When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Summary of Changes to Celluvisc® 0.5% Irish Summary of Product Characteristics (SPC)
The current Celluvisc® SPC is dated 17th December 2010
This supersedes SPC dated 10th November 2006
Section Number
Subject
Change
4.8
Undesirable effects
Added Text:
The frequency of adverse reactions documented during clinical trials is given. The frequency is defined as follows: Very Common (³ 1/10); Common (³1/100, <1/10); Uncommon (³1/1,000, <1/100); Rare (³1/10,000, <1/1,000); Very Rare (<1/10,000), not known (cannot be estimated from the available data).
Eye disorders:
Common: Eye Irritation
The following other adverse reactions have reported since Cellufluid has been marketed:
Eye pain, vision blurred, lacrimation increased, ocular hyperaemia.
Deleted Text:
Temporary burning may occur.
10
Date of Revision of Text
Text added:
17th December 2010
Key:
Unchanged text appears as follows: eg sodium hydroxide
Added text appears as follows: eg Celluvisc
Deleted text appears as follows: eg Not applicable