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AstraZeneca UK Limited
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
Telephone: +44 (0)1582 836 000
Fax: +44 (0)1582 838 000
Medical Information Direct Line: +44 (0)1582 836 836
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +44 (0)1582 837 837
Medical Information Fax: +44 (0)1582 838 003

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?
Summary of Product Characteristics last updated on the eMC: 06/09/2010
SPC Marcain Polyamp Steripack 0.25% and 0.5%

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 06/09/2010 and displayed until Current
Reasons for adding or 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 10 date of revision of the text
Date of revision of text on the SPC:   06-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2

Additional footnote to table

6) There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics. Marcain is not approved for this indication (see also section 4.4).

 

Section 4.4

Additional text concerning chondrolysis in patients receiving post operative intra-articular continuous infusion of local anaesthetics

·       There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics. The majority of reported cases of chondrolysis have involved the shoulder joint. Due to multiple contributing factors and inconsistency in the scientific literature regarding mechanism of action, causality has not been established. Intra-articular continuous infusion is not an approved indication for Marcain.

 

Section 10

New revision date of text: 6 August 2010
Updated on 25/11/2009 and displayed until 06/09/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - addition of text "See section 6.1 for list of excipients.

Section 4.2 - information regarding dosage and recommendations

Section 4.4 - include information on intra-articular injection into areas of recent trauma and bring in line with current medical knowledge.

Section 4.5 - examples of anti-arrhythmics.
"lidocaine and mexiletine"

Section 4.8 - updated to include frequency descriptors

Section 4.9  - information moved to section 4.8. Includes reference to sections 4.8.1 and 4.8.2

Section 5.1 & 5.2 - updated information throughout sections.

Section 6.1 - includes the pH adjustment to 4.0-6.5 for sodium hydroxide

Section 6.4 - additional text "Do not freeze"

Section 6.5 - revised text, deleting "steripack"

Section 10 - Revision date of text: 10 November 2009
Updated on 24/06/2005 and displayed until 25/11/2009
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
Updated on 04/05/2005 and displayed until 24/06/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 04/05/2005 and displayed until 04/05/2005
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
Updated on 04/05/2005 and displayed until 04/05/2005
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
Updated on 17/06/2002 and displayed until 04/05/2005
Reasons for adding or updating:
  • Change to joint SPC covering all presentations
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  bupivacaine hydrochloride