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Marcain Polyamp Steripack 0.5%

*
Pharmacy Only: Prescription

  • Company:

    Aspen

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Bupivacaine Hydrochloride Anhydrous

    *Additional information is available within the SPC or upon request to the company

Updated on 25 September 2023

File name

Bupi_Inj_IE_P_Combined_v4.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 25 September 2023

File name

Bupi_Inj_IE_P_Combined_v4.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 April 2023

File name

Bupi_Inj_IE_S_5mg-ml_v4.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 03 August 2022

File name

Bupi_Inj_IE_S_5mg-ml_v3.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 not be renewed (A)

Updated on 03 August 2022

File name

Bupi_Inj_IE_P_Combined_v3.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to date of revision

Updated on 04 November 2021

File name

Bupi_Inj_IE_S_5mg-ml_v2.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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

Updated on 04 November 2021

File name

Bupi_Inj_IE_P_Combined_v2.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 21 September 2017

Reasons for updating

  • New SPC for new product

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

Updated on 21 September 2017

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Text in red = new text
Text strikethrough = deleted text

 

 

6.6     Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Marketing Authorisation holder

Aspen Pharma Trading Limited,

3016 Lake Drive,

Citywest Business Campus,

Dublin 24,

Ireland.

 

AstraZeneca UK Ltd.,

600 Capability Green,

Luton,

 

Marketing authorisation number(s)

PA 1691/024/002

PA 970/45/2

 

Date of revision of the text

September 2017

21 Oct 2016

 

 

 

Updated on 20 September 2017

File name

PIL_7701_857.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 September 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 08 November 2016

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

Joint SmPC changed to individual SmPCs, changes for this strength from joint SmPC are as follows:

 

Section 4.2: editorial update to dosage recommendation for children table.

Section 4.4: updated with information in relation to hypotension and bradycardia.

Section 10: updated date of revision

Updated on 08 June 2015

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 29 August 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 04 November 2011

Reasons for updating

  • Change to storage instructions
  • Change to further information section
  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 22 April 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change due to user-testing of patient information

Updated on 25 July 2006

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to date of revision

Updated on 24 October 2005

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to information about pregnancy or lactation
  • Change to dosage and administration

Updated on 28 July 2004

Reasons for updating

  • New PIL for medicines.ie