Last Updated on eMC 11-12-2017 View medicine  | E. R. Squibb & Sons Limited Contact details

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.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-12-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change to section 4.4 and 4.5

Section 4.4

....

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. During post marketing use, there have been reports of clinically significant drug interactions in patients receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Therefore, co-administration of triamcinolone acetonide and ritonavir is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.5).

 

Section 4.5

...

CYP 3A4 inhibitors: Triamcinolone acetonide is a substrate of CYP3A4. Co-administration with strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with triamcinolone is not recommended because increased systemic corticosteroid adverse effects may occur (see section 4.8). If the potential benefit of co-administration outweighs the increased risk of systemic corticosteroid side-effects, patients should be monitored for these effects. During post marketing use, there have been reports of clinically significant drug interactions in patients receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression (see section 4.4).

Section 7: Change to MAH (Bristol-Myers Squibb Pharmaceuticals Limited)

Section 8: New License Number

Section 10: Update revision date

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:03-11-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Safety changes to section 4.4 the following text was added:
During post marketing use, there have been reports of clinically significant drug interactions in patients receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Therefore, caution is advised in co-administration of triamcinolone acetonide and ritonavir (see section 4.5).

the below text was replaced
Ketoconazole: Corticosteroid clearance may be decreased, resulting in increased effects.
CYP 3A4 inhibitors: Triamcinolone acetonide is a substrate of CYP3A4. Caution is advised in co-administration with strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with triamcinolone because increased systemic corticosteroid adverse effects may occur (see section 4.8). During post marketing use, there have been reports of clinically significant drug interactions in patients receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression (see section 4.4).

Major changes was carried out to section 4.8 this includes re-structuring he ADR using QRD template; moving Epilepsy from incorrect SOC Psychiatric disorder, to SOC Nervous system disorder; Deleted Psychotic disorder which was repeated twice under SOC Psychiatric disorders and finally correcting the SmPC wording back to the PRAC recommendation published on the 24th Jan 2014 regarding Triamcinolone Acetonide Injection and the occurrence of post-menopausal haemorrhage.

All other changes was in line with the QRD template

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:15-06-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Submission date: 11  July 2014                              

Approval date: 15 June 2015

Type of change: 
updating Section 4.8 of the SmPC with the calculation of frequencies for the ‘adverse drug reactions’, following PRAC recommendations for medicinal products containing triamcinolone.

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 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:26-03-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update in line with PRAC recommendations to include information on the 'risk of postmenopausal haemorrhage'.

Reasons for adding or updating:

  • Correction of spelling/typing errors
  • Improved Electronic Presentation

Date of revision of text on the SPC:21-11-2011

Legal Category:POM

Black Triangle (CHM): NO

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:21-11-2011

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

 

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:17-07-2008

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.

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:01-04-2007

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.
 
 
 

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

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

Reasons for adding or updating:

  • Transferred from eMC version 1