Summary of Product Characteristics
last updated on the eMC:
02/12/2011
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 02/12/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.9 - Overdose
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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: 28-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- Section 4.2 - Dosage in children added. The product should be used by physicians trained in endotracheal intubation with artificial respiration equipment available. Dosage should be adjusted according to individual clinical response.
- Section 4.3 - Hypersensitivity to excipients added.
- Section 4.4 - Use with caution in patients with underlying cortico-adrenal insufficiency such as patients with sepsis. Prolonged suppression of endogenous cortisol and aldosterone may occur. Myoclonus and pain on injection, including venous pain, may occur so administer small dose of suitable opioids, e.g. fentanyl, 1 to 2 minutes before induction.
- Section 4.5 - Hypnotic effect may be enhanced by neuroleptic drugs, opioids, sedatives and alcohol. Slight and transient reduction in peripheral resistance may enhance the effect of other drugs reducing blood pressure. Alfentanil has been reported to decrease the terminal half-life of etomidate. Co-administration with ketamine appears to have no significant effect.
- Section 4.6 - Apgar scores of newborns whose mothers have received etomidate are comparable to those of infants born after the use of other hypnotic agents. A transient fall in cortisol levels lasting about 6 hours was observed in the neonate after the mother was given Hypnomidate.
- Section 4.7 - Major influence on the ability to drive and use machines. Not recommended to use potentially dangerous machinery or to drive a car during the first 24 hours after administration. Post-anaesthesiology treatment team to advise.
- Section 4.9 - Overdosage may depress cortical secretion. Adequate respiratory support is mandatory.
- Section 10 - 28 November 2011
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Updated on 19/10/2010 and displayed until 02/12/2011
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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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: 13-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.3 - reduction to 3 years.
Change to section 6.4 - Do not store above 25°C.
Change to section 10 - 13 October 2010.
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Updated on 11/03/2010 and displayed until 19/10/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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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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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 03-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.4- Special warnings and precautions for use
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Addition of warning regarding potential drop in blood pressure and info re measures that should be taken.
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Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
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Addition of info regarding co-administration with fentanyl.
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Change to section 5.1
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Addition of statement regarding reversible adrenal suppression.
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Change to section 10 – Date of revision of the text
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02 March 2010
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Change to section 4.8 – Undesirable effects
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Addition of single table of Adverse Drug Reactions.
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Updated on 20/03/2009 and displayed until 11/03/2010
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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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: 17-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 5.1 Pharmacodynamic Properties
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Addition of ATC code ‘N01AX07’
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Change to section 10 Date of Revision of the Text
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Amended to ‘17 March 2009’
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Updated on 23/12/2008 and displayed until 20/03/2009
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 30-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 3 – pharmaceutical form
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Amend to “Solution for injection”.
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Change to section 4.4 – Special Warnings and Precautions for Use
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Correction of typographical error.
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Change to section 6.5 – Nature and Contents of Container
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Addition of 10 ampoule pack details (non-marketed)
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Change to section 9 – Date of Renewal of Authorisation
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Correction of date of last renewal to 20 March 2004
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Updated on 04/11/2008 and displayed until 23/12/2008
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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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: 30-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 5.2 - Pharmacokinetic properties
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Update section 5.2 in line with current guidance.
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Change to section 10 – Date of revision of the text
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30th October 2008
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Updated on 17/09/2008 and displayed until 04/11/2008
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Reasons for adding or updating:
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Change to MA holder contact details
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| Date of revision of text on the SPC: 11-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to MA holder contact details
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Change of address from Saunderton to Holmers Farm Way
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Updated on 28/02/2006 and displayed until 17/09/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/01/2004 and displayed until 28/02/2006
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Updated on 07/06/2002 and displayed until 22/01/2004
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 05/06/2002 and displayed until 07/06/2002
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 22/08/2001 and displayed until 05/06/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 22/08/2001
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Reasons for adding or updating:
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