Octagam 10%
Last Updated on eMC 12-Apr-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 12-Apr-2016 and displayed until Current
Reasons for adding or updating:
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 21-Mar-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
$0Section 4.1: New indication – CIDPUpdated on 29-Jan-2016 and displayed until 12-Apr-2016
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
- 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: 30-Oct-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
$0Section 2: Now referring to 50ml + sizecontainers as bottlesUpdated on 12-Feb-2015 and displayed until 29-Jan-2016
Reasons for adding or updating:
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 10-Dec-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
$0Section 6.4: Changed stability of Roomtemperature storage to 9 monthsUpdated on 14-Jul-2014 and displayed until 12-Feb-2015
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC: 02-Jan-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Additional vial size added.Updated on 19-May-2014 and displayed until 14-Jul-2014
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- 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 10 - Date of revision of the text
Date of revision of text on the SPC: 02-Jan-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
All changes are due to either:
A: adoption of EU core SPC template for normal immunolgobulins
B: Addition of new 6g in 60mL vial size.
Section 2:
Max IgA Content stated in micrograms/mL, rather than mg/mL
“One vial” now reads “Each Vial”
New 6g in 60mL presentation listed
Statement added: “Produces from plasma of human donors
Section 4.1:
Addition of “in adults, children and adolescents (0-18 years old)”
Change of indications to match EU core SPC template
Section 4.2
Dosage and physician assessment updated
New statement for paediatric population included
Method of administration now included the statement “for intravenous use”
Section 4.3:
No changes
Section 4.4
Potential causes for increased incidence of ADR list amended
Avoidance of ADR measures listed
Separate section on Hypersensitivity created
Warning added to reduce risk of TEEs during administration
Sections regarding Aseptic meningitis syndrome and haemolytic anaemia added
Expanded section on interference with serological testing made. (moved from section 4.5)
Specific statement about paediatric population added
Section 4.5
Specific statement regarding paediatric population added
Section 4.6
Statement clarifying passage of antibodies across placenta added
Separate sections on breast feeding and fertility added.
Section 4.7
Warnings updated in case of patients suffering ADRs.
Section 4.8
Warning for Aseptic meningitis added
Warning surrounding increased creatinine and ARF added
Side effects now tabulated and MedDRA coded
Clarification of rate of incidences for common, uncommon etc.
Specific section added for paediatric population
New reporting of ADRs section added
Section 4.9
Overdose warning now includes warning for patients with cardiac impairment
Section 5.1
Specific section for paediatric population added
Section 5.2
Specific section for paediatric population added
Section 6.2
Statement clarified for “in absence of stability studies”
Section 6.5
New 6g in 60mL presentation added
Information now tabulated
Section 9
New date of renewal of authorisation
Section
Updated date of revision of text
Updated on 06-Mar-2013 and displayed until 19-May-2014
Reasons for adding or updating:
- Removal of black triangle
Date of revision of text on the SPC: 25-Feb-2010
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Removal of Black Triangle.Updated on 17-Aug-2011 and displayed until 06-Mar-2013
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
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