advantage multi 100 (Canada)

This page contains information on advantage multi 100 for veterinary use.
The information provided typically includes the following:
  • advantage multi 100 Indications
  • Warnings and cautions for advantage multi 100
  • Direction and dosage information for advantage multi 100

advantage multi 100

This treatment applies to the following species:
Manufacturer: Bayer

Pr advantage multi 10 (imidacloprid + moxidectin)

Topical parasiticide for dogs and puppies 7 weeks of age and older, weighing up to 4.5 kg.

DIN 02263556

Pr advantage multi 20 (imidacloprid + moxidectin)

Topical parasiticide for dogs and puppies 7 weeks of age and older, weighing 4.6 to 9 kg.

DIN 02263548

Pr advantage multi 55 (imidacloprid + moxidectin)

Topical parasiticide for dogs weighing 9.1 to 25 kg.

DIN 02263521

Pr advantage multi 100 (imidacloprid + moxidectin)

Topical parasiticide for dogs weighing 25.1 to 45 kg.

DIN 02263564

VETERINARY USE ONLY

Description

advantage multi (imidacloprid + moxidectin) is a clear to slightly opalescent liquid, yellow to brownish ready-to-use solution packaged in unit dosing applicator tubes for once-a-month topical (dermal) treatment of dogs seven weeks of age and older. The formulation and dosage schedule is designed to provide a minimum of 8.8 mg/kg imidacloprid and 2.2 mg/kg moxidectin based on body weight.

Imidacloprid is a chloronicotinyl nitroguanidine insecticide. The chemical composition of imidacloprid is 1-{(6-Chloro-3-pyridinyl)methyl}-N-nitro-2-imidazolidinimine. Moxidectin is a semisynthetic macrocyclic lactone endectocide derived from the actinomycete Streptomycetes cyaneogriseus noncyanogenus.

advantage multi 100 Indications

advantage multi is indicated for the prevention of cardiovascular dirofilariosis (heartworm disease) caused by Dirofilaria immitis, for the treatment of the adult stage of fox lungworm (Crenosoma vulpis), the treatment and control of parasitic infestations caused by the adult stage of the common flea (Ctenocephalides felis), ear mites (Otodectes cynotis), sarcoptic mange mites (Sarcoptes scabiei var. canis), and as an aid in the treatment and control of generalized demodectic mange (Demodex canis).

advantage multi is also indicated for the treatment and control of parasitic infections caused by the developing L4, the sexually immature adult and the adult stages of hookworms (Ancylostoma caninum and Uncinaria stenocephala), the adult stage of ascarids (Toxocara canis and Toxascaris leonina), and as an aid in the treatment and control of whipworm infections caused by the adult form of Trichuris vulpis.

DOSAGE: Apply to the skin at the recommended minimum dose of 8.8 mg of imidacloprid and 2.2 mg of moxidectin per kg of body weight, once a month.

ADMINISTRATION:

1. Remove one unit dose tube from the package.

As specified in the following table, administer the entire contents of the advantage multi applicator tube that correctly corresponds with the body weight of the dog.

Dog weight (kg)

advantage multi

Volume (mL)

mg Imidacloprid

mg Moxidectin

Up to 4.5

advantage multi 10

0.4

40

10

4.6 to 9

advantage multi 20

1.0

100

25

9.1 to 25

advantage multi 55

2.5

250

62.5

25.1 to 45*

advantage multi 100

4.0

400

100

* Dogs over 45 kg should be treated with the appropriate combination of advantage multi tubes.

2. While holding the tube in an upright position, remove the cap from the tube.

3. Turn the cap over and place the other end of cap onto the tip of the tube.

4. Twist the cap to break the seal and then remove cap from the tube.

The dog should be standing for application. Part the hair on the dog’s back until the skin is visible. Place the tip of the tube on the skin and squeeze the entire contents directly on the exposed skin at one spot between the shoulder blades. Apply slowly to allow absorption. Do not apply an amount of solution at any one location that could run off the side of the dog. Do not get this product in your pet’s mouth or eyes. Stiff hair, a damp appearance of the hair, or a slight powdery residue may be observed at the treatment site on some animals.

Exposure to water, as may occur with swimming or rain fall, beginning 60 minutes after treatment, or shampooing or bathing 90 minutes after treatment, does not reduce the effectiveness of advantage multi in the prevention of heartworm disease.

Treatment and Control of Flea Infestations:

For the treatment and control of flea infestations, advantage multi should be administered at one-month intervals throughout the flea season. If the dog is already infested with fleas when the first dose of advantage multi is administered, adult fleas on the dog will be killed. However, reinfestation from the emergence of pre-existing pupae in the environment may continue to occur for six weeks or longer after treatment is initiated.

Dogs treated with advantage multi including those with pre-existing flea allergy dermatitis have shown clinical improvement as a direct result of elimination of fleas from the dog.

Heartworm Disease Prevention:

For prevention of heartworm disease, advantage multi must be administered at one-month intervals during the time of the year when mosquitoes are present. Administration of advantage multi should start one month after the first expected exposure to mosquitoes and should continue at monthly intervals until one month after the last exposure to mosquitoes. When replacing another monthly heartworm preventative product in a heartworm prevention program during heartworm season, the first treatment with advantage multi must be given within one month of the last dose of the previous monthly administered medication.

advantage multi may be safely administered to heartworm infected dogs. However, it is recommended, in accordance with good veterinary practices, that all dogs > 6 months of age should be tested for patent heartworm infections before beginning prophylactic medication for the first time. After the first season on medication, all treated dogs should be retested at the start of the next season to certify treatment compliance before prescribing further medication. Thereafter, the determination of the frequency of testing should be left at the discretion of the practitioner.

Treatment and Control of Intestinal Nematode Infections:

advantage multi will remove the adult, the sexually immature adult and the developing L4 stages of intestinal hookworms (Ancylostoma caninum and Uncinaria stenocephala), the adult stage of ascarids (Toxocara canis and Toxascaris leonina), and aid in the treatment and control of the adult stage of whipworms (Trichuris vulpis). Monthly treatment with advantage multi will control the development of these intestinal nematode infections.

Treatment of Fox Lungworm (Crenosoma vulpis):

For the treatment of the adult stage of the fox lungworm (Crenosoma vulpis), administer a single dose.

Treatment and control of mite infestations:

For the treatment and control of ear mite infestation (Otodectes cynotis), administer a single dose. Administer a second monthly dose if the dog remains mite positive at 4 weeks or in the case of re-infestation.

For the treatment and control of sarcoptic mange (Sarcoptes scabiei var. canis), administer monthly for two applications.

As an aid in the treatment and control of generalized demodectic mange (Demodex canis), administer monthly for four applications. As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Monthly use of advantage multi will treat any subsequent mite infestations.

Warning

Keep this product, and all drugs, out of the reach of children.

May be irritating to skin and eyes. If contact with eyes occurs, flush eyes copiously with water. If eye irritation persists, contact a physician. Wash hands after use. If contact with skin occurs, wash skin immediately with soap and water. If ingested, contact a physician immediately.

advantage multi 100 Caution

Use with caution in sick, debilitated, or underweight animals.

advantage multi, if ingested orally, in collie or collie-crosses, may cause clinical signs of ivermectin toxicity. Oral ingestion must be avoided in all dogs.

See the Animal Safety section. The safe use of advantage multi in dogs used for breeding purposes, during pregnancy, or in lactating bitches has not been evaluated.

ANIMAL SAFETY:

Clinical Field Trials: advantage multi was evaluated in a controlled, double-blind, multi-site clinical field trial. Owners of the 196 dogs participating in the study made a total of 1,764 observations at designated post-treatment intervals. Veterinarians classified the majority of these observations (1,674 / 94.9%) as normal.

In dogs treated with advantage multi, the observations classified as abnormal included application site residue, inappetence, lethargy, medicinal odor/breath and pruritus.

In clinical field studies, advantage multi was used safely in dogs receiving other frequently used veterinary products such as vaccines, antiparasitics, antibiotics, steroids, pesticides and shampoos.

Safety Studies in Puppies: advantage multi was applied topically at 1, 3, and 5 times the recommended dose to puppies between 6 and 7 weeks old once every 2 weeks for a period of 12 weeks. A control group of puppies was treated with topical applications of mineral oil at 5 times the recommended volume of advantage multi over the same time intervals.

Clinical signs seen in some animals from all groups (treatment and control) were occasional soft stools, loose stools, diarrhea, mucous in the stool, and/or blood in the stool. Additionally, ocular discharge was observed in a few animals in each of the study groups. All of the above are clinical signs commonly seen in puppies within this age range. A rough hair coat was observed in some puppies from all groups.

In the group receiving the recommended dose, 1 animal was observed with otitis externa and lesions on the muzzle for 6 days and 2 animals were observed with transient white residue on the hair coat at the site of product application.

In the group receiving 3 times the recommended dose, transient vomiting was seen in 2 animals and 5 animals had transient white residue on the hair coat at the product application site.

At 5 times the recommended dose, transient vomiting was seen in 1 animal and 4 animals had transient white residue on the hair coat at the product application site. One animal in the group experienced transient heavy breathing on study day 13. Raspy and difficult breathing continued for 4 hours on study day 14.

Dermal Dose Tolerance Study: advantage multi was administered once topically to 7-8 month old dogs at 10 times the recommended dosage. There were no adverse clinical signs exhibited during the study. In addition, clinical chemistry or hematology values were not adversely affected by administration of the test article.

Safety Study in Heartworm-Positive Dogs: advantage multi was administered topically at 1 and 5 times the recommended dosage to dogs with adult heartworm infections and circulating microfilariae. A control group of heartworm-positive dogs received topical applications of mineral oil at 5 times the recommended volume of advantage multi. Each animal received 1 treatment every 14 days for a total of 3 treatments. In the control group, 1 dog had loose stools and 1 dog was observed with diarrhea during the observation period. In the group receiving the recommended dose, 1 dog had ocular discharge for 1 day. At 5 times the recommended dose, 1 dog was observed vomiting 3 hours after the second treatment. No additional hypersensitivity reactions have been observed in heartworm infected dogs when advantage multi was administered at 5 times the labeled dose.

Safety Study in Dogs with Natural Heartworm Infections: advantage multi was administered topically at 5 times the recommended dose to naturally infected heartworm positive dogs. A group of control dogs received a topical application of mineral oil at 5 times the recommended volume. Each animal received 1 treatment every 14 days for a total of 3 treatments. In the dogs receiving 5 times the recommended dose, 1 dog was observed to have a mild skin reaction on the day after each application and 1 dog vomited undigested food 1 day after the first treatment. No other signs were noted.

Oral Safety Study in Dogs: advantage multi was administered once orally at the recommended topical dose to address accidental ingestion. Twelve dogs received advantage multi and 12 dogs received water as a control. Of the dogs receiving advantage multi, 6 dogs vomited within 1 hour of receiving the test article and 1 dog vomited up to 18 hours post-dosing. One dog exhibited abnormal neurological signs (circling, ataxia, generalized muscle tremors, and dilated pupils with a slow pupillary light response) for 4 hours post-dosing. This dog was normal at 24 hours post-dosing and throughout the remainder of the study.

Dermal Safety Study in Ivermectin-Sensitive Collies: advantage multi was administered dermally at 3 and 5 times the recommended dosage to Collies which had been pre-screened for ivermectin sensitivity. No clinical abnormalities were observed.

Oral Safety Study in Ivermectin-Sensitive Collies: advantage multi was administered orally to 5 pre-screened ivermectin-sensitive Collies at less than the recommended dose. Four of the dogs experienced signs indicative of ivermectin induced toxicity.

Storage

Store at temperatures between 4° and 30°C, avoiding excess heat or cold.

How Supplied

Code Number

Applicator Tube Size

Applications Per Package

04494605

0.4 mL

6 X 0.4 ml tubes

04494613

1.0 mL

6 X 1.0 ml tubes

04494621

2.5 mL

6 X 2.5 ml tubes

04494648

4.0 mL

6 X 4.0 ml tubes

Bayer and Bayer Cross are registered trademarks of Bayer AG, used under license by Bayer Inc.

Bayer Inc., Bayer Healthcare, Animal Health, 77 Belfield Road, Toronto, ON., M9W 1G6

Revised: February 13, 2014 Version: 5

NAC No.: 1223038.3

BAYER HEALTHCARE
Animal Health Division, Bayer Inc.

77 BELFIELD ROAD, TORONTO, ON, M9W 1G6
Telephone:   416-248-0771 or 800-268-1331
Toll-Free:   800-62-BAYER
Order Desk:   800-387-9179
Order Desk Fax:   800-361-3306
Fax:   416-240-4918
Website:   www.animalhealth.bayer.ca
Every effort has been made to ensure the accuracy of the advantage multi 100 information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-07-28

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