Adcortyl Intra-articular / Intradermal Injection 10mg/ml Suspension for Injection, 1ml

  • Name:

    Adcortyl Intra-articular / Intradermal Injection 10mg/ml Suspension for Injection, 1ml

  • Company:
    info
  • Active Ingredients:

    Triamcinolone Acetonide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/08/18

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 7/8/2018

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Bristol-Myers Squibb Pharmaceuticals uc

Bristol-Myers Squibb Pharmaceuticals uc

Company Products

Medicine NameActive Ingredients
Medicine Name Adcortyl Intra-articular / Intradermal Injection 10mg/ml Suspension for Injection, 1ml Active Ingredients Triamcinolone Acetonide
Medicine Name Adcortyl Intra-articular / Intradermal Injection 10mg/ml Suspension for Injection, 5ml Active Ingredients Triamcinolone Acetonide
Medicine Name Azactam 1g and 2g Powder for Solution for Injection or Infusion Active Ingredients Aztreonam
Medicine Name Hydrea 500 mg Hard Capsules Active Ingredients Hydroxycarbamide
1 - 0 of 4 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 7 August 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 August 2018 SmPC

Reasons for updating

  • New SmPC for medicines.ie

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

Updated on 7 August 2018 SmPC

Reasons for updating

  • Previous version of SmPC reinstated

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

Updated on 6 December 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 6 December 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Change of name and address of MAH (Previous details: BMS Pharmaceuticals Ltd Swords Dublin).

Updated on 6 December 2017 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change of name and address of MAH (Previous details: BMS Pharmaceuticals Ltd Swords Dublin).

Updated on 6 April 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • 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

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

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 6 April 2017 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • 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

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 1 April 2016 SmPC

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects) added the frequency of the ADRs and updated IMB to HPRA

Updated on 1 April 2016 PIL

Reasons for 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

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 June 2014 SmPC

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

PRAC recommendation - update to include 'post menopausal women'.

Updated on 20 June 2014 PIL

Reasons for 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

Free text change information supplied by the pharmaceutical company

PRAC recommendation - update to include 'post menopausal women'.

Updated on 7 February 2014 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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

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 2011 February 2013

 

Updated on 7 February 2014 PIL

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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 2011 February 2013

 

Updated on 12 July 2012 PIL

Reasons for updating

  • Improved electronic presentation

Free text change information supplied by the pharmaceutical company

Improve electronic presentation

Updated on 12 July 2012 SmPC

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Improve electronic presentation

Updated on 2 October 2011 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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 2 October 2011 PIL

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

None provided