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 1% Irish Summary of Product Characteristics (SPC)
The current Celluvisc SPC is dated 13th February 2009
This supersedes SPC dated 28th March 2008
Section Number
Subject
Change
1
Name of the medicinal product
Amended from Celluvisc 1.0% to read Celluvisc 1%
4.5
Interaction with other medicinal products and other forms of interaction
Section title amended to read:
Interaction with other medicinal products and other forms of interactions
7
Marketing Authorisation Holder
Amendment to address (format only):
County Mayo changed to read Co. Mayo
Word Ireland deleted.
9
Date of first authorisation /renewal of authorisation
Date of last renewal amended from 29th September 2003 to 3rd October 2008.
10
Date of revision of text
New Text: 13th February 2009.
Replaces: 28th March 2008.
Summary of Changes to Celluvisc® 1% Irish Summary of Product Characteristics (SPC)
The current Celluvisc® SPC is dated 28th March 2008
This supersedes SPC dated 31st January 2007
2
Qualitative and quantitative composition
Word Inserted:
For a full list of excipients, see section 6.1.
4.2
Posology and method of administration
New Text:
Instil one or two drops in the affected eye/s as needed.
Ensure that the single-dose container is intact before use. The eye drop solution should be used immediately after opening.
To avoid contamination do not touch the tip to the eye or any other surface.
Replaces:
Do not contaminate the open-end of the ampoule when in use. Twist-off tab and apply drops topically as follows:
Instil one to two drops as required or directed into conjunctival sac.
4.3
Contraindications
Words Inserted:
Hypersensitivity to the active substance or to any of the excipients.
4.4
Special warnings and precautions for use
New text:
Discard open single dose container after use.
Discard open ampoule after use.
Text added:
No interaction studies have been performed
4.7
Effects on ability to drive and use machines
Celluvisc has minor or moderate influence on the ability to drive and use machines as it may cause transient blurring of vision.
May cause transient blurring of vision.
4.8
Undesirable effects
The frequency of undesirable effects is defined as follows:
Eye disorders:
Not known: eye irritation, eye pain, vision blurred, lacrimation increased.
Ocular events (transient – typically lasting 1 to 15 minutes):
Ocular irritation, burning or stinging sensation
Blurring of vision
Tearing.
4.9
Overdose
Word change:
Accidental overdose will present no hazard.
Accidental overdosage will present no hazard.
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: Other ophthalmologicals
ATC code: S01XA20
Carmellose sodium has no pharmacological effect. Carmellose sodium has a high viscosity resulting in an increased retention time on the eye.
Celluvisc exerts a physical, not a pharmacological action. Carmellose sodium is a viscosity enhancer which increases the retention time of the product.
5.2
Pharmacokinetic properties
Due to the high molecular weight (approx. 90,000 Daltons) carmellose sodium is unlikely to penetrate the cornea.
Carmellose sodium has a large molecular weight and is unlikely to penetrate the cornea. The period of retention on the cornea is approximately 22 minutes in healthy eyes.
6.5
Nature and contents of container
Words deleted:
Pack sizes may include: 5, 10, 20, 30, 40, 60 or 90 single-dose containers.
6.6
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
Heading change:
Instructions for use and handling
Ensure that the single dose container is intact before use.
Ensure that ampoule is intact before use
Date of first authorization /renewal of authorization
Date of first authorisation: 23rd April 1997
Date of last renewal: 29th September 2003
23rd April 1997 / 29th September 2003
28th March
31st January 2007