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Anectine 50 mg/ml Solution for Injection or Infusion

  • Name:

    Anectine 50 mg/ml Solution for Injection or Infusion

  • Company:
    info
  • Active Ingredients:

    Suxamethonium Chloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/10/19

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Summary of Product Characteristics last updated on medicines.ie: 8/10/2019

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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 8 October 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 October 2019 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 10 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 August 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 16 August 2017 SmPC

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

 

7.         MARKETING AUTHORISATION HOLDER

           

GlaxoSmithKline (Ireland) Limited

12 Riverwalk,

Citywest Business Campus,

Dublin 24

Aspen Pharma Trading Limited,

3016 Lake Drive,

Citywest Business Campus,

Dublin 24,

Ireland

 

 

8.         MARKETING AUTHORISATION NUMBER

 

PA 1077/52/1 PA 1691/033/001

 

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

 

            01 July 2015August 2017

Updated on 16 August 2017 PIL

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

Free text change information supplied by the pharmaceutical company

Text in red = new text
Text strikethrough = deleted text

 

7.         MARKETING AUTHORISATION HOLDER

           

GlaxoSmithKline (Ireland) Limited

12 Riverwalk,

Citywest Business Campus,

Dublin 24

Aspen Pharma Trading Limited,

3016 Lake Drive,

Citywest Business Campus,

Dublin 24,

Ireland

 

 

8.         MARKETING AUTHORISATION NUMBER

 

PA 1077/52/1 PA 1691/033/001

 

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

 

            01 July 2015August 2017

Updated on 15 July 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 7 - change to Ireland MAH address

Updated on 15 July 2015 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 7 - change to Ireland MAH address

Updated on 28 May 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Sec 4.8 - IMB to HPRA name change to reporting.

Updated on 28 May 2015 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Sec 4.8 - IMB to HPRA name change to reporting.

Updated on 9 May 2014 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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

Free text change information supplied by the pharmaceutical company

Section 5.1 - ATC code

Section 4.5 - Adding Selective serotonin reuptake inhibitors to the interaction section

Administrative amendments to all other sections

Updated on 9 May 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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)

Free text change information supplied by the pharmaceutical company

Section 5.1 - ATC code

Section 4.5 - Adding Selective serotonin reuptake inhibitors to the interaction section

Administrative amendments to all other sections

Updated on 5 January 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 6.2 - Incompatibilities

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

Free text change information supplied by the pharmaceutical company

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each 2ml ampoule contains 100mg Suxamethonium Chloride Injection

 

For a full list of excipients, see Section 6.1

……

 

6.2     Incompatibilities

 

Anectine injection should not be mixed with any other drug prior to its administration, except those mentioned in section 6.6.

 

Anectine injection is acidic and should not be mixed with highly alkaline solutions, e.g. barbiturates.

……

 

6.6         Special Precautions for disposal of a used medicinal product or waste material derived from medicinal products and other handling of the product

          (Previously was ‘Instructions for Use and Handling’)

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

1st April 1979/1st April 2009

 

 

10.     DATE OF (PARTIAL) REVISION OF THE TEXT

         

 

December 2009

Updated on 5 January 2010 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 6.2 - Incompatibilities

Free text change information supplied by the pharmaceutical company

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each 2ml ampoule contains 100mg Suxamethonium Chloride Injection

 

For a full list of excipients, see Section 6.1

……

 

6.2     Incompatibilities

 

Anectine injection should not be mixed with any other drug prior to its administration, except those mentioned in section 6.6.

 

Anectine injection is acidic and should not be mixed with highly alkaline solutions, e.g. barbiturates.

……

 

6.6         Special Precautions for disposal of a used medicinal product or waste material derived from medicinal products and other handling of the product

          (Previously was ‘Instructions for Use and Handling’)

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

1st April 1979/1st April 2009

 

 

10.     DATE OF (PARTIAL) REVISION OF THE TEXT

         

 

December 2009

Updated on 13 March 2009 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines

Free text change information supplied by the pharmaceutical company

New text highlighted in red

 

4.4       Special Warnings and Precautions for Use

 

 

Caution should be exercised when administering suxamethonium to patients who have shown hypersensitivity to other neuromuscular blocking agents since a high rate of cross-sensitivity (greater than 50%) between neuromuscular blocking agents has been reported.

 

 

4.7       Effects on ability to Drive and Use Machines

 

This precaution is not relevant to the use of Anectine. Suxamethonium will always be used in combination with a general anaesthietic and therefore, the usual precautions relating to performance of tasks following general anaesthesia apply.

 

Updated on 13 March 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines

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

Free text change information supplied by the pharmaceutical company

New text highlighted in red

 

4.4       Special Warnings and Precautions for Use

 

 

Caution should be exercised when administering suxamethonium to patients who have shown hypersensitivity to other neuromuscular blocking agents since a high rate of cross-sensitivity (greater than 50%) between neuromuscular blocking agents has been reported.

 

 

4.7       Effects on ability to Drive and Use Machines

 

This precaution is not relevant to the use of Anectine. Suxamethonium will always be used in combination with a general anaesthietic and therefore, the usual precautions relating to performance of tasks following general anaesthesia apply.

 

Updated on 29 May 2007 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

                       

            4.3       Contra-indications

 

……………………………………………………………..

…………………………………………………………….

 

Suxamethonium should not be used avoided in patients with skeletal muscle myopathies e.g. Duchenne muscular dystrophy since its administration may be associated with rigidity, malignant hyperthermia, ventricular dysrhythmias and cardiac arrest secondary to acute rhabdomyolysis with hyperkalaemia. myoglobinaemia, cardiac arrest, and post-operative respiratory depression.

 

………………………………………………………………

………………………………………………………………

 

 

 

            4.4       Special Warnings and Precautions for Use

 

Caution should be exercised when using suxamethonium in children since paediatric patients are more likely to have an undiagnosed myopathy or an unknown predisposition to malignant hyperthermia and rhabdomyolysis which places them at increased risk of serious adverse events following suxamethonium administration (see 4.3 Contra-indications and 4.8 Undesirable Effects).

 

…………………………………………………………………….

……………………………………………………………………

 

           

 

            4.8       Undesirable Effects

 

……………………………………………………………………

 

Musculoskeletal and connective tissue disorders

Very common   Muscle fasciculation, post-operative muscle pains (see Warnings and Precautions).

Common                       Myoglobinaemia#, myoglobinuria#.

 

#Rhabdomyolysis has also been reported (see  Contra-indications and  Special Warnings & Precautions for use)

 

Rare                            Trismus

 

General disorders and administration site conditions

Very rare                      Malignant hyperthermia (see Warnings and Precautions).

 

Investigations

Common                       Transient blood potassium increase.

 

           

 

Updated on 29 May 2007 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

                       

            4.3       Contra-indications

 

……………………………………………………………..

…………………………………………………………….

 

Suxamethonium should not be used avoided in patients with skeletal muscle myopathies e.g. Duchenne muscular dystrophy since its administration may be associated with rigidity, malignant hyperthermia, ventricular dysrhythmias and cardiac arrest secondary to acute rhabdomyolysis with hyperkalaemia. myoglobinaemia, cardiac arrest, and post-operative respiratory depression.

 

………………………………………………………………

………………………………………………………………

 

 

 

            4.4       Special Warnings and Precautions for Use

 

Caution should be exercised when using suxamethonium in children since paediatric patients are more likely to have an undiagnosed myopathy or an unknown predisposition to malignant hyperthermia and rhabdomyolysis which places them at increased risk of serious adverse events following suxamethonium administration (see 4.3 Contra-indications and 4.8 Undesirable Effects).

 

…………………………………………………………………….

……………………………………………………………………

 

           

 

            4.8       Undesirable Effects

 

……………………………………………………………………

 

Musculoskeletal and connective tissue disorders

Very common   Muscle fasciculation, post-operative muscle pains (see Warnings and Precautions).

Common                       Myoglobinaemia#, myoglobinuria#.

 

#Rhabdomyolysis has also been reported (see  Contra-indications and  Special Warnings & Precautions for use)

 

Rare                            Trismus

 

General disorders and administration site conditions

Very rare                      Malignant hyperthermia (see Warnings and Precautions).

 

Investigations

Common                       Transient blood potassium increase.

 

           

 

Updated on 9 March 2007 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 9 March 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 12 May 2005 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage

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

Updated on 12 May 2005 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage

Updated on 19 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 19 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie