NURSERY PORTFOLIO

FULL VALUE SOLUTIONSFROM THE START

Through continuous innovation, trusted solutions and actionable insights,

Elanco is invested in helping you achieve the Full Value of every decision. We

believe a Full Value relationship starts with understanding your business and

we know growing the healthiest pigs from the very start determines success to

the finish. The Elanco portfolio offers weaning solutions that manage disease

challenges, minimize variation, and mitigate mortality to optimize pig health.

Get a Full Value pig from the start with Elanco.

RESPIRATORYSOLUTIONS

Having a strong health protocol involves planning ahead and being prepared for

challenges. Respiratory disease is the number one cause of nursery death1 and is

endemic in many herds worldwide.2 Once signs of respiratory disease surface, it’s

often too late to recover. Elanco offers vaccine, injectable, feed additive and water-

soluble solutions for industry critical respiratory challenges. Talk with your Elanco representative to select the right solutions for your challenges.

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Effective. Control. Prevention.Directions for Use, Page 17

SAFE, PROVEN RESPIRATORY SHIELD

Haemophilus parasuis can develop suddenly, often resulting in death in less than two days, even in visibly healthy pigs.3 Stressors associated with weaning and the nursery

environment significantly increase disease possibility.

While clinical signs can be apparent, H. parasuis often localizes at multiple sites impacting what signs appear.3

Disease prevention methods such as controlling primary diseases like PRRSv, as well as vaccination with Para Shield® against H. parasuis, can help piglets during stressful periods such as

weaning and commingling.

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RELIABLE RESPIRATORY DISEASE TREATMENT

Denagard® LC treats swine pneumonia caused by Actinobacillus pleuropneumoniae (APP), a highly contagious disease often characterized by sudden onset, short clinical course, high

morbidity, and high mortality.3

Survivors of the disease often remain carriers, and exhibit chronic coughing and slow growth due to lung adhesions and abscesses that form in recovered lungs.3

Adding Denagard LC to water for treatment for five days, especially during stressors such as weaning and commingling, can reduce mortality and the overall impact of APP.3

Dependable. Effective.

Treatment. Directions for Use, Page 16

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Safe. Smooth. Effective.Directions for Use, Page 17

PRRS CONTROL FROM THE START

PRRS increases mortality and reduces growth performance of wean-to-finish pigs.4 Prevacent® PRRS has proven effective against the respiratory form of PRRS in healthy pigs at least 2 weeks of age or older.

Prevacent is a safe and effective vaccine that does not cause a reduction in growth performance as a result of vaccination, ensuring a strong start for just-weaned piglets.5, 6, 7, 8

With at least 26-weeks of demonstrated duration of immunity, a single 1 mL Prevacent dose is a safe and effective solution to get Full Value from the start.9, 10

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11 mLdose

93.2%reduced lung

lesions7, 8

Safeless* spread and shed11

Lineage 1contemporary & homologous

26weeks

immunity9, 10

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VIREMIA IN VACCINATED ANIMALS11

SAFE & EFFECTIVE, WITH LESS† SPREAD11

Prevacent did spread from vaccinates to controls, but at a lesser† frequency than Ingelvac. Despite spreading of vaccine virus, Prevacent caused less viremia in controls than Ingelvac.

CT VALUE OF CONTROLS AT TIME OF REMOVAL11

†Differences were not always statistically significant.

Viremia in Vaccinated Animals37.0

35.0

33.0

31.0

29.0

27.0

25.0

23.0

21.0

Mea

n C

T v

alue

Study Day

*Statistically di�erent P<0.05Ingelvac PRRS® MLV Prevacent PRRS

0 7 14* 21* 28* 35* 42 49 56 63 70

>3710.0%

25-3020.0%

<2510.0%

30-3530.0%

35-3730.0% 32.0

Mean CT at removalPrevacent Controls

<2580.0%

30-3520.0%

24.4Mean CT at removal

Ingelvac Controls

P-value = 0.002

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Quick.Flexible. Effective.Directions for Use, Page 18

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FLEXIBLE SRD CONTROL, NO INJECTIONS

Pulmotil® sets a foundation for health management by controlling swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae and Pasteurella multocida. Feeding Pulmotil for the duration of

lactation (21 days) to control respiratory disease in lactating sows decreases mortality in the farrowing and nursery phase.12

Its unique mode of action delivers the active ingredient rapidly to the site of infection, and works with the pig’s immune system concentrating at high levels throughout the respiratory tract to

help pigs fight off respiratory pathogens.13, 14

Attached lungs, caused by respiratory disease lesions in the nursery, remain even after the pig recovers — leading to performance losses and packer penalties.15††

ESTIMATED PERFORMANCE LOSS FROM RESPIRATORY DISEASE15

Normal LungEffected / Severity: 1-10%ADG Reduction: 3%

PneumoniaEffected / Severity: 21-30%ADG Reduction: 15%

Severe PneumoniaEffected / Severity: 41-50%ADG Reduction: 24%

††Based on calculations by E. Stevermer. 1987. Respiratory diseases cut profits.

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Quick. Effective.

Easy. Directions for Use, Page 18

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PRRS-INDUCED SRD CONTROL

Pulmotil® AC quickly and effectively manages SRD associated with Mycoplasma hyopneumoniae (Myco) in the presence of PRRSv without the need to formulate new rations, or invest the additional time and labor

associated with individual pig injections.

PRRS impairs natural disease-fighting macrophages, increasing susceptibility to other bacteria. Pulmotil’s unique mode of action concentrates in pulmonary macrophages, slowing the effectiveness of the

PRRSv replication process and killing bacteria associated with swine respiratory disease.16, 17

As the only FDA-approved aqueous concentrate that controls swine respiratory disease associated with Myco in the presence of PRRSv, Pulmotil AC is easy to implement.

Requiring only five days of continuous use, start and stop as needed.

EFFECTIVENESS IN PRRSv AND MYCO CO-INFECTION18

Lung lesion percentage results, following 5-day Pulmotil AC treatment.

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Control

43.04%Pulmotil AC

31.74%

Treatment groupCo-infection (Myco + PRRSv)

P-value = 0.0004

Co-infections with PRRS and secondary bacterial pathogens

exacerbate SRD outbreaks

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A TRUSTED PNEUMONIA SOLUTION

Tylan® Injection is a cost-effective multi-control solution trusted for more than 30 years.

Treating pneumonia and erysipelas both, Tylan Injection along with good sanitation can limit overall herd transmission.

Tylan Injection is also effective at treatment of swine dysentery when followed by appropriate water or feed medication.

EFFECTIVE ATROPHIC RHINITIS CONTROL

Atrophic rhinitis (AR) signs, including sneezing, snorting and nasal discharge, may appear in pigs as young as one week

of age. AR reduces growth of infected piglets.19 Providing protection early in a pig’s

life can prevent them from the impact of AR.

Secondary respiratory infections have been linked to AR19, opening opportunity for further health distress

in weaned pigs.

Passed colostral immunity from protected or immune gilts and sows provides their piglets with

some immunity against the agents that cause AR.19 Vaccination may also

provide an effective solution.

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Effective. Prevention.Piglet benefit.Directions for Use, Page 19

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Effective. Multi-disease. Treatment. Directions for Use, Page 19

ENTERICSOLUTIONS

Enteric diseases account for multi-million dollar annual economic losses to the

food animal industry due to reduced weight gain, mortality of young animals

and treatment costs.20 Effective prevention and control of enteric diseases is

critical to maintain production efficiency, enhance food security and safety, and

animal well-being.20 Elanco offers feed additive and water-soluble solutions for a strong start in just-weaned pigs.

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RELIABLE ENTERIC DISEASE MANAGEMENT

Denagard® effectively controls swine dysentery (SD), a highly contagious, difficult to control and slow immunity generating disease2 and porcine proliferative enteropathies-ileitis (PPE-ileitis), the number one enteric disease in the U.S.21

With both SD and ileitis, impacts on growth can be significant. In addition to treatment costs and mortality, reductions in growth and average daily

gain (ADG) can lead to production losses.

Controlling anticipated disease challenges through whole-herd treatment with pulse dosing or continuous medication mitigates

clinical and unseen impacts on animal health and growth.

DENAGARD* TRIAL RESULTS22

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Dependable. Effective. Control.Directions for Use, Page 16

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Lower overall incidence of

disease**

Respiratory disease, diarrhea

and lameness reduced

Resulting benefits** Reduced

treatments

Health impact on growth**

*Denagard + CTC**Compared to controlTreatment 1 = Negative control (no medication)Treatment 2 = Denagard 35 grams/ton + 400 grams/ton CTC from day 7 to 20 and day 49 to 62

(As a result of feeding according to label directions)

3.5 lbsHeavier final weight

1.4%Better ADG

Increase activity against labeled pathogens and

enlarge the spectrum of

control

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POST-WEANING DIARRHEA CONTROL

Post weaning, incomplete immune systems leave young pigs vulnerable. Diarrhea is a typical sign of disease challenge in the nursery phase. One of the most important causes of post-weaning diarrhea (PWD) in pigs, pathogenic E. coli-induced diarrhea, ranks

among the most common diseases overall in global swine production.23

When fed according to label directions, Kavault® inhibits the production of E. coli pili, reducing its ability to attach to the gut wall and induce diarrhea.24, 25, 26

Due to the contagious nature of E. coli, all pigs (including those not scouring) should be treated.27 Kavault should be fed to pigs that are at risk of developing, but not yet showing signs, of diarrhea in

the presence of pathogenic E. coli.

KAVAULT REDUCTION IN DIARRHEA DAYS28

> 0 score = No visual signs Means with differing superscripts are statistically different P < 0.05

Weaned pigs are at risk during nursery phase

29Trial data shows up to a 22-day risk period for disease onset following weaning

Inhibit.Prevent. Protect.

Directions for Use, Page 17

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0

Per

cent

of

Day

s D

iarr

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> 0

Day 1-21 Day 22-42

ControlKavault % diarrhea days reduction

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a

b

b

52.3%

68.4%

11.45

5.46

3.20

1.01

1.4%Better ADG

22days of

vulnerability

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Quick.Easy. Effective.Directions for Use, Page 19

EFFECTIVE ILEITIS CONTROL

Tylan® Soluble effectively controls ileitis, the number one enteric disease in the U.S.21, by accumulating in the cells of the swine intestinal lining where the infection occurs.30

Often associated with stressors, outbreaks are difficult to eliminate. Treatment after periods of stress and during outbreaks is necessary to control PPE.

Tylan Soluble, which is mixed into drinking water for swine, offers effective PPE ileitis control when followed immediately by Tylan Type A Premix in complete feed.

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SAFETYINFORMATION

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The labels contain complete use information, including cautions and warnings.Always read, understand and follow the label and use directions.

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DIRECTIONS FOR USE• For control of swine dysentery associated with

Brachyspira hyodysenteriae susceptible to tiamulin: Feed 35 g/ton continuously as sole ration (2-day withdrawal).

• For treatment of swine dysentery associated with Brachyspira hyodysenteriae susceptible to tiamulin: Feed 200 g/ton for 14-days for treatment (7-day withdrawal).

• For control of ileitis associated with Lawsonia intracellularis susceptible to tiamulin: Feed 35 g/ton for not less than 10 days (2-day withdrawal).

• + CTC: For control of swine dysentery associated with Brachyspira hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by Pastuerella multocida sensitive to chlortetracycline.

IMPORTANT SAFETY INFORMATION• Swine being treated with Denagard (tiamulin

hydrogen fumarate) should not have access to feeds containing polyether ionophores (e.g. lasalocid, monensin, narasin, salinomycin and semduramicin) as adverse reactions may occur.

• If signs of toxicity occur, discontinue use.• Withdraw 7 days before slaughter at 200 g/ton and

2 days before slaughter at 35 g/ton.• Keep out of reach of children. Avoid contact with

skin.• For use in swine only.• The effects of tiamulin on swine reproductive

performance, pregnancy and lactation have not been determined.

DIRECTIONS FOR USE• For treatment of swine dysentery associated

with Brachyspira hyodysenteriae susceptible to tiamulin: Utilize Denagard LC in drinking water at 3.5 mg/lb (60 ppm) for five days.

• For treatment of swine pneumonia associated with Actinobacillus pleuropneumoniae susceptible to tiamulin: Utilize Denagard LC in drinking water at 10.5 mg/lb (180 ppm) for five consecutive days.

IMPORTANT SAFETY INFORMATION• Swine being treated with Denagard (tiamulin

hydrogen fumarate) should not have access to feeds containing polyether ionophores (e.g. lasalocid, monensin, narasin, salinomycin and semduramicin) as adverse reactions may occur.

• If signs of toxicity occur, discontinue use of medicated water and replace with clean, fresh water.

• Withdraw medicated water 3 days before slaughter after treatment at 3.5 mg/lb and 7 days before slaughter following treatment at 10.5 mg/lb.

• Keep out of reach of children. Avoid contact with skin.

• For use in drinking water of swine only. Prepare fresh medicated water daily. The effects of tiamulin on swine reproductive performance, pregnancy and lactation have not been determined.

• If no response to treatment is obtained within 5 days re-establish the diagnosis.

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INDICATIONFor the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli in groups of weaned pigs.

DIRECTIONS FOR USE• Feed at 73 grams avilamycin per ton of Type C

medicated feed (80 ppm) as the sole ration for 21 consecutive days. The veterinarian may direct feeding for up to a total of 42 consecutive days, based on clinical assessment. Feed to pigs that are at risk of developing, but not yet showing signs of diarrhea in the presence of pathogenic Escherichia coli.

IMPORTANT SAFETY INFORMATIONCAUTION: Federal law restricts medicated feed containing this veterinary feed directive drug to use by or on the order of a licensed veterinarian.

• No withdrawal period required when fed according to the label.

• To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or older or for more than a lifetime total of 42 days.

• VFD expiration date must not exceed 90 days from the date of issuance. VFDs for avilamycin shall not be refilled.

• Avilamycin has not been demonstrated to be effective in pigs showing clinical signs of diarrhea prior to the start of medication.

• Avoid inhalation, oral exposure, and direct contact with skin or eyes.

INDICATIONTo aid healthy swine in the prevention of disease caused by Haemophilus parasuis.

DOSAGE AND ADMINISTRATIONVaccinate with 1 mL dose at 3-4 weeks of age and again in 2-3 weeks. Revaccinate annually or as recommended.

INDICATIONThis product has been shown to be effective for the vaccination of healthy pigs 2 weeks of age or older against PRRS disease, respiratory form. At least a 26-week duration of immunity has been established. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

This product has not been tested in pregnant animals. For use in PRRS virus positive herds only. Not for use in breeding age boars.

DOSAGE AND ADMINISTRATIONRehydrate with the accompanying sterile diluent. Shake well and draw back into the syringe the required amount. Administer 1 mL intramuscularly. The need for annual booster vaccinations has not been established for this product; consultation with a veterinarian is recommended.

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DIRECTIONS FOR USE• For the control of swine respiratory disease

associated with Actinobacillus pleuropneumoniae and Pasteurella multocida, feed continuously at 181–363 g/ton for a 21-day period, beginning approximately 7 days before an anticipated outbreak.

IMPORTANT SAFETY INFORMATIONCAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

• Feeds containing tilmicosin must be withdrawn 7 days prior to slaughter.

• Do not feed more than 21 days during each phase of production without ceasing administration for reevaluation of antimicrobial use by a licensed veterinarian before re-initiating a further course of therapy with an appropriate antimicrobial.

• VFD expiration date must not exceed 90 days from time of issuance. VFDs shall not be refilled.

• Safety has not established in male swine intended for breeding.

• Do not allow horses or other equines access to feeds containing tilmicosin.

DOSAGE• Feed continuously at 181-363 g/ton for a 21-day

period, beginning approximately 7 days before an anticipated outbreak.

USE• For the control of swine respiratory disease

associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

DIRECTIONS FOR USE• For the control of swine respiratory disease

associated with Pasteurella multocida and Haemophilus parasuis, as well as Mycoplasma hyopneumoniae in the presence of porcine reproductive and respiratory syndrome virus in groups of swine in buildings where a respiratory disease outbreak is diagnosed, feed 200 mg/L of water for 5 consecutive days.

DOSAGE AND ADMINISTRATION

• Must be diluted before administration to animals. Include in the drinking water to provide a concentration of 200 mg tilmicosin per liter (200 ppm). One 960 ml bottle is sufficient to medicate 1200 liters (320 gallons) of drinking water for pigs. The medicated water should be administered for (5) five consecutive days. Use within 24 hours of mixing with water. Do not use rusty containers for medicated water as they may affect product integrity. When using a water medicating pump with a 1:128 inclusion rate, add 1 bottle (960 ml) of Pulmotil AC per 2.5 gallons of stock solution.

IMPORTANT SAFETY INFORMATIONSee label for complete safety and use information, including boxed human warning.

Before using this product, it is important to read the entire product insert, including the boxed human warning.

WARNING: Exposure to tilmicosin in humans has been associated with chest pain, increased heart rate, dizziness, headache, and nausea. Death has been reported following ingestion or injection of tilmicosin. Avoid direct skin and eye contact. In case of human exposure, call 1-800-722-0987 and consult a physician immediately.

• Wear overalls, impervious gloves and eye protection when mixing and handling the product. Wash hands after handling the product. Wash affected parts if skin contact occurs. If accidental eye contact occurs, immediately rinse thoroughly with water.

• CAUTION: Pulmotil AC is to be used by, or on the order of, a licensed veterinarian.

• Concurrent use of Pulmotil AC and another macrolide by any route, or use of another macrolide immediately following this use of Pulmotil AC is not advised.

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• Ensure that pigs have continuous access to medicated water during the treatment period. Monitor pigs for signs of water refusal and dehydration while being treated.

• For use only in swine. Not for injection. Injection of tilmicosin has been shown to be fatal in swine and non-human primates, and may be fatal in horses and goats.

• Swine intended for human consumption must not be slaughtered within 7 days of treatment.

• Always treat the fewest number of animals necessary to control a respiratory disease outbreak. Prescriptions shall not be refilled.

INDICATIONIn swine, Tylan 200 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.

Inject intramuscularly 4 mg per lb of body weight (1 mL per 50 lbs.) twice daily. Treatment should be continued 24 hours following remission of disease signs, not to exceed 3 days. Do not inject more than 5 mL per site.

IMPORTANT SAFETY INFORMATION• Not for human use. Keep out of reach of children.

CAUTION: Adverse reactions, including shock and death, may result from overdose in baby pigs.

• Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.

• Swine intended for human consumption must not be slaughtered within 14 days of the last use.

• Tylan 200 Injection: Use automatic syringe equipment only. Do not attempt injection into pigs weighing less than 25 pounds with the common syringe. Use Tylan 50 Injection in pigs weighing less than 25 pounds.

• Tylan 50 Injection: Do not attempt injection into pigs weighing less than 6.25 pounds (0.5 mL) unless the syringe is capable of accurately delivering 0.1 mL.

INDICATION• For the treatment and control of swine dysentery

(SD) associated with Brachyspira hyodysenteriae.• For the control of porcine proliferative

enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed by Tylan Type A medicated article in feed.

DIRECTIONS FOR USE• Feed 40 to 100 grams of tylosin per ton of

complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin (as Tylan Soluble) per gallon in drinking water for 3 to 10 days.

IMPORTANT SAFETY INFORMATIONCAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

• Not for human use. Keep out of reach of children. Avoid contact with skin.

• Always add the water to the powder. Do not pour the powder into the water. Prepare a fresh Tylan Soluble solution every three days. When mixing and handling tylosin, use protective clothing and impervious gloves.

• Only medicated water should be available while medicating with Tylan Soluble.

INDICATION• To aid healthy swine in the prevention of atrophic

rhinitis caused by Bordetella bronchiseptica or the toxin of Pasteurella multocida Types A and D, erysipelas caused by Ersipelothrix rhusiopathiae and pneumonia caused by Pasteurella multocida Type A.

• Nursery: Vaccinate with 1 mL dose at 7-10 days of age and 2 mL dose two weeks later.

• Sows/gilts: Vaccinate with 5 mL at 5 weeks and 2 weeks prior to farrowing.

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IndicationsChickens: For the control of mortality caused by necrotic enteritis (NE) associated with Clostridium perfringens in broiler chickens. As an aid inthe treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum in broiler and replacement chickens.For the control of CRD associated with Mycoplasma gallisepticum atthe time of vaccination or other stress in chickens. For the control of CRD associated with Mycoplasma synoviae in broiler chickens.

Turkeys: For the reduction in severity of effects of infectious sinusitis associated with Mycoplasma gallisepticum.

Swine: For the treatment and control of swine dysentery (SD) associated with Brachyspira hyodysenteriae. For the treatment and control of SDassociated with Brachyspira hyodysenteriae when followed immediatelyby Tylan Type A medicated article in feed. For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by Tylan Type Amedicated article in feed.

Honey Bees: For the control of American Foulbrood (Paenibacillus larvae).Ingredients

Tylosin (as tylosin tartrate) ..................................................................100 gDosage and Administration

Dosages:Chickens: NE indication: 851 to 1,419 mg/gallon (225 to 375 ppm) in drinking water. CRD indications: 2,000 mg/gallon (528 ppm) in drinking water.Turkeys: 2,000 mg/gallon (528 ppm) in drinking water.Swine: 250 mg/gallon (66 ppm) in drinking water.Honey Bees: 200 mg/colony in confectioners/powdered sugar.

Mixing Directions for Medicated Drinking Water:Always add the water to the powder. Do not pour the powder into the water. Prepare a fresh Tylan Soluble solution every three days. When mixing and handling tylosin, use protective clothing and impervious gloves. If using a water medicating pump see table below, otherwise mix as follows:To assure thorough dissolution, first place the contents of one jar in a mixing container and add one gallon of water (3785 mL) to the powder to make a concentrated solution. To make medicated drinking water containing 250 mg/gallon (66 ppm), mix this concentrated solution with water to make 400 gallons (1514 liters) of medicated drinking water. To make medicated drinking water containing 851 to 1,419 mg/gallon (225 to 375 ppm), mix this concentrated solution with water to make from 117 gallons + 51 ounces (444 liters) to 70 gallons + 64 ounces (267 liters) of medicated drinking water, respectively. To make medicated drinking water containing 2,000 mg/gallon (528 ppm), mix this concentrated solution with water to make 50 gallons (189 liters) of medicated drinking water.

Equivalent to 100 g (3.53 oz) tylosin baseCAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in chickens, turkeys, swine, and honey bees. Macrolide Antibiotic, NADA 13-076, approved by FDA

AF1300

Tylosin Tartrate

AF1300 YL101681X W1b

Mixing Directions for Water Medicating Pump (1:128 inclusion)*:Desired Concentration Jars of Volume of Water to Make

in Drinking water Tylan Soluble Stock Solution250 mg/gallon (66 ppm) 1 3 gallons + 13 ounces

851 mg/gallon (225 ppm) 5 4 gallons + 77 ounces1,419 mg/gallon (375 ppm) 9 5 gallons + 0 ounces2,000 mg/gallon (528 ppm) 10 3 gallons + 115 ounces

*This table applies only if the water medicating pump is set to deliver1 ounce of stock solution per gallon of drinking water.Mixing Directions for use in Honey Bees: Mix 200 mg tylosin in20 g confectioners/powdered sugar. Use immediately.

Directions for UseChickens: NE indication: Administer medicated drinking water for a single five day period in broiler chickens. To assure all birds receive the intended medication, only medicated water should be available. These practices should be followed to assure both food safety and responsible antimicrobial drug use in chickens: 1) Use in flocks exhibiting signs of a necrotic enteritis outbreak, for example, increased mortality and lesions characteristic of necrotic enteritis upon necropsy; 2) Administer the full dose and dosing regimen once medication is initiated; 3) Use of Tylan Soluble or another macrolide is not advised if additional therapy is needed beyond the original course of medication. CRD indications: Administer medicated drinking water for three days; however, medicated water may be administered for one to five days depending upon severity of infection. Treated chickens must consume enough medicated water to provide 50 mg per pound of body weight per day. Only medicated water should be available to the birds.Turkeys: Administer medicated drinking water for three days; however, medicated water may be administered for two to five days depending upon severity of infection. Treated turkeys must consume enough medicated water to provide 60 mg per pound of body weight per day. Only medicated water should be available to the birds.Swine: SD indication: Administer medicated drinking water for 3 to 10 days, depending upon severity of infection. Alternatively, administer medicated drinking water for 3 to 10 days, followed by 40 to 100 g tylosin per ton of complete feed (Type C medicated feed manufactured from Tylan Type A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while medicating with Tylan Soluble. PPE indication: Administer medicated drinking water for 3 to 10 days, followed by 40 to 100 g of tylosin per ton of complete feed (Type C medicated feed manufactured from Tylan A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while medicating with Tylan Soluble.Honey Bee Colonies: Administer three treatments of medicated confectioners sugar once weekly for 3 weeks. The 200 mg dose is applied (dusted) over the top bars of the brood chamber.

WarningsUser Safety Warnings: Not for Human Use. Keep Out of Reach of Children. Avoid contact with human skin. Exposure to tylosin may cause a rash.

Residue Warnings: Chickens must not be slaughtered for food within 24 hours after treatment. Do not use in layers producing eggs for human consumption. Turkeys must not be slaughtered for food within five days after treatment. Swine must not be slaughtered for food within 48 hours after treatment. Honey bees: The drug should be fed early in the spring or fall and consumed by the bees before the main honey flow begins, to avoid contamination of production honey. Complete treatments at least 4 weeks prior to main honey flow.

Manufactured For:Elanco US, Inc. Store at or below 25°C (77°F)Greenfield, IN 46140 U.S.A. Excursions Permitted to 40°C (104°F)Product of the United Kingdom Avoid Moisture.

Restricted Drug (California) – Use Only as Directed.

To report suspected adverse events, for technical assistance, or to obtain a Material Safety Data Sheet (MSDS), call 1-800-428-4441.

Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

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Aqueous concentrate for oral use in drinking water.For swine only.Macrolide Antibiotic.Do not inject this product. Injection of tilmicosin has been shown to be fatal in swine and non-human primates, and may be fatal in horses and goats.

macrolide by any route is not advised. Use of another macrolide immediately following this use of Pulmotil AC is not advised.Adverse Reactions in Animals: Decreased water consumption was observed in healthy pigs administered tilmicosin in target animal safety studies. Ensure that pigs have continuous access to medicated water during the treatment period. Monitor pigs for signs of water refusal and dehydration while being treated. If decreased water consumption occurs, replace the medicated drinking water with fresh non-medicated water and contact your veterinarian.Clinical Pharmacology: Tilmicosin is a macrolide antibiotic with in vitro antibacterial activity primarily against Gram-positive bacteria, although certain Gram-negative bacteria are also susceptible. Macrolides interfere with bacterial protein synthesis by reversibly binding to the 50S subunit of the ribosome. They are typically regarded as being bacteriostatic, but at high concentrations can be bactericidal. When administered orally to pigs via the drinking water, tilmicosin is rapidly absorbed and slowly eliminated from the body. Tilmicosin distributes rapidly to the target tissues. Detectable levels are found in lung tissue as early as 6 hours and peak at about 5 days after the commencement of treatment. The relationship of serum tilmicosin concentration to lung tilmicosin concentration or the concentrations in bronchial secretion has not been determined. In addition, the extent to which total lung concentrations represent free (active) drug has not been defined. Therefore, no conclusions can be made with regard to the clinical relevance of elevated tilmicosin concentrations in the lung. Tilmicosin has been shown to concentrate within alveolar macrophages. It is also found at fairly high concentrations in liver and kidney tissue, as it is excreted both via the bile into the feces and also via the urine.Effectiveness: The effectiveness of Pulmotil AC for the control of SRD associated with P. multocida and H. parasuis was confirmed in a natural infection field study across six U.S. sites. A total of 960 commercial-type grower pigs were enrolled and assigned to the tilmicosin-treated group (200 mg tilmicosin/L in drinking water for 5 consecutive days), or a non-medicated control group. Pigs that 1) were found dead and were diagnosed with SRD, or 2) had a depression score and a respiratory score ≥ 2 (on a scale from 0 [normal] to 3 [severe]) and a rectal temperature of ≥ 104.5 °F were considered clinically affected. At each site, treatments were initiated when at least 15% of the pigs were classified as clinically affected. After the 5-day treatment period and a 4-day post-treatment period, pigs were evaluated for treatment success (respiration and depression scores of 1 or 0 and rectal temperature < 104.5 °F), and were euthanized and evaluated for lung lesions. A significantly higher (p = 0.0118) success rate (based on back-transformed least squares means) was detected for the tilmicosin-treated group (275/473, 58.64%) compared to the control group (230/475, 47.89%).The effectiveness of Pulmotil AC for the control of SRD associated with M. hyopneumoniae in the presence of PRRSV was confirmed in an induced infection model study. A total of 340 commercial-type pigs were enrolled and challenged with M. hyopneumoniae (single infection) or M. hyopneumoniae and PRRSV (co-infection). When necropsied sentinel pigs had at least 5% lung lesion involvement, study pigs were treated with Pulmotil AC (200 mg tilmicosin/L in drinking water) or non-medicated water for 5 consecutive days. After the 5-day treatment period and a 4 day post-treatment period, pigs were euthanized and evaluated for lung lesions. For both the single infection and co-infection groups, the lung lesion percentage was statistically significantly different (p = 0.005 and p = 0.0004, respectively) in favor of the tilmicosin phosphate-treated group (21.01% and 31.74%, respectively) compared with the control group (28.26% and 43.04%, respectively).Animal Safety: A pharmacokinetic study was conducted to evaluate Pulmotil AC concentrate solution in pigs. The results were compared to pharmacokinetic data generated with Pulmotil 90 Type A medicated article (NADA 141-064). The data demonstrates that blood and tissue levels of tilmicosin when administered to pigs at 200 mg/L (ppm) in water were consistently lower than when tilmicosin was administered to pigs at 181 g/ton (200 ppm) in feed.A target animal safety study was conducted to evaluate the tolerance of Pulmotil AC concentrate solution in pigs when administered in drinking water. Twenty pigs were administered medicated water at 0, 200, 400, or 600 mg/L (0, IX, 2X, or 3X the labeled dose) for 5 consecutive days or 200 mg/L for 10 consecutive days. No treatment-related lesions were observed in any animals at necropsy. Water consumption was decreased in all tilmicosin-treated groups compared to the non-medicated group. One pig in the 600 mg/L group was euthanized due to decreased water consumption, neurological signs attributed to severe dehydration, and subsequent refusal to drink non-medicated water. Two pigs in the 400 mg/L group had reduced water intake and displayed mild clinical signs attributed to dehydration. One pig recovered after being offered non-medicated water. The second pig completed the treatment regimen without intervention.Hydration and water consumption were evaluated during the control of SRD effectiveness field study. Tilmicosin was administered to study pigs in drinking water at 200 mg/l for 5 consecutive days. There was no statistically significant difference in water consumption between tilmicosin-treated pigs and pigs receiving non-medicated water. A subset of study pigs (20 tilmicosin-treated pigs and 20 non-medicated pigs) were evaluated for hydration via a physical examination and analysis of blood samples for hematocrit, total protein, creatinine, and blood urea nitrogen. There were no abnormal physical examination findings or clinically relevant differences in clinical pathology variables between tilmicosin-treated pigs and pigs receiving non-medicated water.How Supplied: Pulmotil AC is provided in a 960 ml amber-colored plastic bottle sealed with a plastic screw cap. Storage Conditions:Store at or below 86° F (30° C). Protect from direct sunlight.Restricted Drug (California) - Use Only as DirectedNADA # 141-361, Approved by FDAManufactured For:Elanco US Inc.Greenfield, IN 46140, USAPulmotil, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

WARNINGExposure to tilmicosin in humans has been associated with chest pain, increased heart rate, dizziness, headache, and nausea. Death has been reported following ingestion or injection of tilmicosin. Avoid ingestion. Avoid direct skin and eye contact. In case of human exposure, call 1-800-722-0987 and consult a physician immediately.NOTE TO THE PHYSICIAN:The cardiovascular system is the target of toxicity and should be monitored closely. The primary cardiac effects are tachycardia and decreased contractility. Cardiovascular toxicity may be due to calcium channel blockade.See User Safety Warnings for additional information.

960 ml

tilmicosin phosphate (250 mg/ml tilmicosin)

™

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.Active Drug Ingredient: tilmicosin (as tilmicosin phosphate) 250 mg/mlDescription: Pulmotil is a formulation of the antibiotic tilmicosin. Tilmicosin is produced semi-synthetically and is in the macrolide class of antibiotics. Each milliliter (mL) of Pulmotil aqueous concentrate solution contains 250 mg of tilmicosin.Indications: For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.Dosage and Administration: Must be diluted before administration to animals. Include in the drinking water to provide a concentration of 200 mg tilmicosin per liter (200 ppm). One 960 ml bottle is sufficient to medicate 1200 liters (320 gallons) of drinking water for pigs. The medicated water should be administered for (5) five consecutive days.Use within 24 hours of mixing with water. Do not use rusty containers for medicated water as they may affect product integrity.When using a water medicating pump with a 1:128 inclusion rate, add 1 bottle (960 ml) of Pulmotil AC per 2.5 gallons of stock solution.WARNINGS:USER SAFETY WARNINGS: FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. SEE BOXED WARNING AND NOTE TO THE PHYSICIAN FOR ADDITIONAL INFORMATION. Wear overalls, impervious gloves and eye protection when mixing and handling the product. Wash hands after handling the product. Wash affected parts if skin contact occurs. If accidental eye contact occurs, immediately rinse thoroughly with water. To report suspected adverse events, for technical assistance, or to obtain a Material Safety Data Sheet (MSDS), call 1-800-428-4441.

RESIDUE WARNING: Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this product.

Note to the Physician:The cardiovascular system is the target of toxicity and should be monitored closely. Cardiovascular toxicity may be due to calcium channel blockade. In dogs, administration of intravenous calcium offset tilmicosin-induced tachycardia and negative inotropy (decreased contractility). Dobutamine partially offset the negative inotropic effects induced by tilmicosin injection in dogs. ß-adrenergic antagonists, such as propranolol, exacerbated the negative inotropy of tilmicosin injection in dogs. Epinephrine potentiated lethality of tilmicosin injection in pigs. This antibiotic persists in tissues for several days.Precautions:Do not allow horses or other equines access to water containing tilmicosin. The safety of tilmicosin has not been established in male swine intended for breeding purposes.Always treat the fewest number of animals necessary to control a respiratory disease outbreak. Prescriptions shall not be refilled. Concurrent use of Pulmotil AC and another

AH0470 YL209855X W1b

1USDA APHIS Veterinary Services. October 2007. “Swine 2006, Part 1: References of Swine Health and Management Practices in the United States, 2006.”2Merck & Co. 2008. “Respiratory Disease of Pigs: Introduction.” The Merck Veterinary Manual. Accessed 3/31/09. www.merckvetmanual.com/mvm/htm/bc/121400/htm.3Iowa State University. AAP. Available at: https://vetmed.iastate.edu/vdpam/FSVD/swine/index-diseases/actinobacillus-pleuropneumoniae. Access on December 6, 2019. 4Iowa State University. Porcine Reproductive and Respiratory Syndrome (PRRS). Available at: https://vetmed.iastate.edu/vdpam/FSVD/swine/index-diseases/porcine-reproductive. Accessed September 20, 2019. 5Elanco Animal Health. Data on file. 6Elanco Animal Health. Data on file. 7Elanco Animal Health. Data on file. 8Elanco Animal Health. Data on file. 9Elanco Animal Health. Data on file. 10Elanco Animal Health. Data on file. 11Elanco Animal Health. Data on file12Almond, G., Eads, K. and Keffaber, K. 2006. “Assessment of the Therapeutic Effect of Tilmicosin in Lactation Feed.” Proc. 19th IPVS Congress: 523.13Blais, L. and S. Chamberland. 1994. Intracellular accumulation of tilmicosin in primary swine alveolar macrophages. IPVS Congress. 14Elanco Animal Health. Data on file. 15Keenliside, J. 2005. Preventing carcass losses. The Pig Site. Retrieved from: https://thepigsite.com/articles/preventing-carcass-losses. Accessed Sept 20, 2019.16Rossow, K.D. 1998. South Dakota State University. Porcine reproductive and respiratory syndrome. The American College of Veterinary Pathologists 35: 1-20. 17Blais, J. 1994. Intracellular accumulation of tilmicosin in primary swine alveolar macrophages. Food and Agriculture Organization of the United Nations.18Freedom of Information Summary. 2014. NADA 141-361.19Iowa State University. Atrophic Rhinitis. Available at: https://vetmed.iastate.edu/vdpam/FSVD/swine/index-diseases/atrophic-rhinitis. Accessed December 8, 2019. 20Enteric Diseases of Food Animals: Enhanced Prevention, Control and Food Safety. https://www.nimss.org/projects/view/mrp/outline/18356. Accessed December 8, 2019. 21Lehe, K. and Watkins, L. 2003. “Case study: Effect of Pulmotil on mortality and growth in nursery pigs with clinical PRDC initiated by PRRSV.” Proc. AASV: 129-130.22Elanco Animal Health. Data on file. 23Fairbrother, J., Nadeau, E., and Gyles, C.2005. “Escherichia coli in Postweaning diarrhea in pigs: an update on bacterial types, pathogenesis, and prevention strategies.” Anim. Health Res. Rev. 6(1): 17-39.24“Avilamycin Premix 1 - Aid in the Control of Post-Weaning Diarrhea in Swine,” International Summary Dossier Supplement,June 30, 2005.25Rostagno M., Pelger. G. “Exposure to the antibiotic avilamycin inhibits E. coli fimbriae and attachment.” IPVS 2014, Pg. 246.26Elanco Animal Health. Data on file. 27Iowa State University. E. coli. Available at: https://vetmed.iastate.edu/vdpam/FSVD/swine/index-diseases/Ecoli-diarrhea. Accessed on December 5, 2019. 28Marsteller, T. et.al. Effectiveness of avilamycin (Kavault) for reducing the incidence and severity of colibacillosis in post-weaned pigs. 47th American of Swine Veterinarians Annual Meeting: 154. 2016. 29Erlandson, K. et.al. “Characterization of nursery pig colibacillosis in a natural infection study.” Allen D. Leman Swine Conference 2015, Abstracts, 42:32.30Paradis, M. et al. 2005. “Subclinical ileitis produced by sequential dilutions of Lawsonia intracellularis in a mucosal homogenate challenge model.” Proc. AASV: 189-192

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