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Section Number
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Subject
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Change
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2
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Qualitative and quantitative composition
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Text expanded
For a full list of excipients, see section 6.1.
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4.2
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Posology and method of administration
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Whole section amended
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.
Replaced by following 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.
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4.3
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Contraindications
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Text amended from
Hypersensitivity to any of the ingredients
To:
Hypersensitivity to the active substance or to any of the excipients
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4.5
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Interaction with other medicinal products and other forms of interaction
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Text inserted:
No interaction studies have been performed.
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4.7
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Effects on Ability to Drive and Use Machines
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Text deleted
May cause transient blurring of vision.
Replaced by
Celluvisc has minor or moderate influence on the ability to drive and use machines as it may cause transient blurring of vision.
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4.8
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Undesirable Effects
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All text deleted and section replaced as follows:
Ocular events (transient – typically lasting 1 to 15 minutes):
Ocular irritation, burning or stinging sensation
Blurring of vision
Tearing.
The frequency of undesirable effects is defined as follows:
• Very Common (≥ 1/10)
• Common (≥1/100, <1/10)
• Uncommon (≥1/1,000, <1/100)
• Rare (≥1/10,000, <1/1,000)
• Very Rare (<1/10,000), not known (cannot be estimated from the available data).
Eye disorders:
Not known: eye irritation, eye pain, vision blurred, lacrimation increased.
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5.1
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Pharmacodynamic properties
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All text deleted
Celluvisc exerts a physical, not a pharmacological action. Carmellose sodium is a viscosity enhancer which increases the retention time of the product.
Replaced by:
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.
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5.2
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Pharmacokinetic Properties
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All text deleted
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 eye
Replaced by:
Due to the high molecular weight (approx. 90,000 Daltons) carmellose sodium is unlikely to penetrate the cornea.
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6.6
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Special precautions for disposal and other handling
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Text amended:
Ensure that the ampoule single dose container is intact before use. Discard any unused solution (i.e. once opened do not re-use container for subsequent doses).
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10
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Date of revision of text
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Text updated
17th March 2008 replaces 19th January 2007
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