Advantage Multi For Dogs: Product Information (Page 4 of 5)

ANIMAL SAFETY:

Heartworm-Negative Dogs

Field Study: In a controlled, double-masked, field safety study, Advantage Multi for Dogs was administered to 128 dogs of various breeds, 3 months to 15 years of age, weighing 4 to 157 pounds. Advantage Multi for Dogs was used safely in dogs concomitantly receiving ACE inhibitors, anticonvulsants, antihistamines, antimicrobials, chondroprotectants, corticosteroids, immunotherapeutics, MAO inhibitors, NSAIDs, ophthalmic medications, sympathomimetics, synthetic estrogens, thyroid hormones, and urinary acidifiers. Owners reported the following signs in their dogs after application of Advantage Multi for Dogs: pruritus, flaky/greasy residue at the treatment site, medicinal odor, lethargy, inappetence, and hyperactivity.
(See ADVERSE REACTIONS.)

Safety Study in Puppies: Advantage Multi for Dogs was applied topically at 1, 3 and 5X the recommended dose to 7-week-old Beagle puppies once every 2 weeks for 6 treatments on days 0, 14, 28, 42, 56, and 70. Loose stools and diarrhea were observed in all groups, including the controls, throughout the study. Vomiting was seen in one puppy from the 1X treatment group (day 57), in two puppies from the 3X treatment group (days 1 and 79), and in one puppy from the 5X treatment group (day 1). Two puppies each in the 1X, 3X, and 5X groups had decreased appetites within 24 hours post-dosing. One puppy in the 1X treatment group had pruritus for one hour following the fifth treatment. A puppy from the 5X treatment group displayed rapid, difficult breathing from 4 to 8 hours following the second treatment.

Dermal Dose Tolerance Study: Advantage Multi for Dogs was administered topically to 8-month-old Beagle dogs at 10X the recommended dose once. One dog showed signs of treatment site irritation after application. Two dogs vomited, one at 6 hours and one at 6 days post-treatment. Increased RBC, hemoglobin, activated partial thromboplastin, and direct bilirubin were observed in the treated group. Dogs in the treated group did not gain as much weight as the control group.

Oral Safety Study in Beagles: Advantage Multi for Dogs was administered once orally at the recommended topical dose to 12 dogs. Six dogs vomited within 1 hour of receiving the test article, 2 of these dogs vomited again at 2 hours, and 1 dog vomited again up to 18 hours post-dosing. One dog exhibited shaking (nervousness) 1 hour post-dosing. Another dog exhibited abnormal neurological signs (circling, ataxia, generalized muscle tremors, and dilated pupils with a slow pupillary light response) starting at 4 hours post-dosing through 18 hours postdosing. Without treatment, this dog was neurologically normal at 24 hours and had a normal appetite by 48 hours post-dosing.
(See CONTRAINDICATIONS.)

Dermal Safety Study in Ivermectin-Sensitive Collies:
Advantage Multi for Dogs was administered topically at 3 and 5X the recommended dose every 28 days for 3 treatments to Collies which had been prescreened for avermectin sensitivity. No clinical abnormalities were observed.

Oral Safety Study in Ivermectin-Sensitive Collies:
Advantage Multi for Dogs was administered orally to 5 pre-screened ivermectin-sensitive Collies. The Collies were asymptomatic after ingesting 10 % of the minimum labeled dose. At 40 % of the minimum recommended topical dose, 4 of the dogs experienced neurological signs indicative of avermectin toxicity including depression, ataxia, mydriasis, salivation, muscle fasciculation, and coma, and were euthanized.
(See CONTRAINDICATIONS.)

Heartworm-Positive Dogs

Laboratory Safety Study in Heartworm-Positive Dogs: Advantage Multi for Dogs was administered topically at 1 and 5X the recommended dose every 14 days for 3 treatments to dogs with adult heartworm infections and circulating microfilaria. At 5X, one dog was observed vomiting three hours after the second treatment. Hypersensitivity reactions were not seen in the 5X treatment group. Microfilaria counts decreased with treatment.

STORAGE INFORMATION:

Store at temperatures between 4 °C (39 °F) and 25 °C (77 °F), avoiding excess heat or cold.

HOW SUPPLIED:

Applications Per Package:
6 x 0.4 mL tubes
6 x 1.0 mL tubes
6 x 2.5 mL tubes
6 x 4.0 mL tubes
6 x 5.0 mL tubes

Advantage Multi is protected by one or more of the following U.S. patents:
6,232,328, and 6,001,858.
84780812 v-06/2015

NADA # 141-251, Approved by FDA

Made in Germany

© 2015 Bayer HealthCare LLC

Bayer, the Bayer Cross and Advantage Multi are registered trademarks of Bayer
Bayer logo

Bayer HealthCare LLC
Animal Health Division
P.O. Box 390
Shawnee Mission Kansas 66201 U.S.A.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — 3-9 lbs dogs:

advantage multi for dogs (imidacloprid + moxidectin) Topical Solution label -- 3-9 lbs dogs
(click image for full-size original)

advantage multi®

for dogs

(imidacloprid + moxidectin)

Topical Solution

CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian

Once-A-Month Topical Solution

Prevention of heartworm disease
Treatment of Dirofilaria immitis circulating microfilariae
Kills adult fleas and is indicated for the treatment of flea infestations
Treatment and control of hookworms, roundworms, and whipworms
Treatment and control of sarcoptic mange
For dogs and puppies 7 weeks of age and older and 3 to 9 lbs.

WARNING

DO NOT ADMINISTER THIS PRODUCT ORALLY
For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.
Children should not come in contact with application sites for two (2) hours after application.

(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information)

Each tube contains 40 mg of imidacloprid and 10 mg of moxidectin.
Keep this and all drugs out of the reach of children.Do not use this product on cats.

NADA # 141-251, Approved by FDA

SIX 0.4 mL Tubes

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 9.1-20 lbs dogs:

advantage multi for dogs (imidacloprid + moxidectin) Topical Solution label -- 9.1-20 lbs dogs
(click image for full-size original)

advantage multi®

for dogs

(imidacloprid + moxidectin)

Topical Solution

CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian

Once-A-Month Topical Solution

Prevention of heartworm disease
Treatment of Dirofilaria immitis circulating microfilariae
Kills adult fleas and is indicated for the treatment of flea infestations
Treatment and control of hookworms, roundworms, and whipworms
Treatment and control of sarcoptic mange
For dogs and puppies 7 weeks of age and older and 9.1 to 20 lbs.

WARNING

DO NOT ADMINISTER THIS PRODUCT ORALLY
For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.
Children should not come in contact with application sites for two (2) hours after application.

(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information)

Each tube contains 100 mg of imidacloprid and 25 mg of moxidectin.
Keep this and all drugs out of the reach of children.Do not use this product on cats.

NADA # 141-251, Approved by FDA

SIX 1.0 mL Tubes

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