and/or phakic patients who do not have red eye(s), are suitable for contact lens wear and do not have more than 1 d of astigmatism. ( 1 )

dence of corneal ulcers than nonsmokers. 5.2 contact lens-related complications acuvue theravision with ketotifen should not be used to treat or prevent lens-related symptoms including irritation, discomfort or redness. acuvue theravision with ketotifen insertion could result in serious injury if a patient is experiencing these symptoms. patients should be cautioned that proper use and care of contact lenses and lens care products are essential for the safe use of these products. if patients experience symptoms of contact lens intolerance or keratitis, the lens(es) should be immediately removed. 5.3 chemical exposures if chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into the eyes, the patient should: flush eyes immediately with water and immediately contact the eye care professional or visit a hospital emergency room without delay. 5.4 acanthamoeba keratitis acuvue theravision with ketotifen should not be worn while swimming or in hot tubs. the lens should not be rinsed in water from the tap. tap water contains many impurities that can contaminate or damage the lenses and may lead to eye infection or injury. contact lens wear in these settings increases the risk of sight threatening eye infections from microorganisms. 5.5 backup spectacles eye care professionals should instruct the patient to always have a functional pair of spectacles with a current prescription available to use if the patient becomes unable to wear contact lenses, or in circumstances where contact lens wear is not advised. 5.6 eye protection patients should be advised to notify the employer of being a contact lens wearer. some jobs may require the use of eye protection equipment or may require that the patient not wear contact lenses. 5.7 concomitant use of eye drops or eye medications eye drops or eye medications containing benzalkonium chloride should not be used simultaneously with acuvue® theravision™ with ketotifen. wait at least 10 minutes after eye drop application before inserting lenses.

eye drop with benzalkonium chloride before inserting or reinserting lenses. if the lens sticks (stops moving), the patient should be instructed to remove the lens. a few drops of non-preserved sterile saline solution may be applied directly to the eye to assist with removal. if non-movement of the lens continues after a few minutes, the patient should immediately consult their eye care professional. do not use contact lens cleaning and disinfectant solutions with acuvue ® theravision™ with ketotifen. 2.2 contact lens fitting information see the acuvue® theravision™ with ketotifen fitting instruction guide for professional fitting instructions and information.

s observed in the clinical trials of a product cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in practice. the most commonly observed adverse reactions in clinical studies, occurring in ≥1% of acuvue ® theravision™ with ketotifen treated eyes, were eye irritation, eye pain, and instillation site irritation.

d human ophthalmic dose (mrhod) of 0.038 mg. no adverse embryofetal effects were observed in rats or rabbits orally administered 100 mg/kg/day and 15 mg/kg/day, respectively, during organogenesis. these doses (normalized to body surface area) were approximately 26,000 and 7,700 times higher than the mrhod, respectively. an oral dose of 50 mg/kg/day ketotifen (approximately 13,000 times higher than mrhod) administered to rats from day 15 of pregnancy until day 21 postpartum produced maternal toxicity, a slight increase in postnatal mortality and a slight decrease in body weight gain in offspring during the first four days post-partum. 8.2 lactation risk summary there is no information regarding the presence or absence of ketotifen fumarate or its metabolites in human milk following use of acuvue ® theravision™ with ketotifen, or on the breastfed infants and milk production. ketotifen fumarate has been identified in breast milk in rats following oral administration. it is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for acuvue ® theravision™ with ketotifen and any potential adverse effects on the breast-fed child from ketotifen fumarate. 8.3 pediatric use the safety and efficacy of acuvue ® theravision™ with ketotifen in pediatric patients below the age of 11 years has not been established. 8.4 geriatric use clinical studies of etafilcon a with ketotifen did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

) of 0.038 mg. no adverse embryofetal effects were observed in rats or rabbits orally administered 100 mg/kg/day and 15 mg/kg/day, respectively, during organogenesis. these doses (normalized to body surface area) were approximately 26,000 and 7,700 times higher than the mrhod, respectively. an oral dose of 50 mg/kg/day ketotifen (approximately 13,000 times higher than mrhod) administered to rats from day 15 of pregnancy until day 21 postpartum produced maternal toxicity, a slight increase in postnatal mortality and a slight decrease in body weight gain in offspring during the first four days post-partum.

days prior to mating.

in 3 minutes and the response was sustained for up to 12 hours after lens insertion. visual acuity was comparable between acuvue ® theravision™ with ketotifen and 1•day acuvue ® . not all refractive powers, design configurations, or lens parameters available were tested in clinical investigation of the lenses. therefore, when selecting an appropriate lens design, the eye care professional should consider all characteristics of the lens that can affect lens performance and ocular health, including oxygen permeability, wettability, central and peripheral thickness and optic zone diameter. the potential impact of these factors on the patient's ocular health should be carefully weighed against the patient's need for refractive correction and prevention of itching associated with allergic conjunctivitis; therefore, the continuing ocular health of the patient and lens performance on the eye should be carefully monitored by the prescribing eye care professional.

lenses. advise patients to avoid contaminating hands or lenses with cosmetics, lotions, soaps, creams, deodorants or sprays. instruct patients to put in lenses prior to applying makeup. advise patients not to touch contact lenses if hands have any foreign materials as microscopic scratches of the lenses may occur, which can cause distorted vision and/or injury to the eye. instruct patients to examine the lens after opening to be sure that it is a single, moist, clean lens that is free of any nicks or tears. if the lens appears damaged, patients should be instructed not to use it. instruct patients not to use contact lens cleaning and disinfectant solutions with acuvue ® theravision™ with ketotifen. discard lens after a single day's use. advise patients that acuvue® theravision™ with ketotifen should not be worn while swimming or in hot tubs. contact lens wear in these settings increases the risk of sight threatening eye infections from microorganisms. if the lens sticks (stops moving), the patient should be instructed to remove the lens. a few drops of non-preserved sterile saline solution may be applied directly to the eye to assist with removal. if non-movement of the lens continues after a few minutes, the patient should immediately consult their eye care professional. patients should be advised to notify the employer of being a contact lens wearer. some jobs may require the use of eye protection equipment or may require that the patient not wear contact lenses. advise patients to avoid all harmful or irritating vapors and fumes while wearing lenses. if aerosol products, such as hair spray, are used while wearing lenses, exercise caution and keep eyes closed until the spray has settled. instruct patients to never use tweezers, fingernails, or other tools to remove lenses from the lens container. instead, patients should remove acuvue ® theravision™ with ketotifen from the blister container packing solution using their fingertips. patients should not touch the lens with fingernails. the patients should be advised to never rinse the lenses in water from the tap. tap water contains many impurities that can contaminate or damage the lenses and may lead to eye infection or injury. advise patients to always dispose of lenses when removed and have spare non-medicated lenses or spectacles available. concomitant use of other medications advise patients to consult with their eyecare professional before using any medicine in the eyes. advise patients that eye drops containing benzalkonium chloride should not be used simultaneously with acuvue® theravision™ with ketotifen. instruct patients to wait 10 minutes after eye drop application before inserting lenses. daily self-examination instruct the patient to immediately remove the lens if any eye discomfort, eye pain, eye redness or decreased vision are experienced. if the symptoms stop after lens removal, the patient should discard the lens(es) and replace with new non-medicated lens(es). acuvue ® theravision™ with ketotifen should not be worn for the remainder of the day. if the problem continue after inserting a new non-medicated lens, the patient should remove the lens and immediately consult their eye care professional. emergencies advise the patient that if chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into the eyes, the patient should: flush eyes immediately with tap water and immediately contact the eye care professional or visit a hospital emergency room without delay. symbols key the following symbols may appear on the label or packaging: symbol definition caution, consult instructions for use manufacturer date of manufacture use by date (expiration date) batch code sterilized using steam heat do not re-use (single use) do not use if package is damaged store away from direct sunlight indicates a single sterile barrier system authorized representative in the european community medical device in the european community fee paid for waste management ce-mark and identification number of notified body contains hazardous substances contains a medicinal substance caution: u.s. federal law restricts this device to sale by or on the order of a licensed practitioner contact lens contact lens lens orientation correct lens orientation incorrect (lens inside out) package opening icon (blister) dia diameter bc base curve d diopter (lens power) image image image image image image image image image image image image image image image image image image image image