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

  • Name:

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

  • Company:
    info
  • Active Ingredients:

    Caffeine citrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/01/19

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Summary of Product Characteristics last updated on medicines.ie: 24/1/2019

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Chiesi Limited

Chiesi Limited

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1 - 0 of 9 items.Total: Infinity pages

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 24 January 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 24 January 2019 SmPC

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

Updated on 8 May 2018 Ed-HCP

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

Updated on 8 May 2018 Ed-HCP

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 23 October 2017 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 October 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 18 August 2017 SmPC

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 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 1 June 2015 SmPC

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 PIL

Reasons for updating

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

Updated on 12 February 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 25 March 2014 SmPC

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 PIL

    Reasons for updating

    • Change to side-effects
    • Change to name of manufacturer
    • Introduction of new pack/pack size

    Updated on 16 October 2013 SmPC

    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 PIL

    Reasons for updating

    • Change of distributor details

    Updated on 15 May 2012 SmPC

    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 PIL

    Reasons for updating

    • New PIL for new product