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3239 SATELLITE BLVD., DULUTH, GA, 30096

Telephone:   888-637-4251
Website:   www.merial.com

Every effort has been made to ensure the = accuracy of the=20 information published. However, it remains the responsibility of = the=20 readers to familiarize themselves with the product information = contained=20 on the product label or package = insert.

IVOMEC=AE

Merial

NADA 128-409, Approved by the FDA

(ivermectin)

Injection for Cattle and Swine

1% = Sterile=20 Solution

A = Parasiticide for=20 the Treatment and Control of Internal and External Parasites in Cattle = and=20 Swine

Consult = your=20 veterinarian for assistance in the diagnosis, treatment and control of=20 parasitism.

INTRODUCTION

IVOMEC* = (ivermectin) is=20 an injectable parasiticide for cattle and swine. One low-volume dose = effectively=20 treats and controls the following internal and external parasites that = may=20 impair the health of cattle and swine: gastrointestinal roundworms = (including=20 inhibited Ostertagia ostertagi in cattle), lungworms, grubs, = sucking=20 lice, and mange mites of cattle; and gastrointestinal roundworms, = lungworms,=20 lice, and mange mites of swine. Discovered and developed by scientists = from=20 Merck Research Laboratories, ivermectin is a novel chemical entity. Its=20 convenience, broad-spectrum efficacy, and safety margin make IVOMEC = Injection a=20 unique product for parasite control of cattle and swine.

PRODUCT=20 DESCRIPTION

Ivermectin = is derived=20 from the avermectins, a family of potent, broad-spectrum antiparasitic = agents=20 isolated from fermentation of Streptomyces = avermitilis.

IVOMEC = Injection is a=20 clear, ready-to-use, sterile solution containing 1% ivermectin, 40% = glycerol=20 formal, and propylene glycol, q.s. ad 100%. IVOMEC Injection is = formulated to=20 deliver the recommended dose level of 200 mcg ivermectin/kilogram of = body weight=20 in cattle when given subcutaneously at the rate of 1 mL/110 lb (50 kg). = In=20 swine, IVOMEC Injection is formulated to deliver the recommended dose = level of=20 300 mcg ivermectin/kilogram body weight when given subcutaneously in the = neck at=20 the rate of 1 mL per 75 lb (33 kg).

MODE OF=20 ACTION

Ivermectin = is a member=20 of the macrocyclic lactone class of endectocides which have a unique = mode of=20 action. Compounds of the class bind selectively and with high affinity = to=20 glutamate-gated chloride ion channels which occur in invertebrate nerve = and=20 muscle cells. This leads to an increase in the permeability of the cell = membrane=20 to chloride ions with hyperpolarization of the nerve or muscle cell, = resulting=20 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=20 neurotransmitter gamma-aminobutyric acid (GABA).

The wide = margin of=20 safety is attributable to the fact that mammals do not have = glutamate-gated=20 chloride channels, the macrocyclic lactones have a low affinity for = other=20 mammalian ligand-gated chloride channels and they do not readily cross = the=20 blood-brain barrier.

INDICATIONS

Cattle: IVOMEC Injection is indicated for the = effective=20 treatment and control of the following harmful species of = gastrointestinal=20 roundworms, lungworms, grubs, sucking lice, and mange mites in=20 cattle:

Gastrointestinal=20 Roundworms (adults and = fourth-stage larvae):

Ostertagia=20 ostertagi (including = inhibited=20 O. ostertagi)

O.=20 lyrata

Haemonchus=20 placei

Trichostrongylus=20 axei

T.=20 colubriformis

Cooperia=20 oncophora

C.=20 punctata

C.=20 pectinata

Oesophagostomum=20 radiatum

Bunostomum=20 phlebotomum

Nematodirus=20 helvetianus (adults=20 only)

N. = spathiger=20 (adults = only)

Lungworms (adults and fourth-stage = larvae):

Dictyocaulus=20 viviparus

Cattle = Grubs=20 (parasitic = stages):

Hypoderma = bovis

H.=20 lineatum

Sucking=20 Lice:

Linognathus=20 vituli

Haematopinus=20 eurysternus

Solenopotes=20 capillatus

Mites=20 (scabies):

Psoroptes = ovis=20 (syn. P. = communis var.=20 bovis)

Sarcoptes = scabiei var.=20 bovis

Persistent=20 Activity

IVOMEC = Injection has=20 been proved to effectively control infections and to protect cattle from = reinfection with Dictyocaulus viviparus for 28 days after = treatment;=20 Ostertagia ostertagi for 21 days after treatment; = Oesophagostomum=20 radiatum, Haemonchus placei, Trichostrongylus axei, Cooperia = punctata, and=20 Cooperia oncophora for 14 days after treatment.

Swine: IVOMEC Injection is indicated for the = effective=20 treatment and control of the following harmful species of = gastrointestinal=20 roundworms, lungworms, lice, and mange mites in swine:

Gastrointestinal=20 Roundworms:

Large = roundworm,=20 Ascaris suum

(adults and = fourth-stage=20 larvae)

Red stomach = worm,=20 Hyostrongylus rubidus

(adults and = fourth-stage=20 larvae)

Nodular = worm,=20 Oesophagostomum spp.

(adults and = fourth-stage=20 larvae)

Threadworm,=20 Strongyloides ransomi (adults)

Somatic = Roundworm=20 Larvae:

Threadworm,=20 Strongyloides ransomi (somatic larvae)

Sows must be = treated at=20 least seven days before farrowing to prevent infection in = piglets.

Lungworms:

Metastrongylus spp. (adults)

Lice:

Haematopinus=20 suis

Mange=20 Mites:

Sarcoptes = scabiei var.=20 suis

DOSAGE

Cattle: IVOMEC Injection should be given only = by=20 subcutaneous injection under the loose skin in front of or behind the = shoulder=20 at the recommended dose level of 200 mcg ivermectin per kilogram of body = weight.=20 Each mL of IVOMEC contains 10 mg of ivermectin, sufficient to treat = 110 lb=20 (50 kg) of body weight (maximum 10 mL per injection = site).

Body = Weight
(lb)

Dose = Volume
(mL)

220

2

330

3

440

4

550

5

660

6

770

7

880

8

990

9

1100

10

Swine: IVOMEC Injection should be given only = by=20 subcutaneous injection in the neck of swine at the recommended dose = level of 300=20 mcg of ivermectin per kilogram (2.2 lb) of body weight. Each mL of = IVOMEC=20 contains 10 mg of ivermectin, sufficient to treat 75 lb of body=20 weight.

 

Body = Weight
(lb)

Dose = Volume
(mL)

Growing=20 Pigs

19

1/4

38

1/2

75

1

150

2

Breeding=20 Animals
(Sows, Gilts, and Boars)

225

3

300

4

375

5

450

6

ADMINISTRATION

Cattle: IVOMEC Injection is to be given = subcutaneously=20 only, to reduce risk of potentially fatal clostridial infection of the = injection=20 site. Animals should = be=20 appropriately restrained to achieve the proper route of administration. = Use of a=20 16-gauge 1/2" to 3/4" needle is suggested. Inject under the loose skin = in front=20 of or behind the shoulder (see illustration).

When using = the 200, 500=20 or 1000 mL pack size, use only automatic syringe equipment.

Use sterile = equipment=20 and sanitize the injection site by applying a suitable disinfectant. = Clean,=20 properly disinfected needles should be used to reduce the potential for=20 injection site infections.

No special = handling or=20 protective clothing is necessary.

Swine: IVOMEC=AE (ivermectin) = Injection is to=20 be given subcutaneously in the neck. Animals should be appropriately = restrained=20 to achieve the proper route of administration. Use of a 16- or 18-gauge = needle=20 is suggested for sows and boars, while an 18- or 20-gauge needle may be=20 appropriate for young animals. Inject under the skin, immediately behind = the ear=20 (see illustration).

When using = the 200 mL,=20 500 mL or 1000 mL pack size, use only automatic syringe equipment. As = with any=20 injection, sterile equipment should be used. The injection site should = be=20 cleaned and disinfected with alcohol before injection. The rubber = stopper should=20 also be disinfected with alcohol to prevent contamination of the = contents. Mild=20 and transient pain reactions may be seen in some swine following = subcutaneous=20 administration.

Recommended Treatment=20 Program

Swine: At the time of initiating any parasite = control=20 program, it is important to treat all breeding animals in the herd. = After the=20 initial treatment, use IVOMEC Injection regularly as follows:

BREEDING=20 ANIMALS

Sows:

Treat = prior to=20 farrowing, preferably 7-14 days before, to minimize infection of=20 piglets.

Gilts:

Treat = 7-14 days=20 prior to breeding.
Treat 7-14 days prior to = farrowing.

Boars:

Frequency and need=20 for treatments are dependent upon exposure.
Treat at least two = times a=20 year.

FEEDER=20 PIGS

(Weaners/Growers/Finishers)

All = weaner/feeder pigs=20 should be treated before placement in clean quarters.

Pigs exposed = to=20 contaminated soil or pasture may need retreatment if reinfection=20 occurs.

NOTE:

(1) IVOMEC = Injection has=20 a persistent drug level sufficient to control mite infestations = throughout the=20 egg to adult life cycle. However, since the ivermectin effect is not = immediate,=20 care must be taken to prevent reinfestation from exposure to untreated = animals=20 or contaminated facilities. Generally, pigs should not be moved to clean = quarters or exposed to uninfested pigs for approximately one week after=20 treatment. Sows should be treated at least one week before farrowing to = minimize=20 transfer of mites to newborn baby pigs.

(2) Louse = eggs are=20 unaffected by IVOMEC Injection and may require up to three weeks to = hatch. Louse=20 infestations developing from hatching eggs may require = retreatment.

(3) Consult = a=20 veterinarian for aid in the diagnosis and control of internal and = external=20 parasites of swine.

Special = Minor=20 Use

Reindeer: For the treatment and control of = warbles=20 (Oedemagena tarandi) in reindeer, inject 200 micrograms = ivermectin per=20 kilogram of body weight, subcutaneously. Follow use directions for = cattle as=20 described under ADMINISTRATION.

American=20 Bison: For the = treatment and=20 control of grubs (Hypoderma bovis) in American bison, inject 200=20 micrograms ivermectin per kilogram of body weight, subcutaneously. = Follow use=20 directions for cattle as described under = ADMINISTRATION.

RESIDUE=20 INFORMATION: Do = not treat=20 reindeer or American bison within 8 weeks (56 days) of=20 slaughter.

WARNING

Not for = use in=20 humans.

Keep this = and all=20 drugs out of the reach of children.

The Material = Safety Data=20 Sheet (MSDS) contains more detailed occupational safety information. To = report=20 adverse effects, obtain an MSDS or for assistance, contact Merial at=20 1-888-637-4251.

RESIDUE=20 INFORMATION: Do = not treat=20 cattle within 35 days of slaughter. Because a withdrawal time in = milk has=20 not been established, do not use in female dairy cattle of = breeding=20 age.
Do not treat swine within 18 days of = slaughter.

PRECAUTIONS

Transitory = discomfort=20 has been observed in some cattle following subcutaneous administration. = A low=20 incidence of soft tissue swelling at the injection site has been = observed. These=20 reactions have disappeared without treatment. For cattle, divide doses = greater=20 than 10 mL between two injection sites to reduce occasional discomfort = or site=20 reaction.

Use sterile = equipment=20 and sanitize the injection site by applying a suitable disinfectant. = Clean,=20 properly disinfected needles should be used to reduce the potential for=20 injection site infections.

Observe = cattle for=20 injection site reactions. Reactions may be due to clostridial infection = and=20 should be aggressively treated with appropriate antibiotics. If = injection site=20 infections are suspected, consult your veterinarian.

This product = is not for=20 intravenous or intramuscular use.

Protect = product from=20 light.

IVOMEC = Injection for=20 Cattle and Swine has been developed specifically for use in cattle, = swine,=20 reindeer and American bison only. This product should not be used = in=20 other animal species as severe adverse reactions, including fatalities = in dogs,=20 may result.

When to = Treat Cattle=20 with Grubs

IVOMEC = effectively=20 controls all stages of cattle grubs. However, proper timing of treatment = is=20 important. For most effective results, cattle should be treated as soon = as=20 possible after the end of the heel fly (warble fly) season. Destruction = of=20 Hypoderma larvae (cattle grubs) at the period when these grubs = are in=20 vital areas may cause undesirable host-parasite reactions including the=20 possibility of fatalities. Killing Hypoderma lineatum when it is = in the=20 tissue surrounding the esophagus (gullet) may cause salivation and = bloat;=20 killing H. bovis when it is in the vertebral canal may cause = staggering=20 or paralysis. These reactions are not specific to treatment with IVOMEC, = but can=20 occur with any successful treatment of grubs. Cattle should be treated = either=20 before or after these stages of grub development. Consult your = veterinarian=20 concerning the proper time for treatment.

Cattle = treated with=20 IVOMEC after the end of the heel fly season may be retreated with IVOMEC = during=20 the winter for internal parasites, mange mites, or sucking lice without = danger=20 of grub-related reactions. A planned parasite control program is=20 recommended.

Environmental=20 Safety

Studies = indicate that=20 when ivermectin comes in contact with the soil, it readily and tightly = binds to=20 the soil and becomes inactive over time. Free ivermectin may adversely = affect=20 fish and certain water-borne organisms on which they feed. Do not permit = water=20 runoff from feedlots or production sites to enter lakes, streams, or = ponds. Do=20 not contaminate water by direct application or by the improper disposal = of drug=20 containers. Dispose of containers in an approved landfill or by=20 incineration.

HOW=20 SUPPLIED

IVOMEC = Injection for=20 Cattle and Swine is available in five ready-to-use pack = sizes:

The 50 mL = pack is a=20 multiple dose, rubber-capped bottle. Each bottle contains sufficient = solution to=20 treat 10 head of 550 lb (250 kg) cattle or 100 head of 38 lb (17.3 kg)=20 swine.

The 200 mL = pack is a=20 soft, collapsible pack designed for use with automatic syringe = equipment. Each=20 pack contains sufficient solution to treat 40 head of 550 lb (250 kg) = cattle or=20 400 head of 38 lb (17.3 kg) swine.

The 500 mL = pack is a=20 soft, collapsible pack designed for use with automatic syringe = equipment. Each=20 pack contains sufficient solution to treat 100 head of 550 lb (250 kg) = cattle or=20 1000 head of 38 lb (17.3 kg) swine.

The 2x 500 = mL includes=20 two 500 mL packs with sufficient solution to treat 200 head of 550 lb = (250 kg)=20 cattle or 2000 head of 38 lb (17.3 kg) swine.

The 1000 mL = pack is a=20 soft, collapsible pack designed for use with automatic syringe = equipment. Each=20 pack contains sufficient solution to treat 200 head of 550 lb (250 kg) = cattle or=20 2000 head of 38 lb (17.3 kg) swine.

*IVOMEC, Cattle=20 Head Logo and Pig Head Logo are registered trademarks of = Merial.

(Merial = Limited:=20 Registered in England and Wales [Reg. No. 3332751] with registered = offices at 27=20 Knightsbridge, London, SW1X 7QT, England and domesticated in Delaware, = USA as=20 Merial LLC).

Merial=20 Limited

Iselin, NJ,=20 U.S.A.

U.S. Pat. = 4,199,569=20 & 4,853,372

November = 1999

8913412

Disclaimer: Every effort has been made to ensure the = accuracy of=20 the information published. However, it remains the responsibility of the = readers=20 to familiarize themselves with the product information contained on the = product=20 label or package insert. NAC No.: 11110312


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