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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. …… 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
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
(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
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.
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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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.