Genticin Eye/Ear Drops Solution

Product Information *

  • Company:

    ADVANZ Pharma
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

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 28 May 2021

File name

Gentamicin sulf EarEye drops, 3_SPC_IE_1622196024.pdf

Reasons for updating

  • Other

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 28 May 2021

File name

Gentamicin sulf EarEye drops, 3_PIL_IE_1622195987.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 December 2013

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

Free text change information supplied by the pharmaceutical company

Section 4.8:-Undersirable effects:- How to report a side effect.
SEction 10:-Date of Revision of Text

Updated on 06 December 2013

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:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8:-Undersirable effects:- How to report a side effect.
SEction 10:-Date of Revision of Text

Updated on 06 December 2013

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 May 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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

Free text change information supplied by the pharmaceutical company

Section 1: NAME OF MEDICINAL PRODUCT

 

Removed the word ‘Trade’ from the title of section 1 to read: NAME OF MEDICINAL PRODUCT

 

 

Section 2: QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Inserted the words ‘equivalent to’ to read: Gentamicin Sulphate equivalent to≡ 0.3% w/v gentamicin base.

Inserted a statement regarding the presence of benalkonuim chloride in product.

 

 

Section 4.4 Special warnings and special precautions for use

 

Inserted text regarding the risk of irritation due to the presence of benalkonium chloride.

 

 

Section 4.6.      Fertility, pregnancy and lactation

 

Added word ‘fertility’ to title of this section (previously used to read ‘Pregnancy & lactation).

 


Section 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

Title of section amended to text above.

 
Section 9.        DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Amended to read:

Date of first authorisation: 20 April 1995

Date of last renewal: 20 April 2010

 

 

10.        DATE OF REVISION OF THE TEXT

 

Updated to read:

May 2012

Updated on 15 May 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1: NAME OF MEDICINAL PRODUCT

 

Removed the word ‘Trade’ from the title of section 1 to read: NAME OF MEDICINAL PRODUCT

 

 

Section 2: QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Inserted the words ‘equivalent to’ to read: Gentamicin Sulphate equivalent to≡ 0.3% w/v gentamicin base.

Inserted a statement regarding the presence of benalkonuim chloride in product.

 

 

Section 4.4 Special warnings and special precautions for use

 

Inserted text regarding the risk of irritation due to the presence of benalkonium chloride.

 

 

Section 4.6.      Fertility, pregnancy and lactation

 

Added word ‘fertility’ to title of this section (previously used to read ‘Pregnancy & lactation).

 


Section 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

Title of section amended to text above.

 
Section 9.        DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Amended to read:

Date of first authorisation: 20 April 1995

Date of last renewal: 20 April 2010

 

 

10.        DATE OF REVISION OF THE TEXT

 

Updated to read:

May 2012

Updated on 14 August 2008

Reasons for updating

  • New SPC for medicines.ie

Updated on 14 August 2008

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)