Marcain Polyamp Steripack 0.25%

  • Name:

    Marcain Polyamp Steripack 0.25%

  • Company:
    info
  • Active Ingredients:

    Bupivacaine hydrochloride anhydrous

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/09/17

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 21/9/2017
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Aspen

Aspen

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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 21 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 September 2017 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

6.6     Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

 

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(s)

PA 1691/024/001

PA 970/45/1

 

Date of revision of the text

September 2017

21 Oct 2016

 

Updated on 20 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 September 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 4 November 2016 SmPC

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 10 - Date of revision of the text
  • Change from joint to individual SPCs

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: editorial update to dosage recommendation for children table.

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

Section 10: updated date of revision

Change from joint to individual SmPCs

Updated on 11 June 2015 SmPC

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 8 June 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 3 September 2013 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Section 4.1 – Clarification of the age groups in which the different strengths are indicated

Section 4.2 – Addition of instructions for use in Paediatric patients (1 to 12 years of age). Addition of Field block and Peripheral Nerve Block posology for paediatrics.

Section 4.4 – Amendment to section title in line with QRD. Addition of warnings and precautions for paediatric use.

Section 4.6 – Amendment to section title in line with QRD.

Section 4.8 – Addition of statement that adverse drug reactions are similar in paediatric population to adult population. Addition of reporting of suspected adverse reactions statement.

Section 5.2 – Addition of statement that in children the pharmacokinetics is similar to that in adults.

Section 6.6 – Amendment of section title in line with QRD.

Section 10 – Update to "Date of Revision"

Updated on 29 August 2013 PIL

Reasons for updating

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

Updated on 29 April 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.2: Footnote 7 has been added to the "Duration of effect hours" column, to clarify that the duration of effect is based on Marcain without adrenaline. Footnote 4 has been applied to Thoracic Epidural Administration Continuous infusion.

Section 4.8: Treatment of acute toxicity has been updated to include lipid emulsion as a treatment option in cases of cardiovascular depression. The paragraph regarding cardiovascular depression has also been moved slightly.

Section 10: Update to "Date of Revision"

Updated on 4 November 2011 PIL

Reasons for updating

  • Change to storage instructions
  • Change to further information section
  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 16 November 2010 SmPC

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 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
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 April 2010 SmPC

Reasons for 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

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 22 April 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change due to user-testing of patient information

Updated on 25 July 2006 PIL

Reasons for updating

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

Updated on 21 June 2006 SmPC

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 4.9 - Overdose
  • 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

  • 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 24 October 2005 PIL

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 14 September 2005 SmPC

Reasons for 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

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

Updated on 9 August 2004 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 28 July 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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