IPR Page 1/7
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`Santen/Asahi Glass Exhibit 2054
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
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`Exhibit 1
`Exhibit 1
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`IPR Page 2/7
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`“Kusuri No Shiori” lets you search through 16,181 drugs.
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`Kusuri No Shiori
`[Drug Information Sheet]
`
`Santen Pharmaceutical Co., Ltd.
`
`External application
`
`Revised July 2017
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`Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize
`efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
`
`Brand name: TAPROS Mini ophthalmic solution 0.0015%
`Active ingredient: Tafluprost
`Dosage form: Colorless, transparent ophthalmic solution, 0.3 mL (container)
`clear, transparent, (label) white (front), red (back)
`Print on sheet:
`
`[illegible]
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`Effects of this medicine
`This medicine lowers pressure in the eye by promoting aqueous humor outflow through stimulation of the prostanoid FP receptor.
`It is usually used to treat glaucoma or ocular hypertension.
`
`Before using this medicine, be sure to tell your doctor and pharmacist
` If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have: aphakic/pseudophakic eyes,
`bronchial asthma/history of bronchial asthma, or intraocular inflammation (iritis, uveitis). If you wear contact lenses.
` If you are pregnant or nursing.
` If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of
`over-the-counter medicines and dietary supplements as well as other prescription medicines.)
`
`Dosing (How to take this medicine)
`Your dosage (to be filled in by a healthcare professional))
`
`
` In general, apply 1 drop at a time, once a day. Strictly follow the instructions.
` Before applying, wash your hands thoroughly with soap and running water. Next, twist off the tab (the part where no solution is
`contained) and discard 1 or 2 drops. Then, pull down your lower eyelid so that the dropper tip does not touch your eye or eyelashes
`and apply the medicine. After applying, keep your eyes closed for 1 to 5 minutes pressing the inner corner of the eye lightly. Wipe
`off any excess liquid with a wet gauze or tissue immediately, or wash your face with eyes closed. After applying, make sure to
`dispose of the dropper. Once the tab is removed, remaining solution must not be stored for later applying. If you need to apply other
`eye drops at the same time, wait more than 5 minutes.
` If you miss a dose, apply 1 drop as soon as possible in case of the same day. If you notice on the next day, skip the missed dose and
`continue your regular dosing schedule. You should not apply twice a day or 2 drops at one time.
` If you accidentally apply more than your prescribed dose, consult with your doctor or pharmacist.
` Do not stop applying this medicine unless your doctor instructs you to do so.
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`Precautions while taking this medicine
` This medicine may cause blurred vision temporarily after applying. Do not operate machinery or drive a car until these symptoms
`recover.
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`
`
`Possible adverse reactions to this medicine
`The most commonly reported adverse reactions include bloodshot eyes, changes in eyelashes (increased length,
`thickness and number of lashes), itchy/stinging eyes, eyelid pigmentation (darkening around the eyes), corneal
`epithelial disorder (eye pain, focus disorder, foreign body sensation in eyes), and hypertrichosis of eyelid. If any of
`these symptoms occur, consult with your doctor or pharmacist.
`The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets.
`If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
` changes in the color of the iris [iris pigmentation]
`The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or
`pharmacist if you notice any symptoms of concern other than those listed above.
`
`Storage conditions and other information
` Keep out of reach of children.
` Store in a refrigerator (2 to 8°C) before opening foil pouch.
` After opening the foil pouch, store in a shading bag in a refrigerator (2 to 8°C) and use within 1 year, or store in a shading bag at
`room temperature (1 to 30°C) and use within 1 month.
` Discard the remainder. Do not store them. Ask your pharmacy or medical institution how to discard.
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`For healthcare professional use only: Day
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`For details, talk to your doctor or pharmacist. The Pharmaceuticals and Medical Devices Agency
`website has “Drug Guides for Patients” and “package inserts” for healthcare professionals.
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`IPR Page 3/7
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`IPR Page 4/7
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`Exhibit 2
`Exhibit 2
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`IPR Page 5/7
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`IPR Page 5/7
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