Moxicloprid 100 (Canada)

Company: Modern Veterinary Therapeutics

Pr Moxicloprid™ 10

(imidacloprid and moxidectin topical solution)

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

DIN 02523647

Pr Moxicloprid™ 20

(imidacloprid and moxidectin topical solution)

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

DIN 02523655

Pr Moxicloprid™ 55

(imidacloprid and moxidectin topical solution)

Topical parasiticide for dogs weighing 9.1 to 25 kg.

DIN 02523663

Pr Moxicloprid™ 100

(imidacloprid and moxidectin topical solution)

Topical parasiticide for dogs weighing 25.1 to 45 kg.

DIN 02523671

VETERINARY USE ONLY

Description

Moxicloprid™ (imidacloprid and moxidectin topical solution) is a clear to slightly opalescent liquid, yellow to brownish ready-to-use solution packaged in single dose applicator tubes. 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.

Moxicloprid 100 Indications

Moxicloprid™ is indicated for the prevention of cardiovascular dirofilariasis (heartworm disease) caused by Dirofilaria immitis and angiostrongylosis (French heartworm) caused by L4 larvae and immature adults of Angiostrongylus vasorum, for the treatment and control 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).

Moxicloprid™ 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.

For the Prevention of:

For the Treatment and Control of:

As an Aid in the Treatment of:

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 Moxicloprid™ applicator tube that correctly corresponds with the body weight of the dog.

* Dogs over 45 kg should be treated with the appropriate combination of Moxicloprid™ tubes.

2. While holding the tube in an upright position, twist off the cap.

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. Until Moxicloprid™ dries, keep pet off furniture and away from hardwood floors.

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 Moxicloprid™ in the prevention of heartworm disease.

Contraindications

Do not administer orally. (See the Animal Safety Section for more information).

CAUTIONS:

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

Use with caution in dogs with MDR1 mutation. Dogs with this mutation are more sensitive to avermectins and may develop clinical signs of severe avermectin toxicity (depression, salivation, dilated pupils, incoordination, generalized muscle tremors, coma, death) if they ingest this product. The most common breeds with this mutation include collies and collie crosses (See the Animal Safety section).

The safe use of Moxicloprid™ in dogs used for breeding purposes, during pregnancy, or in lactating bitches has not been evaluated.

Warnings

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.

Adverse Reactions

Use of the product may result in transient pruritus in dogs. Rarely, greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases, cause local hypersensitivity reactions. If the animal licks the application site after treatment, transient, self-limiting neurological signs such as ataxía, generalized tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur infrequently.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimize licking of the application site. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence. In case of accidental oral uptake, symptomatic treatment should be performed by a Veterinarian. There is no known specific antidote. The use of activated charcoal may be beneficial. If you notice any serious effects or other effects not mentioned in the leaflet, please inform your veterinarian.

Post-market experience:

Although all adverse reactions are not reported, the following adverse reaction information is based on voluntary post-approval drug experience reporting from a similar product. It is generally recognized that this method of reporting results in significant under-reporting of adverse drug reactions. It should be noted that suspected adverse drug reactions listed here reflect reporting and not causality. The categories of adverse reactions are listed in decreasing order of frequency by body system:

Systemic disorders: lethargy, inappetence, lack of efficacy

Behavioural disorders: agitation, vocalization, disorientation, aggression, anxiety, inappropriate defecation/urination, excessive appetite

Digestive tract disorders: salivation, vomiting, diarrhea

Application site disorders: pruritus, erythema, alopecia, dermatitis, lesion at the application site

Neurological disorders: ataxia, tremor, twitching, mydriasis, paresis, nystagmus, hyperesthesia

Skin and appendages disorders: pruritus, erythema, alopecia, dermatitis, lesion, pyoderma

Respiratory tract disorders: panting, cough, tachypnea, dyspnea

Immune system disorders: urticaria, allergic edema

ANIMAL SAFETY:

Clinical Field Trials: An imidacloprid and moxidectin topical solution 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 an imidacloprid and moxidectin topical solution, the observations classified as abnormal included application site residue, inappetence, lethargy, medicinal odor/ breath and pruritus.

In clinical field studies, an imidacloprid and moxidectin topical solution was used safely in dogs receiving other frequently used veterinary products such as vaccines, antiparasitics, antibiotics, steroids, pesticides and shampoo.

Safety Studies in Puppies: An imidacloprid and moxidectin topical solution 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 imidacloprid and moxidectin topical solution 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, one 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 one animal and four 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: An imidacloprid and moxidectin topical solution 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: An imidacloprid and moxidectin topical solution 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 the imidacloprid and moxidectin topical solution. Each animal received one treatment every 14 days for a total of 3 treatments. In the control group, one dog had loose stools and one dog was observed with diarrhea during the observation period. In the group receiving the recommended dose, one dog had ocular discharge for 1 day. At 5 times the recommended dose, one dog was observed vomiting 3 hours after the second treatment. No additional hypersensitivity reactions have been observed in heartworm infected dogs when an imidacloprid and moxidectin topical solution was administered at 5 times the labeled dose.

Safety Study in Dogs with Natural Heartworm Infections: An imidacloprid and moxidectin topical solution 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 one treatment every 14 days for a total of 3 treatments. In the dogs receiving 5 times the recommended dose, one dog was observed to have a mild skin reaction on the day after each application and one dog vomited undigested food 1 day after the first treatment. No other signs were noted.

Oral Safety Study in Dogs: An imidacloprid and moxidectin topical solution was administered once orally at the recommended topical dose to address accidental ingestion. Twelve dogs received imidacloprid and moxidectin topical solution and 12 dogs received water as a control. Of the dogs receiving imidacloprid and moxidectin topical solution, six dogs vomited within 1 hour of receiving the test article and one 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: An imidacloprid and moxidectin topical solution 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: An imidacloprid and moxidectin topical solution 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 15°C and 30°C.

How Supplied

Manufactured for:

Modern Veterinary Therapeutics, LLC, Miami, FL 33186 - USA

info@modernveterinarytherapeutics.com

Imported by:

Modern Veterinary Therapeutics Inc, 261065 Wagon Wheel Way, Bay 3, Balzac (Rocky View County), AB T4A 0T5

Revision date: 6 December 2021

CPN: 1354026.0