Peyona (caffeine citrate) 20 mg/ml solution for infusion and oral solution

*
Pharmacy Only: Prescription
  • Company:

    Chiesi Limited
  • 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

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

EDM Updated on 08 May 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

EDM Updated on 08 May 2018

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

  • 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
  • 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

    Date of revision of text amended to reflect PIL

    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

    None provided

    Updated on 14 May 2012

    Reasons for updating

    • New PIL for new product