advantage multi 18 (Canada)

This page contains information on advantage multi 18 for veterinary use.
The information provided typically includes the following:
  • advantage multi 18 Indications
  • Warnings and cautions for advantage multi 18
  • Direction and dosage information for advantage multi 18

advantage multi 18

This treatment applies to the following species:
Manufacturer: Bayer

(80 mg imidacloprid + 8 mg moxidectin)

Topical parasiticide for cats 8 weeks of age and older, weighing 4.1 to 8.2 kg.

DIN 02263513

VETERINARY USE ONLY

Description

advantage multi® (imidacloprid + moxidectin) is a colorless to yellow ready-to-use solution packaged in unit dosing applicator tubes for once-a-month topical (dermal) treatment of cats eight weeks of age and older. The formulation and dosage schedule is designed to provide a minimum of 9.7 mg/kg imidacloprid and 0.9 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 18 Indications

advantage multi® is indicated in cats and kittens, 8 weeks of age and older, for the prevention of cardiovascular dirofilariosis (heartworm disease) caused by Dirofilaria immitis and for the treatment and control of parasitic infestations caused by the adult stage of the common flea, (Ctenocephalides felis) and due to ear mites (Otodectes cynotis). 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 tubaeforme) and ascarids (Toxocara cati).

DOSAGE:

Apply to the skin at the recommended minimum dose of 9.7 mg of imidacloprid and 0.9 mg of moxidectin per kg of body weight, once a month.

ADMINISTRATION:

1. Remove one unit dose tube from the package.

2. Administer the entire contents of a unit dose applicator tube of advantage multi® topically as specified in the following table:

Cat weight [kg]

Volume [mL]

Imidacloprid [mg]

Moxidectin [mg]

4.1 to 8.2 kg

0.8

80

8

Cats over 8.2 kg should be treated with the appropriate combination of advantage multi® tubes.

3. While holding the tube in an upright position, pull the cap off the tube.

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

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

The cat should be standing for application. Part the hair on the neck at the base of the skull until the skin is visible. Place the tip of the tube on the skin and squeeze the tube twice to expel the entire contents directly on the skin. Do not get this product in your pet’s eyes or mouth. The product is bitter tasting and salivation may occur for a short time if the cat licks the product immediately after treatment. Treatment at the base of the skull will minimize the opportunity for the cat to lick the product. A wet “paint brush,” oily appearance of the hair, or a slight powdery residue may be observed at the site of application for a short period of time in some animals following treatment.

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 cat is already infested with fleas when the first dose of advantage multi® is administered, adult fleas on the cat will be killed. However, re-infestation from the emergence of pre-existing pupae in the environment may continue to occur for six weeks or longer after treatment is initiated.

Cats 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 cat.

Treatment And Control Of Ear Mite Infestations:

For the treatment and control of ear mite infestations, administer a single dose of advantage multi®. Administer a second monthly dose if the cat remains mite positive at 4 weeks or in the case of re-infestation.

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

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 before the first expected exposure to mosquitoes and should continue at monthly intervals until one month after the last exposure to mosquitoes. When replacing another heartworm preventative product in a heartworm prevention program, the first treatment with advantage multi® must be given within one month of the last dose of the former medication.

advantage multi® may be safely administered to heartworm infected cats. However, cats six months of age or older in heartworm endemic areas may be tested to determine the presence of existing heartworm infections before beginning medication with advantage multi®.

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 tubaeforme) and ascarids (Toxocara cati). Monthly treatment with advantage multi will control the development of these intestinal nematode infections.

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 18 Caution

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

Oral ingestion must be avoided in all cats.

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

SAFETY IN CATS AND KITTENS:

In a clinical field safety study, advantage multi® was used safely in cats concomitantly receiving other classes of veterinary pharmaceuticals including anticonvulsants, antimicrobials, and progestins. In cats treated with advantage multi®, owner observations classified as non-normal included: behavioral changes (including fright, irritability, isolation, nervousness and/or restlessness), coughing, head shaking, salivation, vocalization, scratching, and somnolence. No other reactions were reported.

Tolerance in Kittens:

In a formal tolerance study, advantage multi® was applied topically at 1, 3 and 5 times the recommended dosage in 8-9 week-old kittens, once every two weeks for 12 weeks, for a total of 6 consecutive treatments. A control group of kittens received dermal application of mineral oil at five times the recommended volume of advantage multi®.

The most common clinical signs occurring in kittens during the pre-treatment period (Day-14 to Day-1) included soft/loose stools and/or diarrhea, vomition, and occasional mydriasis and eye discharge. The most common clinical signs occurring in kittens on the first three treatment days (Days 0, 14 and 28) included rough hair coat appearance at application site (all kittens, including controls), soft/loose stools and/or diarrhea, and occasional pruritus, mydriasis, depression, eye discharge and salivation; similar observations were made during each following 13-day post-treatment period. The most common clinical signs occurring in kittens on the last three treatment days (Days 42, 56 and 70) included rough hair coat appearance at application site (all kittens, including controls), and occasional soft/loose stools; similar observations were made during each 13-day post-treatment period. Clinical signs were distributed in the various treatment groups, including controls, without any pattern indicative of treatment relationship.

Due to the apparent ingestion of the drug shortly after the second dosing on day 14, one kitten treated at 5 times the recommended dosage reacted violently. Major clinical signs of moxidectin toxicosis including mydriasis, salivation, depression, unsteadiness and respiratory distress (slow or rapid, difficult breathing) were observed on several occasions, i.e. at 1, 2, 3, 4, 6, 8 and 12 hours after treatment administration. In addition, anorexia, vomition and generalized tremors were observed on Day 15. Finally, additional signs of dehydration and nystagmus were observed on Day 16, at which time the animal was euthanised.

Collectively, the results of this study indicate that the topical administration of the new drug to 8-9 week-old kittens, at 1 x, 3 x or 5 x the recommended dosage, applied at 2-week intervals over a 12-week period does not pose serious safety concerns to kittens; however, oral administration must be avoided.

Tolerance in Juvenile Cats:

The topical administration of advantage multi® at 10 x the proposed dosage to 4-5 months old juvenile cats did not result in any significant local or systemic toxic changes in the parameters examined, i.e. clinical observations, dermal irritation at application site, physical examination, body weight, food consumption, haematology and clinical biochemistry.

Effect of Inadvertent Oral Administration:

In a safety study designed to investigate the potential misuse of advantage multi® by oral administration, 24 adult cats, 11 to 16 months of age, were randomly allocated to two groups of 12 cats, each consisting of equal numbers of each sex. The test article at 1 x (Group A) the unit dosage or control article (Group B, water), were administered by oesophageal feeding tube on study Days 0 (study duration = 14 days). No reactions of any kind were observed in the control cats. Three of 12 cats administered the drug had excess salivation within 1 hour after treatment; four vomited within 1-24 hours after treatment; one cat vomited twice, 5 and 7 days after treatment.

Safety in Heartworm Infected Cats:

A controlled, laboratory study was conducted to evaluate the safety of advantage multi® administered topically at 1 x or 5 x the recommended dosage, to cats artificially infected with Dirofilaria immitis. Abnormal clinical signs noted during the post-treatment observation period included: salivation within 2 hours of treatment administration in 1 of 12 cats in the 1 x group and in 7 of 12 cats in the 5 x group; skin irritation in 2 of 12 cats in the 5 x group (from 0 to 12 hours after the second dose in one cat and for 25 days after the second dose in another). The data generated in this trial indicate that the administration of the new drug as per label recommendations should not pose serious safety concerns in heartworm-positive cats.

Clinical Safety under Field Conditions of Administration:

A controlled, double-blind, multi-centered, field study was conducted in four veterinary clinics/hospitals, in client-owned cats randomly assigned to two treatment groups: animals in Group 1 (principals) were treated with advantage multi®, and animals in Group 2 (positive controls) were treated with a topical parasiticide approved for sale in Canada.

Treatments were administered once monthly, for three consecutive months, by pet owners according to instructions provided by the attending veterinarian.

Scoring of post-treatment clinical observations was defined as:

(1) Animal normal, no observation;

(2) Definitely no relationship between observation and treatment;

(3) Probably no relationship between observation and treatment;

(4) Probable relationship between observation and treatment;

(5) Definite relationship between observation and treatment.

Animals were found normal (score of 1) in 96.9% of the cases. No observations with scores of 4 and 5 were noted. Forty-two post-treatment observations with scores of 2 or 3 can be summarized as follows:

- Post-treatment behavioral changes including fright, irritability, isolation, nervousness and/or restlessness, were the most frequently reported observations: 15 incidences in 7 principals; the modified behavior was transient in duration.

- Cats may react rather vigorously following oral administration of advantage multi®. In this study, owners described 13 post-treatment responses in 9 cats (11 incidences in 8 principals and 2 incidences in 1 control cat) that were consistent with oral exposure to an unpalatable substance; the observed signs included coughing, head shaking, bursts of hyperactivity (pacing, running, spinning), salivation and vocalization. All signs were transient in duration and resolved without intervention.

- In 9 observations involving 5 principals, owners described post-treatment attempts by cats to scratch or rub the application site. Most attempts (7 of 9) occurred within 30-60 minutes post-treatment and all were transient in duration. Neither owners nor attending veterinarians observed visible lesions at the application site of any cat participating in the study.

- Five incidences of post-treatment somnolence were described in 3 geriatric principals (13 to 15 years of age at the time of treatment). These cats experienced an extended period of sleep that began approximately 60-90 minutes after the first treatment and persisted for the next 30-40 hours, after which they returned to normal. Clinical signs of somnolence/lethargy did not recur in conjunction with the 2nd and 3rd treatments.

Storage

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

How Supplied

Code Number

Applicator Tube Size

Applications Per Package

04494591

0.8 mL

6 x 0.8 mL tubes

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

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

01552312

NAC No.: 1223037.3

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 18 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: 2014-09-05

(web1)