Genticin 80 mg/2 ml Solution for Injection
*Company:
ADVANZ PharmaStatus:
UpdatedLegal 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
Updated on 15 April 2024
File name
Genticin 80mg_2ml Solution for Injection_PIL.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 15 April 2024
File name
Genticin 80mg_2ml Solution for Injection_SPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
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_SPC_IE.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.pdf
Reasons for updating
- New PIL for new product
Updated on 07 September 2021
File name
GENTICIN Soln for inj 80 mg2ml_SPC_IE.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.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.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.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
- 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
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
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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
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 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 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
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 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 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