, and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis and Staphylococcus spp.

(iii) Limitations. Use for 5 to 7 days. Continue for 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.

(c) Related tolerances. See §556.510 of this chapter.

(d) Conditions of use. Swine-(1) Amount. 40 milligrams orally, twice a day using a dosing pump.

(2) Indications for use. Treatment of baby pigs under 10 pounds for porcine colibacillosis caused by Escherichia coli susceptible to amoxicillin.

(3) Limitations. Treat animals for 48 hours after all symptoms have subsided but not beyond 5 days. Do not slaughter during treatment or for 15 days after latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995]

$520.88d Amoxicillin trihydrate soluble powder.

(a) Specifications. Each gram contains amoxicillin trihydrate equivalent to 115.4 milligrams of amoxicillin.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.38 of this chapter.

(d) Conditions of use. Preruminating calves including veal calves—(1) Amount. 400 milligrams per 100 pounds of body weight twice daily.

(2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves.

(3) Limitations. Administer by drench or by mixing in milk. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days. For use in preruminating calves including veal calves only, not for use in other animals which are raised for food production. Do not slaughter animals during treatment or for 20 days after the lat

(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.

(c) Related tolerances. See $556.38 of this chapter.

(d) Conditions of use. Preruminating calves including veal calves—(1) Amount. 400 milligrams per 100 pounds of body weight twice daily.

(2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves.

(3) Limitations. For oral use in preruminating calves including veal calves only, not for use in other animals which are raised for food production. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997] $520.88f Amoxicillin trihydrate tablets.

(a) Specifications. Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 200, or 400 milligrams of amoxicillin.

(b) Sponsor. See Nos. 000031 or 000093 in § 510.600(c) of this chapter.

(c) Conditions of use-(1) Dogs-(i) Amount. 5 milligrams per pound of body weight twice a day.

(ii) Indications for use. Treatment of bacterial dermatitis due to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and Escherichia coli; and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Streptococcus spp., E. coli, Proteus mirabilis, and Staphylococcus spp.

(c) Conditions of use-(1) Dogs—(i) Amount. 6.25 milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic acid) per pound of body weight twice daily.

(ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of betalactamase (penicillinase) Staphylococcus aureus, nonbeta-lactamase S. aureus, Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment of periodontal infections due to susceptible strains of aerobic and anaerobic bacteria.

(iii) Limitations. Wounds, abscesses, cellulitis, and superficial/juvenile pyoderma: Treat for 5 to 7 days or for 48 hours after all signs have subsided. If no improvement is seen after 5 days of treatment, discontinue therapy and reevaluate diagnosis. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days. Not for use in dogs maintained for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats (i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams amoxicillin

and 12.5 milligrams clavulanic acid) twice daily.

(ii) Indications for use. Treatment of skin and soft tissue infections, such as wounds, abscesses and cellulitis/dermatitis due to susceptible strains of betalactamase (penicillinase) producing S. aureus, nonbeta-lactamase producing S. aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella spp. Also, treatment of urinary tract infections (cystitis) due to susceptible strains of E. coli.

(iii) Limitations. Skin and soft tissue infections: abscesses, cellulitis/dermatitis should be treated for 5 to 7 days or for 48 hours after all signs have subsided. If no response is seen after 3 days of treatment, therapy should be discontinued and diagnosis reevaluated. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days. Safety of use in pregnant or breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, 1998]

§ 520.88h Amoxicillin trihydrate and clavulanate potassium for oral suspension.

(a) Specifications. When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin with clavulanate potassium equivalent to 12.5 milligrams of clavulanic acid.

(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.

(c) Conditions of use-(1) Dogs-(i) Amount. 6.25 milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic acid) per pound of body weight twice daily.

(ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of betalactamase (penicillinase) producing Staphylococcus aureus, nonbetalactamase Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment of periodontal infections due to susceptible