Celluvisc 1.0% w/v Eye drops, solution

  • Name:

    Celluvisc 1.0% w/v Eye drops, solution

  • Company:
    info
  • Active Ingredients:

    Carmellose sodium

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/02/15

files-icon(Click to Download)

XPIL

Summary of Product Characteristics last updated on medicines.ie: 16/2/2015
print

Print ViewKeyword Search SmPC

Allergan Ltd

Allergan Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Acular Active Ingredients Ketorolac Trometamol
Medicine Name Alphagan Active Ingredients brimonidine tartrate
Medicine Name Betagan Active Ingredients Levobunolol hydrochloride
Medicine Name Betagan Unit Dose Active Ingredients Levobunolol hydrochloride
Medicine Name BOTOX 100 Units Active Ingredients Botulinum Toxin Type A
Medicine Name BOTOX 200 Units Active Ingredients Botulinum Toxin Type A
Medicine Name BOTOX 50 Units Active Ingredients Botulinum Toxin Type A
Medicine Name Celluvisc 0.5% Active Ingredients Carmellose sodium
Medicine Name Celluvisc 1.0% w/v Eye drops, solution Active Ingredients Carmellose sodium
Medicine Name Combigan Active Ingredients brimonidine tartrate, Timolol Maleate
Medicine Name Exocin Active Ingredients Ofloxacin
Medicine Name FML Active Ingredients Fluorometholone
Medicine Name Ganfort Active Ingredients Bimatoprost, Timolol Maleate
Medicine Name Ganfort SD Active Ingredients Bimatoprost, Timolol Maleate
Medicine Name Lacri-Lube Active Ingredients No Active Ingredients
Medicine Name Liquifilm Tears Active Ingredients Polyvinyl Alcohol
Medicine Name Lumigan 0.1mg/ml Active Ingredients Bimatoprost
Medicine Name Ozurdex Active Ingredients Dexamethasone
Medicine Name Pred Forte Active Ingredients Prednisolone Acetate
Medicine Name Pred Mild Active Ingredients Prednisolone Acetate
Medicine Name Refresh Ophthalmic Active Ingredients Polyvinyl Alcohol, Povidone
Medicine Name Relestat 0.5 mg/ml, eye drops, solution Active Ingredients Epinastine Hydrochloride
Medicine Name Vistabel Active Ingredients Botulinum Toxin Type A
1 - 0 of 23 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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.

Updated on 16 February 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 16 February 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

To update Irish Medicines Board (IMB) name to Health Products Regulatory Authority (HPRA)

Updated on 12 February 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 February 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 21 July 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update SPC in line with CCDS V1.0

Updated on 17 July 2014 PIL

Reasons for updating

  • Change of contraindications
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision

Updated on 4 March 2009 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 4 March 2009 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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.

 

Updated on 1 September 2008 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 28 August 2008 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 22 August 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

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

 

 

Section Number

Subject

Change

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.

 

Replaces:

Discard open ampoule after use.

4.5

Interaction with other medicinal products and other forms of interaction

Text added:

No interaction studies have been performed

4.7

Effects on ability to drive and use machines

New text:

Celluvisc has minor or moderate influence on the ability to drive and use machines as it may cause transient blurring of vision. 

 

Replaces:

May cause transient blurring of vision. 

4.8

Undesirable effects

New text:

The frequency of undesirable effects 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:

Not known: eye irritation, eye pain, vision blurred, lacrimation increased.

 

Replaces:

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.

 

Replaces:

Accidental overdosage will present no hazard.

5.1

Pharmacodynamic properties

New text:

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.

 

Replaces:

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

New text:

Due to the high molecular weight (approx. 90,000 Daltons) carmellose sodium is unlikely to penetrate the cornea.

 

Replaces:

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:

Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

Replaces:

Instructions for use and handling

 

Word change:

Ensure that the single dose container is intact before use.

 

Replaces:

Ensure that ampoule is intact before use

9

Date of first authorization /renewal of authorization

New text:

Date of first authorisation: 23rd April 1997

 

Date of last renewal: 29th September 2003

 

Replaces:

23rd April 1997 / 29th September 2003

10

Date of revision of text

New Text:

28th March

 

Replaces:

31st January 2007

 

 

 

Updated on 12 March 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Text in bold was added to section 1 Name of the medicinal product   
 
Celluvisc 1.0% w/v Eye drops, solution, unit dose

Updated on 9 March 2007 PIL

Reasons for updating

  • Addition of marketing authorisation holder
  • Change to date of revision
  • Change of active ingredient

Updated on 1 September 2006 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to appearance of the medicine
  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 15 August 2005 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 9 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 August 2004 SmPC

Reasons for updating

  • Correction of spelling/typing errors
  • Change to section 1 - Name of medicinal product

Legal category: Supply through pharmacy only

Updated on 27 August 2003 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Updated on 13 June 2003 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only