NOROMECTIN PLUS FOR CATTLE- ivermectin and clorsulon injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D), clorsulon (UNII: EG1ZDO6LRD) (clorsulon - UNII:EG1ZDO6LRD)

Available from:

Norbrook Laboratories Limited

INN (International Name):

ivermectin

Composition:

ivermectin 10 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

OTC

Therapeutic indications:

Noromectin Plus Injection is indicated for the effective treatment and control of the following parasites 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 Bunostomum phlebotomum Nematodirus helvetianus (adults only) N. spathiger (adults only) Oesophagostomum radiatum Lungworms (adults and fourth-stage larvae): Dictyocaulus viviparus Liver Flukes: Fasciola hepatica (adults only) 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 Ivermectin and clorsulon injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days

Product summary:

Noromectin Plus Injection 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. The 100 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 20 head of 550 lb (250 kg) cattle. 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. 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. 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. Restricted Drug - California. Use Only as Directed. Made in the UK. Norbrook Laboratories Limited, Newry, BT35 6PU, Co. Down, Northern Ireland. ® Noromectin is a registered trademark of Norbrook Laboratories Limited Approved by FDA under ANADA # 200-436 Rev. September 2020 003670|07

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

NOROMECTIN PLUS FOR CATTLE- IVERMECTIN AND CLORSULON INJECTION,
SOLUTION
NORBROOK LABORATORIES LIMITED
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_NOROMECTIN _
_(IVERMECTIN AND CLORSULON) PLUS_
_INJECTION FOR CATTLE_
FOR THE EFFECTIVE TREATMENT AND CONTROL OF INTERNAL PARASITES,
INCLUDING ADULT
LIVER FLUKES, AND EXTERNAL PARASITES.
CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS, TREATMENT
AND
CONTROL OF PARASITISM.
INTRODUCTION
The ability of ivermectin to deliver internal and external parasite
control has been proven
in cattle markets around the world. Now, Norbrook Laboratories Limited
combines
ivermectin with clorsulon, an effective adult flukicide.
A single injection of Noromectin Plus (ivermectin and clorsulon)
offers all the benefits
of an ivermectin injection plus control of adult _Fasciola hepatica._
THE DOSAGE LEVEL OF CLORSULON SUPPLIED BY NOROMECTIN PLUS IS EFFECTIVE
ONLY
AGAINST ADULT LIVER FLUKES _(FASCIOLA HEPATICA)._
PRODUCT DESCRIPTION
Noromectin Plus is a ready-to-use sterile solution containing 1% w/v
ivermectin, 10%
clorsulon, 40% glycerol formal, and propylene glycol, q.s. ad 100%. It
is formulated to
deliver the recommended dose level of 200 mcg ivermectin/kg and 2 mg
clorsulon/kg
given subcutaneously behind the shoulder at the rate of 1 mL per 110
lb (50 kg) body
weight.
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
membrane to chloride ions
with hyperpolarization of the nerve or muscle cell, resulting in
paralysis and death of the
parasite. Compounds of this class may also interact with other
ligand-gated chloride
channels, such as those gated by the neurotransmitter
gamma-aminobutyric acid
(GABA).
The margin of safety for compounds of this class is attributable to
the fact that
mammals do not have glutamate-gated chloride ch