Parasedge Multi for Dogs

How to Order Prescriptions

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Description

PARASEDGE™ Multi for Dogs is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs. PARASEDGE™ Multi for Dogs kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis). PARASEDGE™ Multi for Dogs is indicated for the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis. PARASEDGE™ Multi for Dogs is also indicated for the treatment and control of the following intestinal parasites:

Intestinal Parasite		Intestinal Stage
		Adult	Immature Adult	Fourth Stage Larvae
Hookworm Species	Ancylostoma caninum	x	x	x
	Uncinaria stenocephala	x	x	x
Roundworm Species	Toxocara canis	x		x
	Toxascaris leonina	x
Whipworm	Trichuris vulpis	x

Contraindications

Do not administer this product orally. (See WARNINGS.) Do not use this product (containing 2.5 % moxidectin) on cats.

Warnings

For the first 30 minutes after application: Ensure that dogs cannot lick the product from application sites on themselves or other treated dogs. Separate treated dogs from one another and from other pets to reduce the risk of accidental ingestion. Ingestion of this product by dogs may cause serious adverse reactions including depression, salivation, dilated pupils, incoordination, panting, and generalized muscle tremors. In avermectin sensitive dogs,a the signs may be more severe and may include coma and death.b a Some dogs are more sensitive to avermectins due to a mutation in the MDR1 gene. Dogs with this mutation may develop signs of severe avermectin toxicity if they ingest this product. The most common breeds associated with this mutation include Collies and Collie crosses. b Although there is no specific antagonist for avermectin toxicity, even severely affected dogs have completely recovered from avermectin toxicity with intensive veterinary supportive care.

Human Warnings

Not for human use. Keep out of the reach of children. Children should not come in contact with application sites for two (2) hours after application. Causes eye irritation. Harmful if swallowed. Do not get in eyes or on clothing. Avoid contact with skin. Exposure to the product has been reported to cause headache; dizziness; and redness, burning, tingling, or numbness of the skin. Wash hands thoroughly with soap and warm water after handling. If contact with eyes occurs, hold eyelids open and flush with copious amounts of water for 15 minutes. If eye irritation develops or persists, contact a physician. If swallowed, call poison control center or physician immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by the poison control center or physician. People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In case of allergic reaction, contact a physician. If contact with skin or clothing occurs, take off contaminated clothing. Wash skin immediately with plenty of soap and water. Call a poison control center or physician for treatment advice. The safety data sheet (SDS) provides additional occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS or online at www.fda.gov/reportanimalae.

Precautions

Do not dispense dose applicator tubes without complete safety and administration information. Use with caution in sick, debilitated, or underweight animals. The safety of PARASEDGE™ Multi for Dogs has not been established in breeding, pregnant, or lactating dogs. The safe use of PARASEDGE™ Multi for Dogs has not been established in puppies and dogs less than 7 weeks of age or less than 3 lbs. body weight. Prior to administration of PARASEDGE™ Multi for Dogs, dogs should be tested for existing heartworm infection. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of PARASEDGE™ Multi for Dogs has not been evaluated when administered on the same day as an adulticide. PARASEDGE™ Multi for Dogs is not effective against adult D. immitis. Although the number of circulating microfilariae is substantially reduced in most dogs following treatment with PARASEDGE™ Multi for Dogs, the microfilaria count in some heartworm positive dogs may increase or remain unchanged following treatment with PARASEDGE™ Multi for Dogs alone or in a dosing regimen with melarsomine dihydrochloride. (See ADVERSE REACTIONS and ANIMAL SAFETY - Safety Study in Heartworm Positive Dogs.) PARASEDGE™ Multi for Dogs has not been evaluated in heartworm-positive dogs with Class 4 heartworm disease.

Dosage and Administration

The recommended minimum dose is 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month by topical solution.
Do not apply to irritated skin.

1. Use scissors to open the foil pack, taking care not to damage the tube inside. Remove one dose applicator tube from the package and hold the tube in an upright position. As specified in the following table, administer the entire contents of the Parasedge Multi for Dogs tube that correctly corresponds with the body weight of the dog.

Dogs (lbs.)	Parasedge Multi for Dogs	Volume (mL)	imidacloprid (mg)	Moxidectin (mg)
3 - 9	Parasedge Multi 9	0.4	40	10
9.1 - 20	Parasedge Multi 20	1.0	100	25
20.1 - 55	Parasedge Multi 55	2.5	250	62.5
55.1 - 88	Parasedge Multi 88	4.0	400	100
88.1 - 110*	Parasedge Multi 110	5.0	500	125

*Doga over 110 lbs. should be treated with the appropriate combination of Parasedge Multi for Dogs tubes. 

2. Bend the tip back until it snaps off. If it doesn't snap off at first, cut it using scissors.
3. The dog should be standing for application. Part of the hair on the back of the dog between the shoulder blades until the skin is visible. For dogs weighing 20 lbs. or less, place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at 3 or 4 spots on the top of the backline from the base of the neck to the upper back in an area inaccessible to licking. Do not apply an amount of solution at any one location that could run off the side of the dog. 
4. Keep tube compressed on the final squeeze to avoid drawing liquid back into tube. While keeping tube squeezed, drag it away from liquid and lift up to remove.
5. Ensure tube is empty.

Do not let this product get in your dog's mouth or eyes. Do not allow the dog to lick any of the application sites for 30 minutes. In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes after application to prevent licking the application sites.

Stiff fair, a damp appearance of the hair, pink skin, or a slight powdery residue may be observed at the application site on some animals. This is temporary and does not affect the safety and effectiveness of the product.

Shampooing 90 minutes after the treatment does not reduce the effectiveness of Parasedge Multi for Dogs in the prevention of heartworm disease. Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of Parasedge Multi for Dogs in the treatment of flea infestations. However, shampooing as often as once weekly may reduce the effectiveness of the product against fleas.

Storage

Store below 25ºC (77ºF).