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   <title>QUEST<sup>®</sup> PLUS GEL<br/> (moxidectin/praziquantel)</title>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Equine Oral Gel</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Contains 20 mg moxidectin/mL (2.0% w/v)<br/>and 125 mg praziquantel/mL (12.5% w/v)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">DEWORMER &amp; BOTICIDE</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">FOR ORAL USE IN HORSES AND PONIES<br/>SIX MONTHS OF AGE AND OLDER</content>
                     </content>
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               <title>INDICATIONS</title>
               <text>
                  <paragraph>QUEST PLUS Gel (moxidectin/praziquantel) when administered at the recommended dose level of 0.4 mg moxidectin/kg and 2.5 mg praziquantel/kg (2.2 lb) body weight is effective in the treatment and control of the following stages of gastrointestinal parasites in horses and ponies:</paragraph>
                  <paragraph>
                     <content styleCode="bold">Large Strongyles:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Strongylus </content>
                     <content styleCode="italics">vulgaris </content>– (adults and L4/L5 arterial stages)</paragraph>
                  <paragraph>
                     <content styleCode="italics">     Strongylus edentatus </content>– (adults and tissue stages) </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Triodontophorus brevicauda </content>– (adults)</paragraph>
                  <paragraph>
                     <content styleCode="italics">     Triodontophorus serratus </content>– (adults)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Small Strongyles</content>(adults)<content styleCode="bold">:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">    </content> <content styleCode="italics">Cyathostomum</content>spp., including </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">          </content>
                     </content>
                     <content styleCode="italics">Cyathostomum catinatum </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">          </content>
                     </content>
                     <content styleCode="italics">Cyathostomum pateratum </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">     </content>
                     </content>
                     <content styleCode="italics">Cylicostephanus </content>spp., including</paragraph>
                  <paragraph>
                     <content styleCode="italics">          Cylicostephanus</content>
                     <content styleCode="italics">calicatus</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">           </content>
                     <content styleCode="italics">Cylicostephanus</content>
                     <content styleCode="italics"> goldi</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">           </content>
                     <content styleCode="italics">Cylicostephanus</content>
                     <content styleCode="italics"> longibursatus</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">           </content>
                     <content styleCode="italics">Cylicostephanus</content>
                     <content styleCode="italics"> minutus</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Cylicocyclus </content>spp., including </paragraph>
                  <paragraph>          <content styleCode="italics">Cylicocyclus insigne </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">          Cylicocyclus leptostomum </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">          Cylicocyclus nassatus </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">          Cylicocyclus radiatus</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Coronocyclus</content>spp., including </paragraph>
                  <paragraph>          <content styleCode="italics">Coronocyclus coronatus </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">          Coronocyclus labiatus </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">          Coronocyclus labratus</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Gyalocephalus capitatus</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">      </content>
                     <content styleCode="italics">Petrovinema </content>
                     <content styleCode="italics">poculatus</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Small Strongyles:</content>
                  </paragraph>
                  <paragraph>     Undifferentiated lumenal larvae</paragraph>
                  <paragraph>
                     <content styleCode="bold">Encysted cyathostomes:</content>
                  </paragraph>
                  <paragraph>     Late L3 and L4 mucosal cyathostome larvae</paragraph>
                  <paragraph>
                     <content styleCode="bold">Ascarids:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Parascaris</content>
                     <content styleCode="italics">equorum </content>– (adults and L4 larval stages)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Pinworms:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Oxyuris equi </content>– (adults and L4 larval stages)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Hairworms:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Trichostrongylus axei</content>– (adults)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Large-mouth stomach worms:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Habronema muscae</content>– (adults)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Horse stomach bots:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Gasterophilus intestinalis</content>– (2nd and 3rd instars)</paragraph>
                  <paragraph>
                     <content styleCode="italics">     Gasterophilus nasalis</content>– (3rd instars)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Tapeworms:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">     Anoplocephala </content>
                     <content styleCode="italics">perfoliata </content>– (adults)</paragraph>
                  <paragraph>One administration of the recommended dose rate of QUEST PLUS Gel also suppresses strongyle egg production through 84 days.</paragraph>
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               <title>STRATEGIC PROTECTION PROGRAMS</title>
               <text>
                  <paragraph>Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. For best control of parasites, all horses and ponies should be included in a strategic treatment program, with particular attention given to high performance animals. In foals, initial treatment is recommended at 6 months of age, after which they should be included in a recurrent treatment program. Because QUEST PLUS Gel provides eff ective control of the mucosal stages of small strongyles (encysted cyathostomes) and tapeworms, it is useful in reducing the frequency of treatment required for successful strategic equine parasite control. A veterinarian can assist in preparing the best program for your needs.<br/>
                  </paragraph>
                  <paragraph>QUEST PLUS Gel when used at the recommended dose rate suppresses strongyle egg production through 84 days following a single oral administration. This residual strongyle control reduces pasture contamination and provides a period of protection from reinfection for horses and ponies maintained on the same pasture.</paragraph>
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               <title>MODE OF ACTION</title>
               <text>
                  <paragraph>QUEST PLUS Gel contains two active pharmaceutical ingredients, moxidectin and praziquantel. Moxidectin acts by interfering with chloride channel-mediated neurotransmission in the parasite. This results in paralysis and elimination of the parasite. Moxidectin is safe for use in horses and ponies because it does not have the same injurious eff ect on the mammalian nervous system. Praziquantel increases the tapeworm’s membrane permeability to calcium and other cations causing severe contraction and paralysis of the tapeworm’s muscles.</paragraph>
                  <paragraph>This spastic paralysis results in the inability of tapeworms to attach to the host’s intestinal wall.<br/>Detached tapeworms are either destroyed by the host’s immune defense system or passed in the feces.</paragraph>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>ADMINISTRATION AND DOSAGE</title>
               <text>
                  <paragraph>QUEST PLUS Gel is specially formulated as a palatable gel which is easily administered to horses and ponies. QUEST PLUS Gel is packaged in ready-to-use SURE-DIAL® syringes. The syringe is calibrated in 50-pound increments, up to 1500 pounds. This enables the administration of the recommended dose level by choosing a setting consistent with the animal’s weight.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Do not underdose.</content> Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineff ective treatment, and encourage the development of parasite resistance.</paragraph>
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               <title>HOW TO SET THE DOSE</title>
               <text>
                  <paragraph>Since the dose is based on the weight of the animal, you need to use a scale or weight tape to find each animal’s weight before treating with QUEST PLUS Gel. Once the weight is known, set the dose for each horse or pony as follows.<br/>     1. Hold the syringe with the capped end pointing to the left and so that you can see the<br/>          weight measurements and tick marks (small black lines). Each tick mark relates to 50 lb<br/>          of body weight.<br/>     2. Turn the white dial ring until the left side of the ring lines up with the weight of the animal.</paragraph>
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               <title>HOW TO GIVE QUEST PLUS GEL TO A HORSE OR PONY</title>
               <text>
                  <paragraph>1. Make sure there is no feed in the animal’s mouth.<br/>2. Remove the cap from the end of the syringe. Save the cap for reuse.<br/>3. Place the tip of the syringe inside the animal’s mouth at the space between the teeth.<br/>4. Gently push the plunger until it stops, depositing the gel on the back of the tongue.<br/>5. Remove the syringe from the animal’s mouth and raise the animal’s head slightly to make<br/>      sure it swallows the gel.<br/>6. Replace the syringe cap.</paragraph>
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               <effectiveTime value="20180131"/>
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               <title>TREATING A SECOND HORSE OR PONY WITH THE SAME SYRINGE</title>
               <text>
                  <paragraph>If the first animal you treat weighs less than 1500 lb, there will be gel left in the syringe. You can use this gel to treat other horses or ponies. To set the next dose, add the weight of the animal you want to treat to the dose setting already on the syringe. For example, if the syringe was first used to treat a 250 lb animal, the white dial ring is set on 250 lb. To treat a 500 lb animal next, move the white dial ring to the 750 lb marking (250+500=750). You need more than one syringe to treat horses weighing more than 1500 lb.</paragraph>
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               <title>ANIMAL SAFETY</title>
               <text>
                  <paragraph>QUEST PLUS Gel can be safely administered at the recommended dose to horses and ponies of all breeds at least 6 months of age and older. Transient ataxia, incoordination, lethargy, depression and droopy lips and eyelids may be seen when very young or debilitated animals are treated. In these instances, supportive care may be advisable. QUEST PLUS Gel is safe for use 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.</paragraph>
                  <paragraph>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. 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 fi rst 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. To report adverse drug reactions or to obtain a copy of the Safety Data Sheet (SDS) call 1-888-963-8471.</paragraph>
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               <title>ENVIRONMENTAL SAFETY</title>
               <text>
                  <paragraph>Care should be taken to avoid the release of significant volumes of this product into either ground or free-running water since moxidectin may be injurious to aquatic life. SURE-DIAL<sup>®</sup> syringes and their contents should be disposed of in an approved landfill or by incineration.</paragraph>
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               <title>PRECAUTIONS</title>
               <text>
                  <paragraph>QUEST PLUS Gel has been formulated specifically for use in horses and ponies only.</paragraph>
                  <paragraph>Reproductive safety studies on breeding stallions have not been conducted. </paragraph>
                  <paragraph>
                     <content styleCode="bold">This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.</content>
                  </paragraph>
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               <title>WARNINGS</title>
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                  <paragraph>
                     <content styleCode="bold">Extreme caution should be used when administering the product to foals, young and miniature horses, as overdosage may result in serious adverse reactions. Do not use in sick, debilitated, or underweight animals. Do not use in horses intended for human consumption.</content>
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               <title>HUMAN WARNINGS</title>
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                  <paragraph>
                     <content styleCode="bold">Not for use in humans. Keep this and all drugs out of the reach of children. </content>Do not ingest. If swallowed, induce vomiting. Wash hands and contaminated skin with soap and water. If accidental contact with eyes occurs, flush repeatedly with water. If irritation or any other symptom attributable to exposure to this product persists, consult your physician.</paragraph>
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               <title>OTHER WARNINGS</title>
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                  <paragraph>Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug’s effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
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               <title>HOW SUPPLIED</title>
               <text>
                  <paragraph>QUEST PLUS Gel is available in one syringe applicator size.<br/>Each SURE-DIAL® syringe contains 0.5 oz (14.0 g) of QUEST PLUS Gel which is suffi cient to treat a single horse weighing up to 1500 lb, or two or more lighter animals with a combined body weight of up to 1500 lb.</paragraph>
                  <paragraph>0.5 oz (14.0 g) syringe - 20 mg moxidectin and 125 mg praziquantel per mL</paragraph>
                  <paragraph>Store at or below 77°F (25°C). Avoid freezing. If frozen, thaw completely before use. Store partially used syringes with the cap tightly secured.</paragraph>
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                  <paragraph>zoetis</paragraph>
                  <paragraph>Distributed by:<br/>Zoetis Inc.<br/>Kalamazoo, MI 49007<br/>
                  </paragraph>
                  <paragraph>Revised: May 2019</paragraph>
                  <paragraph>40027574</paragraph>
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               <title>PRINCIPAL DISPLAY PANEL - 20mg moxidectin 125mg praziquantel label</title>
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