Summary of Product Characteristics
last updated on the eMC:
11/06/2009
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 11/06/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 19-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Warning relating to cross-sensitivity strengthened as below:
High rates of cross-sensitivity (greater than 50%) between neuromuscular blocking agents have been reported. Therefore, where possible, before administering suxamethonium, hypersensitivity to other neuromuscular blocking agents should be excluded. Suxamethonium, should only be used when absolutely essential in susceptible patients. Patients who experience a hypersensitivity reaction under general anaesthesia should be tested subsequently for hypersensitivity to other neuromuscular blockers.
Section 4.7 - Effects on Ability to Drive and Use Machines amended as below:
This precaution is not relevant to the use of suxamethonium injection. Suxamethonium will always be used in combination with a general anaesthetic and therefore the usual precautions relating to performance of tasks following general anaesthesia apply.
Section 10 - Date of (Partial) Revision of Text:
19 January 2009
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Updated on 22/09/2008 and displayed until 11/06/2009
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 08-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3 - The last paragraph of this section has been updated to read:
"Anectine should
not be usedavoided 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."
Section 4.4 - The fifth paragraph from the end of this section has been updated to read:
"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 (see section 4.3 Contraindications and section 4.8 Adverse Reactions)."
Section 4.8 - The first paragraph has been updated to read:
"Adverse reactions are listed below by system organ class
and frequency. Estimated frequencies were determined from published data. Frequencies are defined as follows: very common (=1/10); common (=1/100 and <1/10), uncommon (=1/1,000 and <1/100); rare (=1/10,000 and <1/1,000); very rare (<1/10,000)."
also, Musculoskeletal and connective tissue disorders and General disorders have been updated as follows:
"Musculoskeletal and connective tissue disorders
Very common Muscle fasciculation, post-operative muscle pains (Please refer to section 4.4 Special Warnings and Precautions for Use).
Common Myoglobinaemia
#, myoglobinuria#.
Rare Trismus
# Rhabdomyolysis has also been reported (see section 4.3 Contraindications and section 4.4 Special Warnings and Precautions for Use)
General disorders and administration site conditions
Very rare Malignant hHyperthermia (Please refer to section 4.4 Special Warnings and Precautions for Use)."
Section 10 - Change date to:
"
8 September 2008".
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Updated on 25/03/2008 and displayed until 22/09/2008
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 12/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4: Update on information on cross-sensitivity, BAN to rINN change. Muscle pain paragraph moved from section 4.8
Section 4.5: BAN to rINN change
Section 4.8: Updated to include transient blood potassium increase. Muscle pain paragraph moved to section 4.4
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Updated on 22/04/2003 and displayed until 25/03/2008
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Change to section 7 - Marketing Authorisation Holder
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Updated on 01/11/2002 and displayed until 22/04/2003
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Improved Electronic Presentation
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Updated on 30/09/2002 and displayed until 01/11/2002
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Improved Electronic Presentation
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Updated on 26/09/2002 and displayed until 30/09/2002
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 25/02/2002 and displayed until 26/09/2002
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Change to section 4.8 - Undesirable Effects
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Updated on 02/08/2001 and displayed until 25/02/2002
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Transferred from eMC version 1
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Updated on 15/02/2000 and displayed until 02/08/2001
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Updated on 06/09/1999 and displayed until 15/02/2000
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