Anectine 50 mg/ml Solution for Injection or Infusion *

Pharmacy Only: Prescription

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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

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

Section 7 - change to Ireland MAH address

Section 7 - change to Ireland MAH address

Sec 4.8 - IMB to HPRA name change to reporting.

Sec 4.8 - IMB to HPRA name change to reporting.

Section 5.1 - ATC code

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

Administrative amendments to all other sections

Section 5.1 - ATC code

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

Administrative amendments to all other sections

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each 2ml ampoule contains 100mg Suxamethonium Chloride Injection

 

For a full list of excipients, see Section 6.1

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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.

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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

 

1^st April 1979/1^st April 2009

 

 

10.     DATE OF (PARTIAL) REVISION OF THE TEXT

         

 

December 2009

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

 

1^st April 1979/1^st April 2009

 

 

10.     DATE OF (PARTIAL) REVISION OF THE TEXT

         

 

December 2009

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.

 

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.

 

                       

            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

 

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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.

 

           

 

                       

            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.