Summary of Product Characteristics
last updated on the eMC:
21/10/2010
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 21/10/2010 and displayed until Current
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 01-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 28/07/2009 and displayed until 21/10/2010
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Reasons for adding or updating:
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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| Date of revision of text on the SPC: 01-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.7 has been re-written
TRANSTEC® has major influence on the ability to drive and use machines.
Even when used according to instructions, TRANSTEC® may affect the patient’s reactions to such an extent that road safety and the ability to operate machinery may be impaired.
This applies particularly at the beginning of treatment, at any change of dosage and when TRANSTEC® is used in conjunction with other centrally acting substances including alcohol, tranquillisers, sedatives and hypnotics.
Patients who are affected (e.g. feeling dizzy or drowsy or experience blurred or double vision) should not drive or use machines while using TRANSTEC® and for at least 24 hours after the patch has been removed.
Patients stabilized on a specific dosage will not necessarily be restricted if the above mentioned symptoms are not present.
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Updated on 21/06/2007 and displayed until 28/07/2009
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Reasons for adding or updating:
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New SPC for new product
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Change to section 4.2 - Posology and method of administration
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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: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 - opioid conversion table removed and dose titration recommendations added.
Section 5.1 updated relative potency of buprenorphine updated as per literature refs.
Section 10 date of revision updated to May 2007.
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Updated on 05/06/2006 and displayed until 21/06/2007
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.2 - Posology and Method of Administration
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 01/09/05 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections 2 and 4.2 updated as variation approved so that the patch can be worn longer, for up to 96 hours.
Section 6.5 patches now supplied in packs of 4 not 5.
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Updated on 14/09/2005 and displayed until 05/06/2006
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Reasons for adding or updating:
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Addition of Legal Category
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Updated on 13/07/2005 and displayed until 14/09/2005
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Removal of Black Triangle
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Updated on 12/12/2002 and displayed until 13/07/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 30/09/2002 and displayed until 12/12/2002
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Reasons for adding or updating:
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Change to section 1 - trade name
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Correction of spelling/typing errors
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Updated on 10/05/2002 and displayed until 30/09/2002
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Reasons for adding or updating:
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Addition of Black Triangle
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Updated on 07/05/2002 and displayed until 10/05/2002
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Reasons for adding or updating:
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