octanine
Last Updated on eMC 23-Feb-2016 View document | Octapharma 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.
Updated on 23-Feb-2016 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
Date of revision of text on the SPC: 14-Feb-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.2:$0Update statement regarding lack of Data in PUPs$0$0Updated recommendations for treatment monitoring.$0$0$0$0$0Section 4.4:$0$0Updated warning regarding cardiovascular risks added$0$0$0$0$0Section 10:$0$0Updated date of revision of text$0Updated on 22-Apr-2015 and displayed until 23-Feb-2016
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: 28-Nov-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
$0Section 4.2: New statement regardingcontinuous infusion addedUpdated on 20-May-2014 and displayed until 22-Apr-2015
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 6.5 - Nature and contents of container
- 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: 01-Oct-2010
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.2
Rewording of where to find information for reconstitution
Section 4.3
Direction for where to find list of excipients added
Section 6.5
Contents of pack changed from “double ended needle and filter needle” to “mix-2-vial”
Section 6.6
warning added to use immediately after reconsitiution
warning added to use injection set provided only
instructions for reconstitution and injecting updated to reflect new reconstitution device
Section 9
Updated date of renewal of text
Section 10
Updated date of revision of text
Updated on 14-Dec-2011 and displayed until 20-May-2014
Reasons for adding or updating:
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Legal Category:POM
Black Triangle (CHM): YES
Octapharma Limited
The Zenith Building, 26 Spring Gardens, Manchester, Lancashire, M2 1AB
+44 (0)161 837 3799
+44 (0)161 837 3770
0845 1300 522
+44 (0)161 837 3799
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?
Active ingredients
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