ANADA 200-228, Approved by FDA
1% Sterile Solution
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A Parasiticide for the Treatment and Control of Internal and External Parasites of Cattle and Swine.
Introduction:
ProMectin™ (ivermectin) Injection is an injectable parasiticide for cattle and swine. One low-volume dose effectively treats and controls the following internal and external parasites that may impair the health of cattle and swine: gastrointestinal roundworms (including inhibited Ostertagia ostertagi in cattle), lungworms, grubs, sucking lice, and mange mites of cattle; and gastrointestinal roundworms, lungworms, lice, and mange mites of swine.
Product Description:
Ivermectin is derived from the avermectins, a family of potent, broad-spectrum antiparasitic agents isolated from fermentation of Streptomyces avermitilis. ProMectin™ Injection is a clear, ready-to-use, sterile solution containing 1% ivermectin, 40% glycerol formal, 1.5% benzyl alcohol (preservative), and propylene glycol, q.s. ad 100%. It is formulated to deliver the recommended dose level of 200 mcg ivermectin/kilogram of body weight in cattle when given subcutaneously at the rate of 1 mL/110 lb (50 kg).
In swine, ProMectin™ Injection is formulated to deliver the recommended dose level of 300 mcg ivermectin/kilogram body weight when given subcutaneously in the neck at the rate of 1 mL/75 lb (33 kg).
Product Indications:
Cattle: ProMectin™ Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice and mange mites in cattle: Gastrointestinal Roundworms (adults and fourth-stage larvae): Ostertagia ostertagi (including inhibited O. ostertagi), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora C. punctata, C. pectinata, Oesophagostomum radiatum, Bunostomum phlebotomum, Nematodirus helvetianus (adults only), N. spathiger (adults only)
Lungworms: (adults and fourth-stage larvae): Dictyocaulus viviparus Cattle 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
Dosage in Cattle:
ProMectin™ Injection should be given only by subcutaneous injection under the loose skin in front of or behind the shoulder at the recommended dose level of 200 mcg ivermectin per kilogram of body weight. Each mL of ProMectin™ Injection contains 10 mg of ivermectin, sufficient to treat 110 lb (50 kg) of body weight (maximum 10 mL per injection site).
Body Weight (lb) Dose (mL) Body Weight (lb) Dose (mL)
220 2 660 6
330 3 770 7
440 4 880 8
550 5 990 9
1100 10
Product Indications:
Swine: ProMectin™ Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice and mange mites in swine:
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, Strongyloides ransomi (somatic larvae) Sows must be treated at least seven days before farrowing to prevent infection in piglets.
Lungworms: Metastrongylus spp. (adults)
Lice: Haematopinus suis
Mange Mites: Sarcoptes scabiei var. suis
Dosage in Swine:
ProMectin™ Injection should be given only by subcutaneous injection in the neck of swine at the recommended dose level of 300 mcg ivermectin per kilogram (2.2 lb) of body weight. Each mL of ProMectin™ Injection contains 10 mg of ivermectin, sufficient to treat 75 lb of body weight.
Growing Pigs
Body Weight (lb) Dose (mL)
19 1/4
38 1/2
75 1
150 2
Breeding Animals (Sows, Gilts, and Boars)
Body Weight (lb) Dose (mL)
225 3
300 4
375 5
450 6