Glanatec Adverse Reactions

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Full Prescribing Info

Adverse Reactions

Summary of the safety profile: In clinical studies conducted by the time of approval in Japan, 500 out of 662 subjects (75.5%) experienced adverse reactions. The main adverse reactions included conjunctival hyperaemia in 457 subjects (69.0%), conjunctivitis (including conjunctivitis allergic) in 71 subjects (10.7%), and blepharitis (including allergic blepharitis) in 68 subjects (10.3%).
Summary of adverse reactions: Adverse reactions and frequencies observed in clinical studies conducted by the time of approval in Japan are listed as follows by body site or by mechanism of onset of events. (See Table 5.)

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Corneal thickness tended to decrease in clinical studies. Decreases in corneal thickness caused by instillation of GLANATEC were reversible.
Postmarketing experience: Following adverse reactions have been reported, but the incidence of events cannot be calculated and are unknown because these events include the events reported as spontaneous reports. (See Table 6.)

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Glanatec Adverse Reactions

Manufacturer:

Teika Pharma

Distributor:

DKSH