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Bristol-Myers Squibb Pharmaceutical Limited
Watery Lane, Swords, Co. Dublin,
Telephone: 1 800 749 749
Medical Information Direct Line: Freephone: 1 800 749 749
Medical Information e-mail: Medical.information@bms.com
Summary of Product Characteristics last updated on medicines.ie: 06/04/2017
SPC Adcortyl Intra-articular / Intradermal Injection 10mg/ml Suspension for Injection, 5ml

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 06/04/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   04-Apr-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Note that the changes to section 4.4 and 4.5 are in line with PRAC recommendation Nov 2016.
Updated on 01/04/2016 and displayed until 06/04/2017
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07-Jan-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects) added the frequency of the ADRs and updated IMB to HPRA
Updated on 20/06/2014 and displayed until 01/04/2016
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   17-Jun-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
PRAC recommendation - update to include 'post menopausal women'.
Updated on 07/02/2014 and displayed until 20/06/2014
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Feb-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
6.4 Special precautions for storage
Do not store above 25°C.
Do not freeze. Do not freeze or refrigerate. Protect from light.

10. DATE OF (PARTIAL) REVISION OF THE TEXT
August 2011February 2013
Updated on 12/07/2012 and displayed until 07/02/2014
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Improve electronic presentation
Updated on 29/09/2011 and displayed until 12/07/2012
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
None provided

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Active Ingredients

 
  Triamcinolone Acetonide