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), clorsulon (UNII: EG1ZDO6LRD) (clorsulon - UNII:EG1ZDO6LRD)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

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
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
----------
IVOMEC
PLUS
(IVERMECTIN AND CLORSULON)
INJECTION FOR CATTLE
Approved by FDA under NADA # 140-833
160022, 160023, 160024, 160025
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, Boehringer
Ingelheim Animal
Health 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