Quest Plus Gel (Canada)

Treating a second horse or pony with the same syringe

If the animal you treat weighs less than 575 kg, there will be gel left in the syringe. The administrator can use this gel to treat other horses or ponies. To set the next dose, add the weight of the animal to be treated to the dose setting already on the syringe. For example, if the syringe was fi rst used to treat a 100 kg animal, the white dial ring is set on 100 kg. To treat a 250 kg animal next, move the white dial ring to the 350 kg marking (100+250=350). More than one syringe are needed to treat horses weighing more than 575 Kg (1260 lb).

Each syringe of QUEST PLUS Gel may be used to treat more than one animal especially when dosing foals, ponies and growing and lighter breeds of horses. The table below will help to estimate the number of horses or ponies the contents of each syringe will treat.

If the animals are likely to be reinfected, a strategic parasite control program should be established: see Parasite Control Program below.

Parasite control program

For the best control of parasites, all horses and ponies should be included in a strategic treatment program, with particular care given to high performance animals, brood mares, stallions and foals. In foals, initial treatment is recommended at 4 months of age, after which they should be included in a routine retreatment program. Since QUEST PLUS Gel provides an aid in the control of developing, encysted cyathostomes (small strongyles), it may be particularly useful in reducing the frequency of dosing in a strategic treatment program. QUEST PLUS Gel, when used at the recommended dose, suppresses strongyle egg production for up to 84 days following a single administration, thereby reducing pasture contamination and providing a period of protection from reinfection for equines grazing that pasture. Consult your veterinarian for the diagnosis, prevention and treatment of parasitic infections in horses and ponies.

CAUTIONS

1. Extra care should be taken with foals to ensure that the correct dose is administered. Do not use in foals less than 4 months of age or in sick, debilitated and underweight horses.

2. QUEST PLUS Gel has been formulated specifically for use in horses and ponies only. This product should not be used in other animal species as serious adverse reactions may result, such as death in dogs.

3. Overdoses, should they occur, may manifest themselves as transient depression, drowsiness and ataxia 8 to 24 hours post administration. Supportive treatment is not generally necessary and recovery is usually complete within 24 to 72 hours. There is no specific antidote for overdosing with moxidectin.

4. Do not mix this product with other veterinary medicinal preparations before administration.

5. Dispose of any containers and any residual content safely (e.g., bury or incinerate). Bury away from water courses, as free moxidectin may adversely affect fish and certain water borne organisms.

6. Some horses have experienced reactions with swelling and itching shortly after treatment. In most such cases, the horses have been diagnosed as carrying heavy infections of Onchocerca microfilariae, and it is assumed the reactions were the result of microfilariae dying in large numbers. Although the signs have resolved spontaneously in a few days, symptomatic treatment may be advisable. Consult your veterinarian should these symptoms persist.

7. QUEST PLUS Gel has not been tested in breeding stallions.

WARNINGS

1. This drug is not to be administered to horses and ponies that are to be slaughtered for use in food.

2. Avoid oral exposure and direct contact with skin and eyes. Wash hands after handling. If accidental contact with eyes occurs, flush repeatedly with water. If irritation or any other symptom attributable to exposure to this product persists, consult a physician.

3. Keep out of reach of children.

Adverse Reactions

Although all adverse reactions are not reported, the following information is based on voluntary post-approval drug experience reporting. It is generally recognized that this results in significant under-reporting. The adverse events listed here reflect reporting and not necessarily causality. Adverse events are listed by body system, in decreasing order of frequency:

- Digestive tract disorders: colic, diarrhea,

- Systemic disorders: lethargy, anorexia,

- Immune system disorders: urticaria, allergic edema, hypersensitivity reaction,

- Neurologic disorders: ataxia.

Animal Safety

QUEST PLUS Gel can be safely administered at the recommended dose of 0.4 mg moxidectin and 2.5 mg praziquantel per kg of body weight to horses and ponies of all breeds, 4 months of age or older. Transient depression and/or ataxia has been observed occasionally in a small number of animals at three times the recommended dose level; however, it has been demonstrated that these effects diminish over time with minimal or no supportive therapy and result in no permanent cellular damage in the animal. The product has not been fully tested in young horses less than four months of age where multiple overdoses may result in reactions consistent with the known neurological mode of action for this class of compounds.

QUEST PLUS Gel has been tested in breeding, pregnant, and lactating mares. In a reproductive safety study, 10 mares received QUEST PLUS Gel at three times the recommended dosage, and 10 mares received tap water (control). Mares were dosed at least once a month from breeding through 30 days post-foaling, with increased frequency (every 2 weeks) around breeding. Nine out of 10 QUEST PLUS Gel-treated mares became pregnant, and gave birth to live foals. Ten control mares became pregnant, and 8 out of the 10 mares gave birth to live foals. One QUEST PLUS Gel-treated mare had episodes of depression, decreased appetite and diarrhea shortly after receiving 5 of the 17 (29%) doses. The same mare had one episode of colic shortly after one administration of QUEST PLUS Gel. This mare’s colic, depression, decreased appetite, and diarrhea all resolved without treatment. The foal born from this mare was observed shortly after birth with reduced menace and repetitive tongue rolling which resolved within a few days and the foal was normal at Day 30 post-foaling. In addition, a mare in QUEST PLUS Gel-treated group was reported with anxiety, nervousness accompanied with diarrhea throughout the trial when left alone. She gave birth to a foal which had a mild depression, chronic diarrhea and died from infectious colitis at Day 8 of age. Another QUEST PLUS Gel-treated mare had an abnormal reproductive cycle (prolonged time to ovulation) following foal heat (at least 39 days). This mare became pregnant on the first breeding and gave birth to a female foal that was normal at birth; however, the foal developed an enlarged clitoris by Day 30 post-foaling. One more observation in foals from QUEST PLUS Gel-treated group was a case of angular limb deformities (carpal valgus). This condition was resolved within a few days and the foal was normal at Day 30 post-foaling.

Storage

Store between 15 and 30°C. Keep from freezing.

Environmental Safety

Care should be taken to avoid release of significant volumes of moxidectin into either ground water or free-running water. Free moxidectin may adversely affect fish and certain water borne organisms. Moxidectin is readily and tightly bound to soil and rendered inactive over time. QUEST PLUS Gel syringes and their residual contents should be disposed of in an approved manner.

Presentation

QUEST PLUS Gel, is supplied as an individual, ready-to-use syringe which contains sufficient product to treat a 575 kg (1250+ lb) animal at the recommended dose of 0.4 mg moxidectin and 2.5 mg praziquantel per kg of body weight.

Zoetis is a trademark and Quest Plus and SURE-DIAL are registered trademarks of Zoetis or its licensors, used under license by Zoetis Canada Inc.

Zoetis Canada Inc., Kirkland QC H9H 4M7

2698-11-2

40026525

CPN: 1198432.3