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AstraZeneca Pharmaceuticals (Ireland) Ltd
College Park House, 20 Nassau Street, Dublin 2,
Telephone: +353 1 609 7100
Fax: +353 1 679 6650
Medical Information Direct Line: 1800 800 899 Freephone
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +353(0)1 609 7100 Supply & non-medical enquiries
Medical Information Facsimile: +44 (0)1582 838 003
Summary of Product Characteristics last updated on medicines.ie: 16/11/2010
SPC Marcain Polyamp Steripack 0.25% & 0.5%

When a pharmaceutical company changes an SPC or PIL, 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 16/11/2010 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:   28-Jul-2010
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
Dose change in first table under ‘Major Nerve Block’
Additional footnote number 6.

Section 4.4
Additional bullet point of text:
• 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
Revision date of text: 28th July 2010
Updated on 22/04/2010 and displayed until 16/11/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   19-Feb-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 2

Additional text end of section

Both products also contain sodium chloride 8 mg/ml equivalent to sodium 3.2 mg/ml (0.14 mmol).


Section 6.1

Additional text:

Sodium hydroxide/hydrochloric acid (for pH-adjustment)


Section 6.2

Change of text:

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

 

Section 6.3

Additional text:

Unopened: 2 years.

Once opened: for single use, discard any unused solution immediately.

 
Section 9 – Date of Renewal from: 19th September 2008
Section 10 - Revision date of text: 19th February 2010
Updated on 21/06/2006 and displayed until 22/04/2010
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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.2

  • The dosing table has been replaced by separate adult and paediatric dosing tables.
  • Guidance on paediatric dosing has been added.

 

Section 4.4

  • A list of patient populations requiring special attention to reduce the risk of serious side effects has been added.
  • A list of certain local anaesthetic procedures associated with serious adverse reactions, regardless of the local anaesthetic drug used has been added.
  • A warning for bupivacaine administered as an intra-articular injection has been added.

 

Section 4.8

This section has been divided into

4.8.1 – General

4.8.2 – Acute systemic toxicity

4.8.3 – Treatment of acute toxicity

Text has been moved from section 4.9 to this section.

  • A paragraph stating that ‘adverse reactions caused by the drug per se are difficult to distinguish from the physiological effects of the nerve block’ has been added.
  • A table of adverse reaction frequencies has been added.
  • A paragraph on systemic toxic reactions involving the central nervous system and cardiovascular system has been added.
  • A sentence on detecting early signs of local anaesthetic toxicity in children has been added.
  • Paragraphs stating actions to be taken should circulatory arrest or cardiovascular depression occur have been added.

Section 4.9

Text from this section has been moved to sections 4.8.1 – 4.8.3.

·        A paragraph comparing the results of accidental intravascular injection versus overdose has been added.
Updated on 14/09/2005 and displayed until 21/06/2006
Reasons for adding or updating:
  • 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 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 09/08/2004 and displayed until 14/09/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 23/06/2003 and displayed until 09/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Bupivacaine Hydrochloride