Alverin Plus for Cattle

Zoetis Inc
Norbrook Laboratories Limited

ANADA 200-436, Approved by FDAAlverin PLUSInjection for Cattle

FULL PRESCRIBING INFORMATION: CONTENTS*

• INTRODUCTION
• PRODUCT ALVERIN PLUS FOR CATTLE DESCRIPTION
• MODE OF ACTION
• INDICATIONS
  • Persistent Activity
• DOSAGE
• ADMINISTRATION
• ANIMAL SAFETY
• WARNING
  • Keep this and all drugs out of the reach of children.
• PRECAUTIONS
  • When to Treat Cattle with Grubs
• STORAGE
• ENVIRONMENTAL SAFETY
• HOW SUPPLIED
• Principal Display Panel - Vial Label
• Principal Display Panel - Carton Label

FULL PRESCRIBING INFORMATION

1% w/v ivermectin and 10% w/v clorsulon in a sterile solution

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, ALVERIN PLUS combines ivermectin with clorsulon, an effective adult flukicide.

A single injection of ALVERIN 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 ALVERIN PLUS is effective only against adult liver flukes (Fasciola hepatica).

PRODUCT DESCRIPTION

ALVERIN 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 channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

Clorsulon is rapidly absorbed into the circulating blood. Erythrocytes with bound drug as well as plasma are ingested by Fasciola hepatica. Adult Fasciola hepatica are killed by clorsulon because of inhibition of enzymes in the glycolytic pathway, which is their primary source of energy.

INDICATIONS

ALVERIN 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

Persistent Activity

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 after treatment; Ostertagia ostertagi, Trichostrongylus axei and Cooperia punctata for 21 days after treatment; Haemonchus placei, and Cooperia oncophora for 14 days after treatment.

* Ivermectin has been approved as a scabicide by USDA/APHIS. Federal regulations require that cattle infested with or exposed to scabies (i.e., infestations with Psoroptes ovis) be treated. Ivermectin when used according to label instructions meets this requirement. Treated cattle may be shipped interstate, but they must not be mixed with other cattle for 14 days following treatment. The federal regulations make no restriction on the movement of cattle not affected with or exposed to scabies. However, individual states have additional regulations to govern the interstate shipment of cattle and the regulatory veterinarian in the state of destination should be consulted for applicable regulations on the use of ivermectin in the control of scabies.

DOSAGE

ALVERIN PLUS should be given only by subcutaneous injection at a dose volume of 1 mL per 110 lb (50 kg) body weight. This volume will deliver 10 mg ivermectin and 100 mg clorsulon. For example:

ADMINISTRATION

ALVERIN PLUS (ivermectin and clorsulon) Injection is to be given subcutaneously only. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16-gauge, 1/2" to 3/4" sterile needle is recommended. Inject the solution subcutaneously (under the skin) behind the shoulder (see illustration).