Summary of Product Characteristics
last updated on the eMC:
05/10/2011
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 05/10/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 10 date of revision of the text
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 21-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| 4.4 Special warnings and precautions for use
The virus safety statements have been revised. Measures taken are now considered effective for specified non-enveloped viruses (see Virus safety below, added text shown in bold). The information in italics below has been deleted.
The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.
Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
The relevant paragraph of Section 4.4 now read as follows (new information shown in bold).
Virus safety
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped viruses HAV and parvovirus B19.
10. Date of revision of the text
21 September 2011
|
|
Updated on 04/08/2008 and displayed until 05/10/2011
|
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 6. 5 - Nature and Contents of Container
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 10 date of revision of the text
-
Change to section 1 -Name of the Medicinal product
|
| Date of revision of text on the SPC: 17-Jan-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 1: Unit/ml included
Section 2: Unit/ml and sodium content included
Section 4.4: The following was added:
Mononine 1000 contains up to 20.3 mg sodium per 1000 IU. To be taken into consideration by patients on a controlled sodium diet.
and viral safety statement has been re-worded.
Section 4.8: Side effects have been categorised into body systems and frequency of side effects explained.
Section 6.4 and 6.5: Sentences reworded and reformatted
Section 6.6: The following was added:
Any unused product or waste material should be disposed of in accordance with local requirements.
Section 9 and 10: Date of renewal and text revised have been updated
|
|
Updated on 06/04/2005 and displayed until 04/08/2008
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 9 - Date of Renewal of Authorisation
-
Change to section 10 (date of (partial) revision of the text
-
SPC Product / presentation discontinued
|
|
Updated on 11/05/2004 and displayed until 06/04/2005
|
Reasons for adding or updating:
|
-
Addition of separate SPCs covering individual presentations
|
|
