IVOMEC PLUS- ivermectin and clorsulon injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Merial, Inc.

INN (International Name):

ivermectin

Composition:

ivermectin 10 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

OTC

Therapeutic indications:

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. IVOMEC Plus Injection is indicated for the effective treatment and control of the following parasites of 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

Product summary:

IVOMEC Plus Injection is available in four 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 200 mL pack is a soft, collapsible pack designed for use with automatic syringe equipment. Each pack contains sufficient solution to treat 40 head of 550 lb (250 kg) cattle. The 500 mL pack is a soft, collapsible pack designed for use with automatic syringe equipment. Each pack contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle. The 1000 mL pack is a soft, collapsible pack designed for use with automatic syringe equipment. Each pack contains sufficient solution to treat 200 head of 550 lb (250 kg) cattle.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

IVOMEC PLUS- IVERMECTIN AND CLORSULON INJECTION
MERIAL, INC.
----------
IVOMEC
_PLUS_
(IVERMECTIN AND CLORSULON)
INJECTION FOR CATTLE
NADA 140-833, Approved by the FDA
67302, 67303, 67304, 67305
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 IVOMEC (ivermectin) to deliver internal and external
parasite control has been proven
in cattle markets around the world. Now, Merial combines ivermectin,
the active ingredient of
IVOMEC, with clorsulon, an effective adult flukicide. A single
injection of IVOMEC Plus (ivermectin
and clorsulon) offers all the benefits of IVOMEC plus control of adult
_Fasciola hepatica_.
THE DOSAGE LEVEL OF CLORSULON SUPPLIED BY IVOMEC PLUS IS EFFECTIVE
ONLY AGAINST ADULT LIVER FLUKES
(_FASCIOLA HEPATICA_).
PRODUCT DESCRIPTION
IVOMEC 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 c