IVOMEC PLUS- ivermectin and clorsulon injection

IVOMEC Plus by

Drug Labeling and Warnings

IVOMEC Plus by is a Animal medication manufactured, distributed, or labeled by Boehringer Ingelheim Animal Health USA Inc., Alivira Animal Health Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Persistent Activity

IVOMEC Plus 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.

  • DOSAGE

    IVOMEC 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:

    Body Weight
    (lb)
    Dose
    (mL)

    220

    2

    330

    3

    440

    4

    550

    5

    660

    6

    770

    7

    880

    8

    990

    9

    1100

    10

    Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

  • ADMINISTRATION

    IVOMEC 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).

    Administration illustration

    Any single-dose syringe or standard automatic syringe equipment may be used with the 50 mL bottle. Use the 50 mL bottle within 6 months of first puncture and puncture a maximum of 12 times. If more than 12 punctures are anticipated, the use of multi-dosing equipment is recommended. When using a draw-off spike or needle with bore diameter larger than 16-gauge, discard any product remaining in the bottle immediately after use.

    When using the 200 mL, 500 mL or 1000 mL pack size, use only automatic syringe equipment. Discard any product remaining in the pack immediately after use.

    Use sterile equipment and sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infections.

    No special handling or protective clothing is necessary.

    The viscosity of the product increases in cool temperatures.

    Administering IVOMEC® Plus at temperatures of 5°C (41°F) or below may be difficult. Users can make dosing easier by warming both the product and injection equipment to about 15°C (59°F).

  • ANIMAL SAFETY

    In breeding animals (bulls and cows), ivermectin and clorsulon used at the recommended level had no effect on breeding performance.

  • WARNING

    NOT FOR USE IN HUMANS.
    Keep this and all drugs out of the reach of children.

    The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance, or to obtain a copy of the SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251.

  • RESIDUE WARNING

    Do not treat cattle within 21 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

  • PRECAUTIONS

    Transitory discomfort has been observed in some cattle following subcutaneous administration. Soft-tissue swelling at the injection site has also been observed. These reactions have disappeared without treatment. Divide doses greater than 10 mL between two injection sites to reduce occasional discomfort or site reaction. Different injection sites should be used for other parenteral products.

    IVOMEC Plus Injection has been developed specifically for use in cattle only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

    For subcutaneous injection in cattle only.

    This product is not for intravenous or intramuscular use.

    Restricted Drug (California) - use only as directed.

  • When to Treat Cattle with Grubs

    IVOMEC Plus effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season.

    Destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possibility of fatalities. Killing Hypoderma lineatum when it is in the tissue surrounding the esophagus (gullet) may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. These reactions are not specific to treatment with IVOMEC Plus, but can occur with any successful treatment of grubs. Cattle should be treated either before or after stages of grub development. Consult your veterinarian concerning the proper time for treatment.

    Cattle treated with IVOMEC Plus after the end of the heel fly season may be retreated with ivermectin during the winter for internal parasites, mange mites or sucking lice, without danger of grub-related reactions. A planned parasite control program is recommended.

  • OTHER WARNINGS:

    Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.

    Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance.

    Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).

    A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

  • Environmental Safety

    Studies indicate that when ivermectin comes in contact with soil it readily and tightly binds to the soil and becomes inactive overtime. Free ivermectin may adversely affect fish and certain aquatic organisms. Do not permit water runoff from feedlots to enter lakes, streams or ponds. Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

    As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific.

    When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

  • STORAGE CONDITIONS

    Store at or below 25°C (77°F) with excursions permitted up to 30°C (86°F). Protect product from light.

  • HOW SUPPLIED

    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.

  • SPL UNCLASSIFIED SECTION

    ®IVOMEC and Cattle Head Logo are registered trademarks of Boehringer Ingelheim Animal Health USA Inc.

    © 2022 Boehringer Ingelheim Animal Health USA Inc. All rights reserved.

    Distributed by:
    Boehringer Ingelheim Animal Health USA Inc.
    Duluth, GA 30096

    Made in Brazil

    Rev. 04/2022 4030364

    156264-004

  • PRINCIPAL DISPLAY PANEL - 1000 mL Display Carton

    1000 mL
    Picture of 1000 mL display carton

  • INGREDIENTS AND APPEARANCE
    IVOMEC PLUS 
    ivermectin and clorsulon injection
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC: 0010-4747
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D) ivermectin10 mg  in 1 mL
    clorsulon (UNII: EG1ZDO6LRD) (clorsulon - UNII:EG1ZDO6LRD) clorsulon100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    glycerol formal (UNII: 3L7GR2604E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0010-4747-011 in 1 CARTON
    150 mL in 1 BOTTLE
    2NDC: 0010-4747-021 in 1 CARTON
    2200 mL in 1 BOTTLE
    3NDC: 0010-4747-031 in 1 CARTON
    3500 mL in 1 BOTTLE
    4NDC: 0010-4747-041 in 1 CARTON
    41000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14083301/24/2022
    Labeler - Boehringer Ingelheim Animal Health USA Inc. (007134091)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alivira Animal Health Limited650916617API MANUFACTURE

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