VETRIMEC PLUS FOR CATTLE- ivermectin and clorsulon injection, solution
Vetrimec Plus for Cattle by
Drug Labeling and Warnings
Vetrimec Plus for Cattle by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Norbrook Laboratories Limited, Armagh Road, Carnbane Industrial Estate. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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SPL UNCLASSIFIED SECTION
Injection for Cattle
1% w/v ivermectin and 10% w/v clorsulon in a sterile solution
ANADA 200-436 Approved by the FDA
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.
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INTRODUCTION
The ability of ivermectin to deliver internal and external parasite control has been proven in cattle markets around the world. Now, Vetrimec™ Plus combines ivermectin with clorsulon, an effective adult flukicide.
A single injection of Vetrimec™ 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 Vetrimec™Plus is effective only against adult liver flukes (Fasciola hepatica).
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PRODUCT DESCRIPTION
Vetrimec™ 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.
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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.
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INDICATIONS
Vetrimec™ 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 radiatumLungworms (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 capillatusMange Mites (cattle scab*):
Psoroptes ovis (syn. P. communis var. bovis)
Sarcoptes scabiei var. bovisPersistent 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.
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ADMINISTRATION
Vetrimec™ 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,½" to ¾" sterile needle is recommended. Inject the solution subcutaneously (under the skin) behind the shoulder (see illustration).
Any single-dose syringe or standard automatic syringe equipment may be used with the 50 mL or 100 mL pack size. When using the 250 mL, 500 mL or 1000 mL pack size, use only automatic syringe equipment.
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 Vetrimec™ 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
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WARNING
NOT FOR USE IN HUMANS.
Keep this and all drugs out of the reach of children.
The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance, contact MWI at 1-888-694-8381.
RESIDUE INFORMATION: Do not treat cattle within 49 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.
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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.
Vetrimec™ 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.
When to Treat Cattle with Grubs
Vetrimec™ 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 Vetrimec™ Plus, but can occur with any successful treatment of grubs. Cattle should be treated either before or after these stages of grub development. Consult your veterinarian concerning the proper time for treatment.
Cattle treated with Vetrimec™ 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.
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ENVIRONMENTAL SAFETY
Studies indicate that when ivermectin comes in contact with soil it readily and tightly binds to the soil and becomes inactive over time. 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.
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HOW SUPPLIED
Vetrimec™ Plus Injection is available in five 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 100 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 20 head of 550 lb (250 kg) cattle.
The 250 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 50 head of 550 lb (250 kg) cattle.
The 500 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle.
The 1000 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 200 head of 550 lb (250 kg) cattle.
Restricted Drug - California. Use Only as Directed.
Made in the UK.
Manufactured by:
Norbrook Laboratories Limited,Newry, Co. Down, Northern Ireland.
Distributed by: MWI
Meridian, ID 83680
(888) 694-8381
www.vetone.netVETone™
002684I03
- Principal Display Panel – 1000 mL – Bottle Label
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Principal Display Panel – 1000 mL – Carton Label
NDC: 13985-038-06 1000 mL
VETone™
Vetrimec™ PLUS
(Ivermectin-Clorsulon)
(Injection for Cattle)
1% w/v ivermectin and 10% w/v clorsulon in a sterile solution
Treat 200 – 550 lb Cattle
For the treatment and control of internal parasites, including adult liver flukes, and external parasites.
ANADA 200-436
Approved by the FDA
V1 504036 Net Contents: 1000 mL
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INGREDIENTS AND APPEARANCE
VETRIMEC PLUS FOR CATTLE
ivermectin and clorsulon injection, solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC: 13985-038 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D) ivermectin 10 mg in 1 mL clorsulon (UNII: EG1ZDO6LRD) (clorsulon - UNII:EG1ZDO6LRD) clorsulon 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength propylene glycol (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 13985-038-01 1 in 1 CARTON 1 50 mL in 1 VIAL, PLASTIC 2 NDC: 13985-038-02 1 in 1 CARTON 2 100 mL in 1 VIAL, PLASTIC 3 NDC: 13985-038-04 1 in 1 CARTON 3 250 mL in 1 VIAL, PLASTIC 4 NDC: 13985-038-05 1 in 1 CARTON 4 500 mL in 1 VIAL, PLASTIC 5 NDC: 13985-038-06 1 in 1 CARTON 5 1000 mL in 1 VIAL, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200436 04/20/2007 Labeler - MWI/VetOne (019926120) Registrant - Norbrook Laboratories Limited (214580029) Establishment Name Address ID/FEI Business Operations Armagh Road 232880554 MANUFACTURE, ANALYSIS Establishment Name Address ID/FEI Business Operations Carnbane Industrial Estate 211218325 MANUFACTURE
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