About Vethical ComboGuard^® (spinosad + milbemycin oxime) for Dogs

Convenience. Proven effectiveness. All in one chewable tablet.

Benefits of Vethical ComboGuard^®:

• Prevents heartworm disease
• Kills fleas and prevents infestations. Treats and controls intestinal parasite infections (hookworm, roundworm, whipworm)
• One easy-to-administer chewable tablet

With Vethical ComboGuard^®, you can play with your dog immediately after treatment. There is no need to isolate your pet. Just treat and play!

Vethical ComboGuard^® may be an ideal choice for:

• Families with children or other pets
• Dogs that swim or are bathed frequently
• Dogs with certain skin conditions

ComboGuard is a prescription product for dogs, that is not for use in humans. Like all medications, keep ComboGuard out of reach of children.

Green Chemistry

The introduction of spinosad for use in agriculture resulted in the receipt of a Presidential Green Chemistry Challenge Award³ in 1999 from the U.S. Environmental Protection Agency. The award was presented to Dow Agro Sciences LLC in the category of Designing Safer Chemicals for the introduction of spinosad as an insect control product for use on crops. This award demonstrates that spinosad, as a technology for insect control, has a favorable environmental profile. This award is not relevant to the safety and efficacy of Vethical ComboGuard, nor does it confer any environmental benefit to Vethical ComboGuard^®.

³ The Presidential Green Chemistry Challenge Awards Program, Summary of 1999 Award Entries and Recipients

Controlling Internal and External Parasites in U.S. Dogs¹

Parasite Testing and Protection

• Conduct preventive physical examinations at least every 6 to 12 months.
• Conduct annual heartworm testing in dogs.
• Conduct fecal examinations by centrifugation at least four times during the first year of life, and at least two times per year in adults, depending on patient health and lifestyle factors.
• Prescribe control programs to local parasite prevalence and individual pet lifestyle factors.
• Adapt prevention recommendations to address emerging parasite threats.
• Confirm pets have been both recently tested for parasite infection and are current on broad-spectrum internal and external parasite control prior to boarding or visiting shared space animal facilities.
• Administer year-round broad-spectrum parasite control with efficacy against heartworm, intestinal parasites, fleas, and ticks. Control of parasites with zoonotic potential is essential.
• Maintain pregnant and nursing dams on broad-spectrum control products.
• Encourage annual testing for heartworm and other vector-borne infections in dogs and routine, year-round use of heartworm preventive, monthly intestinal parasite control, and flea and tick control in all pets.

ComboGuard^® is approved for dogs and puppies 8 weeks of age and older and 5 lbs. or greater.

¹ Companion Animal Parasite Council at https://www.capcvet.org/guidelines/general-guidelines/ accessed April 17 2018

Your veterinarian will know

Your veterinarian is your best source of advice about your dog's healthcare.

Your dog should be tested for heartworm infection before starting Vethical ComboGuard^®.

To minimize the likelihood of fleas continuing to jump onto your dog, it is important to treat all household pets with an approved flea protection product.

If a dose is missed and a monthly interval between doses is exceeded, then immediately give Vethical ComboGuard^® with food and resume monthly dosing. This will minimize the opportunity for the development of adult hearworm infections and flea reinfestations. Vethical ComboGuard^® should be administered at monthly intervals beginning within 1 month of the dog's first seasonal exposure to mosquitoes and continuing until at 3 months after the last seasonal exposure.

Heartworm Disease is a serious and potentially deadly disease.

Heartworm disease is caused by worms that are transmitted to dogs by mosquitoes. Although heartworms can live for as long as 7 years in an infected pet¹, they often cause no visible symptoms — which is one reason they can potentially be so deadly. And it's also one of the reasons the Companion Animal Parasite Council recommends year-round heartworm protection.

All dogs should have a yearly blood test performed by the veterinarian to detect heartworm infection.

References

1. Heartworm Society at https://www.heartwormsociety.org/pet-owner-resources/heartworm-basics accessed Feb 12 2017

What Are Fleas?

Adult fleas (Ctenocephalides felis) are reddish-brown insects with bodies that are compressed, or flattened, from side to side. Because fleas are so small, they can be difficult to detect, much less eliminate from your home.

Fleas are wingless, but possess incredible jumping ability. This enables them to jump easily from ground level to “ambush” a pet.

Fleas begin feeding almost immediately when on the host. Incompletely digested blood is excreted from the fleas and dries into reddish-black pellets that stay in the hair coat. This fecal matter/dried blood is commonly referred to as "flea dirt." ¹ Egg production begins within 20 to 24 hours after females take their first blood meal. Female fleas can produce 40 to 50 eggs per day. Under normal conditions, most adult fleas generally survive 2-3 months.

Why worry about fleas?

Fleas can pose a serious problem for your dog’s health.
Not only can fleas make your dog miserable, but depending on his age and overall physical condition, fleas can pose a serious threat to his health.

• Fleas can cause severe discomfort for dogs, including scratching, chewing, biting and restlessness.
• Fleas are the source of flea allergy dermatitis (FAD), one of the most common veterinary dermatological conditions.².
• Severe flea infestations can cause anemia, especially in puppies or debilitated adult dogs.
• Ingested fleas also can transmit tapeworm (D. caninum) infection to dogs.

Public Health Considerations ¹

The common flea of dogs and cats, C. felis, transmits a number of zoonotic agents, including those that cause cat scratch disease (B. henselae), murine typhus (R. typhi), flea-borne typhus (R. felis), and tapeworms (D. caninum).Ingestion of infected fleas by children has resulted in development of adult D. caninum (tapeworm) in a large number of pediatric cases.

Rodent fleas that may be acquired by dogs and cats in southern Rocky Mountain states and southwestern states may be vectors for bubonic plague (Yersinia pestis). These fleas may leave the host to bite humans.

Flea infestation of homes and areas around a home often results in humans being bitten by newly emerging fleas, inciting an allergic response. The resulting papular rash can be mild to extensive, depending on numbers of fleas and individual hypersensitivity reactions.

Preventing and Treating Flea Infestations

Fleas can be a major problem for dogs and their owners. Even if they never leave the house, dogs can be exposed to these blood-sucking parasites. Preventing flea infestations is the best protection against them. ComboGuard^® (spinosad + milbemycin oxime) starts killing fleas on dogs in 30 minutes, before they can lay eggs. And ComboGuard^® lasts a whole month — it can’t be rubbed, washed or shaken off.

Why are fleas so hard to control?
Once in your home, a female flea can produce 40–50 eggs per day¹, so even a few fleas can quickly turn into a major infestation. Adult fleas erupt out of their pupal stage, or cocoon, and quickly find a host, such as your dog. Because these cocoons can be found almost anywhere, including your own living room, it seems to pet owners that fleas appear out of nowhere.

This is why it's important to treat fleas as quickly as possible and to make sure your dog is protected, even before he encounters fleas.

What you can do to control flea infestations

Even with flea protection for your dog, you still want to be sure your household is rid of fleas that were hidden in egg, larva or pupa stages when you treated your dog. An effective means of controlling severe environmental flea infestations is the use of a pest management specialist (exterminator).

If you discover fleas in your home:

• Consult your veterinarian. Your veterinarian is your best source of information about flea control for your dog. Depending on your individual situation, your veterinarian might make specific recommendations.
• Kill fleas on your dog. ComboGuard^® kills fleas quickly, providing fast relief.
• Kill fleas in your home. While treating your dog is an important step, you should also kill fleas in your home to prevent family members and any unprotected pets that visit your home from becoming exposed to a flea infestation.
• Prevent future infestations. Once-monthly ComboGuard^® for dogs kills fleas before they can lay eggs. A key to preventing infestations is making sure other pets in the household are protected too with an approved flea product.

References

1. Companion Animal Parasite Council https://www.capcvet.org/capc-recommendations/fleas/ accessed May 15 2018
2. Merck Veterinary Manual Online http://www.merckvetmanual.com/integumentary-system/fleas-and-flea-allergy-dermatitis/overview-of-fleas-and-flea-allergy-dermatitis accessed February 28 2017

Intestinal Parasite Lifecycle: Worms Within

ComboGuard^® (spinosad + milbemycin oxime) chewable tablet for dogs provides protection from three intestinal parasites.

Roundworm, hookworm, and whipworm can be contracted either through ingesting the eggs or larvae, or by coming into direct contact with contaminated soil¹. In each case, the larval forms of the worms migrate to the intestinal tract, where they mature into adults. The following descriptions are brief but provide a general idea of each worm's lifecycle.

Roundworm

Hookworm

Whipworm

ComboGuard^® helps make controlling intestinal parasites easy, with one monthly, chewable tablet.

References

1. Information summarized from the Companion Animal Parasite Council site: https://www.capcvet.org/capc-recommendations/ascarid-roundworm/ and https://www.capcvet.org/capc-recommendations/hookworms/ Accessed April 10 2018

Vethical ComboGuard^® (spinosad + milbemycin oxime) for Dogs:
Frequently Asked Questions

Q: What is Vethical ComboGuard^®?

Vethical ComboGuard^® is a monthly chewable tablet for dogs. Vethical ComboGuard^® kills fleas and prevents flea infestations, treats and controls hookworms^*, whipworms and roundworms, and prevents heartworm disease. Vethical ComboGuard^® is for use in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater. If you do not administer Vethical ComboGuard^® monthly throughout the year, the final dose must be given no fewer than three months following the last seasonal exposure to mosquitoes. ^*(A. caninum)

Q: Why has my veterinarian prescribed Vethical ComboGuard^®

Your veterinarian has prescribed Vethical ComboGuard^® as a way of preventing your dog from developing problems caused by infection with three commonly occurring parasites. Heartworm infection can make dogs very sick and can even be fatal. This parasite is spread to dogs by mosquitoes. Vethical ComboGuard^® can prevent flea infestations from becoming established, and can also kill any fleas that are on your dog at the time of treatment. Vethical ComboGuard^® will also treat and control common adult intestinal worm infections (roundworms, hookworms and whipworms). ^*(A. caninum)

Q: Should I give Vethical ComboGuard^® each month all year round?

Consult your veterinarian regarding the need for year-round use of Vethical ComboGuard^®. If you do not administer Vethical ComboGuard^® monthly throughout the year, the final dose must be given no fewer than three months following the last seasonal exposure to mosquitoes.

Q: Will Vethical ComboGuard^® kill heartworms?

Vethical ComboGuard^® prevents heartworm disease by killing certain stages that develop after an infected mosquito bites a dog. As with other heartworm preventives, Vethical ComboGuard^® does not kill adult heartworms. Speak to your veterinarian about treatment options if your dog is diagnosed with an adult heartworm infection.

Q: Will my dog still need to be tested for heartworm infection while taking Vethical ComboGuard^®?

You should speak to your veterinarian about the frequency of heartworm testing while your dog is taking Vethical ComboGuard^®.

Q: How do I switch to Vethical ComboGuard^® from another heartworm preventive?

Follow the advice of your veterinarian about switching heartworm preventives.

Q: What should I discuss with my veterinarian regarding Vethical ComboGuard^® for my dog?

Your veterinarian is your dog's healthcare expert and can make the best recommendation for medications for your dog. This includes the prevention, control and/or treatment of parasites such as fleas, heartworms and intestinal parasites that may cause conditions that include flea allergy dermatitis, anemia and heart disease. Key points of your discussion may include the following:

• As with other heartworm preventatives, dogs should be tested for heartworm prior to beginning treatment with Vethical ComboGuard^®.
• If a dose is missed and a monthly interval between doses is exceeded, then immediately give Vethical ComboGuard^® with food and resume monthly dosing. This practice will minimize the opportunity for heartworms to grow. Also, continuing normal monthly dosing will allow you to gain control of any flea or intestinal parasites that might have infected your dog.
• To minimize the likelihood of fleas continuing to jump onto your dog, it is important to treat all household pets with an approved flea protection product.
• Vethical ComboGuard^® is not for use in humans. Like all medications, keep Vethical ComboGuard^® out of reach of children.

Q: How should I give Vethical ComboGuard^® to my dog?

Give Vethical ComboGuard^® with food for maximum effectiveness. Vethical ComboGuard^® is a chewable tablet and may be offered as a treat. Consult your veterinarian regarding the need for year round administration of Vethical ComboGuard^®. To help you remember the monthly dosing schedule, stick-on labels are included for your calendar.

Q: What if I give more than the prescribed amount of Vethical ComboGuard^® to my dog?

Contact your veterinarian as soon as possible if you believe your dog has ingested more than the recommended dose of Vethical ComboGuard^®. In a study in which dogs were dosed at 1, 3, and 5 times the upper half of the recommended dose, dogs exhibited vomiting, tremors, decreased activity, salivation, coughing and vocalization.

Q: Should I restrict either my dog's activity or contact with my dog after the tablet is consumed?

Since Vethical ComboGuard^® is an oral formulation, you may maintain normal activities and interactions with your dog.

Q: How quickly will Vethical ComboGuard^® kill fleas?

In a laboratory study of spinosad alone, an active ingredient of Vethical ComboGuard^®, spinosad started to kill fleas within 30 minutes and killed 100% of the fleas within 4 hours. Vethical ComboGuard^® kills fleas before they can lay eggs.

Q: Does seeing fleas on my dog mean that the treatment is not working?

Vethical ComboGuard^® kills fleas before they can lay eggs when used monthly according to the label directions. Remember that all animals in the household should be treated with an approved flea product to help control the flea population. Your dog can continue to be exposed to the fleas that live in the environment. When fleas jump onto your dog and take a blood meal, they will be killed by Vethical ComboGuard^®. If within a month after your dog receives Vethical ComboGuard^® you see fleas on your dog, it is most likely that these are new fleas. These new fleas will be killed before they can produce eggs that contaminate the environment. Continued monthly use of Vethical ComboGuard^® can prevent any new infestations.

Q: What if I see worms in my dog's stool during the month after administration of Vethical ComboGuard^®?

Vethical ComboGuard^® is indicated to treat and control intestinal parasite infections of adult hookworms^*, roundworms and whipworms in dogs 8 weeks of age or older and 5 pounds of body weight or greater. Use with caution in breeding females. The safe use of ComboGuard® in breeding males has not been evaluated. In occasional cases, it is possible that the action of Vethical ComboGuard^® in killing the intestinal worms will lead to the dog expelling them in the stool. If you have questions, consult with your veterinarian for measures you can take to prevent a reinfection with intestinal parasites.

Q: Is it safe to give my dog Vethical ComboGuard^®?

Vethical ComboGuard^® has been demonstrated to be safe in pure and mixed breeds of healthy dogs when used according to label directions for dogs and puppies 8 weeks of age and older and five pounds of body weight or greater. Use with caution in breeding females. The safe use of ComboGuard® in breeding males has not been evaluated. You should discuss the use of Vethical ComboGuard^® with your veterinarian prior to use if your dog has a history of epilepsy (seizures). Puppies less than 14 weeks of age may experience a higher rate of vomiting.

Q: Is it safe to give my breeding dogs Vethical ComboGuard^®?

It is recommended to use ComboGuard^® with caution in breeding females. The safe use of ComboGuard^® in breeding males has not been evaluated. It is imporant to ask your Veterinarian what they think is best for your pet.

Q: What side effects might occur with Vethical ComboGuard^®?

Like all medications, sometimes side effects may occur. In some cases, dogs vomited after receiving Vethical ComboGuard^®. During field studies, no severe or prolonged vomiting occurred. To ensure heartworm prevention, observe your dog for 1 hour after administration. If vomiting occurs within an hour of administration, redose with another full dose. Additional adverse reactions observed in the clinical studies were itching, decreased activity, diarrhea, inflammation of the skin, redness of the skin, decreased appetite and redness of the ear. All reactions were regarded as mild. The following adverse reactions are based on post-approval adverse drug event reporting. The adverse reactions are listed in decreasing order of frequency: vomiting, depression / lethargy, pruritus, anorexia, diarrhea,trembling/shaking, ataxia, seizures, hypersalivation, and skin reddening. For technical assistance or to report a suspected adverse drug reaction, contact Elanco Animal Health at 1-888-545-5973. Alternatively, suspected adverse drug reactions may be reported to FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

Q: Is Vethical ComboGuard^® FDA approved?

Yes, Vethical ComboGuard^® is a prescription product approved by the FDA and should only be obtained through a licensed veterinarian with whom you have a proper vet/client/patient relationship.

Q: Can other medications be given while my dog is taking Vethical ComboGuard^®?

Yes, Vethical ComboGuard^® has been given safely with a wide variety of products and medications. Your veterinarian should be made aware of all products that you administered and/or intend to administer to your dog. Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with spinosad, one of the components of ComboGuard^®.

Q: Can Vethical ComboGuard^® be given to cats?

No. Vethical ComboGuard^® is not labeled for use on cats. Vethical ComboGuard^® was developed exclusively for administration to dogs. If you also need flea control for your cat, Vethical offers SimpleGuard and AcuGuard for flea control for cats.

Print the client information sheet for Vethical ComboGuard^®