The frequency of adverse reactions documented during clinical trials is defined as follows:
Very Common (≥1/10)
Common (≥1/100,<1/10)
Uncommon (≥1/1000,<1/100)
Rare (≥1/10000, <1/1000)
Very Rare (<1/10000)
Not known (cannot be estimated from the available data).
Eye disorders:
Common: Eye irritation (including burning and discomfort), eye pain, eye pruritus, visual disturbance.
Postmarketing Experience
The following additional adverse reactions have been identified during postmarketing use of Celluvisc 1.0% in clinical practice.
Immune System Disorders
Uncommon: Hypersensitivity including eye allergy with symptoms of eye swelling or eyelid edema.
Eye Disorders
Uncommon: Lacrimation increased, vision blurred, eye discharge, eyelid margin crusting and/or medication residue, foreign body sensation in eye, ocular hyperemia, visual impairment.
Injury, Poisons and Procedural Complications
Uncommon: Superficial injury of eye (from the vial tip touching the eye during administration) and/or corneal abrasion
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.