NOROMECTIN FOR CATTLE AND SWINE- ivermectin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D)

Available from:

Norbrook Laboratories Limited

INN (International Name):

ivermectin

Composition:

ivermectin 10 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

OTC

Therapeutic indications:

Cattle: Noromectin 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 Ivermectin injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radi

Product summary:

Noromectin Injection for Cattle and Swine is available in five ready-to-use pack sizes: The 50 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 10 head of 550 lb (250 kg) cattle or 100 head of 38 lb (17.3 kg) swine. The 100 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 20 head of 550 lb (250 kg) cattle or 200 head of 38 lb (17.3 kg) swine. The 250 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 50 head of 550 lb (250 kg) cattle or 500 head of 38 lb (17.3 kg) swine. The 500 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle or 1000 head of 38 lb (17.3 kg) swine. The 1000 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 200 head of 550 lb (250 kg) cattle or 2000 head of 38 lb (17.3 kg) swine. Restricted Drug - California. Use Only as Directed. Approved by FDA under ANADA # 200-437 Made in the UK. Norbrook Laboratories Limited, Newry, BT35 6PU, Co. Down, Northern Ireland ® Noromectin is a registered trademark of Norbrook Laboratories Limited Rev. September 2020 Norbrook ®

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

NOROMECTIN FOR CATTLE AND SWINE- IVERMECTIN INJECTION, SOLUTION
NORBROOK LABORATORIES LIMITED
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_NOROMECTIN_
(IVERMECTIN)
_INJECTION FOR CATTLE AND SWINE_
1% Sterile Solution
A PARASITICIDE FOR THE TREATMENT AND CONTROL OF INTERNAL AND EXTERNAL
PARASITES OF CATTLE AND SWINE.
CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS, TREATMENT
AND
CONTROL OF PARASITISM.
INTRODUCTION
Noromectin (ivermectin) 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.
Ivermectin's convenience, broad-spectrum efficacy and safety margin
make Noromectin
Injection a unique product for parasite control of cattle and swine.
PRODUCT DESCRIPTION
Ivermectin is derived from the avermectins, a family of potent,
broad-spectrum
antiparasitic agents isolated from fermentation of _Streptomyces
avermitilis._
Noromectin Injection is a clear, ready-to-use, sterile solution
containing 1% ivermectin,
40% glycerol formal, and propylene glycol q.s. ad 100%. Noromectin
Injection 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, Noromectin 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 per 75 lb (33 kg).
MODE OF ACTION
Ivermectin is a member of the macrocyclic lactone class of
endectocides which have a
unique mode of action. Compounds of the class bind selectively and
with high affinity to
glutamate-gated chloride ion channels which occur in invertebrate
nerve and muscle
cells. This leads to an increase in the permeability of the cell
memb