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: 31-May-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4: General formatting updates

Section 4.8: Updates to side effect profile based on new company core safety information.

Reasons for adding or updating:

• Change to section 6.3 - Shelf life
• Change to section 6.5 - Nature and contents of container
• Change to section 10 - Date of revision of the text
• Improved presentation of SPC

Date of revision of text on the SPC: 17-Jun-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

General Changes to wording to clarify that octaplasLG comes in four blood groups and should be used as group specific.$0$0$0$0Wording changes to improve readability.$0$0$0$0$0Statement added to clarify that no solid or gelatinous particles should be present following thawing.$0$0$0$0$0Prion removal step now in a separate statement rather than grouped with virus removal.$0$0$0$0$0Definition of ADR frequencies have been added as per QRD template requirements.$0$0$0$0$0Shelf life once thawed has now been updated to include in use shelf life.$0$0$0$0$0$0$0

Reasons for adding or updating:

• Change to section 6.6 - Special precautions for disposal and other handling
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 16-Mar-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.6: Updated Thawing instructions

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 4.6 - Fertility, pregnancy and lactation
• Change to section 4.7 - Effects on ability to drive and use machines
• Change to section 4.8 - Undesirable effects - how to report a side effect
• 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: 01-Nov-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2: Statement added that Octaplas is ABO Blood Group specific

Section 4.2: Paediatric usage statement has been added

Section 4.6: statement of unknown effect on reproduction capacity added

Section 4.7: Updated ability to drive statement added.

Section 4.8: New AE reporting statement added

Section 6.5: Statement added that Octaplas LG is supplied in blood group specific bags

Section 9: Updated data of licence renewal

Section 10: Updated date of revision of text.

Reasons for adding or updating:

• Change to section 6.3 - Shelf life
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 24-Jul-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The shelf-life of octaplasLG® is 4 years when stored at ≤ -18ºC and protected from light.

After thawing octaplasLG® can be stored for up to 24 hours at +2-8ºC, or 8 hours at room temperature (+20-25ºC), before use.
Once the bag has been opened, the product must be used immediately.

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): NO