Noromectin

Oral:

The most common side effects of ivermectin tablets include:

• dizziness
• loss of appetite
• nausea
• vomiting
• stomach pain or bloating
• diarrhea
• constipation
• weakness
• sleepiness
• uncontrollable shaking of a part of the body
• chest discomfort

Topical:

The most common side effects of ivermectin lotion include:

• eye redness or soreness
• eye irritation
• dandruff
• dry skin
• burning sensation of the skin

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ivermection. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Oral:

Before taking ivermectin,

• tell your doctor and pharmacist if you are allergic to ivermectin or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had meningitis, human African trypanosomiasis (African sleeping sickness; an infection that is spread by the bite of the tsetse fly in certain African countries), or conditions that affect your immune system, such as human immunodeficiency virus (HIV).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant during your treatment with ivermectin, call your doctor.
• ask your doctor about the safe use of alcoholic beverages while you are taking ivermectin.
• if you have had loiasis (Loa loa infection with a type of worm that causes skin and eye problems) or if you have ever lived in or traveled to areas of West or Central Africa where loiasis is common.

Topical:

Before using ivermectin lotion, tell your healthcare provider if you or your child:

• have any skin conditions or sensitivities
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• are taking any prescription and/or nonprescription medications, vitamins, nutritional supplements, and herbal products

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

ANADA 200-437, Approved by the FDA

A Parasiticide for the Treatment and Control of Internal and External Parasites of Cattle and Swine.

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

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.

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

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

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

When using the 250, 500 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.

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

When using the 100, 250, 500 or 1000 mL pack size, use only automatic syringe equipment. As with any injection, sterile equipment should be used. The injection site should be cleaned and disinfected with alcohol before injection. The rubber stopper should also be disinfected with alcohol to prevent contamination of the contents. Mild and transient pain reactions may be seen in some swine following subcutaneous administration.

Recommended Treatment Program

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

BREEDING ANIMALS

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

Gilts: Treat 7-14 days prior to breeding.

Treat 7-14 days prior to farrowing.

Boars: Frequency and need for treatments are dependent upon exposure.

Treat at least two times a year.

FEEDER PIGS

(Weaners/Growers/Finishers)

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

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

NOTE:

1. Noromectin Injection has a persistent drug level sufficient to control mite infestations throughout the egg to adult life cycle. However, since the ivermectin effect is not immediate, care must be taken to prevent reinfestation from exposure to untreated animals or contaminated facilities. Generally, pigs should not be moved to clean quarters or exposed to uninfested pigs for approximately one week after treatment. Sows should be treated at least one week before farrowing to minimize transfer of mites to newborn baby pigs.
2. Louse eggs are unaffected by Noromectin Injection and may require up to three weeks to hatch. Louse infestations developing from hatching eggs may require retreatment.
3. Consult a veterinarian for aid in the diagnosis and control of internal and external parasites of swine.

Special Minor Use

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

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

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

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 Norbrook, Inc. at 1-913-599-5777.

RESIDUE INFORMATION: Do not treat cattle within 35 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.
Do not treat swine within 18 days of slaughter.

Bottle Label – 1000 mL
ANADA 200-437 Approved by the FDA
Noromectin® (ivermectin)
Injection for Cattle and Swine
1% Sterile Solution
1000 mL
Norbrook®

Carton Label – 1000 mL

ANADA 200-437

Approved by the FDA

Noromectin®

(ivermectin)

Injection for Cattle and Swine

1% Sterile Solution

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

1000 mL

Norbrook®