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Marcain 0.25% with Adrenaline (5 micrograms per ml) 1:200,000

*
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):

    Adrenaline TartrateBupivacaine Hydrochloride

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

Updated on 26 August 2022

File name

Bupi,Epin_Inj_IE_S_0.25%+5mcg-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

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

Updated on 26 August 2022

File name

Bupi,Epin_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 section 6 - what the product contains

Updated on 03 August 2022

File name

Bupi,Epin_Inj_IE_S_0.25%+5micrograms-ml_v2.pdf

Reasons for updating

  • Previous version of SPC reinstated

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

Updated on 03 August 2022

File name

Bupi,Epin_Inj_IE_P_Combined_v2.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 August 2022

File name

Bupi_Inj_IE_S_2.5mg-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 24 August 2021

File name

Bupi,Epin_Inj_IE_S_0.25+5micrograms-ml_v2.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 not be renewed (A)

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 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

 

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

PA 970/46/1

PA 1691/025/001

 

 

DATE OF REVISION OF THE TEXT

September 2017

26 Oct 2016

 

Updated on 08 November 2016

File name

PIL_8037_710.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 November 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties
  • 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



Section 4.2: update in relation to Epidural use of Marcaine adrenaline in adults and editorial update to dosage recommendation for children table.

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

Section 5.2: updated to describe the effect of adrenaline on the absorption of bupivacaine in epidural block

Section 10: updated date of revision

Updated on 08 November 2016

Reasons for updating

  • Improved presentation of PIL

Updated on 15 June 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • 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

Editorial changes to reflect Latest QRD for the following sections:

2

4.1

4.2

4.3

4.4

4.5

4.6

4.8

4.9

5.1

5.2

6.3

6.6

 

and Section 10 – change to 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 03 September 2013

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 29 August 2013

Reasons for updating

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

Updated on 29 April 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 04 November 2011

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to name of manufacturer

Updated on 12 June 2009

Reasons for updating

  • Change of trade or active ingredient name
  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to dosage and administration

Updated on 30 July 2007

Reasons for updating

  • Change to packaging
  • Change of manufacturer

Updated on 10 August 2006

Reasons for updating

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

Updated on 09 December 2005

Reasons for updating

  • Change of manufacturer
  • Change to storage instructions
  • Change to date of revision
  • Change from the BAN of the active substance to the rINN

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 09 August 2004

Reasons for updating

  • New PIL for medicines.ie