Keppra 100mg/ml concentrate for solution for infusion

Product Information *

  • Company:

    UCB (Pharma) Ireland Limited
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

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 2021

File name

IE SPC IV_1627395545.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

IA - Change of container closure (Removal of grey rubber stopper)

Updated on 13 January 2021

File name

PIL IV_1610504890.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

Update to recommend the same dosing for monotherapy and adjunctive therapy – SmPC Section 4.2 - PIL section 3

Updated on 13 January 2021

File name

SPC IV_1610504841.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to recommend the same dosing for monotherapy and adjunctive therapy – SmPC Section 4.2

Updated on 20 October 2020

File name

PIL IV_1603187622.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Correction to the stated Manufacturer in section 6

Updated on 20 October 2020

File name

PIL IV_1603182653.pdf

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

Free text change information supplied by the pharmaceutical company

Addition of warning and adverse reaction of QT Prolongation – Section 2 & 4

Updated on 20 October 2020

File name

SPC IV_1603182608.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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of warning and adverse reaction of QT Prolongation – Section 2 & 4

Updated on 31 July 2020

File name

pil IV ie _1596189071.pdf

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

Free text change information supplied by the pharmaceutical company

Addition of the warning and ADR on “Worsening Seizures”

Updated on 31 July 2020

File name

spc IV ie_1596189039.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of the warning and ADR on “Worsening Seizures”

Updated on 18 October 2019

File name

ie spc iv 100 mgml_1571398703.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 18 October 2019

File name

keppra pil i.v. injection_1571397243.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 01 April 2019

File name

20190328-ie-pil-conc-en-approved-current_1553866866.pdf

Reasons for updating

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

Updated on 29 March 2019

File name

20190328-ie-spc-conc-en-approved-current_1553866885.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 be renewed (B)

Updated on 13 March 2019

File name

20180426-ema-ie-pil-conc-h277-en-approved-current_1552475507.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 13 March 2019

File name

20180426-ema-ie-spc-conc-h277-en-approved-current_1552475573.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Pregnancy wording update, dysgeusia, pregnancy malformation update and gait disturbance

Updated on 02 January 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 23 December 2016

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 23 December 2016

File name

PIL_11237_598.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 September 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 24 March 2014

Reasons for updating

  • Change to side-effects

Updated on 09 January 2014

Reasons for updating

  • Change to side-effects

Updated on 10 August 2012

Reasons for updating

  • Change to side-effects

Updated on 16 December 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 28 November 2011

Reasons for updating

  • Change to side-effects

Updated on 19 October 2011

Reasons for updating

  • Change of manufacturer
  • Change to side-effects

Updated on 13 May 2011

Reasons for updating

  • Change to MA holder contact details

Updated on 06 December 2010

Reasons for updating

  • Change to improve clarity and readability

Updated on 06 April 2010

Reasons for updating

  • Change to dosage and administration

Updated on 10 March 2009

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 18 February 2008

Reasons for updating

  • Change of manufacturer

Updated on 09 August 2007

Reasons for updating

  • Change of manufacturer

Updated on 05 February 2007

Reasons for updating

  • Change to, or new use for medicine

Updated on 14 August 2006

Reasons for updating

  • New PIL for new product