Cidomycin Paediatric 20mg/2ml Solution For Injection * Pharmacy Only: Prescription
Company:
SANOFIStatus:
No Recent UpdateLegal 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 12 July 2021
File name
Cidomycin Paediatric Injection Text Leaflet_1626105878.pdf
Reasons for updating
- XPIL Removed
Updated on 06 July 2020
File name
Cidomycin Paediatric Injection Text Leaflet.pdf
Reasons for updating
- XPIL Removed
Updated on 02 March 2020
File name
1.3.1 SPC Labelling and Package Leaflet_1583143773.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 March 2020
File name
1.3.1 SPC Labelling and Package Leaflet_1583143441.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 July 2018
File name
Cidomycin Paediatric Injection Text Leaflet.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 26 July 2018
File name
Cidomycin Paediatric Injection SPC.pdf
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
File name
Cidomycin Paediatric 20 mg2ml Solution For Injection Text Leaflet.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 18 July 2018
File name
Cidomycin Paediatric 20mg2ml Solution for Injection SPC.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 October 2017
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
File name
PIL_8362_455.pdf
Reasons for updating
- New PIL for new product
Updated on 27 October 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 August 2017
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 07 August 2017
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
Updated on 18 September 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 09 September 2015
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
Updated on 14 November 2013
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 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
Reasons for updating
- Addition of manufacturer
Updated on 01 June 2011
Reasons for updating
- Change to date of revision
Updated on 31 May 2011
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
Updated on 13 May 2011
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
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
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
Reasons for updating
- Change due to user-testing of patient information
Updated on 24 August 2007
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
Updated on 24 August 2007
Reasons for updating
- Improved electronic presentation
Updated on 18 December 2006
Reasons for updating
- Improved electronic presentation
Updated on 16 August 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 May 2005
Reasons for updating
- Improved electronic presentation
Updated on 21 February 2005
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
Reasons for updating
- New PIL for medicines.ie
Updated on 21 May 2004
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 March 2004
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
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)