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E. R. Squibb & Sons Limited
Uxbridge Business Park , Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
Telephone: +44 (0)1895 523 000
Fax: +44 (0)1895 523 010
Medical Information Direct Line: +44 (0)1895 523 740
Medical Information e-mail: Medical.information@bms.com
Medical Information Fax: +44 (0)1895 523 677

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 20/12/2011
SPC Adcortyl Intra-Articular/Intradermal Injection 10mg/ml

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
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
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


The sections highlighted have been incorporated into the SmPC


Section 4.2


Adcortyl is for intra-articular or intra-dermal injection ONLY.   The safety and efficacy of administration by other routes has yet to be established (see sections 4.3 and 4.4).  

4.4       Special warnings and precautions for use

Adequate studies to demonstrate the safety of Adcortyl 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


 

4.8       Undesirable effects

Hypersensitivity: Anaphylactoid reaction, anaphylaxis including anaphylactic reactions and anaphylactic shock

 
Updated on 12/08/2008 and displayed until 20/12/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
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
Section 4.4 and 4.8:  Update of product information to include early psychiatric effects associated with corticosteroids.
Updated on 01/05/2007 and displayed until 12/08/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
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
Section 4.3 Addition of intra-ocular injection as a contra-indication.
 
Section 4.4 Addition of further warning regarding the use of Adcortyl around the eye area:
Adequate studies to demonstrate the safety of Adcortyl 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.
 
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.
 
 
 
Updated on 08/07/2005 and displayed until 01/05/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 20/11/2002 and displayed until 08/07/2005
Reasons for adding or updating:
  • 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 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 14/08/2001 and displayed until 20/11/2002
Reasons for adding or updating:
  • Transferred from eMC version 1

Active Ingredients/Generics

 
  triamcinolone acetonide