Peyona (caffeine citrate) 20 mg/ml solution for infusion and oral solution
*Company:
Chiesi LimitedStatus:
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 11 July 2024
File name
Peyona PIL CP0038-10_IE+UK.pdf
Reasons for updating
- Correction of spelling/typing errors
- Change to improve clarity and readability
Updated on 26 June 2024
File name
Peyona PIL CP0038-9_EU+GB.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 09 April 2024
File name
Peyona EU SmPC CS0067-9.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Osmolality range added 144-166 mOsm/kg,
Updated on 10 November 2020
File name
Peyona EU CP0038-8.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to date of revision
Updated on 10 November 2020
File name
Peyona EU CS0067-8.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Type IB application has been approved for Peyona:
- Update from ml to mL (section 1, 2, 4.2, 4.9, 6.5, 6.6)
- Inclusion of the sodium content statement (section 4.4 of the SmPC)
- 4.4 Special warnings and precautions for use
The following statement has been added
- Sodium content
- This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’
- Update to the relevant PV reporting details for UK + IE in line with EU guidance (section 4.8)
- Update to date of revision of text from Nov 2018 to Oct 2020 (section 10
Updated on 24 January 2019
File name
Peyona EU CP0038-7.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 24 January 2019
File name
Peyona EU CS0067-7.pdf
Reasons for updating
- 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
Changed from 09/2017 to November 2018
File name
Peyona 20mg DHPC Letter CLC018-1 UK and IE.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Information on the safe use of Peyona (caffeine citrate) 20mg/ml solution for infusion and oral solution
File name
Peyona Lam Card CLC002-3 IE.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Peyona (caffeine citrate) 20 mg/ml Solution for Infusion and Oral Solution Laminated Card
Updated on 23 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 23 October 2017
Reasons for updating
- 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
A Type IA Variation was submitted to change the name of product manufacturer & batch release site registered on the licence.
Section 10 change of date of revision from August 2017 to October 2017
Updated on 19 October 2017
File name
PIL_15376_773.pdf
Reasons for updating
- New PIL for new product
Updated on 19 October 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 18 August 2017
Reasons for updating
- 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
10. DATE OF REVISION OF THE TEXT February 2015 changed to August 2017
Updated on 18 August 2017
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 June 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 – Hepatic and renal impairment – The safety of caffeine citrate in patients with renal impairment has not been established – has been removed
Section 4.4 – Renal and hepatic impairment - In a post-authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic impairment appeared to be higher as compared to premature infants without organ impairment – has been added
(see sections 4.2,4.8 and 5.2) has been amended to add 4.8
Section 4.8 – and - had been removed
Convulsion, arrhythmia, metabolism and nutrition disorders such as hyperglycaemia, and obtained from a post-authorisation safety study – has been added
Changes to the side effects table include – Hyperglycaemia , common
Hyperglycaemia changed to Hypoglycaemia
Convulsion, Uncommon
Convulsion removed from frequency unknown
Tachycardia , common
Arrhythmia, Uncommon
Tachycardia also associated with – removed
New section added - Other special populations
In a post-authorisation safety study on 506 preterm infants treated with Peyona, safety data have been collected in 31 very premature infants with renal/hepatic impairment. Adverse reactions appeared to be more frequent in this subgroup with organ impairment than in other observed infants without organ impairment. Cardiac disorders (tachycardia, including one single case of arrhythmia) were mostly reported.
Section - Reporting of suspected adverse reactions
the national reporting system listed in Appendix V has been replaced by UK: Yellow Card Scheme at www.mhra.gov.uk/yellowcard .
ROI: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax:
+353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie
Section 6.5 – Nature and contents of container - Type I clear glass 3 ml ampoule – removed
Section 8 – Marketing Authorisation Number(s) - 1 ml ampoules EU/1/09/528/001 3 ml ampoules – removed
Section 10 - Date of revision of the Text – February 2015
Updated on 22 May 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 12 February 2015
Reasons for updating
- Improved electronic presentation
Updated on 25 March 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 21 March 2014
Reasons for updating
- Change to side-effects
- Change to name of manufacturer
- Introduction of new pack/pack size
Updated on 16 October 2013
Reasons for updating
- 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 16 October 2013
Reasons for updating
- Change of distributor details
Updated on 15 May 2012
Reasons for updating
- New SPC for new product
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 May 2012
Reasons for updating
- New PIL for new product