BIMECTIN PLUS- ivermectin 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:

Bimeda, Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

OTC

Therapeutic indications:

Approved by FDA under ANADA #200-450 Restricted Drug (California)-Use Only as Directed Bimectin® Plus (ivermectin and clorsulon) 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, Bimectin® Plus combines ivermectin, the active ingredient of Bimectin 1%, with clorsulon, an effective adult flukicide. A single injection of Bimectin® Plus (ivermectin and clorsulon) offers all the benefits of Bimectin 1% plus control of adult Fasciola hepatica . The dosage level of clorsulon supplied by Bimectin® Plus is effective only against adult liver flukes (Fasciola hepatica ). PRODUCT DESCRIPTION Bimectin® Plus is a ready-to-use sterile solution containing 1% w/v ivermectin, 10% w/v cl

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

BIMECTIN PLUS- IVERMECTIN CLORSULON INJECTION
BIMEDA, INC.
----------
APPROVED BY FDA UNDER ANADA # 200-450 RESTRICTED DRUG (CALIFORNIA)-USE
ONLY AS DIRECTED
BIMECTIN® PLUS
(IVERMECTIN AND CLORSULON)
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, Bimectin® Plus combines
ivermectin, the active ingredient of
Bimectin 1%, with clorsulon, an effective adult flukicide. A single
injection of Bimectin® Plus
(ivermectin and clorsulon) offers all the benefits of
Bimectin 1% plus control of adult _Fasciola hepatica_.
THE DOSAGE LEVEL OF CLORSULON SUPPLIED BY BIMECTIN® PLUS IS EFFECTIVE
ONLY AGAINST ADULT LIVER
FLUKES (_FASCIOLA HEPATICA_).
PRODUCT DESCRIPTION
Bimectin® Plus is a ready-to-use sterile solution containing 1% w/v
ivermectin, 10% w/v 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 fac