Sentinel

Lufenuron:

• Information for dosing dogs
• Introduction
• Warnings
• Administration
• Description
• Indications
• Precautions
• Flea infestations on dogs
• Dosage
• Once a month
• Adverse reactions
• How supplied
• Storage conditions
• Flea management sysytem
• Warnings
• Directions
• Step 1: prevention and control
• Step 2: kill adult fleas
• Dosage
• Adverse reactions
• Other information
• Flea infestations on dogs
• Storage conditions
• Information for dosing cats
• Introduction
• Warnings
• Administration
• Description
• Indications
• Precautions
• Flea infestations on cats
• Dosage
• Once a month
• Adverse reactions
• How supplied
• Storage conditions
• Flea management sysytem
• Warnings
• Directions
• Step 1: prevention and control
• Step 2: kill adult fleas
• Dosage
• Adverse reactions
• Other information
• Flea infestations on cats
• Storage conditions
• Sentinel (Lufenuron) reviews

PROGRAM® (LUFENURON) Flavor Tabs®

Information for Dosing Dogs

The flavored once-a-month tablet that prevents and controls flea populations in dogs.

Introduction

Novartis Animal Health encourages you to take the time to read this package insert, which describes the use of PROGRAM® (lufenuron) Flavor Tabs® as a convenient monthly flea control treatment. Controlling flea infestations is very important to the health of your pet.

Warnings

Not for human use. Keep this and all drugs out of the reach of children.

Administration

Be certain the dog consumes the entire tablet or tablets. As an alternative to direct dosing, tablets may be offered in food. Watch the dog closely following dosing to be sure the entire dose has been consumed. If it is not entirely consumed, redose once with the full recommended dose as soon as possible.

Treatment with Sentinel (Lufenuron) may begin at any time of year. In geographic areas where flea infestations are seasonal, the treatment schedule should begin several weeks prior to the expected onset of infestations. Treatments should continue until the end of “flea season.” If there is risk of exposure to fleas year-round, then treatment should continue the entire year without interruption. Ask your veterinarian for details concerning your geographic area and the most effective treatment schedule for your pet.

Description

The active ingredient of Sentinel (Lufenuron) is Sentinel (Lufenuron), a benzoylphenyl-urea derivative classified as an insect development inhibitor (IDI).

As an insect development inhibitor, Sentinel (Lufenuron) do not kill adult fleas but effectively and safely control flea populations on your pet by breaking the flea’s life cycle at the egg stage.

Indications

Sentinel (Lufenuron) are labeled for use in dogs and puppies, four weeks of age and older, for the prevention and control of flea populations.

Sentinel (Lufenuron) controls flea populations by preventing the development of flea eggs and does not kill adult fleas. You may also need to use a product that kills adult fleas.

PROGRAM Flavor Tabs may be used along with CAPSTAR® (nitenpyram) Tablets to provide a Flea Management System that kills adult fleas and prevents flea eggs from hatching. Please see the Supplemental Package Insert provided with this product for information about using the two products together.

Without concurrent use of an adulticide, adequate flea control may not be achieved in dogs that have repeated exposure to flea infested animals or environments.

Precautions

Sentinel (Lufenuron) have no effect on adult fleas but act to immediately break the flea life cycle by preventing eggs from developing into adults. However, pre-existing immature fleas in the dog’s environment may continue to develop and emerge as adults after treatment with Sentinel (Lufenuron) has begun. Based on results of clinical studies, this emergence generally occurs during the first 30-60 days. Therefore, if you pet already has a flea infestation before starting Sentinel (Lufenuron), noticeable results may not be observed until several weeks after dosing. In cooler climates, immature fleas may take longer to complete the life cycle and emerge as adults.

To speed control, products that kill adult fleas, like CAPSTAR Tablets may be used temporarily with Sentinel (Lufenuron), depending on the severity of the infestation. Your veterinarian can recommend the most effective treatment plan for your pet.

To ensure that your pet gets the greatest benefit from Sentinel (Lufenuron), you must administer the tablet or tablets once a month in conjunction with a normal meal. If you miss the 30-day interval, give Sentinel (Lufenuron) immediately and resume your monthly dosing schedule. It is important to treat all dogs in the household. Fleas can reproduce on untreated pets and allow infestations to persist. All cats in the household should be treated with an approved product like Sentinel (Lufenuron).

The active ingredient in Sentinel (Lufenuron) is excreted in high concentrations in the milk, however, no resulting adverse effects have been recognized.

Flea Infestations on Dogs

Although other flea species my be found on dogs, the cat flea (Ctenoceph a lides felis) is the predominant flea associated with infestations on dogs in the United States. In addition to the common nuisance irritations associated with infestations, fleas can be responsible for medical problems in your pet such as flea allergy dermatitis (FAD), a skin reaction to flea bites. Fleas also transmit other parasites, including tapeworms. Controlling flea infestations is important to your pet’s health while also reducing the major and minor annoyances associated with these parasites.

The following diagram illustrates the flea’s life cycle and where Sentinel (Lufenuron) acts to break this cycle.

Fleas can be a problem because they reproduce so rapidly. A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood from your dog and subsequently lay eggs that drop off your dog’s coat. Within days, larvae hatch from the eggs and live undetected in your dog’s surroundings, such as the carpet, bedding and other unprotected areas. Flea larvae spin a cocoon, and when appropriately stimulated, a young adult flea emerges and jumps onto your dog to continue the life cycle.

After biting a Sentinel (Lufenuron) treated dog, the female flea ingests Sentinel (Lufenuron) which is deposited in her eggs. Sentinel (Lufenuron) prevents these flea eggs from developing into mature adults. This safe and convenient approach to flea control effectively breaks the flea’s life cycle and controls flea populations.

Life Cycle of the Flea

Dosage

Sentinel (Lufenuron) are given orally, once a month at the recommended minimum dosage of 4.5 mg Sentinel (Lufenuron) per pound (10 mg/kg) of body weight.

Dogs over 90 lbs. should receive the appropriate combination of tablets.

*Please see supplemental insert in this package for concurrent dosing of Sentinel (Lufenuron) and CAPSTAR Tablets.

Once a Month

Sentinel (Lufenuron) will safely and effectively control flea infestations only if administered in conjunction with a normal meal on a monthly dosing schedule. To help you remember the monthly dosing, use the enclosed reminder stickers on the appropriate dates on your calendar.

Adverse Reactions

The following adverse reactions have been reported in dogs after giving Sentinel (Lufenuron): vomiting, depression/lethargy, pruritus (itchy, scratchy skin), urticaria (wheals, hives), diarrhea, anorexia (loss of appetite), and skin congestion (red skin).

How Supplied

Sentinel (Lufenuron) are available in four tablet sizes, formulated according to the weight of the dog. Each tablet size is available in color-coded packages of six tablets each.

Storage Conditions

Sentinel (Lufenuron) should be stored at room temperature between 59º and 77ºF (15-25ºC).

Questions? Comments?

Please call 1-800-332-2761

Visit our website at www.petwellness.com

Manufactured for:

Novartis Animal Health US, Inc.

Greensboro, NC 27408

PROGRAM, CAPSTAR, and Flavor Tabs are registered trademarks of Novartis AG.

NADA # 141-035, Approved by FDA

©2008 Novartis Animal Health US, Inc.

NAH/PRO-FT/PI/3

2003201

01/08

FLEA MANAGEMENT SYSYTEM

Supplemental Product Information

Information for Dosing Dogs

This insert describes the concurrent use of PROGRAM® (lufenuron) Flavor Tabs® and CAPSTAR® (nitenpyram) Tablets for the management of fleas on dogs and puppies. Please read the insert contained in each package for complete information on the individual products prior to dosing.

Warnings

Not for human use. Keep this and all drugs out of reach of children.

Directions

In dogs and puppies the concurrent use of Sentinel (Lufenuron) and CAPSTAR Tablets is indicated to kill adult fleas and prevent eggs from hatching. The effects of Sentinel (Lufenuron), which prevent and control flea populations, and CAPSTAR Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM.

Step 1: Prevention and Control

Give Sentinel (Lufenuron) once per month to prevent and control flea populations. Sentinel (Lufenuron) contain Sentinel (Lufenuron). Sentinel (Lufenuron) controls flea populations by preventing the development of flea eggs and does not kill adult fleas. If a dog currently has a flea infestation, more rapid relief can be accomplished by adding CAPSTAR Tablets to the treatment as follows.

Step 2: Kill Adult Fleas

If your pet currently has a flea infestation, use CAPSTAR Tablets to kill adult fleas. CAPSTAR Tablets contain nitenpyram and are effective for the treatment of flea infestations. Nitenpyram starts killing adult fleas within 30 minutes of administration.

• Administer CAPSTAR Tablets once per week until adult fleas are no longer observed.
  

• For a severe flea infestation, administer CAPSTAR Tablets twice per week until adult fleas are no longer observed.
  

• Additional CAPSTAR Tablets may be administered as needed to kill the occasional adult flea picked up from infested environments.
  

• It is important to treat all cats and dogs in the household. Fleas can reproduce on untreated pets and allow infestations to persist.

Dosage

The combination of Sentinel (Lufenuron) and CAPSTAR Tablets should be administered according to the following schedule. Weigh the dog prior to administration to ensure proper dosage. Do not administer to dogs under 2 pounds.

*If adult fleas are seen

** Dogs over 90 lbs. are provided the appropriate combination of Sentinel (Lufenuron).

Adverse Reactions

The following adverse reactions have been reported in dogs after giving Sentinel (Lufenuron): vomiting, depression/lethargy, pruritus (itch, scratchy skin), urticaria (wheals, hives), diarrhea, anorexia (loss of appetite), and skin congestion (red skin).

Other Information

The safety of the concurrent use of Sentinel (Lufenuron), the active ingredient in Sentinel (Lufenuron) and CAPSTAR Tablets has not been evaluated in puppies less than 11 weeks old.

Flea Infestations on Dogs

In addition to the common nuisance irritations associated with infestations, fleas can be responsible for skin conditions in the dog such as flea allergy dermatitis. Fleas also transmit other parasites, including tapeworms. The control of flea infestations is important to the pet’s health and reduces the problems associated with these parasites.

Sentinel (Lufenuron) break the flea life cycle by inhibiting egg development. CAPSTAR Tablets kill adult fleas on the dog. The concurrent use of these two products provides an effective flea management system.

The following diagram illustrates the flea’s life cycle and where the combination of Sentinel (Lufenuron) and CAPSTAR Tablets work:

A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood from the pet and subsequently lay eggs, which drop off the pet’s coat. Within days, larvae hatch from the eggs and live undetected in the pet’s surroundings, such as the carpet and bedding. Flea larvae spin a cocoon, and when, appropriately stimulated, a young adult flea emerges and jumps onto the pet to continue the life cycle.

After reading this insert, if you have any questions about the concurrent use of Sentinel (Lufenuron) and CAPSTAR Tablets in your dogs, please call Novartis Animal Health Veterinary Product Support at 1-800-332-2761.

Life Cycle of the Flea

Storage Conditions

Store Sentinel (Lufenuron) and CAPSTAR Tablets as described on the individual product inserts.

Questions? Comments?

Please call 1-800-332-2761

Visit our website at www.petwellnesss.com

Manufactured for:

Novartis Animal Health US, Inc.

Greensboro, NC 27408

NADA# 141-205, Approved by FDA

U.S. Patent # 5,750,548

©2008 Novartis Animal Health US, Inc.

PROGRAM, CAPSTAR, and Flavor Tabs are registered trademarks of Novartis AG.

NAH/PFT-FMS/PI/2

2003201

01/08

Information for Dosing Cats

The once-a-month flavored tablet that controls flea populations on cats.

Introduction

Novartis Animal Health encourages you to take the time to read this package insert which describes the use of PROGRAM® (lufenuron) Flavor Tabs® as a convenient monthly flea control treatment. Controlling flea infestations is very important to the health of your cat. After reading this insert, if you have any questions about Sentinel (Lufenuron), flea control, or medical problems associated with flea infestations, consult your veterinarian, who is your pet’s health care expert.

Warnings

Not for human use. Keep this and all drugs out of the reach of children.

Administration

Be certain the cat consumes the entire tablet or tablets. The tablets can be broken prior to direct dosing for ease of administration to small cats and kittens. As an alternative to direct dosing, tablets can be broken and mixed into wet food. In multiple cat households, each cat should be treated separately to achieve adequate dosing. Watch the cat closely following dosing to be sure the entire dose has been consumed. If it is not entirely consumed, redose once with the full recommended dose as soon as possible.

Treatment with Sentinel (Lufenuron) may begin at any time of year. Treatment should continue until the end of “flea season.” If there is risk of exposure to fleas year-round, then treatment should continue the entire year without interruption. Ask your veterinarian for details concerning your geographic area and the most effective treatment schedule for your cat.

Description

Sentinel (Lufenuron) are available in two sizes of tablets for oral administration to cats and kittens according to their weight. The active ingredient of Sentinel (Lufenuron) is Sentinel (Lufenuron), a benzoylphenyl-urea derivative classified as an insect development inhibitor (IDI).

As an insect development inhibitor, Sentinel (Lufenuron) do not kill adult fleas, but effectively and safely control flea populations on your cat by breaking the flea’s life cycle at the egg stage.

Indications

Sentinel (Lufenuron) are indicated for use in cats and kittens, four weeks of age and older, for the control of flea populations.

Sentinel (Lufenuron) controls flea populations by preventing the development of flea eggs and does not kill adult fleas. You may also need to use a product that kills adult fleas.

Sentinel (Lufenuron) may be used along with CAPSTAR® (nitenpyram) Tablets to provide a Flea Management System that kills adult fleas and prevents flea eggs from hatching. Please see the Supplemental Package insert provided with this product for information about using the two products together.

Without concurrent use of an adulticide, adequate flea control may not be achieved in cats that have repeated exposure to flea infested animals or environments.

Precautions

Sentinel (Lufenuron) have no effect on adult fleas, but act to immediately break the flea life cycle by preventing eggs from developing into adults. However, pre-existing immature fleas in the cat’s environment my continue to develop and emerge as adults after treatment with Sentinel (Lufenuron) has begun. Based on results of clinical studies, this emergence generally occurs during the first 30-60 days. Therefore, if your pet already has a flea infestation before starting Sentinel (Lufenuron), noticeable results may not be observed until several weeks after dosing. In cooler climates, immature fleas may take longer to complete the life cycle and emerge as adults.

To speed control, products that kill adult fleas, like CAPSTAR Tablets may be used temporarily with Sentinel (Lufenuron), depending on the severity of the infestation. Your veterinarian can recommend the most effective treatment plan for your pet.

To ensure that your pet gets the greatest benefit from Sentinel (Lufenuron), you must administer the tablet or tablets once a month in conjunction with a normal meal. If you miss the 30-day interval, administer Sentinel (Lufenuron) immediately and resume your monthly dosing schedule. It is important to treat all cats in the household. Fleas can reproduce on untreated pets and allow infestations to persist. All dogs in the household should be treated with an approved product like Sentinel (Lufenuron).

The active ingredient in Sentinel (Lufenuron) is excreted in high concentrations in the milk, however, no resulting adverse effects have been recognized.

Flea Infestations on Cats

Although other flea species my be found on cats, the cat flea (Ctenoceph a lides felis) is the predominant flea associated with infestations on cats in the United States. In addition to the common nuisance irritations associated with infestations, fleas can be responsible for medical problems in your pet such as miliary dermatitis, a skin reaction to flea bites. Fleas also transmit other parasites, including tapeworms. Controlling flea infestations is important to your cat’s health while also reducing the major and minor annoyances associated with these parasites.

The following diagram illustrates the flea’s life cycle and where Sentinel (Lufenuron) acts to break this cycle.

Fleas can be a problem because they reproduce so rapidly. A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood from your cat and subsequently lay eggs that drop off your cat’s coat. Within days, larvae hatch from the eggs and live undetected in your cat’s surroundings, such as the carpet, bedding and other unprotected areas. Flea larvae spin a cocoon, and when appropriately stimulated, a young adult flea emerges and jumps onto your cat to continue the life cycle. After biting a Sentinel (Lufenuron) treated cat, the female flea ingests Sentinel (Lufenuron) which is deposited in her eggs. Sentinel (Lufenuron) prevents these eggs from hatching and developing into mature adults. This safe and convenient approach to flea control effectively breaks the flea’s life cycle and controls flea populations.

Dosage

Sentinel (Lufenuron) are given orally, once a month, at the recommended minimum dosage of 13.6 mg Sentinel (Lufenuron) per pound (30 mg/kg) of body weight.

Cats over 15 lbs. are provided the appropriate combination of tablets.

*Please see the supplemental insert in this package for concurrent dosing of Sentinel (Lufenuron) and CAPSTAR Tablets.

Once a Month

Sentinel (Lufenuron) will safely and effectively control flea infestations only if administered on a monthly dosing schedule. To help you remember the monthly dosing, use the enclosed reminder stickers on the appropriate dates on your calendar.

Adverse Reactions

The following adverse reactions have been reported in cats after giving Sentinel (Lufenuron): vomiting, depression/lethargy, anorexia (loss of appetite), diarrhea, hyperactivity, dyspnea (labored breathing), pruritus (itchy skin) and skin eruptions (rash).

How Supplied

Sentinel (Lufenuron) are available in two tablet sizes, formulated according to the weight of the cat. Each tablet size is available in color-coded packages of six tablets each.

Storage Conditions

Sentinel (Lufenuron) should be stored at room temperature between 59º and 77ºF (15-25ºC).

Questions? Comments?

Please call 1-800-332-2761

Visit our website at www.petwellness.com

Manufactured for:

Novartis Animal Health US, Inc.

Greensboro, NC 27408

PROGRAM, CAPSTAR, and Flavor Tabs are registered trademarks of Novartis AG.

NADA # 141-035, Approved by FDA

©2008 Novartis Animal Health US, Inc.

NAH/PRO-FT/PI/3

2003201

01/08

FLEA MANAGEMENT SYSYTEM

Supplemental Product Information

Information for Dosing C ATS

This insert describes the concurrent use of PROGRAM® (lufenuron) Flavor Tabs® and CAPSTAR® (nitenpyram) Tablets for the management of fleas on cats and kittens. Please read the insert contained in each package for complete information on the individual products prior to dosing.

Warnings

Not for human use. Keep this and all drugs out of reach of children.

Directions

In cats and kittens the concurrent use of Sentinel (Lufenuron) and CAPSTAR Tablets is indicated to kill adult fleas and prevent eggs from hatching. The effects of Sentinel (Lufenuron), which control flea populations, and CAPSTAR Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM.

Step 1: Prevention and Control

Give Sentinel (Lufenuron) once per month to control flea populations. Sentinel (Lufenuron) contain Sentinel (Lufenuron). Sentinel (Lufenuron) controls flea populations by preventing the development of flea eggs and does not kill adult fleas. If a cat currently has a flea infestation, more rapid relief can be accomplished by adding CAPSTAR Tablets to the treatment as follows.

Step 2: Kill Adult Fleas

If your pet currently has a flea infestation, use CAPSTAR Tablets to kill adult fleas. CAPSTAR Tablets contain nitenpyram and are effective for the treatment of flea infestations. Nitenpyram starts killing adult fleas within 30 minutes of administration.

• Administer CAPSTAR Tablets once per week until adult fleas are no longer observed.
  

• For a severe flea infestation, administer CAPSTAR Tablets twice per week until adult fleas are no longer observed.
  

• Additional CAPSTAR Tablets may be administered as needed to kill the occasional adult flea picked up from infested environments.
  

• It is important to treat all dogs and cats in the household. Fleas can reproduce on untreated pets and allow infestations to persist.

Dosage

The combination of Sentinel (Lufenuron) and CAPSTAR Tablets should be administered according to the following schedule. Weigh the cat prior to administration to ensure proper dosage. Do not administer to cats under 2 pounds.

Recommended Dosage Schedule

*If adult fleas are seen

** Cats over 15 lbs. are provided the appropriate combination of Sentinel (Lufenuron).

Adverse Reactions

The following adverse reactions have been reported in cats after giving Sentinel (Lufenuron): vomiting, depression/lethargy, anorexia (loss of appetite), diarrhea, hyperactivity, dyspnea (labored breathing), pruritus (itch y skin), and skin eruptions (rash).

Other Information

The safety of the concurrent use of Sentinel (Lufenuron) and CAPSTAR Tablets has not been evaluated in kittens less than 7 months of age.

Flea Infestations on Cats

In addition to the common nuisance irritations associated with infestations, fleas can be responsible for skin conditions in the cat such as miliary dermatitis. Fleas also transmit other parasites, including tapeworms. The control of flea infestations is important to the pet’s health and reduces the problems associated with these parasites.

Sentinel (Lufenuron) break the flea life cycle by inhibiting egg development. CAPSTAR Tablets rapidly kill adult fleas on the cat. The concurrent use of these two products provides an effective flea management system.

The following diagram illustrates the flea’s life cycle and where the combination of PROGRAM Flavor Tabs and CAPSTAR Tablets work:

A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood form the pet and subsequently lay eggs, which drop off the pet’s coat. Within days, larvae hatch from the eggs and live undetected in the pet’s surroundings, such as the carpet and bedding. Flea larvae spin a cocoon, and, when appropriately stimulated, a young adult flea emerges and jumps onto the pet to continue the life cycle.

After reading this insert, if you have any questions about the concurrent use of Sentinel (Lufenuron) and CAPSTAR Tablets in your cats, please call Novartis Animal Health Veterinary Product Support at 1-800-332-2761.

Storage Conditions

Store Sentinel (Lufenuron) and CAPSTAR Tablets as described on the individual product inserts.

Questions? Comments?

Please call 1-800-332-2761

Visit our website at www.petwellness.com

Manufactured for:

Novartis Animal Health US, Inc.

Greensboro, NC 27408

NADA# 141-205, Approved by FDA

U.S. Patent # 5,750,548

©2008 Novartis Animal Health US, Inc.

PROGRAM, CAPSTAR, and Flavor Tabs are registered trademarks of Novartis AG.

NAH/PRT-FMS/PI/2

2003201

01/08

Milbemycin Oxime:

• Description:
• Indications:
• Human warnings:
• Precautions:
• Adverse reactions:
• Dosage:
• Administration:
• Effectiveness:
• Safety:
• Storage conditions:
• How supplied:
• Sentinel (Milbemycin Oxime) reviews

(0.1% Sentinel (Milbemycin Oxime))

Caution: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

Sentinel (Milbemycin Oxime) OTIC Solution is available in plastic dispensing tubes. Each plastic tube contains 0.25 mL of Sentinel (Milbemycin Oxime) OTIC Solution as a 0.1% solution of Sentinel (Milbemycin Oxime). Sentinel (Milbemycin Oxime) consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A4 (C₃₂H₄₅NO₇, MW 555.71) and 20% A₃ (C₃₁H₄₃NO₇, MW 541.68).

Indications:

Sentinel (Milbemycin Oxime) OTIC Solution is indicated for treatment of ear mite (Otodectes cynotis) infestations in cats and kittens four weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.

Human Warnings:

Not for human use. Keep this and all drugs out of the reach of children.

Precautions:

The safe use of Sentinel (Milbemycin Oxime) OTIC Solution in cats used for breeding purposes, during pregnancy, or in lactating queens, has not been evaluated.

Adverse Reactions:

No adverse reactions caused by Sentinel (Milbemycin Oxime) OTIC Solution have been reported in controlled effectiveness studies in adult cats and kittens (4 weeks of age).

Dosage:

Sentinel (Milbemycin Oxime) OTIC Solution should be administered topically into the external ear canal as the entire contents of a single-dose tube per ear. The volume delivered will be approximately 0.2 mL, with 0.05 mL residual volume remaining in dispensing tube. Repeat the treatment one time if necessary, based upon the ear mite life cycle and the response to treatment.

Administration:

Sentinel (Milbemycin Oxime) OTIC Solution should be administered as one tube per ear as a single treatment. Each foil pouch contains two tubes of solution, one for each ear. Open the tube by pressing cap down firmly to break seal. Remove cap and check to be sure tip of tube is open. Squeeze the tube to administer the contents of one tube into each external ear canal. Massage the base of the ear for optimal distribution. In clinical field trials, ears were not cleaned and many animals still had debris in their ears at the end of the study. Cleaning of the external ear canal prior to treatment may be performed, but is not necessary to provide effectiveness.

Effectiveness:

The clinical effectiveness of Sentinel (Milbemycin Oxime) 0.1% solution was evaluated in a placebo-controlled clinical field trial of client-owned cats. Otodectes cynotis infestation was diagnosed by direct microscopic visualization of ear swab debris. Test or placebo treatment was administered to both ears of the cat following the pre-treatment examination. Cats' ears were examined by ear swab microscopy at multiple intervals throughout the life cycle of the mite (up to day 30). Ninety-nine percent (99%) of the milbemycin oxime-treated group were ear mite negative at the microscopic exams.

Safety:

A study was conducted using otic doses of 0.1, 0.3 or 0.5% Sentinel (Milbemycin Oxime) solutions administered once weekly for six applications in kittens that were 4 weeks of age at the initiation of the study. Otic doses of 0.1 and 0.3% did not produce adverse systemic or local effects. One kitten treated with 0.5% was lethargic 8 hours after the second treatment. The kitten was offered milk replacer and by 10 hours post-treatment it appeared normal. In this kitten, lethargy was not observed after subsequent treatments. A study was conducted to evaluate the safety of a 0.1% Sentinel (Milbemycin Oxime) solution in adult cats. Topical doses at 1X, 3X or 5X the recommended dose applied in one ear did not produce adverse effects.

Storage Conditions:

Sentinel (Milbemycin Oxime) OTIC Solution should be stored at room temperature, between 59° and 77°F (15-25°C).

How Supplied:

Sentinel (Milbemycin Oxime) OTIC Solution is supplied in individual white polypropylene tubes, paired in a foil overlay pouch. The product is packaged in a box of 10 pouches of 2 tubes of 0.25 mL each.

Product of Japan

Manufactured for: Elanco US Inc.

Greenfield, IN 46140, USA

NADA #141-163, Approved by FDA.

Elanco, Sentinel (Milbemycin Oxime) and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

PA100047AMX

Sentinel (Milbemycin Oxime)

OTIC Solution (0.1% Sentinel (Milbemycin Oxime))

A topical medication for the treatment of ear mite

(Otodectes cynotis) infestations in cats and kittens.

FOR USE IN CATS & KITTENS

FOUR WEEKS OF AGE AND OLDER

Net Contents:

10 pouches of

2 tubes of

0.25 mL each

Elanco

Keep out of the

reach of children.

YL100047AMX

Sentinel (Milbemycin Oxime)

OTIC Solution

(0.1% milbemycin

oxime)

0.25mL

Sentinel (Milbemycin Oxime)

OTIC Solution (0.1% Sentinel (Milbemycin Oxime))

For the treatment of ear mite (Otodectes cynotis)

infestations in cats and kittens.

FOR USE IN CATS & KITTENS FOUR WEEKS OF

AGE AND OLDER

Net Contents: 2 tubes of 0.25 mL each

HUMAN WARNINGS:

Not for human use. Keep this and all drugs out

of the reach of children.

CAUTION: Federal (USA) law restricts this drug

to use by or on the order of a licensed veterinarian.