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Novartis Ireland Limited

Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, Ireland
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 20/04/2017
SPC Simulect 20mg powder and solvent for solution for injection or infusion

When a pharmaceutical company changes an SPC or PIL, 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 20/04/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   19-Apr-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

In Section 4.4 Special Warnings and precautions for use, BK Virus has been added under Neoplasms and infections

In Section 4.8, wording has been added on how to report side effect
Updated on 05/01/2015 and displayed until 20/04/2017
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Nov-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 7 revised to change address of MAH
Updated on 22/09/2014 and displayed until 05/01/2015
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04-Sep-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.4 of SmPC updated to include the following text:

Use in heart transplantation

The efficacy and safety of Simulect for the prophylaxis of acute rejection in recipients of solid organ allografts other than renal have not been demonstrated. In several small clinical trials in heart transplant recipients, serious cardiac adverse events such as cardiac arrest (2.2%), atrial flutter (1.9%) and palpitations (1.4%) have been reported more frequently with Simulect than with other induction agents.

Updated on 22/05/2012 and displayed until 22/09/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   14-Dec-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Update of section 4.4 of the SPC to add a cautionary statement regarding the use of live and attenuated vaccines in immunosuppressed patients and to revise the existing warning of hypersensitivity reactions as well as neoplasms and infections. Furthermore, section 4.8 is updated based on post-marketing experience.

 

Updated on 13/11/2008 and displayed until 22/05/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5 - Pharmacological properties
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 4 - Clinical particulars
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

2 Inclusion of API description & origin
4.1 Inclusion of paediatric age range
4.2 Text clarifications
4.3text clarifications
4.4 Inclusion of warning using immunosuppressive combinations increasing the susceptibility to infection and warning in 4.2 that simulect must not be used unless a patient is certain to receive a graft is included here.
4.5 trade name replaced by generic name
4.6 text clarified
4.8 trade name replaced with generic name. Frequency of post marketing adverse reactions deleted.
5.1 5.2 trade replaced with generic name
6.1 headings included
6.3 text clarified
6.5 addl information on type of glass is deleted
6.6 additional precaution inspecting reconstituted samples and statement on disposal included
Updated on 26/06/2003 and displayed until 13/11/2008
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Basiliximab