Summary of Product Characteristics
last updated on the eMC:
20/12/2011
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 20/12/2011 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 4.4 - 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: 21-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The following sections which have been highlighed have been added to the SmPC:
4.2 Posology and method of administration
Kenalog is for Intra-articular/Intramuscular injection ONLY. . The safety and efficacy of administration by other routes has yet to be established(See sections 4.3 and 4.4).Strict aseptic precautions should be observed. Since the duration of effect is variable, subsequent doses should be given when symptoms recur and not at set intervals.
4.4 Special warnings and precautions for use
Warnings
Adequate studies to demonstrate the safety of Kenalog use by intra-turbinal, subconjunctival, sub-tenons, retrobulbar and intraocular (intravitreal) injections have not been performed. Endophthalmitis, eye inflammation, increased intraocular pressure and visual disturbances including vision loss have been reported with intravitreal administration. Several instances of blindness have been reported following injection of corticosteroid suspensions into the nasal turbinates and intralesional injection about the head.
Cases of serious anaphylactic reactions and anaphylactic shock, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration
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Updated on 28/01/2010 and displayed until 20/12/2011
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5 - removal of 1ml and 2ml pre-filled syringes.
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Updated on 18/12/2009 and displayed until 28/01/2010
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5 - Delete 1ml and 2ml syringes (2ml syringe discontinued 15th July 2009 and 1ml syringe discontinued 1s November 2009).
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Updated on 12/08/2008 and displayed until 18/12/2009
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 17-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 and 4.8: Update of product information to include early psychiatric effects associated with corticosteroids.
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Updated on 01/05/2007 and displayed until 12/08/2008
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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 4.4 - 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: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 Addition of intraocular use as a contra-indication.
Section 4.4 Addition of a further warning regarding the use of Kenalo around the eye area:
Adequate studies to demonstrate the safety of Kenalog use by intra-turbinal, subconjunctival, sub-tenons, retrobulbar and intraocular (intravitreal) injections have not been performed. Endophthalmitis, eye inflammation, increased intraocular pressure and visual disturbances including vision loss have been reported with intravitreal administration. Several instances of blindness have been reported following injection of corticosteroid suspensions into the nasal turbinates and intralesional injection about the head.
Also addition of warning regarding benzyl alcohol content:
This product contains 15mg/ml benzyl alcohol and must not be given to premature babies or neonates. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
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Updated on 30/11/2006 and displayed until 01/05/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 08/07/2005 and displayed until 30/11/2006
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 12/12/2002 and displayed until 08/07/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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