Cidomycin Paediatric 20mg/2ml Solution For Injection

  • Name:

    Cidomycin Paediatric 20mg/2ml Solution For Injection

  • Company:
    info
  • Active Ingredients:

    Gentamicin sulfate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/07/18

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Summary of Product Characteristics last updated on medicines.ie: 26/7/2018

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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 27 July 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 26 July 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 added under Hypersensitivity

 

Not known: anaphylaxis/anaphylactic reaction (including anaphylactic shock)

 

Updated on 18 July 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 18 July 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

 

4.4       Special Warnings and Precautions for Use

Increased mortality was observed, in neonates/infants (aged up to 1 year) who received gentamicin solution for injection intraventricularly.

Gentamicin should be used with caution in the elderly, those with a history of, or existent ear disease, or those previously on aminoglycosides.

 

Ototoxicity (including irreversible hearing loss) has been reported following the use of aminoglycosides, including gentamicin. 

Important risk factors include renal impairment, high doses, prolonged duration of treatment and age (neonate/infant, elderly).

Due to the potential for ototoxicity, monitoring of vestibule and cochlea function is recommended before, during and shortly after treatment  (see section 4.8).

Groups at special risk include patients with impaired renal function, infants and possibly the elderly.  .  To avoid adverse events, continuous monitoring (before, during and after) of renal function (serum creatinin, creatinin clearance), control of function of vestibule and cochlea as well as hepatic and laboratory parameters is recommended

 

4.8       Undesirable Effects

……

Ear and labyrinth disorders:

Not known: transitory hearing loss, irreversible hearing loss, deafness (see section 4.4).

Vestibular damage or hearing loss, particularly after exposure to ototoxic drugs or in the presence of renal dysfunction.   

 

Renal disorders:

Nephrotoxicity (usually reversible) and occasionally

Very rare: acute renal failure, Fanconi-like syndrome in patients treated with a prolonged course of high-dose

Updated on 31 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 31 October 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

4.8       Undesirable Effects – Added:-

 

The following CIOMS frequency rating is used, when applicable: Very common ≥ 10%; Common ≥1 and < 10%; Uncommon ≥ 0.1 and < 1%; Rare ≥ 0.01 and < 0.1%; Very rare < 0.01%; Not known (cannot be estimated from available data).

 

 

Not known Peripheral neuropathy

 

Vascular disorders

Not known Hypotension

Updated on 27 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 October 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 16 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 7 August 2017 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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)

Free text change information supplied by the pharmaceutical company

Type II (C.I.4) variation to update the product information (SmPC sections 4.3 & 4.4) following publication of Gentamycin CCSI version 2

Updated on 18 September 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 9 September 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 updated to include 'Peripheral neuropathy – frequency unknown' and the new PV wording on the reporting of an adverse event.

Updated on 14 November 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • 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 updated with the removal of Methyl Parahydroxybenzoate & Propyl Parahydroxybenzoate

Section 4 updated to include:

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’

Section 6.1: Disodium edetate, Methyl Parahydroxybenzoate & Propyl Parahydroxybenzoate removed and Sodium Chloride added

Updated on 13 November 2013 PIL

Reasons for updating

  • Addition of manufacturer

Updated on 1 June 2011 PIL

Reasons for updating

  • Change to date of revision

Updated on 31 May 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Update sections 4.1, 4.2, 4.4 & 5.2 of the SPC in accordance with Article 45

Updated on 13 May 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Amendments made to the SPC, affecting sections:

 

Section 2 : Qualitative and Quantitative Composition

Section 4.4: Special Warnings and Special Precautions for Use

Section 4.8: Undesirable Effects

Section 6.1 : List of Excipients

Updated on 16 October 2009 SmPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Update:
4.2 Revision of wording
4.3 Addition of MG
4.4 Additional information on renal impairment
4.5 Additional interactions included
4.8 Additional side-effects included

Updated on 14 October 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 24 August 2007 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 6.3: Shelf life reduced from 3 years to 2 years
Section 7: MA Holder changed to sanofi-aventis

Updated on 24 August 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 16 August 2005 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 16 May 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 February 2005 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Updated on 19 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 May 2004 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 9 March 2004 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 20 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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