Anectine 50 mg/ml Solution for Injection or Infusion * Pharmacy Only: Prescription
Company:
AspenStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 11 September 2020
File name
Suxa_Inj_IE_P_50mg-ml_v4_1599830318.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 08 October 2019
File name
Suxa_Inj_IE_P_50mg-ml_v3_1570538084.pdf
Reasons for updating
- New PIL for new product
Updated on 08 October 2019
File name
Suxa_Inj_IE_S_50mg-ml_Aug2017_v1_1570537886.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 August 2017
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
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
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
Updated on 15 July 2015
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
Updated on 28 May 2015
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
Updated on 28 May 2015
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
Updated on 09 May 2014
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 09 May 2014
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 05 January 2010
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 05 January 2010
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
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 13 March 2009
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 29 May 2007
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
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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.
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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).
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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
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 09 March 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 March 2007
Reasons for updating
- Improved electronic presentation
Updated on 12 May 2005
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
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
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
Reasons for updating
- New SPC for medicines.ie