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

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 24 August 2021

File name

Bupi,Epin_Inj_IE_S_0.25+5micrograms-ml_v2_1629821312.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 24 August 2021

File name

Bupi,Epin_Inj_IE_P_Combined_v2_1629820974.pdf

Reasons for updating

  • New PIL for medicines.ie
  • New individual PIL (was previously included in a combined PIL)
  • Change to Section 1 - what the product is
  • Change to section 4 - possible side effects
  • Change to how the medicine works

Updated on 08 April 2019

File name

Bupi,Epin_Inj_IE_P_Combined_Sep2017_v1_1554715664.pdf

Reasons for updating

  • Change of licence holder

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