Genticin 80 mg/2 ml Solution for Injection *
Pharmacy Only: Prescription

  • Company:

    ADVANZ Pharma
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 07 September 2021

File name

GENTICIN Soln for inj 80 mg2ml_SPC_IE_1631010730.pdf

Reasons for updating

  • Updated inline with QRD template and/or excipient guideline

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

Updated on 07 September 2021

File name

GENTICIN Soln for inj 80 mg2ml_PIL_IE_1631010367.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 September 2021

File name

GENTICIN Soln for inj 80 mg2ml_SPC_IE_1631007542.pdf

Reasons for updating

  • Other

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

Free text change information supplied by the pharmaceutical company

change in finished product specification parameters

Updated on 07 September 2021

File name

GENTICIN Soln for inj 80 mg2ml_SPC_IE_1631006845.pdf

Reasons for updating

  • Other

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

Free text change information supplied by the pharmaceutical company

A Type II, category B.II.d.1.e variation for change in finished product specification parameters; ‘Appearance’ and ‘Colour of solution’ outside the approved specifications limits range.

Updated on 10 June 2021

File name

Gentamicin Sol for Inject 80mg-2ml - Genticin_IE_SmPC_1623341608.pdf

Reasons for updating

  • Updated inline with QRD template and/or excipient guideline

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

Updated on 15 March 2021

File name

Agency approved SPC_1615831229.pdf

Reasons for updating

  • Change to product name

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

Free text change information supplied by the pharmaceutical company

update spelling “sulphate” to “sulfate”

Updated on 14 March 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Update to SmPC section 1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2 and 6.6 and corresponding section of PIL was inline with the SPC

Updated on 14 March 2017

Reasons for updating

  • New SPC for new product

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

Updated on 14 March 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

Update to SmPC section 1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2 and 6.6 and corresponding section of PIL was inline with the SPC

Updated on 13 January 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

The sections 2, 4.1- 4.6, 4.8, 4.9,  5.1, 5.2, 6.2, 6.6, 7 & 10 of the SmPC were upadted

Updated on 13 January 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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

The sections 2, 4.1- 4.6, 4.8, 4.9,  5.1, 5.2, 6.2, 6.6, 7 & 10 of the SmPC were upadted

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:- Undesirable effects - How to report adverse event
Section 10:- Date of revision of the text is amended

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:- Undesirable effects - How to report adverse event
Section 10:- Date of revision of the text is amended

Updated on 15 May 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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 2.        QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Updated description of composition to read:

Each 2 ml ampoule contains gentamicin sulphate equivalent to 80 mg gentamicin base.

 

Inserted words ‘a full list’ in the sentence to read:

For a full list of excipients, see section 6.1.

 

 

Section 4.1.      Therapeutic indications

 

Removed word ‘injectable’ from this section.

 

 

Section 4.6.      Fertility, pregnancy and lactation

 

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

 

 

Section 4.8.      Undesirable effects

 

Inserted the word ‘system’ here to read: Gastro-intestinal system disorders

 

Inserted a hyphen between the words serum and bilirubin to read serum-bilirubin.

 

 

Section 6.1.      List of excipients

 

Added the words ‘for pH adjustment’ after the excipient sulphuric acid.

 

 

Section 6.2.      Incompatibilities

 

Removed word ‘injectable’ from this section

 

 

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.

Added the phrase ‘For single use only


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 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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 2.        QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Updated description of composition to read:

Each 2 ml ampoule contains gentamicin sulphate equivalent to 80 mg gentamicin base.

 

Inserted words ‘a full list’ in the sentence to read:

For a full list of excipients, see section 6.1.

 

 

Section 4.1.      Therapeutic indications

 

Removed word ‘injectable’ from this section.

 

 

Section 4.6.      Fertility, pregnancy and lactation

 

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

 

 

Section 4.8.      Undesirable effects

 

Inserted the word ‘system’ here to read: Gastro-intestinal system disorders

 

Inserted a hyphen between the words serum and bilirubin to read serum-bilirubin.

 

 

Section 6.1.      List of excipients

 

Added the words ‘for pH adjustment’ after the excipient sulphuric acid.

 

 

Section 6.2.      Incompatibilities

 

Removed word ‘injectable’ from this section

 

 

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.

Added the phrase ‘For single use only


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 27 August 2008

Reasons for updating

  • New SPC for new product

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

Updated on 27 August 2008

Reasons for updating

  • New SPC for new product