Last Updated on eMC 03-08-2017 View medicine  | Aspen Contact details

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.

Reasons for adding or 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

Date of revision of text on the SPC:01-08-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text

 

 

7.         MARKETING AUTHORISATION HOLDER

 

Aspen Pharma Trading Limited, 3016 Lake Drive, City West Business Campus, Dublin 24, Ireland

Service-Tel: 0800 008 7392 (+ 44 1748 828 391)

 

 

The Wellcome Foundation Ltd

980 Great West Road,

Brentford,

Middlesex,

TW8 9GS,

United Kingdom

 

trading as:

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex UB11 1BT

 

 

 

8.         MARKETING AUTHORISATION NUMBER(S)

 

PL 39699/0098

00003/5203R

 

 

 

10.       DATE OF REVISION OF THE TEXT

 

01 August 2017  12/01/2016

 

 

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
  • Correction of spelling/typing errors
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:12-01-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SPC changes:
- Update Section 4.2 of SmPC to include information relating to dosage of Anectine in renal impairment, hepatic impairment and in patients with reduced plasma cholinesterase

-
Update section 4.2 of SmPC to include recommendation to monitor neuromuscular function during infusion & cross refer to Section 4.4

-
Update section 4.4 of the SmPC to revise the statement about mixing suxamethonium with other agents

-
Correction to Section 4.8 The footnote symbol "†" under Respiratory, thoracic and mediastinal disorders should also appear after "apnoea".

- U
undershould also appear after "apnoea".- U
pdate the product information to QRD v9.

 

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:22-07-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 1 – QRD update to include strength in product name

Section 2 – QRD update

Section 3 – formatting and change in declaration of pharmaceutical form

Section 4.2 – Instructions to open ampoule moved from this section to 6.6

Section 4.4 – Warning added about effect on consciousness, cross references to other SPC sections made in bullet point listings

Section 4.5 – formatting updates, addition of SSRI

Section 4.6 – QRD update to heading

Section 4.8 – Addition of footnote, reporting details added

Section 5.1 – ATC code added

Section 6.2 – instruction not to mix with other drugs before administration added

Section 6.4 – update to storage statement

Section 6.6 – Instructions to open ampoule now included in this section

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:06-11-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 7 - Change in address of marketing authorisation holder

Section 10 - Updated with new date of revision of text

Reasons for adding or 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
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:19-01-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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

 

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC:08-09-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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".

 

Reasons for adding or updating:

  • 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 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-12-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to section 6. 4 - Special Precautions for Storage

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied