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                  <paragraph>
                     <content styleCode="bold">                                    AGRIMYCIN® 200</content>
                     <br/>
                     <content styleCode="bold">                             (oxytetracycline injection)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">                                           Antibiotic</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution: </content>Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>Each mL contains 200 mg of oxytetracycline base as oxytetracycline dihydrate.</paragraph>
                  <paragraph>For the treatment of disease in beef cattle; dairy cattle; calves, including preruminating<br/>(veal) calves; and swine </paragraph>
                  <paragraph>                                 For animal use only <br/>                     Approved by FDA under ANADA # 200-128</paragraph>
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               <text>
                  <paragraph>AGRIMYCIN® 200 (oxytetracycline injection) is a sterile, preconstituted<br/>solution of the broad-spectrum antibiotic oxytetracycline. Each mL<br/>contains 200 mg of oxytetracycline base as oxytetracycline dihydrate,<br/>and on a w/v basis, 40.0% 2-pyrrolidone, 5.0% povidone, 1.8%<br/>magnesium oxide, 0.2% sodium formaldehyde sulfoxylate (as a<br/>preservative), monoethanolamine and/or hydrochloric acid as<br/>required to adjust pH.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> When administered to cattle, muscle discoloration may<br/>necessitate trimming of the injection site(s) and surrounding tissues<br/>during the dressing procedure.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Warnings:</content> Discontinue treatment at least 28 days prior<br/>to slaughter of cattle and swine. Milk taken from animals<br/>during treatment and for 96 hours after the last treatment<br/>must not be used for food.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Precautions:</content> Exceeding the highest recommended level of drug per lb<br/>of body weight per day, administering more than the recommended<br/>number of treatments, and/or exceeding 10 mL subcutaneously per<br/>injection site in adult beef and dairy cattle, and 5 mL intramuscularly<br/>per injection site in adult swine, may result in antibiotic residues<br/>beyond the withdrawal period.</paragraph>
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               <text>
                  <paragraph>® Registered Trademark of Huvepharma, Inc.<br/>Manufactured for Huvepharma, Inc., Peachtree City, GA 30269</paragraph>
                  <paragraph>
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                  </paragraph>
                  <paragraph>
                     <content>LOT NO.:                                              EXP. DATE:</content>
                  </paragraph>
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                     <text>Take Time</text>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Dosage: Cattle:</content> A single dosage of 9 mg of oxytetracycline per lb<br/>of body weight (4.5 mL/100 lb) administered subcutaneously is<br/>recommended in the treatment of the following conditions:<br/>1) bacterial pneumonia caused by <content styleCode="italics">Pasteurella</content> spp. (shipping fever)<br/>in calves and yearlings, where retreatment is impractical due to<br/>husbandry conditions, such as cattle on range, or where repeated<br/>restraint is inadvisable; 2) infectious bovine keratoconjunctivitis<br/>(pinkeye) caused by <content styleCode="italics">Moraxella bovis</content>.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Swine:</content> A single dosage of 9 mg of oxytetracycline per lb of body<br/>weight (4.5 mL/100 lb) administered <content styleCode="italics">intramuscularly</content> is recommended<br/>in the treatment of bacterial pneumonia caused by <content styleCode="italics">Pasteurella</content>
                     <br/>
                     <content styleCode="italics">multocida</content> in swine, where retreatment is impractical due to husbandry<br/>conditions or where repeated restraint is inadvisable.</paragraph>
                  <paragraph>Refer to Package Onsert for Complete Directions.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">How Supplied:</content> AGRIMYCIN® 200 is available in 100 mL, 250 mL and<br/>500 mL multi-dose amber vials.</paragraph>
               </text>
               <effectiveTime value="20230512"/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Storage:</content> Store at room temperature 15°-25°C<br/>(59°-77°F). Keep from freezing. Use within 12<br/>months of first puncture. Puncture a maximum<br/>of 100 times.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Not For Human Use</content>
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               <text>
                  <paragraph>
                     <content styleCode="bold">                              AGRIMYCIN® 200</content>
                     <br/>
                     <content styleCode="italics">                        (oxytetracycline injection)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">                                     Antibiotic</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution: </content>Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>
                     <content styleCode="italics">Each mL contains 200 mg of oxytetracycline base as oxytetracycline dihydrate.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">For the treatment of diseases in beef cattle; dairy cattle; calves, including</content>
                     <br/>
                     <content styleCode="italics">preruminating (veal) calves; and swine</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">                                For animal use only</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">               Read Entire Package Onsert Carefully Before</content>
                     <br/>
                     <content styleCode="bold">                                 Using This Product.</content>
                  </paragraph>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <text>
                  <paragraph>AGRIMYCIN® 200 (oxytetracycline injection) is a sterile,<br/>ready-to-use solution for the administration of the<br/>broad-spectrum antibiotic oxytetracycline by injection.</paragraph>
                  <paragraph>AGRIMYCIN® 200 administered to cattle or swine for the<br/>treatment of bacterial pneumonia at a dosage of 9 mg of<br/>oxytetracycline per lb of body weight has been demonstrated<br/>in clinical trials to be as effective as 2 or 3 repeated, daily<br/>treatments of oxytetracycline injectable at 3-5 mg/lb of body<br/>weight.</paragraph>
                  <paragraph>AGRIMYCIN® 200 does not require refrigeration; however, it is<br/>recommended that it be stored at room temperature, 15º-25ºC<br/>(59º-77ºF). The antibiotic activity of oxytetracycline is not<br/>appreciably diminished in the presence of body fluids, serum,<br/>or exudates.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> When administered to cattle, muscle discoloration may necessitate trimming of the<br/>injection site(s) and surrounding tissues during the dressing procedure.</paragraph>
                  <paragraph>
                     <content styleCode="bold">WARNINGS:</content> Discontinue treatment at least 28 days prior to slaughter of cattle and swine. Milk<br/>taken from animals during treatment and for 96 hours after the last treatment must not be used<br/>for food. Rapid intravenous administration may result in animal collapse.</paragraph>
                  <paragraph>Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes.</paragraph>
                  <paragraph>
                     <content styleCode="bold">PRECAUTIONS:</content> Exceeding the highest recommended dosage level of drug per lb of body weight per<br/>day, administering more than the recommended number of treatments, and/or exceeding 10 mL<br/>subcutaneously per injection site in adult beef and dairy cattle, and 5 mL intramuscularly per<br/>injection site in adult swine, may result in antibiotic residues beyond the withdrawal period.</paragraph>
                  <paragraph>At the first sign of any adverse reaction, discontinue use of the product and seek the advice of <br/>your veterinarian. Some of the reactions may be attributed either to anaphylaxis (an allergic <br/>reaction) or to cardiovascular collapse of unknown cause.</paragraph>
                  <paragraph>Shortly after injection, treated animals may have transient hemoglobinuria resulting in darkened<br/>urine.</paragraph>
                  <paragraph>As with all antibiotic preparations, use of this drug may result in overgrowth of non-susceptible<br/>organisms, including fungi. A lack of response by the treated animal, or the development of new<br/>signs, may suggest that an overgrowth of nonsusceptible organisms has occurred. If any of these<br/>conditions occur, consult your veterinarian.</paragraph>
                  <paragraph>Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable<br/>to avoid giving AGRIMYCIN® 200 in conjunction with penicillin.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">ADVERSE REACTIONS:</content> Reports of adverse reactions associated with oxytetracycline administration include <br/>injection site swelling, restlessness, ataxia, trembling, swelling of eyelids, ears, muzzle, anus and vulva (or <br/>scrotum and sheath in males), respiratory abnormalities (labored breathing), frothing at the mouth, collapse <br/>and possibly death. Some of these reactions may be attributed to anaphylaxis (an allergic reaction) or to <br/>cardiovascular collapse of unknown cause.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">STORAGE:</content> Store at room temperature 15°-25°C (59°-77°F).<br/>Keep from freezing. Use within 12 months of first puncture.<br/>Puncture a maximum of 100 times.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">CARE OF SICK ANIMALS:</content> The use of antibiotics in the management of diseases is based on<br/>an accurate diagnosis and an adequate course of treatment. When properly used in the<br/>treatment of diseases caused by oxytetracycline susceptible organisms, most animals<br/>that have been treated with AGRIMYCIN® 200 show a noticeable improvement within 24-48<br/>hours. </paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">INDICATIONS:</content> AGRIMYCIN® 200 is intended for use in the treatment of the following<br/>diseases in beef cattle; dairy cattle; calves, including preruminating (veal)<br/>calves; and swine when due to oxytetracycline-susceptible organisms:</paragraph>
                  <paragraph>
                     <content styleCode="bold">Cattle:</content> AGRIMYCIN® 200 is indicated in the treatment of pneumonia and shipping<br/>fever complex associated with <content styleCode="italics">Pasteurella</content> spp. and <content styleCode="italics">Haemophilus</content> spp; infectious<br/>bovine keratoconjunctivitis (pinkeye) caused by <content styleCode="italics">Moraxella bovis</content>; foot rot and<br/>diphtheria caused by <content styleCode="italics">Fusobacterium necrophorum</content>; bacterial enteritis (scours)<br/>caused by <content styleCode="italics">Escherichia coli</content>; wooden tongue caused by <content styleCode="italics">Actinobacillus lignieresii</content>;<br/>leptospirosis caused by <content styleCode="italics">Leptospira pomona</content>; and wound infections and acute metritis<br/>caused by strains of staphylococci and streptococci organisms sensitive to<br/>oxytetracycline.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Swine:</content> AGRIMYCIN® 200 is indicated in the treatment of bacterial enteritis (scours,<br/>colibacillosis) caused by <content styleCode="italics">Escherichia coli</content>; pneumonia caused by <content styleCode="italics">Pasteurella multocida</content>;<br/>and leptospirosis caused by <content styleCode="italics">Leptospira pomona</content>.</paragraph>
                  <paragraph>In sows, AGRIMYCIN® 200 is indicated as an aid in the control of infectious enteritis<br/>(baby pig scours, colibacillosis) in suckling pigs caused by <content styleCode="italics">Escherichia coli</content>.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">DOSAGE:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Cattle:</content> AGRIMYCIN® 200 is to be administered by subcutaneous (SC, under<br/>the skin) or intravenous injection according to Beef Quality Assurance<br/>Guidelines.</paragraph>
                  <paragraph>A single dosage of 9 mg of AGRIMYCIN® 200 per lb of body weight administered<br/>subcutaneously is recommended in the treatment of the following conditions:<br/>1) bacterial pneumonia caused by <content styleCode="italics">Pasteurella</content> spp. (shipping fever) in calves<br/>and yearlings, where retreatment is impractical due to husbandry conditions,<br/>such as cattle on range, or where their repeated restraint is inadvisable;<br/>2) infectious bovine keratoconjunctivitis (pinkeye) caused by <content styleCode="italics">Moraxella bovis</content>.</paragraph>
                  <paragraph>AGRIMYCIN® 200 can also be administered by subcutaneous or intravenous injection<br/>at a level of 3-5 mg of oxytetracycline per lb of body weight per day. In the<br/>treatment of severe foot rot and advanced cases of other indicated diseases, a<br/>dosage level of 5 mg/lb of body weight per day is recommended.<br/>Treatment should be continued 24-48 hours following remission of disease signs;<br/>however, not to exceed a total of 4 consecutive days. Consult your veterinarian<br/>if improvement is not noted within 24-48 hours of the beginning of treatment.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Swine:</content> A single dosage of 9 mg of AGRIMYCIN® 200 per lb of body weight<br/>administered <content styleCode="italics">intramuscularly</content> in the neck region is recommended in the treatment<br/>of bacterial pneumonia caused by <content styleCode="italics">Pasteurella multocida</content> in swine, where retreatment<br/>is impractical due to husbandry conditions or where repeated restraint is<br/>inadvisable.</paragraph>
                  <paragraph>AGRIMYCIN® 200 can also be administered by intramuscular injection at a level of<br/>3-5 mg of oxytetracycline per lb of body weight per day. Treatment should be<br/>continued 24-48 hours following remission of disease signs; however, not to<br/>exceed a total of 4 consecutive days. Consult your veterinarian if improvement<br/>is not noted within 24-48 hours of the beginning of treatment.</paragraph>
                  <paragraph>For sows, administer once intramuscularly in the neck region 3 mg of oxytetracycline<br/>per lb of body weight approximately 8 hours before farrowing or immediately after<br/>completion of farrowing.</paragraph>
                  <paragraph>
                     <content styleCode="italics">For swine weighing 25 lb of body weight and under</content>, AGRIMYCIN® 200 should be<br/>administered <content styleCode="italics">undiluted</content>
                     <content styleCode="bold"> for treatment</content> at 9 mg/lb but should be administered <content styleCode="italics">diluted</content>
                     <br/>for treatment at 3 or 5 mg/lb.</paragraph>
                  <paragraph>
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                  <paragraph>* To prepare dilution, add 1 part AGRIMYCIN® 200 to 3, 5 or 7 parts of sterile water,<br/>or 5% dextrose solution as indicated; the diluted product should be used immediately.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">DIRECTIONS FOR USE:</content> AGRIMYCIN® 200 is intended for use in the treatment of<br/>disease due to oxytetracycline-susceptible organisms in beef cattle; dairy<br/>cattle; calves, including preruminating (veal) calves; and swine. A thoroughly<br/>cleaned, sterile needle and syringe should be used for each injection (needles<br/>and syringes may be sterilized by boiling in water for 15 minutes). In cold<br/>weather, AGRIMYCIN® 200 should be warmed to room temperature before administration<br/>to animals. Before withdrawing the solution from the bottle, disinfect the rubber<br/>cap on the bottle with suitable disinfectant, such as 70% alcohol. The injection<br/>site should be similarly cleaned with the disinfectant. Needles of 16-18 gauge and<br/>1-1/2 inches long are adequate for intramuscular and subcutaneous injections.<br/>Needles 2-3 inches are recommended for intravenous use.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Intramuscular Administration:</content>
                  </paragraph>
                  <paragraph>Intramuscular injections in swine should be made by directing the needle of suitable<br/>gauge and length into the fleshy part of a thick muscle in the neck region; avoid<br/>blood vessels and major nerves. Before injecting the solution, pull back gently on<br/>the plunger. If blood appears in the syringe, a blood vessel has been entered;<br/>withdraw the needle and select a different site. No more than 5 mL should be injected<br/>at any one site in adult swine; rotate injection sites for each succeeding treatment.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Subcutaneous Administration:</content>
                     <br/>Subcutaneous injections in beef cattle, dairy cattle, and calves, including<br/>preruminating (veal) calves, should be made by directing the needle of suitable<br/>gauge and length through the loose folds of the neck skin in front of the shoulder.<br/>Care should be taken to ensure that the tip of the needle has penetrated the skin<br/>but is not lodged in muscle. Before injecting the solution, pull back gently on the<br/>plunger. If blood appears in the syringe, a blood vessel has been entered; withdraw<br/>the needle and select a different site. The solution should be injected slowly into<br/>the area between the skin and muscles. No more than 10 mL should be injected<br/>subcutaneously at any one site in adult beef and dairy cattle; rotate injection<br/>sites for each succeeding treatment. The volume administered per injection site<br/>should be reduced according to age and body size so that 1-2 mL per site is injected<br/>in small calves.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Intravenous Administration:</content>
                     <br/>AGRIMYCIN® 200 may be administered intravenously to beef and dairy cattle. As with all<br/>highly concentrated materials, AGRIMYCIN® 200 should be administered <content styleCode="italics">slowly</content> by the<br/>intravenous route.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Preparation of the Animal for Injection:</content>
                     <br/>1. Approximate location of vein. The jugular vein runs in the jugular groove on each<br/>side of the neck from the angle of the jaw to just above the brisket and slightly<br/>above and to the side of the windpipe. (See Fig. I) </paragraph>
                  <paragraph>2. Restraint. A stanchion or chute is ideal for restraining the animal. With a halter,<br/>rope, or cattle leader (nose tongs), pull the animal's head around the side of the<br/>stanchion, cattle chute, or post in such a manner to form a bow in the neck (See Fig. II),<br/>then snub the head securely to prevent movement. By forming the bow in the neck,<br/>the outside curvature of the bow tends to expose the jugular vein and make it easily<br/>accessible.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution:</content> Avoid restraining the animal with a tight rope or halter around the throat or<br/>upper neck which might impede blood flow. Animals that are down present no problem so far<br/>as restraint is concerned.</paragraph>
                  <paragraph>3. Clip hair in area where injection is to be made (over the vein in the upper third of<br/>the neck). Clean and disinfect the skin with alcohol or other suitable antiseptic.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">Entering the Vein and Making the Injection:</content>
                     <br/>1. Raise the vein. This is accomplished by tying the choke rope tightly around the neck close<br/>to the shoulder. The rope should be tied in such a way that it will not come loose and so that<br/>it can be untied quickly by pulling the loose end (See Fig. II). In thick-necked animals, a<br/>block of wood placed in the jugular groove between the rope and the hide will help considerably<br/>in applying the desired pressure at the right point. The vein is a soft flexible tube through<br/>which blood flows back to the heart. Under ordinary conditions it cannot be seen or felt with<br/>the fingers. When the flow of blood is blocked at the base of the neck by the choke rope, the<br/>vein becomes enlarged and rigid because of the back pressure. If the choke rope is sufficiently<br/>tight, the vein stands out and can be easily seen and felt in thin-necked animals. As a further<br/>check in identifying the vein, tap it with the fingers in front of the choke rope. Pulsations<br/>that can be seen or felt with the fingers in front of the point being tapped will confirm the<br/>fact that the vein is properly distended. It is impossible to put the needle into the vein<br/>unless it is distended. Experienced operators are able to raise the vein simply by hand pressure,<br/>but the use of a choke rope is more certain. </paragraph>
                  <paragraph>2. Inserting the needle. This involves 3 distinct steps. First, insert the needle through the hide.<br/>Second, insert the needle into the vein. This may require 2 or 3 attempts before the vein is entered.<br/>The vein has a tendency to roll away from the point of the needle, especially if the needle is not<br/>sharp. The vein can be steadied with the thumb and finger of one hand. With the other hand, the needle<br/>point is placed directly over the vein, slanting it so that its direction is along the length of the<br/>vein, either toward the head or toward the heart. Properly positioned this way, a quick thrust of the<br/>needle will be followed by a spurt of blood through the needle, which indicates that the vein has been<br/>entered. Third, once in the vein, the needle should be inserted along the length of the vein all the<br/>way to the hub, exercising caution to see that the needle does not penetrate the opposite side of the<br/>vein. Continuous steady flow of blood through the needle indicates that the needle is still in the vein.<br/>If blood does not flow continuously, the needle is out of the vein (or clogged) and another attempt<br/>must be made. If difficulty is encountered, it may be advisable to use the vein on the other side of<br/>the neck. </paragraph>
                  <paragraph>3. While the needle is being placed in proper position in the vein, an assistant should get the<br/>medication ready so that the injection can be started without delay after the vein has been entered.</paragraph>
                  <paragraph>4. Making the injection. With the needle in position as indicated by continuous flow of blood, release<br/>the choke rope by a quick pull on the free end. This is essential - the medication cannot flow into<br/>the vein while it is blocked. Immediately connect the syringe containing AGRIMYCIN® 200 to the needle<br/>and slowly depress the plunger. If there is resistance to depression of the plunger, this indicates<br/>that the needle has slipped out of the vein (or is clogged) and the procedure will have to be<br/>repeated. Watch for any swelling under the skin near the needle, which would indicate that the medication<br/>is not going into the vein. Should this occur, it is best to try the vein on the opposite side of the neck.</paragraph>
                  <paragraph>5. Removing the needle. When injection is complete, remove needle with straight pull. Then apply pressure<br/>over area of injection momentarily to control any bleeding through needle puncture, using cotton soaked<br/>in alcohol or other suitable antiseptic.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">Not For Human Use</content>
                     <br/>Approved by FDA under ANADA # 200-128</paragraph>
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                  <paragraph>Manufactured for Huvepharma, Inc., Peachtree City, GA 30269</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Dosage: Cattle:</content> A single dosage of 9 mg of oxytetracycline per lb of body weight<br/>(4.5 mL/100 lb) administered subcutaneously is recommended in the treatment of<br/>the following conditions: 1) bacterial pneumonia caused by <content styleCode="italics">Pasteurella</content> spp.<br/>(shipping fever) in calves and yearlings, where retreatment is impractical<br/>due to husbandry conditions, such as cattle on range, or where repeated<br/>restraint is inadvisable; 2) infectious bovine keratoconjunctivitis (pinkeye)<br/>caused by <content styleCode="italics">Moraxella bovis</content>.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Swine:</content> A single dosage of 9 mg of oxytetracycline per lb of body weight<br/>(4.5 mL/100 lb) administered <content styleCode="italics">intramuscularly</content> is recommended in the treatment<br/>of bacterial pneumonia caused by <content styleCode="italics">Pasteurella multocida</content> in swine, where retreatment<br/>is impractical due to husbandry conditions or where repeated restraint is<br/>inadvisable.</paragraph>
                  <paragraph>Refer to Package Onsert for Complete Directions.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">How Supplied:</content> AGRIMYCIN® 200 is available in 100 mL,<br/>250 mL and 500 mL multi-dose amber vials.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Storage: </content>Store at room temperature<br/>15°-25°C (59°-77°F). Keep from<br/>freezing. Use within 12 months of first<br/>puncture. Puncture a maximum of 100<br/>times.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Not For Human Use</content>
                  </paragraph>
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