Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter E - Animal Drugs, Feeds, and Related Products |
Part 520 - Oral Dosage Form New Animal Drugs |
§ 520.45a - Albendazole suspension.
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(a) Specifications . Each milliliter of suspension contains 45.5 milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole.
(b) Sponsor . See No. 000069 in §510.600 of this chapter.
(c) Related tolerances . See §556.34 of this chapter.
(d) Special considerations . See §500.25 of this chapter.
(e) Conditions of use —(1) Cattle . Administer 11.36 percent suspension:
(i) Amount . 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as a single oral dose using dosing gun or dosing syringe.
(ii) Indications for use . For removal and control of adult liver flukes ( Fasciola hepatica ); heads and segments of tapeworms ( Moniezia benedeni and M. expansa ); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae ( Ostertagia ostertagi ), barberpole worm ( Haemonchus contortus and H. placei ), small stomach worm ( Trichostrongylus axei )); adult and 4th stage larvae of intestinal worms (thread-necked intestinal worm ( Nematodirus spathiger and N. helvetianus ), small intestinal worm ( Cooperia punctata and C. oncophora )); adult stages of intestinal worms (hookworm ( Bunostomum phlebotomum ), bankrupt worm ( Trichostrongylus colubriformis ), nodular worm ( Oesophagostomum radiatum )); adult and 4th stage larvae of lungworms ( Dictyocaulus viviparus ).
(iii) Limitations . 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.
(2) Sheep . Administer 4.45 or 11.36 percent suspension:
(i) Amount . 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose using dosing gun or dosing syringe.
(ii) Indications for use . For removal and control of adult liver flukes ( Fasciola hepatica and 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 worm ( Haemonchus contortus ), small stomach worm ( Trichostrongylus axei )); adult and fourth stage larvae of intestinal worms (thread-necked intestinal worm ( Nematodirus spathiger and N. filicollis ), Cooper's worm ( Cooperia oncophora ), bankrupt worm ( Trichostrongylus colubriformis ), nodular worm ( Oesophagostomum columbianum ), and large-mouth bowel worm ( Chabertia ovina )); adult and larval stages of lungworms ( Dictyocaulus filaria ).
(iii) Limitations . 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.
(3) Goats . Administer 11.36 percent suspension:
(i) Amount . 4.54 mg/lb body weight (10 mg/kg) as a single oral dose using dosing gun or dosing syringe.
(ii) Indications for use . For the treatment of adult liver flukes ( Fasciola hepatica ) in nonlactating goats.
(iii) Limitations . Do not slaughter within 7 days of last treatment. Do not administer to does during the first 30 days of pregnancy or for 30 days after removal of bucks.
[73 FR 11027, Feb. 29, 2008]