Summary of Product Characteristics
last updated on the eMC:
04/01/2011
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 04/01/2011 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 4.4 - 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 revision of the text
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| Date of revision of text on the SPC: 21-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - Updated with additional information regarding use of remifentanil for total intravenous anaesthesia (TIVA) in infants.
Section 4.4 - Updated with a cross-referral to sections 4.2.1.3 and 5.1 regarding use in neonates and infants
Section 5.1 - Updated with information regarding use in infants/neonates (aged less than 1 year) following analysis of clinical trial data.
Section 10 - Date
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Updated on 12/04/2010 and displayed until 04/01/2011
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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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 25-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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General tidy up of sections 4.2 – 4.9 and as a result section 6.6 has been updated to provide for infusion guidance for a 20 mcg/ml solution.
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Updated on 13/10/2009 and displayed until 12/04/2010
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 17-Sep-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 5.3 - Added the following to section 5.3 of SmPC:
"...Remifentanil, like other opioid agonists, produced increases in action potential duration (APD) in dog isolated Purkinje fibres. For remifentanil, the effects were seen at concentrations of 1M or higher (which are higher than plasma concentrations seen in clinical practice). There were no effects at a concentration of 0.1M.
The major metabolite remifentanil acid had no effect on APD up to the maximum tested concentration of 10M.
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Updated on 06/05/2009 and displayed until 13/10/2009
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 27-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 - Anaesthesia in spontaneously breathing anaesthetised patients with a secured airway (e.g. laryngeal mask anaesthesia): In spontaneously breathing anaesthetised patients with a secured airway respiratory depression is likely to occur. Special care is needed to adjust the dose to the patient requirements and ventilatory support may be required. The recommended starting infusion rate for supplemental analgesia in spontaneously breathing anaesthetised patients is 0.04 microgram/kg/min with titration to effect. A range of infusion rates from 0.025 to 0.1 microgram/kg/min has been studied. Bolus injections are not recommended in spontaneously breathing anaesthetised patients.
Section 4.4 - Special warnings and precautions for use
Change to wording re discontinuation of treatment as below:
Discontinuation of Treatment
Common post-operative events associated with the emergence from general anaesthesia, such as shivering, agitation, tachycardia, hypertension, may occur earlier following discontinuation of Ultiva.Symptoms including tachycardia, hypertension and agitation have been reported infrequently upon abrupt cessation, particularly after prolonged administration of Ultiva. Where reported, re-introduction and tapering of the infusion has been beneficial.
Section 10 - 27/04/09
27/4/2009
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Updated on 14/06/2005 and displayed until 06/05/2009
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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 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 05/08/2004 and displayed until 14/06/2005
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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