When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Section 6.1 List of Excipients. The following excipient has been added:
all-rac-α-tocopherol
Section 10. Date of (Partial) Revision of the Text: Update to:
July 2011
The following sentence has been added to this section: 'Systemic chemotherapy is required if bacterial infection persists'. Section 4.8: Under the sub-heading of 'Immune System reactions', 'allergic reaction', is now listed as a frequency of 'Unknown', it previously came under the heading of 'very rare'. Under the subheading of 'Skin and subcutaneous tissue disorders', 'rash' is now listed under the frequency of 'Frequency Unknown', it previously came under the heading of 'Very rare'. Allergic contact dermatitis and skin depigmentation are also listed as an undesirable effect resulting from the use of corticosteroids. Section 6.5: The following sentence has been added: 'Not all pack sizes may be marketed'.
Section 1 Trade Name of the Medicinal Product: The quantities of the actives are now listed in this section as mg/g.
Section 2 Qualitative and Quantitative Composition - The quantities of the excipients are now stated in this section.
Section 5.1 Pharmacodynamic Properties - The pharmacotherapeutic group is now listed
Section 6.1 List of Excipients - Glycerol is now listed as glycerol 85%, Hydrochloric acid is now listed as an excipient for pH adjustment Section 6.5 Nature and contents of container - Editorial only - not all pack sizes may be marketed