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Bupivacaine Hydrochloride 0.125%w/v Solution for Infusion

Last Updated on eMC 13-Nov-2014 View document  | Concordia International - formerly AMCo Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 13-Nov-2014 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 27-Feb-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.8.1 and 4.8.2 are updated in the SPC

Updated on 02-Sep-2014 and displayed until 13-Nov-2014

Reasons for adding or updating:

  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 27-Feb-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section:- 4.1 Therapeutic indications
Section:- 4.2 Posology and method of administration
Section:- 4.3 Contraindications
Section:- 4.4 Special warnings and precautions for use
Section:- 4.8 Undesirable effects
Section:- 10. Date of revision of the text

Updated on 05-Dec-2012 and displayed until 02-Sep-2014

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC: 30-Sep-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 of Marketing Authorisation Holder was changed from Antigen International Ltd. to Mercury Pharma International Ltd.

Updated on 19-Sep-2012 and displayed until 05-Dec-2012

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product

Date of revision of text on the SPC: 25-May-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To change section 1 of the SPC that is the name of the medicinal product in order to comply with the new QRD Template.

Updated on 20-Apr-2012 and displayed until 19-Sep-2012

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC: 31-Mar-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section4.4: Warnings about use in the folliwing patients has been added:
-The elderly and patients in poor general condition.
- Patients with partial or complete heart block., patients in later stages of Pregnancy.

Warning about the use of certain local anaesthetic procedures may be associated with serious adverse reactions, regardless of the local anaesthetic drug used, especially relateed to the procedure has been added.

Updated on 18-Jan-2011 and displayed until 20-Apr-2012

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 12-Jan-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8: Horner’s syndrome has been included.

Updated on 12-Nov-2010 and displayed until 18-Jan-2011

Reasons for adding or updating:

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

Date of revision of text on the SPC: 21-Oct-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:


A warning on cardiac arrest and resuscitation has been added in section 4.4.

Updated on 13-Jul-2009 and displayed until 12-Nov-2010

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Concordia International - formerly AMCo

Company image
Address

Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK

Fax

+44 (0)208 588 9200

Medical Information e-mail
Medical Information Fax

+44 (0)20 8588 9200

Telephone

+44 (0)208 588 9131

Medical Information Direct Line

08700 70 30 33

Customer Care direct line

+44 (0)208 588 9273

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

bupivacaine hydrochloride anhydrous

Legal categories

POM - Prescription Only Medicine

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